Professional Documents
Culture Documents
Santoro
Andrzej P. Wieczorek
Abdul H. Sultan
Editors
123
Pelvic Floor Disorders
Giulio A. Santoro • Andrzej P. Wieczorek
Abdul H. Sultan
Editors
Second Edition
Editors
Giulio A. Santoro Andrzej P. Wieczorek
Tertiary Referral Pelvic Floor and Incontinence Department of Pediatric Radiology
Center, IV°Division of General Surgery Medical University of Lublin
Regional Hospital, Treviso Children’s University Hospital
University of Padua Lublin
Padua Poland
Italy
Abdul H. Sultan
Urogynaecology and Pelvic Floor
Reconstruction Unit
Croydon University Hospital
St George’s University of London
London
UK
This Springer imprint is published by the registered company Springer Nature Switzerland AG
The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
This book is dedicated to all the patients, some of whom have suffered whilst
allowing us to learn and improve our skills
Learn from yesterday, live for today, hope for tomorrow.
Education is not the learning of facts, but the training of the mind to think
Albert Einstein
Foreword
David Castro Diaz
General Secretary of the International Continence Society
Functional Urology Unit
University Hospital of Canary Islands
Tenerife, Spain
ix
Preface
The pelvic floor is one of the most complex anatomical and functional areas of the human body
and to this day has remained an enigma. Although it is still empirically divided in anterior,
middle, and posterior compartments, the pelvic floor components act in unison to maintain
bowel, bladder, and sexual function. Pelvic floor disorders represent a significant physical,
social, and economic problem that often poses a challenge to specialists dealing with them.
The reason for this is that the functional mechanisms are so complex and poorly understood
that patient’s symptoms do not always correspond to physical examination findings, because
various co-existing occult conditions are often underestimated. In order to achieve the optimal
treatment, it is mandatory to overcome the fractured uni-disciplinary approach to the pelvic
floor with multidisciplinary teams of experts (colorectal surgeons, urologists, urogynecolo-
gists, gastroenterologists, radiologists, physiatrists) having a unitary vision.
In 2010 we published the book Pelvic Floor Disorders: Imaging and Multidisciplinary
Approach to Management. Since then there have been more than 180,000 downloads of the
online version of the chapters, confirming the huge interest and demand in this field. Major
developments in diagnostics and treatments of pelvic floor disorders over the last few years led
us to work on a new edition: Pelvic Floor Disorders: A Multidisciplinary Textbook. The result
is not simply an update of the previous book, but to a considerable extent providing a compre-
hensive overview of pelvic floor anatomy and physiology, principles and technical aspects of
imaging modalities, mechanisms of pelvic floor trauma during vaginal delivery, epidemiology,
etiology, assessment and management of urinary incontinence and voiding dysfunction, anal
incontinence, pelvic organ prolapse, constipation and obstructed defecation, pelvic pain and
sexual dysfunctions, perineal and perianal fistula, and management of failures or recurrences
after surgery.
This textbook was also produced to meet the needs of education. It is a manual of practical
instructions that we hope could be of great value to both medical students and specialists in the
field. In particular, the various ultrasonographic techniques for the imaging of the pelvic floor
(transperineal, endovaginal, endoanal, endorectal, 2D/3D/4D) are presented in a systematic
way. Hundreds of images and anatomical illustrations have been included to help the reader to
learn how to visualize and interpret ultrasound images but also provide more experienced
examiners with an opportunity to review and re-appraise their techniques. Standardization of
the methodology is fundamental to increase accuracy, reliability, and repeatability, leading to
a wider acceptance of these modalities in the daily practice. Surgical procedures described in
every detail in the text are accomplished by videos on the e-book version. In the Appendix
Section, the algorithms for the treatment of pelvic floor disorders, according to the 6th
International Consultation on Incontinence, summarize step-by-step the approach to these dif-
ferent pathological conditions. These algorithms should be considered for adoption into rou-
tine clinical practice to standardize management in accordance with the best available
evidence-based medicine. This would enable consistent management with a view to reducing
unnecessary surgeries, thereby minimizing the risk of failure, as well as faster and more effec-
tive treatment of postoperative complications.
Our sincere gratitude goes to Springer for supporting the idea of publishing the new edition
as a textbook and, in particular, to Subramaniam Vinodhini, Hemalatha Gunasekaran, Donatella
xi
xii Preface
Rizza and Elisa Geranio for their constant assistance throughout the development of the proj-
ect, organizing every stage of the editorial work. Our deep appreciation to all international
authors who have contributed to many chapters, sharing their knowledge and expertise. Without
their invaluable help, this book would not have been possible. Further, thanks must go to our
hospitals and institutions (Prof. Giacomo Zanus, Chief of IV°Division of General Surgery,
Regional Hospital Treviso, Dr. Francesco Benazzi, CEO of AULSS 2 Marca Trevigiana, Italy;
Medical University of Lublin, Children’s Teaching Hospital, Department of Pediatric
Radiology, Lublin, Poland; Department of Obstetrics and UroGynaecology, Croydon
University Hospital, Croydon, Surrey, UK) whose advanced technological support made it
possible to accomplish this new project.
We hope that this textbook would be a necessary companion to all clinicians involved in the
care of our patients suffering from pelvic floor disorders.
xiii
xiv Contents
Part XI Miscellaneous
xix
xx Contributors
Mauro Cervigni Female Pelvic Medicine and Reconstructive Surgery Center, “La Sapienza”
University, ICOT-Polo Pontino, Latina, Italy
Christopher R. Chapple Department of Urology, Sheffield Teaching Hospitals NHS
Foundation, Trust, Sheffield, UK
Michał Chlebiej Faculty of Mathematics and Computer Science, Nicolaus Copernicus
University in Toruń, Toruń, Poland
Alexander Clark Imaging Department, University Hospitals of North Midlands NHS Trust,
Keele University, Stoke-on-Trent, UK
Eduardo Cortes Kingston Hospital, London, UK
Andrè D’Hoore Department of Abdominal Surgery, University Hospitals Gasthuisberg
Leuven, Leuven, Belgium
G. Willy Davila Department of Gynecology, Section in Female Pelvic Medicine Reconstructive
Surgery, Cleveland Clinic Florida, Weston, FL, USA
Dorothy Mangurian Comprehensive Women’s Center, Holy Cross Medical Group, Fort
Lauderdale, FL, USA
Sarah De Bastiani IRCCS San Raffaele Scientific Institute, Milan, Italy
John O. L. DeLancey Norman F. Miller Professor of Gynecology, Female Pelvic Medicine
and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Michigan
Medical School, Ann Arbor, MI, USA
Fabio Del Deo IRCCS San Raffaele Scientific Institute, Milan, Italy
Jan Deprest Pelvic Floor Unit, University Hospitals Leuven, Leuven, Belgium
Paolo Di Benedetto Department of Rehabilitation Medicine, Institute of Physical Medicine
and Rehabilitation, University of Udine, Udine, Italy
Hans Peter Dietz Sydney Medical School-Nepean, University of Sydney, Sydney, NSW,
Australia
Peter L. Dwyer Department of Urogynaecology, Mercy Hospital for Women, Melbourne,
VIC, Australia
Tim W. Eglinton Division of Colorectal Surgery, Department of Academic Surgery,
University of Otago, Christchurch, New Zealand
Sohier Elneil Division of Pain Medicine, University College London Hospitals, London, UK
Anton Emmanuel Gastrointestinal Physiology Unit, University College Hospital, London,
UK
Montserrat Espuña-Pons Pelvic Floor Unit, Institut Clínic de Ginecologia, Obstetrícia i
Neonatologia (ICGON), Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona,
Spain
Luanne Force Department of Colorectal Surgery, Digestive Disease Center, Cleveland Clinic
Florida, Weston, FL, USA
Frank A. Frizelle Division of Colorectal Surgery, Department of Academic Surgery,
University of Otago, Christchurch, New Zealand
Mahmoud Abu Gazala Department of Colorectal Surgery, Digestive Disease Center,
Cleveland Clinic Florida, Weston, FL, USA
Julia Geynisman-Tan Department of Obstetrics and Gynecology, Female Pelvic Medicine
and Reconstructive Surgery, Northwestern University Feinberg School of Medicine, Chicago,
IL, USA
Contributors xxi
ANTERIOR
LATERAL
MIDDLE
POSTERIOR
Fig. 1.1 Room analogy. © Shobeiri 2013 Fig. 1.3 Room analogy with anterior, middle, and posterior compart-
ments and the lateral walls marked. © Shobeiri 2013
Pubic Bone
Pubocervical Fascia
Rectovaginal Fascia
hiatus as the door out of the pelvis (Fig. 1.1). Using this very
simplified analogy, if one views the pelvic floor hiatus from derstanding of the anatomy. The pubocervical fibromuscu-
the S1 location on the sacrum, the door frame for this room laris and the rectovaginal fibromuscularis are attached
is the perineal membrane, the walls and the floor the levator laterally to the levator ani muscle with thickening of adven-
ani muscle, and the ceiling the pubic bone. Pelvic floor con- titia in this area. Anatomically, the endopelvic fascia refers to
tains three viscus hollows (Fig. 1.2). We arbitrarily call these the areolar connective tissue that surrounds the vagina. It
anterior and posterior compartments with lateral and apical continues down the length of the vagina as loose areolar tis-
support segments (Fig. 1.3). The tissue separating the ante- sue surrounding the pelvic viscera. Histologic examination
rior compartment and vagina is pubocervical fibromuscularis has shown that the vagina is made up of three layers—epi-
or pubocervical fascia or fibromuscularis. The tissue thelium, muscularis, and adventitia [8, 9]. The adventitial
separating the vaginal canal from the posterior compartment layer is loose areolar connective tissue made up of collagen
has been called several names: the rectovaginal fibromuscu- and elastin, forming the vaginal tube. Therefore, the tissue
laris or rectovaginal fascia or septum (Fig. 1.4). Some have that surgeons call fascia at the time of surgery is best
even argued that this tissue doesn’t exist which may be due described as fibromuscularis, since it is a mixture of muscu-
to its complex anatomy. The term “fascia” is often used by laris and adventitia.
surgeons to refer to the strong tissue that they sew together Anteriorly, pubocervical fibromuscularis is attached to
during anterior repairs. This has led to confusion and misun- the levator ani using arcus tendineus fascia pelvis (Fig. 1.5).
1 Pelvic Floor Anatomy 5
Bladder outlet
Vaginal canal
Anal canal
Fig. 1.5 Retropubic anatomy showing points of attachments of the Fig. 1.7 Room analogy: three compartments separation. © Shobeiri 2013
arcus tendineus levator ani (ATLA) and the arcus tendineus fascia pel-
vis (ATFP). The urethra (U) sits on the hammock like pubocervical
fibromuscularis. # denotes the levator ani attachment to the obturator
internus muscle Pubic symphysis (PS). © Shobeiri 2013
Perineal Membrane
Arcus Tendineus
Posterior Arcus
Fig. 1.6 Room analogy: the line of attachment of the pubocervical fas-
cia to the levator ani is arcus tendineus fascia pelvis. The line of attach- If one looks at the vaginal canal from the side, he or she
ment of the rectovaginal fascia to the levator ani is the posterior arcus. can appreciate different levels of support as described by
Both are shown as red lines. © Shobeiri 2013 DeLancey and colleagues [11] (Fig. 1.10). Looking at these
supportive structures from the sagittal view exposes the con-
Posterior attachment of rectovaginal fibromuscularis to the nective tissue elements that keep the room standing.
levator ani is poorly understood, but we will refer to it as the Generally, a “suspension bridge” analogy is useful for
posterior arcus (Fig. 1.6) [10]. The anterior compartment is describing these structures (Fig. 1.11). Although in the room
home to the urethra and the lower part of the bladder. The analogy, the anterior and posterior compartments house the
vaginal canal is in the middle, and the posterior compartment pelvic organs, in reality, the pelvic organs are part of the
is home to anorectum (Fig. 1.7). This analogy is not far from whole pelvic biomechanical system and play an important
reality. When one looks at the pelvic floor structures, the supportive role through their connections with structures,
anterior and posterior compartments are clearly separated as such as the cardinal and uterosacral ligaments. Adapting this
described (Fig. 1.8). Compartmentalization of the pelvic suspension bridge to the human body and the perineal body
floor has led to different medical specialties looking at that and the sacrum become the two anchoring points of the
specific compartment and paying less attention to the whole bridge. The perineal membrane (Level III) and the uterosac-
pelvic floor (Fig. 1.9). ral ligaments (Level I) form the two masts of the suspension
6 S. A. Shobeiri and J. O. L. DeLancey
Post-Arcus USL
Sacrum
PV
Fig. 1.10 Room analogy: Level I supports are provided by the
uterosacral-cardinal ligament complex (yellow arrows), which keep the PA
“room” upright. Level II supports are provided by the lateral tendineus
attachments (red lines). The support is provided by perineal membrane
(green area). © Shobeiri 2013
bridge (Fig. 1.12). The lateral wires are the levator ani mus- LP
cles of the lateral wall (Fig. 1.13), and the attachments of the
vagina to the levator ani muscles laterally in the mid part of
the vagina form Level II support. The levator ani muscles Fig. 1.13 Suspension bridge analogy; the depiction of a suspension
and the interconnecting fibromuscular structures support the bridge adapted to human female pelvic floor structures. The levator ani
bladder and urethra anteriorly, the vaginal canal in the mid- fibers have intricate and overlapping paths. The puboanalis (PA) and
puboperinealis form some of the supportive structures of the perineum.
dle, and the anorectal structures posteriorly (Fig. 1.14). The puborectalis (PR) fibers form the sling behind the rectum.
Like a room or a suspension bridge, the pelvic floor is Pubovisceralis (PV) is a collective term we have applied here to the
subjected to loads that should be appropriate for its design. iliococcygeus and pubococcygeus fibers. The levator plate (LP) is
formed by overlapping of the PV and PR fibers. © Shobeiri 2013
1 Pelvic Floor Anatomy 7
Bladder IS
Vagina
Rectum
Sacrum
Anus
PB
a b
Fig. 1.16 (a) The relative position of levator ani subdivisions during pink = puboperinealis muscle (PP), orange = puboanalis muscle (PA).
ultrasound imaging. Iliococcygeus (IC), puboperinealis (PP), superfi- The labels are placed to orient the viewer to the relative position of the
cial transverse perinei (STP), puboanalis (PA). Illustration: John other structures in the pelvis. Copyright © Shobeiri 2009. (c) The left
Yanson. From Shobeiri et al. [25], with permission. (b) The levator ani lateral view of the left hemi-pelvis. Arcus tendineus levator ani (ATLA),
muscle is color coded: from left to right, light brown = coccygeus mus- bladder (B), external anal sphincter (EAS), iliococcygeus (IC), pubo-
cle (CG), brown = iliococcygeus muscle (IC), magenta = ATLA/ATFP, coccygeus (PC), puborectalis (PR), pubic symphysis (PS), urethra (U).
red = pubovisceralis muscle (PV), green = puborectalis muscle (PR), © Shobeiri 2013
1.2.3 Anterior Compartment tendineus from the levator ani is associated with stress
incontinence and anterior prolapse. The detachment can be
Anterior compartment support depends on the integrity of unilateral (Fig. 1.21) or bilateral (Fig. 1.22), causing a dis-
vaginal muscularis and adventitia and their connections to placement cystocele. In addition, the defect can be complete
the arcus tendineus fascia pelvis. The arcus tendineus fascia or incomplete. The surgeon who performs an anterior repair
pelvis is at one end connected to the lower sixth of the pubic (Fig. 1.22) in reality worsens the underlying disease pro-
bone, 1–2 cm lateral to the midline, and at the other end to cess. The upper portions of the anterior vaginal wall can
the ischial spine. A simple case of a distension cystocele prolapse due to lack of Level I support and failure of utero-
could result from a defect in pubocervical fibromuscularis sacral-cardinal complex. Over time this failure may lead to
(Fig. 1.20). increased load in the paravaginal area and failure of Level II
The anterior wall fascial attachments to the arcus tendin- paravaginal support. A study of 71 women with anterior
eus fascia pelvis have been called the paravaginal fascial compartment prolapse has shown that paravaginal defect
attachments by Richardson et al. [14]. Detachment of arcus usually results from a detachment of the arcus tendineus fas-
1 Pelvic Floor Anatomy 9
cia pelvis from the ischial spine, and rarely from the pubic as it will require bridging of the anterior compartment with
bone [15]. Resuspension of the vaginal apex at the time of autologous fascia lata graft [16]. The commercially avail-
surgery, in addition to paravaginal or anterior colporrhaphy, able biologic tissue has had high failure rates for the anterior
may help to return the anterior wall to a more normal posi- compartment and no improvement in the posterior
tion or at least to prevent future failures. Another scenario compartment.
that the surgeon faces is the lack of any tangible fibromus- Various grading systems such as Pelvic Organ Prolapse
cular tissue in the anterior compartment (Fig. 1.23). Plication Quantification (POPQ) system [17] used to describe pro-
of the available tissue may cause vaginal narrowing and lapse do not take into account the underlying cause of the
dyspareunia. The knowledge of this condition is essential, prolapse. Site of care pelvic floor imaging augments the
physical examination to delineate the pathophysiology of
pelvic organ prolapse.
Fig. 1.17 Right hemipelvis of a fresh frozen pelvis showing the over-
lapping of the levator ani subdivisions fibers. Orange arrows: puborec-
talis; blue arrows: iliococcygeus; white arrows: pubococcygeus. Note Fig. 1.19 Right hemipelvis of a fresh frozen pelvis showing the utero-
the relationship between the iliococcygeus and pubococcygeus fibers. sacral fibers. The borders of the ligament are shown in dotted line.
© Shobeiri 2013 Cervix (Cx), coccyx (C), pubic symphysis (PS). © Shobeiri 2013
a b
Fig. 1.18 (a) Right hemipelvis of a fresh frozen pelvis with the organs (PS). © Shobeiri 2013. (b) The same right hemipelvis of a fresh frozen
removed. The puborectalis (PR), iliococcygeus (IC), and pubococ- pelvis with the organs removed. The puboanalis and the puboperinealis
cygeus (PC) form the lateral sidewall. Note the relationship between the are outlined. These fibers are involved in the stabilization of the anus
iliococcygeus and pubococcygeus fibers. Coccyx (C), pubic symphysis and the perineum, respectively. © Shobeiri 2013
10 S. A. Shobeiri and J. O. L. DeLancey
1.2.4 P
erineal Membrane (Urogenital
Diaphragm)
a b
Fig. 1.24 Three levels of support. (a) Attachments of the cervix and vagina is attached to the arcus tendineus fasciae pelvis and the superior
vagina to the pelvic walls demonstrating different regions of support fascia of levator ani. (c) Close up of the lower margin of Level II after a
with the uterus in situ. Note that the uterine corpus and the bladder have wedge of vagina has been removed (inset). Note how the anterior vagi-
been removed. (b) Levels of vaginal support after hysterectomy. Level I nal wall, through its connections to the arcus tendineus fascia pelvis,
(suspension) and Level II (attachment). In level I the paracolpium sus- forms a supportive layer clinically referred to as the pubocervical fascia
pends the vagina from the lateral pelvic walls. Fibers of Level I extend (From DeLancey [11], with permission)
both vertically and also posteriorly toward the sacrum. In Level II the
level of the hymen and attaches the urethra, vagina, and peri- that can be unilateral (Fig. 1.26) or bilateral (Fig. 1.27). Such
neal body to the ischiopubic rami. defects need to be differentiated from total loss of rectovagi-
nal fibromuscularis that may require augmentation of the
compartment with autologous or cadaveric tissue. Most
1.2.5 P
osterior Compartment and Perineal often, the separation of the posterior arcus may be apical and
Membrane may require reattachment of the posterior arcus to the utero-
sacral ligament or the iliococcygeal muscle.
The posterior compartment is bound to perineal body and the The fibers of the perineal membrane connect through the
perineal membrane caudad (Level III), paracolpium and the perineal body, thereby providing a layer that resists down-
uterosacral ligaments cephalad (level I), and the posterior ward descent of the rectum. A separate Level I support does
arcus connected to the levator ani laterally (Level II). As in not exist for anterior and posterior compartments. In the
the anterior compartment, a simple defect in rectovaginal room analogy used here, the perineal membrane is analogous
fibromuscularis (Fig. 1.25) can cause a distention rectocele. to the door frame. If the bottom of the door frame is missing
A defect in the posterior arcus also called arcus tendineus (Fig. 1.28), then the resistance to downward descent is lost
rectovaginalis (ATRV) is associated with a pararectal defect and a perineocele develops. This situation can be elusive, as
12 S. A. Shobeiri and J. O. L. DeLancey
a a
b
b
a b
Normal
c d
Posterior
Prolapse
Downward
Displacement
“Kneeling”
Distal Perineal
Forward Widening Descent
Protrusion
Fig. 1.30 Characteristics of posterior prolapse. Comparison of control the upper two thirds part of the vagina, (3) forward protrusion, (4) peri-
(a, b) and case (c, d) in lateral view (a, c) and oblique view (b, d) show- neal descent, and (5) distal widening in the lower third part of the
ing five characteristic features (c, d) during rest (blue) and Valsalva vagina. Pubis and sacrum are shown in white. The P-IS line is shown in
(pink): (1) increased folding (kneeling), (2) downward displacement in turquoise. © DeLancey 2011
the puboperinealis fibers, which are medially located, can be separation does not exist between concentric portion of
palpated as a distinct band of fibers joining the perineal body EAS-M and the winged EAS-W. The EAS-W fibers have
(see Figs. 1.29b and 1.32). differing fiber directions than the other portions, forming
Per MRI studies done by Hsu and colleagues, the EAS an open “U-shaped” configuration that cannot be visual-
includes a subcutaneous portion (EAS-SQ) (see Fig. 1.32), ized in midsagittal view except in the posterior anus.
a visibly separate deeper portion (EAS-M), and a lateral These fibers are contiguous with the EAS but visibly sep-
portion that has lateral winged projections (EAS-W). The arate from the levator plate muscles, whose fibers they
EAS-SQ is the distinct part of the EAS (Fig. 1.33). A clear parallel [22].
1 Pelvic Floor Anatomy 15
a b
Fig. 1.31 (a) Perineal dissection in a fresh frozen pelvis shows the (STP) to the other puboanalis fibers that start inserting at the perineal
relationship of the external anal sphincter (EAS) to the perineal body level at Fig (a) and then wrap around the anal canal. The ischiocaverno-
(PB) and the puboanalis/puboperinealis complex (PA). Ischiorectal fat sus (ISC) and the bulbospongiosus muscle (BS) are depicted here.
(IRF), Vagina (V). © Shobeiri 2013. (b) Perineal dissection in a fresh Levator ani muscle (LAM). © Shobeiri 2013
frozen pelvis shows the relationship of the superficial transverse perinei
1.2.6 L
ateral Segment Comprising from one pelvic sidewall to the other; the pubococcygeus
of the Levator Ani Muscle Support muscle, which travels from the tip of the coccyx to the pubic
bone (see Fig. 1.17); the puborectalis muscle, originating
It is generally accepted that the levator ani muscles and the from the anterior portion of the perineal membrane and the
associated fascial layer surround pelvic organs like a funnel pubic bone to form a sling behind the rectum; and the pubo-
to form the pelvic diaphragm [23]. Given that we employ perinealis and puboanalis, which are thin broad fibromuscular
concepts such as pelvic floor spasm, levator spasm, and pel- poorly described structures that attach to the perineal body
vic floor weakness, understanding the basic concepts of pel- and anus to stabilize the perineal region.
vic floor musculature is essential to formulate a clinical Margulies and colleagues showed excellent reliability and
opinion. The area posterior to the pubic bone is dense with reproducibility in visualizing major portions of the levator
bands of intertwined levator ani muscles; this defies conven- ani with magnetic resonance imaging (MRI) in nulliparous
tional description of the levator ani as comprising the puborec- volunteers [25]. Because puboanalis, pubovaginalis, and
talis, pubococcygeus, and iliococcygeus. The anatomy of puboperinealis are small, they are proven hard to visualize
distal subdivisions of the levator ani muscle was further with conventional MRI. However, these muscles are easily
described in a study by Kearney et al. [24]. The origins and seen with three-dimensional (3D) endovaginal ultrasonogra-
insertions of these muscles as well as their characteristic ana- phy (EVUS) [26].
tomical relations are shown in Table 1.1 and Fig. 1.16. Using The shortest distance between the pubic symphysis and
a nomenclature based on the attachment points, the lesser the levator plate is the minimal levator hiatus. This is d ifferent
known subdivisions of the levator ani muscles, the muscles from the urogenital hiatus, which is bounded anteriorly by
posterior to the pubic bone are identified as pubovaginalis, the pubic bones, laterally by levator ani muscles, and poste-
puboanalis, and puboperinealis [21]. The pubovaginalis is riorly by the perineal body and EAS. The baseline tonic
poorly described but may be analogous to the urethrovaginal activity of the levator ani muscle keeps the minimal levator
ligaments. The puboanalis originates from behind the pubic hiatus closed by compressing the urethra, vagina, and rectum
bone as a thin band and inserts around the anus into the longi- against the pubic bone as they exit through this opening [27].
tudinal ligaments. The puboperinealis, which is most often The levator ani fibers converge behind the rectum to form the
0.5 cm in diameter, originates from the pubic bone and inserts levator plate. With contraction, the levator plate elevates to
into the perineal body. The four major components of the form a horizontal shelf over which pelvic organs rest. The
levator ani muscle are the iliococcygeus, which forms a thin, deficiency of any portion of the levator ani results in weaken-
relatively flat, horizontal shelf that spans the potential gap ing of the levator plate and descensus of pelvic organs [28].
16 S. A. Shobeiri and J. O. L. DeLancey
Vaginal anal
a b
PB
EAS-M
Perineal
Skin
c
Vagina Anal Canal EAS-SQ
IAS
STP
RVF EAS-W EAS-SQ
d IRF PR (C)Shobeiri
EAS-M
PA
IAS
Fig. 1.33 (a) Perineal dissection in a cadaveric specimen shows the verse perinei (STP). © Shobeiri 2013. (d) Histologic slide of the left
relationship of the subcutaneous external anal sphincter (EAS-SQ) to the coronal view of the anal canal showing the relationship of the anal
main portion of EAS, the winged portion of EAS, and the superficial sphincter subdivisions to the puboanalis fibers (PA lined with small
transverse perinei (STP). The internal anal sphincter is marked with the arrows pointing downward). The small arrows on the bottom line the
dotted line. Anal canal (A), main body of EAS (EAS-M), winged portion course of the longitudinal muscle fibers (LMF), which is an extension of
of EAS (EAS-W), rectum (R), rectovaginal fascia (RVF), urethra (U), the iliococcygeus fibers that become progressively fibrous until they
vagina (V). © Shobeiri 2013. (b) Histological slide showing relationship insert into the anal sphincter complex. The puboanalis and the puboperi-
of the subcutaneous external anal sphincter (EAS-SQ) to the main por- nealis muscle fibers stabilize the perineum, while the puborectalis (PR)
tion of EAS (EAS-M) and the internal anal sphincter (IAS). © Shobeiri closes the levator hiatus. External anal sphincter-subq (EAS-Q), external
2013. (c) Drawing of the mid left sagittal section as seen in Fig. 1.32a. anal sphincter-main portion (EAS-M), external anal sphincter-winged
Bulbospongiosus (BS), external anal sphincter (EAS), internal anal portion (EAS-W), internal anal sphincter (IAS), ischiorectal fat (IRF),
sphincter (IAS), rectovaginal fibromuscularis (RVF), superficial trans- vagina (V). © Shobeiri 2013
Table 1.1 Divisions of the levator ani muscles—international stan- pull of the pubococcygeal portions of the levator ani mus-
dardized terminology cle to swing the levator plate more horizontally to close
Origin/insertion the urogenital hiatus. From another point of view, the
Puboperinealis (PP) Pubis/perineal body levator plate is the point where the pubococcygeus, ilio-
Pubovaginalis (PV) Pubis/vaginal wall at the level of the coccygeus, and the puborectalis come together under the
mid-urethra rectum to create the anorectal angle (see Figs. 1.13, 1.17,
Puboanalis (PA) Pubis/intersphincteric groove between internal and 1.18). In e ndovaginal ultrasound the movement of the
and external anal sphincter to end in the anal skin
levator plate relative to the transducer can be measured as
Puborectalis (PR) Pubis/forms sling behind the rectum
Iliococcygeus (IC) Tendineus arch of the levator ani/the two sides levator plate descent angle (LPDA) [28]. LPA and LPDA
fuse in the iliococcygeal raphe likely measure different functions. LPDA change has been
Pubococcygeus Pubic symphysis to superficial part of correlated with levator ani deficiency (Fig. 1.40). The
(PC) anococcygeal ligament location of the levator plate depends on the integrity of the
18 S. A. Shobeiri and J. O. L. DeLancey
USL
a b
ATLA
PS
CX
IC
IS
PAM
RVF
V ATRV
R
(C)Shobeiri
CL
↑Ligament
Tension
USL
Balanced Unbalanced
Pressures Pressures
Pulls on
Uterus
© DeLancey
Hiatus Closed Hiatus Open Pressure
Differential
A. Normal B. Levator Injury C. Exposed Vagina
Fig. 1.34 (a) Right lateral standing anatomic depiction of the levator symphysis (PS), rectum (R), rectovaginal fibromuscularis (RVF), utero-
ani muscle and uterosacral-cardinal complex interaction. © Shobeiri sacral ligament (USL), vagina (V). © Shobeiri 2013. (c) Diagrammatic
2013. (b) Drawing of the interaction between the rectovaginal fibromus- representation of interactions between levator ani muscle, anterior vagi-
cularis and the uterosacral ligaments. The levator ani muscle and utero- nal prolapse, and cardinal/uterosacral ligament suspension. With normal
sacral-cardinal complex give cephalad static support, while the levator function (A), the vaginal walls are in apposition, and anterior
iliococcygeus fibers give lateral support to the posterior compartment. and posterior pressures are balanced. Levator damage (B) results in hia-
The puboanalis and the puboperinealis muscles stabilize the perineum, tal opening, and the vagina becomes exposed to a pressure differential
while the puborectalis closes the levator hiatus. Arcus tendineus levator between abdominal and atmospheric pressures. This pressure differen-
ani (ATLA), arcus tendineus fascia rectovaginalis (ATRV), cervix (CX), tial (C) creates a traction force on the cardinal ligament (CL) and utero-
iliococcygeus (IC), ischial spine (IS), puboanalis muscle (PAM), pubic sacral ligament (USL). From © DeLancey [32] with permission
1 Pelvic Floor Anatomy 19
a a
b b
Fig. 1.36 Room analogy: (a) unilateral levator ani tears may or may
not result in prolapse or incontinence initially, but over time the other
supportive structures will decompensate resulting in pelvic floor laxity
(b). © Shobeiri 2013
a b
c d
Fig. 1.37 Conceptual diagram showing the mechanical effect of spine has been lost, allowing the fascial plane to swing downward. (c)
detachment of the arcus tendineus fascia pelvis from the ischial spine. Normal anterior vaginal wall as seen with a weighted speculum in
(a) The trapezoidal plane of the pubocervical fascia. The attachments to place. (d) The effect of dorsal detachment of the arcus from the ischial
the pubis and the ischial spines are intact. (b) The connection to the spine. © DeLancey 2002
1 Pelvic Floor Anatomy 21
1.2.10 Nerves
There are three main nerves that supply the pelvic floor:
PS
LPDA
LP Pubic Levator Ultrasound
PBDA
Reference Line
EAS
PB Shobeiri©
a b
Fig. 1.41 (a) The mid-sagittal view of the right hemi-pelvis with the red transverse perinei muscle (STP), urethra (U), uterus (UT), vagina (V). ©
box highlighting the levator plate region. Anus (A), anococcygeal liga- Shobeiri 2013. (b) The mid-sagittal view of the right hemi-pelvis with the
ment (ACL) bladder (B), external anal sphincter muscle (EAS), internal red box highlighting the levator plate region zoomed in from Fig 1.39a.
anal sphincter (IAS), levator plate (LP), pubic symphysis (PS), rectum Anococcygeal ligament (ACL), pubococcygeus (PC), puborectalis (PR),
(R), rectovaginal fibromuscularis (RVS), sacrum/coccyx (S), superficial rectum (R), sacrum/coccyx (S). © Shobeiri 2013
1 Pelvic Floor Anatomy 23
0° 0° J J
10 10
1 Normal
1
Cystocele A
-90° Rectocele -90° A
Movement Angle
1 2 3 4 5 6 7 8 9 10 A B C D E F G H I J
0 0
-20 -20
Angle of Movement
Angle of Movement
-40 -40
-60 -60
-80 -80
-100 -100
-120 -120
-140 -140
Location Location
Fig. 1.42 Top Direction and magnitude (mm) of vaginal wall displace- cystocele, and women with rectocele. From D.M. Spahlinger et al. [29]
ment of the anterior and posterior support system. Bottom Angle of dis- with permission
placement (degrees from the horizontal) in normal women, women with
PP
C
1.3 Summary
IC
PV PA
The knowledge of pelvic floor anatomy and function is
PR
essential for effective ultrasound imaging of pelvic floor
pathologies. With advancing ultrasound technology, new A
ultrasound techniques have increased our ability to detect
pelvic floor defects and have helped us to gain insight into Fig. 1.43 The levator ani nerve in relation to the levator ani muscle
pathophysiology of pelvic floor disorders. complex and pelvic structures. Anal canal (A), arcus tendineus fascia
pelvis (ATFP), arcus tendineus levator ani (ATLA), coccyx (C), coc-
cygeus (CG), iliococcygeus (IC), levator ani nerve (LAN), puboanalis
(PA), perineal body (PB), puboperinealis (PP), puborectalis (PR), pubo-
visceralis (PV), vagina (V). © Shobeiri 2013
24 S. A. Shobeiri and J. O. L. DeLancey
2.1.1 T
he Role of Reproductive Hormones
Learning Objectives on the Pelvic Floor Function During
• Thus, the goals of this chapter are to (1) discuss the the Life Span
ultrastructural components of the pelvic floor and to
review the biochemical processes of pelvic floor Reproductive hormones, especially estrogen, have a signifi-
remodeling and (2) to discuss the influence of sex- cant impact on the pelvic floor.
ual hormones on pelvic floor function and to give Due to the natural hypoestrogenic state, some girls before
the advices for the clinical practice. the onset of menarche present various voiding dysfunctions
and vaginal problems. Between the age of 9 and 12, estrogen
levels rise. Cyclic changes in estrogen and hormonal changes
during pregnancy markedly bring into focus what estrogen
2.1 I ntroduction: How Complicated Is means to the pelvic floor function [1].
That? However, pelvic floor is mostly affected in perimeno-
pause and menopause. Menopause, as one example of pro-
Pelvic floor function is very complex and depends on many longed duration of estrogen deprivation, leads to well-known
factors as anatomical modifications and mechanical strength. consequences such as urogenital atrophy [2].
These depend also on many other factors as injury of the Women who never leaked urine before may develop uri-
muscles, connective tissue remodeling, and degradation, pel- nary leakage. Although the bladder neck and the proximal
vic enervation, and vascularization. urethra form the continence mechanism, the folds in the sub-
Numerous other predisposing conditions may lead to mucosal tissues of the urethra can offer an additional seal
abnormalities in pelvic floor tissues, including lifestyle affect. If the urethral tissues are thinner and drier from estro-
factors, such as heavy lifting, smoking, and adverse work- gen deficiency, they cannot make as tight a closure to prevent
ing environment, and chronic medical conditions, such as leakage. Sexual intercourse may also become uncomfortable
obesity, anemia, malnutrition, or pulmonary disease. because of thinner and drier vaginal tissues [3].
The impact of gene polymorphisms and genetically Nevertheless, the role of menopause on pelvic floor dys-
predisposed susceptibility on the occurrence of the pelvic functions is unclear. Neither menopausal status nor the
floor function has been proven as well. The aim of this length of hormone deficiency has been clearly associated
chapter is to clarify how all these factors affect the biome- with the risk or severity of pelvic floor disorders [4]. As
chanical properties and hormonal changes of the pelvic many as 50% of postmenopausal women complain of uro-
floor. genital symptoms [5].
2.1.2 H
ormonal Changes and Pelvic Floor
Symptoms
H. Koelbl (*) · K. Halpern-Elenskaia Hormonal changes that occur during a woman’s life span
Department of Obstetrics and Gynecology, Medical University impact many aspects of female physiology. The lower uri-
Vienna, Vienna, Austria nary and female genital tracts are closely related and both
e-mail: heinz.koelbl@meduniwien.ac.at; ksenia.halpern@
derive embryologically from the urogenital sinus.
meduniwien.ac.at
The mutual embryology of the urethra and vagina (from (mERs) (GPER (GPR30), ER-X, and Gq-mER), which are
the urogenital sinus and the Mueller’s ducts), together with mostly G protein-coupled receptors.
the hormone receptors known to be present in the urethra and Once activated by estrogen, the ER is able to translocate
the bladder neck, explains the hormone-dependent cyclical into the nucleus and bind to DNA to regulate the activity of
and trophic changes in the urogenital region that have an different genes. There are two different forms of the estrogen
onset shortly after. receptor, usually referred to as α and β, each encoded by a
As age has been clearly shown to affect the prevalence separate gene (ESR1 and ESR2, respectively). Hormone-
and progression of both stress urinary incontinence (SUI) activated ERs form dimers, and, since the two forms are
and pelvic organ prolapse (POP) [6], it is intuitive to believe coexpressed in many cell types, the receptors may form ERα
that declining sexual hormone levels may contribute to bio- (αα) or ERβ (ββ) homodimers or ERαβ (αβ) heterodimers.
chemical changes observed within tissues. A loss of estrogen Estrogen is involved in the increase of the cell maturation
results in urogenital aging. index of epithelial structures. It has been demonstrated that
Dyspareunia, dysuria, urinary frequency and urgency, alterations in the ratio of the estrogen receptor α (ERα) to
nocturia, incontinence, and thinning of tissues make it sus- ERβ may be related to the development of SUI [9].
ceptible to trauma, and recurrent infections are all facilitated Progesterone receptors (PR) are also expressed in the
by estrogen withdrawal. lower urinary tract, even if with less density than ER [10].
In addition to vulvo-vaginal symptoms, lower acid pH of
the estrogen-deficient vagina increases the likelihood of uri-
nary tract infections. 2.2.2 B
iochemical Properties of Pelvic Floor
It has been noticed that progesterone has adverse effects Tissues
on the female urinary tract function since it is linked to an
increase in the adrenergic tone, provoking a decreased tone The female pelvic floor is an anatomically complex structure
in the ureters, urethra, and bladder [7]. This could be the rea- made of smooth and skeletal muscles, ligaments, and fascia.
son why urinary symptoms worsen during the secretory Structurally, the female pelvic organs are supported by pel-
phase of the menstrual cycle, and progesterone may be vic floor muscles, cardinal and uterosacral ligaments, and the
responsible for the increase in urgency during pregnancy, endopelvic fascia. The ligaments and fascia are primarily
although the precise mechanism is not fully figured out. composed of extracellular matrix (ECM). The latter is made
of a ground substance of proteoglycans and glycoproteins
with collagen, along with elastin, which confers the extraor-
2.2 he Role of Biochemical Properties
T dinary compliance and elasticity required for vaginal
and Hormonal Receptors of Pelvic childbirth.
Floor Tissues in Epidemiology The integrity of the pelvic floor is maintained mostly by
of Pelvic Floor Function fibrillary ECM components, collagen and elastin. It has been
well described that women suffering from connective tissue
2.2.1 Sexual Hormone Receptors diseases such as Ehlers–Danlos syndrome or Marfan’s dis-
ease have a higher risk of POP and SUI, suggesting that con-
Estrogen receptors (ERs) are a group of proteins found inside nective tissue disorder is an etiological factor [11].
cells. They are different from peptide hormones, which tend
to be cell surface receptors built into the plasma membrane 2.2.2.1 Collagen of Pelvic Floor Tissues
of cells. However, some ERs associate with the cell surface As mentioned above, collagen is playing a major role in the
membrane and can be rapidly activated by exposure of the pelvic floor’s supportive structures. ECM is in constant rear-
cells to estrogen. Upon hormone binding, the receptor can rangement with synthesis and breakdown of collagen through
initiate multiple signaling pathways which ultimately lead to a process of remodeling.
changes in the behavior of the target cells. ERs are present in There are 28 types of collagen described in the body, but
the epithelial tissues of the urethra, bladder, and vaginal the most abundant in the pelvic floor are types I and III.
mucosa and also in diverse structures of the pelvic floor as Type I collagen is considered the strongest, being highly
uterosacral ligaments, levator ani muscles, and pubocervical prevalent in fascia, ligaments, and fibrous tissues. Type III,
fascia [8]. reticulate collagen, is also found in the same tissues but tends
ERs are activated by the hormone estrogen (17β-estradiol). to be located on the surface of the fibril.
Two classes of ERs exist: nuclear estrogen receptors (ERα The arrangement of the different types of collagen into
and ERβ), which are members of the nuclear receptor family fibrils of variable sizes confers strength or laxity depending
of intracellular receptors, and membrane estrogen receptors on the ratio, density, and degree of cross-linking that are
2 Biochemical Properties and Hormonal Receptors of Pelvic Floor Tissues 27
important for the maintenance of the mechanical properties III in uterosacral ligaments is correlated with a decrease in
of the extracellular matrix, which is tissue-specific. function of this homeobox gene, HOXA11, involved in the
Several studies have taken a closer look at tissue proper- development of the lower uterine segment and cervix and
ties through the use of human pelvic floor biopsies of women can be also associated with POP [17].
with either POP or SUI. Here is the small overview on the
distribution of collagen in pelvic floor function and its influ- Endopelvic Fascia
ence on the pelvic floor disorders. Diminished collagen levels have been found in multiple
pelvic tissues of women with SUI, including the endopelvic
Anterior Vaginal Wall fasciae [18].
It was found that women with POP have statistically signifi-
cantly less dense staining of collagen type III than women in The Arcus Tendineus Fasciae Pelvis (ATFP)
the control group after controlling for age, weight, parity, ATFP which provides support to the anterior vagina is com-
urodynamic stress incontinence, and menopause [12]. prised primarily of parallel bundles of type III collagen fibers
(84%), an intermediate amount of elastin (13%), and very
Periurethral Tissue little smooth muscle. It was shown that menopause in the
Weakened pelvic floor support may result from lower colla- absence of hormone therapy is associated with a decrease in
gen content, but also from alterations within the distribution quantity of collagen I in the ATFP, resulting in a decrease in
of collagen fibers. Much more disordered collagen fiber dis- the ratio of collagen I/(III + V). This may compromise the
tribution within periurethral specimens of women with SUI tensile strength and an increase susceptibility to anterior
compared with unaffected controls were detected [13]. vaginal wall prolapse [19].
Collagen type III is significantly reduced in patients with
SUI and POP. Some findings are pointing out that women Elastin
with SUI have less collagen type III around the urethra Another important mechanical component of ECM is elas-
regardless of the degree of pelvic relaxation. So it appears tin, which affords resiliency through its ability to recoil,
that collagen has a significant role in the maintenance of uri- returning the collagen fibers to their original configuration
nary continence (Table 2.1) [14, 15]. post-loading. The length and amount of elastin could also
change the mechanics of the vagina and are associated with
Cardinal Ligaments changes in the phenotype of smooth muscle, which synthe-
In women with POP, loosely arranged connective tissue sizes the elastin. For example, elastin fibers are smaller and
fibers and less dense ECM as well as smaller collagen fibers less expressed in vaginal tissue of women with POP [20].
were seen under the electron microscope [16]. Tissue strength relies on cross-linkages between elastin
and collagen fibers formed by the enzyme lysyl oxidase
Uterosacral Ligament (LOX). A lower elastin content and decreased mRNA expres-
Recent research is going even deeper and analyzes the sion of LOX were found in uterosacral ligaments of women
molecular mechanisms of the POP development. One excit- with POP compared with normal controls [21].
ing example is the transcriptional regulator genes as homeo- Elastin is synthesized and broken down in the female gen-
box (HOX). HOX genes are involved in embryonic ital tract and allows for tremendous accommodation and
development of the urogenital tract. It could be demonstrated regeneration after childbirth.
that HOXA11 is essential for organogenesis of the uterosac- A loss of vaginal elastin can result in widening of the
ral ligament. A decreased expression of collagen types I and vaginal opening, which, in turn, could alter the loading con-
ditions of the attached connective tissues and in turn pelvic
Table 2.1 Periurethral connective tissue status, Goepel et al. [14] organ support.
Extracellular matrix proteins Continent women Incontinent women
Collagen type 1 +++ ++
Collagen type III +++ ++ 2.2.3 T
he Role of Matrix Metalloproteinases
Collagen type IV + + (MMPs) on Pelvic Floor Tissue
Collagen type V + +
Remodeling
Collagen type VI +++ +
Fibronectin + +
Laminin + + Since Jackson et al. described the increased MMP activity in
Vitronectin ++ −(+) women with POP, there has been increasing interest in exam-
− = negative; + = weak; ++ = moderate and +++ = strong ining the relationship between collagen degradation and pel-
immuno-reactivity vic floor disorders (PFD) [22].
28 H. Koelbl and K. Halpern-Elenskaia
Collagen breakdown is regulated by matrix metallopro- type for the ER β gene is probably associated with an
teinases (MMPs). These enzymes are secreted as proen- increased risk of POP [26].
zymes and require activation. There are 23 different types SNPs are present in the progesterone receptor gene that
identified as being involved in different tissue types. The can alter its expression. Similarly, the estrogen receptor β
interstitial and neutrophil collagenases (MMP-1, MMP-8, gene also contains multiple SNPs affecting its expression.
MMP-13) cleave fibrillar collagen, while the denatured pep-
tides are degraded by the gelatinases (MMP-2 and MMP-9).
These enzymes’ actions are further regulated by tissue- 2.4 ormonal Impact on Vaginal Atrophy,
H
derived inhibitors of metalloproteinases (TIMPs) that bind to the Role on Pelvic Floor Dysfunction,
them and regulate their activity. and Treatment
The recent findings indicate that women who suffer from
POP have a higher expression level of MMP-1 than women Synthesis and metabolism of collagen in the genital and uri-
without POP. nary tract are under the control of estrogens [27]. It also
Therefore, enhanced activity of MMPs may explain the increases the number of muscle fibers in the detrusor muscle
reason for the reduced collagen content in the pelvic connec- and in the urethral muscles [28].
tive tissues, which eventually causes POP. With an average life expectancy of 75–80 years, women
Also a concurrent decrease in the expression of tissue spend about 25–30 years of their life in menopause, i. e., in a
inhibitor of matrix metalloproteinase-1 (TIMP-1) is one of state of hormone deficiency. Within the scope of menopause
the hypotheses of elevated MMP-1 activity [23]. The role of syndrome, signs of degeneration in the urinary and genital
an overactive degradation mechanism can be an interesting organs caused by estrogen deficiency play a significant role
linkage, as helical peptide α1, a collagen breakdown product, [29]. Studies have shown lower serum estradiol (E2) levels in
is excreted in higher amounts in the urine of women with premenopausal women with SUI, with and without concur-
SUI [24]. Recent studies show consistent results of the rent POP [9, 30].
impact of higher MMP activity in the development of SUI The proof of steroid hormone receptors in the female ure-
and POP. The contribution of TIMP to this process remains thra and the associated ability of tissue containing estrogen
to be established [25]. receptors to respond to estrogens are the real rationale for
providing hormone replacement. In addition to improving
the degree of proliferation in the vagina and urethra, the
2.3 he Recent Investigations
T blood flow in the periurethral venous plexus is increased, and
and Possibilities for Future Research the collagen content in the periurethral connective tissue is
raised, thus improving elasticity [29].
The extracellular matrix content of the pelvic floor is the The intensity of the effect of estrogen replacement on the
major focus of recent investigations and pointed for potential urethra, for example, depends on the receptor density and the
molecular markers of the dysfunction. The identification of binding affinity of the estrogen to the receptor. Estriol has a
women predisposed to develop PFD would help in the lower binding capacity on the estrogen receptor complex and
patients’ management and care. However, it is important to thus a shorter retention time in the cell nucleus. At low doses,
highlight that the techniques used to measure collagen and estriol only demonstrates the early estrogen effects, e.g., epi-
elastin content vary between the abovementioned studies. thelium proliferation in the vagina and urethra, but not the
Different structures and biopsy sites of the pelvic floor late estrogen effects such as proliferation in the endome-
(vagina wall, arcus tendineus fasciae pelvis, paraurethral tis- trium. Epithelium proliferation leads to a significant improve-
sue, parametrium, and uterosacral ligaments) have been ment of subjective complaints, and presumably to a
examined, and further studies are needed to understand the quantitative decrease in urinary leakage due to a “sealing
real process of pelvic floor remodeling. effect” [31], without any measurable effect on pressure. In
Future research will deal with the discovery of the genetic order to achieve an influence on the urethral pressure compo-
contribution to PFD. Genetic mutations or polymorphisms nents, a higher estradiol dose or the use of estrogens with
affect the transcription of mRNA coding for a wide variety of greater receptor binding affinity (estradiol, conjugated estro-
proteins responsible for ECM metabolism. Polymorphisms gens), a longer duration of substitution, and possibly even
have been identified in genes of ECM component proteins, adjuvant therapy measures such as pelvic floor training are
proteolytic enzymes, regulatory proteins, and receptors. probably necessary.
These mutations may therefore downregulate the synthesis The impact of estrogen on tissue may be related to its sys-
of collagen and elastin or upregulate their breakdown. temic or local levels, or altered sensitivity from a decreased
Single nucleotide polymorphisms (SNPs) are the most amount of receptors noted in genitourinary tissues [9, 32].
abundant type of DNA sequence variation in the human Sex hormones may exert their effect through pathways
genome and are also in focus of research. A specific haplo- other than ECM metabolism. An increase in periurethral
2 Biochemical Properties and Hormonal Receptors of Pelvic Floor Tissues 29
vasculature in postmenopausal women treated with exoge- PFD. Current data also indicates that sex hormones may alter
nous estrogens possibly improves the periurethral blood ECM metabolism by having variable interactions with their
flow, urethral adaptation, and periurethral stability and corresponding receptors.
thereby increases maximum urethral pressure [33]. Comprehension of the pathophysiology responsible for
Recent studies also indicate that a low estradiol level PFD is clinically relevant on various levels. First, identifying
might have a negative impact on the lower urinary tract and the patient population at risk can lead to preventive strate-
continence mechanism and work as a possible risk factor for gies. Second, it may allow the development of interventional
female SUI [34]. therapies that could modify ECM maturation and turnover.
Interestingly, the WHI study reported that hormone ther- Future research will focus on understanding what processes
apy (HT) users ran a higher risk of developing SUI and that control ECM remodeling and aging to offer each single
hormonal supplementation with estrogen alone led to a patient the appropriate therapy.
higher risk for developing UI than an estrogen/progestin Future studies addressing the genetic basis of pelvic floor
combination [35]. The effect of HT on urinary incontinence dysfunction are required, and investigations of biomechani-
symptoms is still a matter of debate. Some studies conclude cal properties of pelvic floor support should be performed
that the route of therapy has different effects, as oral sys- together with identification of candidate genes for pelvic
temic estrogen worsened incontinence, while vaginal estro- dysfunctions to determine the relationship between genetics
gen improved incontinence [36]. However, this raises the and biomechanics in the pelvic floor.
question why exogenous estrogens seem to be bad and
endogenous estrogens seem to be good for lower urinary
tract symptoms (LUTS). One possible explanation for the References
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H. HOXA11 is critical for development and maintenance of utero- organ prolapse. Int J Gynaecol Obstet. 2003;80:35–9.
sacral ligaments and deficient in pelvic prolapse. J Clin Invest. 31. Chung AK, Peters KM, Diokno AC. Epidemiology of the dysfunc-
2008;118:1050–5. tional urinary sphincter. In: Corcos J, Schick E, editors. The urinary
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Neurourol Urodyn. 2004;23:367–73. H, Umek W. Association of endogenous circulating sex ste-
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Meyn LA, et al. Impact of menopause on collagen subtypes in pausal women with pelvic floor disorders. Arch Gynecol Obstet.
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Mar;190(3):620–7. 33. Klutke J, Bergman A. Hormonal influence on the urinary tract. Urol
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The Integral System of Pelvic Floor
Function and Dysfunction 3
Peter Petros, Michael Swash, and Darren Gold
central
inhibitory or
acceleratory
instructions
SPINAL
CORD
efferent
PUL afferent
BLADDER USL
N CX N
MUSCLES
MUSCLES ATFP CL
PELVIC RIM
Fig. 3.1 Binary control of bladder and bowel. Schematic 3D sagittal cygeus for urethra (broken circle) and puborectalis for anus (not
view. The system is in normal closed mode. The pelvic floor works like shown); this allows the posterior muscles (posterior arrows) to unre-
a trampoline which is suspended by PUL (pubourethral ligaments) strictedly open out the posterior wall of anus and urethra (broken lines)
anteriorly, ATFP (arcus tendineus fascia pelvis) and CL (cardinal liga- just prior to bladder/rectal evacuation by smooth muscle contraction
ments) laterally, and USL (uterosacral ligaments) posteriorly. The (spasm). If PUL or USL is loose, the muscles contracting against them
organs are stretched and balanced by three opposite vector forces (arrows) weaken. Urethra/anus cannot be closed (incontinence) and
(arrows), contracting against PUL and USL (uterosacral ligament). opened (emptying problems); neither can the organs be bidirectionally
Afferent impulses from stretch receptors “N” are reflexly suppressed stretched sufficiently to support “N” and to prevent activation of the
cortically (white arrow). When required, the cortex activates the defeca- evacuation reflexes (“urge incontinence”). CX cervix
tion and micturition reflexes: the forward muscles relax, pubococ-
nence), evacuate them (constipation, bladder emptying prob- 3.3 The Integral System
lems), or tension the bladder and rectum sufficiently to
prevent inappropriate activation of the micturition and defe- The Integral System [1, 2] applies the Theory toward a practi-
cation reflexes by peripheral stretch receptors (urinary and cal, everyday system for management of female pelvic floor
fecal urge incontinence). The pelvic muscles are themselves disorders. Diagnosis of ligament damage is guided by a vali-
often damaged during childbirth, both by direct injury and dated ligament-specific questionnaire “ITSQ” [7] or other
by damage to their nerve supply, causing primary weakness questionnaire capable of detailing the symptoms in Fig. 3.2b.
of these muscles, in addition to ligamentous stretch injury. The symptoms are transcribed to the pictorial algorithm shown
Symptoms from the pictorial diagnostic algorithm (Fig. 3.2b) in Fig. 3.2b. This indicates the sites of ligament damage which
accurately indicate which ligaments are damaged. Due to should be confirmed by vaginal examination. Surgery shortens
childbirth and ageing, all five ligaments may be stretched and reinforces the damaged ligaments, so that the pelvic floor
and weakened (Fig. 3.3). Each damaged ligament is linked to muscles, even though weakened, can act more efficiently
a specific prolapse (Fig. 3.2a) and specific symptoms against them. Surgical treatment consists of precise insertion
(Fig. 3.2b). of thin strips of tape along the line in any of the five damaged
3 The Integral System of Pelvic Floor Function and Dysfunction 33
uterus uterus
3 3
1 2 2
1
4 bowel
4 bowel
vagina
vagina
acnormal
S emptying
frequency and
urgency
B UT
nocturia
PS
2 USL
faecal faecal obstructed
ATFP CL incontinence incontinence defecation
PUL 3
4
PB tethered vagina
Fig. 3.2 (a) How birth damage creates ligament damage to cause pel- urethal ligament (anterior ligaments); ATFP, CL (middle ligaments);
vic organ prolapse (POP). Lower figure—The circles represent damage USL, PB perineal body (posterior ligaments). ∗EUL attaches the exter-
to six ligaments and vagina by the fetal head as it descends down the nal meatus to the anterior surface of pubic bone. (b) The pictorial diag-
vaginal canal. The positions of the ligaments create three natural zones, nostic algorithm—prolapse and symptoms are related. 3D sagittal view
anterior, middle, and posterior. Upper figure—correlations of damaged sitting position. The three zones contain two ligaments each, and these
ligaments with a specific prolapse. “1”: damaged PUL (pubourethral may cause specific prolapse or symptoms as indicated. The size of the
ligament) causes bladder neck opening and stress incontinence. “2”: bar correlates broadly with the site and probability of symptom causa-
damaged CL (cardinal ligament) causes transverse defect; dislocation tion. Labelling as in Fig. 3.2a. Tethered vagina is caused by anterior
of vagina from ATFP (arcus tendineus fascia pelvis) causes lateral/cen- vaginal scarring in middle zone. The main symptom is unstoppable
tral defect. “3”: damaged USL (uterosacral ligaments) uterine prolapse. urine loss on getting out of bed in the morning. B bladder, PS pubic
“4”: damaged PB (perineal body) causes rectocele. The main ligaments symphysis, S sacrum, UT uterus
are indicated in capital letters, two in each zone: PUL, EUL external
ligaments (Fig. 3.4) so as to reinforce them, plus reattachment method has the capacity to reduce care costs due to inconti-
of stretched or displaced vaginal fascia. Up to 90% cure for nence, to improve quality of life for older women, and, poten-
POP and up to 80% for pelvic pain and for bladder and bowel tially, to reduce admissions to nursing homes. Data from the
dysfunction can be achieved by reconstruction of these five Kamakura group in Japan (Table 3.1) and others confirms that
ligaments [8] (Fig. 3.4). Properly taught and administered, this the functional disorders that commonly present to each of the
34 P. Petros et al.
PUL
CL
ATFP
PB
3 The Integral System of Pelvic Floor Function and Dysfunction 35
Table 3.1 Data from Inoue et al. (mean age 70 years) [8]
Test
Observed 95%- 96%- results H0:
No of cure rate lower upper p ≤ p0 vs.
Variable N cured (%) CI CI H1: p > p0
Prolapse 278 257 92.10 0.891 0.952 ∗
Urgency 133 124 93.20 0.879 0.971 ∗
Nocturia 86 62 72.10 0.597 0.809 /
Day time 132 120 90.10 0.935 0.999 ∗
frequency
Dragging 56 52 92.90 0.862 0.998 ∗
pain
Fecal 52 46 88.50 0.798 0.977 #
incontinence
Lower and upper 95% confidence intervals for the observed relative
frequencies of prolapse, urgency, nocturia, daytime frequency, dragging
pain, and fecal incontinence. Parallelly the results of testing the hypoth- Fig. 3.5 Formation of artificial collagenous neoligaments. Tapes were
esis. H0: p < p0 vs. H1: p > p0 have entered. ∗, #, and / mean significant inserted in the position of the pubourethral ligaments (white arrows).
p values when p0 is setting equal to 0.80, 0.75, and 0.60, respectively. In Specimen of vagina (V), vulva, bladder (B) dissected from a dog
other words these symbols depict that the observed cure rates are sig- 2 weeks after the tape which had been implanted for 12 weeks was
nificant (p < 0.05, binomial tests) removed. Note the significant artificial collagenous neoligament cre-
ated by tissue reaction against the tape (white arrows)
1980s. A hemostat applied immediately behind the studies, including testing for collagen I and III. It was found
symphysis pubis, at the level of and lateral to the midure- that the new collagen fibers of the neoligament were aligned
thra (so that it could not obstruct the urethra), controlled in linear formation along the tape [9]. Thus a new surgical
urine loss on coughing without bladder neck elevation (see principle, using a thin tape for planned formation of an arti-
Video 1). The second observation was that an implanted ficial collagenous neoligament (Fig. 3.5), was developed [9]
Teflon tape created a collagenous tissue reaction around it applicable for repair of any damaged ligament in the pelvis
when implanted. It was hypothesized that a tape implanted and pelvic floor.
in the exact position of a damaged PUL would create a col-
lagenous neoligament to reinforce it, thereby restoring
function and continence. It is well-established that liga- 3.4.2 Application of the Neoligament
ments with an estimated breaking strength of 300 mg/mm2, Surgical Principle to PUL and Other
rather than the vagina (breaking strength approximately Ligaments
60 mg/mm2), are the major structural components of the
pelvic floor. Their strength derives from Type 1 collagen. Between 1988 and 1989, 30 women with genuine stress
During pregnancy collagen is stretched and weakened, and incontinence (USI) underwent the prototype MUS operation
age also weakens it and reduces its elasticity. It was rea- for repair of PUL [10] (Fig. 3.6). In 1996, the original MUS
soned that, especially in older women, simply suturing a operation evolved to the “tension-free” vaginal tape (TVT)
damaged ligament was not the answer. Only a process procedure [11, 12], which was adapted in 1992 to repair the
which creates de novo collagen, as in Fig. 3.4, could repair uterosacral ligaments (USLs) as a posterior sling [13] and,
the PUL. then, in 2003 as the tissue fixation system (TFS), a tensioned
mini sling applicable to the other three ligaments, CL, ATFP,
and PB [8, 14–17].
3.4.1 Development of the Artificial
Collagenous Neoligament for PUL
Repair 3.4.3 C
linical Relevance of Some Initial MUS
Operation Findings (1988–1989)
Following human cadaver testing on a half pelvis, a surgical
technique was developed in canines (1987–1988) to test the Many findings from the prototype midurethral sling opera-
hypothesis that a precisely inserted tape in the anatomical tions are still relevant today:
position of the PUL would create a collagenous neoligament
(Fig. 3.5). This methodology was tested at the Royal Perth 1. Stress and urge seemed etiologically related (Fig. 3.6a);
Hospital animal laboratory in 13 canines [9]. Post-op evalu- they were simultaneously cured in almost all patients ini-
ation comprised extensive histological, bacteriological, bio- tially, but both symptoms recurred in 50% when the tape
chemical, X-ray, radioactive gallium, and biomechanical was removed at 6 weeks. The observation of urge inconti-
36 P. Petros et al.
RECTUS SHEATH
U
tape
vagina
Rubber
tube
sutures
Fig. 3.6 (a) Prototype midurethral sling. Perspective: coronal section same patient. Left column: at rest. Right column/straining. Middle
immediately behind the pubic symphysis. The tape was configured X-ray right, post-op. Intravaginal tape grasped by a hemostat “H”
around the rectus sheath into the vagina, through both ends of a rubber reveals three-directional forces acting in the position of PUL. Bottom
tube, exiting at its inferior end, both ends secured with interrupted X-ray, post-op. Bladder neck below symphysis at rest and during strain-
sutures in holes set 0.5 cm apart and cut sequentially to lower the tape ing. Patient cured
as required. (b) Standing sagittal X-rays from 1990 prototype MUS,
nence cure was a remarkable result. If a patient has both lowered cm by cm (the operation was performed under
USI and urge incontinence without other posterior zone LA), symptomatic obstructed micturition resolved. At
symptoms (Fig. 3.2b), a high likelihood of cure of both about the lower border of the symphysis, the patient
symptoms can be predicted after MUS. remained continent and was able to pass urine freely, with
2. In the prototype midurethral sling operations, the tape no symptoms of obstruction or urgency, showing that the
(Fig. 3.6a) was initially set high, at the upper level of the mechanism of USI cure was not obstructive. Therefore, if
symphysis. At this level, urine could not flow, and the a patient cannot pass urine within about 72 h after MUS,
urethra was mechanically obstructed. As the tape was most likely there is tape compression as a cause. The tape
3 The Integral System of Pelvic Floor Function and Dysfunction 37
BN
bladder
a arc Rotational
Vector
PVL forces
PU
L E
ZC
LP
PCM
LMA
vagina
Fig. 3.8 (a) Role of PUL and USL in urethral closure. The change of area of vagina “zone of critical elasticity” (see “ZCE” in insert figure) so
shape of the vagina “V” and the positions of bladder “B,” rectum “R,” as to allow the opposite muscle forces which stretch the vaginal mem-
and levator plate “LP” relative to the vertical and horizontal bony coor- brane to operate independently of each other. PB perineal body. (b) Role
dinates (white broken lines) during straining. An elastic vagina is critical of PUL in urethral closure. Transperineal ultrasound, patient with USI.
for the correct transmission of muscle forces by directional vectors Left figure, REST S symphysis, U urethra, B bladder, a anterior vaginal
(arrows). Upper XR. Resting closed position Urethral closure is main- wall, p posterior vaginal wall. Middle figure STRAIN a loose PUL as in
tained by tissue elasticity and slow-twitch muscle contraction against the Fig. 3.7b allows the posterior pelvic muscles to stretch the vaginal walls
pubourethral ligament (PUL) anteriorly and uterosacral ligament (USL) “a” and “b” backward; this action pulls open the posterior urethral wall.
posteriorly. CX cervix, U urethra, Ra anorectal angle, Bv ligamentous The urethra opens out proximally and distally exactly as in micturition.
attachment of bladder base to upper vagina. Lower XR. On effort Right figure MID/UR ANCHOR When a hemostat (white arrow) sup-
(Straining down) fast-twitch directional vector forces stretch the distal ports (shortens) the pubourethral ligament, the musculoelastic closure is
vagina and urethra forward against PUL; the bladder base is stretched restored; “a” and “b” tension; distal and bladder neck closure are
backward against PUL; LP pulls downward against USL to close blad- restored. LMA longitudinal muscle ani, PCM pubococcygeus muscle,
der neck. Adequate elasticity is required in the bladder neck (BN) PVL pubovesical ligament
Videos 2 and 3 provide X-ray and ultrasound validation of restoration of PUL to its correct length and reinforcement
the bladder neck and urethral closure mechanisms. with a tape. This restores the muscular closure mechanisms
as in Fig. 3.7a. The classical symptom of PUL defect is
urine loss coincident with effort. PUL laxity causes
3.4.6 R
ole of Lax PUL in the Causation USI. Diagnosis is by applied mechanical support of the lax
of Urinary Stress Incontinence PUL at midurethra, as shown in Video 1. Figure 3.8b is an
ultrasound demonstration of the anatomical effect of PUL
A weak PUL (Figs. 3.7b and 3.8b) cannot hold the pelvic shortening as in Video 1. This maneuver restores the ana-
floor tissues in position. They descend on effort with L
P/ tomical geometry and therefore continence [21]. This also
LMA contraction to open out the posterior urethral wall, demonstrates why an MUS sling must be shortened during
much as during micturition. Corrective surgery requires the procedure.
3 The Integral System of Pelvic Floor Function and Dysfunction 39
3.4.7 E
xternal Urethral Ligament Laxity:
A Rarely Recognized Cause
of Nonstress Urine Leakage
EUL PUL
Fig. 3.11 (a) Role of pubourethral ligament (PUL) and uterosacral ani (LMA) (downward arrow) pulls the anterior margin of down against
ligament (USL) in anorectal closure. Resting closed (right figure): USL to rotate the rectum (R) around a contracted puborectalis muscle
slow-twitch muscle fibers “S” close urethral and anal tubes. Active (PRM) (yellow) to “kink” the rectum and close the anorectal angle
closed (continence) (left figure): fast-twitch fibers exaggerate the “Ra.” (b) Anorectal closure (schematic). PRM contracts forward to sta-
actions of “resting closed.” Forward pubococcygeus muscle (PCM) bilize the posterior wall of anorectum. LP inserts into the posterior wall
contraction against PUL (forward arrow) stabilizes the anterior rectal of the rectum. LP contracts backward against PUL to stretch the rectum
wall; backward contraction by levator plate (LP) against PUL (back- backward. LMA contracts downward to rotate the rectum around PRM
ward arrow) stretches the rectum backward. The longitudinal muscle to close it. B bladder, CX cervix, PB perineal body, V vagina
and testing either by cough or suprapubic pressure for urine 3.4.11 Surgical Results for PUL Repair
loss during the procedure. To minimize postoperative urinary (Midurethral Sling)
retention, it is recommended that the surgeon always tighten
the tape over a No. 8 Hegar dilator or a No. 18 Foley catheter. More than 2000 papers have been published on the standard
If further tightening is required, it should also be done over a retropubic and TOT midurethral sling procedures, reporting
Hegar dilator or catheter. EUL/hammock laxity repair cure rates for both between 80 and 90%. TFS was the first
(Fig. 3.13) should be carried out at the same time as the mini sling for USI, performed in September 2003. A ran-
midurethral sling repair (Video 4). domized clinical trial by Sivaslioglu et al. [27] gave 5-year
3 The Integral System of Pelvic Floor Function and Dysfunction 41
cure rates for TFS of 89% against 78% for TOT. Nakamura 3.4.12 Zone of Critical Elasticity: Tethered
from the Yokohama Clinic reported a 91% cure rate for ISD Vagina Syndrome and Role of Fibrosis
(MUP <20 cm H2O) at 12 months, the operations being per- in Incontinence After Post-obstetric
formed entirely under local anesthesia, and there were no Fistula Repair
tape rejections [28].
Conserving vaginal elasticity is a core surgical principle as
this elasticity is essential for the independent function of the
distal and proximal closure mechanisms [2]. The bladder
neck area of vagina—the “zone of critical elasticity” (ZCE)
(Fig. 3.14)—needs to be elastic so as to allow the two oppo-
site urethral closure mechanisms to work independently of
each other. Scarring in the anterior vaginal wall may link
these independent forces. The stronger posterior forces may
then overcome the anterior forces to forcibly open out the
posterior urethral wall. This will cause sudden uncontrolla-
ble urine loss, the “Tethered Vagina Syndrome” [2, 29]. In
obstetric fistula patients who continue to leak urine after suc-
cessful closure of the fistula, the scarring and fibrosis may be
so severe that there is not even sufficient elasticity at ZCE for
the slow-twitch muscles of the pelvic floor to function ade-
quately. Urinary leakage is constant, day and night. Treatment
requires restoration of elasticity in the anterior vaginal wall
[29, 30]. The most important application of the TVS method-
ology to date has been in obstetric fistula surgery; 95% of
fistula closures are successful but, despite this, urine loss
continues in up to 55% of cases [29]. Browning et al. found
that augmenting the ZCE with a Singapore flap skin graft,
identical in principle to the skin-on Martius flap graft
(Fig. 3.14), produced a dramatic improvement in such
patients. Browning et al. reported at least a 400% greater
return to dryness than previous attempts at restorative sur-
gery [30]. In first world countries, scarring in the anterior
vaginal wall may be a consequence of the mesh sheets used
for cystocele repair, scarring from vaginal excision, over-
Fig. 3.12 Mini sling repair of pubourethral ligament (PUL). The elevation of vagina by a Burch colposuspension operation or
vagina immediately below middle part of urethra is opened as per a after fascial bladder neck slings. These may scar or remove
standard midurethral sling. The retropubic space is entered, and the elasticity at ZCE and cause severe uninhibited urine loss,
anchors are placed in the position of PUL insertion into the pubic bone
S EUL
f
U
Fig. 3.13 External urethral ligament (EUL) hammock suture reinforces tighten it toward the EUL. The EUL attaches the external meatus of the
the loose EUL and lax suburethral vagina of Figs. 3.9 and 3.10. Tightening urethra (U) to the anterior surface of the pubic bone. This operation is
of the distal supports of the urethra (EUL) with a 20 vicryl suture “S,” always performed with a No18 Foley catheter in the urethra. The suture is
which passes through the musculoelastic layer (f) of the vagina (V) to left slightly loosely tightened
42 P. Petros et al.
PS
PCM
PUL PUL
BLADDER
LP
H SCAR
C
O
ZCE
LMA
Fig. 3.14 Tethered Vagina Syndrome—mechanics and surgical cure. Fig. 3.16). The closed urethra “C” is forcibly pulled open to “O.” This
Right figure. There is a scar over the zone of critical elasticity (ZCE). causes a massive unrestrained loss of urine. A skin graft applied to blad-
The scarring “tethers” the stronger posterior LP/LMA forces (arrows) to der neck of vagina (left frame) restores vaginal elasticity in the area of
the weaker forward PCM force (arrow). On effort, when the signal is scarring “scar.” This forces the three-directional muscle to work inde-
given to close (classically on getting out of bed in the morning), the pendently of each other again to close the distal and proximal urethra. H
posterior vectors overcome the forward force (“PCM” arrow) to open hammock, LMA longitudinal muscle ani, LP levator plate, PCM pubo-
out the posterior urethral wall exactly as happens during micturition (see coccygeus muscle, PS pubic symphysis, PUL pubourethral ligament
most characteristically immediately on getting out of bed in From a structural perspective, USL laxity causes uterine
the morning. In a few cases, the leakage may be constant. prolapse (Fig. 3.15). Uterine prolapse is caused by weak and
Anatomical restoration is by dissection of adherent scar tis- elongated cardinal (CL) and uterosacral (USL) ligaments,
sue and direct application of abdominal skin, by skin-on not primarily by vaginal damage. It is self-evident from
Martius graft, or by the Singapore graft [30] (Video 5). Fig. 3.15 that the only way uterine prolapse can be cured is
to shorten and strengthen CL and USL. “Native tissue repair”
of the vagina will not strengthen the ligaments, nor will a
3.5 art 2: The Uterosacral Ligament
P mesh repair. The ultimate proof that the vagina is not a struc-
“USL”: Cure of Uterine Prolapse tural organ was recently provided by the Lancet PROSPECT
with Posterior Sling
RCT [5], where native tissue repair of the vagina was com- An overtight SCP or rectopexy mesh will counteract
pared against vaginal mesh repair. Both methods had >80% the downward vectors; urethra and anus cannot be ade-
failure rate at 6 months. In contrast, using TFS ligament quately opened; the patient presents with obstructive def-
repair, the Kamakura [8] and Yokohama [31] units reported ecation or micturition. It has been demonstrated that
>90% surgical cure rate for third- and fourth-degree POP at correction of a lax USL can improve symptoms of
12 months, with minimal deterioration (79% cured at “obstructive micturition,” reduce residual urine, and, in
60 months) [15] and minimal tape erosions. The Yokohama some cases, restore normal micturition in women who
units reported no tape erosions. It was the view of the needed to self-catheterize [32].
Yokohama unit [28, 31] that the lightweight purpose-knitted
tape, or prevention of tape slippage by the anchor, and pre-
cise mm by mm tensioning of the tape all contributed to their 3.5.2 Role of USL in Normal Defecation
report of no tape rejections.
The mechanisms of defecation and micturition are almost
identical, except that it is PRM, not PCM which relaxes for
3.5.1 Role of USL in Micturition defecation. PCM actually contracts to pull forward the ante-
rior anorectal wall during defecation. The pressure of PRM
The mechanisms for micturition and defecation are similar. on the posterior rectal wall is released (Fig. 3.18). The poste-
With reference to Fig. 3.16, relaxation of the PCM forward rior vectors LP/LMA pull against USL to stretch open the
vector (insert) allows the posterior vectors LP/LMA to pull posterior rectal wall (Fig. 3.18) [33]. This decreases the
open the posterior urethral wall. Opening out the urethral tube internal resistance to evacuation inversely by the third power
as in Fig. 3.16, lower figure, lowers the internal resistance to of the anal radius [34]; the rectum contracts to empty.
urine flow inversely by the fourth power of the radius. For Abendstein cured obstructive defecation syndrome (ODS)
example, if the radius is doubled, resistance to flow decreases and intussusception with a posterior sling which lifted the
16 times (2 × 2 × 2 × 2). If USL is loose, the muscle forces prolapsed vagina and rectum “like the apex of a tent” [25].
weaken; the urethra cannot be fully opened; and the detrusor This was validated by pre- and postoperative defecating
has to empty against a narrower tube (Fig. 3.17). The detrusor proctograms. The anatomical rationale was that the USLs
has to work harder to empty the bladder, and the patient expe- not only suspend the uterus; they also attach to the lateral
riences this as “obstructed micturition” (Video 6). walls of the rectum (Video 7).
bladder
arc
PVL
PU
L
E
ZC LP
PCM
LMA
vagina
Fig. 3.16 Micturition. Upper XR. Resting closed Directional slow- ment to the arc of Gilvernert (PVL, insert figure) prevents the anterior
twitch muscle fibers maintain urethral closure distally and at bladder neck bladder wall prolapsing into the outflow tract. B bladder, CX cervix, LMA
(2). Lower XR. Micturition The forward vector (insert) relaxes. The back- longitudinal muscle ani, LP levator plate, PCM pubococcygeus muscle,
ward vectors stretch the vagina (V) backward and downward against USL PUL pubourethral ligament, R rectum, S sacrum, U urethra, USL utero-
to open out the posterior urethral wall. The pubovesical ligament attach- sacral ligament, ZCE zone of critical elasticity
44 P. Petros et al.
Fig. 3.17 “Obstructive” micturition is consistent with muscle inability The weak muscles cannot “grip” sufficiently to pull open the urethral
to open urethral tube. The electromyography (EMG) in the posterior tube, and so they have to continually contract to force the urine through
fornix of vagina shows muscle activity preceding detrusor contraction. an insufficiently opened tube
3.5.3 L
ax USLs: Anatomical Pathways to Pain, posteriorly acting muscle forces, LP/LMA, which contract
Bladder, and Bowel Dysfunction against USLs. A loose USL (Fig. 3.20) will cause weaken-
ing of the urethral or anorectal LP/LMA opening forces
The USLs are the anchoring point for the backward/down- [32–35]. The bladder detrusor or rectum then contracts
ward vectors which are critical for control of bladder and against an unopened tube. This is perceived by the patient
bowel function. A fundamental tenet of the Integral System as “obstructed micturition” or “obstructed defecation,”
is that even minor laxity in the USL may cause major symp- with symptoms such as “feeling bladder has not emptied,
toms of: “stopping and starting,” multiple emptying, post-micturi-
tion dribble, raised residual urine [32], and, for bowel,
• Micturition difficulty and obstructive defecation “ODS”. constipation or obstructive defecation (ODS) [25].
• Bladder and bowel urgency and frequency. Shortening and reinforcing CL/USL by a posterior sling
• Nocturia. restores prolapse and the external opening mechanisms
• Bladder and bowel incontinence. with improvement of “obstructive” symptoms and reduced
• Chronic pelvic pain. residual urine volume for bladder [32] and improved bowel
emptying [25].
The reason a minor change in USL length can cause such
major symptoms is the exponential nature of the control
mechanisms: Poiseuille’s Law governing urine flow (inversely 3.5.5 L
ax USL: Pathways from Ligament
by the fourth power of the radius) and Gordon’s Law which Laxity to Symptoms of Urge,
governs muscle contractile strength. A striated muscle con- Frequency, and Nocturia
tracts efficiently only over a limited length [35] (Fig. 3.19). If
the insertion point is loose (Figs. 3.19 and 3.20), the muscle The Integral Theory interprets urgency to micturate or
effectively lengthens and loses contractile force. When a defecate as an inappropriate activation of the micturition
muscle is already inherently damaged, for example, by partial or defecation reflexes. One important cause is lax PUL or
denervation, this deleterious effect is magnified. USL (Fig. 3.21). The directional muscles which contract
against PUL or USL will suffer reduced contractile
strength. The weakened LP/LMA muscles (Fig. 3.21) can-
3.5.4 L
ax USLs: Role in “Obstructive not stretch the vagina or anorectum sufficiently to support
Micturition and Defecation” (Organ the stretch receptors “N,” so they now fire off at a lower
Emptying Problems) volume to activate the micturition or defecation reflexes.
The cortex perceives these impulses as frequency and
X-ray video studies presented here demonstrate that both urgency symptoms and if this happens at night, nocturia
bladder and anorectum are actively opened out by the same (Fig. 3.22).
3 The Integral System of Pelvic Floor Function and Dysfunction 45
Fig. 3.18 Anorectal opening (defecation) X-ray defecating procto- rectum. The conjoint longitudinal muscle of the anus (downward vector,
myogram sitting position. (a) At rest The anorectal angle (ARA) to the LMA) pulls down the anterior margin of the contracted LP. This is iden-
upper left of the green square is angled. The anus is closed. The superior tical with what happens during micturition [21]. (b) The resultant diago-
surface of the levator plate (LP) muscle is almost horizontal. Defecation nal vector (arrow) opens out the ARA. The anterior wall of anus is pulled
mode ARA is opened out by backward and downward vectors LP/LMA forward by pubococcygeus (arrow) further opening out the anal canal
(arrows). Note the insertion of levator plate into the posterior wall of [33]. LMA longitudinal muscle ani, PRM puborectalis muscle
20
0
2,0 2,5 3,0 3,5 4,0
sarcomere length [µm]
46 P. Petros et al.
Fig. 3.20 Potential
consequences of loose
uterosacral ligaments (USL) as
interpreted by Gordon’s Law.
View from above. The uterus has
prolapsed to first degree. The
USLs have elongated by “L.”
The rectum (R) also has
descended, by virtue of its
attachments laterally to the
elongated USL. The rectum loses
tension. LP (levator plate) inserts
into the posterior wall of R, so
LP also lengthens. LMA
(longitudinal muscle ani) now
has to pull against a lax LP and
USLs. The contractile force and
resulting movement of the
anorectal angle will be
diminished. The large wavy
arrows signify diminished
contractile strength. ATFP arcus
tendineus fascia pelvis, EAS
external anal sphincter, PB
perineal body, PCM
pubococcygeus muscle, PS pubic
symphysis, PUL pubourethral
ligament, S sacrum
L
3 The Integral System of Pelvic Floor Function and Dysfunction 47
PCM
LMA
CORTEX
N C
0 PONS
G afferent
USL impulses inhibitory
centre
LP
Fig. 3.22 Mechanical origin of nocturia—patients asleep. Pelvic mus- cess of evacuation: the patients is awakened by a feeling of urgency
cles (large arrows) are relaxed. As the bladder (broken line outline) fills, (nocturia); PCM (pubococcygeus muscle) is actively relaxed by the cor-
it is distended downward by gravity “G.” If the uterosacral ligaments tex. If the micturition reflex is not adequately controlled, LP/LMA con-
(USL) are weak, the bladder base continues to descend; at a critical tracts to open the urethra and the detrusor contracts; the patient may lose
point, the cortical closure reflex “C” is overcome; the stretch receptors urine on the way to toilet. LMA longitudinal muscle ani, LP levator plate
“N” now activate the micturition reflex “O” which accelerates the pro-
3.5.6 L
ax USL: Anatomical Pathway anesthetic injection into the cervical part of the USLs [39] as
to Chronic Pelvic Pain did Petros in three patients with interstitial cystitis, abdomi-
nal pain, and suburethral tenderness [41]. Gunnemann
The role of USLs in producing chronic pelvic pain was reversed anterior rectal wall intussusception with a cylindri-
described in detail by Heinrich Martius in 1938 [36] but was cal vaginal pessary, inserted under ultrasound control [42].
rediscovered only in 1996 [37]. Chronic pelvic pain is per-
ceived in the visceral nerve distributions T12-L1 and S2–4,
causing pain in the lower abdomen, groin, lower sacrum 3.6 art 3: Cardinal Ligament (CL): Its
P
[38], introitus [39], paraurethral tissues [40], the pain of Role in Cystocele Causation
interstitial cystitis [41], and deep dyspareunia [37]. Inability
of the weakened pelvic muscles to tension the uterosacral Dislocation of CL and anterior vaginal wall from their attach-
ligaments may cause unsupported nerve plexuses within the ments to the anterior cervical ring is the principal cause of
USLs to fire (Fig. 3.23). Objective proof of USLs as the path- cystocele (Fig. 3.24). Surgical cure for POP is best per-
way to chronic pelvic pain origin was obtained by different formed vaginally, ideally repairing both CL and USL with a
types of “simulated operations.” Simulated operations tape (Fig. 3.25) [8, 31, 43]. CL/USL reconstruction will also
mechanically support pelvic ligaments, while the physician improve urinary hesitancy and residual urine [32]. The cervi-
directly observes changes in symptoms. Digital support of cal TFS tape will reattach the insertion point of ATFP if it is
PUL can control USI (Video 1). USL support with the lower dislocated from the ischial spine (Fig. 3.25) and so reconsti-
blade of a speculum or by a tampon can relieve chronic pain tute the depth of the sulcus on that side.
and urge symptoms. Speaking clinically, the stretch recep-
tors are very sensitive. Digital or mechanical support of the
bladder base stretch receptors N, PUL and USL, will usually 3.7 art 4: ATFP: Role in Lateral Cystocele
P
relieve urge symptoms in a clinical situation by inhibiting the and Urinary Stream Diversion
micturition reflex (Video 8). However, excess pressure may
cause urge or even urine loss (Video 9). Wu et al. reported The role of ATFP (arcus tendineus fascia pelvis) is to support
relief of pelvic pain and suburethral tenderness by insertion the paracolpium of the vagina in the manner of a sheet strung
of the lower part of a bivalve speculum to support the poste- across two washing lines. Birth-related dislocation of the
rior fornix [40]. Bornstein relieved vulvodynia pain by local ATFP is almost invariably at the ischial spine. This is
48 P. Petros et al.
3.8.1 A
natomical and Surgical Significance
of DTP Ligaments
a b
Uterus
r
PCF
CL
vagina
Fig. 3.24 Pathogenesis of “high cystocele” (transverse defect). (a) anterior cervical ring allow PCF to rotate down as a cystocele. (b)
Dislocation of cardinal ligament (CL) and the pubocervical fascial Appearance on vaginal examination. The prolapsed CL and the overly-
(PCF) layer of the anterior vaginal wall from their attachments to the ing vagina (V) are located on the lateral side of the cervix (CX)
a b
IS
Fig. 3.25 (a) TFS cardinal (CL) and uterosacral (ULS) ligaments repair. Ligaments are shortened and reinforced by a thin tape placed along their
length. (b) Posterior IVS with a tape on the anterior cervical ring. IS ischial spine (with permission from [43])
3.8.2 PB Function Is Linked to USL Function rectal evacuation by reducing frictional resistance to fecal
flow. Structural damage to PB and its RVF attachment may
The perineal bodies and uterosacral ligaments work as a result in a patient having to splint her perineum to ade-
unit. The extension of rectovaginal fascia (RVF) from PB to quately evacuate feces or mitigate anal mucosal prolapse or
cervix (Fig. 3.28) helps anchor the PBs when the backward hemorrhoidal descent during defecation. In a normal
acting vector (LP) contracts. Tensioning the RVF by LP patient, slow-twitch levator plate contractions at rest stretch
“smooths out” the rectal mucosa, and this helps to facilitate RVF backward. This helps to prevent mucosal in folding
50 P. Petros et al.
OF OF
Vagina TP 2
DTP A DTP
PB PB TP 1
Rectocoele Tape
Fig. 3.26 Surgical cure of descending perineal syndrome. Left figure. downward displaced position of DTP. TP2 shows how a tensioned tape
Stretched and laterally displaced deep transversus perinei (DTP) liga- inserted into the body of DTP and tensioned will elevate and restore the
ments. The attachment to perineal body (PB) is also stretched. This position of DTP, also curing descending perineal syndrome. A anal
allows protrusion of rectocele into the vagina. Right figure. TP1 is the canal, OF obturator foramen
The Japanese TFS surgeons [8, 31] have found that fol-
UT lowing these rules greatly diminishes postoperative pain and
urinary retention and allows the TFS to be performed as a
USL day procedure under local anesthesia. Once the ligaments
have been shortened and reinforced, the directional muscle
CX
forces act immediately to restore all the functions dependent
P of D on the competent ligaments.
RVF
AVF LP
3.8.4 C
omplications of Total Ligament Repair
V
R Surgery Using the TFS Tensioned Mini
Sling
Venous return The minimal nature of the TFS tensioned mini sling and its
obstructed
universal applicability allow surgeons to repair even all five
PB
ligaments at the same time. This method was followed by
the Kamakura and Yokohama units in Japan. Approximately
3600 TFS tapes were inserted into 1495 Japanese patients
between 2007 and 2016 by two units, Kamakura [8] and
Fig. 3.28 Structural effect of loose uterosacral ligaments (USL). The
Yokohama [31]. Almost all patients were discharged within
rectum is held up by USLs like the apex of a tent. Loose USLs may cause
rectal prolapse and anterior rectal wall intussusception (“R,” downward 24 h. This indicates, in general, that short-term complica-
arrows). The prolapsed rectal mucosa may cause back pressure in the tions were minimal. However, from a total of 700 patients,
rectal veins to cause hemorrhoids. CX cervix, LP levator plate, PB peri- the Kamakura unit had three cases of ileus which presented
neal body, R rectum, RVF rectovaginal fascia, UT uterus, V vagina
some months after the initial surgery and required surgical
intervention. The cause was attributed to inadvertent intra-
vagina stretched, very significantly. It follows that any recon- peritoneal placement of the tape. In these 700 patients, 6
structive surgery has to reinforce the structural part of the reported postoperative pain after a 4-ligament TFS repair
ligaments, which consist mostly of Type 1 collagen and elas- (ATFP, cardinal, uterosacral, perineal body ligaments). All
tic tissue. Only an implanted tape can do this [9]. The vagina pain settled by 6 weeks except for a patient with hip pain,
is an elastic organ which plays an important role in transmit- which settled by 24 months (Inoue personal
ting the vector forces to close and open the bladder [2]. communication).
Because healing is by scarring and not regeneration, elastic- In 989 TFS tape implants for PB, ATFP, CL, and USL,
ity cannot be surgically reproduced in the vagina. Therefore the Kamakura unit reported a 1.1% erosion rate for TFS
the vagina must be conserved. Excision of vagina reduces the repair PUL, USL, ATFP, and CL ligaments [8]. However,
quantum of elastin and Type 3 collagen available for proper initial tape erosion rate for PB TFS was 25%; wrong place-
function. Finally, the uterus is the direct or indirect insertion ment of the TFS was identified as the cause. Following mod-
point for all the ligaments. Mesh sheets create dense colla- ification of the insertion technique, the erosion rate fell to
gen which may shrink to cause pain and the Tethered Vagina 2.5%. The Kamakura unit’s experience with TFS PB repair
Syndrome. Hysterectomy should therefore be avoided where emphasized that the TFS ligament repair method is tech-
possible. As well as dividing the cardinal and uterosacral nique and operator dependent. In 60 POP patients [31], the
ligaments, hysterectomy severs the descending uterine artery, Yokohama unit reported one case of hemorrhage requiring
which is the main blood supply of the proximal ends of the hospitalization for several days, but no transfusion. There
cardinal and uterosacral ligaments. This may cause ligament was one case of urinary retention which settled by 2 weeks,
atrophy even with cervical preservation. Three rules of sur- two cervical protrusions requiring cervical amputation.
gery evolve from this discussion: There were no erosions; five patients had postoperative pain
which settled by 3 months. In 100 USI cases [28], Nakamura
1. A loose ligament must be shortened and reinforced with
et al. reported no erosions, 1 bladder perforation (recog-
thin strips of tensioned tape to create a collagenous neo-
nized at the time of implant), 6 cases with de novo urgency,
ligament [9]. This was the surgical principle applied in
and 2 with postoperative pain; 1 settled in 2 weeks and 1 in
the original midurethral sling procedure.
3 months.
2. The vagina must be conserved, not excised.
3. The uterus must not be removed without good cause.
52 P. Petros et al.
l
x
rvi
we
bladder ce
bo
et al. [51]. The Unifying Theory postulated that bladder and SSL
bowel symptoms were caused by neurological and muscle
damage occasioned at childbirth. The Integral System is
le
ce
complementary to these findings and expands our under-
sto
e
cy
urethra
standing. It emphasizes the role of ligaments, which act as el
toc
force transducers of muscle contraction. The latter occur in pubic bone r ec
carefully modulated sequence in the various pelvic floor
functions of continence and evacuation of bladder and bowel.
There are critical roles for muscles pulling against competent
Fig. 3.29 The anatomy of sacrocolpopexy (SCP) or rectopexy mesh.
ligaments for all pelvic floor functions. It follows that at
Schematic sagittal view. Patient standing. SCP mesh is attached to the
some point a damaged muscle must affect bladder and bowel sacral promontory. Uterosacral ligaments (USL) are attached at S3-4.
functions. The Swash theory taken together with the Integral SSL sacrospinous ligament
System therefore provides a cogent explanation for the range
of failed symptoms following successful ligament surgery 3-month regime showed very significant improvement in all
for prolapse. pelvic floor symptoms [58, 59], although mainly in younger
women. This regime was oriented mainly toward strength-
ening the three-directional muscle forces which close the
3.8.6 Muscle, Ligament, or Both? urethra. The regime was home-based. It ran over 3 months
with only four visits. It included electrical stimulation in the
The question is “at what point of damage does this hap- posterior vaginal fornix using a 50 Hz cylindrical probe. Of
pen?” Results from a blinded experiment carried out by PP 147 patients (mean age 52.5 years), 53% completed the pro-
and MS in 47 women with a mean age of 47 years (range gram. Median QoL improvement reported was 66%, mean
18–78) emphasized the importance of ligaments. A group cough stress test urine loss reduced from 2.2 g to 0.2 g; 24-h
of 47 women had muscle biopsies of the PCM at the same pad loss reduced from a mean of 3.7 g to a mean of 0.76 g
time as a midurethral sling. Almost all biopsies showed evi- frequency; nocturia and pelvic pain were significantly
dence of severe muscle damage; 89% were cured the next improved. Residual urine reduced from mean 202 ml to
day after a midurethral sling (MUS) [57]. It was concluded mean 71 ml. Approximately 3% of patients reported wors-
that correction of ligamentous laxity can cure incontinence, ening of their stress incontinence, and these were referred
even when there is muscle weakness. Clearly more research for surgery [58].
is needed to more fully evaluate the role of damaged mus-
cles in those patients who were not cured by ligament
repair. 3.8.8 I s Rectopexy or Sacrocolpopexy (SCP)
an Anatomically Correct Method
for Restoration of Rectal
3.8.7 T
he Three-Muscle, 3-Month Pelvic Floor Intussusception and Rectal Prolapse?
Muscle Strengthening Study
Using pre- and postoperative X-ray proctography,
Further insights into this question may be deduced from Abendstein demonstrated high rates of cure for rectal
Patricia Skilling’s squatting-based pelvic floor study. This intussusception with a posterior sling which was inserted
3 The Integral System of Pelvic Floor Function and Dysfunction 53
in the position of the uterosacral ligaments [25]. 2. Petros PE, Ulmsten U. An Integral Theory of female urinary incon-
Abendstein’s study confirmed the Integral Theory’s pre- tinence. Acta Obst Gynecol Scand. 1990;69(Suppl. 153):1–79.
3. Holm-Larsen T. The economic impact of nocturia. Neurourol
diction that rectal intussusception in women was mainly Urodyn. 2014;33:S10–4.
caused by USL prolapse. Because USL is attached to the 4. Abrams P, Andersson KE, Birder L, 4th International Consultation
lateral walls of the rectum, the rectal wall would also pro- on Incontinence Recommendations of the International Scientific
lapse (Fig. 3.28). Figure 3.29 demonstrates that a mesh Committee. 4th International Consultation on Incontinence
Recommendations of the International Scientific Committee.
used for rectopexy or sacrocolpopexy is far more vertical Evaluation and treatment of urinary incontinence, pelvic
than the natural attachments of rectum to USL. It follows organ prolapse and faecal incontinence. Neurourol Urodyn.
that if the mesh is too tight, it may impede the downward 2010;29(1):1767–820.
acting LMA opening vector for urethra and anorectum to 5. Cathryn MA Breeman S, Elders A, et al. (for the PROSPECT study
group). Mesh, graft, or standard repair for women having primary
cause obstructive evacuation symptoms. Alternatively, if it transvaginal anterior or posterior compartment prolapse surgery:
is too loose, it may not fully restore the intussusception two parallel-group, multicentre, randomised, controlled trials
and mucosal prolapse. (PROSPECT). Lancet 2017;389(10067):381–392.
6. Liedla B, Inoue H, Sekiguchic Y, Gold D, Wagenlehner F,
Haverfieldf M, Petros P. Update of the integral theory and sys-
3.9 Conclusion tem for management of pelvic floor dysfunction in females. Eur
J Urol. 2018;17(3):100–8.
7. Wagenlehner FM, Frohlich O, Bschleipfer T, Weidner W, Perletti
These and other data presented in the main body of this chap- G. The integral theory system questionnaire: an anatomically
ter are consistent with both the Unifying and Integral directed questionnaire to determine pelvic floor dysfunctions in
Theories. The Skilling study confirmed that pelvic floor women. World J Urol. 2014;32:769.
8. Inoue H, Kohata Y, Sekiguchi Y, Kusaka T, Fukuda T, Monnma
muscles play an important role in all the mechanisms out- M. The TFS minisling restores major pelvic organ prolapse
lined in this chapter. Why the exercises do not work so well and symptoms in aged Japanese women by repairing damaged
in older women may have several explanations, in particular, suspensory ligaments—12-48 month data. Pelviperineology.
postmenopausal collagen loss and more marked muscle 2015;34:79–83.
9. Petros PE, Ulmsten U, Papadimitriou J. The autogenic neo-
weakness. However, the high cure rates attained by TFS CL/ ligament procedure: a technique for planned formation of an
USL tapes in 70-year-old women plus the muscle biopsy artificial neo- ligament. Acta Obstet Gynecol Scand Suppl.
data tend to indicate that muscle function, though critically 1990;69(153):43–51.
important, is ultimately reliant on a firm ligamentous inser- 10. Petros PE, Ulmsten U. The combined intravaginal sling and tuck
operation. An ambulatory procedure for stress and urge inconti-
tion point. nence. Acta Obstet Gynecol Scand Suppl. 1990;153:53–9.
11. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory
surgical procedure for treatment of female urinary incontinence.
Scand J Urol Nephrol. 1995;1:75–82.
Take-Home Messages 12. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory
1. Ligaments suspend organs. Collagen is their main surgical procedure under local anesthesia for treatment of female
structural component. Collagen weakens at child- urinary incontinence. Int Urogynecol J. 1996;7:81–6.
13. Petros PE. New ambulatory surgical methods using an anatomi-
birth, menopause to cause prolapse, symptoms.
cal classification of urinary dysfunction improve stress, urge, and
Vagina needs elasticity to function. abnormal emptying. Int J Urogynecol. 1997;8(5):270–8.
2. Opening/closure on anus/urethra is exponentially 14. Liedl B, Inoue H, Sekiguchi Y, et al. Is overactive bladder in the
controlled. Accurate restoration of tension in PUL female surgically curable by ligament repair? Cent Eur J Urol.
2017;70:51–7.
and USL is mandatory to achieve reliable symptom
15. Inoue H, Kohata Y, Fukuda T, Monma M, et al. Repair of dam-
cure. aged ligaments with tissue fixation system minisling is sufficient to
3. Longer-term surgical cure for POP/symptoms is not cure major prolapse in all three compartments: 5-year data. J Obstet
possible if ligaments are weak. Collagenous neo- Gynaecol Res. 2017;43(10):1570–7.
16. Enhorning G. Simultaneous recording of intravesical and intraure-
ligaments (MUS, posterior sling, SCP) can only be
thral pressure. Acta Chir Scandinavica. 1961;27(276):61–8.
created using mesh tapes. 17. Constantinou CE, Govan DE. Contribution and timing of trans-
mitted and generated pressure components in female urethra.
In: Zimmer NR, Sterling AM, editors. Progression in clinical
and biological research, vol. 78. New York: Alan R. Liss; 1981.
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34. Bush M, Petros P, Swash M, Fernandez M, Gunnemann
anal and urinary sphincter musculature in incontinence. J Neurol
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Martius, pioneer in the ligamentous origin of chronic pelvic pain in to the innervation of the pelvic floor musculature: a double pathol-
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The Pelvic Floor: Neurocontrol
and Functional Concepts 4
Michael Swash and Peter Petros
in the intermediolateral columns of the lumbosacral cord. nance of faecal continence, generating tension and kinking
Muscle fibres in the bladder base and in the internal ure- of the recto-anal junction by opposing muscle forces [11].
thral sphincter are innervated by sympathetic nerve fibres, In addition to sympathetic motor innervation of the base
also originating in the intermediolateral cell columns of of the bladder and internal urinary sphincter muscle, there
the spinal cord, but using norepinephrine as transmitter is an extensive sensory innervation of the bladder wall and
[6]. Relaxation of the internal urethral sphincter is depen- mucosa [6]. This consists of mechanoreceptors, sensitive to
dent, in part, on sympathetic innervation of the muscle, stretch and distension, and other receptors that signal
utilising beta-adrenergic parasympathetic efferents that inflammatory change, including pain. The receptors respon-
release nitric oxide as transmitter. Although it is widely sible for these sensations are complex and interdependent.
believed that urinary continence is achieved by low resting The main sensitive area in the bladder is at the bladder base
tone in the bladder detrusor muscle, and tonic contraction in the trigone region and in the immediately adjacent proxi-
of the internal urethral sphincter, this concept is an over- mal urethra, in the urinary sphincter region. There are simi-
simplification. Circumferential contraction around a nar- lar anatomical specialisations in the anal canal [12]. Slight
row tube, such as the urethra, is not, in general, an effective relaxation of the internal anal sphincter allows fractional
sphincteric mechanism. A more effective mechanism uti- extrusion of faecal content into the proximal anal canal,
lises kinking of the urethra, due to a backward muscular inducing the ‘sampling reflex’ [13], that acts as a potent
vector pulling the urethra posteriorly and causing a kink, stimulus which, unless voluntarily suppressed, leads to the
thus obstructing any urine flow. This is achieved by con- initiation of defaecation. Similarly, the increasing sense of
traction of the posterior muscle vectors in a backward/ urinary urgency felt when the bladder is full, particularly in
downward direction, i.e. by the levator plate and the con- response to a change of posture, such as standing, or cough-
joint longitudinal muscle of the anus (Fig. 4.1), a muscle ing, reflects the passage of small quantities of urine into the
grouping that has been shown to be in a state of continuous proximal urethra within the urinary sphincter pressure
mild tonic contractile activity in the default storage mode zone, initiating an urgent voiding response. The external
[10]. The pubococcygeus muscle provides an opposing urinary sphincter is innervated by somatic efferent motor
force, centered on the urethra. Mild resting contraction of fibres from the S2/S3 spinal segments. This voluntary stri-
the puborectalis muscle is a major factor in the mainte- ated sphincter muscle does not totally encircle the urethra
MUSCLES
MUSCLES ATFP
CL
PELVIC RIM
4 The Pelvic Floor: Neurocontrol and Functional Concepts 59
and so is incapable of completely occluding it when con- injury, the reflex relationship between the Onuf nucleus and
tracted [14]. Like the external anal sphincter in faecal con- the bladder and bowel is intact, and urinary voiding and
tinence, the striated external urinary sphincter, or its smooth defaecation are therefore then under strictly lower-level
muscle counterpart, is not the major muscle of urinary reflex control, without the possibility of voluntary modula-
continence. tion. Voluntary control of these functions requires supraspi-
nal mechanisms [16].
Voluntary urinary voiding occurs in response to increasing The first of these supraspinal systems depends on another
pressure and volume within the bladder, causing excitation ‘switch mechanism’ involving the periaqueductal grey
of afferents from bladder trigone sensory receptors, and also (PAG) matter of the midbrain and the pontine micturition
in response to subtle passage of urine into the upper ure- centre (PMC), first described by Barrington in 1933 [19].
thra—the equivalent to the sampling reflex within the anal Two groups of neurons have been recognised in this region,
canal [15]. In babies and young children, or in spinal cord subserving storage (PAG activity) and voiding (PMC activ-
injury above the sacral level, the response to this afferent ity), respectively [12]. Sensory information from the bladder
information, signalling the immediate need to void urine, is projects from the Onuf system in the sacral cord to this clus-
a switch in equilibrium from storage to voiding. ter of neurons adjacent to the periaqueductal grey matter in
the midbrain [16].
4.3.5 C
entral Representation of Afferent
4.3.2 The Lumbosacral Loop Information from Bladder and Bowel
In the normal human, the simple spinal mechanism limited Processing of afferent information from the bladder and
to the sacral spinal cord for urinary voiding and defaecation bowel therefore involves relaying this information, most of it
described above is subject to modulation from higher CNS carried in autonomic afferents, to the thalamus, and thence to
centres. After spinal transection, for example, due to spinal the insular cortex, a region of the brain concerned with infor-
60 M. Swash and P. Petros
4.3.6 U
niversal Organisation of CNS Control
Systems
4.4 The Pelvic Floor and Its Innervation with damage to the innervation of the pelvic floor muscula-
ture, a combination of abnormality especially associated with
The basic structure of the pelvic floor consists of muscular disorders of continence. In the presence of weakness of the
and fascial planes positioned in relation to the anorectal, pelvic floor due to lax ligaments, tearing of muscle fibres, and
vaginal, and urethral openings. The perineal musculature damage to the somatic innervation of pelvic floor muscles and
within the pelvic floor functions as a whole during urinary sphincters, the central nervous system will adapt and modify
and faecal storage, which should be regarded as the default descending motor commands, insofar as it is capable of doing
mode, but the anterior and posterior components are capable so, to prevent urinary or faecal leakage. Similarly, adaptations
of distinct, separate function during micturition and defaeca- in CNS function occur in relation to other pelvic floor disor-
tion, respectively. These functions are under separate but ders, for example, urgency. These natural adaptations form
analogous control within the central nervous system, as the functional basis for the use of conditioning therapy, or
described above. The innervation of the pelvic floor muscu- other neuromodulation procedures, usually based on methods
lature is largely from somatic efferent and afferent nerve to facilitate increased sensory awareness [28]. These manage-
fibres travelling within the lumbosacral plexus, and therefore ment strategies reinforce the process of maintaining storage
entering these muscles superiorly, but the external anal at rest but are unlikely to have any biological effect on the
sphincter and external urethral sphincter muscles, and the already damaged system, particularly regarding its multifac-
puborectalis and pubococcygeus muscles, are innervated by torial nature. When the innervation of some of the muscles of
branches of the pudendal nerve, the external urethral and the pelvic floor is damaged, there is less capacity for resetting
inferior rectal nerves, that supply these muscles from a cau- of control systems.
dal aspect. All these nerves are derived from sacral spinal
segments via the lumbosacral plexus [25].
4.6 Investigation of the Pelvic Floor
inhibitory
centre
efferents
relax 0
PCM
afferent impulses
LP
LMA
PS 4.11 W
hen Things Go Wrong: Urge,
PCM
Frequency, and Nocturia
LMA
4.12 Overactive Bladder Syndrome (OAB)
Fig. 4.6 The trigone. The trigone extends to the external urethral meatus.
Pubococcygeus muscle (PCM) relaxation is indicated by a broken line
pink arrow. When the upward and forward contracting PCM relaxes, In 1993, it was shown that prematurely activated, but other-
levator plate (LP) stretches the vagina and trigone backwards into a semi- wise normal micturition [31, 32], usually termed urge incon-
rigid structure. Longitudinal mascle ani (LMA) pulls down the trigone. C tinence but also known as ‘detrusor instability’ or more
closed diameter of urethra (storage reflex dominant), O open diameter of
urethra (voiding reflex dominant). H hammock, PS pubic symphysis, recently ‘detrusor overactivity’ (DO), followed the same
PUL pubourethral ligaments activation sequence as normal micturition (Fig. 4.4): first, a
feeling of urgency, then a decrease in urethral pressure (X),
followed detrusor contraction causing increased detrusor
4.9 he Bladder Trigone During
T pressure, and urine flow (Fig. 4.7). At the onset of the syn-
Micturition drome, there is a strong afferent phase of urethral sensory
activation, due to urine entering the upper urethra, as the tri-
The trigone (Fig. 4.6) extends from the bladder base to the gone opens out slightly. Conflict between a natural desire to
tip of the external meatus. Its intrinsic stiffness resembles inhibit this unwanted signal for micturition and the urge to
that of the anterior vaginal wall. The posterior muscular vec- void produces physiological uncertainty between the storage
tor, the levator plate muscle, stretches the trigone posteriorly. (C) and voiding responses, which can be recognised urody-
This reduces urethral resistance to urine flow because the namically (Fig. 4.8).
posterior urethral wall becomes semi-rigid, creating a fun-
nel, as seen in the micturition X-ray.
4.13 H
ow Does Detrusor Overactivity
Relate to Feedback Control?
4.10 N
eurological Feedback Control
of Anorectal Function Detrusor overactivity represents a prematurely activated
micturition sequence. Close examination of the urody-
A system similar to that for bladder control operates for ano- namic patterns in Fig. 4.7 indicates that the micturition
rectal closure and evacuation (Fig. 4.1) (see also Video 2). As reflex has been activated and bladder (B) and urethra (U)
the rectum fills, the stretch and surface receptors (N) send show identical wave patterns. When the micturition
signals to the cord that are relayed to the frontal cortex. response is activated, excitation of smooth muscle fibres by
These can be suppressed voluntarily by the storage response parasympathetic nerve endings in the detrusor muscle
(white arrow), which activates contraction of the opposed causes the bladder to contract as a whole [30], as seen in the
directional musculoligamentous forces (arrows) that support video X-ray voiding study (see Video 1). However, the
the anorectum from below. A further temporary control detrusor muscle spasms. It does not relax and contracts
mechanism for both bladder and rectum is voluntary upward like a striated muscle. What the bladder pressure transducer
contraction of the puborectalis muscle. This counteracts the is measuring is the repeated striated muscle contractions of
downward mechanical pressure of the bladder or faecal con- the rhabdosphincter as it tries to close the urethra at the
tents and diminishes sensory activation (green arrows). base of the bladder.
4 The Pelvic Floor: Neurocontrol and Functional Concepts 65
O X
CLOSED
C
C O OPEN
feeling of
urgency
CP
1.0gm
Ou urine loss
Od
Om
Cm
(voiding) response ‘O’ is dominant, the striated muscles act- nally acting striated muscle forces (Fig. 4.10). This
ing on the urethra relax and the urethral pressure falls. Because external mechanism causes a non-linear change in resis-
there is a brief delay between the afferent signals from the blad- tance to flow that is inversely proportional to the fourth
der reaching brainstem and higher centres causing this switch power of the radius (Poiseuille’s Law; see Fig. 4.10) [17,
to the voiding response via the pontine micturition centre, the 18]. Therefore, in the urinary system, the flow response to
system may ‘hunt’ between the two states of storage and void- narrowing or opening the urethral diameter is very rapid.
ing, thus creating a ‘wave pattern’ (Fig. 4.9). For example, young people empty their bladders in just a
few seconds. This concept of internal resistance to flow
within the urethra is key to understanding normal storage
4.15 N
on-linear Flow Mechanics Enhance (continence) and voiding (micturition) and abnormal
the Storage and Voiding Responses bladder states, e.g. incontinence, ‘obstructive’ micturi-
tion, and obstructive defaecation. This interpretation is
Bladder and rectum are elastic and expansile receptacles. also important in understanding data from urodynamics,
The urethral and anal diameters are narrowed during stor- especially its wide variance, and the results of corrective
age and widened during voiding or evacuation by exter- surgery.
20
straight tube
10
4mm diam
0
0 5 10 15 20 25 30
4.16 W
hy Urodynamic Urethral Pressure controlling the rate of urine outflow is the diameter of the
Measurements Correlate Poorly urethra (Figs. 4.9, 4.10, and 4.11) which, in turn, regulates
with Clinical States the resistance to flow against the pressure (P) of detrusor
contraction. Whether urine leaks or not depends on the resis-
During passage of urine, including incontinent leakage, urine tance to flow within the urethra (see above). Urodynamic
flows from the bladder to the exterior. Bench testing [17] and studies are limited to measurement of intravesical and intra-
mathematical modelling [18] indicate that the key factor urethral pressures ‘P’ and flow rates. Pressure is derived
Fig. 4.12 ‘Outflow
obstruction’ in the female—
Lax ligament insertions for
the LP/LMA opening vectors
cannot open the urethra
sufficiently against its elastic
forces. Even with constant
activation of the pelvic
muscles, the stream is slow
and prolonged with
electromyography (EMG)
activity seen throughout the
micturition cycle
from the relation between applied force and transverse ure- DU is present in 9–48% of men and 12–45% of older women
undergoing urodynamic evaluation for non-neurogenic lower
thral area (πr2). Intra-urethral pressure ‘P’, being proportion- urinary tract symptoms (LUTS). Multiple aetiologies are impli-
ate to r2, is not what prevents urine loss. Pressure at any point cated, affecting myogenic function and neural control mecha-
on the urethral diameter is not a sufficiently sensitive mea- nisms, as well as the efferent and afferent innervations.
surement index of incontinence, because it is the resistance Diagnostic criteria are based on urodynamic approximations
relating to bladder contractility such as maximum flow rate and
to urine flow, which is proportionate to r2, which prevents detrusor pressure at maximum flow. Other estimates rely on
urine loss, not external urethral pressure. mathematical formulas to calculate isovolumetric contractility
Conversely, for urine to flow easily, there must be ade- indexes or urodynamic "stop tests." Most methods have major
quate external opening of the urethra, by opening out its pos- disadvantages or are as yet poorly validated. Contraction
strength is only one aspect of bladder voiding function. The oth-
terior wall, as shown in the micturition X-ray (Figs. 4.5 and ers are the speed and persistence of the contraction.
4.11). If the urethra cannot be opened out adequately, there is
a sensation of obstruction to flow. In Fig. 4.11, the urethra The ‘myogenic function and neural control mechanisms’
has been rapidly opened out by prior external muscle con- mentioned by Osman et al. [33] are relevant but undefined
traction, so micturition is rapid and effective. Continued concepts, as they are at present impossible to quantify. We
external striated muscle contraction is not required as urine present here an alternative mechanism based on research by
is incompressible and itself maintains urethral opening. In Bush et al. [17] which is consistent with Osman’s conceptual
contrast, in Fig. 4.12, the urethra cannot be adequately analysis [33]. If the urethra can be opened by the external mus-
opened. The posterior muscles LP and LMA (Fig. 4.6) have cle forces to 4 mm diameter (Fig. 4.11), urine could flow at a
to contract repeatedly, and urine flow is slow. rate of 7 ml/second with no recordable detrusor pressure. This
does not mean that the bladder is ‘underactive’. The bladder
smooth muscle will contract sufficiently that the bladder can
4.17 H
ow Repeatable Are Urine Flow empty fully. Demonstrable urinary flow indicates that the ure-
Measurements in an Individual? thra has been opened sufficiently to lower the internal resis-
tance to a point at which the detrusor force enables flow to
Urine flow studies measure the volume of urine flowing occur. For example, at a flow rate of 20 ml/s (Fig. 4.10), a
through the urethra at a defined diameter expressed as ml/ 50 cm head of pressure from the detrusor is needed to over-
second. Urine flow is determined by the internal resistance to come the internal resistance to flow in a 3.25 mm tube, but
flow [17, 18] as discussed above. Individual repeat flow mea- only a 20 cm head of pressure is required for a 4 mm tube. The
surements [18] are remarkably variable, because the opening graph (Fig. 4.10) illustrates the difference in voiding patterns
mechanism assisting micturition is activated by pelvic floor in Fig. 4.11 (rapid flow) and Fig. 4.12 (slow flow).
striated muscle vectors (see EMGs in Fig. 4.12) and detrusor
contractile power may vary from void to void. A very minor
change in urethral diameter causes a profound change in 4.19 Low Bladder Compliance
flow rate.
In a study of detrusor instability (now termed detrusor over-
activity) and low compliance [34], the low compliance data
4.18 Detrusor Underactivity could only be reconciled by considering ‘low compliance’ as
a partially activated micturition reflex. Bladder ‘stiffness’ is
Detrusor underactivity (DU) is an ill-defined entity. Osman a consequence of smooth muscle contraction by an activated
et al. [33] noted that: but modulated micturition reflex.
4 The Pelvic Floor: Neurocontrol and Functional Concepts 69
4.20 Clinical Variations in Bladder tional modes conform with classic Chaos Theory feedback
Symptoms Are Consistent calculations. As long as the closure reflex mechanisms, both
with the Chaos Theory Feedback central and peripheral, can control the increasing sensory
Equation input ‘X’ (X = no of afferent impulses), the patient’s bladder
remains in ‘stable closed’ mode, and the patient is dry. At the
One of the mysteries of clinical urology is the marked vari- peak of the curve, the reflex closure mechanisms are over-
ability of symptoms such as urgency and nocturia. This vari- come by the excessive number of afferent impulses (X) arriv-
ability is consistent with the classic Chaos Theory [35] ing at the pontine micturition centre and cortex; the
feedback equation Xnext = Xc (1 − X). In Fig. 4.13 the feed- micturition response begins to be activated. The system
back control system [34] was tested for compatibility with becomes unstable and oscillates between ‘open’ and ‘closed’
the Chaos Theory graph derived from the Chaos Theory (Figs. 4.8 and 4.9). Patients may therefore report complete
feedback equation Xnext = Xc (1 − X). Calculations were made dryness on some days, yet they may wet four to five times on
(see below) in three functional modes: low afferent activity other days.
(normal mode), increased afferent activity from a micturition
reflex activated but controlled (low compliance mode), and
excessive afferent activity exceeding the ability of the closure 4.21 Concluding Remarks
reflex to inhibit the afferent impulses ‘overactive bladder’
mode (see Fig. 4.1). An excess of afferent signals brings the The neurocontrol systems responsible for appropriate void-
system into the ‘chaotic zone’ in which equilibrium oscil- ing of urine and faeces are linked to the default position of
lates between voiding (open) and storage (closed): in this continent storage. The control system is organised on a lay-
zone the closure reflex is in unstable competition with the ered sequence of neural systems that consist of local pelvic
micturition reflex (see Figs. 4.8 and 4.9). These three func- floor and bladder and anorectal structures—the end-organs—
and spinal, brainstem, and higher-level cortical circuits.
These circuits are integrated and responsive to each other.
When the pelvic floor and its sphincteric systems are dam-
aged, for example, by a difficult childbirth, or prostatic
OPEN obstruction, a measure of adaptation in these neural systems
CHAOTICZONE
unstable
is possible, although little is known about their adaptive
CLOSED
unstable
capacity. It is essential that any corrective pelvic floor surgi-
cal procedures should retain the inherent musculo-elasticity
c
XNEXT of this system, since this determines the musculotendinous
stabled closed function necessary for normal function of the pelvic floor
and its sphincteric systems.
retention
Fig. 4.13 (after Gleick 1987). The graph is that of a classic Chaos 1. Snooks SJ, Barnes RPH, Swash M. Damage to the voluntary
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Urogynecol. 1998;9:103–7. different levels of disturbance in peripheral feedback control of the
19. Barrington FJ. The relation of the hind-brain to micturition. Brain. micturition reflex. Neurourol Urodynamics. 1999;18:81–91.
1921;44:23–53. 35. Gleick J. “Inner Rhythms” in chaos—making a new science.
20. Blok BFM, Sturms LM, Holstege G. Brain activation during mictu- London: Cardinal Penguin; 1987. p. 275–300.
rition in women. Brain. 1998;121:2033–41.
Part II
Pelvic Floor Imaging
Principles and Technical Aspects
of Integrated Pelvic Floor Ultrasound 5
Andrzej P. Wieczorek, Magdalena Maria Woźniak,
Jacek Piłat, and Giulio A. Santoro
to perform pelvic floor ultrasound as the first-line or screen- lung tissue 650 m/s, in bone tissue from 1500 to 4300 m/s
ing tool modality [3–5]. [3]. The speed of ultrasound wave c is determined by the
“Pelvic floor ultrasound” is a synonymous of a large vari- formula:
ety of techniques (translabial, transperineal, endovaginal,
endoanal, 3D/4D acquisitions, dynamic US, assessment of C
c=
vascularity patterns, and tissue stiffness—elastography), hav- p
ing different advantages and limitations [6, 7]. Understanding
the physics of ultrasound, the mechanism of interactions of c—speed of sound, C—coefficient of stiffness, p—density.
ultrasound beam with tissues, the process of image formation, Different materials respond differently to interrogation by
the choice of imaging parameters, the optimization of quality ultrasound, depending on the extent to which their medium
of image (gain, focus, resolution), the identification of arti- particles will resist change due to mechanical disturbance.
facts, the characteristics of transducers (mechanical and elec- This medium property is referred to as the characteristic
tronic frequencies, field of view, convex, end-fire, linear) and acoustic impedance of a medium. It is a measure of the resis-
scanners, and the different anatomical approaches that can be tance of the particles of the medium to mechanical vibra-
used is therefore of utmost importance [8–11]. Despite ultra- tions. This resistance increases in proportion to the density of
sound is considered operator-dependent, an adequate training the medium and the velocity of ultrasound in the medium.
and use of standardized methodology have demonstrated a Acoustic impedance, Z, may be defined as the product of
very good intra- and interobserver reproducibility of this medium density and ultrasound velocity in the medium [8]:
modality [12–14]. Great advance has been made in develop- Z = density ´ velocity
ing a very sophisticated ultrasound technology; however the
vertical model for care of disease has limited a clinician’s Ultrasound waves are generated by piezoelectric crystals
understanding to the vertical unit in which the clinician (urol- in the transducers. The number of piezoelectric crystals in
ogist, gynecologist, and colorectal surgeon) has an expertise. the transducers and the range of frequencies they can operate
The emerging concept of horizontal integration of pelvic in are very important features. In case of 2D technology, the
floor dysfunction evaluation and management is expanding to number usually exceeds 190 elements; in 3D and 4D tech-
ultrasound approach that must be integrated and multicom- nologies, the transducer may be designed as a matrix array,
partmental [6, 15]. Global or total ultrasound addresses all where the number of piezoelectric elements may be multi-
pelvic floor anatomy and functionality in one setting, allow- plied to more than a 1000 elements. The signals generated in
ing identification of coexisting dysfunctions of the three com- the transducer are subsequently sent to the tissue and received
partments [6]. back by transmit channels. The number of physical active
channels can reach a few hundred (over 500), whereas trans-
mit channels used in post-processing may reach even a few
5.2 Principles of Pelvic Floor Ultrasound millions. Ultrasound imaging is based on the signals gener-
ated by the returning echoes at the transducer that are elec-
Ultrasound imaging is a technique of generating images tronically processed to increase their sizes and organized in
using a very high-frequency sound. Sound is a mechanical, computer memory before being displayed to the user. The
vibration form of energy. Ultrasound for medical imaging is echoes returning from different tissue depths must be sub-
generated in special crystalline materials which, when elec- jected to compensation for attenuation differences. Time
trically excited, are capable of vibrating at frequencies of gain compensation (TGC) is a process of applying differen-
millions of vibrations per second [8]. Operating frequencies tial amplification to signals received from different tissue
for medical ultrasound are in the 1–40 MHz range, with depths, with echoes originating from longer distances being
external imaging machines typically using frequencies of amplified to a greater extent than those from shorter dis-
1–20 MHz. Higher frequencies are in principle more desir- tances in such a way that similar tissue boundaries give
able, since they provide higher resolution, but tissue attenua- equal-sized signals regardless of their depth in tissue. The
tion limits how high the frequency can be for a given latest generations of scanners have automatic adjustment of
penetration distance. However, one cannot arbitrarily TGC independent from the operator.
increase the ultrasound frequency to get finer resolution, The difference between the maximum and minimum val-
since the signal experiences an attenuation of about 1 dB/cm/ ues of the displayed signal is defined as dynamic range, and
MHz [9]. it is one of the most essential parameters that determine its
The velocity of propagation of ultrasonic longitudinal image quality [11]. Nowadays dynamic range may vary
waves in soft tissues varies depending on the type of tissue, from 70 Db to over 300 Db. Because the dynamic range of
in single collagen fibers (tendons) equals c = 1700 m/s, in signal sizes may be very wide, the range of signal sizes is
5 Principles and Technical Aspects of Integrated Pelvic Floor Ultrasound 75
compressed by using logarithmic amplifiers. Pulses with image such as zooming, rotating, contrasting, sharpening,
identical waveforms are repeated each time the crystal is changing the transparency, removing artifacts in order to
excited, at a rate known as the pulse repetition frequency present the volumetric image in the most diagnostic
(PRF). The PRF represents the number of pulses or bursts of manner.
ultrasonic energy, released by the transducer in one second, In order to produce high-quality images, it is crucial to
and is different from the vibration frequency of the trans- understand the nature of artifacts in pelvic floor imaging.
ducer [8]. The major causes of artifacts include multiple reflections
The most basic but at the same time a crucial mode in across acoustic boundaries, acoustic shadowing due to strong
pelvic floor ultrasound is the brightness mode (B-mode). In reflectors or absorbers of ultrasound, and poor physical con-
B-mode the signals from returning echoes are displayed as dition of the transducer. Other artifacts may be caused by
dots of varying intensities (gain). The intensity of a dot (the refraction of ultrasound, scattering, wave interference phe-
brightness) is a relative measure of echo size, with large nomena, or less than perfect mechanical and electrical isola-
echoes appearing as very bright dots, while at the other tion of crystal elements.
extreme non-reflectors, they appear totally dark. Lastly important features influencing the diagnostic value
It is important to notice that an ultrasound pulse consists of pelvic floor ultrasound are the environmental conditions
of a range of frequencies, not a single frequency. For exam- such as proper room lightning, proper monitor settings
ple, a pulse from a 5 MHz transducer could be composed of (Fig. 5.1), and the ability of the user to operate the scanner
a range of frequencies from 4 MHz to 6 MHz. This range of accordingly.
frequencies is called the bandwidth [5]. Another important Summarizing, a variety of factors contributes to the over-
feature is use of harmonics imaging. The ultrasound pulse all quality of the ultrasound image. These include the design
starts out with a sinusoidal waveform. As the wave passes of equipment components, especially the transducer; the
through tissue, the wave speeds up very slightly during the choice of imaging parameters, particularly the beam fre-
compression phase, and during the refraction phase, the quency; and the skilled use of the equipment by the operator.
wave slows slightly. This causes a distortion of the wave and A good-quality image should contain information that is
creates the harmonic frequencies. Harmonics are frequencies associated with high spatial resolution (ability to distinguish
at multiples above the fundamental frequency—the fre- between objects in space), high contrast resolution (ability to
quency that was emitted from the transducer. The fundamen- distinguish between signals of different size), and high tem-
tal frequency is also known as the first harmonic [5]. The poral resolution (ability to separate between events in time).
main advantage of the harmonic imaging is increasing the In addition, the image should be free of any avoidable arti-
resolution of the image obtained. facts [8].
More advanced techniques in pelvic floor ultrasound
include the use of multidimensional imaging—three-
dimensional (3D) and four-dimensional (4D). The main pre- 5.3 Two-Dimensional Transperineal
requisite for construction of three-dimensional (3D) Ultrasound (2D TPUS)
ultrasound images is very fast data acquisition. Transducers
for real-time imaging may be classified broadly into two cat- 2D TPUS is performed with the patient placed in the dorsal
egories: mechanical transducers and electronic transducers. lithotomy position, with hips flexed and abducted and a convex
In mechanical transducers, the beam sweep is achieved transducer positioned on the perineum between the mons pubis
through physical movement of some part of the transducer, and the anal margin (perineal approach). The dimension of the
usually the crystal element(s), whereas in electronic trans- transducer should be large enough to cover in the midsagittal
ducers the beam is swept by electronic activation of crystal plane all anatomical structures between posterior margin of the
elements, without causing the transducer to move physically. symphysis pubis and anterior margin of the coccyx/posterior
The collected data are processed at high speed, so that real- part of the levator ani, e.g., bladder, urethra, vaginal walls, anal
time presentation on the screen is possible. This is called the canal, and rectum. TPUS is a term that should be regarded as
four-dimensional (4D) technique (4D = 3D + real time) [8]. being synonymous with “translabial ultrasound” (transducer
The 3D image can be displayed in various ways, such as placed on one of the labia majora) or “perineal ultrasound”
transparent views of the entire volume of interest (render (transducer placed between the posterior vaginal wall and anal
mode), images of surfaces (surface mode), images in three canal), while “introital ultrasound” is usually assumed to imply
perpendicular sections (axial, sagittal, coronal) called multi- placement of transducers with smaller footprints (such as end-
planar reconstruction (MPR), or as a volume 3D box acces- fire transvaginal probes or hokey-stick intraoperative transduc-
sible from every side and section. Post-processing options of ers) within the introitus. The general term of “TPUS” is often
3D and 4D images enable numerous manipulations of the adopted for all these techniques. Imaging is usually performed
76 A. P. Wieczorek et al.
with the patient at rest, during maximal Valsalva maneuver and cies ranging from 2 to 6–8 MHz, with a field of view at least
during pelvic floor muscle contraction (squeeze test) to dynam- 70° (Fig. 5.2a). The number of crystals/piezoelectric elements
ically define the position and anatomical relationship between in large convex transducers may differ depending on manufac-
urethra and bladder, vaginal walls, and the anorectal region turers; however it is around 192 elements placed on a surface of
anal canal. In order to avoid false-negative results, transducer approx. 50–62 mm length and 8–13 mm width (acoustic aper-
pressure on the perineum must be as small as possible, while ture). Another type of transducer also used for 2D TPUS scan-
still m
aintaining good tissue contact, in order to allow full pel- ning is a “small” convex transducer designed primarily for
vic organ descent [16, 17]. pediatric or early pregnancy examinations. It is characterized
by higher frequency (from 5 to 9–10 MHz) in comparison to
“large” convex transducers and smaller sizes of acoustic aper-
5.3.1 Convex Transducers ture (Table 5.1, Fig. 5.2b). A third type of transducer also suit-
able for 2D TPUS scanning is an endocavitary end- fire
Two-dimensional transperineal ultrasound (2D TPUS) in microconvex probe used for gynecological/urological pur-
B-mode represents the most frequently used modality provid- poses. It is characterized by frequency ranging from 5–6 to
ing 2D imaging of the pelvic floor in the midsagittal section [6, 8–9 MHz and smallest acoustic aperture (Table 5.1, Fig. 5.2c).
16, 17]. It is performed with convex transducers that may differ Some scanners have dedicated protocol for urogynecology;
depending on frequency and surface of contact (Table 5.1). The however the operator can adjust the setting to get good-quality
higher is the frequency, the smaller is the shape of convex sur- images. The focal zone should be concentrated at the level of
face. The conventional “large” convex transducers usually used the bladder neck, which is approx. 30–40 mm deep, whereas
for abdominal and obstetrical scanning have low resolution due the field of view and the ultrasound angle can be regulated to
to low frequencies, because they must have high penetration to focus on a certain anatomical structure to obtain better image.
image deep organs in the patient’s body. They work at frequen- A limitation of the 2D TPUS technique is its sensitivity in
5 Principles and Technical Aspects of Integrated Pelvic Floor Ultrasound 77
Table 5.1 Types and characteristic of convex transducers used in 2D TPUS examinations
Type of probe Example transducer Example ultrasound 2D TPUS image
“Large” 6C2 Fig. 5.2 Two-dimensional transperineal ultrasound performed with
convex BK-Medical 4 different types of transducer. Pelvic floor structures are visualized in
10
the midsagittal section. Differentiation of the external and internal
sphincters and the lumen of anal canal are visible better with
27
higher-frequency (small convex and end-fire) transducer than with
77
lower-frequency (large convex) transducer. (a) Large convex
Primary Abdominal
purpose Obstetrical
Range of 2–6 MHz
frequencies
Number of 192
elements
Image field 62°/71°
Acoustic 62.5 × 13 mm
aperture
a
“Small” 9C2 (b) Small convex
convex BK-Medical
1,5
10
30,7
56
Primary Pediatric
purpose Early pregnancy
Range of 2–9 MHz
frequencies
Number of 192
elements
Image field 74°/104°
Acoustic 52 × 8 mm
aperture
b
End-fire 8819 (c) End-fire. A anal canal, B bladder, SP symphysis pubis, U urethra
BK-Medical
319
22,1
18,2
Primary Gynecology
purpose Urology
Range of 6–9 MHz
frequencies
Number of 128
elements
Image field 150°
Acoustic 26 × 5 mm
aperture
c
78 A. P. Wieczorek et al.
dynamic studies when the image may be distorted by artifacts ers. Frequency of linear transducers is higher than large
caused by the reflections from gases in the anal canal in patients convex transducers and may range from 5–7 MHz even up
with rectocele/enterocele (Fig. 5.3). to 20–22 MHz. The most common range of frequency var-
ies from 8 to 10–12 MHZ for the transducers dedicated to
small part imaging, breast imaging, and musculoskeletal
5.3.2 Linear/Microconvex Transducers scanning. “Hokey-stick” intraoperative linear transducers
are also appropriate for this purpose due to small size,
For introintal use in adult patients and in case of children angulated shape, and high frequency, delivering high-res-
and newborns to find out the anatomical disorder in pelvic olution image. These transducers can be introduced endo-
floor, higher-frequency transducers (linear, microconvex, vaginally/endoanally with a finger guidance to the
or end-fire gynecological/obstetrical or urological) can be suspected area. Microconvex and end-fire gynecological/
used (Table 5.2, Fig. 5.4). Linear transducers provide visu- obstetrical or urological transducers have higher frequen-
alization of superficial pelvic anatomical structures or cies starting from 5 up to 9–12 MHz, with better resolu-
subcutaneous fluid collections/fistulas and anorectal mal- tion than large convex transducers, but are limited by a
formations that can be missed by low-frequency transduc- small surface of contact (Table 5.2, Fig. 5.4).
5 Principles and Technical Aspects of Integrated Pelvic Floor Ultrasound 79
Table 5.2 Types and characteristic of linear transducers used in 2D TPUS examinations
Type of
probe Example transducer Example ultrasound 2D TPUS image
“Lower- 13 L5 Fig. 5.4 Pelvic floor structures by transperineal ultrasound
frequency” BK-Medical visualized with different types of transducers. (a) “Lower-
linear 0
frequency” linear transducer— sagittal section (A anal canal, B
10
bladder, U urethra)
a
66
22
Primary Small parts
purpose MSK (large joints)
Range of 5–13 MHz
frequencies
Number of 192
elements
Image field 49.9 + 2 × 15°
Acoustic 50 × 4 mm
aperture
“Higher- 18L5 (b) “Higher-frequency” linear transducer—sagittal section showing
frequency” BK-Medical intraurethral tumor (T)
linear
97
b
30,5
57
9,5
Primary Intraoperative
purpose MSK (finger/toe joints)
Range of 5–18 MHz
frequencies
Number of 150
elements
Image field Trapezoidal: 24.0 mm wide + expansion
angle 2 × 15°
Acoustic 3.5 × 24 mm
aperture
80 A. P. Wieczorek et al.
5.4 T
hree-Dimensional/Four-Dimensional [21]; with high-multifrequency (9–16 MHz), 360° rotational
Transperineal Ultrasound (3D/4D mechanical transducer (type 2052, 20R3 BK-Medical) [21];
TPUS) or with radial electronic probe (type AR 54 AW, 5–10 MHz,
Hitachi Medical Systems) (Table 5.4, Fig. 5.6 and 5.7).
5.4.1 Volumetric Transducers It is important to keep the transducer inserted into the
vagina in a neutral position and to avoid excessive pressure
Volumetric transabdominal probes developed for obstetric on surrounding structures, which might distort the anatomy
imaging (RAB 8–4, GE Healthcare Ultrasound, Milwaukee, [6, 21]. The biplane electronic probe provides 2D sagittal
WI, USA; AVV 531, Hitachi Medical Systems, Tokyo, (linear array) and axial (transverse array) sectional imaging
Japan; V 8–4, Philips Ultrasound, Bothell, WA, USA; 3D of the anterior and posterior compartments. Imaging is usu-
4–7 EK, Medison, Seoul, South Korea) and other may be ally performed with the patient at rest, during maximal
used for 3D/4DTPUS. These transducers combine an elec- Valsalva maneuver and during squeeze test. The vascular
tronic curved array of 4–8 MHz with mechanical sector tech- pattern of the pelvic floor structures may also be assessed
nology, allowing fast motorized sweeps through the field of using color Doppler mode [21, 22].
view, a technology that was pioneered in the Voluson sys- Dressler et al. [13] reported from good to excellent repeat-
tems manufactured by Kretztechnik, now GE Healthcare ability and reproducibility of the measurements of the subu-
Ultrasound [18]. For the “pelvic floor” assessment, the sug- rethral tape location obtained by pelvic ultrasound performed
gested set is maximum aperture and acquisition angles (70° with transvaginal end-fire probe. This demonstrates that for
and 85°, respectively), depth of 8 cm, two focal zones at experienced operators which have no access to dedicated
1.5 cm and 4.5 cm, low or medium harmonics, speckle pelvic floor equipment, conventional gynecological trans-
reduction 5, and crossbeam 2 [18] (Table 5.3, Fig. 5.5). ducers provide adequate results.
An advantage of 3D TPUS compared with 2D mode is the
opportunity to obtain tomographic or multislice imaging (TUI),
for example, in the axial plane, in order to assess the entire 5.6 T
hree-Dimensional Endovaginal
puborectalis muscle and its attachment to the pubic rami, as Ultrasound (3D EVUS)
described by Dietz et al. [19, 20]. It is also possible to measure
the diameter and area of the levator hiatus and to determine the Radial electronic transducer, electronic linear transducer, and
degree of hiatal distension on Valsalva maneuver. 4D TPUS rotational mechanical transducer provide a 360° view of the pel-
imaging involves real-time acquisition of volume ultrasound vic floor [6, 21]. However with the radial electronic transducer,
data, which can then be visualized instantly in orthogonal the 3D acquisition is freehand, whereas with the linear elec-
planes or rendered volumes. This simplifies the assessment of tronic transducer and the mechanical transducer, the 3D acquisi-
functional anatomy since 3D data can be archived as a cine tion is automatic. The mechanical probe has an internal
loop, encompassing maneuvers such as squeeze test or Valsalva motorized system that allows an acquisition of 300 aligned
maneuver [6]. Similar to DICOM viewer software used in radi- transaxial 2D images over a distance of 60 mm in 60 s, without
ology, offline analysis is possible on the actual system or on a any movement of the probe within the tissue. The set of 2D
personal computer (PC) with the help of dedicated software. images is reconstructed instantaneously into a high-resolution
Similarly as in 2D TPUS, particularly on prolapse assess- 3D image for real-time manipulation and volume rendering.
ment, pressure on the perineum must be kept to a minimum However the operator may individually adjust the distance of
to allow full development of the prolapse [18]. The limitation acquisition, slice thickness, and time of acquisition which is
of 3D/4D TPUS is a small region of interest (acquisition subsequently reflected in the image quality obtained (shorter
angle) not able to cover all pelvic floor organs in patients time and thicker slice thickness are related to lower quality of
with high-grade prolapse and in patients with high BMI. the image). An advantage of 3D compared with 2D mode is the
opportunity to obtain sagittal, axial, coronal, and any desired
oblique sectional image. The 3D volume can also be archived
5.5 T
wo-Dimensional Endovaginal and further post-processed for offline analysis on the ultrasono-
Ultrasound (2D EVUS) graphic system or on a PC with the help of dedicated software.
The methodology of 2D and 3D EVUS was described by
EVUS is performed with the patient placed in the same posi- Santoro and Wieczorek [6, 7, 14, 21]. Detailed ultrasound
tion as that adopted for TPUS. It may be performed with morphology of the urethra and its vasculature was described
electronic linear transducer, frequency 4–14 MHz (type by Wieczorek et al. [7, 12, 22–24] and Lone et al. [25, 26].
8838, X14L4 BK-Medical, Herlev, Denmark); with elec- Shobeiri et al. [27] described the ultrasonographic anatomy
tronic biplane transducer (linear and transverse perpendicu- of levator ani subdivisions, whereas Santoro et al. [28]
lar arrays), frequency 5–12 MHz (type 8848, BK-Medical) described the perineal body anatomy.
Table 5.3 Types and characteristic of volumetric transducers used in 3D/4D TPUS examinations
Type of probe Example transducer Example ultrasound 2D TPUS image
“Large” RAB 4–8 Fig. 5.5 Three-dimensional image of pelvic floor structures by 3D TPUS visualized with different types of
volumetric GE Medical transducers. (a) Volumetric “abdominal/obstetrical” transducer—multiplanar reconstruction and surface mode (A
anal canal, B bladder, SP symphysis pubis, U urethra)
a
5 Principles and Technical Aspects of Integrated Pelvic Floor Ultrasound
b
(continued)
81
Table 5.3 (continued)
82
Endovaginal RIC5-9-D (c) Volumetric endovaginal transducer—multiplanar reconstruction and surface mode
volumetric GE Medical
c
Matrix RSM 5-14
GE Medical
Table 5.4 Types and characteristic of transducers used in 2D/3D EVUS and 2D/3D EAUS examinations
Type of probe Example transducer Example ultrasound 3D EVUS/EAUS image
High- 20R3 38
resolution BK-Medical
(3D EVUS) and endoanal (3D EAUS) approaches visualized with different
360°
2
types of transducers. High-resolution 360° transducer: (a) 3D EVUS, (b, c)
54
3D EAUS. A anus, ES external sphincter, IS internal sphincter, R rectum, SP
symphysis pubis, U urethra, V vagina
17
Primary EVUS
purpose EAUS
Range of 9–16 MHz
frequencies
Number of 1
elements
Image field 360°
Acoustic NA
aperture
(continued)
84 A. P. Wieczorek et al.
Table 5.4 (continued)
Type of probe Example transducer Example ultrasound 3D EVUS/EAUS image
Linear X14L4 (d, e) 3D EVUS with linear 360° transducer
360° BK-Medical
2
36
5
15
55
36
θ16.4
Primary EVUS
purpose EAUS
Range of 4–14 MHz
frequencies
Number of 192
elements
Image field 360°
d
Acoustic 65 × 5.5 mm
aperture
e
(f) 3D EAUS with linear 360° transducer. A anal canal, B bladder, ES
external sphincter, IS internal sphincter, PB perineal body, R rectum, SP
symphysis pubis, U urethra, V transducer into vagina
f
(continued)
5 Principles and Technical Aspects of Integrated Pelvic Floor Ultrasound 85
Table 5.4 (continued)
Type of probe Example transducer Example ultrasound 3D EVUS/EAUS image
Linear E14CL4b Fig. 5.7 Axial section of the urethra visualized with linear biplane
biplane BK-Medical transducer. (a) Elastographic image of the urethra during Valsalva
2,5
35
F 32,4 maneuver; (b) compare B-mode gray scale of the urethra image shown
simultaneously to the elastographic image. U urethra; white arrow,
rhabdosphincter muscle at rest (blue, soft); yellow arrow, longitudinal
F 20 smooth muscle during contraction/bladder neck opening (red, hard)
Primary Urology/prostate
purpose Prostate elastography
Range of 4–14 MHz
frequencies
Number of 128 transverse
elements 192 sagittal
Image field 138°/178°
transverse
65 mm + 2 × 15°
sagittal
Acoustic 23 × 5.5 mm
aperture transverse
65 × 5.5
sagittal
5.7 T
wo-Dimensional Endoanal ring is applied to the probe handle, sealing the probe cover.
Ultrasound (2D EAUS) The cover is filled with a variable amount of degassed water
(approx. 60–100 ml) depending on the compliance of the
Endoanal ultrasound (EAUS) includes examination of the examined section of the bowel. Using a dedicated rectoscope
anal canal (endoanal ultrasound—EAUS) and of rectal region (slightly wider than the standard one), the probe can be
(endorectal ultrasound—ERUS). EAUS is performed with inserted to a depth of 20 cm enabling examination of the
high-multifrequency, 360° rotational mechanical transducer, deeply located lesions and precise assessment of the depth/
linear electronic transducer, or a radial electronic transducer, extend of the infiltration of tumors (Fig. 5.8) as well as precise
as described above for EVUS (2052, 20R3, 8838; E14CL4b
BK-Medical). During examination, the patient may be placed
in a dorsal lithotomy, left lateral or prone position. However,
irrespective of patient position, the transducer should be
rotated so that the anterior aspect of the anal canal is superior
(12 o’clock position) on the screen: the right lateral aspect is
to the left (9 o’clock), the left lateral aspect is to the right (3
o’clock), and the posterior aspect is inferior (6 o’clock) [6].
The recording of data should extend from the upper aspect of
the puborectalis muscle to the anal verge [6, 29] (Table 5.4,
Fig. 5.6). The high-resolution 360° transducers provide mini-
mal slice thickness of 1 mm. The rotating crystal moves
mechanically, and the operator can decide individually and
adjust the distance scanned up from a minimum of 0 mm to a
maximum of 60 mm using two buttons on the probe. The
number and the depth of the focal zone/zones can be also
manually adjusted by the user. The location of the buttons
directly on the probe enables manipulation of the image with-
out the need of changing the position of the transducer intro-
duced endoanally, which is mostly important in rectal Fig. 5.8 3D ERUS. High-resolution 360° transducer. Examination per-
examination performed with a distension of rectal ampulla by formed with degassed water-filled balloon. A ampulla recti, B water
a water-filled balloon. For such type of examination, a special balloon, T tumor
86 A. P. Wieczorek et al.
assessment of very high fistulas. In the evaluations of fistulas, elastography, as well as the opportunity of ultrasound/MR
it is helpful to use hydrogen peroxide (approx. 2–5 ml) as a fusion allow for assessment of female pelvic floor structures
contrast medium that is injected through the external opening. of all three compartments in 2D, 3D, and 4D techniques.
Hydrogen peroxide allows precise visualization of the anat- Different anatomical approaches such as TPUS, EVUS,
omy of the fistulas and helps to differentiate active tract from EAUS, and abilities of post-processing give the clinicians
scar tissue. Similar technical solution with the opportunity of diagnostic power to understand the anatomy and anatomical
examining the anorectal region is offered with the transrec- abnormalities. Ultrasound can be used as an extension for
tum composite probe type UST-678 (Hitachi, Japan). This clinically obtained dose of information and its better under-
probe enables scanning with the field of view of 120° (convex standing but can be also employed for qualification for cer-
array), on the length of 60 mm (linear array). The frequency tain surgical procedures. Another advantage of using
of the transducer can be adjusted from 3 to 9 MHz (convex ultrasound is the opportunity of detailed diagnosis of post-
array) and from 4 to 10 MHz (linear array). A balloon cover surgical complications and explanation of the causes of sur-
filled with water and fixed by the dedicated rubber band to the gical failure. All these factors make ultrasound the modality
transducer allows examination of the rectal ampulla. which should be considered as the first choice imaging tech-
Compared to the transducers previously described, the new nique in diagnostics of female pelvic floor disorders.
linear electronic probe (type 8838, BK-Medical), frequency
of 4–4 MHz, or its recent version X14L4 offers similar imag-
ing opportunities (only in sagittal section) (360°, length of
scanning from 0 to 60 mm length, 1 mm minimal slice thick- Take-Home Messages
ness, manual adjustment of focal zones) with full measure- • Pelvic floor ultrasound can be performed with a
ment capabilities as the probes above but with higher variety of transducers and anatomical approaches.
resolution. The limitation of this probe is lack of a system for • The knowledge of capabilities and limitations of
the distension of rectal ampulla by a water-filled balloon. each type of transducer, anatomical access, and
post-processing options is crucial for performing
pelvic floor ultrasound in a proper way and making
5.8 Three-Dimensional Endoanal reliable diagnosis.
Ultrasound (3D EAUS) • Modern ultrasound technologies such as Doppler
ultrasound, elastography, three- and four-
The methodology of 2D and 3D EAUS was described by dimensional ultrasound, and tomographic ultra-
Santoro et al. [6, 29]. The mechanical rotational transducer sound imaging (TUI) can enhance significantly the
or the electronic linear transducer allows automatic 3D quality of information obtained; however good
acquisition without movement of the probe relative to the knowledge of the technical aspects of the tech-
tissue under investigation. After the dataset has been niques and their pros and cons is essential.
recorded, it is possible to interrogate the dataset in 3D, with
multiplanar imaging [6]. The 3D image may be rotated,
tilted, and sliced to allow the operator to vary infinitely the
different section parameters and to visualize and measure References
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ume rendering) [29]. multidisciplinary approach. London: Springer-Verlag; 2006.
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3. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans
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dysfunction. Int Urogynecol J. 2017;28:5–31. dimensional or volume imaging. Ultrasound Obstet Gynecol.
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Gynecol. 2011;37:381–96. endovaginal ultrasonography in the assessment of pelvic floor
7. Wieczorek AP, Stankiewicz A, Santoro GA, Wozniak MM, anatomy: a preliminary study. Internat Urogynecol J Pelvic Floor
Bogusiewicz M, Rechberger T. Pelvic floor disorders: role of new Dysfunct. 2009;20:1213–22.
ultrasonographic techniques. World J Urol. 2011;29:615–23. 22. Wieczorek AP, Wozniak MM, Stankiewicz A, Bogusiewicz M,
8. Tole NM, Ostensen H, World Health Organization. Diagnostic Santoro G, Rechberger T, Scholbach J. The assessment of normal
Imaging and Laboratory Technology Team. Basic physics of ultra- female urethral vascularity with Color Doppler endovaginal ultra-
sonic imaging. In: Tole NM; editor. Ostensen,Harald: World Health sonography: preliminary report. Pelviperineology. 2009;28:59–61.
Organization. 2005. P. 95. 23. Wieczorek AP, Wozniak MM, Stankiewicz A, Santoro GA,
9. Brunner E. How ultrasound system considerations influence front- Bogusiewicz M, Rechberger T, Scholbach J. Quantitative assessment
end component choice. Analog Dialogue. 2002;36:1–3. of urethral vascularity in nulliparous females using high-frequency
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Transperineal Ultrasonography:
Methodology and Normal Pelvic Floor 6
Anatomy
Hans Peter Dietz
should be suitable for pelvic floor ultrasound, provided the tation, the first published translabial images had the perineum
aperture angle is 70° or better and provided the acquisition at the top and the symphysis pubis on the left [7], and this is
angle can be set to at least 70°. For severe prolapse and hiatal still the most commonly used orientation. It is particularly
ballooning, aperture and acquisition angles of 80–90° can convenient when using three-dimensional (3D)/four-
become necessary. dimensional (4D) systems as shown in Fig. 6.2. The top left
The examination is performed in dorsal lithotomy with image represents the midsagittal plane, with the bottom right
the hips flexed and slightly abducted or alternatively in the showing a rendered volume of the levator hiatus.
standing position. Asking the patient to place her heels close The advent of 3D/4D imaging has given easy, noninvasive
to the buttocks will result in an improved pelvic tilt. A full access to the axial plane allowing imaging of the caudal part of
bladder or bowel may prevent full development of pelvic the levator ani muscle and the opening in this muscular plate,
organ prolapse [7]. Therefore, imaging is best performed the levator hiatus (Fig. 6.2). The levator hiatus is an important
after bladder emptying; otherwise bladder filling should be part of the birth canal and the largest potential hernial portal in
specified. Occasionally, catheterization will be necessary. the human body. It is of central importance in the pathophysi-
For preparation of the probe, it is covered with either a ology of female pelvic organ prolapse (POP), a highly preva-
powder-free glove, condom, or thin plastic wrap for hygienic lent condition that may require surgery at least once during the
purposes, after covering the transducer surface with ultra- lifetime of 10–20% of the female population [8, 9].
sound gel and while avoiding air bubbles between transducer POP is best understood as a hernia through the levator
surface and glove. The probe is then placed on the perineum hiatus. In childbirth the hiatus is distended massively [10],
after parting the labia, producing a midsagittal view showing and the limiting structure, the puborectalis muscle, runs a
urethra and anal canal at the same time (see Fig. 6.1). Tissue substantial risk of permanent damage, either due to irrevers-
hydration and scar tissue can affect visibility, but obesity is ible overdistension or due to actual disruption in the shape of
virtually never a problem. Conditions are best in pregnancy avulsion, i.e., disconnection from its insertion on the os pubis
and poorest in the senium. The probe can be placed firmly [11, 12]. Both forms of trauma seem to be risk factors for
without causing significant discomfort, unless there is POP and POP recurrence after reconstructive surgery [13–
marked atrophy or vulvitis. During a Valsalva it is essential, 16]. Hence, imaging of the levator hiatus and puborectalis
however, not to exert undue pressure to allow full develop- muscle in axial plane images is becoming increasingly
ment of pelvic organ descent. After scanning the probe is popular.
mechanically cleaned, followed by disinfection with alco- Most recently, the coronal plane has attracted increasing
holic wipes. Sterilization as for intracavitary transducers is interest as it provides excellent views of the anal canal, espe-
usually considered unnecessary. cially the anal sphincter complex, and volume acquisition is
On translabial ultrasound, pelvic floor structures are ini- optimally performed in the coronal plane, as shown in
tially shown in the midsagittal plane [1]. This orientation, Fig. 6.3. The increasing prevalence of anal sphincter trauma,
shown in Fig. 6.1, allows imaging of the urethra, the bladder especially in jurisdictions with rising forceps rates such as in
neck and trigone, the cervix, the rectal ampulla, and the anal the UK and Australia [17], makes the development of this
canal. While there is no universal consensus on image orien- method particularly timely and important.
Urethra vagina
and
canal
symphysis
bladder
Fig. 6.1 Transducer placement on the perineum (left) with schematic representation of the resulting midsagittal field of vision. Right image
adapted from [1], with permission
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 91
Fig. 6.2 Standard representation of female pelvic floor structures on a–c) in the axial plane is given in (d). Often, a and d are of the most inter-
translabial/perineal ultrasound. The midsagittal plane is shown in (a), the est and are combined, leaving out b and c. In d the patient’s right-hand
coronal in (b), the axial in (c). A rendered volume (i.e., the semitranspar- side is represented on the left, as if the pelvic floor was viewed from
ent representation of all pixels in the “region of interest,” the box seen in below. L levator ani, S symphysis pubis. From [74], with permission
transversus
perineum
perinei
IAS
EAS
ischio-
rectal
fossa
a b anal
mucosa
Fig. 6.3 Transducer placement for exo-anal sphincter imaging (left), and schematic illustration of imaged structures in the resulting coronal or
transverse plane (right). EAS external anal sphincter, IAS internal anal sphincter. From [32], with permission
92 H. P. Dietz
Live anatomy of pelvic floor structures as observed on shape; in the midsagittal plane, it is harder to see due to the
real-time imaging commonly bears only limited resemblance echogenicity of retropubic fibrofatty tissue. Echogenicity of
to textbook illustrations. The “urogenital diaphragm” is a fig- smooth and striated urethral muscle changes with the angle
ment of the imagination to those performing translabial of the incident beam, i.e., the angle between urethra and
ultrasound. The levator plate appears very different from transducer. On Valsalva the urethra frequently rotates around
textbook illustrations derived from cadaver dissection, and the symphysis pubis, changing the angle between urethral
the anal canal is longer and slimmer in reality than in draw- structures and the incident beam; and the hypoechogenic
ings derived from endo-anal ultrasound which necessarily stripe of urethral smooth muscle seems to disappear
dilates and shortens this structure. Common forms of pro- (Fig. 6.5). If the urethra rotates more than 90°, it may “reap-
lapse such as cystocele and rectocele appear rather different pear” once the smooth muscle of the proximal urethra is
from textbook illustrations when imaged live. again more parallel with the incident beam, which often
Given that cadaver dissection and illustrations derived from occurs in severe cystocele.
dissection are frequently misleading, it seems a ppropriate to
use this chapter to describe the normal anatomy of the pelvic
floor as seen on 3D/4D pelvic floor ultrasound. 6.3.2 Paraurethral Tissues
a b
Fig. 6.4 The urethra as seen on translabial 4D ultrasound. The midsag- indicate the urethral rhabdosphincter which appears as two hyperechoic
ittal plane is on the left (a). Small arrows show the external meatus at stripes on the left and as a hyperechoic ring shape on the right (b)
the top, and the internal urethral meatus at the bottom. Large arrows
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 93
a b
Fig. 6.5 Determination of bladder neck descent and retrovesical angle: measurement of distances between interior symphyseal margin and
Ultrasound images show the midsagittal plane at rest (a) and on Valsalva bladder neck (vertical, x; horizontal, y) and the retrovesical angle at rest
(b). A anal canal, B bladder, L levator ani, R rectal ampulla, S symphy- (rva-r) and on Valsalva (rva-s). From [53], with permission
sis pubis, U urethra, Ut uterus, V vagina. The images demonstrate the
Fig. 6.7 Midsagittal imaging at rest (left) and on Valsalva (right) in and the large arrow the location of urethral kinking. The variability of
patient with grade II cystocele. There is marked urethral kinking at mid- urethral echogenicity relative to the angle between urethra and incident
urethral level, i.e., at the location of urethral tethering to the pelvic side- beam is also clearly apparent
wall. The small arrows indicate external and internal urethral meatus,
a b
c d
Fig. 6.8 Measurement of bladder wall thickness at the dome in four women with non-neuropathic bladder dysfunction. In all cases shown in
images (a–d) residual urine is well below 50 ml. The limit of normality is usually taken to be 5 mm. From [74], with permission
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 95
6.6.1 N
ormal Anatomy in the Midsagittal
Plane
Fig. 6.10 Fornices are assessed by tomographic ultrasound, with eight triangular appearance, with the apex aiming toward the os pubis) and
slices obtained from the plane of minimal hiatal dimensions to 12.5 mm indicated with (∗). From [26], with permission
above this plane. In the figure, the fornices are all intact (i.e., showing a
Fig. 6.11 Anteverted uterus as seen in the midsagittal plane, with the
corpus resting on the roof of the empty bladder. The cervix is just visi-
ble cranial to the rectal ampulla which often obscures a normally situ-
ated cervix. B bladder, POD pouch of Douglas, R rectal ampulla, Fig. 6.12 Appearance of a normal, well-supported vaginal vault in
S symphysis pubis, V vagina. The uterus is outlined by dots; both cervix patient with stage 2 cystocele. The position of bladder (B), vault (V),
and endometrial echo are clearly visible and rectal ampulla (R) are measured against the inferoposterior margin
of the symphysis pubis (S)
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 97
Fig. 6.13 The echogenicity and appearance of the perineum vary slices of the perineum. Sometimes fibers seem to be completely sepa-
greatly even in vaginally nulliparous women. However, in the latter it is rate from the EAS (top row; fat oblique arrows); at other times some
often possible to identify a hyperechoic transverse structure superficial fibers clearly merge with the EAS (bottom row; thin vertical arrows)
to the external anal sphincter (EAS); see those tomographic transverse
a b
Fig. 6.14 Appearance of a presumably intact rectovaginal septum on 3D pelvic floor imaging in orthogonal planes (a–c). Arrow indicates the
location of the septum which appears as a linear hyperechogenic structure in the midsagittal (a) and axial (c) plane
98 H. P. Dietz
6.6.4 T
he Anal Canal on Tomographic (more vertical than horizontal) and by varying the posi-
Imaging tion of the transducer relative to the fourchette and anus.
A view of the three sectional planes allows centering of
The anal canal and rectal ampulla are conveniently imaged the sphincter in the volume (Fig. 6.15). The anal canal should
in the midsagittal plane, but this is not the case for the be horizontal in the B (midsagittal) plane and vertical in the
anal sphincters. Traditionally, sphincter imaging is under- C (transverse) plane, an orientation that helps identify the
taken by endo-anal probes which provide a coronal plane cranial extent of the EAS (Fig. 6.16) by locating the fascial
view of the sphincters, visualizing them as donut- or tar- plane between EAS and levator ani. The EAS is then imaged
get-shaped structures. On pelvic floor ultrasound, this in tomographic slices, from above the EAS cranially to the
requires rotation of the transducer to the coronal plane subcutaneous EAS below the termination of the IAS cau-
(see Fig. 6.3). Volume acquisition at 60–70° aperture and dally (Fig. 6.17) [32]. Depending on EAS length, which can
acquisition angle, with harmonics set to “high” and focal vary from 8 to 35 mm in healthy individuals [33], the inter-
zones adjusted to sit at the depth of the area of interest, slice interval may have to be set to anywhere from 1.5 to
provides optimal imaging. A pelvic floor muscle contrac- 5 mm.
tion and adjustment of transducer pressure may also help The cranial termination of the EAS is of importance for
to optimize resolutions. The distance between external the reproducibility of slice location, and several factors may
anal sphincter and transducer surface is highly variable, impact on the identification of this structure. Commonly, the
not the least due to the state of the perineum, but is easily ventral and dorsal aspects of the EAS show “rotational asym-
adjusted by holding the transducer at a rather steep angle metry,” that is, on average the EAS is slightly longer ven-
a b
Fig. 6.15 Imaging of the anal sphincters in cross-sectional planes. The b plane, providing proof that the entire EAS is included in the volume. An
a plane shows the typical donut appearance of the external anal sphincter oblique axial view is represented in the c plane and demonstrates that the
(EAS, hyperechogenic) and the internal anal sphincter (IAS, hypoechoic) anal canal is properly centered in the volume, i.e., seen as vertical in c.
in the coronal plane. The standard midsagittal orientation is given in the Reproduced with permission from [74]
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 99
Fig. 6.16 A crucial step in translabial 4D sphincter imaging is the tal plane (usually given in the plane of an orthogonal representation as
identification of the cranial limit of the external anal sphincter (EAS). in Figure 6.16) allows the identification of the fascial plane between
This has to be obtained dorsally, at least in parous women, as the ventral EAS and levator ani (arrows)
aspect of the EAS may have been altered by birth trauma. The midsagit-
Fig. 6.17 Tomographic imaging of normal external and internal anal sphincter (EAS) (left thick line in the reference image); the most caudad
sphincters. The reference plane at the top left shows the midsagittal plane. (bottom right) is placed below the internal anal sphincter (right thick line)
Vertical lines indicate the location of eight coronal slices given in this fig- in the reference image. As a result, the entire EAS should be covered in
ure. The most cranial slice (center top) is located above the external anal this tomographic representation. From [32], with permission
100 H. P. Dietz
Fig. 6.18 Occasionally, a prominent LMA (longitudinal muscle of the sentation of the EAS. In such cases, the presumed “drop” shape of the
anus, indicated by arrows) may interfere with locating the cranial mar- EAS allows an estimation of its cranial limit, as given here. A small
gin of the external anal sphincter (EAS), as evident in the midsagittal incidental hemorrhoid in slices 6–8 is indicated by (∗)
reference plane (slice 0) given on the top left of this tomographic repre-
trally than dorsally, but the o pposite may also occur. Such 6.7 The Levator Ani Muscle
asymmetry however does not seem to affect diagnostic per-
formance [33]. 6.7.1 2D Imaging
Occasionally, it is possible to distinguish separate compo-
nents of the EAS, with the most distal component often being The puborectalis muscle can be seen on 2D translabial ultra-
more echogenic than the more proximal component of the sound in a parasagittal plane, with the transducer tilted from
muscle. This can lead to ambiguity in the identification of the dorsomedially to ventrolaterally as in Fig. 6.19 [34]. The
cranial EAS margin, since two fascial planes rather than one fibers of the puborectalis muscle may be followed from the
may be identified. In this situation one needs to use the more os pubis to the anal canal; more cranial aspects of the levator
proximal of the two planes. Another source of inter-individual usually show a different fiber direction.
variation is the longitudinal muscle of the anus (LMA) which
can be so thick as to resemble a cranial continuation of the
EAS (Fig. 6.18). Sometimes the cranial termination of the 6.7.2 Axial Plane
EAS has to be extrapolated assuming a teardrop-shaped
EAS. In practice, fortunately, these variations in anatomical Except when using obsolete side-firing vaginal transducers,
appearance are of minor importance and unlikely to interfere access to the axial plane requires 3D/4D transducers, and
with the diagnosis of sphincter trauma. Finally, it has to be this is the main reason why 4D imaging using abdominal
mentioned that hemorrhoids can adversely affect imaging of volume probes has become such an asset to pelvic floor med-
the caudal aspects of the internal anal sphincter. icine over the last 10 years. Noninvasive, easy access to the
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 101
a b
c
caudal
dorsal
Symphysis
pubis
Puborectalis muscle
Pelvic
sidewall
Fig. 6.19 Transducer orientation for imaging of the puborectalis mus- ultrasound, with the hyperechogenic muscle fibers clearly visible
cle by translabial 2D ultrasound (left image), the resulting parasagittal (right). Adapted from [34], with permission
view in a schematic drawing (center), and a normal muscle insertion on
a b c d
Fig. 6.20 Measuring hiatal dimensions as shown in a rendered volume plane is shown in (c) and (d). The midsagittal plane on the left (c) dem-
(a, b) and in an oblique single axial plane (c, d). The region of interest onstrates a line indicating the minimal sagittal diameter of the hiatus,
(ROI) box in (a) (approx. 1.8 cm deep) is located between the symphy- i.e., the location of the oblique axial plane shown in (d). The dotted line
sis pubis and the levator ani posterior to the anorectal angle. Image (b) in (b) and (d) represents hiatal area measurements (21.77 cm2 in (b),
represents a semitransparent view of all pixels in the ROI box on the 23.05 cm2 in (d)). A anal canal, B bladder, L levator ani, R rectum, S
left. The determination of hiatal dimensions using a single oblique axial symphysis pubis. From [36], with permission
axial plane has led to this method largely replacing MRI for 6.7.3 Multislice Imaging
imaging of levator trauma, especially in the form of tomo-
graphic imaging. In addition, the levator hiatus, the largest Contrary to tomographic imaging with computed tomogra-
potential hernial portal in the human body, can be imaged phy (CT) and MRI, volume ultrasound produces not just a
either as a single plane [35] or with the help of a “rendered series of predetermined slices but rather a volume of infor-
volume” [36], i.e., a semitransparent representation of all mation that allows us to alter slice orientation arbitrarily,
volume pixels in a given space, a technology that was origi- after completion of an examination that takes only a few
nally developed for fetal imaging (see Fig. 6.20). Both meth- minutes. This has already been mentioned in the context of
ods are equally valid and repeatable and allow quantification sphincter imaging, and it is equally useful in the assessment
of the “levator hiatus,” through which all forms of uterovagi- of the levator ani, the second major muscular structure to suf-
nal and anorectal prolapse can be seen to herniate out of the fer permanent, clinically relevant damage in childbirth.
abdominal space. The primary component of the levator ani complex, both
Due to the requirements of childbirth, the hiatus is much in childbirth and for pelvic organ support, is the puborectalis
larger in women than in men and constitutes a structural and muscle, a V-shaped structure that inserts on the inferior pubic
functional compromise. The levator ani may be congenitally ramus and the body of the os pubis bilaterally, coursing
overdistensible [35] and vary between individuals and also around the anorectal junction posteriorly where it defines the
between ethnic groups [35, 37], but “ballooning” [38] is anorectal angle. Dorsally the anococcygeal raphe anchors it
clearly more likely in vaginally parous women due to the fact to the coccyx, which explains the commonly used alternative
that childbirth enlarges hiatal dimensions [39]. Hiatal area is anatomical term, pubococcygeus [42]. Figure 6.21 shows a
strongly associated with pelvic organ descent [41] and mod- comparison of graphic representation, dissection, and sono-
erately with prolapse recurrence after pelvic reconstructive graphic representation of the intact puborectalis muscle.
surgery [16, 40, 41], which makes it potentially useful in the As opposed to the anal canal, we are unable to identify the
investigation of women with pelvic floor disorders (see cranial termination of the puborectalis muscle since it is in
Chap. 48). continuity with iliococcygeus and coccygeus muscles.
102 H. P. Dietz
Symphysis Symphysis
pubis pubis
Urethra Urethra
Pubo- Pubo-
rectalis rectalis
Ischiorectal
Ischiorectal
fossa
fossa
Anus Anus
Fig. 6.21 Representation of the puborectalis muscle in a drawing (left), on cadaver dissection (middle), and in a rendered volume, axial plane
(right)
Fig. 6.22 Tomographic imaging of the puborectalis muscle in a nul- 2.5 mm caudad shows the pubic rami further apart. In the right central
liparous patient. The interstice interval is standardized to 2.5 mm. The slice, the pubic rami are usually invisible due to acoustic shadowing.
central slice should show the most inferior aspect of the symphyseal The arrows indicate the location of the pubic rami/the os pubis in the
gap, with the pubic rami appearing hyperechoic. The left central slice three central slices
Hence, we use the symphysis pubis as a reference structure, While imaging on pelvic floor muscle contraction results in
with the central slice placed approximately at the plane of clearer images, assessment at rest may be equally valid [44,
minimal hiatal dimensions showing the symphysis pubis 45]. Using the minimum criterion of three central positive
closing (Fig. 6.22). On tomographic representation, a 2.5 mm slices for the diagnosis of avulsion (see Chap. 48) [46], a
interslice interval allows coverage of the entire muscle [43]. false-positive diagnosis of avulsion seems unlikely [47]. In
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 103
Fig. 6.23 Measurement of the levator-urethra gap (LUG) between the center of the urethra and the insertion of the puborectalis can be helpful in
difficult cases. The limits of normal for this measurement have been defined as 25 mm in Caucasians and 23.6 mm in East Asians
difficult cases, measurement of the “levator-urethra gap” or organ location, but test characteristics are not improved com-
LUG (Fig. 6.23) is useful [48–50]. An equivalent measure- pared to the supine position [58].
ment, the levator-symphysis gap or LSG, has been described Normality of a quantitative measure such as organ descent
on MRI [51]. Cutoffs of 25 mm in Caucasians [48] and can be defined in at least two ways: mathematically as the
23.6 mm in East Asians [49] have been defined as limits of mean plus/minus two standard deviations and against symp-
normality. toms arising from abnormal anatomy, i.e., symptoms of
Function of the levator muscle can be ascertained by stress urinary incontinence in the case of urethral mobility
measuring muscle thickening and shortening on contrac- and bladder neck configuration and symptoms of prolapse in
tion, but indirect measures such as bladder neck lift or a the case of pelvic organ mobility. The mathematical approach
reduction in hiatal dimensions are more practicable (see to defining normality requires assessment of nulliparae,
Fig. 6.24) and associated with other parameters of pelvic since pregnancy and childbirth are clearly the main environ-
floor function [52, 53]. However, excellent pelvic floor mental confounder. The second approach is appropriate in a
functionality may not be evident in high-displacement mea- population in which symptoms are common, e.g., in women
surements due to high resting tone and low tissue elasticity; who seek assessment or treatment for manifestations of pel-
sonographic measures of pelvic floor function may there- vic floor dysfunction.
fore not be superior to other measures of “strength” such as
digital palpation or perineometry.
6.9 rethral Mobility and Bladder Neck
U
Configuration
6.8 Static Versus Dynamic “Normality”
Excessive bladder neck descent or “hypermobility” has been
In clinical medicine, we commonly describe “static” nor- commonly thought to be responsible for stress urinary incon-
mality which is quite often all there is to see and assess. An tinence (SUI) and urodynamic stress incontinence (USI), but
ovary looks “normal” or “not” – it has no “dynamic” nor- “hypermobility” of the bladder neck is usually not defined
mality. The pelvic floor is very different in this regard how- numerically. Bladder neck descent as shown in Fig. 6.26 var-
ever. Most pelvic floor dysfunction is due to abnormalities ies greatly in young, healthy, asymptomatic women [59] and
of dynamic anatomy or function. Female pelvic organ pro- is likely to be genetically determined [60]. It varies between
lapse, obstructed defecation, and stress urinary incontinence ethnic groups [61–63] and is associated with stress urinary
are disorders of functional anatomy—problems usually only incontinence [64, 65]. This association between stress conti-
become apparent once support structures are put under nence and bladder neck mobility is consistent with the con-
strain. cept of force or pressure transmission through “pubourethral
The degree of strain is essential when it comes to measur- ligaments” (see above): the more mobile the urethra, the
ing organ descent. Assessment of organ descent during a greater the likelihood of poor function of these ligaments,
Valsalva maneuver performed in the supine position after and the poorer may be pressure transmission. This concept is
bladder emptying [54] shows good test characteristics even if supported by the observation that mobility at the locus of
Valsalva pressure is not controlled [55], provided it is per- urethral tethering by pubourethral structures, the mid-ure-
formed over a time period of at least 6 s [56] and provided thra, is more strongly associated with continence than blad-
levator co-activation is avoided [57]. Figure 6.25 demon- der neck mobility [19].
strates the importance of an optimal Valsalva maneuver. Recent work suggests a cutoff of 25 mm for the definition
Assessment in the standing position will result in lower of “bladder neck hypermobility” [66]. However, its associa-
104 H. P. Dietz
Fig. 6.24 Three methods of determining the effect of a pelvic floor pair shows reduction of the anteroposterior diameter of the levator hia-
muscle contraction (PFMC) in the midsagittal plane, using 2D transla- tus (LH (ap)), and the bottom pair illustrates bladder neck (BN) dis-
bial ultrasound. The left-hand images in each pair (a, c, e) represent the placement on PFMC, analogous to the way BN descent is measured on
resting state; the right-hand images show findings on PFMC. The top Valsalva. LA levator ani, SP symphysis pubis. From [53], with
pair illustrates measurement of the levator plate angle (angle between permission
symphyseal axis and levator hiatus in the midsagittal plane), the middle
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 105
Fig. 6.25 Levator co-activation as a confounder of Valsalva effort. The and f a full, appropriate Valsalva. It is evident that, while there is some
top row of images shows the midsagittal, and the bottom row the axial bladder neck descent on Valsalva in (b), the levator hiatus in e is in fact
plane. a and d demonstrate findings at rest, b and e a suboptimal smaller than in (d), indicating a confounding PFM contraction. LA leva-
Valsalva confounded by pelvic floor muscle (PFM) activation, and c tor ani. Adapted from [57] with permission
tion with stress urinary incontinence is barely strong enough chosen for numerical evaluation. Figure 6.27 shows the mea-
to use the “symptoms” approach to determining normality, surement of organ descent against a horizontal line placed
with an area under the curve of 0.61 on ROC statistics, and through the inferior margin of the symphysis pubis. There is
the mathematical approach (mean + 2SD) in young Caucasian limited information on the “normality” of pelvic organ
nulliparae would yield 35 mm [59]. descent in young nulliparous women. In the previously men-
The association between proximal urethral rotation and ret- tioned study in 116 nulligravid 18–24-year-old Caucasians
rovesical angle on the one hand and stress continence on the asymptomatic of prolapse, the mean plus two SD yielded
other hand is even weaker, with AUCs below 0.6 [66]. However, potential cutoffs of 6 mm below the symphysis pubis for
an “open” retrovesical angle (RVA) of 140° or higher and proxi- bladder descent, of 5 mm above for uterine descent, and of
mal urethral rotation of >45° have been identified as the “ana- 24 mm below the symphysis for descent of the rectal ampulla
tomical correlate” of stress urinary incontinence since the 1960s [69]. These figures are rather close to values obtained by
[67, 68]. This has been confirmed on translabial ultrasound [66]; using the “symptoms” approach, i.e., by utilizing ROC curve
hence, it seems reasonable to define an RVA of <140° and proxi- statistics in large symptomatic cohorts. This latter approach
mal urethral rotation of up to 45° as normal. yields cutoffs of 10 mm below the SP for bladder descent, of
15 mm above the SP for uterine descent, and of 15 mm below
the SP for descent of the rectal ampulla [69].
6.10 Pelvic Organ Descent Recent work using clinical prolapse assessment [70] has con-
firmed that “normality” of pelvic organ mobility needs to be rede-
Organ descent is measured after bladder emptying, supine, fined, since descent of the uterus to a given level is much more
and on maximal Valsalva of at least 6 s duration, controlling likely to cause symptoms of prolapse than descent of the ante-
for levator co-activation [56]. The best of three maneuvers is rior or posterior compartments. Current clinical usage of the ICS
106 H. P. Dietz
a
b
c d
e f
Fig. 6.26 Normal mobility of the bladder and urethra demonstrated on 29 mm − 14 mm = 15 mm. In panel c and d, “rva” is the retrovesical
Valsalva. The left image in all three panels is obtained at rest, the right angle given at rest (rva-r, 120°) and on Valsalva (rva-s, 85°). In panel e
on maximal Valsalva. “x” and “y” illustrate horizontal and vertical and f, urethral rotation is determined by comparing the angle between
coordinates used to determine bladder neck mobility in a and b. the central symphyseal axis and the proximal urethra (i-s [60°] minus i-r
“Bladder neck descent” is the vertical component of this movement, [35°] = 25°). B bladder, C cervix, R rectal ampulla, S symphysis pubis
i.e., x-r (rest) minus x-s (Valsalva) or, as in this case,
6 Transperineal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 107
Fig. 6.27 Quantification of organ decent and hiatal area in patient with the symphysis pubis (a). Panel b shows measurement of the levator
normal organ support, midsagittal plane. Organ descent is measured hiatus
against a horizontal line placed through the inferoposterior margin of
POP-Q assessment system [71] may result in abnormal uterine “dynamic normality” so that pelvic organ mobility and hia-
descent being rated as normal, while a “second-degree cystocele” tal dimensions under conditions of elevated intra-abdomi-
may be diagnosed in a woman with normal bladder mobility. nal pressure can be classified as normal or abnormal.
Chapter 48 will deal with abnormality, both static and
dynamic.
6.11 Hiatal Dimensions
The same approach, i.e., the “mathematical” and the “symp- Take-Home Messages
toms” approach, may be used to determine normal values for • Translabial pelvic floor ultrasound is the best-
hiatal distensibility. Maximal hiatal distension on Valsalva in documented and most convenient imaging method
the axial plane is known to be strongly associated with POP currently in use in pelvic floor medicine.
and POP symptoms [35, 38], and this is also evident on clini- • Simple 2D systems, available since the 1980s, pro-
cal examination using measurements of the genital hiatus and vide information on organ descent, residual urine,
perineal body [72, 73]. Conveniently, both “mathematical” bladder neck configuration, and urethral anatomy
and “symptoms” approaches yield virtually identical cutoffs and mobility.
when measured in volume data obtained on maximal Valsalva • 3D/4D imaging via the translabial route allows
in the supine position: 25.79 cm2 in 18–24-year-old Caucasian axial plane imaging of the levator ani and anal
nulliparae [35] and 25 cm2 in symptomatic older women [38]. sphincter.
Hence, it is suggested that 25 cm2 be used as the limit of nor- • In combination with tomographic or multislice
mality for hiatal distension on Valsalva. imaging, this enables quick, noninvasive assess-
ment of both structures by standardized, validated
methods.
6.12 Conclusions • Online interactive teaching is available through the
International Urogynecological Association
In this chapter I have tried to cover imaging of the normal (IUGA) at https://www.iuga.org/education/pfic/
pelvic floor by pelvic floor ultrasound, with “normality” pfic-overview.
defined not just in the sense of static anatomy but also as
108 H. P. Dietz
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Endovaginal Ultrasonography:
Methodology and Normal Pelvic Floor 7
Anatomy
mover are fully enclosed within the housing of the probe) that
allows acquisition of 300 transaxial images over a distance of
60 mm in 60 s, at the touch of a button, without requiring any
movement relative to the investigated tissue (Fig. 7.2). The
data from a series of closely spaced 2D images are combined
to create a 3D volume displayed as a cube (Fig. 7.2) [3]. With
the conventional 2D-US, the screen resolution is measured in
number of pixels (display matrix: 700 × 700 pixel elements),
with each pixel having a value between 0 and 255 (256 levels
of gray). The result seen on the ultrasound monitor is a 2D
image (X and Y plane only) with no depth information.
Adding the third dimension means that the pixel is trans-
formed in a small 3D picture element called a voxel, which
will also have an assigned value between 0 and 255. Ideally, a
voxel should be a cubic structure; however, the dimension in
the Z plane is often slightly larger than that in the X and Y
planes. The depth of the voxel is critical to the resolution of
the 3D image, and this depth is directly related to the spacing
between two adjacent images [3]. As already stated, the voxel
should ideally form an exact cube; however sampling in the Z
plane generally has slightly lower resolution than in the
700 × 700 matrix, due to acquisition speed. High-resolution
3D-US acquires four to five transaxial images sampled per
millimeter of acquisition length in the Z plane. This means
that an acquisition based upon sampling of transaxial images
over a distance of 60 mm in the human body will result in a
data volume block consisting of between 240 and 300 trans-
axial images. High-resolution data volumes will consist of
typical voxel sizes around 0.15 × 0.15 × 0.2 mm. Because of
this resolution in the longitudinal plane, which is close to the
axial and transverse resolution of the 2D image, this tech-
nique ensures the true dimensions of the 3D data cube are
also present in the reconstructed Z plane and provides accu-
rate distance, area, angle, and volume measurements [7].
As reported in Chap. 5, the electronic endocavitary probe
(type 8838/X14L4, BK Medical), frequency of 4–14 MHz
(Fig. 7.3), 16 mm diameter, offers similar imaging opportu-
nities than the mechanical rotating transducer, but with
higher resolution. This transducer has a built-in linear array
that rotates 360° inside the probe. It has capability for
dynamic 2D and 3D scanning. The probe allows acquisition
of radial 2D images without any movement of the transducer
within the cavity. The set of 2D images is instantaneously
reconstructed into high-resolution 3D cube for real-time
Fig. 7.1 BK Medical 5000 scanner with transducer type 2052/type manipulation and volume rendering. The 3D volume can be
20R3 (BK Madical, Herlev, Denmark) archived for offline analysis using BK PC software.
The ability to visualize information in the 3D image
rotating at its tip (see Chap. 5) (Fig. 7.2). This probe has a depends critically on the rendering technique [7]. Three
frequency range from 9 to 16 MHz, with a focal length of basic types of technique are used.
2–5 cm and a 90° scanning plane; it is rotated at 4–6 cycles/s,
to give a radial scan of the surrounding structures. The trans- 1. Surface render mode (SRM): an operator or algorithm
ducer has a built-in 3D automatic motorized system (the identifies the boundaries of the structures to create a wire-
proximal–distal actuation mechanism and the electronic frame representation. It is the most commonly known ver-
7 Endovaginal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 113
Fig. 7.2 The transducer type 2052/20R3 (BK Medical, Herlev, the electronic mover are fully enclosed within the housing of the probe)
Denmark) has a crystal that is rotated at 4–6 cycles/s, to give a radial that allows acquisition of 300 transaxial images over a distance of
scan of the surrounding structures. The probe has a built-in 3D auto- 60 mm in 60 s
matic motorized system (the proximal–distal actuation mechanism and
sion of render mode and is extensively used by some 3. Volume render mode (VRM): this is a special feature that
medical centers in producing perhaps the very first images can be applied to high-resolution 3D-US [7]. Under nor-
of an unborn baby’s facial contours. Surface rendering mal circumstances, an US image has no depth informa-
techniques only give good results when a surface is avail- tion because the lateral resolution of the image must be
able to render, such as is possible for the pubovisceral kept as high as possible. The image may be compared to
muscle assessed by 3D transperineal US (see Chap. 6) [4]. looking at a photographic image on a piece of paper.
This technique, however, fails when a strong surface can- Three-dimensional US does not change this fact. All three
not be found such as in the subtly layered structures within of the surfaces visible on the screen when viewing a 3D
the pelvic floor. SRM is, by its requirements, mainly a volume also have no depth information. This can be com-
superficial postprocessed topographical presentation of an pared to looking at a cardboard box from the outside. The
often rapidly acquired 4D dataset, with a lesser degree of contents of the box remain unknown. Volume rendering
information inside the depth of the 3D volume of data changes the depth information of a 3D data volume, so
compared to high-resolution 3D data volumes. information inside the cube is reconstructed to some
2 . Multiplanar reconstruction (MPR): three perpendicular extent (Fig. 7.5). This technique uses a ray tracing model
planes (axial, coronal, and longitudinal) are displayed as its basic operation. A beam is projected from each
simultaneously (Fig. 7.4) and can be moved and rotated to point on the viewing screen (the display) back into and
allow the operator to infinitely vary the different section through the volume data. As the beam passes through the
parameters and visualize the lesion at different angles. volume data, it reaches the different elements (voxels) in
114 G. A. Santoro et al.
2
36
5
15
55
36
φ16.4
Fig. 7.3 The electronic endocavitary probe (type 8838/X14L4, BK Medical) has a built-in linear array that rotates 360° inside the probe
longitudinal
a b c
axial
coronal
Fig. 7.4 Three-dimensional multiplanar reconstruction with 2052 Schematic illustration. Reproduced with permission from: Santoro GA,
probe (BK Medical). (a, b) Axial, coronal, and longitudinal planes are Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders. Springer-
simultaneously displayed in the same ultrasonographic image. (c) Verlag Italy, 2010
7 Endovaginal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 115
a b
Fig. 7.5 Three-dimensional reconstruction with 2052 probe (BK the cube. Four different postprocessing settings may be used: opacity,
Medical). (a) Normal mode only provides information of the three sur- luminance, thickness, and filter
faces of the cube. (b) Volume render mode provides information inside
the dataset. Depending on the various render mode set- with the opacity control for displaying certain voxel
tings, the data from each voxel may be discarded, may be values for optimal visualization. The final image
used to modify the existing value of the beam, or may be impression should be adjusted to the reader’s require-
stored for reference to the next voxel and used in a filter- ments by setting the normal brightness and contrast
ing calculation. All of these calculations result in the cur- controls.
rent color or intensity of the beam being modified in some (c) Thickness: sets an upper limit to the penetration of the
way. In normal VRM, the following four different post- rays into the volume. This value is used in conjunc-
processing display parameters can be used [7]: tion with the opacity parameter to determine when
(a) Opacity: sets the relative transparency of the volume. the ray traversal is terminated. Increasing the thick-
The higher the value, the further into the volume the ness setting allows deeper penetration, and the result
ray can travel before being terminated. Because of is often a slightly smoother presentation together
accumulated brightness as the ray traverses the vol- with a significant increase in the visual depth impres-
ume, the net effect is to make the volume appear sion of a lesion.
brighter as this control value is increased. (d) Filter: sets the lower threshold value for pixel intensi-
(b) Luminance: sets the inverse of the self-luminance ties. Pixel values less than the filter value are not included
value for the pixels and should be used in conjunction in determining the intensity of the final ray value. In nor-
116 G. A. Santoro et al.
Transverse plane floor anatomy (Figs. 7.7 and 7.8). 3D data automatic acquisi-
Sagittal plane tion includes the field of view from the bladder neck to the
external meatus of the urethra. We defined four standard lev-
els of assessment in the axial plane (Fig. 7.9) [9].
mal VRM, the rendering mode stops each ray when the
value found reaches a specified value of opacity. This is
affected by the setting of some of the controls (opacity,
thickness, and to some extent luminance).
Level II Level IV
Fig. 7.9 Four standard levels of assessment of the female pelvic floor muscle, R rectum, STP superficial transverse perinei muscle, U, urethra.
with endovaginal ultrasound (transducer type 2052/20R3, BK Medical). Reproduced with permission from: Santoro GA, Wieczorek AP,
Right side of the image is left side of the patient. A anal canal, B blad- Bartram CI (eds) Pelvic Floor Disorders. Springer-Verlag Italy, 2010
der, BCM bulbocavernosus muscle, PB pubic bone, PVM pubovisceral
a b
Fig. 7.10 3D endovaginal ultrasound (transducer type 2052/20R3, BK visualized on the screen at the 12 o’clock position and the inferior one-
Medical). (a) The transducer is inserted endovaginally until the poste- third of the rectum (R) at the 6 o’clock position
rior fornix. (b) Level 1: at the highest level the bladder base (B) can be
118 G. A. Santoro et al.
Fig. 7.14 Drawing (bottom left): the relative position of the levator ani lateral view. Level 2C: the heart-shaped vaginal sulcus (outlined in red)
subdivisions during ultrasound imaging: Levels 1A–3D are identified in marks the pubovaginalis insertion. Iliococcygeus (IC) fibers (red) come
the individual panels. Midline structures are identified in lateral views into view. The perineal body is outlined in the lateral view. Level 2D:
with corresponding colors in the picture insert at the upper left corner of the puboanalis (PA) is starting to thin out. The puborectalis (PR) is seen
the ultrasound images at each level. The dotted green vertical line in the in the lateral view. Level 3A: the puboperinealis (PP) and puboanalis
insert corresponds to the relative position in the vagina where the image (PA) become obscure. Anatomically, the puboanalis becomes a thick
is obtained. Level 1A: at 0 cm, the first muscle seen is the superficial fibromuscularis layer forming a tendineus sheet, the rectal pillar (RP).
transverse perinei muscle (STP; green) with mixed echogenicity. Level The perivesical venous plexus (VP) is prominent (purple). The recto-
1B: immediately cephalad to the superficial transverse perinei is the vaginal fibromuscularis (RVFM, green) is shown in sagittal view as a
puboperinealis muscle (PP; yellow) that can be traced to pubic bone continuous mixed echogenic structure approaching the perineal body
with manipulation of the 3D cube. It comes in at a 45° angle as a mixed and laterally attaching to the RP. Level 3B: the rectal pillar (orange) is
echoic band to join the perineal body. Lateral to it, the puboanalis mus- easily seen. The iliococcygeus (IC) becomes prominent and widens.
cle (PA, pink) is seen as a hypoechoic triangle. Level 2A: this level Level 3C: the iliococcygeus (IC) widens further and inserts into the
marks the attachment of the muscles to the pubic arch. The external arcus tendineus fascia pelvis. Level 3D: the puborectalis (PR) fades out
urethral meatus is visible (dark red). The puboperinealis and puboanalis of view. The puborectalis (mustard) and iliococcygeus (red) are out-
insertions are highlighted (A anus, U urethra). Level 2B: the pubovagi- lined in the lateral view showing their entire course. Reproduced with
nalis (PV, blue) and puborectalis muscles (PR, mustard) insertions permission from: Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic
come into view. The urethra (U) and the bladder are outlined (red) in the Floor Disorders. Springer-Verlag Italy, 2010
7 Endovaginal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 121
a b
Fig. 7.15 Level 3: corresponds to the midurethra and to the upper one- be accurately evaluated 3D endovaginal ultrasound (transducer type
third of the anal canal. (a) To facilitate assessment of the position of 2052/20R3, BK Medical) lying posteriorly to the AC and attaching to
these structures and for evaluation of the symmetry between the urethra the SP. IPR inferior pubic rami, LA levator ani, OF obturator foramen,
(U) and anal canal (AC), a geometric reference point, termed “gothic PV pubovisceral muscle, T transducer. Reproduced with permission
arch,” is defined at the 12 o’clock position, specifically at the point from: Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic floor disor-
where the inferior branches of the pubic bone join at the symphysis ders. Springer-Verlag Italy, 2010
pubis (SP). (b) At this level, the muscles of the lateral compartment can
Fig. 7.16 The levator hiatus (LH) indices are measured at level 3. In
this 28-year-old female, the anteroposterior diameter (AP) was Fig. 7.17 Paravaginal spaces (PVS) measured on the right (1) and left
42.6 mm, the transverse diameter (LL) was 32.2 mm, and LH area was (2) sides (1.69 cm2 and 1.55 cm2, respectively). Scan obtained by 8838
12.8 cm2. Scan obtained by 2052 transducer (BK Medical). AC anal transducer (T) (BK Medical). AC anal canal, IPR inferior pubic rami,
canal, IPR inferior pubic rami, LA levator ani, SP symphysis pubis, U LA levator ani, SP symphysis pubis, U urethra
urethra. Reproduced with permission from: Santoro GA, Wieczorek AP,
Bartram CI (eds) Pelvic Floor Disorders. Springer-Verlag Italy, 2010
122 G. A. Santoro et al.
and extending from the SP to the perineal body (Fig. 7.18). and appears to be divided into two levels: (1) superficial,
In the same plane, we can determine the anteroposterior which is in contact with the external anal sphincter, the
diameter of the urogenital hiatus (UGH), corresponding bulbospongiosus and the STP muscles (Fig. 7.18), and (2)
to the SP–perineal body distance [21]. We have also found deep level, connected with the puboperinealis and puboa-
that the UGH AP diameter significantly correlated with nalis muscles, which are part of the LA muscle (Fig. 7.20).
LH area (ρ = 0.58; P = 0.008) (Table 7.1) [9]. Santoro Moreover the measurements of the perineal body height,
et al. [20] performed 3D-EVUS in nulliparous cadavers to depth, and width in nulliparous females showed excellent
validate this method for the assessment of the perineal interobserver repeatability (ICC 0.927; ICC 0.969; ICC
body. The perineal body has a pyramidal shape (Fig. 7.19) 0.932, respectively).
a b
Uterus
USL
Bladder
RVF
a LP
gin
Va R
RVF LMA
PB
Fig. 7.19 (a) Schematic illustrations showing that the perineal body EAS external anal sphincter, LMA longitudinal muscle ani, LP levator
(PB) has a pyramidal shape. (b) 3D-EVUS by 2052 transducer (BK plate, R rectum, RVF rectovaginal fascia, USL uterosacral ligament
Medical). The PB pyramidal shape visualized on the longitudinal plane.
a b
Fig. 7.20 The deep level of the perineal body (PB) is connected with EAS external anal sphincter, IAS internal anal sphincter, IRF ischiorec-
the puboanalis (PA) and puboperinealis muscles. (a) Cadaveric dissec- tal fossa, V vagina
tion. (b) 3D-EVUS by 2052 transducer (BK Medical). A anal canal,
124 G. A. Santoro et al.
7.4 Assessment of the Anterior SP), rhabdosphincter (RS) length and thickness, and the dis-
Compartment tance between the bladder neck and the RS (which is also known
as the intramural part of the urethra) (Fig. 7.22). The striated
3D-EVUS performed by 2052 transducer allows to visualize the urethral sphincter (RS) starts in the upper part of the urethra
anterior compartment on the reconstructed longitudinal plane. approximately 9.1 mm (range: ±0.94 mm) from the urinary
Additional information are provided by using the 8848/8838 bladder neck. In the transverse section, it has a typical omega
transducers (Fig. 7.21) (see Chap. 19) [9, 22]. Assessment of the shape, surrounding the ventral and lateral sides of the midure-
anterior compartment in the midsagittal section includes mea- thra and creating a raphe connected to the anterior vaginal wall.
surements of the length (from the bladder neck to the external Its echogenicity is slightly lower than that of smooth urethral
urethral orifice) and thickness of the urethra, bladder–symphy- muscle (Fig. 7.23). The position of the urethra is determined in
sis distance (from the bladder neck to the lowest margin of the the reconstructed coronal plane that allows for recognition of
a b
Fig. 7.21 Schematic illustrations of endovaginal ultrasonography performed by 8848 (a) and 8838 (b) transducers (BK Medical) for the assess-
ment of the anterior compartment
a b
Fig. 7.22 Longitudinal view of the anterior compartment. (a) (2), urethral length (3), rhabdosphincter length (4), and thickness (5). B
Schematic illustration. (b) Ultrasonographic image obtained by 8848 bladder, BN bladder neck, EO external urethral orifice, RS rhabdo-
transducer (BK Medical) using the linear array. Measurements include sphincter, SP symphysis pubis, U urethra, V vagina
bladder neck-rhabdosphincter distance (1), bladder-symphysis distance
7 Endovaginal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 125
a b
Fig. 7.23 (a) Cadaveric dissection of the midurethra. (b) a slightly echoic structure overlapping a more echoic smooth urethral
Ultrasonographic image obtained by 8848 transducer (BK Medical) muscle (SM). SP symphysis pubis, V vagina
using the axial array. In the axial plane, rhabdosphincter (RS) appears as
a b
Fig. 7.24 Vascularity of the urethra assessed in the axial (a) and longi- urethra, 2. midurethra, 3. distal part of the urethra. Scan obtained by
tudinal planes (b). In the midsagittal section, the vascularity appears 8848 transducer (BK Medical)
distributed in three levels corresponding to 1. intramural part of the
any abnormal angulation of the urethra, which may contribute sels. In the reconstructed longitudinal plane, these vessels
to some urinary dysfunctions. Santoro et al. [9] found signifi- appear to form three levels (Fig. 7.24). The first level, situated
cant correlations among several urethral parameters in nullipa- cranially, is seen below the urinary bladder neck. The second
rous females: urethral width with urethral length (ρ = 0.65; level is situated in the middle region of the urethra penetrating
P = 0.002) and urethral thickness (ρ = 0.5; P = 0.02) and ure- from the ventral side to reach the RS. The vessels penetrating
thral volume with urethral thickness (ρ = 0.7; P = 0.002), ure- here, on transverse section, have a typical “V” shape (Fig. 7.24).
thral width (ρ = 0.87; P = 0.0001), urethral length (ρ = 0.75; The third and lowest level is situated below the lower margin of
P = 0.00005), and RS volume (ρ = 0.5; P = 0.03) [9]. Wieczorek the SP, in the area of the external ostium. Using 3D color
et al. [23] reported excellent reliability for urethral measure- Doppler imaging, we can observe the global vascularization of
ments (length, width, thickness, and volume) (ICC > 0.8) and the urethra (Fig. 7.25). It is possible to visualize the spatial dis-
good reliability for rhabdosphincter measurements (ICC > 0.6) tribution of blood flow, to demonstrate vessel continuity and
in a group of 24 asymptomatic nulliparous females. The urethra vessel branching in different planes, and to evaluate the pattern
is surrounded by connective tissue containing numerous ves- of vascularization (density of vessels, branching, caliber
126 G. A. Santoro et al.
changes, and tortuosity). Using special software (Pixel Flux), it value of I and the highest values of RI and PI. The distal urethra
is possible a quantitative assessment of the urethra vascularity, presented the highest value of I and the lowest value of RI. The
measuring velocity (V), perfused area (A), perfusion intensity values of V, A, and I were significantly higher in the external
(I), pulsatility index (PI), and resistance index (RI). Wieczorek part of the midurethra compared with the internal part. Excellent
et al. [24] reported that the midurethra had the highest value of interobserver and intraobserver reproducibility was shown in
V and lowest value of A. The intramural part had the lowest the majority of parameters for the entire urethra.
a b
Fig. 7.26 Schematic illustrations of endovaginal ultrasonography performed by 8848 (a) and 8838 (b) transducers (BK Medical) for the assess-
ment of the posterior compartment
7 Endovaginal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 127
Fig. 7.27 Axial view of the anal complex obtained by 8848 transducer Perineal
(BK Medical) using the transverse array. The external anal sphincter Cranial body
(EAS) appears as a hyperechoic ring surrounding the hypoechoic ring of
the internal anal sphincter (IAS); PVM pubovisceral muscle. Reproduced
Anorectal Junction
with permission from: Santoro GA, Wieczorek AP, Bartram CI (eds)
Pelvic Floor Disorders. Springer-Verlag Italy, 2010
7.6 Discussion
alize it. When we display a normal 2D-US cross-sectional substantial agreement for identification of its subdivisions,
view, there are many elements of the image that will not be and it is not affected by women’s age [30]. As the lateral
correctly recognized as components of a 3D structure, or at attachments of the PVM to the pubic bone are also clearly
least not perceived in their true spatial relationships. With visualized, 3D-EVUS can be utilized to document major
conventional ultrasound we are usually looking at a 3D levator ani trauma, in a similar way to 3D translabial ultra-
structure that contains a solid volume of echoes and which sound (TLUS) [31] and MRI [13, 27, 32]. Javadian et al. [32]
therefore does not readily translate onto a 2D projection. In found no difference between 3D-EVUS and MRI when com-
routine clinical scanning, the operator forms a mental repre- paring “normal” versus “abnormal” LA appearance. Similar
sentation of the 3D anatomic or pathological structure while results were reported by van Gruting et al. [33] who found
viewing a large series of 2D slices interactively. In this case that ultrasound is as good as MRI for the detection of major
the operator is using manual sense information about the LA avulsion, while MRI still remain gold standard when
physical location of the individual slices in building up 3D minor avulsion is suspected. Moreover, LA avulsion seen on
subjective impressions. 3D- and indeed 4D-US have been EVUS correlated better with patient’s symptoms than MRI
promoted by different ultrasound companies for several or 3D-TPUS [33]. Interesting conclusions on LA avulsions
years. The acquisition of a 3D data volume and the underly- were drawn from the recent multicenter study on correlation
ing techniques are, however, different from application to between ultrasound findings and anatomical dissection in the
application. The pelvic floor requires extremely high- same cadaver [34]. 3D-TPUS performed in 30 cadavers
resolution 3D volumes of data for adequate and precise diag- identified avulsions in 11 cases (36.7%; one bilateral and ten
nostic evaluation. An advantage of working with unilateral), while anatomical dissection did not confirm any
high-resolution 3D-US is that the 3D image does not remain LA avulsion. However, the perineal ultrasound approach
fixed; rather, it can be freely rotated, rendered, tilted, and could represent the major limit in this study. Van Delft et al.
sliced to allow the operator to infinitely vary the different [35] reported a good correlation (ICC 0.72) between
section parameters and visualize the different structures at 3D-EVUS and 3D-TPUS to analyze hiatus area and antero-
different angles to obtain the most information from the data. posterior diameter with the patient at rest and to diagnose
After data are acquired, it is possible to select coronal ante- levator avulsion. However, palpation correlates only fair
rior–posterior or posterior–anterior as well as sagittal right– with both methods. Further studies in this field are required.
left views, together with any oblique image plane. The 3D-EVUS allows a detailed evaluation of the LA muscle
multiview function allows the reader to see up to six different subdivisions [15] which are not visualized by TLUS [31].
and specialized views at once with multiplanar reconstruc- Although it may be argued that these subdivisions of the LA
tion [3, 7, 8]. These functions were only available in com- muscle are not important, knowing exactly which muscles
puted tomography scan and magnetic resonance imaging and are damaged may not be inconsequential in clinical practice.
are deemed very helpful for clinicians in visualizing patholo- Many of the functions of the pelvic floor governing micturi-
gies, allowing for precise surgery planning and appropriate tion, defecation, and intercourse are only recently under-
patient management. Three-dimensional US allows us to stood by describing the LA anatomy. Subdivisions are
assess directly the different planes in which anatomic struc- important because the muscles exert their action by contrac-
tures of the pelvic floor are located. It has been shown to be tion. For example, a patient with defecatory dysfunction due
reliably used in visualization of the pelvic floor structures of to a detached puboperinealis will not benefit from a posterior
the anterior and posterior compartments in nullipara [4, 22]. repair. Also, reattachment of the puboperinealis does not
The most extensively evaluated pelvic floor structures are address defecatory dysfunction due to loss of anorectal angle
the LH and the LA muscle, because significant correlations from a damaged puborectalis.
have been reported between LA defects and increased LH Biometric indices of the LH determined in the axial tilted
size and pelvic organ descent [26, 27] (see Chaps. 48 and plane in our study on 20 nulliparous females (AP diameter
49). Tilting the axial plane in the acquired 3D data volume 4.84 cm, LL diameter 3.28 cm, hiatal area 12 cm2) [9] were
provides a maximal transverse section of the PVM, not oth- consistent to the results published by Dietz et al. [11] in 49
erwise obtainable with conventional 2D-EVUS, thus avoid- nulliparous females with 3D-TLUS (AP diameter 4.52 cm,
ing the artifacts due to its oblique shape. Our measurements LL diameter 3.75 cm, hiatal area 11.25 cm2) and Tunn et al.
[9] of PVM thickness (6.0 mm on both sides) in nulliparous [28] in 20 nulliparous females with MRI (AP diameter
volunteers were consistent with measurements taken on 4.1 cm, LL diameter 3.3 cm, hiatal area 12.8 cm2). In the
MRI, which is regarded a gold standard in the assessment of same tilted axial plane, the paravaginal spaces and urethral
LA muscle. Tunn et al. [28] found 6.3 mm muscle thickness symmetry can be assessed [9]. This deems clinically relevant
bilaterally, and Alt et al. [29] reported similar values (6.4 mm) as a lateral paravaginal defect can be suspected when a wider
on 3 Tesla MR scanner. 3D-EVUS shows excellent interob- paravaginal space or an asymmetry of the urethra is observed.
server agreement for identification of LA and moderate to It has been hypothesized that paravaginal defects, due to
7 Endovaginal Ultrasonography: Methodology and Normal Pelvic Floor Anatomy 129
separation of the endopelvic fascia from the arcus tendineus [3, 7]. EVUS offers an alternative imaging modality of the
fascia pelvis, are the underlying anatomical abnormalities in anal sphincter complex and has proven to be as accurate as
anterior vaginal wall descent [36, 37] (see Chap. 49). EAUS [2]. We found that measurements of anal sphincter
Understanding the anatomy of the pelvic diaphragm is thickness by 3D-EVUS were consistent with measurements
important for urogynecologists and proctologists. Damage to reported by using EAUS, TLUS, or MRI [43–45]. However,
the perineal muscles and/or perineal body, frequently occurring regardless of the absolute dimensions of the anal sphincters,
during vaginal childbirth, is associated with pelvic organ pro- the most relevant utility of US modalities applies in the
lapse [14]. As reported by Orno et al. [38], these muscles can- detection of localized EAS defects in patients with idio-
not be visualized in their entirety by using 2D-EVUS because pathic fecal incontinence, passive fecal incontinence, or
they originate from the walls of the pelvis and converge at the obstructive defecation disorders. In a recent study by Ros
perineal body from different angles. 3D-EVUS could over- et al. [46], designed to compare sensitivity and specificity of
come this limitation. Tilting the reconstructed axial plane from 2D/3D- TPUS and 3D-EVUS with the gold standard
the SP, anteriorly, to the ischiopubic rami laterally, we are able 3D-EAUS in detecting residual defects after primary repair
to evaluate the different insertion points and to determine the of obstetric anal sphincter injuries, 2D-TPUS and 3D-EVUS
dimensions of the superficial perineal muscles. In contrast with were found not accurate. 3D-TPUS showed good agreement
these findings, 3D-TLUS cannot properly assess the perineal with 3D-EAUS and high sensitivity in detecting residual
structures due to the shape of the transducer, its position on the defects. The most important advantage of EVUS compared
introital area, and a limited field of view of the acquired volume to EAUS is the access to the longitudinal plane that allows
[37]. In the same scan, the AP diameter of the UGH can also be assessment of the ARA, rectovaginal septum, and perineal
measured. Our study confirmed that this diameter had a posi- body [9, 20].
tive correlation with LH area [9].
In the diagnostics of the anterior compartment dysfunc-
tions, it is very important to assess the morphology and 7.7 Conclusion
location of the urethra and to evaluate its supportive struc-
tures [28]. High-resolution 3D-EVUS gives the opportunity High-resolution 3D-EVUS provides a detailed assessment of
to assess the urethral position in three different planes and the pelvic floor for both identifying and measuring specific
allows the anatomy and morphology of the bladder neck and anatomic structures and for understanding their complex
urethral complex to be quantified [9] (see Chap. 19). spatial arrangements. It is relatively easy and fast to perform,
Biometric indices of the urethral complex determined in our correlates well with other imaging modalities, and delivers
study [9] were comparable to the results reported by Umek additional information on the urethral complex and superfi-
et al. [6] with 3D transrectal US, with regard to both urethral cial perineal structures at the same time.
thickness (11 mm on vaginal vs. 11.5 mm on rectal scans)
and width (14 mm on vaginal vs. 15 mm on rectal scans) and
to RS thickness (3.0 mm on vaginal vs. 2.7 mm on rectal Take-Home Messages
scans) and volume (0.46 cm3 on vaginal vs. 0.5 cm3 on rectal • High-resolution 3D allows real-time manipulation,
scans). Additionally, the mean bladder neck–RS distance volume rendering, and offline analysis.
determined in our study (9.1 mm) was consistent with the • Both static and dynamic anatomy of the pelvic floor
measurement reported by using MRI (10 mm) [39]. muscles and pelvic organs can reliably visualized
Moreover, recent study from Xuan et al. [40] showed that by 3D and dynamic endovaginal ultrasonography.
3D-EVUS has excellent intra- and interobserver repeatabil- • Levator ani muscle subdivisions can be visualized
ity for urethral measurements and higher than 2D ultrasound. in the proper planes in which they are located by 3D
Urethral measurements are important indices in diagnostics endovaginal ultrasonography.
of urinary incontinence. Females with urinary incontinence
have smaller RS as compared to continent patients [41].
Santiago et al. [42] have compared ultrasound urethral mea-
surements in patients with radiological diagnosis of bladder
neck funneling and found that smaller RS length and area are
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Endoanal and Endorectal
Ultrasonography: Methodology 8
and Normal Anorectal Anatomy
The anal canal is surrounded by the internal sphincter (IAS), Endoanal ultrasound, as previously reported in Chap. 5 is
the longitudinal muscle layer (LM), and the external sphinc- commonly performed with high multifrequency, 360° rota-
ter (EAS) [1–3] (Fig. 8.1). The anatomy of the anorectal tional mechanical transducer, linear electronic transducer, or
region is currently of clinical interest. An intact anal sphinc- radial electronic transducer (2052, 20R3, 8838; E14CL4b BK
ter complex has a decisive role for continence [4]. It is very Medical). During examination the patient is placed in dorsal
important for gynecologists to know where birth damage lithotomy or in the left lateral decubitus position. Before the
may occur, leading to rupture of the IAS or EAS as well as probe is inserted into the anus, a digital rectal examination
the puborectalis muscle (PR) [4]. Knowledge of the correct should be performed. If there is an anal stenosis, the inserted
anatomy helps to identify defects and to reconstruct them in finger can be used to check whether easy passage of the probe
a meticulous way to achieve as good a functional result as will be possible. A gel-containing condom is placed over the
possible [4]. With the help of endoanal (EAUS) and endorec- probe, and a thin layer of water-soluble lubricant is placed on
tal ultrasonography (ERUS), it has become possible to dem- the exterior of the condom. Any air interface will cause a
onstrate clearly the morphology of the anal sphincter major interference pattern. The patient should be instructed
complex and to detect sphincter disruptions or defects. The before the examination that no pain should be experienced.
Under no circumstances should force be used to advance the
probe. By convention, the transducer is positioned to provide
G. A. Santoro (*) the following image: the anterior aspect of the anal canal will
Tertiary Referral Pelvic Floor and Incontinence Center,
be superior (12 o’clock) on the screen, right lateral will be left
IV°Division of General Surgery, Regional Hospital, Treviso,
University of Padua, Padua, Italy (9 o’clock), left lateral will be right (3 o’clock), and posterior
e-mail: giulioasantoro@yahoo.com will be inferior (6 o’clock). Some adjustments may be neces-
L. Brusciano sary in the gain of the ultrasound unit to provide optimal
Division of General and Obesity Surgery, Master of Coloproctology, imaging. It is always possible to perfectly depict all layers of
University of Campania “Luigi Vanvitelli”, Napoli, Italy the anal canal circumferentially. This is very important when
e-mail: luigi.brusciano@unicampania.it
assessing the canal at different levels. At the origin of the anal
A. H. Sultan canal, the “U”-shaped sling of the puborectalis is the main
Urogynaecology and Pelvic Floor Reconstruction Unit landmark and should be used for final adjustment.
Croydon University Hospital, St George’s University of
London, London, UK Three-dimensional ultrasound (3D-US) is constructed
e-mail: asultan29@gmail.com from a synthesis of a high number of parallel transaxial two-
a b
Probe
Fig. 8.3 Normal ultrasonographic five-layer structure of the mid-anal representation. Reproduced with permission from: Santoro GA,
canal. (a) Axial image obtained by 2050 transducer (BK Medical); (b) Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders. Springer-
axial image obtained by 8838 transducer (BK Medical); (c) schematic Verlag Italy, 2010
2. The second layer represents the subepithelial tissues and smooth muscle; however, an increased fibrous stroma
appears moderately reflective. The mucosa as well the may account for this. In the intersphincteric space, the
level of dentate line is not visualized. The muscularis sub- LM conjoins with striated muscle fibers from the levator
mucosae ani can be sonographically identified in the ani, particularly the puboanalis, and a large fibroelastic
upper part of the anal canal as a low reflective band. element derived from the endopelvic fascia to form the
3. The third hypoechoic layer corresponds to the IAS. The “conjoined longitudinal layer” (CLL) (Fig. 8.4) [14]. Its
sphincter is not completely symmetric, either in thickness fibroelastic component, permeating through the subcuta-
or termination. It can be traced superiorly into the circular neous part of the EAS, terminates in the perianal skin.
muscle of the rectum, extending from the anorectal junc- According to the “Integral Theory” proposed by Papa
tion to approximately 1 cm below the dentate line. In Petros, the CLL creates the downward force for bladder
older age groups, the IAS loses its uniform low echo- neck closure during effort and stretches open the outflow
genicity, which is characteristic of smooth muscle tract during micturition [16].
throughout the gut, to become more echogenic and inho- 5. The fifth mixed echogenic layer corresponds to the
mogeneous in texture [15]. EAS. The EAS is made up of voluntary muscle that
4. The fourth hyperechoic layer represents the LM. It pres- encompasses the anal canal. It is described as having
ents a wide variability in thickness and is not always dis- three parts [17]: (1) The deep part is integral with the
tinctly visible along the entire anal canal. The LM appears PR. Posteriorly there is some ligamentous attachment.
moderately echogenic, which is surprising as it is mainly Anteriorly some fibers are circular and some decussate
136 G. A. Santoro et al.
a b
LL
PA
PC
CLL
SP
PA
MSA
c
LL
PA
CLL
Fig. 8.4 (a) The puboanalis (PA) rises from the medial border of the Medical). The PA joins the longitudinal muscle layer (LL) of the rectum
pubococcygeus muscle (PC); SP symphysis pubis. (b) Schematic repre- to form the conjoined longitudinal layer (CLL). Reproduced with per-
sentation. Fibers from the longitudinal muscle run through the internal mission from: Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic
anal sphincter to form the muscularis submucosae ani (MSA). (c) Floor Disorders. Springer-Verlag Italy, 2010
Coronal image of the anal canal obtained by 2052 transducer (BK
8 Endoanal and Endorectal Ultrasonography: Methodology and Normal Anorectal Anatomy 137
PR
Level II
Level III
Fig. 8.5 Three levels of assessment of the anal canal in the axial plane. internal anal sphincter, PR puborectalis. Reproduced with permission
Scan obtained by 2052 transducer (BK Medical) (see text). Right side from: Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor
of the image is left side of the patient. EAS external anal sphincter, IAS Disorders. Springer-Verlag Italy, 2010
into the deep transverse perinei. (2) The superficial part • Upper level: the sling of the PR, the deep part of the EAS,
has a very broad attachment to the underside of the coc- and the complete ring of IAS.
cyx via the anococcygeal ligament. Anteriorly there is a • Middle level: the superficial part of the EAS (complete
division into circular fibers and a decussation to the ring), the CLL, the IAS (complete ring), and the trans-
superficial transverse perinei. (3) The subcutaneous part verse perinei muscles.
lies below the IAS. • Lower level: the subcutaneous part of the EAS.
Ultrasound imaging of the anal canal can be divided into The muscles of the lower and the upper part of the anal
three levels of assessment in the axial plane (upper, middle, canal are different. The first ultrasonographic image recorded
and lower levels), referring to the following anatomical is normally the PR muscle and is labeled “Upper level.” The
structures (Figs. 8.5 and 8.6) [18, 19–21]: PR slings the anal canal instead of completely surrounding it.
138 G. A. Santoro et al.
a b
Level I IAS
Level II
EAS
Level III
Fig. 8.6 Three levels of assessment of the anal canal. (a) Schematic level of the junction between the superficial external sphincter (EAS sp)
representation; (b) coronal image and (c) sagittal image obtained by (Md middle level) and subcutaneous external sphincter (EAS sc) (Lo
2052 transducer (BK Medical). The internal sphincter (IAS) ends at the lower level). PR puborectalis, Up upper level
At its upper end, the PR is attached to the funnel-shaped leva- the IAS, CLL, and superficial EAS are all identified. The ante-
tor ani muscle, and the levator ani anchors the sphincter com- rior part of the EAS differs between genders, and anatomic
plex to the inner side of the pelvis. The deep part of the EAS is studies have shown that this difference is already present in the
similar in echogenicity to the PR and cannot be differentiated fetus. In males, the EAS is symmetrical at all levels; in females,
from it posteriorly. Anteriorly, the circular fibers of the deep it is shorter anteriorly, and there is no evidence of an anterior
part of the EAS are not recognizable in females, whereas in ring high in the canal (Fig. 8.8). In females, fibers between the
males thin arcs of muscle from the deeper part of the sphincter transverse perinei fuse with the EAS, so that there is no plane
may be seen extending anteriorly. Moving the probe a few mil- of dissection between these two structures. In males a plane of
limeters in the distal direction will show an intact anterior fat persists between the transverse perinei and the EAS. In
EAS forming just below the superficial transverse perinei examining a female subject, the ultrasonographic differences
muscles, imaged at 11 o’clock and 1 o’clock (Fig. 8.7). This between the natural gap (hypoechoic areas with smooth, regu-
image, labeled “Middle level,” is a mid-anal projection where lar edges) and sphincter ruptures (mixed echogenicity due to
8 Endoanal and Endorectal Ultrasonography: Methodology and Normal Anorectal Anatomy 139
a b
Fig. 8.7 Images of the transverse perinei muscles (TP) in the axial ducer (BK Medical). Reproduced with permission from: Santoro GA,
plane in male (a) and female (b). The anococcygeal ligament (ACL) is Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders. Springer-
seen as a posterior hypoechoic triangle. Scan obtained by 2052 trans- Verlag Italy, 2010
scarring, with irregular edges) occurring at the upper anterior inferiorly along the curve of the sacrum to pass through the
part of the anal canal must be kept in mind. Three-dimensional pelvic diaphragm and become the anal canal. It is sur-
longitudinal images are particularly useful to assess these ana- rounded by fibrofatty tissue that contains blood vessels,
tomic characteristics of the EAS [22–26] (Figs. 8.8 and 8.9). nerves, lymphatics, and small lymph nodes. The superior
EAUS is not able to precisely assess the perineal body because one-third is covered anteriorly and laterally by the pelvic
of the lack of clear limits. Also the proposed use of a finger peritoneum. The middle one-third is only covered with peri-
introduced into the vagina as a landmark seems to be of poor toneum anteriorly, where it curves anteriorly onto the blad-
benefit, altering its normal configuration due to the digital der in the male and onto the uterus in the female. The lower
compression on the central perineum [27, 28]. At this level, the one-third of the rectum is below the peritoneal reflection
anococcygeal raphe is seen as a posterior hypoechoic triangle and is related anteriorly to the bladder base, ureters, seminal
(Fig. 8.7). When the probe is pulled further out, the image of vesicles, and prostate in the male and to the lower uterus,
the IAS will disappear, and only the subepithelium and the cervix, and vagina in the female. The rectal wall consists of
subcutaneous segment of the LM + EAS will be seen. This last five layers surrounded by perirectal fat or serosa (Fig. 8.10).
image is labeled “Lower level” (Fig. 8.6). On ultrasound the normal rectal wall is 2–3 mm thick and is
The perianal anatomic spaces are also visualized by composed of a five- layer structure [28]. There is some
EUAS. The submucosal (subepithelial) space is defined as debate as to what the actual layers represent anatomically.
the layer between the external cone surface and the inner Hildebrandt et al. [29] believe that three layers are anatomi-
border of the IAS. The intersphincteric space, containing the cal, while the other layers represent interfaces between the
longitudinal layer, is located between the IAS and EAS. The anatomical layers. Beynon et al. [30], however, have pro-
ischioanal space, which surrounds the anal canal, is pyramid duced both experimental and clinical evidence that the five
shaped and is located outside the EAS. The supralevator anatomic layers are recognizable. Good visualization
space is located superior to the levator ani muscle. depends on maintaining the probe in the center lumen of the
rectum and having adequate distension of a water-filled
latex balloon covering the transducer to achieve good acous-
8.4 Endosonographic Anatomy tic contact with the rectal wall. It is important to eliminate
of the Rectum all bubbles within the balloon to avoid artifacts that limit the
overall utility of the study. The rectum can be of varying
The normal rectum is 11–15 cm long and has a maximum diameters, and therefore the volume of water in the balloon
diameter of 4 cm. It is continuous with the sigmoid colon may have to be adjusted intermittently. The five layers rep-
superiorly at the level of the third sacral segment and courses resent (Fig. 8.11):
140 G. A. Santoro et al.
a b
c d
e f
Fig. 8.8 The ventral part of the external sphincter differs between external anal sphincter, IAS internal anal sphincter, MD middle level,
males (a, c, e) and females (b, d, f) (see text). (a, b) Schematic repre- PR puborectalis muscle, UP upper level. Scans obtained by 2052 trans-
sentation. (c–f) Three-dimensional endosonographic reconstructions in ducer (BK Medical) (c, e, f) and 8838 transducer (BK Medical) (d).
the longitudinal plane. The distance between the anterior anorectal Reproduced with permission from: Santoro GA, Wieczorek AP,
junction and the external sphincter is called the gap (arrows). EAS Bartram CI (eds) Pelvic Floor Disorders. Springer-Verlag Italy, 2010
8 Endoanal and Endorectal Ultrasonography: Methodology and Normal Anorectal Anatomy 141
a LM c
EAS
d
SC
b
d
SC
Fig. 8.9 External sphincter at three levels of the anal canal in male and s superficial external sphincter, sc subcutaneous external sphincter.
female. (a, b) Schematic representation; (c) Ultrasonographic images in Scans obtained by 2052 transducer (BK Medical). Reproduced with
the axial plane. Male on the left, female on the right. LM longitudinal permission from: Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic
muscle, EAS external anal sphincter, d deep external sphincter, Floor Disorders. Springer-Verlag Italy, 2010
a b
5
4
3
2
1
Fig. 8.10 Diagrammatic representation of the five-layer structure of serosa/perirectal fat interface. Reproduced with permission from:
the normal rectal wall. (a, b): 1, mucosa; 2, submucosa; 3, muscularis Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders.
propria/circular layer; 4, muscularis propria/longitudinal layer; 5, Springer-Verlag Italy, 2010
142 G. A. Santoro et al.
3
T
4
1 2 3 4 5
5
b c
Interface: hyperechoic
Mucosa/MM: hypoechoic
Submucosa: hypoechoic
Serosa/mesorectal fat;
hyperechoic
Fig. 8.11 (a) Schematic and ultrasound representation of the five lay- mal mode). (d) Three-dimensional reconstruction of the rectal wall in
ers of the rectal wall in the axial plane: 1, acoustic interface with muco- the coronal plane (volume render mode). Scans obtained by 2052 trans-
sal surfaces; 2, mucosa; 3, submucosa; 4, muscularis propria; 5, serosa/ ducer (T) (BK Medical). Reproduced with permission from: Santoro
perirectal fat interface. (b) Ultrasound magnification. (c) Three- GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders. Springer-
dimensional reconstruction of the rectal wall in the coronal plane (nor- Verlag Italy, 2010
8 Endoanal and Endorectal Ultrasonography: Methodology and Normal Anorectal Anatomy 143
Fig. 8.14 Sonographic view of the intestinal loops (IL). Scans obtained
by 2052 transducer (BK Medical). Reproduced with permission from:
Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders.
Springer-Verlag Italy, 2010
P = 0.12). Normal values for sphincter dimensions differ ment of all sphincter components. Measurement errors of the
between techniques. It is not really relevant to define the true LM and EAS are related to the ultrasonographic features of
values of sphincter muscle thickness, because the purpose of these muscles, which show low contrast with the surrounding
measuring anal sphincters is to distinguish a normal versus hyperechoic fatty tissue. Both the inner and outer borders of
abnormal measurement, regardless of the absolute values. the EAS are more difficult to define, leading to less reliable
Measurement should be taken at the 3 o’clock and 9 o’clock measurement. In contrast, the IAS is easy to define because it
positions in the midlevel of the anal canal. The IAS thickness is a hypoechoic structure that is highlighted against hyper-
varies between 1.8 ± 0.5 mm and increases with age, because echoic fatty tissues. Williams et al. [23] reported different
of the presence of more fibrous tissue as the absolute amount results. They found an excellent correlation for the interob-
of muscle decreases, measuring 2.4–2.7 mm in individuals server measurement of the EAS, IAS, and submucosal width
aged less than 55 years and 2.8–3.5 mm in those aged more on endosonography and poor correlation only for the
than 55 years. Any IAS > 4 mm thick should be considered LM. Frudinger et al. [11] also reported that the EAS thickness
abnormal whatever the patient’s age; conversely an IAS of was difficult to define in only 2% of patients at all three levels
2 mm is normal in a young patient but abnormal in an elderly examined and in 3% at the subcutaneous level only. A signifi-
one. The LM is 2.5 ± 0.6 mm in males and 2.9 ± 0.6 mm in cant negative correlation with the patients’ age was also dem-
females. The average thickness of the EAS is 8.6 ± 1.1 mm in onstrated in this study, at all anal canal levels. In particular,
males and 7.7 ± 1.1 mm in females. However, EAUS largely the anterior EAS region was found to be significantly thinner
overestimates the size of the EAS due to its failure to recog- in older subjects. The high inherent soft tissue contrast makes
nize and separate the LM. By using the reconstructed 3D MRI a more reliable imaging method to measure anal sphinc-
coronal plane, the anterior longitudinal extent of the EAS can ter components [37–43]. Multiplanar EAUS, however, has
also be measured (Fig. 8.15). Many studies have specifically enabled detailed longitudinal measurement of the compo-
addressed the problems of the reproducibility of EAUS nents of the anal canal [8, 12, 44]. Williams et al. [23] reported
sphincter measurements [11, 33–36]. Enck et al. [35] exam- that the anterior EAS was significantly longer in men than
ined a small group of healthy volunteers and concluded that women (30.1 mm vs. 16.9 mm; P < 0.001). There was no dif-
EAUS did not provide reliable measurements of IAS and ference in the length of the PR between men and women,
EAS thicknesses. Gold et al. [36] examined 51 patients and indicating that the gender difference in anal canal length is
found that measurements of the IAS were more reproducible solely due to the longer male EAS. The IAS did not differ in
than those of the EAS. These findings are consistent with length between males and females. Regadas et al. [24] dem-
results from Beets-Tan et al. [33], which compared EAUS, onstrated the asymmetrical shape of the anal canal and also
endoanal magnetic resonance imaging (MRI), and phased- confirmed that the anterior EAS was significantly shorter in
array MRI for anal sphincter measurement in healthy volun- females. West et al. [44] reported similar results, with IAS
teers. EAUS enabled reliable measurement of IAS thickness and EAS volumes found to be larger in males than in females.
only, whereas both MRI modalities enabled reliable measure- Regardless of the absolute values of the anal sphincter dimen-
sions, the most relevant utility of EAUS application is the
detection of localized sphincter defects, where its benefit has
been proven [45–47]. It has been suggested that measuring
sphincter thickness is important when EAUS cannot depict
any sphincter damage, to exclude diffuse structural sphincter
changes associated with idiopathic fecal incontinence, pas-
sive fecal incontinence, or obstructive defecation disorders
[48–50]. A postulated association between manometric func-
tion of the sphincters and their sonographic appearance, how-
ever, has remained controversial in the literature. Some
authors have found no correlation between muscle thickness
and muscle performance—either resting or squeeze pres-
sures. Scanning anal sphincter muscle may allow determina-
tion of its integrity, but not its morphometric properties.
EAUS is currently regarded by the International
Consultation on Incontinence (ICI) as the diagnostic tool of
choice in the investigation of anal incontinence [4]. Recently,
3D endovaginal ultrasound (3D-EVUS) and transperineal
Fig. 8.15 Measurement of the anterior length of the external sphincter
in the coronal plane (arrows). Scans obtained by 8838 transducer 16 ultrasound (3D-TPUS) have been proposed as alternative
MHz frequency (BK Medical) imaging modalities to describe anal sphincter integrity
8 Endoanal and Endorectal Ultrasonography: Methodology and Normal Anorectal Anatomy 145
[51–54]. Advantages of the endovaginal and transperineal 4. Bliss DJ, Mimura T, Berghmans B, et al. Assessment and conserva-
tive management of faecal incontinence and quality of life in adults.
route include availability of commonly used transducers, In: Abrams P, Cardozo L, Wagg A, Wein L, editors. Incontinence.
absence of distortion of the anal canal, and better patient 6th ed. Bristol: ICUD ICS; 2017. p. 1993–2085.
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[52]. There is some evidence that the external compression 7. Konerding MA, Dzemali O, Gaumann A, et al. Correlation of endo-
anal sonography with cross sectional anatomy of the anal sphincter.
of the perineum on TPUS may distort normal anatomy, Gastrointest Endosc. 1999;50:804–10.
mainly in the anterior quadrant of the anal canal [52]. TPUS 8. Williams AB, Bartram CI, Halligan S, et al. Multiplanar anal
measurements may also be altered by the change in angle endosonography—normal anal canal anatomy. Colorectal Dis.
involved in introital placement of the transducer. Comparative 2001;3:169–74.
9. Thakar R, Sultan A. Anal endosonography and its role in assess-
studies of these different modalities in the identification of ing the incontinent patient. Best Pract Res Clinic Obstet Gynaecol.
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10. Sultan AH, Kamm MA, Talbot IC, et al. Anal endosonography for
identifying external sphincter defects confirmed histologically. Br J
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8.6 Conclusions 11. Frudinger A, Halligan S, Bartram CI, et al. Female anal sphinc-
ter: age-related differences in asymptomatic volunteers with high-
High-resolution 3D-EAUS/ERUS provide a detailed assess- frequency endoanal US. Radiology. 2002;224:417–23.
ment of the anatomy of the anal canal (puborectalis muscle, 12. Santoro GA, Fortling B. The advantages of volume rendering in
three-dimensional endosonography of the anorectum. Dis Colon
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layer, transverse perinei muscles) and of the five-layer struc- 13. Engin G. Endosonographic imaging of anorectal diseases. J
ture of the rectal wall. Ultrasound Med. 2006;25:57–73.
14. Shafik A. A new concept of the anatomy of the anal sphincter mech-
anism and the physiology of defecation III. The longitudinal anal
muscle: anatomy and role in sphincter mechanism. Investig Urol.
Take-Home Messages 1976;13:271–7.
• The normal ultrasononographic anatomy of the anal 15. Starck M, Bohe M, Fortling B, Valentin L. Endosonography of the
anal sphincter in women of different ages and parity. Ultrasound
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lial tissues of moderate reflectivity, the IAS of low 16. Petros PE. The anatomy and dynamics of pelvic floor function
reflectivity, and the LM and the EAS of mixed and dysfunction. In: Petros PE, editor. The female pelvic floor.
reflectivity. Function, dysfunction and management according to the integral
theory. 2nd ed. Heidelberg: Springer-Verlag; 2007. p. 14–50.
• Ultrasound imaging of the anal canal can be divided 17. Shafik A. A new concept of the anatomy of the anal sphincter mech-
into three levels (upper, middle, lower) of assess- anism and the physiology of defecation. The external anal sphinc-
ment in the axial plane. The muscles of the lower ter: a triple-loop system. Investig Urol. 1975;12:412–9.
and the upper part of the anal canal are different. In 18. Santoro GA, Di Falco G. Endosonographic anatomy of the normal
anal canal. In: Santoro GA, Di Falco G, editors. Benign anorec-
males, the EAS is symmetrical at all levels; in tal diseases. Diagnosis with endoanal and endorectal ultrasonog-
females, it is shorter anteriorly, and there is no evi- raphy and new treatment options. Milan: Springer-Verlag; 2006.
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• On ultrasound the normal rectal wall is 2–3 mm 19. Kumar A, Scholefield JH. Endosonography of the anal canal and
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thick and is composed of a five-layer structure. 20. Hussain SM, Stoker J, Schutte HE, Lameris JS. Imaging of the ano-
rectal region. Eur J Radiol. 1996;22:116–22.
21. Stoker J, Halligan S, Bartram CI. Pelvic floor imaging. Radiology.
2001;218:621–41.
22. Oberwalder M, Thaler K, Baig MK, et al. Anal ultrasound and
endosonographic measurement of perineal body thickness. A
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Technical Innovations in Pelvic Floor
Ultrasonography 9
Magdalena Maria Woźniak, Andrzej P. Wieczorek,
Giulio Aniello Santoro, Aleksandra Stankiewicz,
Jakob Scholbach, and Michał Chlebiej
can be used in VRM: opacity, luminance, thickness, and promising method for detailed evaluation of the integrity of
filter. By using these different post-processing display or injuries to the pelvic floor muscles (Figs. 9.2, 9.3, and
parameters, the volume- rendered image provides better 9.6), visualization of the spatial distribution of the vascular
visualization when there are not any large differences in the networks supplying the urethra, and assessment of the loca-
signal levels of pathologic structures compared with sur- tion of tapes or meshes after pelvic floor surgery (Figs. 9.4
rounding tissues [1]. Thus, it is successfully applied for and 9.5). Most recent advanced volume render mode
more precise assessment of some pathological conditions, includes volume-rendering mode of four- dimensional
such as anal sphincter defects, fistulous tracts in perianal translabial ultrasound; this technique appeared very useful
sepsis (Fig. 9.1), and invasiveness of the submucosal layer in the assessment of the association between a widened
in early rectal cancer [7]. Moreover, it seems to be a very vaginal canal with concealed uterine prolapse [8] (Fig. 9.6).
a b
Fig. 9.1 Effects of image processing (volume render mode with filtering) on fistula tract views after hydrogen peroxide injection through an
external opening (a, b). Scan obtained by endoanal ultrasound with 2050 transducer (BK Medical)
a b
Fig. 9.2 (a) Visualization of the puborectalis muscle in different muscle. A anal canal, U urethra, V transducer into vagina. Scan obtained
oblique planes (∗). (b) Post-processing manipulation (volume render by endovaginal ultrasound with 2050 transducer (BK Medical)
mode with high opacity and luminance) improves the visibility of the
9 Technical Innovations in Pelvic Floor Ultrasonography 149
a b
Fig. 9.3 Visualization of puborectalis muscle showing defect on the left side (white arrows). (a) Normal mode, (b) volume render mode. A anal
canal, U urethra, V transducer into vagina. Scan obtained by endovaginal ultrasound with X14L4 transducer (BK Medical)
a b
Fig. 9.4 Visualization of the position of a trans-obturator tape (TOT) in the coronal plane. In the left side, the sling appears dislodged (∗). (a)
Normal mode, (b) volume render mode. Scan obtained by endovaginal ultrasound with 2050 transducer (BK Medical)
9.3 Maximum Intensity Projection is the maximum intensity value found (the highest value of
gray or the highest value associated with a color). Conversely,
Maximum intensity projection (MIP) is a 3D visualization if the value displayed on the screen is the minimum value
modality involving a large amount of computation [3]. It can found, this is termed minimum intensity projection (MinIP).
be defined as the aggregate exposure at each point, which It has been reported in the literature that the application of
tries to find the brightest or most significant color or intensity MIP to 3D color US allows visualization of the distribution of
along an ultrasound beam. Once the beam is projected blood vessels in tumors, providing additional information for
through the entire volume, the value displayed on the screen management. Ohishi et al. [9] found that 3D images with MIP
150 M. M. Woźniak et al.
a b
Fig. 9.5 Visualization of the position of two trans-obturator tapes pubis, V transducer into vagina. Scan obtained by endovaginal ultra-
(TOT) in volume render mode (marked with white and yellow arrows). sound with X14L4 transducer (BK Medical)
(a) The coronal plane, (b) the sagittal plane. A anal canal, SP symphysis
Fig. 9.6 Visualization of hiatus with a 4D transperineal ultrasound (TPUS) showing left-sided defect (white arrows). (a) Surface render mode, (b)
tomographic ultrasound imaging (TUI). Scan obtained by transperineal ultrasound with RM6C transducer (General Electric)
9 Technical Innovations in Pelvic Floor Ultrasonography 151
mode improved evaluation of the entire vasculature of a tumor 9.4 Brush Options:
compared to cross-sectional 2D images. Hamazaki et al. [10] Segmentation—Sculpting
reported that 3D color Doppler US with MIP mode appeared
to be useful for the differential diagnosis of subpleural lesions. Sculpting is a post-processing tool that allows the examiner
Motohide et al. [11] considered this technique an efficient and to mark volume voxels, during off-line assessment of 3D-US
safe modality as an intraoperative navigation system for liver imaging (version 7.0.0.518—BK Medical 3D Viewer), so
surgery. In a preliminary study in nulliparous females, we that they are not displayed in the rendering operations. The
found that application of MIP reconstruction allowed visual- marking process uses a standard projection method to map
ization of the patterns of urethral vessels (spatial distribution screen locations within a boundary of the volume data. There
and localization of vessels) (Fig. 9.7) [12]. are two methods available: (1) in the first technique, the vox-
c
152 M. M. Woźniak et al.
Fig. 9.9 Two methods of sculpting: (1) the levator ani muscle is outlined and is cut off (left) and (2) outlining of the levator ani muscle with cutoff
of all the structures lying beyond (right). Scan obtained by endovaginal ultrasound with 2050 transducer (BK Medical)
a b
Fig. 9.12 Axial views of the female pelvis. (a) MRI scan. (b) provided by each technique. (c) Fusion imaging of the three-dimensional
Endovaginal ultrasound with 2050 transducer (BK Medical). Both reconstruction of the levator ani muscle (brown, US image; green, MR
images were captured simultaneously to allow fusion of the information image)
9 Technical Innovations in Pelvic Floor Ultrasonography 155
muscle; however, MRI, due to a wider field of view than the when opening a video or DICOM file, the software auto-
ultrasound transducer, provided more information about sur- matically finds the scale indicating the colors used for per-
rounding structures. fusion depiction and allows a standardized measurement.
Fig. 9.13 Color Doppler ultrasound for the assessment of the vascularity of the whole urethral complex in PixelFlux. A anal canal, SP symphysis
pubis, U urethra. Sagittal scan of the mid-urethra obtained by endovaginal ultrasound with X14L4 transducer (BK Medical)
156 M. M. Woźniak et al.
of perfused pixels inside the ROI; and (3) the perfusion internal database, facilitating the handling of large amounts
intensity, I. This parameter is defined as the ratio: of patient data, including features for comparison of differ-
I = V ´ A / AROI ent patients or examination of the same patient at different
times. It appears a very promising method for evaluating the
where AROI denotes the total area of the ROI. Consequently, the vasculature of pelvic structures in females at risk for devel-
perfusion intensity increases with the perfusion velocity but oping urinary incontinence or organ prolapse. In addition, it
decreases if less of the total area of the ROI is globally per- could be used to analyze the perfusion intensity in women
fused. These three parameters are computed for each single suffering from any pelvic floor disorder, in order to define
frame of the video examined. Based on the periodic changes whether the severity of their symptoms correlates with perfu-
due to the cardiac cycle, the program then automatically calcu- sion parameters.
lates the heart period and takes into account only one or mul- Using the PixelFlux software for assessment of the blood
tiple full heart cycles. The quantification of complete heart perfusion in the urethra of nulliparous females, we found that
cycles accomplishes the need for a time-independent perfu- the intramural and distal part of the urethra had poorer vas-
sion measurement as outlined above. Figure 9.14 shows a cular intensity than the mid-urethra. Interestingly, we did not
heart cycle recognized by the software (the parts of the chart observe any difference between the perfusion intensity in the
highlighted in red and blue, respectively). inner (including the longitudinal smooth muscle, the circular
Another key parameter of the PixelFlux software is “per- smooth muscle, and the submucosa) and outer (correspond-
fusion relief.” It shows the local distribution of perfusion ing to the rhabdosphincter muscle) rings of the mid-urethra
intensity, like a map depicting the height of mountains [12, 21]. Lone et al. studied vascularity of the urethra in con-
(Fig. 9.14). This tool can be used to gain a visual impression tinent women using color Doppler high-frequency endovagi-
of the vasculature, showing areas with different local perfu- nal ultrasonography and showed that compared to continent
sion (Fig. 9.15). nulliparous women, continent multiparous women demon-
The PixelFlux technique enables a quantitative assess- strated a significant reduction in the vascularity parameters
ment of blood perfusion. The program is completed by an in all measured variables when parity was accounted for [22].
Fig. 9.14 PixelFlux technique. Analysis form shows the heart cycles and the values of velocity, intensity, and area within the region of interest
9 Technical Innovations in Pelvic Floor Ultrasonography 157
Fig. 9.15 PixelFlux technique. Region of interest includes the mid- correspond to regions with moderate or low perfusion velocity). Scan
urethra. Analysis form showing the local perfusion relief (red areas cor- obtained by endovaginal ultrasound with 9C3 transducer (BK Medical)
respond to regions with high perfusion velocity; white and black areas
The same authors in the 1-year prospective follow-up study Dynamic US, however, provides an abundance of informa-
assessing urethral vascularity using 2D color Doppler high- tion that cannot be captured by the observer alone, as it
frequency endovaginal ultrasonography in women treated for occurs too fast.
symptomatic stress urinary incontinence found out that there Framing is a modality that provides a detailed visual-
is no change in vascularity parameters in women who opt for ization of the motion sequences of specific structures.
conservative or surgical treatment of SUI [23]. In the study With use of dedicated software (VIRTUAL-DUB), it is
by Yeniel et al., the authors attempted to find out if overactive possible to analyze consecutive frames of a video file, by
bladder microvasculature disease is a component of systemic cutting off the frame without decompression. It has poten-
atherosclerosis and found that all atherosclerosis indicators tial application in the assessment of functional disorders
were significantly associated with OAB and that there was a of the pelvic floor.
significant relationship between OAB and decreased bladder
neck perfusion. Additionally, there were correlations of OAB
severity with systemic atherosclerosis and impaired vascular 9.8 Motion Tracking and Color Vector
perfusion of the bladder. Decreased perfusion at the bladder Mapping
neck, the Framingham scores in severe OAB, and the cor-
relation between them suggest that OAB microvascular dis- Our ability to understand pelvic floor dysfunction arises
ease may be a component of systemic atherosclerosis rather from understanding the complex functional interactions
than a separate process [24]. among pelvic organs, muscles, ligaments, and connective tis-
sue. Dynamic US imaging provides a quantitative evaluation
of pelvic floor structures. Measurements of bladder neck dis-
9.7 Framing placement, urethral inclination, and retrovesical angle at rest
and during pushing or straining give important information
The motion of pelvic structures can be observed in real time in patients with urinary incontinence [25]. However, due to
by using dynamic ultrasound while asking patients in a small dimensions and different velocities and movements of
supine or standing position to strain or to cough. The data the pelvic structures, it is not possible to describe their inter-
can be registered as video files for off-line examination. actions precisely.
158 M. M. Woźniak et al.
Motion tracking is a modality for the assessment of bio- in the datasets is smoothed, and the boundaries of the
mechanical properties of tissues and organs [26]. image structures are preserved.
Computer-aided vector-based perineal ultrasound appears • Segmentation step using the averaged dataset by iterative
to be a feasible and valuable tool for the assessment of deformable boundary approach.
bladder neck mobility, allowing the user to distinguish • Reconstruction of the motion by applying the deforma-
between women with and without stress urinary inconti- tion field operator.
nence [27, 28]. Peng et al. [29] reported that motion track-
ing may be used for the assessment of puborectalis and For description of the motion, vector displacement was
pubococcygeus contraction, by evaluating the displace- calculated as a total displacement (relative to the reference
ment of the anorectal angle (ARA) during perineal US. To frame T0) and displacement between consequent time frames
map accurately the trajectory of the ARA, every frame was which can be seen as an instantaneous velocity. To visualize
indexed to the same rigid landmark (the symphysis pubis— the motion occurring on the surface (twisting), the instanta-
SP). A template of the SP was initially defined in the first neous velocity vectors were decomposed into tangential and
frame of the ultrasonographic video file, then it was com- normal components.
pared with the second image with different offset in both Different techniques can be used to visualize the local
the x and y direction. The matching procedure employed variations of the motion as follows:
some equations and was repeated until the last image
frame. The relative displacement of the ARA to the SP was • Color-based visualization according to length values of
obtained by subtraction of the SP from the ARA. Results displacement vectors. It is the preferred modality when
of this study showed that during cough, the ARA moves we deal with small moving surfaces.
toward the SP (ventrally) in continent women and away • Vector-based visualization: for significant motion it is
from the SP (dorsally) in urinary-incontinent patients. In preferred to visualize vector values using the arrows rep-
addition, the amplitude of ARA maximal caudal displace- resenting the length and spatial orientation of moving
ment was smaller in continent women compared to incon- matter.
tinent patients [29]. Constantinou [30] described the • Line-paths-based visualization: in this method, the small
dynamics of female pelvic floor function using urodynam- set of surface points is selected, and the path of their
ics, ultrasound imaging with motion tracking, and MR, in motion is visualized. Colors of the line segments repre-
terms of determining the mechanism of urinary conti- sent various time frames. This method enables estimation
nence. Among these modalities, motion tracking provided of the viability of the heart using a single image. In addi-
quantitative measures (displacement, velocity, accelera- tion to the line-paths method, we may also generate the
tion, trajectory, motility, strain) of pelvic floor muscles. “activity surface.” Using this technique, total path length
On the basis of these parameters, the status of continent values (in a single cardiac cycle) for every surface point
and asymptomatic women could be clearly distinguished can be visualized. Thus it allows easy detection of moving
from those with incontinence. regions and evaluation of how significant this motion is,
We developed a novel computer software for quantitative as well as estimation of the spatial extent of pathological
assessment of the motion of pelvic structures. This software regions on single static image. Line-paths visualization
was originally applied to 3D echocardiographic scans to contains complete information about the motion, whereas
evaluate the kinetics of the cardiac walls in patients with activity surfaces show the overall surface activity more
heart infarction [31, 32]. The process of analysis consisted of clearly [32].
several main steps:
The motion tracking procedure described above can be
• Filtering: to improve the US image quality and to remove applied to assessment of the function of pelvic structures.
the noise; the diffusion algorithm was applied, as it dra- The data are collected using transperineal and endovaginal
matically enhances the structure boundaries and reduces ultrasound scanning in B mode, during straining and Valsalva
the speckle noise. maneuver, and registered as video files. The data are then
• Description of the motion: recovery of transformation, analyzed with the use of color and vector mapping (Fig. 9.16).
which aligns the reference frame with all the other frames We believe that this modality could enhance our knowledge
using intensity-based 3D volume registration; this allows of pelvic organ dysfunction, facilitating the diagnosis of
to visualize local deformation of spatial objects. injuries or deficiency of pelvic muscles after childbirth that
• De-noising procedure using time-averaging technique: is not detectable by conventional imaging techniques. It can
the deformation fields are used to generate new datasets also be useful to evaluate muscle strength after biofeedback
elastically aligned with the reference frame T0; the noise treatment.
9 Technical Innovations in Pelvic Floor Ultrasonography 159
a b c
d e f
Fig. 9.16 (a) Longitudinal section of the posterior compartment. closes the anorectal angle, assuring continence. (e, f) During Valsalva
Color and vector mapping were applied for the assessment of the mus- maneuver, the puborectalis activity is suppressed, whereas the external
cles’ motion. AC anal canal, ARA anorectal angle, EAS external anal sphincter opens. Scans obtained by endovaginal ultrasound with 8848
sphincter, PR puborectalis muscle, R rectum. (b–d) During straining, transducer
upward movement of the puborectalis is visualized. This movement
9.9 Elastography 3. in the dynamic case only, the data may be used to record
the propagation of shear-waves, which are used to calcu-
Elastography uses ultrasonic imaging to observe tissue late either.
shear deformation after applying a force that is either
dynamic (e.g., by thumping or vibrating) or varying so (a) regional values of their speed (without making images)
slowly that it is considered “quasi-static” (e.g., by probe using methods referred to herein as transient elastogra-
palpation). The deformation may be represented in an elas- phy (TE) and point shear-wave elastography (pSWE), or,
ticity image (elastogram), or as a local measurement, in one (b) images of their speed using methods referred to
of three ways: herein as shear-wave elastography (SWE) which
includes 2D SWE and 3D SWE [33].
1. tissue displacement which may be detected and displayed
directly, as in the method known as acoustic radiation The strain measurements (including SE and ARFI) are
force impulse (ARFI) imaging, displayed as a semitransparent color map called an elasto-
2. tissue strain which may be calculated and displayed, pro- gram, which is overlaid on the B-mode image. Typically, low
ducing what is termed strain elastography (SE), or, strain (stiff tissue) is displayed in blue, and high strain (soft
160 M. M. Woźniak et al.
tissue) is displayed in red, although the color scale can vary and at all contraction intensities. Multiple regions of
depending on the ultrasound vendor [34, 35]. A pseudo- increased stiffness were detected, with 95.8% of regions sit-
quantitative measurement called the strain ratio can be used, uated ventral to the mid-urethra within the anatomical area
which is the ratio of strain measured in adjacent (usually nor- of the SUS. The increase in stiffness was greater for 50%
mal) reference tissue region of interest (ROI) to strain mea- MVC than both 10% and 25% MVC contraction intensities
sured in a target lesion ROI. A strain ratio > 1 indicates that (P < 0.01). The study has proven that stiffness increases
the target lesion compresses less than the normal reference within the anatomical region of the SUS during voluntary
tissue, indicating lower strain and greater stiffness [36]. In pelvic floor muscle contractions with predictable response to
shear-wave elastography (SWE), measurement of the shear- changes in contraction intensity. These observations support
wave speed results in qualitative and quantitative estimates the potential for ultrasound SWE to study SUS function non-
of tissue elasticity [37]. The elasticity measurements, using invasively [40] (Fig. 9.17).
SWE or 2D SWE, may be expressed as either shear-wave Chen et al. [41] described quasistatic elastography with a
velocity (m/s) or Young’s modulus (kPa) [38]. reference standoff pad as a promising quantitative method
evaluating the elastic modulus of the perineal body. The
authors used an UltraSONIXR P500 ultrasound system
9.9.1 Endovaginal Elastography equipped with elastography software. Approximately 1 Hz
freehand sinusoidal compression loading of the perineum
Strain elastography (SE) is a technique of parametric imaging was used to measure the relative stiffness of the perineal
that allows quantification of the elasticity of tissue. body compared to that of a custom reference standoff pad
Kreutzkamp et al. [39] attempted to determine if the elasticity with a modulus of 36.7 kPa. Measurements were made in
of paraurethral tissue correlates with urethral mobility and 20 healthy nulliparous women. Preliminary data, despite
urinary incontinence (UI). One region of interest was placed their limitations, provided a first order in vivo estimation of
in the tissue between the urethra and vagina at midlevel of the the nulliparous perineal body modulus [41].
urethra bordering the urethral wall. The second ROI was set Xie et al. [42, 43] evaluated the levator ani before and
at the level of the os urethra internum in the tissue of the blad- after Kegel exercise in women with pelvic organ prolapse
der neck in one line to the first ROI. The authors measured (POP) stage I/II by transperineal elastography. The patients
elasticity in both ROIs with TDI-Q (Tissue Doppler Imaging- underwent conventional transperineal ultrasound and elas-
Quantification Software) and calculated the ratio between tography. For each patient, the levator ani was located and
ROIs. Mobility of the urethra was quantified by measuring evaluated in the state of Valsalva. After Kegel exercises for
the angle between a line parallel to the urethra and a line par- 12 weeks, transperineal ultrasound and elastography were
allel to the bladder neck during stress and rest. SE analysis repeated. The elasticity images were assessed using a four-
was feasible in all cases. A correlation between urethral point scale scoring system. The authors showed that the
mobility and elasticity of the paraurethral tissue was found. In mean elastography score was statistically significantly higher
case of increasing urethral mobility, the paraurethral tissue for the levator ani after Kegel exercises (2.90 ± 0.48) than for
close to the bladder neck seems to be more elastic, and the the baseline score (1.90 ± 0.29) (p = 0.025). Transperineal
patients reported about more symptoms of UI. No noticeable elastography was an effective and useful tool in the evalua-
correlation between UI and urethral elasticity was shown. SE tion of the levator ani in patients with POP-Q stage I/II
may be a useful technique for direct quantification of tissue before and after Kegel exercises [42, 43].
elasticity and assessment of pelvic floor biomechanics [39]. Masslo et al. [44] introduced elastography as a new
Female striated urogenital sphincter contraction mea- method for sonographic assessment of levator avulsion
sured by shear-wave elastography during pelvic floor muscle injury in postpartum pelvic floor trauma. The authors showed
activation was described by Aljuraifani et al. [40]. The that the elastographic evaluation revealed more trauma-
authors used ultrasound shear-wave elastography (SWE), a suspicious lesions than the B-mode investigation. In conclu-
noninvasive real-time technique to estimate tissue stiffness. sion sonographic elastography assessment in a new
As muscle stiffness can be used as an estimate of muscle examination plane shows postpartum trauma of the pelvic
force, SWE provides an opportunity to study contraction of floor in women after vaginal delivery. This new method may
the periurethral musculature. Stiffness in a region expected help to identify women with a higher risk of postpartum pel-
to contain the striated urogenital sphincter (SUS) was quanti- vic floor disorders [44].
fied using SWE at rest and during a pelvic floor muscle con- Egorov et al. [45, 46] designed a prototype of vaginal tac-
tractions performed at 10%, 25%, and 50% of maximal tile imager (VTI) for visualization and assessment of elastic
voluntary contraction (MVC). Two repetitions were per- properties of pelvic floor tissues. The prototype of the VTI
formed for 10 s. The authors showed that during contraction, included a transvaginal probe, an electronic unit, and a lap-
stiffness increased in the region of the SUS in all participants top computer with a data acquisition card. The vaginal probe
9 Technical Innovations in Pelvic Floor Ultrasonography 161
Fig. 9.17 Assessment of urethral complex elasticity in an incontinent ity/high stiffness (hard tissues); red represents high elasticity/low stiff-
female during rest and Valsalva maneuver. Four selected frames demon- ness (soft tissues). Images obtained by the endovaginal ultrasound with
strating different elasticity of the urethra and paraurethral structures at E14C4t transducer (BK Medical)
various states of urethral contraction/rest. Blue represents low elastic-
comprised of a tactile sensor array and a tilt sensor. The tac- Sturm et al. demonstrated that [47] ultrasound shear-wave
tile sensor array is installed on the probe head surface con- elastography bladder measurements correlate well with blad-
tacting with the vaginal wall during the examination der storage pressure and shear-wave speed measurements
procedure. The probe head measures 48 mm in length, differ between compliant and noncompliant bladders. This is
20 mm in width, and 14 mm in height having ellipsoidal the first known study to demonstrate that shear-wave elastog-
cross section. The tactile sensor array (Pressure Profile raphy is promising as a bedside modality for the assessment
Systems, Inc., CA) comprises of 120 capacitive pressure sen- of bladder dysfunction in children [47].
sors, which provide 2D pressure pattern being contacted
with vaginal wall. A pilot clinical study performed with 13
patients demonstrated that tactile imaging allows quantita- 9.9.2 Endoanal Elastography
tive evaluation of elastic properties of vaginal walls by means
of the elasticity index and has a potential for differentiation Allgayer et al. [48, 49] analyzed endosonographic elastogra-
of normal tissue and diseased tissue under prolapse condi- phy of the anal sphincter in patients with fecal incontinence
tion. VTI allows imaging of a vaginal wall with increased and found that the IAS, a smooth muscle, and the EAS, a
rigidity due to implanted mesh grafts following reconstruc- striated muscle, have different elastogram color distribu-
tive pelvic surgery [45, 46]. tions, probably reflecting their different elastic properties.
162 M. M. Woźniak et al.
The absence of significant correlations with the major clini- (AT), maximum contrast medium enhancement (time to
cal and functional parameters suggests that in routine clini- peak, TTP), maximum contrast intensity (peak intensity, PI),
cal practice ultrasound, real-time elastography may not yield area under the curve (AUC), loading time (WIT), ascending
additional information in patients with fecal incontinence. slope (AS), and echo intensity (EI) . With the help of these
There may be exceptions, particularly in irradiated patients parameters, CEUS offers very good interobserver variability
[48, 49]. Moreover real-time elastography in patients with [50, 52, 53].
fecal incontinence following anorectal surgery with quanti- The contrast agent is homogeneously retained by all rec-
tation of sphincter elastic properties yields no further diag- tal adenomas, and, compared to tumor-free rectal wall, the
nostic and prognostic information compared to conventional contrast medium becomes visible later and with lower
EUS in irradiated and non-irradiated patients and, therefore, intensity. Difficulty may arise in case of larger adenomas
cannot be regarded as a new tool in the assessment of those with increased uptake. Adenocarcinomas are irregular, and,
patients. Our data further confirm the view that defined compared to the tumor-free rectal wall, the contrast medium
sphincter defects may be a major risk factor for an unfavor- loads faster, and contrast maximum enhancement occurs
able outcome [49]. earlier [54]. Specifically, aggressive tumors with high
Elastography can distinguish malignant from benign degree of angiogenesis have an increased inhomogeneous
tumors (malignant tumor mean strain ratio value over 1.25 contrast uptake. An exception to this rule is that of large
and benign tumor mean strain ratio value below 1.25). In tumors with intratumoral necrosis, which can have a low
terms of cancer staging, elastography, along with TRUS, contrast uptake or even no uptake [50]. Enhanced intensity
is useful to distinguish pT0 stage from pT1 stage, with negatively correlates with histologic grade; however, none
better results than MRI, including pretreatment biopsy. of other parameters correlates with TNM stage and histo-
Elastography, additional to TRUS, does not bring additional logic grade [53].
information regarding T2 and T3 staging, as TRUS is suf-
ficient for final cancer staging. To our knowledge, the char-
acterization of pathological lymph nodes did not include 9.10.2 Contrast-Enhanced Voiding
their elasticity, but, by our experience, these appear more Urosonography (ceVUS)
rigid than perirectal fat during elastography [50]. Li et al.
demonstrated that SWE is a promising tool that yields valu- The most common pediatric application of US con-
able quantitative data additional to that provided by ERUS trast agents is contrast-enhanced voiding urosonography
examination in rectal lesions. The cutoff value 61.3 kPa for (ceVUS), i.e., the intravesical application of US contrast
Emean may serve as a complementary tool in diagnosis of agents via a bladder catheter for the evaluation of vesicoure-
rectal lesions [51]. teral reflux. The procedure and its diagnostic accuracy are
well-established and documented [55]. Contrast-enhanced
voiding urosonography (ceVUS) has become a well-estab-
9.10 Contrast-Enhanced Ultrasound lished method for the diagnosis and treatment monitoring of
(CEUS) vesicoureteral reflux (VUR) in children, particularly after
the recent approval for this application in children in the
9.10.1 Rectal Cancer USA and in Europe [56]. It is a very safe technique [57,
58], which can be used both in diagnostics and monitor-
This application of EAUS has not yet been fully explored in ing of treatment of VUR as well as intraoperatively during
relation to rectal tumors, but there are many studies in other endoscopic anti-reflux therapy [59]. It enables very accurate
areas of interest, where it has demonstrated its importance in assessment of urethra, both in females and in males [60].
the characterization of tumoral lesions [50]. Immediately Other indications for ceVUS include bladder rupture and
after the injection of the contrast medium, the microbubbles urogenital malformation [55].
reach the rectum, especially the areas where microcircula- The introduction of three-dimensional static (3D) and
tion is more abundant. The images must be stored for further real-time (4D) techniques with ultrasound contrast agents
analysis of loading and unloading curves and for a more opens up new diagnostic opportunities for this imaging
objective interpretation, according to the time intervals modality [61–63]. 2D ceVUS and 3D/4D ceVUS allow to
acquired on these curves. In order to calculate these curves diagnose the same number of vesicoureteral refluxes; how-
and easily identify the differences between them, one or ever, there is a statistically significant difference in grading
more ROIs must be manually selected on the equipment, one between the two methods. Thus 3D/4D ceVUS appears at
for the tumor-bearing region and another for an apparently least a valid, if not even a more conspicuous technique com-
tumor-free region. The most important time-intensity param- pared to 2D ceVUS [61–63] (Fig. 9.18).
eters that can be acquired on the loading and unloading Contrast-enhanced urosonography (ceVUS) and its modi-
curves are the following: contrast arrival time in the ROI fications such as contrast-enhanced urethrography can be
9 Technical Innovations in Pelvic Floor Ultrasonography 163
Fig. 9.18 Contrast-enhanced urosonography (ceVUS) in a pediatric according to 2D ceVUS graded as III and according to 4D ceVUS
patient with recurrent urinary tract infections. Two-dimensional (2D) graded as IV. Images obtained by the endovaginal volumetric trans-
(a) and four-dimensional (4D) (b) images of vesicoureteral reflux, ducer RIC5-9D (General Electric) from transabdominal access
164 M. M. Woźniak et al.
Fig. 9.19 Contrast-enhanced
urethrography in an
adolescent female patient with
urinary incontinence showing
ectopic ureter entering the
proximal urethra (arrows).
Images obtained by the
pediatric volumetric
transducer RNA5-9D
(General Electric) from
transperineal access.
B bladder, U urethra
designed to provide automatic volume calculations of fluid- grading from transperineal US video. A two-layer spatiotem-
filled areas. It is either incorporated into the ultrasound poral regression model is proposed to identify the middle
machine or installed on a personal computer for off-line axis and lower tip of the SP and segment the bladder, which
analysis of the datasets acquired by any ultrasound machine are essential tasks for the measurement of the MDB. Both
of the same manufacturer. SonoAVC/5D Follicle identifies appearance and context features are extracted in the spatio-
and quantifies hypoechogenic regions within a 3D dataset temporal domain to help the anatomy detection. Experimental
and provides automatic estimation of their absolute dimen- results on 85 transperineal US videos show that our method
sions, mean diameter, and volume. Because each different significantly outperforms the state-of-the-art regression
volume is color-coded separately, the software is an ideal method [67].
tool for studying follicular development within the ovary.
The software is valid and provides accurate measurements
[66] and reliable report (Fig. 9.20). 9.12 Conclusions
Another type of automatic calculations has been devel-
oped for the grading of cystocele. A number of new ultrasonographic techniques have been
The transperineal ultrasound (US) has recently emerged developed recently which carry the potential of significant
as an alternative tool for cystocele grading. The cystocele improvement of the diagnostic value of ultrasound in pelvic
severity is usually evaluated with the manual measurement floor disorders. Three-dimensional (3D) and real-time four-
of the maximal descent of the bladder (MDB) relative to the dimensional (4D) imaging techniques enable to overcome
symphysis pubis (SP) during Valsalva maneuver. However, limitations of conventional two-dimensional (2D)
this process is time-consuming and operator-dependent. In US. Complex information on the exact location, extent, and
this study, we propose an automatic scheme for cystocele relations of relevant pelvic structures can be displayed with
Fig. 9.20 Three-dimensional (3D) endoanal examination of adoles- coded automatically with a different color. (b) Report from the exami-
cent girl with polycystic ovaries syndrome (PCOS) with the use of nation listing each follicle in both ovaries. Images obtained by the endo-
SonoAVC—a software enabling automatic calculation of the number, vaginal volumetric transducer RIC5-9D (General Electric) from
dimensions, and volumes of the ovarian follicles. (a) Each follicle is endoanal access
166 M. M. Woźniak et al.
Gynecology Report
SonoAVC™ (Semi-)Automatic
Left Ovary Right Ovary
Total#: 24 Total#: 30
1/2
21.12.2016 10:30:55
Fig. 9.20 (continued)
9 Technical Innovations in Pelvic Floor Ultrasonography 167
Dist.
D 2.84 cm 0.84 7.44 3.47 1.03 4.04 0.21 avg.
Vol. 3 Dist.
D1 5.01 cm 4.94 5.08 avg.
D2 2.82 cm 2.91 2.73 avg.
D3 2.28 cm 2.50 2.05 avg.
Vol 16.829 cm³ 18.817 14.886
1/2
21.12.2016 10:30:55
Fig. 9.20 (continued)
168 M. M. Woźniak et al.
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Magnetic Resonance Imaging:
Methodology and Normal Pelvic Floor 10
Anatomy
Jeroen A. W. Tielbeek and Jaap Stoker
B R
V
PS
CUL-DE-SAC
The urethral sphincter complex consists of a circular Although this structure has been identified as the periurethral
proximal portion (urethral sphincter proper), a sling that ligament [5] and the inferior extension of the pubovesical
passes on the vaginal wall laterally to attach to the puborectal muscle [6], it may also represent the compressor urethrae.
muscle (urethral compressor), and a circular portion that sur- The compressor urethrae and urethrovaginal sphincter are
rounds the distal urethra and vagina (urethrovaginal sphinc- urethral supportive structures with multiple (inter)connec-
ter) [4]. tions and have previously been considered part of the deep
The female urethra closes the urinary bladder and is transverse perineal muscle [7]. The compressor urethrae
important for maintaining urinary continence. It is made up forms a broad arching muscular sheet close to the urogenital
of two main components: an inner mucosa and an outer mus- hiatus and adjacent to the rhabdosphincter (Fig. 10.2). It
cular coat. The latter comprises an inner smooth muscle compresses and elongates the urethra. The urethrovaginal
layer and an outer striated muscle layer (Fig. 10.2). These sphincter comprises striated muscle fibers encircling the
layers are easily appreciated on MRI, with their distinct dif- vagina. The urethrovaginal sphincter blends anteriorly with
ferences in intensity. The smooth muscular layer (lisso- the compressor urethrae and posterior fibers may extend to
sphincter) is a cylinder, while the external urethral sphincter the perineal body.
(rhabdosphincter) is a ring at the middle of the urethra, but The urethra is supported by a layer of supportive tissue
relatively thin posteriorly and deficient superiorly and formed by the endopelvic fascia (see Sect. 10.6). The urethra
inferiorly. is at the level of the pelvic diaphragm, bordered by the most
Anterior to the urethra, a sling-like structure can be iden- medial part of the pubococcygeus muscle (i.e., the pubovagi-
tified (Fig. 10.2). This structure courses just anterior to the nal muscle) (Fig. 10.3), which inserts posteroinferiorly into
urethra and has lateral attachments to the levator ani muscle. the perineal body.
10 Magnetic Resonance Imaging: Methodology and Normal Pelvic Floor Anatomy 173
Fig. 10.2 Endovaginal axial oblique T2-weighted turbo spin echo. The Fig. 10.3 External coil axial oblique T2-weighted turbo spin echo
compressor urethra (curved arrow) is anterior to the urethra and attaches shows the lateral support of the vagina by the levator ani (curved
to the levator ani muscle. The urethra has a multilayered appearance arrow). The puboanalis (PA) courses to the longitudinal layer. The
which is central the mucosa/submucosa (U), bordered by the relative triangular-
shaped (ischio)coccygeus muscle (C) is visible with its
hyperintense smooth muscle lissosphincter (LS) and the relative attachment at the ischial spine (ISp). Aorectal junction (AR), internal
hypointense striated rhabdosphincter (RS). The pubococcygeus muscle obturator muscle (IOM), rectum (R), urethra (U), vagina (V)
part of the levator ani muscle (arrow) is attached to the pubic bone
(PB). Anteriorly the pubococcygeus part of the levator ani muscle
the presacral fascia. The cardinal ligament arises from the
courses (arrowheads) from the tendineus arc of the levator ani at the
internal obturator muscle (IOM) (anterior part has origin at pubic bone) area of the greater sciatic foramen and courses to the uterine
and, posteriorly, the iliococcygeus (open arrow). Anorectal junction cervix. Both the cardinal and sacrouterine ligaments sur-
(A), pubic symphysis (PB), vaginal wall (V) round the cervix and envelop the superior part of the vagina.
Both ligaments give lateral support. The anteromedial part of
the vagina is suspended by the endopelvic fascia (pubocervi-
10.4 The Middle Compartment cal fascia), with attachment to the tendineus arc of the pelvic
fascia. The vagina also has lateral support from the medial
The middle compartment consists of the uterus, cervix, and part of the levator ani (level III support) (Fig. 10.3) and from
vagina. The uterus and vagina are supported by several structures the perineal membrane [8, 10, 11].
that, to aid understanding, can be divided into several levels.
The adventitial endopelvic fascia is an important part of the
supportive structures for the uterus and vagina. It covers the 10.5 The Posterior Compartment
parametrium (broad ligament), which comprises the most supe-
rior layer and gives lateral support. The fascia extends to the 10.5.1 The Posterior Compartment Contains
paracolpium and has been indicated as level I vaginal support the Rectum and Anal Sphincter
[8]. Support at this level also includes the round ligaments.
The uterosacral and cardinal ligaments are condensations The rectum acts as a reservoir at the end of the gastrointesti-
of the endopelvic fascia and form the major constituents of nal tract and is crucial in maintaining continence. Within the
the second level of vaginal support [8–10]. The uterosacral mucosa there are distension-sensitive nerve endings, while in
ligaments run from the posterolateral aspect of the cervix to the muscular wall, nerve endings are more sensitive to the
174 J. A. W. Tielbeek and J. Stoker
Fig. 10.4 External coil axial oblique T2-weighted turbo spin echo Fig. 10.6 External coil coronal oblique T2-weighted turbo spin echo. The
shows the pubovisceral muscle (curved arrow), puborectal muscle internal anal sphincter (IS) and outer striated muscle layer formed by the
(PR), and puboanal muscle (short arrows). The puboanal muscle external sphincter (ES; lower half) and puborectal muscle (PR; upper half)
courses to the longitudinal layer (LL). IS internal sphincter, IOM inter- are readily appreciated; the intersphincteric space (ISS) is in between. LA,
nal obturator muscle, VI vaginal introitus iliococcygeal part of the levator ani which attaches to the internal obturator
muscle (IOM) fascia at the tendineus arc of the levator ani (curved arrow).
ES external anal sphincter, IAS ischioanal space, R rectum
10 Magnetic Resonance Imaging: Methodology and Normal Pelvic Floor Anatomy 175
Khoschy Schawkat and Cäcilia S. Reiner
[10]. In a study by Bertschinger et al. [9], all intussuscep- to the middle compartment, the soft tissue contrast is usually
tions found in upright positions were missed in the supine high enough to allow identification of all anatomical land-
position. However, the evacuation phase was not performed marks. Therefore, we do not perform any tagging of the
in this study. Knowing that most pelvic floor pathologies vagina. Exceptions may be specific queries before surgery is
show their full extent during evacuation, these results should performed, such as reconstruction of the pelvic floor in
be interpreted with caution [6, 7]. To minimize straining severe uterus prolapse.
efforts and to facilitate evacuation in the supine position, the For evaluation of the posterior compartment of the pelvic
knees should be elevated (with a pillow or wedge with firm floor, experts agree that the rectum should be filled with con-
consistency which can be positioned underneath the patient’s trast agent. The contrast material in the rectum not only
knee) [6, 11]. allows for better delineation but also allows studying the
actual act of defecation. This is of importance, as some dis-
orders of the pelvic floor, such as rectal prolapse or intussus-
Recommendations for Practice ceptions, only appear in their full size during defecation [7].
• Patient cooperation is critical to obtain a useful Immediately before the examination, the rectum is filled
examination. Therefore, a preexamination training with the rectal enema. The volume of enema used is variable
is recommended on how to correctly perform the and ranges between 120 and 250 ml [6]. Some investigators
maneuvers during the MRD examination. administer contrast agent until the patient feels a sustained
• An essential part of MRD is to encourage and coach desire to defecate. Others use a standardized volume of con-
the patient during the examination in order to obtain trast agent. Although it is not known if the amount of contrast
a viable MRD study. agent administered influences the extent of structural pelvic
• Bladder voiding 2 h before the examination is rec- floor disorders, in our experience, 250–300 ml of enema
ommended, and ideally the bladder is moderately gives the best results. In general, a larger amount of gel
filled during the examination. (180–200 ml) likely improves the capacity of the patient to
• To facilitate the evacuation process in supine posi- defecate [6]. However, the time needed to evacuate the con-
tion, the knees should be elevated by putting a pil- trast agent, and thus the assessment of the evacuation ability,
low underneath the knees. depends on the amount of contrast agent. Therefore, it is nec-
essary to standardize the volume administered. The viscosity
of the contrast agent should be similar to that of normal rec-
tum content because the manifestations of pelvic floor
pathologies vary with different fecal consistency [15–17].
11.3 Patient Preparation Authors recommend ultrasound gel [18–20] or mashed pota-
toes [9, 21, 22]. Depending on the sequence used for dynamic
Patient cooperation is critical for a useful examination. MRI, the rectal enema may be doped with a small amount of
Therefore, a preexamination training is recommended on standard extracellular gadolinium-based MR contrast agent.
how to correctly perform the maneuvers during the dynamic Neither premedication nor oral or rectal preparation for
phase of the examination and the evacuation phase. The bowel cleansing is necessary before imaging [6].
patient should be instructed to repeat the evacuation process The technologist plays a crucial role in obtaining a diag-
until the rectum is emptied [6]. To minimize patients discom- nostic study. It is their important responsibility to put the
fort as much as possible and to protect the scanner from soil- patient at ease prior and during the examination as well as to
ing, a diaper pant should be offered to the patients. encourage the patient to perform the maneuvers correctly
Bladder voiding 2 h before the examination is recom- during the examination communicating with the patient via
mended, and ideally the bladder is moderately filled during microphone and headphone [1].
the examination [6]. Otherwise a markedly distended blad-
der might mask pelvic organ prolapse. The administration of
luminal contrast agent for MRI of the pelvic floor varies in 11.4 Imaging Protocol
different studies, from use of no contrast agent to filling of
the rectum, vagina, urethra, and bladder with contrast agent; Dynamic pelvic MRI can be performed in supine position on
placement of markers in the vagina or rectum; or placement all commercially available closed- or open-configuration
of urethral catheters [12–14]. Vaginal filling with 20 ml MR systems with horizontal access. So far there is no data
ultrasound gel is helpful for better demarcation; however, the available, whether 1.5 T or 3.0 T magnets are preferably for
resent guideline from the European Society of Urogenital dynamic pelvic floor MRI. For MRI with the patient in
Radiology (ESUR) and Gastrointestinal and Abdominal supine position, a pelvic phased-array coil covering the pel-
Radiology (ESGAR) working group does not recommend vis is used. After filling the rectum, the examination starts
general application [6]. In our current imaging protocol, we with a localizer sequence. The imaging protocol usually
do not perform retrograde filling of the bladder. With regard includes static and dynamic sequences. For static imaging
11 Dynamic Magnetic Resonance Imaging of the Pelvic Floor: Technique and Methodology 181
non-fat-suppressed high-resolution static T2-weighted compartment contains the vagina, and the posterior compart-
sequences (e.g., turbo spin echo, TSE; fast spin echo, FSE; ment contains the rectum. Although the three-compartment
rapid acquisition with relaxation enhancement, RARE) in model is used for interpretation of pelvic organ prolapse, the
three planes are recommended [6]. Alternatively, an isovolu- pelvic floor should be considered as one unit since the three
metric three-dimensional T2-weighted sequence could be compartments work as one entity and combined defects are
used, which can be reconstructed in all imaging planes. common.
Subsequently, dynamic MRI is performed as the central part The three compartments of the pelvic floor are assessed
of pelvic floor MRI. For dynamic MRI in the different for morphological changes at different pelvic floor positions.
positions (at squeezing, at straining, and during defecation), Besides the qualitative assessment, quantitative evaluation of
various MR sequences can be used, with similar results. imaging findings is important, because the extent of these
Newest recommendations state to use a steady-state (e.g., findings may influence further management. Metric mea-
FISP, GRASS, FSIF, SSFP, T2-FFE) or balanced-state free surements of the position of the three compartments during
precession sequence (e.g., trueFISP, FIESTA, B-FFE) in the dynamic sequences are assessed with regard to functional
midsagittal plane [6]. Alternatively, T1-weighted multiphase abnormalities and help to assess the grade of pelvic organ
gradient-recalled echo (GRE) sequences may be used. If the prolapse, grade of anterior rectoceles, and enteroceles [6].
T1-weighted multiphase GRE sequence is used, the rectal
enema is usually tagged with a small amount of a gadolinium-
based contrast agent. Which sequence is used depends on the 11.5.2 Reference Systems
scanner. Breath holding is required for the dynamic
sequences, and therefore they should not exceed 20 s each
The use of reference points and lines to determine the pres-
[6]. For the evacuation phase, it is important to have aence and extent of pelvic organ prolapse is helpful. The most
sequence that offers the possibility to acquire images over a
used reference line is the pubococcygeal line (PCL), which is
long time period without the necessity to reload the sequence.
defined on midsagittal images as the line joining the inferior
This is particularly important in patients with a long prolon-
border of the symphysis pubis to the last or second-last coc-
gation period. Only during evacuation the full extent of pel-
cygeal joint. The position of the base of the bladder (anterior
vic organ prolapse is visible and therefore is an essential
compartment), the cervix, or vaginal vault (middle compart-
component of MRD examinations [7]. ment) and the anorectal junction (posterior compartment) is
measured at a 90° angle to the PCL in the different pelvic
floor positions (at rest, squeezing, straining, and evacuation)
11.5 Image Analysis as shown in Fig. 11.1. The anorectal junction (ARJ) is
defined as the cross-point between a line along the posterior
11.5.1 Three-Compartment Model wall of the distal part of the rectum and a line along the cen-
tral axis of the anal canal. To determine pathologic pelvic
Image analysis is performed according to the three- floor descent, the measurements are made on the images,
compartment model of the pelvic floor [23]. The anterior which show maximal organ descent, usually during maximal
compartment contains the bladder and urethra, the middle straining or evacuation. For grading of pelvic floor descent
a b c
Fig. 11.1 36-year old female patient with a minimal descent of the ante- rior compartment), the vaginal vault (2, middle compartment), and the
rior compartment and a moderate descent of the posterior compartment anorectal junction (3, posterior compartment) is measured perpendicular
during defecation. On MR images obtained at rest (a), at squeezing (b), to the PCL. Note the small anterior rectocele during evacuation. B blad-
and during evacuation (c) the position of the base of the bladder (1, ante- der, P symphysis pubis, PCL pubococcygeal line, R rectum, U uterus
182 K. Schawkat and C. S. Reiner
using the PCL system, the pelvic floor working group pro- straining with two reference lines: the H line, which repre-
poses to apply the “rule of three”: prolapse of the organ sents hiatal widening and extends from the inferior aspect of
below the PCL by ≤3 cm is mild, by 3–6 cm is moderate, and the symphysis pubis to the posterior wall of the rectum at
by >6 cm is severe (Table 11.1) [6]. However, these diagnos- the level of the ARJ, and the M line, which represents hiatal
tic thresholds are based on data mainly assessed at straining descent and extends perpendicularly from the PCL to the
and not during defecation. Flusberg et al. observed that addi- posterior end of the H line (Fig. 11.3). Lesions of the pelvic
tional anterior, middle, and posterior compartment descent musculofascial support result in widening of the hiatus and
was seen during defecation compared to the straining phase. descent of the levator plate. Thus, the H and M lines tend to
The authors concluded that looking at pelvic floor descent elongate with pelvic floor relaxation, representing levator
only during straining may underestimate the findings as hiatal widening and levator plate descent, respectively.
higher degrees of pelvic floor descent, and additional pelvic Abnormal pelvic floor relaxation is present, when the H line
floor pathologies are detected as patients progress from exceeds 6 cm and when the M line exceeds 2 cm in length
straining to defecation [7] (Fig. 11.2). (Table 11.2) [25]. Pelvic organ prolapse constitutes the
Beside the three-compartment model with the PCL as a O-component in the HMO system and is defined as any
reference line, which is mainly used by surgeons and gastro- organ descent below the H line.
enterologists, the second known system for grading pelvic The choice of reference line mainly depends on the radi-
floor abnormalities is the “HMO system,” which is mainly ologist and referring clinician, as none of the systems have
used by urologists and gynecologists [24]. The HMO sys- shown clear superiority. The different reference systems
tem distinguishes pelvic organ prolapse and pelvic floor show only moderate to poor agreement with clinical stag-
relaxation, which are two separate but often coexistent ing of pelvic organ prolapse [26]. Using structured report-
pathologic entities. In pelvic floor relaxation, the pelvic ing helps radiologists and referring physicians with
floor, with its active and passive support structures, becomes interpretation and understanding of dynamic pelvic floor
weakened, leading to hiatal descent and widening. The MRI [1, 6].
degree of pelvic floor relaxation is measured at maximal
Table 11.1 Grading of pelvic organ descent using the pubococcygeal 11.5.3 Anorectal Angle
line (PCL) [1]
Grade Measurementsa The anorectal angle (ARA), which is defined as the angle
Small organ descent <3 cm below the PCL between the posterior wall of the distal part of the rectum
Moderate organ descent 3–6 cm below the PCL and the central axis of the anal canal, can be measured at
Large organ descent >6 cm below the PCL rest, squeezing, and straining. It is a measure for the mobil-
a
As measured for anterior, middle, and posterior compartment during ity of the anorectum and expresses the functioning of the
maximal straining or during defecation. Anterior and middle compart-
ment descent of 1 cm below PCL during straining considered normal.
puborectalis muscle. It must be noted that the reproduc-
Posterior compartment descent of 2–3 cm below PCL during straining ibility of ARA measurements has been debated and ques-
considered normal tioned in several studies [27, 28], whereas another study
a b c
Fig. 11.2 Midsagittal steady state free precession T2-weighted image (rest), 2.5 cm (straining), and 4.5 cm (evacuation) below the pubococ-
obtained at rest (a) and straining (b) and T1-weighted image at evacua- cygeal line. The maximum descent of rectal descent is only seen during
tion (c) with the posterior compartment (anorectal junction) 1.5 cm evacuation
11 Dynamic Magnetic Resonance Imaging of the Pelvic Floor: Technique and Methodology 183
Fig. 11.3 Midsagittal steady state free precession T2-weighted image Fig. 11.4 Measurement of the anorectal angle (ARA). The anorectal
obtained at straining shows landmarks used in the HMO-system. The angle is measured between a line drawn along the posterior border of
landmarks are the inferior aspect of the symphysis pubis (A) and the the distal part of rectum and a line drawn through the central axis of the
posterior wall of the rectum at the level of the anorectal junction (B). anal canal
The H line (H) represents the anteroposterior hiatal width and extends
from A to B. The M line (M) represents hiatal descent and extends per-
pendiculary from the pubococcygeal line (PCL) to the posterior end of 11.5.4 Evacuation Ability
the H line
Most institutions perform MRD in a closed configuration
Table 11.2 Grading of pelvic floor relaxation and pelvic organ descent MR imaging scanner in supine position, and for practical
according to the HMO system [1] purposes the defecation phase is often excluded. However,
Grade H-linea M-linea O-linea it has been shown that the defecation phase yields impor-
Normal <6 cm 0–2 cm Cranial to H-line tant additional information on the presence and degree
Small 6–8 cm 2–4 cm 0–2 cm caudal to H-line of pelvic floor abnormalities [7, 34, 35]. Furthermore,
Moderate 8–10 cm 4–6 cm 2–4 cm caudal to H-line in pelvic floor abnormalities such as obstructed defeca-
Large ≥10 cm ≥6 cm ≥4 cm caudal to H-line tion (OD), parameters assessed during defecation such
As measured during maximal straining or during defecation
a
as delayed initiation of evacuation, impaired evacuation,
and prominence of puborectalis are relevant findings.
found the ARA was a consistent and reliable parameter Also intussusception is frequently only visible when the
[29]. Normal values for ARA are reported in literature [30, intrarectal gel is evaluated at the end of the defecation
31]. At rest values vary between 85° and 101° [13, 32, 33]. phase. Therefore it is of upmost importance to perform the
The pelvic floor working group recommends measuring evacuation phase and encourage the patient to repeat the
the ARA at rest, squeezing, and straining [6]. At squeezing defecation maneuver if the first attempts were not success-
the active contraction of the puborectalis muscle is respon- ful. Inability to evacuate can be caused by morphologic
sible for the sharpening of the ARA by 15–35%, while at changes (e.g., retaining rectocele, enterocele, intussus-
straining the puborectalis muscle relaxes, and the ARA ception) or functional inability to relax the puborectalis
becomes more obtuse by 15–20% than when measured at muscle (dyssynergic defecation). At least two-thirds of
rest (Fig. 11.4). Although normal values also exist for the contrast material in the rectum should be evacuated
squeezing and maximum straining because of the wide within 30 s [6]. If no evacuation of rectal content or a
range, it is more important to describe the changes of the delayed evacuation is present although the compliance is
ARA during different pelvic floor maneuvers instead of good and no structural obstacles exist, dyssynergic def-
reporting measured values [11]. ecation should be considered.
184 K. Schawkat and C. S. Reiner
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imaging of anatomic and dynamic defects of the pelvic floor in def- 32. Tirumanisetty P, Prichard D, Fletcher J, Chakraborty S, Zinsmeister
ecatory disorders. Am J Gastroenterol. 2003;98(2):399–411. A, Bharucha A. Normal values for assessment of anal sphincter
19. Kelvin FM, Maglinte DD, Hale DS, Benson JT. Female pelvic morphology, anorectal motion, and pelvic organ prolapse with MRI
organ prolapse: a comparison of triphasic dynamic MR imaging in healthy women. Neurogastroenterol Motil. 2018;30(7):e13314.
and triphasic fluoroscopic cystocolpoproctography. AJR Am J 33. Maccioni F. Functional disorders of the ano-rectal compart-
Roentgenol. 2000;174(1):81–8. ment of the pelvic floor: clinical and diagnostic value of dynamic
20. Vanbeckevoort D, Van Hoe L, Oyen R, Ponette E, De Ridder D, MRI. Abdom Imaging. 2013;38(5):930–51.
Deprest J. Pelvic floor descent in females: comparative study of 34. Bhan SN, Mnatzakanian GN, Nisenbaum R, Lee AB, Colak E. MRI
colpocystodefecography and dynamic fast MR imaging. J Magn for pelvic floor dysfunction: can the strain phase be eliminated?
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21. Hetzer FH, Andreisek G, Tsagari C, Sahrbacher U, Weishaupt 35. Maglinte DD, Bartram C. Dynamic imaging of posterior com-
D. MR defecography in patients with fecal incontinence: imag- partment pelvic floor dysfunction by evacuation proctography:
ing findings and their effect on surgical management. Radiology. techniques, indications, results and limitations. Eur J Radiol.
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22. Dvorkin LS, Hetzer F, Scott SM, Williams NS, Gedroyc W, Lunniss 36. Mortele KJ, Fairhurst J. Dynamic MR defecography of the poste-
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23. Roos JE, Weishaupt D, Wildermuth S, Willmann JK, Marincek B, nance defecography in 10 asymptomatic volunteers. World J
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Part III
Obstetric Pelvic Floor and Anal Sphincter Trauma
Mechanisms of Pelvic Floor Trauma
During Vaginal Delivery 12
James A. Ashton-Miller and John O. L. DeLancey
ultrasound scans of women before and after vaginal birth variants that indicate stretch and overload in women after
have confirmed that these types of injury occur during vagi- first vaginal birth.
nal delivery. There is great variation in the amount of injury, We do not yet know whether, during a birth, injury occurs
from a few fibers on one side of the levator to the entire to a pubovisceral muscle in its active or its passive state or
pubovisceral muscle, both with and without distortion of sur- both. The best predictors of stretch injury in active muscle
rounding tissues. are the strain or the product of force and strain1 (i.e., mechan-
ical work), with strain and work essentially equivalent in
their predictive value [6]. The best predictor of injury in pas-
12.3 Mechanisms of Levator Muscle Injury sive muscle, as measured by the force deficit after 1 min, is
the negative work2 done stretching the muscle during the
There have been several suggestions for why the levator ani stretch. When a passive muscle is stretched, its force depends
muscles might be injured. Information from electrodiagnos- on two factors: the strain rate per unit time and the product of
tic studies has demonstrated that birth causes changes in the strain times the strain rate. An order-of-magnitude
mean motor unit duration after vaginal birth [2], as well as increase in the strain rate can increase the peak force by
changes in pudendal nerve terminal motor latency. Abnormal 25%. Hence, a physician performing an instrumented deliv-
tests have also been found in women with prolapse or stress ery (vacuum or forceps instrumentation) is probably wise to
incontinence. Although the pudendal nerve innervates the keep the rate of pelvic muscle stretch3 as low as possible by
voluntary urethral and anal sphincters, it does not innervate delivering the fetal head as slowly as is reasonable. We rec-
the levator ani muscles, which receive their own nerve sup- ognize that injury can also occur when a shoulder is deliv-
ply from the sacral plexus. It has not been clear whether the ered or when the head is delivered occiput posterior, but the
visible levator defects are from neurological or stretch mechanics of these injury mechanisms remain to be
injury. investigated.
Since it is difficult to make measurements of muscle There have been many competing theories proposed to
stretch during the second stage of labor, a simple geometric explain the cause of birth-related pelvic floor injury includ-
mathematical model (Fig. 12.2) was developed that showed ing muscle damage from compression or tearing and neu-
some muscle damage during the second stage of labor may ropathy from compression or stretch. There is clear evidence
come from overstretching because those parts of the muscle of alterations in neural function (e.g., [7]) and also evidence
that are stretched the most are those that are seen to be from blood samples suggesting ischemia/reperfusion [8]
injured on magnetic resonance (MR) scans [3]. The from compression. In addition, as outlined above, computa-
pubovisceral (also known as the pubococcygeal) muscle, the tional simulations of birth revealed remarkable elongation of
shortest and most medial levator ani muscle, had the largest the levator ani muscles where portions of the muscle more
tissue strain with a stretch ratio of 3.26, a figure subsequently than tripled their lengths [3]. These observations, however,
found to be consistent with measures made in MR images do not indicate which of these proposed mechanisms is
during vaginal birth [4, 5]. Regions of the iliococcygeus, responsible for the levator defect that is associated with pro-
pubococcygeus, and puborectalis muscles reached maximal lapse. Since efforts at prevention must be based on a proper
stretch ratios of 2.73, 2.50, and 2.28, respectively. These val- understanding of why the injury occurs, it is necessary to
ues considerably exceed the maximum stretch ratio of 1.5 decide between these hypotheses. For example, if compres-
tolerated by striated muscle in nonpregnant animal prepara- sion is the proposed mechanism, lessening the duration of
tions. Tissue stretch ratios were found to be proportional to time during which the tissues are compressed is logical. If
fetal head size. For example, increasing fetal head diameter tearing of the muscle is the mechanism involved then, given
by 9% increased medial pubovisceral stretch by the same the viscoelastic nature of muscle and connective tissue,
amount. This analysis revealed that the region of muscle allowing a slow and gradual delivery that may take some-
injured most often, the pubovisceral (pubococcygeal) por- what longer time would be the right solution. Because the
tion, was the portion of the muscle that underwent the great-
est degree of stretch, and the second area of observed injury, Strain is defined as the increase in length divided by the original length
1
the iliococcygeal muscle, was the muscle stretched second of the structure of interest.
most. Furthermore, when the portion of the muscle at risk By convention a muscle is considered to do positive work when it
2
was identified in cross sections cut in the same orientation as shortens and negative work when it is lengthened. Lengthening contrac-
axial MR scans, the pattern of predicted injury matched the tions are widely used by the body in activities of daily living because
they can produce nearly twice the force than shortening contractions;
injury seen in MR scans (Fig. 12.3). Finally, the maximum but the downside is that larger force is more likely to injure either the
stretch ratio was found at the end of the second stage of labor muscle or its attachments to other structures. In fact, muscle can only be
when the fetal head crowned (Fig. 12.2). These theoretical injured during lengthening contractions, not when contracting isometri-
findings suggesting stretch-induced injury are supported by cally or shortening because the forces are lower.
studies showing increased insulin-like growth factor-1 splice The stretch ratio is defined as the current length divided by the original
3
length.
192 J. A. Ashton-Miller and J. O. L. DeLancey
a 1.1 cm b 300
150
100
S 50
0
1 2 5 10 15 20 24
2.9 cm PR PC IC
3.5
Stretch Ratio
2.5
1.5
4.7 cm
1
1 2 5 10 15 20 24
Muscle Band
3.5
PC 2
7.9 cm
3.0
IC 13
Stretch Ratio
IC 11
2.5 PC 3
IC 15
PR 1
IC 9
PC 5
2.0 PC 7
Extremity
9.9 cm
Muscle
Stretch
Limit
1.5 IC 20
IC 24
1.0
0 1.1 2.9 4.7 6.4 7.9 9.1 9.9
Descent (cm)
Fig. 12.2 (a) Simulated effect of fetal head descent on the levator ani the final length divided by the initial length). Note that the value of the
muscles in the second stage of labor. At top left, a left lateral view stretch ratio is not simply proportional to initial or final length. For both
shows the fetal head (as a sphere) located posteriorly and inferiorly to graphs, muscles are arranged left to right, in ventral to dorsal order of
the pubic symphysis (PS) in front of the sacrum (S). The sequence of origin location. (c) The relationship between fetal head descent
five images at left shows the fetal head as it descends 1.1, 2.9, 4.7, 7.9, (abscissa, icons at top) and the resulting muscle stretch ratios (ordinate)
and 9.9 cm below the ischial spines, while the head passes along the in selected levator ani muscles. The labels at right identify the pubococ-
curve of Carus (indicated by the transparent, light blue, curved tube). cygeus (PC), iliococcygeus (IC), and puborectalis (PR) muscle bands.
The sequence of five images at right are front-left, three-quarter views The largest stretch is induced in the medial-most pubovisceral (PC2)
corresponding to those shown at left. (b) The upper bar graph com- muscle, the last muscle to be engaged by the fetal head. The shaded
pares, by muscle, initial and final muscle lengths corresponding to 1.1 region denotes the values of stretch tolerated by nongravid appendicular
and 9.9 cm model fetal head descent, respectively. The lower bar graph striated muscle without injury. ©Biomechanics Research Lab,
shows the maximum corresponding stretch ratio found in each levator University of Michigan, Ann Arbor 2003
ani muscle band (where each muscle’s stretch ratio is calculated from
12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 193
a b c
PS
Fig. 12.3 (a) Normal anatomy in an axial mid-urethra proton density sis (PS), top) and the model levator ani muscles corresponding to those
magnetic resonance image that shows the normal pubovisceral muscle from the patient shown in (b). Intact muscles are shown in dark gray.
(shown by the asterisks). (b) Woman who has lost a part of the left The location of simulated muscle atrophy is illustrated by the light gray
pubovisceral muscle (displayed on the right side of the image, accord- shading of the left-hand pubovisceral muscle. This location is shown to
ing to standard medical imaging convention), with lateral displacement correspond with the location of muscle atrophy demonstrated in (b). OI
of the vagina into the area normally occupied by the muscle. The arrow obturator internus, PB pubic bone, R rectum, U urethra, V vagina.
points to the expected location of the missing muscle. (c) Axial, mid- ©Biomechanics Research Lab, University of Michigan, Ann Arbor
urethral section through the arch of the pubic bone (see pubic symphy- 2003
clinical actions suggested by these two theories are opposite, tears, and 1 had bilateral high- and low-grade tears of the
knowing the specific mechanism of injury matters. levator ani muscles (Fig. 12.4). All tears were located at the
Fluid-sensitive MR scan techniques that document mus- pubic portion of the levator ani muscles. Regarding the com-
cle anatomy as well as tissue edema due to injury and evalu- pression hypothesis, levator edema was present in all women,
ate women at early and later time points during recovery but the internal obturator muscle was never involved. Edema
make it possible to test these hypotheses. Injuries that occur resolved at the later time point. None of the women showed
due to muscle tearing would be evident immediately and a pattern where an initially normal appearing muscle became
would not resolve. On the other hand, muscle injury due to atrophic that would support atrophy due to neural injury. In a
neurological injuries would develop over time. Compression larger subsequent group of women judged to be at high risk
would cause edema that would involve both the internal for the levator injuries, injuries to the pubic bones were seen
obturator muscle and the levator muscle since they are both as well [10]. There were 29% (17/59) who had subcortical
immediately adjacent and would be equally compressed pubic bone fracture, and 66% (39/59) were found to have
between the pubic bones and fetal head. Therefore, if muscle pubic bone marrow edema attesting to the remarkable forces
compression is responsible for injury, the edema would be placed on the bony pelvis during birth. Like the original
expected to affect both internal obturator and pubovisceral study, 90% (53/59) had LA muscle edema, and 41% (28/68)
muscles where they lie between the fetal head and pelvic had low-grade or greater LA tear 7 weeks’ postpartum. The
bones. magnitude of LA muscle tear did not substantially change by
Studies that imaged women with risk factors for pelvic 8 months postpartum, but LA muscle edema and bone inju-
floor injuries both early (1–2 months) and late (7 months) in ries showed total or near-total resolution at 8 months post-
the postpartum period have made it possible to study these partum (P < 0.05). The magnitude of unresolved
injury mechanisms [9]. Among 17 women in this mechanis- musculoskeletal injuries correlated with magnitude of
tic study, 3 women had unilateral high-grade tears (more reduced LA muscle force and posterior vaginal wall descent
than 50% of the muscle involved), 3 had unilateral low-grade (P < 0.05).
194 J. A. Ashton-Miller and J. O. L. DeLancey
a b
c d
Fig. 12.4 Mid-urethral axial MR images in the region show the pubo- scan, shows a more apparent difference. In panel c, a normal pubococ-
coccygeal muscle normally seen lateral to the vagina. Panel a shows a cygeal muscle (black arrow) is seen between the vagina (Vag) and inter-
proton density scan where the solid arrow heads mark the pubococcy- nal obturator (black arrow) while it is absent on the left (L). This pattern
geal muscle and the open arrow heads show the obturator internus (OI). persists in the late scan (d). Panels c and d also show the “architectural
Signal intensity is lower in the pubococcygeal (arrow head) than the distortion” that involves the vaginal wall protruding laterally on the side
adjacent internal obturator (open arrow head). Panel b, a fluid-sensitive (subject’s left) of the injury right (R). ©DeLancey
Injury to the origin of the pubovisceral muscle will result is an open question where the injury actually starts at the
from a larger-than-normal tensile force on the muscle during pubovisceral muscle origin. We recognize that the origin
the second stage exceeding its ultimate tensile strength. The of the pubovisceral muscle is not orthogonal to the pubic
appearance of the injured pubovisceral muscle in that region bone but takes off caudally at an acute angle. It is known
or “injury zone” might appear as that shown in Fig. 12.5, that a tensile structure like a ligament that attaches to a
which illustrates what we have called “Type I” and “Type II” bone at an acute angle has an inherent mechanical stress4
injuries.
The normal histology of this zone seen in Fig. 12.6
shows the muscle taking origin directly from the perios- Mechanical stress in a tissue is the force acting on a given portion of
4
the tissue divided by the cross-sectional area of that portion. In the sim-
teum over the pubic bone medially, from an apophysis plest example, tissue stress might generally be tensile in a ligament
more centrally, and from the passive collagenous structure under tension but compressive in a sulcus of the fetal head during
known as the arcus tendineus levator ani more laterally. It molding.
12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 195
a b c
Fig. 12.5 Illustrations of the right inner pelvic sidewall showing the locally be damaged, which then leads to PVM atrophy (semitransparent
fascial and levator arches originating from the pubic bone. (a) Two dif- closed arrow). (c) Type II injury: detachment of the LArch origin from
ferent types of the pubovisceral muscle (PVM) origin can be identified: the pubic bone (semitransparent open arrow) observed in 32-year-old
one being a direct aponeurotic attachment in the anteromedial portion patient with stress urinary incontinence and history of a traumatic birth
(open arrow) and the other being an indirect catenary attachment (third-degree laceration). Since there is only a single point of pubic ori-
through the levator arch (LArch) in posterolateral region (closed arrow). gin at the LArch for the lateral margin of the PVM, detachment of that
Morphological and functional variation in these locations may account point will result in complete offloading of that region of the PVM
for how injury might occur and progress. (b) Type I injury: PVM can (Reproduced from [11, 12] ©DeLancey)
concentration on the side of the structure where the attach- the risk of soft tissue rupture in the next loading cycle.
ment angle is acute, rather than where it is obtuse on the Were a tissue to exhibit viscoplasticity, it would behave
other side of the ligament. Under high tensile loads, we like a solid below a critical level of stress, but above that
therefore anticipate that injury would be expected to start level, it would flow like a viscous liquid. There is evi-
in the vicinity of that stress concentration (see, e.g., dence that tensile failure in some soft tissues can be pre-
Luetkemeyer et al. [11]). dicted by the product of the stress times the strain extant
in the tissue, so interventions that lower one or both these
variables will reduce the risk of rupture. Pregnancy is
12.4 E
ffect of Pregnancy on Pelvic Floor known to significantly affect the stress-strain behavior of
Tissue Properties vaginal tissues in rat [13] (Fig. 12.7). However, accurate
constitutive laws are lacking for pregnant human pelvic
During pregnancy, hormones affect the biochemical com- floor tissues, and the effects of pregnancy on injury at
position of the solid matrix and hydration phases consti- any human tissue level, and on structural failure, are as
tuting each pelvic floor tissue. Remodeling mechanisms yet largely unknown.
lead to changes in the organization, orientation, and
diameter of the collagen fibers as well as the crimp struc-
ture of the collagen fibrils, reinforcing each tissue. Such 12.5 F
inite Element Models
effects can significantly affect the short- and longer-term of Vaginal Birth
viscoelastic properties of the vaginal wall, the pubovis-
ceral muscles, and the perineal body, for example. They The finite element method is a mathematical technique
will largely determine (a) the extent and rate at which widely used by engineers for simulating how simple or
these structures can be stretched by an expulsive force more complex structures that have known material prop-
acting cyclically on the fetal head and (b) the resistance erties will deform under given forces or pressures. For
to stretch provided by those structures. The more a tissue example, for a given set of forces applied to the structure,
exhibits creep behavior, the further it will stretch under a it allows one to calculate the mechanical stress, or force
constant load. And the more it exhibits relaxation behav- per unit area, in different regions of interest in the struc-
ior, the more the stress in a tissue will decrease over time ture along with the regional deformations. One finite ele-
when held at a constant length, thereby helping to lower ment model of the second stage of vaginal birth has
196 J. A. Ashton-Miller and J. O. L. DeLancey
Fig. 12.6 Examples of intact medial, central, and lateral region histol- denotes missing data due to a technical issue during harvesting process.
ogy of the pubic origin of the PVM. Each row is from a different donor. Central: the central portion originates from the PB in a single aponeu-
Histological images showing the pubic origin of the levator ani from rotic attachment, which is noticeably thinner than medial portion. The
medial (column 1), central (column 2), and lateral (column 3) areas obturator internus muscle (OI) can be seen lateral to the LA. Lateral:
with the orientation picture below. All samples shown are stained in the levator arch (LArch) appears as dense blue connective tissue attach-
Masson’s trichrome, and the scale bars are 5 mm for each row of ing to the PB and forming the lateral margin of the pubic origin of the
images. Medial: the medial levator ani muscle fibers originate from LA. Note that relative preponderance of the three portions varies by
multiple slips attaching in an enthesis to the pubis; oblique interface individual (reproduced from [12]). The inset at the top shows the pos-
between the pubic bone (PB) and the levator ani muscle (LA) can also sible appearance of an avulsion of the left pubovisceral muscle from the
be observed. The thickness of the LA is greater than in other areas. N/A pubic bone seen from a left lateral view point. ©DeLancey
12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 197
12.6 O
ther Approaches to Modeling
Vaginal Birth
a d
229
Maximum
principal strain (%)
11.70
c
0.98
Maximum
principal stress (MPa)
Fig. 12.8 Finite element model results for a simulated single (120 N) (white) are shown. (d) The maximum predicted principal strain and (e)
push delivery for a 31-year-old mother and fetus at 40 weeks gestation. stress distributions in the pelvic floor soft tissues at time of delivery.
(a–c) An inferior three-quarter view of the pelvic floor viscohyperelas- The largest principal strain (d) reached 259% (3.59 stretch ratio). The
tic soft tissue deformations at three stages during the second stage of blue region nearest the pubic bone indicates the local region of highest
labor: (a) Station +2, (b) a middle station, and (c) delivery of the fetal stress (e), corresponding to the location of muscle defects observed on
head. The levator ani muscle (red), fetal head (gray), and public bone magnetic resonance scans. (Reproduced from [16])
There are points of clinical interest. Firstly, the results when the pubovisceral muscle swings down, it also has to
suggest why the pubovisceral muscle is more commonly wrap around the pubic rami, thereby having to stretch more
injured than the puborectal muscle. This is because the to accommodate the passage of the fetal head through its
puborectal muscle swings down like a bucket handle pivot- loop of soft tissue surrounding the urogenital hiatus.
ing around the lower margin of the pubic bone, whereas Secondly, the results predicted that roughly 65% of women
12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 199
c
400 4
Perimetric length
Perimetric length of the
100 1
I
0 0
0 30 60 90 120 150 180
Fetal head displacement along the Curve of Carus (mm)
ric parameters used in the model prior to labor (i.e., the fetal
Public
head and urogenital hiatus diameters), one might be able to
Bone
predict which women need to be monitored closely in labor
PRM
because they may have difficulty just because of cephalole-
DeLancey
PV
M
vator disproportion. But a limitation of the model is that it
does not consider the known interindividual variability in the
viscoelastic behavior of the pelvic floor muscle tissues and
their attachments which we shall address next.
Fig. 12.10 Figure showing simplified geometry of the pubovisceral
muscle (PVM) and puborectal muscle (PRM) based on our published In order to address the lack of representation of soft tissue
measurements of their lines of action viscoelasticity in the Tracy (2016) model [18], we modified
200 J. A. Ashton-Miller and J. O. L. DeLancey
Pre-labor
Pre-labor
Ultimate
Crowning Ultimate
Crowning
Fig. 12.11 Upper left: left lateral view of 3D model of the pelvis (green), around the inferior pubic ramus at point 2 at ultimate crowning. The por-
showing the high origin location (arrow) of the pubovisceralis muscle tion of the PVM between points 1 and 2 lying above the inferior pubic
(PVM, orange) and the PVM insertion on the PB/AS (light blue). Upper ramus point, 2, is the “noncontact” length because it cannot contact and
right: 3D model of the pelvis (green), showing the puborectalis muscle encircle the fetal head due to the rigidity of the pubic bone. That part of the
(PRM) (dark purple, lower right of that image) originating from the PM PVM lying between points 2 and 3 lies below the pubic ramus at 2 so it can
(white). In the upper two figures, A, P, L, R, and I denote anterior, poste- contact and encircle the fetal head to allow it to pass inside the loop formed
rior, left, right, and inferior, respectively. Lower left: the pubic symphysis by the PVM. Lower right: this illustrates the downward rotation of the
is projected in the sagittal view seen in a view from the left showing a PRM from the prelabor to the ultimate crowning position in the manner of
downward rotation of the PVM loop. Note the wrapping of the PVM a hinged bucket handle. Note the absence of PRM wrapping. (From [18])
that model to include values of tissue viscoelasticity deduced called τ2, the longer of the two time constants, which was
from measurements of dilation of the urogenital hiatus by a found to vary 20-fold above and below the mean value, as
constant force performed by researchers at Baylor College of can be seen in Figs. 12.15 and 12.16. This is a truly remark-
Medicine during the first stage of labor in 28 healthy women able difference in these healthy young women and presum-
[19]. Engineering uses mathematical e quations to precisely ably reflects the degree to which hormones, as yet
predict the behavior of specific structural elements such as unidentified, act to ripen these tissues in preparation for
cables in a suspension bridge. These kinds of simulation childbirth. We then integrated these measures of soft tissue
require additional equations, called constitutive equations, to viscoelastic behavior into the Tracy (2016) model to deter-
allow one to predict the element’s material behavior under mine how much it would affect cephalolevator disproportion
specific loading conditions. We described the viscoelastic for the PVM. The results may be seen in Fig. 12.15 which
behavior of the soft tissues using a five-parameter mathemat- shows that, with tissue viscoelastic behavior now included,
ical model (equation) of which three parameters described about 75% of women were predicted to be able to give birth
the elastic response and two time constants, τ1 and τ2, to any size of fetal head without cephalolevator dispropor-
described the short-term and long-term time-dependent tion [20]. The red cells in that figure would be those that one
response of the tissues to stretch. It turned out that parameter would predict would have to have an instrumented delivery.
that best described the difference in the ability of the distal The pink cells are those that one would want to monitor care-
birth canal to dilate in these 28 women was the parameter fully prior to and during labor to minimize the risk for injury.
12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 201
Fig. 12.13 Predicted
DEMAND (Fetal Head Circumference, in Percentile)
maternal capacity-to-fetal
head demand ratio, g, for the 2.3% 5% 10% 25% 50% 75% 90% 95% 97.7%
pubovisceral muscle (PVM) 2.3% 0.67 0.66 0.65 0.63 0.62 0.60 0.59 0.58 0.57
loop with wrapping. The
5% 0.78 0.77 0.76 0.74 0.72 0.70 0.69 0.68 0.67
Circumference, in Percentile)
cephalolevator disproportion
for the PVM. (From [18]) 15% 0.97 0.96 0.94 0.92 0.90 0.88 0.85 0.84 0.83
25% 1.08 1.06 1.05 1.02 0.99 0.97 0.95 0.93 0.92
50% 1.26 1.25 1.22 1.20 1.16 1.14 1.11 1.09 1.08
75% 1.44 1.42 1.39 1.36 1.32 1.29 1.26 1.24 1.23
90% 1.59 1.56 1.54 1.50 1.46 1.43 1.39 1.37 1.36
95% 1.67 1.65 1.62 1.58 1.54 1.50 1.47 1.45 1.43
97.7% 1.75 1.73 1.70 1.66 1.61 1.58 1.54 1.52 1.50
202 J. A. Ashton-Miller and J. O. L. DeLancey
Fig. 12.14 Predicted
DEMAND (Fetal Head Circumference, in Percentile)
maternal capacity-to-fetal
head demand ratio, g, for the 2.30% 5% 10% 25% 50% 75% 90% 95% 97.70%
puborectalis muscle (PRM) 2.30% 1.06 1.04 1.02 1.00 0.97 0.95 0.93 0.92 0.90
loop. The intensity of (red)
5% 1.13 1.12 1.10 1.07 1.04 1.02 0.99 0.98 0.97
Circumference, in Percentile)
shading indicates the degree
of cephalolevator 10% 1.22 1.20 1.18 1.15 1.12 1.09 1.07 1.05 1.04
CAPACITY (Maternal
disproportion for the
PRM. Note how much less 15% 1.27 1.25 1.23 1.20 1.17 1.14 1.11 1.10 1.19
disproportion is for the PRM 25% 1.36 1.34 1.31 1.28 1.25 1.22 1.19 1.17 1.16
in this figure than the
50% 1.51 1.49 1.46 1.42 1.39 1.36 1.32 1.30 1.29
pubovisceral muscle (PVM)
in the preceding figure. This 75% 1.66 1.64 1.61 1.57 1.53 1.49 1.45 1.44 1.42
helps explain the lower risk of
90% 1.80 1.78 1.74 1.70 1.66 1.62 1.58 1.56 1.54
PRM injury during childbirth.
(From [18]) 95% 1.89 1.86 1.83 1.78 1.74 1.70 1.65 1.63 1.61
97.7% 1.97 1.94 1.91 1.86 1.81 1.77 1.72 1.70 1.68
Values of τ2 over 1000 s predicted active second stages of ery. It has been unclear whether these injuries are due to the
greater than 1 h for the 50th percentile maternal capacity and space-occupying nature of the forceps around the fetal head,
50th percentile fetal head, demonstrating the potential of causing increased stretch of the levator ani, or whether the
such modeling in predicting difficult labors antenatally. risk of injury is increased by exerting too much traction force
too rapidly given the viscoelastic nature of the soft tissues.
Tracy [25] ran simulations to address the first question
12.7 P
udendal Nerve Stretch During and determined that the levator injury is not likely to be due
Vaginal Birth to the space-occupying nature of the forceps in the urogenital
hiatus (Fig. 12.18). One can then deduce that they must be
Neurophysiologic studies have clearly associated change in due to too large a traction force, a traction force that is
pudendal nerve function with pelvic floor disorders [21] and increased too rapidly, or a combination of the two. Balancing
also with vaginal birth [22]. Overstretching of the nerve is one that is the unknown ultimate tensile strength of the pubovis-
of the potential injury mechanisms, yet data concerning nerve ceral muscles. One of our earlierstudies shows that the mean
stretch were not available. To gain insight into this process, a (±SD) unilateral cross-sectional area of the PVM in healthy
simple geometric model was used to predict the stretch ratios in young women is 1.25 ± 0.29 cm2 [26]. Knowing that a stri-
the nerves innervating the levator ani, urethra, and anal sphinc- ated muscle can develop about 2.8 kgf/cm2 of muscle cross-
ter during the second stage of vaginal labor [23]. The results sectional area in the direction of the fibers, one can calculate
showed that the inferior rectal branch exhibited the maximum the average maximum isometric tension the pubovisceral
strain, 35%, and this strain varied by 15% from the scenario muscle can develop is about 3.5 kgf. During a lengthening
with the least perineal descent to that with the most perineal (eccentric) contraction, a striated muscle can double its ten-
descent. The strain in the perineal nerve branch innervating the sion, such that the left and right pubovisceral muscle can
anal sphincter reached 33%, whereas the branches innervating each maximally develop a maximum of 7 kgf, such that
the posterior labia and urethral sphincter reached values of together they could maximally resist ~14 kgf without tear-
15% and 13%, respectively (Fig. 12.17). It was concluded that ing. (In the case of forceps, the traction force is actually
during the second stage, (a) nerves innervating the anal sphinc- orthogonal to the pubovisceral muscle, and the loading of
ter are stretched beyond the 15% strain threshold known to that muscle will depend on many other factors including the
cause permanent damage in nonpregnant appendicular nerve, shape of the fetal head, the expulsion and traction forces, the
so this is a risk factor for injury, and (b) the degree of perineal resistance to stretch of the muscle, etc.) But, in the average
descent was shown to influence pudendal nerve strain. woman, a force of 14 kgf or more is likely sufficient to avulse
one or both pubovisceral muscles from the pubic bone
because it exceeds their ultimate tensile strength under con-
12.8 E
ffect of Forceps on Cephalolevator ditions when they are being forcibly stretched.
Disproportion There is, however, considerable variation in the cross-
sectional area of the pubovisceral muscles across women.
In small MRI studies of vaginal birth, it became clear that the For example, in 95% of women, the 2∗SD points would be
use of forceps increases the risk for levator injury up to 0.77–1.73 cm2. This means the maximum allowable dila-
14-fold [1], and multivariable analysis on larger samples tion force can vary from 8.6 to 19.4 kgf, a twofold variation
show odds ratios of over 3 for levator injury [24]. Neither in healthy women. Hence, an average maximum permissi-
study indicated an increased injury rate with vacuum deliv- ble dilation force of 14 kgf would easily cause injury in the
12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 203
10th 2.0E+6 2.3E+6 2.7E+6 2.9E+6 2.8E+6 3.3E+6 3.1E+6 3.6E+6 3.8E+6 4.3E+6 4.4E+6 4.6E+6 4.7E+6 5.6E+6 5.8E+6
15th 1.8E+6 1.9E+6 2.2E+6 2.6E+6 2.5E+6 2.8E+6 3.0E+6 3.2E+6 3.4E+6 3.7E+6 3.6E+6 3.5E+6 4.4E+6 4.8E+6 5.3E+6
20th 1.8E+6 1.9E+6 2.1E+6 2.4E+6 2.3E+6 2.6E+6 2.7E+6 2.8E+6 2.7E+6 3.2E+6 3.3E+6 3.2E+6 3.9E+6 4.0E+6 4.6E+6
25th 1.4E+6 1.7E+6 1.9E+6 2.1E+6 2.0E+6 2.3E+6 2.3E+6 2.6E+6 2.7E+6 2.8E+6 3.1E+6 3.1E+6 3.6E+6 3.4E+6 4.2E+6
30th 1.4E+6 1.4E+6 1. 7E+6 1.9E+6 1.9E+6 2.1E+6 2.1E+6 2.5E+6 2.5E+6 2.4E+6 2.8E+6 2.9E+6 3.0E+6 3.4£+6 3.8E+6
40th 1.2E+6 1.3E+6 1.5E+6 1.6E+6 1.7E+6 1.8E+6 1.9E+6 2.1E+6 2.1E+6 2.3E+6 2.3E+6 2.5E+6 2.8E+6 3.0E+6 3.3E+6
50th 1.1E+6 1.1E+6 1.3E+6 1.4E+6 1.5E+6 1.6E+6 1.6E+6 1.8E+6 1.7E+6 2.0E+6 2.2E+6 2.0E+6 2.1E+6 2.7E+6 2.9E+6
60th 8.7E+5 1.0E+6 1.0E+6 1.3E+6 1.3E+6 1.3E+6 1.5E+6 1.6E+6 1.5E+6 1.8E+6 1.9E+6 1.8E+6 2.2E+6 2.3E+6 2.3E+6
70th 6.8E+5 8.4E+5 9.9E+5 1.0E+6 1.1E+6 1.2E+6 1.1E+6 1.3E+6 1.4E+6 1.6E+6 1.5E+6 1.6E+6 1.9E+6 2.0E+6 1.9E+6
75th 7.1E+5 8.1E+5 7.9E+5 9.9E+5 1.1E+6 1.1E+6 1.1E+6 1.2E+6 1.3E+6 1.2E+6 1.4£+6 1.5E+6 1.7E+6 1.8E+6 2.1E+6
80th 6.8E+5 6.6E+5 8.0E+5 9.4E+5 8.4E+5 9.2E+5 1.1E+6 1.2E+6 1.0E+6 1.2E+6 1.3E+6 1.4E+6 1.4E+6 1.7E+6 1.6E+6
85th 5.6E+5 6.5E+5 7.5E+5 7.6E+5 8.3E+5 9.0E+5 9.9E+5 9.3E+5 1.0E+6 1.2E+6 1.2E+6 1.3E+6 1.3E+6 1.6E+6 1.5E+6
90th 5.2E+5 5.9E+5 5.7E+5 7.1E+5 7.6E+5 8.1E+5 8.8E+5 8.2E+5 9.2E+5 1.0E+6 1.1E+6 1.1E+6 1.1E+6 1.4E+6 1.6E+6
95th 3. 7E+5 4.0E+5 4.9E+5 5.9E+5 6.1E+5 6.7E+5 7.2E+5 6.5E+5 7.2E+5 8.3E+5 8.9E+5 9.5E+5 1.1E+6 1.0E+6 1.2E+6
97.7th 3.3E+5 3.8E+5 4.4E+5 5.0E+5 4.6E+5 4.5E+5 5.2E+5 5.9E+5 6.5E+5 7.2E+5 7.6E+5 8.1E+5 8.0E+5 8.9E+5 1.0E+6
5th 2.9E+6 3.1E+6 3.5E+6 3.9E+6 4.1E+6 4.2E+6 4.5E+6 4.8E+6 5.1E+6 5.4E+6 5.7E+6 5.8E+6 *** *** ***
10th 2.3E+6 2.5E+6 2.7E+6 3.1E+6 3.2E+6 3.4E+6 3.5E+6 3.8E+6 4.0E+6 4.3E+6 4.5E+6 4.7E+6 5.2E+6 5.7E+6 6.2E+6
15th 2.0E+6 2.1E+6 2.4E+6 2.6E+6 2.8E+6 2.9E+6 3.1E+6 3.3E+6 3.5E+6 3.7E+6 3.9E+6 4.0E+6 4.4E+6 4.9E+6 5.3E+6
20th 1.8E+6 1.9E+6 2.1E+6 2.4E+6 2.5E+6 2.6E+6 2.8E+6 3.0E+6 3.1E+6 3.3E+6 3.5E+6 3.6E+6 4.0E+6 4.4E+6 4.7E+6
25th 1.6E+6 1.8E+6 1.9E+6 2.2E+6 2.3E+6 2.4E+6 2.5E+6 2.7E+6 2.8E+6 3.1E+6 3.2E+6 3.2E+6 3.7E+6 4.0E+6 4.4E+6
30th 1.5E+6 1.6E+6 1.8E+6 2.0E+6 2.1E+6 2.2E+6 2.3E+6 2.5E+6 2.6E+6 2.8E+6 2.9E+6 3.0E+6 3.3E+6 3.7E+6 4.0E+6
40th 1.3E+6 1.4E+6 1.5E+6 1.7E+6 1.8E+6 1.9E+6 2.0E+6 2.1E+6 2.2E+6 2.4E+6 2.5E+6 2.5E+6 2.9E+6 3.1E+6 3.4E+6
50th 1.1E+6 1.2E+6 1.3E+6 1.5E+6 1.6E+6 1.6E+6 1.7E+6 1.9E+6 2.0E+6 2.1E+6 2.2E+6 2.2E+6 2.5E+6 2.7E+6 3.0E+6
60th 9.5E+5 1.0E+6 1.2E+6 1.3E+6 1.4E+6 1.4E+6 1.5E+5 1.6E+5 1.7E+5 1.8E+6 1.9E+6 2.0E+6 2.2E+6 2.4E+6 2.6E+6
70th 8.2E+5 9.0E+5 1.0E+6 1.1E+6 1.2E+6 1.2E+6 1.3E+6 1.4E+6 1.5E+6 1.6E+6 1.7E+6 1.7E+6 1.9E+6 2.1E+6 2.3E+6
75th 7.5E+5 8.2E+5 9.2E+5 1.0E+6 1.1E+6 1.1E+6 1.2E+6 1.3E+6 1.4E+6 1.5E+6 1.5E+6 1.6E+6 1.8E+6 1.9E+6 2.1E+6
80th 6.9E+5 7.6E+5 8.4E+5 9.5E+5 9.8E+5 1.0E+6 1.1E+6 1.2E+6 1.3E+6 1.4E+6 1.4E+6 1.5E+6 1.6E+6 1.8E+6 2.0E+6
85th 6.2E+5 6.8E+5 7.6E+5 8.3E+5 9.0E+5 9.4E+5 1.0E+6 1.1E+6 1.1E+6 1.2E+6 1.3E+6 1.3E+6 1.5E+6 1.6E+6 1.8E+6
90th 5.3E+5 5.9E+5 6.6E+5 7.5E+5 7.9E+5 8.2E+5 8.8E+5 9.5E+5 1.0E+6 1.1E+6 1.1E+6 1.2E+6 1.3E+6 1.4E+6 1.6E+6
95th 4.3E+5 4.8E+5 5.4E+5 6.1E+5 6.4E+5 6.8E+5 7.1E+5 7.8E+5 8.3E+5 9.0E+5 9.3E+5 9.7E+5 1.1E+6 1.2E+6 1.3E+6
97.7th 3.5E+5 3.9E+5 4.4E+5 5.0E+5 5.3E+5 5.5E+5 6.1E+5 6.4E+5 6.9E+5 7.5E+5 7.8E+5 8.2E+5 9.0E+5 1.0E+6 1.1E+6
Fig. 12.15 Predicted pubovisceral muscle (PVM) state parameters (PVM state parameter of 1) is exceeded. In the median table, the pre-
across the full range of pairings of maternal capacity-to-fetal head dicted PVM tear cutoffs for each of the other two tables are marked by
demand are shown for τ2 values of 27 s (top panel), 550 s (middle the dashed lines. Cells with ∗∗∗ denote labors predicted to exceed 24 h.
panel), and 11,000 s (bottom panel). The intensity of the (red) shading (For interpretation of the references to color in this figure legend, the
indicates the extent by which the predicted injury threshold of 2.7 MPa reader is referred to the web version of this article.) (From [20])
woman with the smallest pubovisceral muscle cross- the strength of the levator muscles, could be used to hyper-
sectional area, being 1.62 times too large, whereas it would trophy the pubovisceral muscle and its collagenous attach-
constitute only 72% of the maximum strength of those with ments such that they become more resistant to tensile
the largest muscles. This makes us wonder whether antena- failure during birth. For example, in one study we found a
tal pelvic floor exercise training, which is known to increase 10% hypertrophy in vastus type II fibers following 16 weeks
204 J. A. Ashton-Miller and J. O. L. DeLancey
Diameter (cm) 6
3
Device Distension
0
0 5 10 15 20 25 30 35 40 45
Time (min)
10
0
0 2 4 6 8 10
Fetal Head Descent (cm)
Soft
tissue loop
Original (no
40
Percentile)
forceps) 1.16 1.14 1.13 1.11 1.10 1.09 1.08 1.07 1.05
50 1.23 1.21 1.19 1.18 1.17 1.15 1.14 1.13 1.11
60 1.29 1.27 1.25 1.24 1.23 1.22 1.20 1.19 1.17
70 1.36 1.33 1.32 1.30 1.29 1.28 1.27 1.25 1.23
80 1.44 1.41 1.39 1.38 1.37 1.35 1.34 1.32 1.30
90 1.54 1.51 1.49 1.48 1.46 1.45 1.43 1.42 1.39
Forceps (no 30 1.07 1.05 1.04 1.03 1.02 1.01 1.00 0.99 0.97
Circumference, in
indentation
Percentile)
of the fetal 40 1.14 1.12 1.11 1.10 1.09 1.08 1.06 1.05 1.03
head) 50 1.21 1.19 1.17 1.16 1.15 1.14 1.12 1.11 1.09
60 1.27 1.25 1.23 1.22 1.21 1.20 1.18 1.17 1.15
70 1.34 1.31 1.30 1.28 1.27 1.26 1.25 1.23 1.21
80 1.41 1.39 1.37 1.36 1.34 1.33 1.32 1.30 1.28
90 1.51 1.49 1.47 1.45 1.44 1.43 1.41 1.39 1.37
Fig. 12.18 The results of the simulation show that whether the forceps either excessive traction force or traction force that is increased too rap-
indent the fetal head or not, the space-occupying nature of the forceps idly for soft tissues to stretch without rupture. Given the demonstrated
within the urogenital hiatus has no meaningful effect on the risk for viscoelastic nature of the PVM tissues, slowing the rate of application
cephalolevator disproportion. This suggests that forceps-related injuries of the traction force as much as is practical is advisable. (From [25])
to the pubovisceral muscle (PVM) are instead likely associated with
206 J. A. Ashton-Miller and J. O. L. DeLancey
of progressive resistance training [27], and such training pressure at different points during the uterine contraction
could be expected to also hypertrophy the passive tissues in (Fig. 12.19).
series with the muscle. The results showed that while the triple-push pattern was
predicted to result in a 16% shorter second stage, with 59
volitional pushes, this came at the energetic expense of a
12.9 E
ffect of Maternal Pushing Styles 61% increase in the number of pushes required compared to
During the Second Stage the peak push pattern, which only required 23 pushes
(Fig. 12.20). Since we know that the tensile stiffness of stri-
Many different variations of pushing styles are advocated by ated muscle increases about threefold when a muscle is
clinicians during the second stage of labor. Some advocate tensed, teaching the woman who is delivering without anes-
starting to push once the uterine pressure rises and sustaining thesia not to contract her PVM during pushing would seem
multiple pushes as long as the uterus is active, while others to be important, because then the PVM are three times less
suggest only pushing only when the mother feels the urge to stiff and viscous; these are importat because minimizing
push, usually at the peak of the contraction. Because direct both attributes would make for considerably easier dilation
experimental measurements are difficult to make in labor of the distal birth canal. In addition, a woman’s ability to
without intrusive procedures, we used a mathematical model push with full force is limited by the onset of fatigue, so if
to assess how they might compare from the point of view of she becomes exhausted before the baby is born, then the
efficacy [28]. First, we modeled six different pushing styles, weakening of her efforts may necessitate assistance with for-
whereby the mother generated increases in intra-abdominal ceps or vacuum.
a b
20 20
Intraurethral pressure
Intraurethral pressure
(kPa)
(kPa)
0 0
0 1 2 3 0 1 2 3
c Time (min) d Time (min)
20 20
Intraurethral pressure
Intraurethral pressure
(kPa)
(kPa)
0 0
0 1 2 3 0 1 2 3
20 20
Intraurethral pressure
Intraurethral pressure
(kPa)
(kPa)
0 0
0 1 2 3 0 1 2 3
Time (min) Time (min)
Fig. 12.19 (a–f) Illustration of the assumed time histories of the intrauterine pressure in the triple, peak, pre and peak, peak and post, pre and post
pushing patterns, respectively. (From [28]) ©Biomechanics Research Laboratory, University of Michigan
12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 207
80
Duration of labor (min)
60
40
20
0
Pre–and Peak and
Triple push Peak push Pre–push Post–push
peak push post–push
b
60
Numbers of voluntary pushes
40
20
0
Pre–and Peak and
Triple push Peak push Pre–push Post–push
peak push post–push
Fig. 12.20 (a) The predicted effect of the six different push patterns stage. (From [28], ©Biomechanics Research Laboratory, University of
(Fig. 12.18) on the duration of labor. (b) The estimated number of vol- Michigan)
untary pushes required for the different push patterns during the second
12.10 Conclusions birth, but this is a fruitful area for future research. We
believe combining biomechanical models with ultra-
1. We have learned that simple models can yield powerful sound imaging input holds promise in this regard.
insights to answer clinical questions and such models 6. The tissues forming the distal birth canal are viscoelastic
are always our first choice before tackling a more com- in nature. That is to say that under a constant dilation
plicated model in order to address the effects of addi- force, they stretch elastically at first and then continue to
tional factors. dilate further at an initially rapid rate that decreases
2. Based on our present understanding of the biomechanics exponentially with time. By the same token, they take
of the second stage of labor, the majority of women, time to return to their original length, even after the
75%, can give birth to any fetal head size without risk force is removed. There is a truly remarkable variation
for cephalolevator disproportion and injury. in how rapidly these tissues dilate in healthy women.
3. The minority of women, perhaps 5%, will need instru- The hormonal mechanisms underlying these changes
mented delivery, but this likely increases with advancing are poorly understood and deserve to be studied in the
age over 32 years. Why deserves further study. future.
4. The remaining 20% are in a gray zone in which obstetri- 7. The biomechanical models of the second stage of labor
cal and biomechanical factors interact to determine correctly describe when, where, and why injury is most
whether the second stage will be successfully concluded likely to occur: at the origin of the pubovisceral muscle
within a reasonable time and without a levator injury. near the end of the second stage due to excessive stretch.
5. It is not yet possible to predict before labor which 8. Clinicians intuitively know to slow the rate of delivery
women will sustain pubovisceral muscle injuries during as the fetal head crowns, and this intuition is supported
208 J. A. Ashton-Miller and J. O. L. DeLancey
by biomechanical principles that the soft tissues, being Acknowledgements We gratefully acknowledge the many talented
students and trainees whose work this chapter really represents and
viscoelastic, are sensitive to strain rate. funding from the National Institutes of Health grant P50 HD044406.
9. The origin and architecture of the puborectal muscle
mean that it is almost never injured during birth, whereas
the more cranial origin of the pubovisceral muscle
means that it has to wrap around the pubic rami as the References
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12 Mechanisms of Pelvic Floor Trauma During Vaginal Delivery 209
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Posterior Compartment Trauma
and Management of Acute Obstetric 13
Anal Sphincter Injuries
Abdul H. Sultan and Ranee Thakar
a b c
Fig. 13.1 Diagrammatic representation (a) and photo (b) of a rectocele following disruption of the rectovaginal fascia and detachment from the
perineal body with widening of the genital hiatus and herniation of the rectum. (c) Photograph demonstrating a deficient perineum (arrow)
also not repaired adequately. Surgical repair techniques are smooth muscle smooth
muscle
Rectum
described in Chap. 37.
13.3 O
bstetric Anal Sphincter Injuries
(OASIS)
muscle of the bowel. It contributes about 70% of the resting inserting a deep catgut suture through the inner third of the
pressure and is under autonomic control. It is separated from sphincter muscle and a second set through the outer third of
the EAS by the conjoint longitudinal muscle that is a continu- the sphincter [18]. In 1948, Kaltreider and Dixon described
ation of the longitudinal smooth muscle of the bowel. As their series of women since 1935 in whom one mattress or
shown in Fig. 13.2, the subcutaneous EAS lies at a lower level figure-of-eight suture was used [19]. Fulsher and Fearl
than the IAS, but during regional or general anesthesia, the described a technique in which sutures were inserted in the
paralyzed EAS lies almost at the same level as the IAS. fascial sheath or capsule of the anal sphincter, and no sutures
Damage to the EAS results in fecal incontinence, which is were allowed to pass through the sphincter muscle [20].
usually associated with urgency, and damage to the IAS is More specifically, Cunningham and Pilkington described
usually associated with flatus incontinence and passive soil- inserting four interrupted sutures in the capsule of the EAS at
ing. However, damage to both sphincters can occur, giving the anterior, posterior, superior, and inferior points [21]. The
rise to mixed symptoms. end-to-end approximation type of repair has been the stan-
dard and is still used widely. However, in 1999, Sultan et al.
[22] explored the overlap technique of primary repair of the
13.3.2 Diagnosis of OASIS EAS (as described by Parks and McPartlin for secondary
sphincter repair [23]). In addition, Sultan et al. highlighted
A careful vaginal and rectal examination must be performed in the importance of recognition and separate repair of the
all women who have undergone a vaginal delivery. In order to freshly torn IAS, which is largely responsible for maintain-
do this, there must be adequate exposure, good lighting, and ing the resting tone of the anal sphincter, as persistent IAS
analgesia [13, 15]. OASIS cannot be excluded without perform- injury is associated with incontinence of flatus and passive
ing a proper rectal and vaginal examination (Fig. 13.3), as third-/ soiling [22].
fourth-degree tears can occur despite an apparent intact The morbidity associated with perineal trauma depends
perineum [17]. The IAS is thinner and paler than the striated on the extent of perineal damage, technique and materials
EAS. The appearance of the IAS can be described as being used for suturing, and the skill of the operator. Practitioners
analogous to the flesh of raw fish, as opposed to the red meat should therefore be adequately trained and adopt evidence-
appearance of the EAS. The EAS is demarcated laterally by the based techniques during perineal repair.
perianal fat, an important landmark in identification of the EAS. Repair should be conducted in the operating room where
there is access to good lighting, appropriate equipment, and
aseptic conditions. A specially prepared instrument tray con-
13.3.3 Repair of OASIS taining a Weitlander self-retaining retractor, four Allis tissue
forceps, McIndoe/Metzenbaum dissecting scissors, tooth
In 1930, Royston described a commonly practiced technique forceps, two artery forceps, stitch-cutting scissors, and a
in which the ends of the torn sphincter were approximated by needle holder is useful (www.perineum.net).
A general or regional (spinal, epidural, caudal) anes-
thetic will provide analgesia as well as muscle relaxation,
which is an important prerequisite to enable proper evalua-
tion of the full extent of the injury. As the EAS is a striated
muscle ring, under tonic contraction, the torn muscle ends
are prone to retract within its capsular sheath. Adequate
muscle relaxation allows the torn ends of the EAS to be
grasped and retrieved. This would enable repair of the torn
muscles without tension, especially if the intention is to
overlap the EAS [9].
Repair of OASIS should only be conducted by a doctor
who has been formally trained (or under supervision) in pri-
mary anal sphincter repair. In view of the observed subopti-
mal outcome associated with primary anal sphincter repair
when performed by obstetricians with varying degrees of
experience, it has been suggested that perhaps a repair per-
formed by colorectal surgeons may be associated with a bet-
ter outcome [24, 25]. Kairaluoma et al. reported on 31
Fig. 13.3 A partial tear along the length of the external anal sphincter
(EAS) (arrow) that could be missed without a rectal examination. consecutive women who sustained OASIS (third and fourth
Reproduced from [9], with permission degree) [26]. All had an EAS overlap repair immediately
214 A. H. Sultan and R. Thakar
Fig. 13.5 (a) The torn ends of the internal sphincter being held by Allis forceps (E = external sphincter) and (b) repaired using mattress PDS 3-0
sutures. Reproduced from [9], with permission
length [36], and it has been shown that a shorter anal canal
length after primary repair is associated with a poorer out-
come [37]. After repair of the sphincter, the perineal muscles
should be sutured to reconstruct the perineal body, in order to
provide support to the repaired anal sphincter [9].
Fig. 13.7 A rectal buttonhole tear with an intact external anal sphincter 13.3.9 Stool Softeners
demonstrated during a digital rectal examination
Constipation should be avoided, as passage of constipated
This is best repaired via the transvaginal approach. The stool, or indeed fecal impaction requiring manual evacuation,
proximal and distal ends of the rectal mucosa must be may disrupt the repair, and the majority consensus in the litera-
identified, and the mucosa should be repaired using a con- ture is that stool softeners should be prescribed [29]. Mahony
tinuous 3-0 Vicryl suture. To minimize the risk of the devel- et al. performed a randomized trial (n = 105) of constipating
opment of a rectovaginal fistula, a second layer of tissue versus laxative regimens and found that the use of laxatives
should be interposed between the rectum and vagina by was associated with a significantly earlier and less painful first
approximating the rectovaginal fascia before suturing the bowel motion, as well as earlier discharge from hospital [40].
vaginal skin. A colostomy is rarely indicated unless there is Nineteen percent in the constipated regimen group experienced
a large tear extending above the pelvic floor or there is gross troublesome constipation (two required hospital admission for
fecal contamination of the wound [9]. fecal impaction) compared to 5% in the laxative regimen group.
There were no significant differences in continence scores, anal
manometry, or endoanal scan findings.
13.3.7 Suture Material A randomized study [41] has indicated that stool bulking
agents such as ispaghula husk (Fybogel) should be avoided,
The anal epithelium is repaired using Vicryl 3-0. The sphinc- as the authors found that incontinence occurred significantly
ter muscles are repaired with either monofilament fine more often (33% vs. 18%) when lactulose and Fybogel were
sutures such as 3-0 PDS (polydioxanone) or modern braided consumed compared to lactulose only. We recommend lactu-
sutures such as 2-0 Vicryl (polyglactin), as these may cause lose 15 ml twice a day for 10 days, but the dose could be
less irritation and discomfort with equivalent outcome. modified according to the stool consistency.
Complete absorption of PDS takes longer than Vicryl, with
50% tensile strength lasting more than 3 months compared to
3 weeks, respectively [38]. To minimize suture migration, 13.3.10 Postoperative Catheterization
care should be taken to cut the suture ends short and ensure
that they are covered by the overlying superficial perineal Severe perineal discomfort, particularly following instru-
muscles. Williams et al. [38] performed a factorial random- mental delivery, is a known cause of urinary retention, and
ized controlled trial (n = 112), in which women were ran- following regional anesthesia, it can take up to 12 h before
domized into four groups: overlap with polyglactin (Vicryl; full bladder sensation returns. A Foley catheter should be
Ethicon, Edinburgh, UK), end-to-end repair with Vicryl, inserted for up to 24 h unless medical staff can ensure that
overlap repair with polydioxanone (PDS; Ethicon, Edinburgh, spontaneous voiding occurs at least every 3–4 h without
UK), and end-to-end repair with PDS [34]. This trial was undue bladder overdistension.
13 Posterior Compartment Trauma and Management of Acute Obstetric Anal Sphincter Injuries 217
13.3.11 Postoperative Analgesia reported that only 9% of women have symptoms of anal
incontinence at 6 months follow-up [47]. Ramage et al.
The degree of pain following perineal trauma is related to the have shown that with recent repair techniques, favorable
extent of the injury, and OASIS are frequently associated outcomes can be achieved irrespective of the grade of
with other more extensive injuries such as paravaginal tears. tear [48].
In a systematic review, Hedayati et al. found that rectal anal-
gesia such as diclofenac is effective in reducing pain from
perineal trauma within the first 24 h after birth [42]. In 13.3.14 Management of Subsequent
women who had a repair of a fourth-degree tear, diclofenac Pregnancies
should be administered orally, as insertion of suppositories
may be uncomfortable, and there is a theoretical risk of poor There are no randomized studies to determine the most
healing associated with local anti-inflammatory agents. appropriate mode of delivery following a third-/fourth-
Codeine-based preparations are best avoided as they may degree tear. At the first postpartum visit, a careful vaginal
cause constipation leading to excessive straining and possi- and rectal examination should be performed to check for
ble disruption of the repair. complete healing, scar tenderness, and sphincter tone. In
order to counsel women with previous third-/fourth-degree
tears appropriately, we find it useful to have a symptom ques-
13.3.12 Follow-Up tionnaire along with anal ultrasound (Fig. 13.7) and manom-
etry results. If vaginal delivery is contemplated, then these
Ideally, these women should be under the care of a specialist tests should be performed during the current pregnancy.
team, e.g., a perineal clinic, and follow-up should be about Figure 13.8 presents a simple flow diagram demonstrating
8–12 weeks after delivery. The perineal clinic is viewed as a the management of subsequent delivery after OASIS that we
supportive environment, and women feel confident about the follow in our unit [49]. One study has shown that if a large
information provided by the team [43]. An information sonographic defect (more than one quadrant) is present, or if
booklet should be given to these women to ensure that they the squeeze pressure increment (above resting pressure) is
understand the implications of sustaining OASIS and also to less than 20 mmHg, then the risk of impaired continence dra-
provide information as to where and when to seek help if matically increases after a subsequent delivery [50]. We con-
symptoms of infection or incontinence develop. There is no ducted a prospective study over a 5-year period and found
consensus of opinion on when pelvic floor and anal sphincter that if there is no evidence of significant compromise of anal
exercises are best initiated, although it is recommended that
they should be commenced when the discomfort resolves
and the woman feels comfortable. Neels et al. found that the
intensity of pain during pelvic floor exercises is low (visual
analogue score = 2) and their results showed that fear of peri-
neal pain should not discourage women to start pelvic floor
muscle training shortly after childbirth [44]. Mathé et al. rec-
ommended early pelvic floor exercises to be commenced
within 30 days of delivery [45].
sphincter function, a subsequent vaginal delivery is not asso- necessary, e.g., because of a thick inelastic or scarred
ciated with subsequent deterioration in function or symp- perineum, a mediolateral episiotomy should be performed.
toms [51]. We were therefore able to encourage asymptomatic There is emerging evidence that routinely performed episi-
women who have minimal compromise of their anal sphinc- otomies prevent recurrence of OASIS [54]. The threshold at
ter function to have a vaginal delivery. Other studies have which these women may be considered for a cesarean sec-
found similar results, and based on these criteria, 70% of tion may be lowered if a traumatic delivery is anticipated,
women with previous OASIS go on to have a vaginal deliv- e.g., in the presence of one or more additional relative risk
ery [49, 52, 53] (Fig. 13.9). factors, such as a large baby, shoulder dystocia, prolonged
These women should be counseled that they have an 88% labor, or difficult instrumental delivery. However, in decid-
[6] (in centers practicing midline episiotomy) to 93% [4] (in ing the mode of delivery, counseling (and its clear documen-
centers practicing mediolateral episiotomy) chance of not tation) is extremely important. Some of these women who
sustaining recurrent OASIS. If an episiotomy is considered have sustained OASIS may be scarred both physically and
Perineal clinic
Anorectal manometry
Endoanal ultrasound
Symptomatic Asymptomatic
Severe Mild
Caesarian section
Family not complete Family complete
Fig. 13.9 Flowchart of a suggested management of OASIS in a subsequent pregnancy [49]. EAS external anal sphincter, MSP maximal strength
pressure, PFE pelvic floor excercise
13 Posterior Compartment Trauma and Management of Acute Obstetric Anal Sphincter Injuries 219
emotionally and may find it difficult to cope with the thought the UK, Sultan et al. demonstrated inconsistencies in the
of another vaginal delivery. These women will require sym- classification of perineal trauma, as one-third of doctors
pathy, psychological support, and serious consideration of were classifying third-degree tears as second-degree [58].
their request for cesarean section. Most trainee doctors admitted that their training in recog-
Women who have minor degrees of incontinence (fecal nizing (84%) and repairing (94%) OASIS was poor.
urgency or flatus incontinence) may be controlled with Furthermore, in another older study, 64% of consultants
dietary advice, constipating agents (loperamide or codeine reported unsatisfactory or no training in the management
phosphate), physiotherapy, or biofeedback. These women of OASIS [27]. OASIS that were previously believed to be
who have some degree of anal sphincter compromise occult injuries [10] have now been proven to be undiag-
(Fig. 13.8) but whose symptoms are controlled should be nosed injuries that could have been diagnosed clinically
counseled and recommended a cesarean section. by a trained clinician [56]. McLennan et al. also raised
Women who sustained a previous third-/fourth-degree concern about training in the USA [59]. They surveyed
tear with subsequent severe incontinence and have failed 1177 4-year residents and found that the majority had
conservative management should be offered secondary received no formal training in pelvic floor anatomy, episi-
sphincter repair by a colorectal surgeon (or a urogynecolo- otomy, or perineal repair and supervision during perineal
gist with expertise in secondary sphincter repair), and all repair was limited. Similarly, Uppal et al. demonstrated
subsequent deliveries should be by cesarean section. Some that ob-gyn residents demonstrated substandard skill in
women with fecal incontinence may choose to complete repairing anal sphincter laceration. Only 42.5% passed
their family before embarking on anal sphincter surgery. It their evaluation criteria, 42.5% suggesting a lack of ade-
remains to be established whether these women should be quate training in repair [60].
allowed a vaginal delivery, but it is likely that the damage A recent survey of candidates attending a hands-on train-
has already occurred and the risk of further damage is mini- ing course using a latex model and fresh animal tissue has
mal and possibly insignificant in terms of the outcome of shown that training in this fashion was useful in diagnosis
surgery. The benefit, if any, should be weighed against the and repair of OASIS [28]. Siddighi et al. demonstrated that
risks associated with cesarean section for all subsequent residents in obstetrics and gynecology who underwent a
pregnancies. Women who have had a previous successful structured training workshop improved their surgical ability
secondary sphincter repair for fecal incontinence should be with respect to managing OASIS [61]. As the occurrence of
delivered by cesarean section [55]. Clearly there are going OASIS is unpredictable and unplanned, and opportunities
to be women who do not entirely fit into any of the above for trainees to repair these injuries under authentic circum-
categories, e.g., those who have isolated internal sphincter stances are few, a hands-on workshop in conjunction with
defects or those who have irritable bowel syndrome. The competency-based training appears to be the best way for-
management of these women should be individualized, and ward (www.perineum.net).
a mutual decision should be made taking into account the
symptoms, examination findings, and results of the
investigations. 13.4 Conclusions
If there are no facilities for anal manometry and endo-
sonography, then the management will depend on symptoms Obstetric trauma to the posterior compartment can result in
and clinical evaluation. In the absence of scientific evidence, pelvic floor denervation, disruption of the fascial supports,
it would appear reasonable that asymptomatic women with- and injury to the anal sphincter. Injuries to the anal sphinc-
out any clinical evidence of sphincter compromise as deter- ter can give rise to anal incontinence, and therefore accu-
mined by assessment of anal tone could be allowed a vaginal rate detection and diagnosis of the full extent of the injury
delivery. All women who are symptomatic should be referred are mandatory at delivery. Repair should be conducted by a
to a center with facilities for anorectal assessment and should trained clinician, and the aim should be to restore the nor-
be counseled for cesarean section. mal high-pressure zone of the anal canal represented by the
anal length. Failure to identify and repair the internal
sphincter at the time of the acute injury will increase the
13.3.15 Training Issues risk of fecal incontinence and jeopardize the ability to
repair it at a later date. Attention needs to be focused on
It has been shown that up to half of OASIS are not recog- training of doctors and midwives internationally in the
nized by the obstetrician or midwife [56, 57]. Inadequate identification and repair of OASIS. Failure to recognize the
training of doctors and midwives in perineal and anal full extent of the injury and repair, it appropriately can have
sphincter anatomy [58] is believed to be a major contrib- devastating long-term consequences to the quality of life of
uting factor. In a survey of 75 doctors and 75 midwives in women [62, 63].
220 A. H. Sultan and R. Thakar
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London: Springer-Verlag; 2007. p. 13–9.
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lowing central episiotomy. Southern Med J. 1948;41:814–20.
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• The injury should be classified as described above obstetrics. Am J Obstet Gynecol. 1955;69:786–93.
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Urogynecol J. 2018;29(11):1579–88. Tekkis P. Does a missed obstetric anal sphincter injury at time of
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Neurogenic Trauma During Delivery
14
Kimberly Kenton and Julia Geynisman-Tan
connective tissue sheath that protects individual fibers from Table 14.1 Types of nerve injury seen in delivery
external trauma. Groups of fascicles are embedded in the Types of
epineurium, a loose connective tissue, which provides a nerve injury Neuropraxia Axonotmesis Neurotmesis
cushion of protection during stretching and compression. Description Transient Prolonged Complete
stretching or stretching or neural
Importantly, the epineurium also contains the vascular sup- compression that compression separation
ply, which crosses the perineurium to supply the nerve fiber results in leads to including
itself. This arrangement of nerve fibers into fascicles sur- short-term significant disruption of
rounded by loose connective tissue and the elasticity of the ischemia leading ischemia which the axon,
to a focal disrupts the Schwann cell,
perineurium have important implications for the protection conduction block axon, while and connective
and resilience of the peripheral nerves. They help to make across the affected preserving the tissue elements
peripheral nerves resistant to both compression and stretch portion of the Schwann cell
injury. nerve. There is no
disruption to the
axons or Schwann
cells
14.3 Pudendal Neuropathy Prevalence Common Frequent Rare
during
childbirth
The lumbosacral plexus is susceptible to compression and/or
Time to Days Weeks to Complete
stretch of peripheral nerves that innervate the pelvic floor resolution months recovery is
muscles and their vascular supply during childbirth. impossible
Compression and/or stretch may result in only a mild injury
to the myelin sheath, creating a local conduction block and
temporary loss of nerve function. This type of injury recov- mildest form of nerve injury. The nerve sustains stretching or
ers completely within hours to weeks. Unfortunately, a more compression that results in transient ischemia leading to a
severe injury occurs frequently, in which the axons them- focal conduction block across the affected portion of the
selves are injured, but the connective tissue framework is nerve. There is no disruption to the axons or Schwann cells,
intact. In these cases, the axon can regenerate over months. so the conduction block often resolves within a few minutes;
The pudendal nerve is the primary branch of the lumbosa- however, longer periods of compression or stretch may result
cral plexus thought to result in pelvic floor disorders associ- in edema or demyelination, which make take longer to
ated with vaginal delivery. The pudendal nerve arises from resolve. Neuropraxic injuries usually resolve within days to
the anterior roots of S2–4 to coalesce in the pelvis just proxi- weeks.
mal to the sacrospinous ligament. It leaves the pelvis through Prolonged or excessive compression or stretch to a nerve
the greater sciatic foramen only to reenter through the lesser can result in actual disruptions of the axons, while preserv-
sciatic foramen at which point it travels along the obturator ing the Schwann cell. This results in axonotmesis, and
internus fascia or Alcock’s canal. The pudendal nerve even- Wallerian degeneration begins within 24–36 h of the injury.
tually splits into its three terminal branches: dorsal nerve to It affects motor, sensory, and autonomic functions that may
the clitoris, which provides sensation to the clitoral area; the take weeks to months to resolve. Even though the axon is
perineal nerve, which innervates the striated urethral sphinc- disrupted, regeneration is usually complete, because the sup-
ter muscle and perineal skin; and the inferior hemorrhoidal porting Schwann cell remains intact. Axons grow at a rate of
nerve, which innervates the external anal sphincter and peri- 1–2 mm per day, so physicians can estimate the time to neu-
anal skin. romuscular recovery after childbirth.
The pudendal nerve is susceptible to compression and Neurotmesis is the most severe form of nerve injury
stretch injury during childbirth as it travels through the fixed resulting from complete neural separation including disrup-
point of Alcock’s canal in the pelvis. Studies have shown tion of the axon, Schwann cell, and connective tissue ele-
neurophysiologic evidence of pudendal nerve injury to the ments. This is not commonly associated with vaginal
external anal sphincter, levator ani, and striated urethral childbirth.
sphincter after vaginal childbirth [9, 11–13]. When a nerve injury does occur from compression, both
the amount of pressure and duration of compression have
important implications in nerve recovery. Locally applied
14.4 Mechanism of Nerve Injury pressure of 80 mmHg results in complete vascular obstruc-
tion and ischemia in the compressed nerve segment [14], and
The severity of nerve injury is related to the degree and dura- when the pressure or ischemia is sustained for 70 min, it
tion of ischemia from compression or stretch of the nerve results in irreversible nerve injury [15]. Compression at
(Table 14.1). Neuropraxia, or a local conduction block, is the lower pressures can also result in irreversible nerve injury
14 Neurogenic Trauma During Delivery 225
from both ischemia and mechanical deformation of the neu- Cesarean delivery conferred a significantly lower risk of
ral structure [16]. Pressure between the fetal head and vagina stress incontinence than vaginal delivery [5]; however, other
during the second stage of labor can reach as high as delivery risks factors are not well established and vary in the
240 mmHg [17] and thereby easily lead to compression literature. While the precise mechanism of injury is unclear,
neuropathy. neurogenic injury to the pudendal nerve plays an important,
Similarly, if a nerve is stretched, the arrangement of nerve if not the most important, role.
fibers into fascicles embedded in the epineurium allows for Electrophysiologic and histologic studies demonstrated
natural movement of fibers. However, when a nerve is that women with stress incontinence have decreased urethral
stretched beyond 15% of its length, the vascular supply to skeletal muscle volume and urethral neuromuscular changes
the nerve fiber is compromised resulting in irreversible nerve consistent with denervation injury [27, 28]. DeLancey et al.
injury [18]. Theoretically, if the pudendal nerve is stretched compared urodynamic and clinical measures of urethral
beyond 1.35 cm during the second stage of labor, irreversible function and support in a large cohort of women with stress
neuropathy will likely result. Using 3D computer modeling, incontinence to women without urinary symptoms [29].
investigators demonstrated that nerves to the anal sphincter Urethral closure pressure alone predicted half of the occur-
stretch more than 15% during vaginal delivery [19]. The rence of stress incontinence, while anatomic measures of
inferior hemorrhoidal nerve sustained the greatest amount of urethral support only predicted 16% of stress incontinence
stretch (35%) in this model, although the perineal branches cases. As urethral closure pressure is directly related to the
to the anal sphincter (33%) and urethral sphincter (13%) innervation (tone) of the urethral sphincter, these findings
were also stretched to the point of possible vascular emphasize the important role vaginal delivery has on neuro-
disruption. genic trauma to the pudendal nerve and the subsequent
development of stress incontinence.
Weider et al. reported important differences in electro-
14.5 Measuring Nerve Injury myographic parameters of the striated urethral sphincter in
nulligravid and primigravid women [20]. Women who under-
Electromyography is an electrodiagnostic technique that went one vaginal delivery showed significant electromyo-
plays an important role in differentiating neurogenic injury graphic changes consistent with denervation-reinnervation
from primary muscle pathology; localizing the site of nerve injury of the pudendal nerve compared with their nulligravid
injury; and providing information about the chronicity and controls. This is supported by multiple other studies which
prognosis of the injury. show that women with stress incontinence have abnormali-
Needle electromyography has been used to confirm the ties on electromyography and nerve conduction studies con-
association between pelvic nerve injury and vaginal delivery, sistent with pudendal nerve injury [6, 23, 30].
stress incontinence, and fecal incontinence. Significant
changes in motor unit action potential morphology have
been reported after vaginal childbirth by multiple authors 14.7 External Anal Sphincter
[10–12, 20, 21]. Similarly, needle electromyography of the
striated urethral sphincter, levator ani, and external anal Anal incontinence affects up to 25–35% of women 6
sphincter muscles has shown electromyographic evidence of months after delivery [31–33] and 31% 15 years after
denervation with subsequent reinnervation in women with delivery [5]. Using data from the Nurses’ Health Study,
stress incontinence and pelvic organ prolapse [6, 22–25]. investigators found that the odds of fecal incontinence to
Neurogenic trauma to the pudendal nerve primarily liquid stools (remote from delivery) increased with each
impacts three important pelvic floor structures: striated ure- pregnancy, suggesting an additive impact from each preg-
thral sphincter, external anal sphincter, and levator ani mus- nancy [34].
cles. The next sections of the chapter will focus on the role of Anal incontinence is more common after operative vagi-
obstetric neurogenic trauma on these three muscles groups nal delivery [5] and after obstetric anal sphincter injury [35]
and their effect on pelvic floor function. suggesting an anatomic etiology in addition to a neurogenic
one. Sultan et al. first reported high rates of occult anal
sphincter disruption on endoanal ultrasound (35%) in pri-
14.6 Striated Urethral Sphincter miparous women and associated these findings with anal
incontinence [36]. Other investigators continued to report
Vaginal delivery clearly impacts rates of stress urinary incon- similarly high rates of occult anal sphincter injury on endo-
tinence in women. Two well-designed longitudinal cohort anal ultrasound ranging from 20 to 40% [37, 38]. With pri-
studies followed women for 12–15 years after vaginal deliv- mary repair of obstetric anal sphincter injury, 60–80% of
ery and found stress incontinence rates of 34–42% [5, 26]. women are asymptomatic 1 year after delivery [38].
226 K. Kenton and J. Geynisman-Tan
Gregory et al. performed anal sphincter electromyogra- strong correlation between prolapse beyond the hymen (odd
phy on 28 nulliparous and 23 vaginally parous women ratio 2.7, 95% CI 1.3–5.7), symptoms of prolapse (odd ratio
12 weeks after delivery and found quantifiable evidence of 3.0, 95% CI 1.2–7.3), and levator ani avulsion. Other pelvic
pudendal neuropathy in the parous women [11]. Earlier floor disorders, such as stress incontinence, overactive blad-
investigators performed anal sphincter electromyography in der, and anal incontinence, were less impacted by levator ani
14 women immediately postpartum and 5 years after their avulsion, suggesting that these disorders may be more
first delivery and found continuous decline in the function of impacted by neurogenic trauma than anatomic disruptions of
the pudendal nerve over time [8]. These investigators also the levator ani.
reported that pudendal nerve injury to the external anal Anatomic disruptions to the levator ani seem to improve
sphincter was associated with both fecal incontinence and over time on imaging studies [42, 43]. One study reported
stress urinary incontinence. that 62% of levator ani avulsions diagnosed 3 months post-
partum resolved by 12 months [44]. However, unresolved
avulsions can lead to a persistently enlarged levator hiatus,
14.8 Levator Ani Musculature which is a risk factor for pelvic organ prolapse. A larger leva-
tor hiatus is associated with an increasing number of vaginal
Multiple authors have demonstrated electromyographic deliveries [45] and is more likely to remain enlarged after a
changes in the levator ani of women with stress incontinence vaginal delivery than an unlabored cesarean [46].
and prolapse [9, 22]. One study of 58 primiparous women
found that 24% and 29% had electromyographic evidence of
neuropathic injury to the levator ani 6 weeks and 6 months 14.9 Conclusions
after their first delivery [39]. Another study similarly showed
that one third of women demonstrated denervation- The relationship between childbirth, especially vaginal, and
reinnervation of the levator ani 6 weeks after delivery [40]. neurogenic trauma to the pelvic floor muscles is well estab-
However, in the case of the levator ani muscles, it is more lished. The anatomic position of the pudendal nerve makes it
difficult to separate the role of anatomic or mechanical particularly vulnerable to both compression and stretch injury
trauma from neurogenic trauma. Up to 30% of women sus- during pregnancy and childbirth. Electrophysiologic studies
tain an avulsion of their levator ani muscles with vaginal using needle electromyography consistently show evidence of
childbirth [21]. A recent study followed 453 women for denervation-reinnervation injury to the striated urethral sphinc-
6–17 years after their first delivery [41]. Fifteen percent of ter, external anal sphincter, and levator ani muscles in parous
women had an identifiable levator ani avulsion on ultrasound women. These neurogenic findings seem to be associated with
(Fig. 14.1). Not surprisingly, levator ani avulsion was more multiple pelvic floor disorders, including stress urinary incon-
common after forceps-assisted delivery. There was also a tinence, anal incontinence, and pelvic organ prolapse.
a b
Fig. 14.1 (a) The levator ani is intact bilaterally with attachment to the pubic symphysis. (b) the left levator ani is avulsed (arrow) and hanging at
a wider angle than its counterpart on the right
14 Neurogenic Trauma During Delivery 227
13. Weidner AC, Barber MD, Visco AG, Bump RC, Sanders DB. Pelvic
Take-Home Messages muscle electromyography of levator ani and external anal sphincter
in nulliparous women and women with pelvic floor dysfunction.
• The 15-year cumulative incidence of pelvic floor Am J Obstet Gynecol. 2000;183(6):1390–9. discussion 9-401
disorders after first delivery: stress incontinence 14. Rydevik B, Lundborg G, Bagge U. Effects of graded compression
34%, overactive bladder 22%, anal incontinence on intraneural blood blow. An in vivo study on rabbit tibial nerve. J
31%, and prolapse 30%. Hand Surg Am. 1981;6(1):3–12.
15. Lundborg G. Ischemic nerve injury. Experimental studies on intra-
• Vaginal delivery, and especially operative vaginal neural microvascular pathophysiology and nerve function in a limb
delivery, leads to pelvic floor disorders by two subjected to temporary circulatory arrest. Scand J Plast Reconstr
mechanisms: neuropathy and muscular avulsion. Surg Suppl. 1970;6:3–113.
These injuries can be identified by EMG and ultra- 16. Dahlin LB, Danielsen N, Ehira T, Lundborg G, Rydevik
B. Mechanical effects of compression of peripheral nerves. J
sound and are not mutually exclusive. Biomech Eng. 1986;108(2):120–2.
• The pudendal nerve is susceptible to compression 17. Rempen A, Kraus M. Pressures on the fetal head during normal
and stretch injury during childbirth as it travels labor. J Perinat Med. 1991;19(3):199–206.
through the fixed point of Alcock’s canal in the pel- 18. Lundborg G, Rydevik B. Effects of stretching the tibial nerve of
the rabbit. A preliminary study of the intraneural circulation and
vis. Neurogenic trauma to the pudendal nerve pri- the barrier function of the perineurium. J Bone Joint Surg Br.
marily impacts three important pelvic floor 1973;55(2):390–401.
structures: striated urethral sphincter, external anal 19. Lien KC, Morgan DM, Delancey JO, Ashton-Miller JA. Pudendal
sphincter, and levator ani muscles. nerve stretch during vaginal birth: a 3D computer simulation. Am J
Obstet Gynecol. 2005;192(5):1669–76.
20. Weidner AC, South MM, Sanders DB, Stinnett SS. Change in ure-
thral sphincter neuromuscular function during pregnancy persists
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Prevention of Perineal Trauma
15
Ranee Thakar and Abdul H. Sultan
trauma reduction requiring suturing (mainly episiotomies), in A Cochrane review of immersion in water in labor and dur-
women who had not previously given birth vaginally. When ing delivery [15] was unable to draw conclusions on the out-
comparing those who massage with controls, there was no come of perineal trauma including OASI in these situations.
difference in the rates of first-, second-, third-, or fourth-
degree tears, instrumental deliveries, sexual satisfaction, or
urinary and anal incontinence. Furthermore, the authors 15.3.2 Position During Labor and Birth
found that for every 15 women who practiced perineal mas-
sage in the antenatal period, one less woman would receive It is controversial whether being upright or lying down has
perineal suturing following the birth. Women who massaged advantages for women delivering their babies. Several physi-
up to an average of 1.5 times per week experienced a 16% ological advantages have been claimed for non-recumbent or
reduction, women who massaged an average of 1.5–3.4 times upright labor, such as the effects of gravity, lessened risk of
per week experienced a 8% reduction, and women who mas- aortocaval compression, improved acid-base outcomes in the
saged more than 3.5 times per week did not experience a sta- newborns, stronger and more efficient uterine contractions,
tistically significant reduction in the incidence of trauma improved alignment of the fetus for passage through the pel-
requiring suturing. Although perineal massage causes some vis, and radiological evidence of larger pelvic outlet diameters
transient discomfort in the first few weeks, it is generally well with an increase in the total outlet area in the squatting and
accepted by women. The majority (79%) report that they kneeling positions. The supine or semi-recumbent position for
would massage again, and 87% would recommend it to birth is widely used in modern obstetrics due to the medical-
another pregnant woman [10]. Therefore, women should be ization of childbirth. The main advantage cited is easy access
informed about the benefits of antenatal perineal massage and of the caregiver to the woman’s abdomen to monitor the fetal
also provided with information on the technique (Fig. 15.1). heart rate. In addition, caregivers are comfortable with the dor-
sal position as it is the position in which they have usually
been trained to conduct deliveries and is the conventional ref-
15.2.2 Pelvic Floor Muscle Training erence position for textbook descriptions of the mechanisms
of vaginal delivery [16]. During labor and delivery, the woman
Although evidence has shown that antenatal pelvic floor may be placed in the lithotomy, lateral recumbent, kneeling,
muscle training can prevent and treat urinary incontinence squatting, or standing position. A recent Cochrane review [16]
during pregnancy and in the immediate postpartum period which included 30 trials showed that the use of any upright or
[11, 12], the effect on perineal trauma is not known. A large lateral position, compared with supine or lithotomy positions,
cohort study (Norwegian mother and child cohort study) was associated with reduced duration of the second stage of
conducted to estimate whether women doing pelvic floor labor, a reduction in assisted deliveries and episiotomies, an
muscle training before and during pregnancy were at increase in second-degree perineal tears, and estimated blood
increased risk of perineal lacerations [13], episiotomy, loss greater than 500 mL with fewer abnormal fetal heart rate
instrumental delivery, or emergency cesarean section found patterns. Due to the heterogenic nature of the trials included,
15 Prevention of Perineal Trauma 231
the authors concluded that women should be encouraged to meta-analysis of both randomized controlled trials (RCTs)
give birth in the position they find most comfortable. Further and non-randomized studies (NRSs) to evaluate the effect
research is needed in this area. A recent well-designed, multi- of manual perineal support on OASIS during vaginal deliv-
center study in 41 UK units, aiming to determine whether ery. The meta-analysis of RCTs did not demonstrate a pro-
being upright in the second stage of labor in nulliparous tective effect (relative risk 1.03, 95% confidence interval
women with a low-dose epidural increases the chance of spon- 0.32–3.36). In the three RCTs included, the technique of
taneous delivery, showed that lying down in the second stage perineal support and delivery practice was not well
of labor results in more spontaneous vaginal births in nullipa- described. The method and duration of teaching, training,
rous women with epidural analgesia, with no apparent disad- and supervision to learn the intervention were unknown,
vantages in relation to short- or longer-term outcomes for which makes it difficult to judge the quality. It is also
mother or baby and this included OASI [17]. important to note that for most of the included RCTs, MPP
was used at the time of delivery of the head, and not neces-
sarily the shoulders. This is relevant because it is well
15.3.3 Application of Warm Perineal known that OASIS can occur as the shoulders deliver.
Compresses in the Second Stage Furthermore, in the study by McCandlish et al. [22], lower
of Labor compliance with allocated management was noted in the
“hands-poised” group (70.1%) compared with the “hands-
Perineal warm packs/compressors have not shave has been on” group (95.3%). Another limitation was that implemen-
advocated for many years in the belief that they reduce peri- tation of the “hands-on” technique varied enormously
neal trauma and increase comfort during the late second stage between studies. More importantly, OASI was not the pri-
of labor. Physiological studies support the potential beneficial mary outcome of the study.
effects of warm packs in dilating blood vessels, and increasing Meta-analysis of NRSs showed that the OASIS rate was
blood flow, the transmission of blood by reducing the level of reduced by more than 50% (from 4–5% to 2%) in a total
nociceptive stimulation, and collagen extensibility [18]. A population of >75,000 deliveries and was not restricted to
Cochrane review showed that compared to women with no low-risk births as in the RCTs. Among the three NRSs that
warm compresses during the second stage of labor, approxi- qualified for the meta-analysis, the two largest were from
mately 50% fewer women in the warm-compress group expe- Norway [23, 24]. In these studies the intervention period
rienced third- or fourth-degree tears; however the effect of lasted 6–14 weeks, and the training included compulsory
warm compresses on the incidence of other perineal trauma lectures, simulation training, and education of a group of
and grades of perineal tears is uncertain [19]. trainer-midwives who taught and supervised the entire staff
Dahlen et al. questioned women and midwives about the in the clinical setting before the intervention started. In
effects of warm packs on pain, perineal trauma, comfort, and these studies the classical Finnish method of MPP was
feeling of control, satisfaction, and intentions of views dur- used. In this technique, the delivery assistant presses the
ing future pregnancies and found that warm packs were baby’s head with the non-dominant hand to control the
highly acceptable as a means of relieving pain during the late speed of crowning through the vaginal introitus.
second stage of labor. Eighty per cent of women and mid- Simultaneously, using the thumb and index finger of the
wives felt that warm packs reduced perineal pain during dominant hand is used to support the perineum while the
birth. The majority of women (86%) said they would like to flexed middle finger is used to take a grip on the baby’s
use perineal warm packs again for their next birth and would chin. When a good grip has been achieved, the woman is
recommend them to friends. Likewise, 91% of midwives asked to stop pushing, to breathe rapidly, while the midwife
were positive about using warm packs, with 93% considered slowly helps the baby’s head through the vaginal introitus.
using them in future as part of routine care in the second When most of the head is out, the perineal ring is pushed
stage of labor [20]. Based on this, the authors recommended under the baby’s chin (Fig. 15.2).
that this simple inexpensive practice should be incorporated The main focus of the intervention was on (1) good
into second stage labor care. However there are concerns communication between the accoucheur and woman
regarding risks of infection and burns from hot water. who was asked to do fast upper-costal breathing without
pushing just before delivery of the fetal head; (2) ade-
quate perineal support; (3) a delivery position that
15.3.4 Manual Perineal Protection (MPP) allows visualization of the perineum; and (4) episiot-
omy only on indication [24]. The coordination of all
MPP continues to be a point of debate among maternity these components was stressed and MPP, was not car-
healthcare professionals with some advocating “hands-on” ried in isolation.
and others advocating “hands-off/poised” policies. Randomized controlled trials are designed to measure the
Bulchandani et al. [21] carried out a systematic review and efficacy of interventions and are considered to be the most
232 R. Thakar and A. H. Sultan
15.3.6 Episiotomy
A mediolateral episiotomy is defined as one that is per- with instrumental deliveries have higher rates of anal sphinc-
formed between 40° and 60° from the midline. However, in ter tears [35–38]. The risk of having a severe perineal injury
a prospective study of women having their first vaginal deliv- has been reported to be 1.5–14.0 times higher with forceps,
ery, Andrews et al. [30] demonstrated that no midwives and and up to four times higher with a vacuum extractor, than
only 13 (22%) doctors performed a truly mediolateral episi- with spontaneous vaginal delivery [35, 39–42]. Perineal
otomy and that the majority of the incisions were in fact trauma is more likely to occur with forceps delivery as unlike
directed closer to the midline indicating a need for improved the vacuum extractor; the blades of the forceps applied
training in the art of performing an episiotomy. The inci- around the baby’s head occupy an additional 12% of the pel-
dence of OASIS appears to be related to the angle of episi- vic outlet. Sequential instrumental use of vacuum and for-
otomies as episiotomies angled closer to the midline were ceps has been shown to increase the risk of OASI 1.8-fold
associated with a higher incidence of OASIS [31]. Eogan compared with single instrument use [43]. This highlights
et al. [32] demonstrated that there was a 50% reduction in the need to choose the most appropriate instrument at first
OASIS for every 6° away from the midline. However, if the attempt and, in particular, the best type of cup for vacuum
episiotomy angle becomes nearly horizontal (90 degrees), deliveries. If the appropriately chosen instrument is applied
the pressure on the perineum is not relieved, and OASIs inci- correctly and fails, cesarean section should be considered.
dence increases ninefold [33]. In a prospective study, an inci- A study in England, United Kingdom, involving one mil-
sion angle of mediolateral episiotomy of 60° resulted in a lion primiparous women found that the use of forceps with-
low incidence of anal sphincter tearing, anal incontinence, out an episiotomy increased the odds of sustaining OASIS
and perineal pain [34]. When episiotomy is indicated, the sixfold compared with a vaginal delivery without an episi-
mediolateral technique should be used on the distended otomy [44]. In keeping with this, an observational study
perineum, with careful attention to ensure that the angle is from the Netherlands showed that mediolateral episiotomy
60° away from the midline [1]. protected significantly for anal sphincter damage in both
An episiotomy is defined by its length and depth. vacuum extraction (OR 0.11, 95% CI 0.09–0.13) and forceps
Stedenfeldt [33] found episiotomies longer than 17 mm and delivery (OR 0.08, 95% CI 0.07–0.11). The number of
a depth > 16 mm were associated with a lower rate of OASIs. mediolateral episiotomies needed to prevent one sphincter
Perineal pressure on the central posterior perineum may be injury in vacuum extractions was 12, compared to 5 with for-
relieved only by episiotomies of a certain length and depth. ceps deliveries [45].
One randomized trial of 200 women compared selective
episiotomy versus routine episiotomy in women where an
15.3.7 Instrumental Delivery operative vaginal delivery was intended. No clear difference
was found between restrictive and routine use of episiotomy
Mode of delivery has a huge influence on the risk of perineal in terms of severe perineal trauma; however the study was
tears, with studies consistently demonstrating that women underpowered for this outcome [46] (Fig. 15.3).
a b
Fig. 15.3 Perineal trauma is more likely to occur with forceps delivery as the blades of the forceps applied around the fetus’s head occupy 12%
more of the pelvic outlet (a), while this does not occur with the vacuum extractor (b)
234 R. Thakar and A. H. Sultan
15.3.8 Epidural Analgesia it is equally important to recognize and repair trauma appro-
priately, and therefore a focused and intensive training pro-
Epidural analgesia has become popular in modern obstetric gram for doctors and midwives is essential. While cesarean
practice because of its excellent pain relief in labor. Albers section may eradicate perineal trauma, it is associated with an
et al. [47] found that epidural analgesia use in labor was increased risk of mortality and morbidity and therefore should
associated with a higher incidence of sutured perineal trauma only be offered selectively.
and this was attributed to factors such as nulliparity, a pro-
longed second stage, being non-Hispanic white, and having
an infant birth weight greater than 4000 g. Similarly, Take-Home Messages
Robinson et al. demonstrated an association between epi- • Obstetric perineal trauma can have a devastating
dural use and increased OASIS because of more frequent use effect on a woman’s physical and social life, with
of operative vaginal delivery and episiotomy [48]. Epidural associated psychological sequelae.
placement after engagement of the fetal head has been shown • Proven strategies to minimize perineal trauma
to be associated with a lower incidence of malposition, include the practice of perineal massage in the ante-
which in turn could reduce the need for instrumental delivery natal period, the use of warm perineal compresses
and associated perineal trauma [49]. in the second stage of labor, the restrictive use of
episiotomy, the preference of a correctly performed
mediolateral over a midline episiotomy, and the use
15.3.9 Interventions to Correct or Deliver of a vacuum extractor instead of forceps for instru-
with an Occipito-Posterior Position mental delivery.
• Rather than resorting to cesarean section to eradi-
Persistent occipito-posterior (OP) positioning of the fetal cate perineal trauma, which is associated with an
head is a risk factor for prolonged labor, instrumental deliv- increased risk of mortality and morbidity, and there-
ery, and perineal trauma in primiparous and multiparous fore every attempt should be made to make vaginal
women, probably due to the greater presenting cephalic delivery safer.
diameters [50]. In a case-control study, Fitzpatrick et al. [51]
compared 246 cases with persistent OP position in labor to
13,543 controls delivered with an occipito-anterior position
and found that anal sphincter trauma was significantly more References
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Part IV
Urinary Incontinence and Voiding Dysfunction
Overview: Epidemiology and Etiology
of Urinary Incontinence and Voiding 16
Dysfunction
Ian Milsom and Maria Gyhagen
2
16.2 Prevalence of Urinary Incontinence
0
20-29 30-39 40-49 50-59
Population studies have demonstrated that urinary inconti-
Age, year
nence is more common in women than in men and that
approximately 10% of all women suffer from urinary incon- Fig. 16.1 Comparison of the prevalence of urinary incontinence in
tinence [2, 3]. Prevalence figures increase with increasing women from two independant population-based studies [28, 29]
age, and in women aged ≥70 years, more than 40% of the
female population are affected. The reported prevalence of Two population-based studies from Sweden have
urinary incontinence [4] and other forms of urinary tract dys- described the prevalence of UI in women of different ages. In
function among women varies widely in different studies due both studies, prevalence was restricted to women who had
to the use of different definitions, the heterogenicity of dif- urinary leakage at least once per week. Although the study
ferent study populations, and population sampling proce- performed by Samuelsson and co-workers [28] was under-
dures. Thus, for the reasons given above, it is difficult to taken in a rural area and that by Simeonova et al. [29] was
compare the results of different population studies. However, carried out in an inner city, there are strong similarities
when reviewing the literature, there is considerable evidence between the results of the two studies, with a linear increase
to support the theory that the prevalence of urinary inconti- in the prevalence of urinary incontinence which continues
nence in women increases with age, but there are divergent over the perimenopausal years (Fig. 16.1).
opinions regarding the pattern of this increase [3, 4, 9–41]. Another Swedish population study [26] could not demon-
The prevalence of UI ranged from approximately 5% to strate an increase in the prevalence of urinary incontinence
70% in published reviews [3, 4] based on population studies, between women aged 46 and 56 years of age (prevalence
with most studies reporting a prevalence of any UI in the 12% for both cohorts). The majority of 46-year-old women
range of 25–45%. For daily incontinence, prevalence esti- were premenopausal, whereas the majority of 56-year-old
mates typically range between 5% and 15% for middle-aged women were postmenopausal. There were no differences in
and older women. prevalence rates between pre- and postmenopausal women
Thomas et al. [9] performed a postal survey in order to within the respective birth cohorts. Thus, there was no evi-
investigate the prevalence of urinary incontinence in two dence to suggest that the prevalence of urinary incontinence
London boroughs. The reported prevalence of urinary incon- increased at the time of the last menstrual period. The sixth
tinence increased from 5.1% in girls aged 5–14 years to International Consultation on Incontinence after an evalua-
16.2% in 85-year-old women. There was, however, little or tion of the available literature came to the conclusion that the
no change in prevalence rates up to 35 years of age. The menopause per se did not influence the prevalence of UI [4].
prevalence rates then increased to approximately 10% in the However, this is not necessarily synonymous with the fact
35–44 years age group. There was no significant increase at that the reduction in circulating estrogens is not associated
the time of the menopause, but a further increase to approxi- with an increase in the prevalence of urinary incontinence in
mately 16% occurred in women ≥75 years. In contrast, Iosif women after the menopause.
and Bekassy [12] and Jolleys [17] reported a maximum prev- The prevalence of urinary incontinence in women has
alence of urinary incontinence at the time of the menopause been compared with the prevalence in men of the same age
and in a large Norwegian study, Hannestad et al. [30] demon- from the same urban population [26, 38]. There was a higher
strated an increased prevalence during the perimenopausal prevalence of urinary incontinence in women than in men in
years, with prevalence rates being lower both before and all the age groups studied. However in the oldest age studied,
after the time of the menopause. the prevalence of UI in men was only marginally lower than
16 Overview: Epidemiology and Etiology of Urinary Incontinence and Voiding Dysfunction 241
from residual or unmeasured confounding, further limiting postpartum, UI prevalence was 30% and most women had
conclusions about causality. stress UI [59]. In uncomplicated courses of pregnancy and
The influence of various factors on the prevalence of uri- labor, UI usually declines rapidly during the first 3 months
nary incontinence was evaluated in women aged 46–86 years following childbirth, indicating that most symptoms are part
resident in the city of Gothenburg, Sweden [26]. Age, parity, of a normal pregnancy and delivery [51]. Several studies
and a history of hysterectomy were all correlated to the prev- have also demonstrated that postpartum UI is a risk factor for
alence of urinary incontinence which increased in a linear UI after longer (7 months to 6 years) terms of follow-up [52,
fashion from 12.1% in women 46 years of age to 24.6% in 60–62].
women aged 86 years of age. The prevalence of urinary The first delivery is considered to increase the prevalence
incontinence was greater in parous women compared to nul- of UI the most, and recent studies have demonstrated a fur-
liparous women, and prevalence increased with increasing ther increase for each delivery [26, 63–66]. Many cross-
parity. Urinary incontinence was more prevalent in women sectional and several longitudinal studies show a protective
who had undergone a hysterectomy. There was no evidence effect of CS for UI [67–70].
in this study to suggest that the prevalence of urinary incon- BMI is considered to be an established risk factor for UI
tinence specifically increased at the time of the last menstrual [48, 65], whereas the association between UI and age is com-
period. plicated by confounders [71]. In a study of nulliparous
Several studies suggest that the risk of urinary inconti- women, it was possible to assess the influence of BMI on the
nence “runs in the family” [4, 32, 42–44]. Family history prevalence of UI without the concomitant influence of child-
studies have found a two- to threefold greater prevalence of birth. The prevalence of UI increased with increasing BMI in
stress UI among first-degree relatives of women with stress women of the same age (Fig. 16.3a, b).
UI compared to first-degree relatives of continent women. In
the EPINCONT study, daughters of mothers with urinary
incontinence had an increased risk of stress incontinence, 16.4 OAB and Other LUTS
mixed incontinence, and urgency incontinence [29]. In gen-
eral the risk was somewhat higher for sisters of a woman Several epidemiological studies [72–76] describing the
with UI than for daughters. prevalence and the impact of OAB and other LUTS have
Studies from the Swedish twin register indicated that her- been published (Fig. 16.4). The reported prevalence of
itability contributes to the liability of developing urinary OAB in females varied between 7.7% and 31.3%, and in
incontinence. The authors presented evidence that for both general, prevalence rates increased with age (Fig. 16.5)
disorders genetic and non-shared environmental factors [72–76]. The prevalence of OAB grouped according to
equally contributed 40% of the variation in liability [43, 44]. gender and nationality is described in Fig. 16.6. OAB has
Although study methodology and the magnitude of the risk been shown to be associated with other chronic debilitat-
estimates vary, studies on familial transmission of inconti- ing illnesses such as depression, constipation, and diabe-
nence are in agreement [32, 43, 44] having a first-degree tes as well as neurological illnesses. OAB is commonly
female family member with stress urinary incontinence associated with other LUTS (Fig. 16.4) which was well
increases the risk for an individual becoming afflicted by the illustrated by the cluster analysis performed by Coyne
same disorder. et al. [77].
Many studies have assessed the influence of pregnancy The prevalence of overactive bladder symptoms was
and in particular vaginal delivery on the risk of developing estimated in a large European study involving more than
UI. The prevalence of UI in nulliparous women of childbear- 16,000 individuals [72]. Data were collected using a
ing age has been reported to be 10–25% [45–48]. UI preced- population-based survey (conducted by telephone or face-
ing pregnancy in nulliparous has been shown to be a strong to-face interview) of men and women aged ≥40 years,
indicator for increased prevalence of UI 4–12 years postpar- selected from the general population in France, Germany,
tum [49, 50]. Pregnancy in itself, independent of labor and Italy, Spain, Sweden, and the UK using a random, strati-
delivery practices, seems to be a risk factor for postpartum fied approach. The main outcome measures were preva-
UI [51, 52] especially if the incontinence started during the lence of urinary frequency (>8 micturitions/24 h); urgency
first trimester [53]. During pregnancy the prevalence of UI and urge incontinence; proportion of participants who had
increases with gestational age [54] so that more than half of sought medical advice for overactive bladder symptoms;
all women report UI during the third trimester [55–57]. and current or previous therapy received for these
Stress UI and mixed UI increased the most during pregnancy symptoms.
compared to before pregnancy, whereas urge UI did not The progression or regression of OAB and other LUTS
change during the same period [58]. During the first 3 months was studied by Wennberg et al. [39] in the same women
16 Overview: Epidemiology and Etiology of Urinary Incontinence and Voiding Dysfunction 243
35
30
25
20 35-
15 30-34,9
10 BMI
25-29,9
5
-24,9
0
25-34 35-44 45-54 55-64
Age groups
(aged ≥20 years) followed over a period of 16 years (from In the FINNO study [78], conducted in men and women
1991 to 2007). The overall prevalence of OAB, nocturia, and aged 18–79 years of age, approximately one out of eight men
daytime micturition frequency of eight or more times per day and women reported at least two voids per night. In addition
increased by 9%, 20% (p < 0.001), and 3% (p < 0.05), one third reported one void per night. Young women reported
respectively, from 1991 to 2007. The incidence of OAB was more nocturia than young men, prevalence of nocturia in
20% and the corresponding remission rate was 43%. Women men and women equalized only in the sixth to seventh decade
with OAB symptoms were classified as OAB dry or wet of life, and in older age groups, men had more nocturia than
depending on the presence or absence of concomitant women.
UI. The prevalence of OAB dry did not differ between the
two assessment occasions (11% and 10%, respectively), but
the prevalence of OAB wet increased from 6% to 16% 16.5 P
ublic Health Consequences of UI
(p < 0.001). Among women with no OAB in 1991, the preva- and LUTS on a Global Scale
lence in 2007 was 8% and 12% for OAB dry and wet, respec-
tively. There was a progression from OAB dry to wet in 28%. The economic consequences of UI and other LUTS have
Remission from OAB dry or wet to no OAB occurred in 50% been investigated [4], and there are now numerous reports to
and 26%, respectively. support the statement that UI and LUTS have a huge bearing
Nocturia is a very common symptom, the prevalence of on healthcare costs [1, 3, 4, 79–81]. Prevalence rates vary
which increases with aging [4]. throughout the world, but a recent review indicated that urge
244 I. Milsom and M. Gyhagen
60
54,2
%
48,5
50
Men
40 Women
30
20
12,8 14,2 13,4 12,2
12,6
10,8 9,8
8,4 7,1 8,8
10 6,7 7,3 5,5 6,3 6,7 5,5
3,9 3,1
0
ria cy cy ce cy am
g al et
e
io
n
in in
ct
u
ge
n
ue
n
ne
n
tte
n
tre ai
n e pl g rit e
rm bb
l
yi
n u bl
No Ur q ti ni s
St
r
Te om ct ib
Fr
e n er ow dr
i
nc pt i
dr
co t
Sl I
em -m
In In st
Po
Fig. 16.4 The prevalence of individual lower urinary tract symptoms in women and men based on data from the EPIC study [73]
25 Women - 2006
20
15
10
0
18 -29 30 -34 35 -39 40 -44 45 -49 50 -54 55 -59 60 -64 65 -69 70+
Age, years
urinary incontinence rates were particularly high in the Mean life expectancy in the industrialized world is
Nordic countries [3] and in particular Sweden. The economic increasing, and in some countries 25% of all persons are at
consequences of urinary incontinence in Sweden were present ≥65 years of age. Thus, the number of women
assessed by Ekelund et al. [1]. The estimated annual cost for requiring treatment for urinary incontinence is expected to
urinary incontinence in Sweden at that time of the study was increase in the future. Another important factor to consider,
1.8 billion Swedish crowns. The Swedish healthcare budget apart from the numerical increase in the number of elderly
at that time amounted to 93 billion Swedish crowns. Based women, is the fact that many elderly women of today suffer
on the results of this evaluation, the annual costs of urinary in silence, accepting these symptoms as a normal part of the
incontinence in Sweden accounted for approximately 2% of aging process. Women who are at present 30 and 40 years of
the total healthcare costs. Ten years later, the annual esti- age have other demands on their physical condition and will
mated costs had increased from 1.8 billion Swedish crowns undoubtedly not accept what their older counterparts
to 2.8–4.4 billion Swedish crowns [82]. accepted later in life.
16 Overview: Epidemiology and Etiology of Urinary Incontinence and Voiding Dysfunction 245
Prevalence, %
15
10
0
Germany Italy Sweden United Canada
Kingdom
Country
16.7 Overall Conclusion prolapse (POP) and anal (AI) incontinence. In: Abrams P, Cardozo
L, Wagg A, Wein A, editors. Incontinence. 6th ed. London: Health
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and the condition known as overactive bladder has been well Abrams P, Cardozo L, Wagg A, Wein A, editors. Incontinence. 6th
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the younger age groups, and approximately 10% of all women Society (ICS) joint report on the terminology for female pelvic
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Urinary Incontinence and Voiding
Dysfunction: Patient-Reported 17
Outcome Assessment
Eduardo Cortes and Linda Cardozo
Clinical history has traditionally been used by clinicians as Criteria for recommendation of questionnaires for LUTD at the fourth
consultation 2009
the main clinical resource to collect and understand patients’
symptoms in relation to a health condition. However, clinical Grade of
recommendation Evidence required
history alone fails to assess the perception and impact that
Grade A Highly Published data indicating that it is valid,
their condition has in their daily activities and can be also recommended reliable and responsive to change on
subject to clinician’s bias when interpreting the severity of psychometric testing with rigor in one data set
these symptoms. By providing a standardised method of data Grade B Published data indicating that it is valid and
collection, patient reported outcomes (PRO) provide clinic- Recommended reliable on psychometric testing with rigor in
several data sets
tians with a more objective rather than subjective clinical
Grade C With Published data (including abstracts)
review of patients’ experiences of their symptoms [1]. PROs potential indicating that it is valid or reliable or
can be used both in the clinical setting for clinicians and for responsive on psychometric testing
patients making informed decisions and in the context of Grade D Expert opinion/no data
clinical trials and research serving as primary or secondary
Lower urinary tract dysfunction (LUTD) is a debilitating
outcome measures while evaluating treatment impact [2].
health condition, and it encompasses a range of disease enti-
A PRO is any clinical condition as described by the patient
ties and symptom complexes, generally having a negative
without interference from a clinician’s interpretation [3].
impact on QoL [6]. The aetiology behind LUTD became more
Over 30 years, since the initial focus on QoL, a fruitful and
complex than appreciated in the past involving both organ-
industrious period led to the development of a more multifac-
specific factors and systemic contributions. These complexi-
eted framework leading to a multiplicity of options when
ties gave birth to the need for a more comprehensive assessment
selecting the right tool clinically or in a research setting.
strategy integrating both clinical markers and patient PROs
[1], leading to a major shift in the understanding and evalua-
E. Cortes (*)
tion of LUTD by giving more emphasis to patients’ self-
Kingston Hospital, London, UK
e-mail: eduard@doctors.org.uk reported symptom severity and the subsequent impact on their
quality of life (QoL). In a series of reports from the International
L. Cardozo
King’s College Hospital, London, UK Continence Society (ICS), Hays RD et al. [7] proposed gen-
e-mail: linda@lindacardozo.co.uk eral guidelines to standardise well-defined outcome measures
´
• Evaluate modifications as Claim • Select mode/method or
appropriate administration/data collection
• Document all changes • Conduct patient cognitive
interviewing
• Pilot test draft instrument
• Document content validity
iV. Collect, Analyze, and
Interpret Data
• Prepare protocol and statistical analysis plan
(final endpoint model and responder iii. Confirm Conceptual Framework and
definition) Assess Other Measurement Properties
• Collect and analyze data • Confirm conceptual framework with scoring rule
• Evalute treatment response using • Assess score reliability, construct validity, and ability to
cumulative distribution and responder setect change
definition
• Finalize instrumen content, formats, scoring, procedures
• Document interpretation of treatment benefit and traning materials
in relation to claim • Document measurement development
Fig. 17.1 Patient reported Outcomes: The ICIQ and the state of the development FDA (2009). Guidance for industry-patient-reported out-
Art. Karin Coyne and Con Kelleher. Neurology and Urodynamics come measures: use in medical product development to support label-
29:645–651 (2010). The iterative process of patient reported outcome ling claims. Silver Spring FDA
and endpoints in clinical trials. Accurate assessment of • It is appropriate for the condition or populations being
patient’s symptoms and perspective of their own symptoms investigated.
becomes paramount, and as such the means by which this is
measured must itself be precise. The five specific steps that are required for developing a
PRO are shown in Fig. 17.1.
Establish
Cultural and language conceptual framework
adaptations • Intended population
• Cultural adaptation • Intended application
• Linguistic validation • Concepts and domains measured
• Psychometric validation • How concepts relate to other endpoints
Modify instrument
• Concepts measured Develop instrument
• Population studied • Item generation
• Instrumentation • Choice of response option
• Application • Recall period
• Administration • Item reduction
Assess
measurement properties • Scoring
• Relationship among concepts, items, domains,
• Reliability
• Instructions and format
• Validity
• Respondent and administrative burden
• Ability to detect change
• Minimum important differences
Fig. 17.2 PRO development process. Developing guidance issues: the patient-reported outcome development process. Source: Food and Drug
Administration. Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. (FDA.
Federal Register 2009;74:65132–3)
Interviews can be exploratory (conducted to provide Internal consistency reliability helps measure cor-
insight into patient experience before instrument selec- relation of internal items within the same domain.
tion), developmental (explicitly capture patient Typically, a Cronbach’s alpha higher than 0.70 reflects
description of the proposed condition rather than using good internal consistency.
clinical terminology, i.e. when assessing symptom • Validity: the ability of an instrument to measure what was
bother) or confirmatory (assessing whether an existing intended [11, 13, 14]. Four aspects of validity process
instrument is appropriate for a specific purpose and need to be fulfilled to achieve full validation of a PRO:
patient population) [9]. The results may lead to modifi- –– Content validity: the instrument reflects the range
cation of wording, response options or recall period in of concept intended to measure. Construct-related
order to improve the format of the instrument and facil- validity refers to evidence that an instrument
itating administration. Saturation is defined when no behaves in a way that is consistent with the theoreti-
substantial adaptations are introduced following addi- cal implications associated with the constructs
tional focus group interviews. being measured [14].
• Step III: Confirm conceptual framework and assess other –– Convergent validity: the extent to which the mea-
measurements properties sure correlates with similar instruments.
A final scoring rule confirms the conceptual frame- –– Discriminant validity: the extent to which it does
work. The draft instrument is subjected to qualitative not correlate with other instruments designed to
assessment establishing content validity (the PRO reflects assess dissimilar constructs or discriminates
the spectrum of symptoms intended to measure among between constructs that should be related.
the population which is addressed to [10]), to score reli- –– Criterion validity: correlation between the proposed
ability and ability to detect change. After content validity construct and the gold standard, if available. When this
has been established, psychometric evaluation should is possible, the desirable correlation should range
confirm that the adapted instrument performs according between 0.40 and 0.70. Any results close to 1.0 would
to its reliability, validity and responsiveness: suggest redundancy of the proposed construct.
• Reliability, the ability of a measure to produce simi- • Responsiveness should reflect whether the construct can
lar results when assessments are repeated [11, 12], is detect change in a patient’s response to treatment or
critical to establish any changes related to treatment change of circumstances, making sure the measure is
or intervention. This is achieved by the patient com- equally sensitive to gains and losses in the concept [15].
pleting the PRO more than once—7–14 days apart— It is also important not to assume that the responsiveness
in the absence of change in symptoms (test-retest of a PRO will apply to a different patient sample or sub-
reliability). Good reproducibility is demonstrated group, so the clinician should not assume that that
with a Spearman’s correlation coefficient of at least responsiveness can be equally applied following medi-
0.70. cal and surgical treatment of the condition (Fig. 17.2).
252 E. Cortes and L. Cardozo
17.3 Linguistic and Cultural Validation vidual indicators, they may pose a statistical challenge if the
instrument selection is not as precise as required.
Most of the original work on PRO was and still is conducted
in the English language. However when using these tools
worldwide, one cannot assume that the psychometric proper- 17.4 Types of PROs
ties are automatically transferable [16, 17], hence the need
to also establish a systematic and robust process of adapta- PRO is any reported symptom coming directly from
tion to the different cultures and languages. For this purpose patients, without interference from clinicians, about how
the ICIQ regulates this process, and for a PRO to be recom- their symptoms are perceived by the patient and their
mended by the ICIQ, the translated version must have under- impact in their daily lives in relation to a disease or follow-
gone the following process: ing treatment [18].
Knowingly, urogynaecological symptoms as perceived by
• Two forward translations into the new language. the patient do not always provide a definitive diagnosis [15,
• A backward translation as quality control process. 16]. The use of PRO in urogynaecological health helps pro-
Irregularities exposed at this stage may suggest the need vide a framework to agree treatments and goals as well as
to redevelop the PRO as opposed to simply translate it. inform decisions about treatment options and assess treat-
• Adjudication of all translated versions. ment outcomes.
• Expert panel discussion to ensure clarity. PROs are generally divided into two groups: generic and
• Testing the suggested instrument in bilingual participants. condition specific.
As with all other constructs generated, a translated PRO • Generic questionnaires are multidimensional tools that
will also need to be psychometrically validated within the cover physical, social and emotional aspects of life and
target language for reliability, validity and responsiveness. can be used as population survey tools. One drawback of
Health-related quality of life (HRQL) PROs are multi- generic questionnaires is that they often lack sufficient
item questionnaires that usually collect information on vari- sensitivity to measure clinically relevant change in
ous aspects or “domains” relating to patient’s life or patients with LUTS.
condition. These domains may refer to different aspects of • Condition-specific HRQL questionnaires focus on the
our lives such as sleep, energy, emotions, social and work impact of specific conditions including items (groups in
life, sexuality, etc. but vary to some extent between the dif- domains) particular to both the condition and the popula-
ferent questionnaires. tions assessed. The type of PRO used in either a clinical
General principles that should guide selection of health or research setting will depend on the goals of the inter-
outcome measure (HOM) in order to optimise use of these vention and the specific research question to be addressed.
tools are as follows:
When using a PRO, it is important to differentiate between
• Psychometric robustness. The tool used measures the con- the concept being measured, the instrument chosen to assess the
cepts it claims to measure (validity) that the measure pro- condition and the “endpoint” or outcome of a clinical trial [8].
cess is consistent (reliability) and is able to depict change in Several patient outcome categories such as bother, frequency of
health status when change has indeed happened. symptoms, impact on activities of daily living (ADL), discom-
• Appropriateness. Is the selected tool applicable to the par- fort, productivity, quality adjusted life years (QALYs) and costs
ticular problem and the adequate population? which can often overlap. Health-related quality of life (HRQL)
• Acceptability. Any HOM selected should be pilot tested defined as “those attributes valued by patients including their
as lengthy or inappropriate questionnaires compromis- resultant comfort or sense of well-being; the extent to which
ing its completion would jeopardise the integrity of any they are able to maintain reasonable physical, emotional, and
study. intellectual function which allows them to contribute positively
• Feasibility. Ease of administration (face-to-face, tele- to their families, workplace and in the community” has become
phone interview). a more inclusive conceptual outcome measure which encom-
• Precision. Does a yes/no response suffice to gather the passes most of the concepts described [19, 20].
item required?
Further to the above, one must consider the use of single 17.4.1 Symptom Frequency and Bother
versus composite measures. Whereas a single measure may
facilitate an easier and more efficient administration, it may Symptoms are defined by the ICS [21] as the “subjective
however capture the multiple layers of a specific field exhib- indicator of a disease or change in condition as perceived by
iting limitations on variability scores. In contrast composite the patient, caregiver or partner and may lead him/her to seek
measures while providing a more holistic reflection of indi- help from care professionals”. An example of questionnaire
17 Urinary Incontinence and Voiding Dysfunction: Patient-Reported Outcome Assessment 253
focusing on the area of specific bothersomeness of symptom there will be inevitable areas of overlap among the different
is Bristol female Lower Urinary Tract Symptoms (BFLUTS) tools available. When choosing a questionnaire either for
and its short form (SF) [22]. clinical practice or for research, care must be exercised to
choose from the most fitting options making sure that the
questionnaire content is understood and it is suited for the
17.4.2 Discomfort and ADL chosen measure, avoiding questionnaire overload. If avail-
able, the clinician should always try to use a Grade A or
Discomfort is usually adapted from generic tools to specific Grade A∗ questionnaire (where validity, reliability and
urogynaecology conditions, whereas pain is infrequently responsiveness have been established with rigor in several or
assessed separately in urogynaecology as they are frequently at least one data set).
incorporated in into condition-specific HRQL measures. As a general rule, when choosing a questionnaire, the cli-
nician should know:
17.4.5 QALY
17.4.7 Health-Related Quality of Life (HRQL)
Quality-adjusted life years (QALY) is a universal outcome PRO
measure that combines gains and losses in both mortality and
morbidity, enabling cost-effectiveness across diseases and HRQL PROs are multi-item questionnaires that often col-
programs, in order to allocate limited healthcare resources. lect data relating to patient’s life (domains) such as social
This economic evaluation allows to compare interventions in and work life, energy and sleep, emotional and sexual
terms of costs and benefits, and its use is widely spread and problems, etc. Due to the multidomain nature of HRQL
recommended in current health economic models. In line questionnaires, they tend to be longer instruments and are
with this, algorithms have been developed to convert PROs more limited when exploring in detail a specific problem.
like the KHQ into QALYs [25]. A useful tool for consideration when assessing HRQL in
any research or clinical setting is the availability of the
minimal important difference (MID), as the value regarded
17.4.6 Types for Urinary Problems as a clinically meaningful difference to the participant.
MID values have been calculated for the King’s Health
There are multiple PRO questionnaires available for the Questionnaire (KHQ); Protection, Amount, Frequency,
assessment of pelvic floor disorders, and to a certain extent, Adjustment, Body Image Questionnaire (PRAFAB); and
254 E. Cortes and L. Cardozo
Overactive bladder questionnaire (OAB-q) [26, 27] There are currently two grade A evidence questionnaires
(Table 17.1). to assess symptom bother: the patient perception of bladder
condition (PPBC) [34] and the Urogenital Distress Inventory
(UDI-6) [35], Table 2. When assessing urgency, defined as
17.4.8 PROs for LUTS in Women: Symptom “the sudden compelling desire to pass urine which is difficult
Bother and Urgency to defer” [21], several tools have been developed with only
the Indevus Urgency Severity Scale (IUSS) [35] having a
These are short and relatively easy questionnaires which grade A evidence score available for both men and women
assess the impact of symptoms on patients and not merely and the patient perception of intensity of urgency scale
their presence only. They are frequently used in clinical tri- (PPIUS) [37]. The IUSS is a 4-point qualitative scale, devel-
als, and patients regard them as extremely helpful to repli- oped to reflect urgency severity at urination in a 7-day mictu-
cate the severity of their symptom bother. rition diary. It is structured in four distinct subjective degrees
of urgency linked to the level of impairment in relation to the
ability to complete activities. The PPIUS is a 5-point scale
Table 17.1 The most relevant HRQL PRO (Grade A) used in clinical questionnaire designed to rate the level of urinary urgency for
settings and research for the assessment of women with lower urinary each void during completion of a micturition diary. It has
tract dysfunction shown excellent content validity and test-retest reliability
Impact on Treatment Other [41]. Other grade B and C questionnaires available for men
PRO Q Symptoms HRQL outcome languages and women are shown on Table 17.2.
BFLUTS LUTS ✓ ✓ ✓
[22]
ICIQ-UI SF UI ✓ ✓ ✓
[28] 17.4.9 Screening Questionnaires
IIQ [29] UI/SUI ✓ ✓
KHQ [30] UI/SUI ✓ ✓ ✓
Completed patient screeners help urogynaecologists in the
OAB-q [31] OAB ✓ ✓ ✓
OAB-q SF OAB ✓ ✓ ✓ diagnosis and treatment of LUTs. Development of screeners
[31] must follow the same scientifically robust process as
PRAFAB UI ✓ ✓ ✓ described above from conceptual design, psychometric and
[32] linguistic validation. Screeners also have additional criteria
UISS [33] UI ✓ ✓ ✓ such as sensitivity and specificity they must fulfil to be con-
LUTS lower urinary tract symptoms, UI urinary incontinence, SUI sidered sound measures.
stress urinary incontinence, OAB overactive bladder
BFLUTS Bristol Female Lower Urinary Tract Symptoms questionnaire,
Types of LUTS screeners
ICIQ-UI SF International Consultation on Incontinence Modular
Questionnaire—Short Form, IIQ Incontinence Impact questionnaire, 1. LUTS screeners: these groups of questionnaires improve
KHQ King’s Health Questionnaire (ICIQ-LUTSqol), OAB-q Overactive detection of urinary symptoms including urinary inconti-
bladder questionnaire (ICIQ-OABqol), PRAFAB Protection, Amount,
Frequency, Adjustment, Body Image, UISS Urinary incontinence sever-
nence, OAB and other LUTS. The International
ity score Consultation on Incontinence has evaluated several LUTS
screeners that are available on their website www.iciq.net on symptoms and quality of life assessment tools in urinary
[42]. One of the limitations of many screeners is the chal- incontinence and make grades of recommendation according
lenge to reflect the mixed nature of urinary incontinence to their degree of validation in the published literature.
in most patients, therefore failing to detect more than one Inclusion criteria were determined by the highest scrutiny on
symptom complex. With that premise as a starting point, the level of validation, i.e. the robustness of their psychomet-
the Bladder Control Self-Assessment Questionnaire ric standards of validity, reliability and sensitivity to change.
(B-SAQ) was developed by a European panel of experts Ultimately, the aim of this complex and laborious exer-
encompassing both OAB and stress urinary symptoms cise was to provide the wider clinical and research commu-
with bothersome scales [43]. nity with high-quality questionnaires and disseminate a
2. OAB awareness tool/OAB-V8 is an adaptation from the standardised assessment of pelvic floor dysfunction.
OAB-questionnaire (OAB-q) consisting of 33 items The result of this joint effort delivered 14 ICIQ modules
assessing HRQL and bothersomeness in relation to OAB with further modules in development. To facilitate clinicians
[31]. OAB-V8 is an 8-item screening questionnaire grad- and researchers tailoring questionnaires to achieve a com-
ing answers on a Likert scale. Patients scoring 8 and plete evaluation, the ICIQ divided these modules into three
above are advised to seek medical expertise. categories:
3. Interstitial cystitis index (ICSI)/pelvic pain and urgency/
frequency (PUF): The ICSI has been validated as painful (a) Core modules: provide evaluation of core problems for
bladder syndrome tool showing good test-retest reliabil- urinary, vagina and bowel symptoms and urinary
ity, internal consistency, construct validity and sensitive incontinence
to change [44]. It is a 4-item questionnaire measuring the (b) Specific patient groups: provide evaluation of specific
severity of day-night frequency, urgency and bladder symptom complexes such as nocturia, OAB, neurogenic
pain. However, the ICSI lacks specificity as a diagnostic bladder, long-term catheter users
tool and the reliability of a 1-month recall period has not (c) Add-on modules on QoL: recommended in addition to
yet been tested. one of the above
The PUF [45] questionnaire is an eight-question
screening tool for IC/PBS which shows good sensitivity In order to include all relevant clinical aspects of the indi-
but also limited specificity. When correlated with clinical vidual with pelvic floor dysfunction/LUTS and be aware that
findings on hydrodistention cystoscopy (under GA), it symptom relief does not always correlate with QoL improve-
failed to predict positive findings. Reproducibility and ment post treatment [48, 49], the ICIQ recommends the use
lack of patient input in their design have further question of a core- or symptom-specific module and an add-on quality
its validity as a symptom-based diagnostic tool. of life measure which can include a questionnaire on sexual
4. MESA (Medical, Epidemiological and Social aspects of matters, intimately related to outcomes following pelvic floor
Aging questionnaire) [46] was designed to test urinary dysfunction treatments and a post-treatment evaluation.
incontinence and urinary symptoms in non- Recommended modules by the ICIQ:
institutionalised elderly women; the MESA is a 15-item
screening questionnaire divided into two subscales scor- • Core modules for women LUTS: ICIQ-FLUTS
ing for stress and urgency urinary incontinence as well as • Specific patient groups for OAB, ICIQ-OAB, and noctu-
other urinary symptoms. Based on the MESA, the ria, ICIQ-N
Continent Index (CI) was further developed as a screen- • Add-on QoL and sexual matters: ICIQ-LUTSqol and
ing questionnaire in the elderly to identify older women ICIQ-FLUTsex
most at risk of UI in order to apply targeted prevention
strategies in those women most likely to benefit [47]. The use of the ICIQ modules is a currently widespread
practice in clinical and research practice. As a result users are
reassured that outcomes follow high-quality and robust psy-
chometric validation data sensitive to change, aiding clini-
17.5 International Consultation cians and researchers in comparing the impact of treatments
on Incontinence Modular and their outcomes in a more holistic way.
Questionnaire (ICIQ)
In the first ICI (1998), worldwide experts were set up in sub- 17.6 Voiding Dysfunction
committees to provide evidence-based recommendations
regarding all areas of incontinence care and research. Female voiding dysfunction (VD) is a complex urinary
One of those sub-committees was convened to review of condition, poorly understood, and challenging to manage.
the relevant literature regarding the questionnaires available The International Urogynaecological Association and the
256 E. Cortes and L. Cardozo
International Continence Society define female voiding dys- urinary and bowel dysfunction, therefore overlooking spe-
function (VD) as “abnormally slow and/or incomplete mic- cific PRO and satisfaction with urinary and bowel manage-
turition (voiding) based on symptoms and urodynamic ment strategies. Other less frequently used but more specific
investigations”. Voiding dysfunction can be due to neuro- tools for neurogenic patients included were the Neurogenic
genic nerve dysfunction, non-relaxing pelvic floor muscles Bladder Symptom Score (NBSS) [56], Qualiveen
or both. Voiding dysfunction is also classified as being Questionnaire [57] and the Incontinence Impact
caused by either underactivity of the bladder (detrusor) or Questionnaire SF. However, one of the main limitations of
outflow obstruction (urethra). Evaluation by a clinician may these questionnaires is not having been validated in larger,
include tests, such as uroflowmetry, post-void residual and heterogeneous populations, and the correlation of results
pressure flow studies. Treatment is individualised, depend- with existing overall and disease-specific QoL question-
ing on specific aetiology [50]. naires is unclear.
The use of PRO specifically designed to assess VD is Urinary-specific QoL tools, such as the I-QOL, KHQ,
scarce, and in the absence of a neurogenic cause, most stud- IIQ7, and ICIQ-OAB, have also been used frequently in the
ies to date have relied on the tools generally available and assessment of urinary dysfunction in patients with neuro-
previously described. Numerous studies have explored the logical conditions. These tools have a high validity and reli-
effect of bladder/bowel dysfunction and specific bladder/ ability for neurologically intact patients affected by
bowel interventions on QoL in the neurologically intact pop- overactive bladder or stress urinary incontinence but may not
ulation. Although several tools have been designed for this have adequate sensitivity and specificity to assess subtle
purpose in the non-neurogenic group, similar studies are effects on QoL following urinary interventions in those with
lacking in the neurogenic group with multiple sclerosis neurologic conditions [58–60].
(MS), spinal cord injury (SCI), Parkinson’s disease (PD), The use of instruments devoted to the assessment of
cerebral vascular accident (CVA) and spina bifida (SB). impairment and disability such as the Craig Handicap
These patients often suffer similar urinary and bowel diffi- Assessment and Reporting Technique (CHART) [61],
culties which significantly affect their QoL including recur- Satisfaction with Life Scale (SWLS) [62], SF-36 and SF-12
rent UTIs and faecal impaction, interpersonal and have on some occasions demonstrated inconsistency with
socialisation limitations, persistent incontinence episodes previous reports of best practice [51]. In a study by Akkoc
and catheterisation difficulties [51, 52]. et al. [63], when looking at QoL in patients with suprapubic
Although most of interventions in patients with VD are catheter (SCI) and bladder management, patients with inter-
addressed to improve their QoL, it is still not routine practice mittent catheterization performed by attendant (IC-A) had
the use of PRO as a primary outcome measure in the neuro- worst QoL outcomes in areas of physical limitations, emo-
genic patient, hence the small numbers of tools available. tions and social limitations using the KHQ when compared
When assessing QoL in VD in the neurogenic patient, there with those self-managing. Interestingly, they also showed
is still a variation in tools used which include both general better or similar scores in incontinence impact, physical lim-
validated questionnaires for UI and specific ones for itations and emotions when compared with indwelling cath-
VD. Selecting a QoL measure when the objective is to mea- eter users, in contrast to previous reports. In another study by
sure symptom burden would be inappropriate given that Cameron et al., using the CHART and SWLS questionnaires,
some patients may have significant symptoms, but despite they demonstrated no significant difference in physical inde-
this they still perceive their QoL to be good. This distinction pendence, mobility, occupation and social integration when
is particularly important amongst individuals with neuro- comparing IDC, CC and CIC despite an increase in hospital
genic bladder dysfunction. admissions and pressure ulcers in the IDC group. PRO has
In a systematic review conducted by Patel et al. [53], also been used to measure the impact in QoL of different
looking at tools used in patients with VD neurogenic blad- interventions in neurogenic patients with VD including con-
der and bowel problems, out of a total of 51 articles, differ- servative measures [64], neuromodulation [65], intravesical
ent questionnaires were used for different purposes. The botulinum toxin A [66] and reconstructive surgery [67].
most common tools used for urinary dysfunction were the Although three urinary- or bowel-specific questionnaires
Medical Outcomes Study Short Form 36-Item and 12-Item exist for SCI and MS patients (Qualiveen, FICQoL and
Health Survey or SF-36 and SF-12 [54, 55]. These ques- QoL-BM), these tools have not been validated in larger, rep-
tionnaires assess general, physical, and emotional health as resentative populations. Most previous studies have relied on
well as limitations on activities of daily living and sociali- non-validated QoL tools or tools originally validated for
sation. They do not include any specific domains regarding another disease entity to assess QoL and PRO.
17 Urinary Incontinence and Voiding Dysfunction: Patient-Reported Outcome Assessment 257
Table 17.3 International consultation on Incontinence Modular Questionnaire (ICIQ) modular structure
Recommended add on modules
Recommended Generic
Condition modules Optional modules QoL QoL Sexual matters Post-treatment
(A) Core modules
Urinary symptoms Males: Males: ICIC- ICIQ-LUTSqol SF-12 Males: ICIQ-
ICIQ-MLUTS MLUTS LF ICIQ-MLUTSsex satisfactiona
Females: Females: ICIQ- Females:
ICIQ-FLUTS FLUTS LF ICIQ-FLUTSsex
Vaginal symptoms and ICIQ-VS ICIQ-VSqola SF-12
sexual matters
Bowel symptoms ICIQ-B ICIQ-Bsqola SF-12
Urinary incontinence (UI) ICIQ-UI short form ICIQ-UI LP ICIQ-LUTSqol SF-12 Males:
ICIQ-MLUTSsex
Females:
ICIQ-FLUTSsex
(B) Specific patient groups
Nocturia ICIQ-N ICIQ-Nqol SF-12 Males:
ICIQ-MLUTSsex
Females:
ICIQ-FLUTSsex
Overactive bladder (OAB) ICIQ-OAB ICIQ-OABqol SF-12 Males:
ICIQ-MLUTSsex
Females:
ICIQ-FLUTSsex
Neurogenic ICIQ-spinal cord SF-12
diseasea
Long-term catheter users ICIQ-LICa
Children ICIQ-CLUTS∗ ICIQ-
CLUTSqola
Textbook of female urology and urogynaecology. Editors Linda Cardozo—David Staskin. Chapter 17 (Table 17.1) (page 139). CLUTS children
lower urinary tract symptoms, FLUTS female lower urinary tract symptoms, MLUTS male lower urinary tract symptoms, QoL quality of life
a
In development
Other PROMs (Table 17.3) are not specifically designed • Multiple Sclerosis Impact Scale 29-item (MSIS-29): a
to assess bladder related QOL or neurogenic bladder symp- 39-item scale examining the physical and psychologi-
toms. However, they contain a bladder domain or have been cal impact of MS acceptable for patient-level assess-
used unvalidated [68]: ment [73].
• Functional Assessment of Multiple Sclerosis (FAMS): a
• Spinal Cord Injury Secondary Conditions Scale (SCI- 59-item scale which broadly examines personal and social
SCS): a 16-item QOL scale examining secondary condi- QOL domains for individuals with MS [74].
tions associated with SCI [69]. • Hamburg Quality of Life Questionnaire in MS
• Spinal Cord Injury Quality of Life (SCI-QOL): a multidi- (HAQUAMS): a 38-item questionnaire for QOL assess-
mensional, computer adaptive PROM with a total of 19 ment across individuals with varying level of disease
item banks, which include a 15-question item bank related severity associated with MS [75].
to bladder management difficulties [70]. • Multiple Sclerosis Quality of Life Inventory (MSQLI): an
• Spinal Cord Injury Functional Index (SCI-FI): a scale inventory containing ten scales including a bladder con-
containing 90 items on self-care which provides a com- trol scale for comprehensive assessment of many domains
prehensive assessment of functional abilities of individu- of QOL affected by MS [76].
als with SCI [71]. • Quality of Life in Spina Bifida (QOLSB) scale: two
• Multiple Sclerosis Quality of Life 54-item scale indexes designed to assess QoL, one for completion by
(MSQOL-54): a 52-item scale distributed across 12 sub- parents and by the child with spina bifida. The scales con-
scales with 2 additional items assessing multiple dimen- tain 44 and 47 items [77].
sions of QoL associated with MS [72].
258 E. Cortes and L. Cardozo
17.7 Limitations of PRO order to overcome the challenges posed by the symptom
complexity within LUTS, it was advised the use of at least
The initial psychometric development of these tools is tai- one condition-specific tool that better would represent the
lored to a very specific indication and patient population, and area to be studied, a choice left to the discretion of the inves-
if applied outside the intended parameters, the data gathered tigator/clinician. This would also enable research engines to
may be invalid in particular if used in research [78]. establish a set of compartmentalised data, more analysis and
A relevant limitation stems from the difficulty with fully evidence-based friendly. With this premise established, a
understanding the patient’s and clinician’s description of new toolkit with the acronym of MOST (Minimum Outcome
symptoms. In a study by Rodriguez et al. [79], patients com- Set for Testing) was designed [81]. It was agreed that such
pleted the UDI-6 and so did their treating physician after an tool should encompass five minimum categories Fig. 17.3
interview, demonstrating that physicians underestimated the for LUT evaluation: global measure, satisfaction (patient’s
degree of bother reported by the patient at least 25–37% of perception of improvement), HRQoL, symptoms (to an
the time. There is often weak relationship between PRO and extent interlinked with the HRQoL category) and adverse
clinically objective definitions. events (currently there is no tool for this purpose). Additional
Another setback seen was the discordance between out- categories suggested included signs (objective measures like
comes reported by patients and outcomes measured by the pad test), psychosocial impact (indicative of improve-
objective clinical parameters. This lack of correlation ment when an additional burden such as depression becomes
between laboratory measures and questionnaires is due to more manageable), health economics (cost-benefit ratio of
these measurement approaches measuring different aspects any intervention) and goal setting (highly specific to each
of LUTD (emotional bother vs. volumes leaked or number of individual).
incontinence episodes). One cannot supplant the other and Due to the heterogeneity of symptoms in LUTD as well as
they must be used in conjunction. the availability of multiple psychometrically validated exist-
Taken by themselves out of clinical context, question- ing PROMs, clinicians routinely find challenging trying to
naires cannot discriminate between related conditions. Two obtain a comprehensive picture of the patient outcomes. The
individual patients with very different symptom complexes limitations seen with bladder diaries as primary endpoints
may generate similar scores in the presence of different such as an intrinsic placebo effect [81], bladder retraining
pathophysiologies; responses to medical and surgical treat- effect [82] or lack of compliance [83, 84] has led to calls for
ments will vary, hence the need for patient characterisation the development of a new multidimensional PROM that
before implementing the different treatment modalities. could replace bladder diaries as the primary endpoint.
Further work is needed to improve the ability of current PRO Supporting this initiative stands the significant positive cor-
to provide symptom discrimination for the multiple of aeti- relations seen between bladder diary endpoints and widely
ologies causing LUTD [80]. used PROM [85–87] in conjunction with the recommenda-
tions of the ICI-RS 2011. Acknowledging the limitations
faced by most of the existing PROs having been developed
17.8 Future of PRO prior to guidelines issued by different international regula-
tory bodies, namely, the European Medicines Agency and
Novel approaches are needed to better categorise different US Food and Drug Administration [88–90], Chapple et al.
LUTD complexes and identify their underlying cause, as [91] have suggested the development of a new multidimen-
well as their proportional contribution to overlapping symp- sional PROM that would incorporate:
tom profiles seen in numerous urological conditions. PROs
are invaluable for both research and clinical assessments of 1. A well-stablished PROM such as the OABSS which dem-
LUTS, but there is need to improve current questionnaires to onstrated good correlations with bladder diary
better discriminate among various pathophysiologies of 2. Evaluation of HRQoL and satisfaction that could reduce
these symptoms. the placebo effect
Due to the broad and numerous symptoms comprised 3. Extension of the recall period reducing the training effect
within LUTD, It is probably unwise, if not impossible, to try
to identify a preferred health outcome for LUTD. At the In line with this more holistic approach to PRO, a new
ICI-RS meeting in 2011, Bristol, a group of experts sug- instrument, the overactive bladder assessment tool (BAT)
gested a new concept aimed at standardising the scope of [92], has been recently developed to provide a superior tool
assessment while providing guidance to develop a minimum rather than the use of bladder diary and other PROs for OAB
outcome dataset for the treatment evaluation of LUTS. In patients in clinical practice and research trials.
17 Urinary Incontinence and Voiding Dysfunction: Patient-Reported Outcome Assessment 259
Optional categories:
Signs
Psychosocial
Health economics
Goal setting
Fig. 17.3 What are the best outcome measures when assessing treatments for lower urinary tract dysfunction (LUTD)? Achieving the MOST out
of outcome evaluation; ICI-RS 2012. With permission from [81]
260 E. Cortes and L. Cardozo
Existing PROs which have been adequately evaluated have 1. Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha
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meaningful treatment benefits. New challenges highlighted patient reported outcome measures. Federal Register
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by the Food and Drug Administration have pushed the indus-
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Urodynamics Techniques
and Clinical Applications 18
Michel Wyndaele and Paul Abrams
M. Wyndaele (*)
Division of Urology, UMC Utrecht, Utrecht, The Netherlands
18.2 Urodynamic Techniques
P. Abrams
Bristol Urological Institute, Southmead Hospital, Bristol, UK
UDS are performed prior to (planning) second- or third-line
e-mail: paul_abrams@bui.ac.uk treatment when noninvasive empiric or conservative treat-
ments have failed to improve a patient’s LUTS. The goal of
the urodynamic evaluation is to reproduce the patient’s 18.2.1 Free Uroflowmetry and Measurement
symptoms and to identify the underlying pathophysiological of Post-void Residual Volume
mechanisms. The general role of UDS in clinical practice is
presented in Table 18.1 [8]. Free uroflowmetry is a first-line noninvasive screening test
The information from the first-line diagnostic evaluation for patients with LUTS that measures the flow rate of the
(i.e. medical history, physical examination, questionnaire, external urinary stream (the micturition volume emitted per
bladder diary, urine analysis and measurement of PVR) is unit of time) and is expressed in mL/s [5]. It is a relatively
crucial in deciding which questions need answering during cheap test and can easily be repeated.
the test, in designing the evaluation to obtain these answers The parameters evaluated in uroflowmetry are presented
and in interpreting the urodynamic test results [9]. To assist in Table 18.3 and these should only be interpreted by account-
in designing the urodynamic evaluation, LUT (dys)func- ing for possible test artefacts (e.g. unsuitable environment,
tion can be classified according to the affected LUT func- psychological factors, etc.). A schematic representation of
tion (storage or voiding) and the anatomical components uroflowmetry is presented in Fig. 18.1.
(bladder or outlet) of the LUT (Table 18.2 [10]). Each of In healthy adult women, Qmax should be above 18 mL/s
the urodynamic techniques studies at least one of these fac- under the age of 45, above 15 mL/s between 46 and 65 years
tors. However, urodynamic evaluation of a patient usually of age and above 10 mL/s above 65 [11]. The flow curve pat-
consists of a series of tests over the course of one appoint- tern should be bell-shaped, but the interpretation thereof is
ment, as one of the roles of UDS is to obtain information on
other, asymptomatic aspects of LUT function or dysfunc-
Table 18.3 Parameters of uroflowmetry
tion (Table 18.1 [8]). As an example, in a patient with a
Parameter Unit Definition
storage dysfunction such as urinary incontinence (UI),
VV Voided volume mL Total amount of urine voided
voiding function should also be evaluated in the UDS to
Qmax Maximum flow mL/s Highest flow rate for a given curve
allow prediction of possible postoperative voiding rate
difficulties. TQ Flow time s Time of urine flow
TQmax Time to s Time until the maximum flow rate
Table 18.1 General role for urodynamics in clinical practice [8] maximum flow is achieved
PVR Post void mL Remaining intravesical urine
1. To identify all factors contributing to LUTD and/or the origin of residual volume after completion of
the symptoms and assess their relative importance voiding
2. To obtain information on all other (symptomatic and non-
symptomatic) factors of LUT function: bladder and outlet
function both during bladder filling and during voiding (see
mL
Table 18.2)
3. To predict the possible consequences of LUTD on the UUT: V
identifying the “unsafe” bladder o
4. To allow prediction of the outcome (including undesirable side l
effects) of a treatment for LUTD u
m Qmax (Maximum flow rate – mL/s)
5. To confirm the effects of, or the mode of action of a (new or
experimental) treatment for LUTD e
6. To understand the reason of failure of previous treatments of
LUTD
LUT lower urinary tract, LUTD lower urinary tract dysfunction, UUT
upper urinary tract
p
r 20 Pves
e
s
s
u
r
e 20 Pabd
s
cmH2O
Cystometric capacity
Cough tests
s
Time
in pressure because of its viscoelastic properties and PFS are performed as a continuation of the filling cystom-
because of the beta 3 adrenoreceptors which induce relax- etry and start from the moment the “permission to void” has
ation of the detrusor muscle. “Normal” values or cut-offs been given, once the maximum cystometric capacity has been
for compliance have been difficult to identify, but less than reached. A schematic representation of a normal pressure-flow
40 mL/cmH2O rise in detrusor pressure can be regarded as study (and filling cystometry) trace is provided in Fig. 18.4.
normal and prohibits secondary pressure transfer from the Normal voiding is characterised by a voluntarily initiated
bladder to the kidneys, thereby providing protection from sustained urethral relaxation and a maximal detrusor con-
upper tract damage and renal impairment. traction (without abdominal contraction) and, resulting in a
• Continence: normal bladder filling is characterised by continuous flow and complete emptying of the bladder
the absence of urine flow. If urinary incontinence within a normal time span and in the absence of obstruction
occurs, it should be related to bladder sensation [e.g. [17]. However, it is important to note that many women void
urgency UI (UUI) secondary to DO] or to stress tests successfully by urethral relaxation alone, without much of a
which increase abdominal pressure [urodynamic stress rise in pdet [18], because their outlet resistance is low.
UI (SUI) due to cough or Valsalva], or to both [mixed PFS also allow evaluation of the bladder outlet, as pdet
UI (MUI)] during voiding is a function of outlet resistance: the greater
the outlet resistance during voiding, the higher pdet will be
in a patient with normal detrusor contractility, still allowing
complete bladder emptying in a healthy bladder with BOO
18.2.3 Evaluation of Voiding Function: [19]. Therefore, the urinary flow rate is a product of detrusor
Pressure-Flow Studies or Voiding contractility, and abdominal pressure, working “against”
Cystometry bladder neck and urethral resistance.
Maximum
detrusor
Pdet pressure
Maximum
Q flow rate
t Qmax Time
Opening tQ
time
Table 18.4 Video-urodynamic findings in relation to anatomical site Video-UDS are the gold standard for the evaluation of
Anatomical site Video-urodynamic finding neurogenic LUT dysfunction [6, 7]. Figure 18.5 illustrates
Ureters and renal Vesico-ureteral reflux + grade (in relation to the finding of detrusor-sphincter dyssynergia (often found in
pelvis bladder function) patients with multiple sclerosis) on a video-urodynamic
Bladder Trabeculation trace. In non-neurogenic women, video-UDS are helpful to
Diverticula
distinguish dysfunctional voiding (functional BOO) from
Christmas tree appearance
Post-void residual (+ quantification)
anatomical BOO (see Sect. 18.3.4) [6, 20]. Furthermore,
Vesico-vaginal fistula some anatomical abnormalities may influence the interpreta-
Filling defect (e.g. prostate median lobe, bladder tion of the urodynamic evaluation. Identification of vesico-
tumour, bladder stone) ureteric reflux (VUR), or of bladder diverticula, for example,
Bladder base Cystocoele + grade (at rest, during stress testing has to be taken into account when interpreting bladder com-
and during voiding)
pliance as they can accommodate a pop-off for the bladder
Bladder neck Filling: Bladder neck incompetence (during
stress testing) pressure, leading to overestimation of bladder compliance,
Filling: Bladder neck opening during detrusor when bladder compliance appears more normal than it is, as
overactivity contractions bladder pressure is reduced (pressure-sink effect). The indi-
Voiding: Bladder neck dysfunction or cations for video-UDS are displayed in Table 18.5 [21].
dyssynergia
Voiding: Bladder neck fibrosis
Urethra Urinary incontinence
Urethral stricture 18.2.5 Ambulatory Urodynamics
Urethral diverticula
Urethro-vaginal fistula Ambulatory UDS are defined as any functional test of the
(Neurogenic) detrusor—(external urethral) LUT predominantly utilising natural filling of the LUT and
sphincter dyssynergia reproducing the subject’s normal activity (including activity
Dysfunctional voiding due to pelvic floor
overactivity
by which the symptoms are provoked) [22]. “Ambulatory”
refers to the patient being freely mobile, and the test being
conducted outside the UDS suite.
(LUT) function and anatomy in complicated patients with The lack of data on the reproducibility of ambulatory
bladder and/or urethral dysfunction with a high chance of a UDS, and the dependence on the investigator for the post-
coexisting anatomical abnormality. Table 18.4 lists the possi- test analysis are big limitations [8]. Further standardisation is
ble video-urodynamic findings in relation to anatomical site. needed to improve applicability.
268 M. Wyndaele and P. Abrams
Fig. 18.5 Video-urodynamic trace displaying detrusor-external nal pressure (pabd), red; electromyography (EMG), white; voided
sphincter dyssynergia—type 3. Bladder volume (Vinfus), green; detru- volume (Vura), blue; urethra flow rate (Qura), yellow
sor pressure (pdet), violet; vesical pressure (pves), light blue; abdomi-
Distance
In women the UPP is usually a bell-shaped curve, which tract infection (UTI) or other obvious pathology (e.g. bladder
begins to rise from the bladder neck and reaches the maxi- tumour, distal ureteral or bladder stones, or a foreign body)
mum pressure at the mid-urethral point, due to the activity of [17]. It is classified as a bladder storage dysfunction
the intraurethral striated musculature. The pressure then (Table 18.2, [10]).
decreases and has negative values at the level of the external
meatus. The functional profile length indicates the urethral 18.3.1.1 F ree Uroflowmetry and Measurement
length across which a positive pressure (above bladder pres- of Post-void Residual Volume
sure) is measured and is thereby indicative of the urethral The first test to be performed in women with OAB-S, is free
area assisting in preserving continence. uroflowmetry and measurement of PVR. Uroflowmetry can
indicate a voiding dysfunction, which may be worsened by
treatment with antimuscarinics [3, 6]. Furthermore, incom-
18.3 Clinical Applications plete bladder emptying, identified by measuring PVR, can
lead to quicker refilling of the bladder to full capacity, and
The goal of UDS is to reproduce the patient’s symptoms and can hence induce an increase in micturition frequency and
to identify the underlying pathophysiological mechanisms. nocturia. Suspicion for an increased PVR in women with
Once the patient’s LUTS have been classified (Table 18.2, OAB-S should arise when they are/have [25]:
[10]), the questions which need answering can be identified,
and the test can be designed to allow the urodynamic ques- • aged above 55 years
tions to be answered and interpreted. • had prior incontinence surgery
• a history of multiple sclerosis
• a vaginal prolapse stage 2
18.3.1 Overactive Bladder
Detrusor Overactivity ing cystometry does not rule out its existence. Induction of
DO is the objective urodynamic observation of an involun- DO can be attempted by using provocative measures such as
tary detrusor contraction during bladder filling, which may coughing, moving to a more vertical position or running a
be spontaneous or provoked and which may be phasic (dur- tap [24]. It is therefore very important to correlate a patient’s
ing filling) or terminal (near cystometric capacity, which symptoms with the objective urodynamic observations in
often leads to involuntary initiation of micturition) [1]. It OAB-S [26].
needs to be clearly distinguished from urgency, which is the
key symptom of OAB and which is defined as a sensation Reduced Bladder Compliance
(and therefore subjective) [1]. DO can be classified into neu- Reduced bladder compliance is diagnosed when pressure
rogenic DO, if a clear underlying neurologic disease is pres- rises significantly (true cut-offs have been difficult to define)
ent, or idiopathic DO if no clear underlying cause can be with increasing volume in the absence of a detrusor contrac-
identified [1]. Finally, DO can directly lead to UI during uro- tion [1], as illustrated in Fig. 18.8. When a reduction in blad-
dynamics, which is referred to as DO incontinence [1]. der compliance is observed during UDS, filling should be
Figure 18.7 illustrates the presence of detrusor overactivity stopped for at least 2 min, as a too high filling rate may
on a urodynamic trace. induce a bladder pressure rise. If the pressure declines again,
The correlation between OAB-S (a sensation, subjective) filling can be restarted at a much lower rate.
and the presence of DO (an observation, objective) is mod- Reduced bladder compliance is usually caused by struc-
est in women [26, 27]. Furthermore, DO can also be test- tural bladder changes and can therefore be found in neuro-
induced, and can be found in healthy asymptomatic genic bladders (spina bifida, spinal cord injury), when detrusor
volunteers who are unaware of its presence, or describe it as hypertrophy occurs as a result of increased outlet resistance
a normal desire to void [6, 15]. On the other hand, an (detrusor-sphincter dyssynergia), or after bladder wall scar-
increased sensation of bladder filling may be the sole under- ring due to tuberculosis or pelvic radiotherapy. It always
lying cause of OAB, although the absence of DO during fill- warrants intervention (e.g. bladder relaxants, botulinum
Fig. 18.8 Urodynamic trace displaying reduced bladder compliance. Abdominal pressure (pabd), dark green; vesical pressure (pves), blue; detru-
sor pressure (pdet), light green; flow rate (Flow), red; voided volume, black; electromyography (EMG), pink
toxin injections in the detrusor, or augmentation cysto- increase in urethral pressure [due to urethral hypermobility
plasty) due to its possible negative long-term effects on or intrinsic sphincter deficiency (ISD)], leading to leakage
renal function. of urine.
The indications for video-UDS when reduced bladder Two recent well-designed randomized controlled trials
compliance is suspected have been discussed in Sect. 18.2.4. [29, 30] showed that UDS do not affect treatment outcome in
An important observation in patients with reduced blad- women with “uncomplicated SUI”. However, the majority of
der compliance is the detrusor leak point pressure (DLPP) women present with non-typical or complicated SUI, which
which is defined as the lowest pdet at which urine leakage is SUI with concomitant OAB symptoms with or without
occurs in the absence of either a detrusor contraction or UUI, concomitant bladder emptying problems, prior SUI
increased pabd [1]. It is an indication of outlet resistance and surgery, an uncertain clinical diagnosis or failure to demon-
a measure of the urethral pop-off mechanism in patients with strate SUI on physical examination, a history of pelvic radia-
reduced bladder compliance. An absolute cut-off of less than tion, neurologic disease, or very severe symptoms [31]. It is
40 cmH2O DLPP is considered safe. A DLPP of greater than recommended that urodynamic evaluation is performed prior
40 cmH2O with or without VUR often leads to hydronephro- to proceeding to invasive, potentially morbid or irreversible
sis and subsequent upper tract deterioration and possibly treatments in these patients [8, 32].
renal impairment [28].
18.3.2.1 F ree Uroflowmetry and Measurement
of Post-void Residual Volume
18.3.2 Stress Urinary Incontinence The first test to be performed in women with SUI is free
uroflowmetry and measurement of PVR. Uroflowmetry can
SUI, is classified as a urethral storage dysfunction indicate a voiding dysfunction, which should prompt addi-
(Table 18.2, [10]), and is defined as the complaint of invol- tional urodynamic testing as this may worsen after invasive
untary leakage on effort or exertion, or on sneezing or treatment for SUI [3, 6]. Furthermore, concomitant pelvic
coughing [1]. It occurs when a sudden rise in intra-abdom- organ prolapse (POP) may lead to an increased PVR in
inal pressure is not followed by a sufficiently strong women with SUI [33].
272 M. Wyndaele and P. Abrams
18.3.2.2 Assessment of Urethral Function ability of the urethral sphincter to resist a rise in pabd during
Several tests (UPP and measurement of abdominal leak point filling cystometry. As urine leakage is required to measure
pressure or ALPP) have been proposed to identify ALPP, it can only be measured in patients with SUI, and
ISD. Urethral hypermobility on the other hand is a clinical hence there are no normal cut-off values. If leakage cannot
diagnosis (physical examination) and should always be be provoked in a patient with SUI symptoms, the urethral
assessed. Urethral hypermobility and ISD can coexist, but catheter(s) should be removed, to unmask the SUI [6], and
when no urethral hypermobility is found in a patient with hence allow ALPP assessment [35]. The rise in pabd can be
SUI, then it must be caused by ISD, regardless of urody- induced by a cough (CLPP) or Valsalva (VLPP—Fig. 18.9):
namic testing. in general, it is easier to define the ALPP during Valsalva.
ALPP < 60 cmH2O indicates ISD and ALPP > 90 cmH2O
Urethral Pressure Profilometry indicates little or no ISD, while values in between are con-
In women with SUI and no urethral hypermobility, a MUCP sidered equivocal for ISD [36]. However, the association
of 20 cmH2O or less has been used as a definition of ISD between ALPP, the patient’s perception of bother, and the
[34]. However, UPP does not diagnose SUI, it cannot dis- amount of UI is weak [24]. Furthermore, ALPP parameters
criminate urethral incompetence from other disorders, it can- are not a helpful predictor of success of surgery in women
not estimate the severity of UI, and it does not provide an with SUI [8]. Nevertheless, ALPP (and/or MUCP) may
indicator for success after surgery [3, 23]. affect the type of surgery chosen by the clinician [6].
Fig. 18.9 Urodynamic trace displaying stress urinary incontinence ommended [17]. Vesical pressure (pves), blue; abdominal pressure
and Valsalva testing to determine Valsalva leak point pressure. Multiple (pabd), red; detrusor pressure (pdet), green; flow rate (Flow), black
estimates of the ALPP at a fixed bladder volume (200–300 mL) are rec-
18 Urodynamics Techniques and Clinical Applications 273
ring forceps or vaginal pack [6], as (surgical) POP reduction A distinctive finding is an acontractile detrusor [1] when
may lead to occult SUI or latent SUI [17], and therefore has no detrusor contraction can be detected and voiding is only
implications for management or planning [37]. Furthermore, by straining, which is defined as neurogenic acontractile
POP may also be associated with BOO or with detrusor detrusor when the cause is neurologic [17].
underactivity (DU), and hence PFS may help in predicting
postoperative bladder function.
18.3.4 Bladder Outlet Obstruction
18.3.3 Underactive Bladder and Detrusor BOO is classified as voiding dysfunction of the urethra
Underactivity (Table 18.2, [10]) and is relatively rare and more difficult to
grasp in women (compared to men). It is characterised by a
The clinical presentation of the underactive bladder (UAB) is high pdet and low flow (in contrast to DU, see Sect. 18.3.3),
fairly atypical, making it difficult to define [38, 39], as it and hence requires PFS to be diagnosed (Fig. 18.10) [6]. Two
often combines storage LUTS, voiding LUTS and postmic- types of BOO can be distinguished in women: anatomical
turition LUTS [40]. UAB is classified as a voiding dysfunc- BOO (e.g. post-SUI surgery, urinary stone, bladder tumour,
tion of the bladder (Table 18.2, [10]), as opposed as BOO urethral stricture, POP, etc.) and functional BOO (e.g. idio-
(voiding dysfunction of the urethra), but clinical distinction pathic urinary retention (Fowler’s syndrome) or dysfunc-
is difficult due to its non-diagnostic clinical presentation. tional voiding). This makes standardisation of measurements,
creation of nomograms and identification of cut-offs diffi-
18.3.3.1 F ree Uroflowmetry and Measurement cult. The urodynamic criteria used in men to diagnose BOO
of Post-void Residual Volume (e.g. BOO Index) cannot be used in women due to a different
Free uroflowmetry and measurement of PVR can be used in pressure-flow relation.
women with voiding LUTS and suspected incomplete blad- Three methods of diagnosing BOO in women have been
der emptying, but they do not allow identification of the evaluated [43]:
underlying pathophysiology [40]. A Qmax < 12 mL/s (with
>100 mL VV and with or without PVR >150 mL) could dis- • pdetQmax and Qmax cut-off points [44]
tinguish women with voiding difficulties from women who • video-UDS, to identify the site of obstruction between the
void normally [41], but does not allow distinction between bladder neck and distal urethra in the presence of a sus-
UAB and BOO. tained detrusor contraction (Fig. 18.5) [45]
• a nomogram to identify and classify BOO in
18.3.3.2 Pressure-Flow Studies women [46]
UAB has a urodynamic correlate: detrusor underactivity
(DU), which is defined by the ICS as a contraction of reduced A correlation between these findings and clinical history
strength and/or duration, resulting in prolonged bladder (such as LUTS, incomplete bladder emptying, recurrent
emptying and/or a failure to achieve complete bladder emp- UTI, history of POP or SUI surgery) is recommended to
tying within a normal time span [1]. Diagnosis requires PFS, accurately diagnose BOO in women [6].
as it requires measurement of pdet and flow rate, which are
both low in DU (as opposed to BOO which is characterised
by high pdet and low flow rate). 18.4 Future Perspectives
Various methods have been proposed to evaluate the
strength of the detrusor contraction in women [39]. For exam- The following topics are or should be the subject of further
ple, a pdetQmax (detrusor pressure at maximum flow rate) of investigation:
less than 30, 20 and 10 cmH2O combined with a respective
Qmax of less than 10, 15 and 12 mL/s have been proposed as • The role of UDS in female SUI.
criteria for DU [40, 42]. Bladder voiding efficiency (BVE), Many urodynamicists insist on doing UDS prior to
defined as VV divided by VV + PVR (measured after uro- SUI surgery pointing out that few women have “simple”
flowmetry or PFS), has also been proposed as a distinctive or pure SUI symptoms. It has not been feasible to con-
measure between DU and BOO. A cut-off of 90% allowed duct a RCT in unselected women with SUI, to determine
differentiation between DU and BOO [42]. Furthermore, this whether or not UDS lead to a better outcome. This is
measure was shown to correlate well with the above men- largely due to the lack of equipment of many functional
tioned pdetQmax criteria [40]. However, none of the described urologists and urogynaecologists. There is also some evi-
methods include evaluation of prolonged emptying, which is dence that women, after discussion, prefer to have preop-
an important part of the definition by ICS [39, 42]. erative UDS.
274 M. Wyndaele and P. Abrams
Fig. 18.10 Pressure-flow study in bladder outlet obstruction as indicated by high pressure—low flow. Vesical pressure (Pves), blue; abdominal
pressure (Pabd), red; detrusor pressure (Pdet), green; flow rate (Flow), black
• The role of UDS in female voiding difficulty. be designed to allow reproduction of a patient’s lower uri-
As noninvasive testing such as uroflowmetry cannot nary tract symptoms and identification of underlying patho-
distinguish between BOO and DU in women with poor physiological mechanisms.
flow, and/or poor bladder emptying, UDS are required for In patients with a suspected storage dysfunction, filling
definitive diagnosis prior to interventions such as sacral cystometry allows identification of detrusor overactivity or
neuromodulation. Academic work continues in an attempt reduced bladder compliance as possible underlying causa-
to develop a reliable standard for measuring DU in tion of overactive bladder. Most women with stress inconti-
women. Existing methods and indices are restricted by: nence have other storage and/or voiding symptoms and
complexity (e.g. Watts factor, only studied in experimen- urodynamics should always be performed prior to invasive
tal settings), impracticality or patient discomfort (e.g., treatment. In the minority with “pure stress urinary inconti-
occlusion testing to assess detrusor contractility), relative nence”, urodynamic observations can guide the type of sur-
lack of applicability in women (e.g., BOO index as gery chosen, but this has not yet been shown to change
described in men), or lack of consensus on normal values treatment outcome.
(e.g., pdetQmax and Qmax, BVE) [38]. Voiding dysfunction in women has recently received more
research attention and various urodynamic parameters are
Similarly the diagnosis of BOO in women remains diffi- being evaluated on their ability to distinguish detrusor underac-
cult as BOO is only seen in about 5% of women coming for tivity from bladder outlet obstruction in pressure-flow studies.
UDS, the causes of female BOO are diverse and there is no Video-urodynamics can provide a useful addition when
single reliable curative treatment, as there is in men with anatomical information is needed in complex patients (e.g.
prostatic obstruction. Hence it will remain difficult to create prior surgery or neurogenic patients). Ambulatory urody-
a BOO index for women. namics can be used when symptoms cannot be reproduced or
explained by conventional urodynamics.
Whichever urodynamic tests are chosen for the individual
18.5 Conclusions patient, the quality of the testing is paramount and that means
that urodynamic staff must be properly trained to carry out the
When empiric and conservative treatment does not provide test in an excellent technical fashion. They must also be able to
sufficient symptom improvement, further assessment with adapt the test during the investigation and to be expert in the
urodynamics is indicated. The urodynamic evaluation should evaluation of the urodynamic test and its clinical significance.
18 Urodynamics Techniques and Clinical Applications 275
31. Agur W, Housami F, Drake M, Abrams P. Could the National and the underactive bladder: a new clinical entity? A review of cur-
Institute for Health and Clinical Excellence guidelines on urody- rent terminology, definitions, epidemiology, aetiology, and diagno-
namics in urinary incontinence put some women at risk of a bad out- sis. Eur Urol. 2014;65:389–98.
come from stress incontinence surgery? BJU Int. 2009;103:635–9. 40. Jeong SJ, Lee JK, Kim KM, Kook H, Cho SY, Oh SJ. How do
32. Nambiar AK, Lemack GE, Chapple CR, Burkhard FC. The role we diagnose detrusor underactivity? Comparison of diagnos-
of urodynamics in the evaluation of urinary incontinence: The tic criteria based on an urodynamic measure. Investig Clin Urol.
European Association of Urology Recommendations in 2016. Eur 2017;58:247–54.
Urol. 2017;71:501–3. 41. Groutz A, Gordon D, Lessing JB, Wolman I, Jaffa A, David
33. Haylen BT, Lee J, Logan V, Husselbee S, Zhou J, Law M. Immediate MP. Prevalence and characteristics of voiding difficulties in
postvoid residual volumes in women with symptoms of pelvic floor women: are subjective symptoms substantiated by objective urody-
dysfunction. Obstet Gynecol. 2008;111:1305–12. namic data? Urology. 1999;54:268–72.
34. Swift S. Intrinsic sphincter deficiency: what is it and does it matter 42. Gammie A, Kaper M, Dorrepaal C, Kos T, Abrams P. Signs and
anymore? Int Urogynecol J. 2013;24:183–4. symptoms of detrusor underactivity: an analysis of clinical presen-
35. Turker P, Kilic G, Tarcan T. The presence of transurethral cys- tation and urodynamic tests from a large group of patients undergo-
tometry catheter and type of stress test affect the measurement of ing pressure flow studies. Eur Urol. 2016;69:361–9.
abdominal leak point pressure (ALPP) in women with stress uri- 43. Akikwala TV, Fleischman N, Nitti VW. Comparison of diag-
nary incontinence (SUI). Neurourol Urodyn. 2010;29:536–9. nostic criteria for female bladder outlet obstruction. J Urol.
36. McGuire EJ, Fitzpatrick CC, Wan J, Bloom D, Sanvordenker J, 2006;176:2093–7.
Ritchey M, Gormley EA. Clinical assessment of urethral sphincter 44. Defreitas GA, Zimmern PE, Lemack GE, Shariat SF. Refining diag-
function. J Urol. 1993;150:1452–4. nosis of anatomic female bladder outlet obstruction: comparison
37. Elser DM, Moen MD, Stanford EJ, Keil K, Matthews CA, Kohli of pressure-flow study parameters in clinically obstructed women
N, Mattox F, Tomezsko J. Abdominal sacrocolpopexy and uri- with those of normal controls. Urology. 2004;64:675–9.
nary incontinence: surgical planning based on urodynamics. Am J 45. Nitti VW, Tu LM, Gitlin J. Diagnosing bladder outlet obstruction in
Obstet Gynecol. 2010;202:375. women. J Urol. 1999;161:1535–40.
38. Cohn JA, Brown ET, Kaufman MR, Dmochowski RR, Reynolds 46. Blaivas JG, Groutz A. Bladder outlet obstruction nomogram for
WS. Underactive bladder in women: is there any evidence? Curr women with lower urinary tract symptomatology. Neurourol
Opin Urol. 2016;26:309–14. Urodyn. 2000;19:553–64.
39. Osman NI, Chapple CR, Abrams P, Dmochowski R, Haab F, Nitti
V, Koelbl H, van Kerrebroeck P, Wein AJ. Detrusor underactivity
Ultrasonographic Techniques
and Clinical Applications 19
Andrzej P. Wieczorek, Magdalena Maria Woźniak,
and Aleksandra Stankiewicz
Moreover in women after deliveries, US can assess not various specialties, low cost, high reproducibility, and rela-
only abnormal location but also the degree and extent of tive simplicity of the method.
defect of various pelvic floor structures, for example,
levator ani muscle which could be causative factors of UI
and VD. 19.2 External Ultrasound
Ultrasound is also a very useful technique in postoperative
assessment as it allows for the precise visualization of the Transabdominal ultrasonography (TAUS) has limited use-
location/position of tapes and meshes and also in follow-up fulness in the assessment of urinary incontinence and void-
postsurgical complications such as fistulas, hematomas, and ing dysfunction. Due to the wide distance between the
other. transducer and the examined organs and to the low frequen-
Summarizing, ultrasound can provide anatomical infor- cies used, this modality provides low-resolution images of
mation which cannot be obtained in clinical examination the urethra and pelvic floor structures [8]. Its role is reserved
allowing for categorization of patients for various types of for the evaluation of bladder shape and bladder wall thick-
treatment. ness, calculation of post-voiding bladder volume, and
In recent guidelines for urinary incontinence and voiding assessment of the upper urinary tract. Asymmetry of the
dysfunctions issued by various societies, ultrasound is not urinary bladder, particularly its lower wall, can help in
the first-line diagnostic tool and is not recommended; selecting the patients with lateral defect and prolapse
however it can be a very valuable add-on to clinical examina- (Fig. 19.1). Transabdominal US is also used for defining
tion particularly in case of complex inborn or postdelivery upper and lower urinary tract abnormalities, e.g., duplica-
disorders [7]. Dynamic character of the examination can give tions of collecting systems, ectopic ureters, urachal abnor-
a huge dose of functional information. A number of publica- malities (Fig. 19.2), and other.
tions describe how to quantify the mobility of pelvic floor Transperineal ultrasound (TPUS) is the general term used
structures. The advantage of US is its wide availability for for the ultrasound performed with the transducer placed on
the perineum (Fig. 19.3). This encompasses translabial ultra- 19.2.1 Examination Technique
sound (TLUS), where transducer is positioned on the right or
left labia, introital ultrasound when the transducer is placed No patient preparation or micturition is required before the
between the labia, and true TPUS when transducer is placed examination, and no rectal or vaginal contrast is used.
on the perineum between the vaginal orifice and the anal Patients are recommended to feel comfortable with the
margin. amount of the urine in their bladder. Standardization of
The amount of anatomical and functional information bladder filling is not possible in patients with urinary incon-
obtained is similar in each of these techniques, as all pelvic tinence as most are not able to hold urine. However, the
structures (bladder, urethra, vaginal walls, anal canal, and amount of the urine in the bladder can influence the results
rectum) located between the dorsal/posterior surface of the of measurements, with a full bladder resulting in a reduced
symphysis pubis and the ventral/anterior part of the sacral mobility of the urethra [9]. The patient is placed in a supine
bone could be visualized. Moreover, all techniques enable to position but, if necessary, can be asked to stand during the
obtain sagittal, coronal, and oblique sections, although the examination.
most commonly used is the midsagittal plane, which allows Different types of probe can be used: convex transducers
overall assessment. are normally reserved for abdominal or obstetric examina-
Currently, no guidelines exist on which transperineal tions, at a frequency of 4–6 MHz, and end-fire transducers
approach to use; however we know from our experience that are routinely used for gynecological or urological purposes,
translabial approach is the most appropriate in patients with at higher frequencies (7–12 MHz), but with a smaller
associated pelvic organ prolapse, as the probe placed on the insonation angle resulting in a smaller field of view. Both
labia allows prolapse to fully develop. types of probe allow the application of color Doppler for
280 A. P. Wieczorek et al.
a b
c d
Fig. 19.3 Scheme of transducer placement on the perineum for perineal/transperineal (a), translabial (b), and introital (c) approach. The field of
view depends on the placement of the transducer and may focus on either the anterior compartment (d) or the posterior compartment (e)
19 Ultrasonographic Techniques and Clinical Applications 281
evaluation of urethral vascularity [10, 11], urethral funnel- pubis. The value of BSD should be equal to approxi-
ing, and assessment of the passage of urine [12]. mately two-thirds of the length of the urethra, and differs
Two-dimensional (2D) TPUS is the simplest US tech- individually, normally ranging between 20 and 30 mm
nique, and it is set as default technique on the US scanner. It (Fig. 19.4). The BSD value enables assessment of the
can be performed with almost every ultrasound scanner, position and mobility of the urethra and the bladder neck
which makes this method broadly accessible. It enables with good interobserver reliability at rest and excellent
imaging in coronal, sagittal, and oblique sections, providing during Valsalva maneuver [17]. There is no definition of
a flat image of the visualized anatomy. A limitation of this “normal” for bladder neck descent, although a cut-off of
modality is represented by the low frequencies used and rela- 20 mm has been proposed to define hypermobility [12]
tively poor resolution. and reported to be strongly correlated with stress urinary
2D TPUS enables measurements of the pelvic structures incontinence [18].
in the midsagittal plane at rest or during functional tests • Urethral length (taken as the distance from the bladder
(coughing, Valsalva maneuver, maximal pelvic floor con- neck to the visible end of the external urethral orifice) and
traction). These are as follows: width. Normal values vary individually, ranging between
30 and 45 mm.
• Bladder wall thickness (BWT) normal value up to 5 mm; • γ angle: i.e., angle between the inferior edge of the sym-
abnormal over 5 mm [13]. physis pubis and the urethrovesical junction, at rest
• Post-voiding residual bladder volume: for the assessment (Fig. 19.5) and on Valsalva [5].
of bladder outlet or obstruction; post-voiding residual • Urethral rotation: i.e., rotation of the proximal urethra on
bladder volume should not exceed 50 mL [14–16]. Valsalva [5].
• Bladder–symphysis distance (BSD): the distance between • Retrovesical angle (RVA): i.e., angle between proximal
the bladder neck and the lower margin of the symphysis urethra and trigonal surface of the bladder (Fig. 19.5) [5].
a b
Fig. 19.4 Assessment of pelvic organs with 2D transperineal ultrasound, gin of the symphysis pubis. The horizontal line indicates the lower margin
(a) at rest and (b) during Valsalva maneuver. Bladder–symphysis distance of the symphysis pubis and is a reference point for the measurements of
is the distance (vertical line) between the bladder neck and the lower mar- bladder neck movement. B bladder, SP symphysis pubis, U urethra
282 A. P. Wieczorek et al.
a b
UVJ
RVA
SP
c d
Fig. 19.5 Scheme of the ultrasound parameters in transperineal ultra- (a). 2D transperineal ultrasound at rest; γ angle (b). Retrovesical angle
sound: γ angle, between the inferior edge of the symphysis pubis (SP) (c). A anal canal. Transperineal ultrasound during Valsalva maneuver
and the urethrovesical junction (UVJ). Retrovesical angle (RVA), showing (d) cystocele and (e) enlarged gamma angle. B-mode image
between proximal urethra (U) and trigonal surface of the bladder (B) with transducer type 9C2, BK Medical
19 Ultrasonographic Techniques and Clinical Applications 283
The following reference lines have been proposed for the avulsion is diagnosed if the muscle insertion is clearly abnor-
assessment of pelvic organ descent by transperineal mal in slices at the plane of minimal hiatal dimensions and at
ultrasound: 2.5 and 5 mm cranial to this [28].
Four-dimensional ultrasound gives live action images of
• A horizontal reference line touching the inferior edge of the pelvic floor anatomy. This technique is particularly
the symphysis pubis drawn parallel to the border of the helpful in recording functional tests of the pelvic floor
screen proposed by Dietz and Wilson (H-line) [19] (coughing, Valsalva maneuver, maximal pelvic floor con-
• A central reference line drawn through the longitudinal traction) [29, 30]. It is a simple technique assessing sym-
axis of the interpubic disk of the symphysis pubis (the metry or asymmetry of pelvic floor structures indicating
central pubic line) proposed by Schaer et al. [20] potential defect.
• A reference line between two hyperechoic contours of the
symphysis pubis proposed by Hennemann et al. [21]
19.3 Endoluminal Ultrasound
In the study by Hennemann et al. comparing three above-
mentioned reference lines for the assessment of pelvic organ Endoluminal US includes endovaginal (EVUS), endoanal/
descent by TPUS, the authors concluded that the central endorectal (EAUS/ERUS), and historical method being
pubic line [21] was shown to be inferior owing to poor visi- transurethral (TUUS) ultrasound (see [31, 32]).
bility in volumes, whereas the reference line between two Endovaginal US can be performed with the following
hyperechoic contours of the symphysis pubis obtained transducers (see [31]): (1) end-fire transducer, commonly
repeatability parameters comparable to the horizontal line of used in gynecological and urological practice; this type of
Dietz and Wilson [19]. probe gives sector 2D images and allows visualization of
Recently 2D TPUS can be also performed with ultrasound sagittal and transverse sections of the urethra and surround-
elastography options which can show elastic properties of ing tissues; (2) electronic biplane transducer, with linear and
pelvic floor organs, for example, perineal body or superficial transverse arrays (type 8848, BK Medical, Herlev, Denmark)
perineal muscles [22]. and perpendicular beam formation (type 8838 and its recent
Two-dimensional TPUS can be enriched by adding a third version X14L4, BK Medical, Herlev, Denmark); and (3)
dimension (depth) or fourth dimension (time) to it, which is 360° rotational probe, with multifrequencies (6–16 MHz)
known as 3D and 4D TPUS, respectively. and axial ultrasound beam formation (type 2052, and its
The main advantage of 3D/4D TPUS, compared to 2D recent version 20R3, BK Medical, Herlev, Denmark). An
mode, is the possibility of obtaining reconstructed sections advantage of high-frequency EVUS is the detailed evalua-
to precisely visualize the relevant pelvic floor structures tion of pelvic floor morphology, due to the close distance
along their proper planes and to measure their volume. The between the transducer and examined organs. There are also
reconstructed axial plane allows evaluation of the levator ani other vendors offering similar solutions such as Hitachi
muscle (LAM) and its attachments to the pubic rami and (Tokyo, Japan).
measurement of the diameter, area, and volume of the uro- The presence of the transducer in the vagina, however, has
genital hiatus [23–26]. Another advantage of the 3D tech- the limitation that in patients with pelvic organ prolapse it
nique is the possibility of recording data for subsequent can prevent the descent during functional assessment.
off-line assessment. Recently EVUS can be performed additionally with the
Recently a new display technique called tomographic use of ultrasound shear wave elastography (SWE) which is a
ultrasound imaging (TUI) has been introduced to 3D noninvasive real-time technique used to estimate tissue
TPUS. Tomographic ultrasound imaging (TUI) allows the stiffness.
examiner to obtain a volume dataset that simultaneously dis- Endoanal US (EAUS) is commonly performed with the
plays multiple images at specific distances (Fig. 19.6). Dietz rotational probes (see [32]). Although EAUS provides
et al. established minimal sonographic criteria for the diag- images of the urethra that are comparable to those obtained
nosis of avulsion with the use of TUI when complete avul- by EVUS, its usefulness in clinical practice is limited. The
sion of the puborectalis muscle is best diagnosed by requiring main reasons for this are artifacts due to bowel movements
all three central slices to be abnormal [27]. These findings and the presence of feces or air in the small bowel or rec-
were subsequently confirmed by Shek et al. who described tum; a large distance of the transducer from the area of
3D/4D ultrasound technique for the assessment of levator interest that reduces the resolution [25]; and low accep-
avulsion via evaluation of TUI as a gold standard method tance by patients due to embarrassment and discomfort
used by dozens of research groups around the world. Levator during scanning.
284 A. P. Wieczorek et al.
Fig. 19.6 (a) Three-dimensional transperineal ultrasound showing unilateral defect of levator ani (arrow), (b) the same examination presented
with the use of tomographic ultrasound imaging (TUI) option
In the past also transurethral US (TUUS), including a urethral morphology. In another study, Schaer et al. [35] cor-
dynamic 3D US, was performed by using a 10 MHz trans- related TUUS findings with histology. Structures that are
ducer, diameter 23 F, allowing 360-degree transverse images well visible with TUUS were the striated and smooth ure-
of the urethra and surrounding tissues (type 1850, BK thral sphincter muscles, vagina, and blood vessels with
Medical, Herlev, Denmark) [33–35]. The main advantage of diameters exceeding 0.2 mm. The longitudinal smooth mus-
TUUS was the lack of a compression effect and the absence cle layer appeared as a w ell-defined internal hypoechoic
of urethral displacement [25]. Direct contact of the trans- ring. The outer circular smooth muscle layers and the striated
ducer (endoluminal character) also gave a precise image of muscle layers were a more irregular and hyperechoic zone.
19 Ultrasonographic Techniques and Clinical Applications 285
The circular smooth muscle layers and the striated sphincter • Measurement of urethral length, depth, width, and vol-
muscle layers could not always be differentiated easily. ume, in the axial and midsagittal planes
The limitation of the endourethral approach was its inva- • Measurement of BSD at rest and during Valsalva maneu-
siveness. It was also very embarrassing for the patient, and ver, in the midsagittal plane
often not accepted by examined women. Additionally, it car- • Measurement of rhabdosphincter muscle length, depth,
ries the risk of transmitting urinary tract infection. Due to width, and volume, in the axial and mid sagittal planes
these limitations, together with the introduction of high- • Evaluation of the integrity of the perineal body
frequency EVUS, the role of TUUS has been largely limited • Functional dynamic assessment of bladder and urethral
and rather no longer used in clinical practice. mobility
• Evaluation of urethral vascularity [41–43]
a c
Fig. 19.7 Endovaginal ultrasound with transducer type 8848, (BK different patients show a poor (a) and rich (b) network of vessels. (c)
Medical). Vascular render mode reconstruction of a 3D color Doppler Transperineal ultrasound with power Doppler shows the spatial distri-
dataset shows the spatial distribution of the vessels in the female ure- bution of the vessels in the female urethra. B bladder, SP symphysis
thra. 1 intramural, 2 midurethra, 3 distal urethra. Scans obtained in two pubis
19.4 Discussion reported in the literature. Bai et al. [51] performed TPUS to
evaluate the differences between patients with or without
Transabdominal ultrasound is a reliable method for assess- urethrovesical junction hypermobility associated with
ment of the urinary bladder to determine bladder wall thick- SUI. They found the two groups differed in the bladder neck
ness (BWT) and bladder neck wall mass, in patients with descent. Hypermobility of the bladder neck in nulliparous
voiding dysfunctions and outflow obstruction [49]. It allows patients is not often seen. Harris et al. [52] reported a bladder
measurement of post-voiding residual urine volume and can neck mobility of 31° in nulliparous patients versus 38° in
help to determine whether additional tests are needed. The parous patients. Volloyhaug et al. studied changes of recto-
efficiency and safety of bladder US makes its use beneficial vesical angle, BND, and urethral rotation between rest and
in a wide variety of populations, including hospitalized Valsalva in patients from their pregnancy to 4 years postpar-
patients, children, and the elderly. Transabdominal US can tum. They have found increase in values of all these param-
also be used for suprapubic aspiration of fluid collections eters irrespective the mode of delivery. The higher values
and evaluation of intravesical masses. Its role in the evalua- were associated with LAM avulsion [53].
tion of urinary incontinence is limited. Sugaya et al. [8] used In patients with stress incontinence, but also in asymp-
this modality to assess the bladder neck morphology in tomatic women [54], urethral funneling may be observed on
women with urethral syndrome or stress urinary inconti- Valsalva maneuver and sometimes also at rest (Fig. 19.8). Its
nence (SUI), in order to determine the ultrasonographic find- morphologic basis is unknown, and its incidence is reported
ings of these conditions. They reported that transabdominal to range from 18.6% to 97.4%. Funneling is often associated
US provides useful information and should be carried out as with leakage, and occasionally weak grayscale echoes may
a routine examination in female patients with micturition be observed in the proximal urethra, suggesting urine flow
disorders. However, recent multicenter study of the and therefore incontinence during straining. However, fun-
Collaborative Group of the Bladder Ultrasound Study (BUS) neling may also be observed in urge incontinence. Marked
reported limited usefulness of the transabdominal measure- funneling has been shown to be associated with poor urethral
ment of BWT in patients with detrusor overactivity. closure pressures [12, 55]. Tunn et al. [56] performed introi-
According to results of this study, BWT could not substitute tal US in patients with SUI, to distinguish those with and
of the urodynamics in patients with overactive bladder [50]. without urethral funneling. The two groups were compared
The usefulness of TPUS in the assessment of urinary for clinical history, urodynamic results, and MRI findings.
incontinence and voiding dysfunction has been widely The results of this study, however, could not elucidate the
19 Ultrasonographic Techniques and Clinical Applications 287
a b
Fig. 19.9 Endovaginal ultrasound with biplane transducer (type 8848, the sagittal section, postsurgical complications are visualized: an
BK Medical). Visualization of folded tape (arrows) being a cause of inserted tape into the urethra (yellow arrow) and abnormal C-shape of
unsuccessful surgery in B mode (a) and volume render mode (b). (c) In the tape (white arrow) suggesting its improper tension
of LAM damage, this modality gives precise information echogenicity area of the puborectalis muscle in patients dur-
about the location of the defect and can be used for monitor- ing and after pregnancy. They found higher values of mean
ing its natural history. Van Delft et al. performed both 3D echogenicity area of puborectalis muscle during pregnancy
EVUS and 3D TPUS in pregnant patients at 36 weeks of ges- and just after delivery, as compared to the scan at 6 months
tation and 4 days and 3 months delivery, and they found that postpartum [30]. Additionally, the perineal membrane, a tri-
in 24% of patients hematomas were present at the puborecta- angular fibrous layer that attaches the perineal body to the
lis insertion to the pubic rami immediately after delivery, pubis, can be visualized.
with no avulsions reported antenatally [37]. Moreover, they Endovaginal US also has a relevant role in detecting pel-
have found that 62% of LAM avulsions were no longer vis- vic organ prolapse (POP) coexisting with urinary inconti-
ible at 1 year postpartum, suggesting that partial avulsion has nence (see Chap. 49).
tendency to improve over time [66, 67]. This studies are in By performing 3D EVUS with the use of a biplane trans-
agreement with study of Grob et al., who analyzed mean ducer, we determined the rhabdosphincter volume that,
19 Ultrasonographic Techniques and Clinical Applications 289
a b
Fig. 19.10 (a) Three-dimensional endovaginal ultrasound in patient Medical. Asymmetry of pelvic floor structures caused by levator ani
with urinary incontinence with transducer type 8838, BK Medical. defect. Enlargement of hiatal area. A anus, B bladder. SP symphysis
Bilateral levator ani defect (arrows) and subsequent enlargement of hia- pubis, U urethra, V vagina
tal area. (b) Three-dimensional EVUS with transducer type X14L4, BK
according to Digesu et al. [59], represents a predictive factor ware, we found that the three regions of interest (ROI)
for surgical outcome. Our results (mean value 1.2 mL) were defined in the longitudinal plane presented significant differ-
comparable to those obtained with 3D EAUS by Athanasiou ences in the intensity of perfusion. The midurethra, which
et al. [68] and with the measurements performed with mag- includes the rhabdosphincter muscle, showed the greatest
netic resonance imaging (MRI) by Tan et al. [69]. In patients intensity of perfusion (mean value 0.014 cm/s, p < 0.05),
with advanced degenerative changes of connective tissue compared to the intramural part of the urethra (0.007 cm/s,
(aging), appearing on ultrasound as inhomogeneity of the p < 0.05) and to the distal urethra (0.005 cm/s, p < 0.05).
urethral complex muscles, a worse therapeutic effect might However, the perfusion between the intramural and distal
be expected compared to patients with normal-appearing urethra was similar (0.57 cm/s, p < 0.05). No significant dif-
rhabdosphincter and smooth muscles. ferences were found in the intensity of perfusion in the two
One of the advantages of the high-frequency EVUS is the ROIs defined in the axial section at the level of the midure-
opportunity to assess the urethral vascularity. The lumen of thra. The parameters of perfusion appeared similar (0.76,
the urethra is surrounded by a prominent vascular plexus that p < 0.05) in the outer layer (rhabdosphincter) and inner layer
is believed to contribute to continence [70]. The spatial dis- of the urethra (circular smooth muscle, longitudinal smooth
tribution of urethral vessels with the different blood supply, muscle, and submucosa) [41]. Lone et al. performed color
their density and localization, and the intensity of perfusion Doppler EVUS in incontinent patients and at 1 year from
of the blood flow play an important role in urethral function. baseline. Out of 67 recruited patients, 50 patients opted for
It is possible that urinary incontinence and pelvic organ dys- conservative management and 17 underwent surgery. The
function may result in a change in urethral vasculature, pos- vascularity of the urethra was assessed in the midurethra.
sibly before the appearance of clinical signs [70]. Analyses Follow-up scan did not show statistically significant differ-
of urethral vasculature could become a predictive parameter, ences in vascular parameters within the groups or between
which would allow implementation of prophylaxis or early the groups at comparison to baseline [43]. This was however
treatment for patients before their symptoms become severe. a pilot study, and further investigation in larger cohort should
In our study [41], performed in a group of 18 nulliparous be carried out.
females, we demonstrated that the urethral vasculature is dif- Historically performed transurethral US also allowed for
ferent along its entire length. With the use of PixelFlux soft- an accurate assessment of urethral morphology. Test–retest
290 A. P. Wieczorek et al.
reliability of TUUS in measuring female urethral sphincter the causes of unsuccessful surgery resulting from improper
indices was performed by Heit [33]. The results showed positioning of tapes and meshes [71], their elongation, too
that the urethral longitudinal smooth muscle layer was the tight placement, folding, or asymmetry, most often seen in
only structure that could be measured reliably using case of transobturator tapes (TOT) (Figs. 19.9 and 19.11).
US. Measurements of the rhabdosphincter were not reliable The study of Bogusiewicz et al. has found that the highest
because the outer portion of that structure lies outside the failure rate of the “outside-in” transobturator tapes is associ-
depth of penetration of a 12.5 MHz transducer [33]. Dynamic ated with the position of the tape in the proximal third ure-
TUUS and 3D reconstruction of the rhabdosphincter and thra, as assessed on the EVUS [72]. The ultrasound
urethra in continent and incontinent women was performed assessment of the position of suburethral slings shows
by Mitterberger et al. [34]. Partial or complete loss of rhab- excellent and good repeatability and reproducibility (ranged
dosphincter function was detected in patients with stress from 0.67 to 0.99), which confirms validity of US and its
incontinence. The ultrasonographic findings were found to usefulness in clinical and academic practice [73].
have a good correlation with the grade of incontinence. Endocavitary US is also very useful in the diagnosis of
Furthermore, under contraction of the rhabdosphincter, an postoperative complications such as hematomas, fistulas,
increase of the urethral length was observed. In incontinent and small fluid collections, not visualized with transabdom-
patients, the urethral length did not increase significantly, inal ultrasound or TPUS. In case of inflammatory processes
due to reduced contractility of this muscle. Normal contrac- following insertion of tapes or meshes, color Doppler mode
tion of the rhabdosphincter resulted in an elongation of the may confirm the presence of inflammation and locate the
urethra [34]. These findings from TUUS appeared important changes (Fig. 19.12). Defreitas et al. [24] used endocavitary
clinically and are still relevant despite the fact that the 3D US to examine the distribution of periurethral collagen
method itself is no longer in clinical practice. and to incorporate this technology into a practical treatment
As already reported for TPUS, endocavitary US is par- decision algorithm for women with stress urinary inconti-
ticularly useful in choosing appropriate management and in nence requiring collagen injection. They found that ultraso-
postoperative follow-up. Endovaginal US may help to define nographic evaluation of collagen volume and periurethral
19 Ultrasonographic Techniques and Clinical Applications 291
location was an affordable, noninvasive, and objective tech- position of the neck of the diverticulum may be precisely
nique to predict improvement after periurethral collagen identified for surgical purposes [79]. The EVUS allows
injection [24] (Fig. 19.13). Similar conclusions were drawn visualization of coexisting anatomical disturbances con-
from the study of Yune et al., who used 3D EVUS in the tributing to voiding dysfunctions, such as inborn abnormal-
assessment of the location and distribution of transurethral ities, as well as acquired conditions—most commonly
bulking agents. They found that the bulking agents are eas- changes connected to aging, post-inflammatory changes, or
ily identified on ultrasound and were most often found at pelvic organ prolapse.
3- and 9-o’clock positions as intended, however at variable Khullar et al. [80] described a technique of measuring
distance from urethrovesical junction. In 41% it did not bladder wall thickness using EVUS. Ultrasonographic
form a typical sphere [74]. In another study, Bacsu et al. measurements showed a good intra- and interobserver
used 3D EVUS to assess durability of collagen bulking reproducibility. Women with urinary symptoms and detru-
agents in treatment of SUI. They found that collagen injec- sor instability were found to have significantly thicker
tion is relatively stable over the time, with a mean period of bladder walls than women with urodynamically diagnosed
43 months free of symptoms [75]. stress incontinence (Fig. 19.18). This result was con-
High-resolution multiplanar US allows comprehensive firmed in another study by the same authors, who reported
evaluation of abnormalities of the female urethra such as that a mean bladder wall thickness greater than 5 mm at
urethral diverticula, abscesses [71], tumors [76], and other EVUS is a sensitive screening method for diagnosing
urethral and paraurethral lesions [77, 78] (Figs. 19.14, detrusor instability in symptomatic women without out-
19.15, and 19.16). A number of diverticula and the loca- flow obstruction [81]. However, recent multicenter study
tion, size, configuration, and possible contents of the sac of the Collaborative Group of the Bladder Ultrasound
may be demonstrated (Fig. 19.17). Most important, the Study (BUS) reported limited usefulness of the transab-
292 A. P. Wieczorek et al.
a b
Fig. 19.14 Endovaginal ultrasound with biplane transducer (type bilateral ureteroceles (yellow arrows) and (c) in the sagittal section a
8848, BK Medical). The images visualize (a) in the axial section a cal- dystopic ureter as solitary abnormality (white arrow). B bladder, DU
cified dystopic insertion of the ureter to the urethra (U) (b) in the axial dystopic ureter
section a dystopic insertion of the ureter (white arrow) with coexisting
19 Ultrasonographic Techniques and Clinical Applications 293
a b
c d
Fig. 19.15 Soft tissue tumors in the area of vesical neck causing void- vaginal ultrasound with transducer type 8848, BK Medical; (d)
ing dysfunction (a) transabdominal B-mode image with transducer type endovaginal ultrasound with transducer type 8838, BK Medical, power
C1-5D, BK Medical; (b) endovaginal ultrasound with transducer type Doppler image showing relatively rich network of vessels within the
8838, BK Medical, color Doppler image showing relatively rich net- small vesical neck tumor in the sagittal section. B bladder, SP symphy-
work of vessels within the tumor in the sagittal section. (c) 3D endo- sis pubis, U urethra
294 A. P. Wieczorek et al.
a b
Fig. 19.16 Calcifications (C) in the urethral complex (U). (a) Axial section. Calcifications localized within the rhabdosphincter and
Endovaginal ultrasound with transducer type 2050 (T), (BK Medical). externally to the rhabdosphincter (RS). (c) Endovaginal ultrasound with
Axial section. Intraurethral localization of calcifications (arrows). (b) end-fire with transducer type IC5-9D, (General Electric). Ureterocele
Endovaginal ultrasound with transducer type 8848, (BK Medical). with calcification (stone) inside (arrow). B bladder, UR enlarged ureter
19 Ultrasonographic Techniques and Clinical Applications 295
a b
Fig. 19.19 Ultrasound elastography showing elastic properties of pelvic floor organs. (a) TPUS shear wave elastography (SWE) of the perineal
body, superficial and deep parts (arrows). (b) EVUS strain elastography of the urethra during contraction
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Biofeedback
20
Kari Bø and Paolo Di Benedetto
Holding Hence, the indications for use of PFMT with and without
ccc cc c Endurance biofeedback are UI, fecal incontinence, pelvic organ pro-
lapse, sexual disorders, voiding difficulties, constipation,
and pain.
Highest:14
Fig. 20.2 Recordings of vaginal squeeze pressure measured by fiber- 20.3 Effect of Biofeedback Training
optic microtup transducer connected to an air-filled balloon (Camtech
AS, Sandvika, Norway). First attempts of pelvic floor muscle contrac-
tion of an 18-year-old female student with proven stress incontinence Since Kegel first presented his results on PFMT [3], several
with urodynamic assessment and 43 g of leakage on ambulatory pad randomized controlled trials (RCTs) have shown that PFMT
test. She can contract correctly, assessed by vaginal palpation, but her without biofeedback is more effective for stress urinary
voluntary contractions are weak and uncoordinated and she fatigues
rapidly. She cannot hold and she is not able to repeat contractions incontinence (SUI) than no treatment [16]. A Cochrane
review found that 24 trials involving 1583 women compared
PFMT with and without biofeedback with 17 trials contribut-
enhance and motivate patients’ effort during training [4, 5]. ing data to the analysis for one of the selected primary out-
Today ultrasound and magnetic resonance imaging (MRI) comes. All trials contributed data to one or more of the
can also be used as biofeedback during a PFM contraction. secondary outcomes. Women who received biofeedback were
These methods have the advantage of being able to show significantly more likely to report that UI was cured or
both the lift (sagittal plane) and the squeeze (constriction of improved compared to those who received PFMT alone (risk
the hiatus in the axial plane) [6, 7]. ratio 0.75, 95% confidence interval 0.66–0.86). However,
As several research groups have found that more than women in the biofeedback arms usually had more contact
30% of women may not be able to perform a correct PFM with the health professional than those in the non-biofeedback
contraction at their first consultation [8–11], some authors arms. Many trials were at moderate to high risk of bias, and
have suggested that biofeedback can be used to teach a cor- the regimens proposed for adding feedback or biofeedback to
rect contraction. A correct PFM contraction is described as a PFMT alone varied considerably [17]. The 2017 International
squeeze around the urethra, vagina, and rectum, with an Consultation on Incontinence (ICI) report concluded that
inward and forward lift of the perineum [8, 12]. The most with regard to clinic-based biofeedback, new evidence (two
common error during attempts to contract the PFM is to use studies) reported no statistically significant differences
outer pelvic muscles (e.g., the hip adductors, abdominal and between BF-assisted and non-biofeedback groups for self-
gluteal muscles) [9]. In addition, Bump et al. [11] found that reported cure, improvement, or frequency of leakage episodes
as many as 25% were straining/pressing down instead of lift- (Level of Evidence: 1). Furthermore, there were no statisti-
ing inward. This is important, as straining/Valsalva opens the cally significant differences between home biofeedback and
levator hiatus, and such maneuvers may weaken the muscles. non-biofeedback groups for self-reported cure, improvement,
It is imperative to be aware that erroneous attempts at PFM frequency of leakage episodes, and pad test measures in
contractions (e.g., straining) may be registered by both women with SUI (Level of Evidence: 2) [5, 18–32].
manometers and dynamometers [13, 14] and contractions of The published biofeedback studies differ in the probes
muscles other than the PFM may affect surface EMG activity used, the type of feedback/biofeedback provided (EMG, pres-
[15]. It takes a person to explain and instruct how to do a cor- sure, ultrasound), and whether biofeedback was undertaken at
20 Biofeedback 303
home or in the clinic. Treatment duration varied from 4 weeks use biofeedback to control and enhance the strength of the
to 6 months, and the total number of participants ranged from contractions when training.
12 [20] to 135 [22]. When participants were randomized, Some of the new apparatus has built in registration of adher-
some of the groups became very small. Although Berghmans ence to the training program. Any factor that may stimulate
et al. [23] demonstrated faster progress in the biofeedback high adherence and intensive training should be recommended
group, there is no convincing evidence that PFMT with bio- for the purpose of enhancing the effect of a training program.
feedback adds any additional benefit to PFMT alone. Four Hence, when available and the patient is motivated to use it,
studies found a significant increase in PFM function in the biofeedback can be suggested as an option for home training.
PFMT + biofeedback group compared to PFMT alone, mea- At office follow-ups, in order to record improvement, detect
sured with either EMG [22, 32] or vaginal pressure transduc- non-improvement at an early stage, and motivate the patient,
ers [30, 31]. Wong et al. [26] found a significant subjective the physiotherapist should use a responsive, reliable, and valid
improvement in PFMT alone over PFMT + biofeedback in assessment tool to measure the response to training [14].
one study, and the opposite in another trial [29]. No statisti-
cally significant differences were found in objective measures
of UI in any of the studies. 20.4 C
linical Recommendations for the Use
Unfortunately, most of the trials are flawed, with different of Biofeedback
training dosages in the two arms of the studies. The study of
Glavind et al. [24] was confounded by a difference in train-
ing frequency, and the effect might be due to a double train- 1. Instruct in correct PFM contraction using vaginal palpa-
ing dosage in the biofeedback group, the use of biofeedback, tion, visual observation, ultrasound, or MRI to give feed-
or both. Pages et al. [30] compared 60 min of group training back of the contraction.
5 days a week with 15 min of individual biofeedback training 2. If a home biofeedback tool is available at an acceptable
5 days a week and found that the individualized biofeedback cost, ask if the woman is motivated to use it in her training
training protocol was more effective as assessed by women’s program.
report and measurement of PFM strength. 3. If the patient is cooperative and motivated, give thorough
Also, the adherence to training with and without bio- instruction on how to use and clean the apparatus.
feedback differed [32]. When the two groups under com- 4. Follow general strength training recommendations with
parison receive different dosage of training in addition to three sets of 8–12 close-to-maximum contractions per day.
biofeedback, it is impossible to conclude what is causing a The sets can be done separately or put together at one time-
possible effect. point, fitting into the individual patient’s time schedule. As
Other factors may also bias the results of studies compar- the use of biofeedback requires the patient to undress, we
ing PFMT with and without biofeedback. Since PFMT is suggest that the training is done in one session.
effective without biofeedback, a large sample size may be 5. Follow-up visits with the physiotherapist at least weekly
needed to show any additional effect over PFMT alone. In or bi-weekly are recommended, to follow up improve-
most of the published studies comparing PFMT with PFMT ment/non-improvement.
combined with biofeedback, the sample sizes are small, and
type II error may have been the reason for not finding an
additional effect [5]. However, in the three largest RCTs, no
significant additional effect on UI of adding biofeedback was 20.5 Conclusion
demonstrated [22, 27, 28].
Only one RCT was found evaluating the effect of PFMT There is no evidence that use of biofeedback is more effec-
with and without biofeedback for overactive bladder (OAB). tive than pelvic floor muscle training alone to treat urinary or
Wang et al. [33] randomized 120 women, mean age fecal incontinence.
52.7 years (standard deviation (SD) 13.7 years), with symp-
toms of OAB to 12 weeks of PFMT, PFMT with biofeed-
back, or electrical stimulation.
The results showed that the groups receiving PFMT with Take-Home Message
and without biofeedback were better than the electrical stim- Biofeedback can be used as a motivational tool for
ulation group, but there were no statistically significant dif- those who are interested in using this technique.
ferences between training with and without biofeedback. Correct contraction of the PFM must be assured by
The use of home-based biofeedback requires patients to either observation, palpation, or ultrasound/MRI
undress, go to a private room, and insert a vaginal or rectal before use of sEMG or manometry/dynamometry as
device in order to exercise, and many patients may not like biofeedback.
this [34]. On the other hand, some may find it motivating to
304 K. Bø and P. Di Benedetto
Joseph K.-S. Lee and Peter L. Dwyer
the largest SPARC vs. TVT RCT, albeit with a short follow-
up of 6–8 weeks, demonstrating higher incidence of urinary
retention within the SPARC group, with more patients
requiring a second operation to loosen the tape (6.5% vs.
none). Meta-analysis confirmed that TVT outperforms
SPARC in subjective cure rate (odds ratio (OR) 0.56 (95%
confidence interval (CI) 0.35, 0.92); p = 0.02) and objective
cure rate (OR 0.53 (95% CI 0.34, 0.82) p = 0.005) assessed
by negative cough test and negative pad test [12]. The most
recent Cochrane review [17] reach a similar conclusion, con-
firming the bottom-up route was more effective for subjec-
tive cure (RR 1.1; 95% CI 1.01, 1.19), incurring less voiding
dysfunction, fewer bladder perforations and vaginal mesh
exposure.
21.2.4 Overview
0.91, 1.23) subjective cure rates between inside-out and out- 2.4%), de novo urgency rate (8.1–8.3%) but have an excess
side-in, although voiding dysfunction was more frequent in of groin pain (20.8% vs. 4.5%) within the transobturator
inside-out group (RR 1.74, 95% CI 1.06, 2.88) [17]. group, compared with retropubic route.
Data from a large Austrian transobturator tape (TOT) reg- Systematic reviews of pooled RCT of small patient num-
istry [45] reported an intraoperative bladder/urethral injury bers, varied quality and relative short follow-up have many
rate of 1%, the majority of which was in the outside-in group.limitations. Looking at large databases (e.g. national) with
Although the incidence of groin pain is reportedly up to 16% long follow-up may provide more accurate information on
[46] for the inside-out technique, the RCT conducted by efficiency and relative risks. Foss Hansen et al. [80] used the
Liapsis et al. [41] reported no difference in postoperative Danish National Patient Registry to identify women who
groin pain; however, But and Faganeli’s RCT reported that had surgery for urinary incontinence from 1998 through
the inside-out technique is more painful [39]. Systematic 2007, and the outcome was a reoperation within 5 years. A
reviews [17, 47] of RCTs report higher vaginal perforation total of 8671 women (mean age, 56.1 years; range, 6.7–
rate from outside-in route; however, a recent report from 93.7 years) underwent surgical treatment for urinary incon-
Austria [48] on 10-year outcome of inside-out route reports tinence. Among these women, 5820 (67%) received a
a cumulative 7% mesh extrusion rate. synthetic midurethral sling at baseline. The cumulative inci-
The jury remains out on whether the outside-in is better dence of reoperation after any surgical treatment for urinary
than inside-out technique. incontinence was 10%. The lowest rate of reoperation was
observed among women having pubovaginal slings (6%),
retropubic midurethral tape (6%) and Burch colposuspen-
21.3.3 Retropubic Versus Obturator sion (6%) followed by transobturator tape (9%) and urethral
injection therapy (44%). The transobturator tape carried a
Comparison between the retropubic and transobturator twofold higher risk of reoperation (HR, 2.1; 95% CI, 1.5–
approaches was evaluated in three meta-analyses [12, 49, 2.9), and urethral injection therapy carried a 12-fold higher
50], four updated RCTs [51–54] and nine further RCTs [55– risk (HR, 11.5; 95% CI, 9.3–14.3) compared with retropu-
63], though there are considerable variations in methodolo- bic midurethral tape.
gies and outcome measures between these studies. RCTs are In a recent large retrospective multivariate analysis of
often powered for non-inferiority with a short- to medium- 1136 patients who underwent MUS [81], bladder perfora-
term follow-up. Nevertheless, meta-analyses and subsequent tions appear to be confined to inexperienced surgeons (<50
RCTs [55–57, 59–63], with the exception of one [58], slings). Other risk factors for bladder perforation include a
showed no significant difference in subjective and objective history of previous caesarean section, colposuspension, body
cure rates for SUI between the RP or TO approaches [64– mass index (BMI) < 30 kg/m2, use of local anaesthesia and
77]. The most recent Cochrane review [17] confirmed no sta- presence of a rectocele. Combination of these risk factors
tistically significant difference in subjective cure rates gave good prediction (area under the curve (AUC) of
between these two routes irrespective if follow-up was less 0.85 ± 0.06 from the receiver operator curve). Despite rela-
than 12 m or 1–5 years or more than 5 years. Despite such tively low rates of bladder or urethral injuries [78], it remains
equivalence, more RCTs have short-term follow-up and are prudent to confirm the integrity of the lower urinary tract by
often not powered to examine important subgroups, such as routine cystourethroscopy following any midurethral sling
patients with intrinsic sphincteric deficiency (ISD) who have procedures. The presence of intravesical mesh in the long
the most severe form of SUI. However, a more recent sys- term can cause bladder pain, irritative urinary symptoms,
tematic review [47] reached a different conclusion. It found recurrent urinary tract infections and stone formation.
transobturator route has poorer objective (OR 0.82; 95% CI Recognition of bladder perforation with trocar replacement
0.70, 0.96) and subjective (OR 0.83; 95% CI 0.70, 0.98) cure appears to have no long-term sequelae.
rates compared with the retropubic route.
Analysis of randomized data comparing the RP and TO
approaches confirmed that the TO approach comes with 21.4 Predictors of Failure
lower odds of bladder perforations (odds ratio (OR) 0.13
(95% CI 0.06, 0.27) [50]), pelvic haematoma (OR 0.25 (95% Despite impressive cure rates for SUI, failure can occur, with
CI 0.05, 0.82) [78]) and symptoms of voiding dysfunction reoperation rates ranging from 1.2% to 7% [50, 82]. It is
(OR 0.55 (95% CI 0.31, 0.98) [79]). Nevertheless the TO unclear whether there are clinical factors that place a patient
approach comes with a higher odds of vaginal perforations at higher risk for objective or subjective failure, since most
(OR 2.08 (95% CI 0.89, 4.95) [79]) and groin ache (OR 9.34 RCTs are not powered for subgroup analyses. Combining
(95% CI 3.02, 28.9) [79]). The 2016 Cochrane review [17] data from heterogenous RCTs would also limit precision,
confirmed their similar vaginal mesh exposure rate (2.1– reflecting inherent limitations of meta-analysis [83].
21 Selection of Midurethral Slings for Women with Stress Urinary Incontinence 309
Nevertheless, it remains a clinical priority to ascertain clinical nence rate by urodynamic definition at 6 months compared
risk factors that could accurately predict surgical failures. to women with higher MUCP (58% vs. 90%, p < 0.01). The
Identification of risk factors could facilitate preoperative largest RCT to date examining the effectiveness of RP vs.
counselling and potentially allow modification of the surgi- TO specifically in ISD patients (VLPP < 60 cm H2O and/or
cal approach to optimize patient outcomes. MUCP < 20 cm H2O) studied at least 164 patients [58]. This
Factors known to influence treatment success after sur- RCT demonstrated a clear superiority in efficacy for the RP
gery for SUI include ageing, medical comorbidities, inconti- route in the treatment of female SUI with ISD, compared to
nence severity, previous anti-incontinence surgery, recurrent the TO approach, as 1 in 16 women requested repeat surgery
SUI, concurrent prolapse procedure, urethral mobility and in the RP group compared to 1 in 6 within the TO group, with
function and the presence or absence of concurrent urgency the risk ratio of repeat surgery being 2.6 (95% CI 0.9, 9.3).
urinary incontinence (UUI) [84]. Retrospective analysis, The importance of urethral closure pressure was further
using multiple logistic regression analysis, of over 1100 highlighted in non-randomized studies that use a combina-
women who underwent MUS at our department has indi- tion of VLPP and MUCP [91, 92]. These studies have shown
cated that BMI > 25 kg/m2, mixed urinary incontinence higher failure rate (postoperative USI risk ratio (RR) 5.89;
(MUI), previous continence surgery (ISD) and diabetes mel- 95% CI 1.02–33.90) [85] and lower success (54.5% vs.
litus are independent risk factors for subjective failure, with 95.8%, p = 0.006) [92] when VLPP < 60 cm H2O and
concomitant prolapse operation conferring a protective effect MUCP < 42 cm H2O were present in women undergoing the
[85]. While there may be significant inconsistency in the lit- TO approach.
erature in this regard, with most studies being retrospective, In a further analysis of the Cochrane review [17], focus-
poorly designed and underpowered, and failing to control for ing only on those with intrinsic sphincter deficiency, retropu-
confounding variables or lacking consistency in evaluation bic route confers greater objective, subjective cure rates
or follow-up [84, 86], data regarding some of these areas are compared with transobturator route, resulting in a higher risk
emerging from randomized trials. of repeat continence surgery in those who had prior transob-
turator sling (RR 14.4; 95% CI 2.0–106).
21.4.3 The Elderly dure with a mean follow-up of 50 months [110] demonstrat-
ing an overall subjective cure rate of 85% (elderly 81%,
Ageing causes functional and anatomical changes in the younger 85%, p = 0.32), with no significant difference in cure
lower urinary tract. The ageing lower urinary tract has a rate between the retropubic and transobturator sling in the
higher rate of detrusor overactivity, urgency incontinence elderly group (82% vs. 79.3%, p = 0.75). The bladder perfo-
and ISD. Older women are also more likely to have had prior ration rate was similar between the two groups (3%). The
procedures for urinary incontinence and therefore may have hospitalization time was significantly longer in the elderly
higher rates of urethral fixation. Severe vaginal atrophy (1.6 ± 1.7 days vs. 0.7 ± 1.1 days, p < 0.001). It is our practice
related to long-standing lack of oestrogen support of the vag- to routinely keep women over 80 years in hospital overnight,
inal tissues in the older woman could potentially pose a as opposed to using day surgery for MUS in younger women.
greater risk of poor healing and erosion after vaginal incon- Major perioperative complications were uncommon (1%). Of
tinence surgery. It should come as no surprise that older age the patients who had an isolated sling procedure, 37% of the
is associated with greater risks of post-sling surgery compli- elderly and 9% of the young patients failed their first trial
cations [100] and postoperative morbidity and mortality, voiding (p < 0.001). However, the long-term rate of voiding
with their higher incidence of medical comorbidities when difficulty was similar between the two groups (elderly 8% vs.
subjected to more major open abdominal and vaginal surgi- young 6%, p = 0.21). The rate of de novo urge incontinence
cal procedures in the past [101, 102]. was similar between the two groups (7%).
Concerns regarding worse outcomes might have contrib- Midurethral slings are effective in alleviating the burden
uted to under-treatment of elderly woman in the past, with of urinary incontinence in elderly woman. There are differ-
literature demonstrating underrepresentation of women aged ences in reported cure rates following TVT in the elderly
over 70 years in SUI surgical trials [103], and elderly woman woman with SUI, with less data for TVTO or Monarc slings.
not receiving SUI surgery as often as younger woman [104]. Older women undergoing midurethral sling surgery can
A recent RCT demonstrated that at 6 months post- expect continence rates that compare favourably to those of
randomization, a group of elderly women over age of 70 who younger women.
underwent immediate TVT surgery had significantly
improved quality of life and patient satisfaction and fewer
urinary problems compared to a control group waiting for 21.4.4 The Obese
the same surgery [105]. The rates of intraoperative and post-
operative complications were similar to those observed in Women who are significantly overweight are more likely to
younger groups of women. Despite an age-related higher have stress and urge urinary incontinence and failed stress
risk from surgery, invasive treatment of SUI in elderly incontinence surgery [111].
women is better than no treatment. Two observational studies with short follow-up of
Divergence in cure rates has been reported in comparative 6 months [112, 113] have not identified BMI as a predictor of
studies involving elderly woman who underwent TVT for surgical failure following TVT. In contrast, a study of 760
SUI [106]. Cure rates ranged from 45% to 93% for elderly women, with 5-year follow-up after TVT, has demonstrated
woman versus 73–95% for younger woman. Contributors to a higher overall cure rate in women of normal weight com-
such differing results include considerable differences pared to those with BMI > 35 kg/m2 (81.2% vs. 52.1%,
between the studies in length of follow-up, definition of cure, p = 0.0005) [114]. In a multivariate analysis of 138 women
methodologies and cut-offs, for ages ranging from 65 to following TVT 5 years later [115], lower cure rates were also
76 years. In an analysis of risk factors for failure, following reported in women with BMI > 25 kg/m2 (68.3% vs. 83.3%,
a TVTO procedure involving 54 women with a mean follow- p = 0.044). In our multivariate analysis of 1225 women,
up of 9 months [107], age and previous incontinence surgery BMI > 25 kg/m2 was again found to be an independent risk
were identified as risk factors for surgical failure on univari- factor for surgical failure, confirming earlier reports, although
ate analysis, although their significance was lost following there is no difference in failure rate between the type of
multivariate analysis. Studies analysing failure following slings for obese women [85].
TVT [108], or TVT and Monarc [82], have identified age as
a risk factor for surgical failure. Larger studies with longer
follow-up have not demonstrated age to be a risk factor fol- 21.5 Biological Slings and Exitless Slings
lowing multiple logistic regressions [109].
A recent large retrospective study from our hospital Suburethral autologous pubovaginal slings have been used
reported outcomes involving 1225 women (96 are more than since first described by Aldridge in 1942. The increasing
80 years of age) who underwent a midurethral sling proce- popularity of minimally invasive midurethral slings has also
21 Selection of Midurethral Slings for Women with Stress Urinary Incontinence 311
led to the use of biological products in sling techniques. The Reported data on the efficacy of Pelvicol slings for the
purported advantages of using non-autologous xenografts treatment of female SUI, apart from one RCT, showed infe-
include avoidance of harvesting, minimal dissection with riority over existing suburethral slings. Data on other bio-
lower perioperative morbidity as well as possible lower rates logical slings are too few to make a definitive clinical
of infection and erosion. Although reports are sparse, ero- conclusion. The updated National Institute for Health and
sions do occur [116, 117]. Clinical Excellence (NICE) Interventional Procedures
Observational studies suggest Pelvicol (Pelvicol®, Bard Programme contains an overview of biological slings [123],
CR, Covington, GA, USA) is inferior when compared with echoing similar concerns about the long-term efficacy of the
autologous fascial pubovaginal slings or TVT in the treat- newer biological slings.
ment of women with SUI. A comparative study reported
3-year outcomes of 48 women who underwent Pelvicol or
autologous rectus fascial sling procedures, confirming an 21.5.1 Exitless Mini-Sling
inferior cure rate (54% vs. 80.4%, p = 0.009) [118]. Women
who underwent either autologous fascia pubovaginal sling or The drive towards minimally invasive MUS has led to the
TVT reported lower scores for symptom severity, in a cross- development of “exitless mini-slings”, the most popular of
sectional questionnaire survey of 173 women (81 autologous these being TVT-Secur (TVT-Secur®, Gynecare,
slings, 60 Pelvicol, 32 TVT) compared to those who had a Somerville, NJ, USA) [124] and MiniArc (MiniArc®,
Pelvicol pubovaginal sling [119]. American Medical Systems, Minnetonka, MN, USA). The
The only RCT comparing retropubic Pelvicol to TVT advantages claimed for these mini-slings over traditional
studied 132 women (74 Pelvicol, 68 TVT) with 3-year fol- RP or TO MUSs mainly relate to avoiding the retropubic
low-up using a non-validated questionnaire. Assuming lost space, limiting the passage of materials through spaces
to follow-up data as failures (4 Pelvicol, 7 TVT), comparable containing known vessels, nerves and viscera. Early studies
cure rates were observed for Pelvicol (77.8%) and for TVT of TVT-Secur and MiniArc reported short-term cure rates
(79.1%) [120]. Similarly, there was no statistically signifi- of 70.4–93.5% [125–127] and 75.7–90.2%, respectively
cant difference in the rates of frequency, nocturia, de novo [127, 128]. Despite being all classified as single incision or
urgency or dyspareunia between the two groups. A similar mini-slings, TVT-Secur®, MiniArc® (AMS, Minnetonka,
RCT comparing transobturator porcine dermis to transobtu- MN, USA), Solyx® (Boston Scientific, Natick MA, USA),
rator synthetic polypropylene reported its 2-year outcomes Ajust® (Bard, New Providence NJ, USA), Altis® (Coloplast,
(75 porcine dermis, 76 synthetic) in an abstract in 2008 Minneapolis, MN, USA), Ophira® (Promedon, Cordoba,
[121]. Favourable results seen at 12 months (89.5% vs. Argentina) and TFS (TFS, South Australia) have macro-
90.8%) were not replicated at 24 months, with the biological scopically very different anchorage systems. In a system-
group reporting a higher failure rate 21.3% vs. 10.5%. atic comparative analysis [129] of mini-slings against
Another recent RCT comparing TVT, Pelvicol and autol- standard midurethral slings, mini-slings were shown to
ogous fascial slings reported its interim results at the have inferior efficacy. TVT-Secur has the largest sample in
International Continence Society (ICS) meeting in 2008. this analysis and possibly has the least “secure” anchorage
Powered to have at least 76 women in each arm, using vali- mechanism. When TVT-Secur was excluded, efficacy of
dated questionnaires, the authors reported a significant mini-slings was comparable to standard MUS. A 3-year
reduction in recruitment, possibly due to increasing popular- Dutch RCT [130] comparing Monarc with MiniArc showed
ity of TVT. In their interim analysis of 115 patients (30 TVT, similar objective and subjective cure rates. A similar
35 Pelvicol, 50 autologous), there was no detectable differ- Australian RCT [131] with 5-year follow-up was recently
ence in clinical outcome (dry rate, improvement rate, reop- reported, demonstrating similar efficacy between Monarc
eration rate and self-catheterization rate) between TVT and and MiniArc, with minimal complications. Nevertheless,
autologous slings, although TVT utilized less operating time mini-slings do come with likely higher learning curve and
and postoperative in-hospital length of stay [122]. Pelvicol at best only have similar efficacy against transobturator
slings, however, had significantly lower improved and dry sling and most likely might have lower cure rates against
rates at 12 months (61% and 22%), compared to TVT (93% those with higher risks for failure, including ISD, obesity
and 55%) or autologous slings (90% and 48%) (p < 0.0015). and previous failed surgery. Quite a few of these mini-
Not surprisingly, Pelvicol also had a significantly higher slings were either deregistered, withdrawn or no longer
reoperation rate of 20% compared to 0% for TVT or autolo- supplied with Solyx, Ophira and Altis available at the time
gous slings. of writing (Fig. 21.3).
312 J. K.-S. Lee and P. L. Dwyer
21.7 Summary
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pubovaginal sling versus tension-free vaginal tape for treatment of
Tape Positioning: Does It Matter?
22
Aparna Hegde and G. Willy Davila
22.1 Introduction
A. Hegde (*)
Tata Center for Urogynecology and Pelvic Health, Mumbai and the
Center for Urogynecology and Pelvic Health, New Delhi, India
e-mail: aparnag.hegde@gmail.com
G. W. Davila
Section of Urogynecology and Reconstructive Pelvic Surgery, Fig. 22.1 Transperineal ultrasound. Midsagittal plane view. The tran-
Department of Gynecology, Cleveland Clinic Florida, sobturator sling can be seen as a slightly curved echodense structure
Weston, FL, USA lying beneath the midurethra. AC anal canal, B bladder, LA levator ani
e-mail: davilag@ccf.org S sling, SP symphysis pubis, T transducer, U urethra, V vagina
the pubourethral ligaments. It could potentially also supplant 22.3.1 The Controversy Regarding Sling
the suburethral hammock support. Location and the Evidence on the
Various articles describing the procedure therefore Importance of Sling Location
emphasized the importance of placing the tape midurethrally
without fixation or elevation of the urethra/bladder neck Though midurethral location is theoretically important, well-
complex and not near the bladder neck or at the proximal designed studies that conclusively establish the relevance of
urethra [6, 16]. sling location are lacking. The available studies differ in the
ultrasound imaging techniques employed and point of refer-
ence used to measure sling location. These variations impact
22.3 P
roposed Mechanism of Action the results of the studies, and hence it is imperative that we
of the Midurethral Tape read the fine details of each study before drawing any
inference.
Given the central role of the midurethral sling in the treat- For example, in a prospective observational study of 142
ment of SUI, it is surprising that its mechanism of action is women whose outcomes were evaluated 5 weeks to 2.1 years
not entirely understood. This is owed significantly to the following TVT sling surgery, Dietz et al. concluded that the
fact that the underlying theories described above are still position and mobility of the TVT vary markedly [7]. Using
hypotheses—largely unproven. It has been described that transperineal ultrasound, the tape position in their study was
midurethral positioning allows the tape to act as a fulcrum found to vary from 30 mm above to 12.7 mm below the sym-
to produce dynamic kinking of the urethra [17, 18] or act as physis pubis at rest and between 15 mm above and 18.7 mm
a mechanical device to enhance the increase in intraurethral below the symphysis pubis on Valsalva [7]. They hypothe-
pressure [19, 20] with stress [9]. The dynamic kinking and sized that the varying degrees of dissection, the localization
formation of a “knee angle” has been shown to be present in of incision, and the preoperative degree of anterior vaginal
approximately 90% of cured patients following TVT sling wall prolapse may be responsible for the same. They also
surgery [14, 21–26] but in only 24–50% of patients who are found that variations in placement seemed to have little
continent following the transobturator procedure [14, 19, effect on symptom resolution and patient satisfaction. The
26, 27]. According to Yang et al. [20], the main anti-inconti- key differentiator in this study is the fact that they have used
nence mechanism of TOT is urethral encroachment by the the symphysis pubis as the reference point for determining
tape which they described on ultrasound as a protrusion of sling location, largely because they contend that midurethral
the tape into the posterior wall of the urethra, with a tran- slings work by “dynamic compression,” i.e., kinking or com-
sient narrowing of its lumen [20, 24]. It has also been pression of the urethra against the posteroinferior contour of
described that during Valsalva maneuver, the TVT tape the pubic symphysis whenever intra-abdominal pressure is
rotates toward the symphysis pubis, compressing the urethra raised [6]. Therefore in their reckoning, it should not matter
and the surrounding tissues [21, 23, 28]. These different much for success as to whether the urethra is compressed
descriptions by various authors cohere around the centrality proximally or distally. A criticism that can be levied at this
of “dynamic compression” of the urethra in the continence paper is that while dynamic compression of the urethra may
mechanism of the tape. be an important component of the continence mechanism,
Placement of the tape does not change the mobility of the role of the symphysis pubis as the focal point for mea-
the proximal urethra in either TVT or TOT tape [19, 20, surement of dynamic effect has not been proven. In the sce-
29]. Several studies do, however, indicate a transient nario that it does act as the focal point against which the
effect on bladder neck mobility in both the TVT [23, 24, compression occurs, is the distance of the sling from the
29–37] and TOT tapes [19, 20, 29]. It may be speculated symphysis pubis an accurate indicator for all the dynamic
that this short-lived restriction of the bladder mobility components involved in such a compression mechanism?
shortly after surgery results from the effect of healing or It must be mentioned that the results of this paper are sup-
from less effective Valsalva maneuver due to pain or anxi- ported by two smaller studies: In a study of 31 patients who
ety over “spoiling” the effect of the cure [38]. If placed underwent TVT sling surgery, all enrolled women were con-
correctly, the TVT tape lies close to the high-pressure tinent though the sling was located midurethrally in only 21
zone of the urethra [2]; hence in a majority of cured women [8]. Another study used metal clips and an X-ray-
patients, a positive pressure transmission in the middle proof string to mark the TVT sling location intraoperatively
portion of the urethra is observed during urethral pressure and found that all the 20 women were continent postopera-
profilometry [24]. The maximal urethral closure pressure tively though the sling was located under the proximal ure-
and the urethral closure area appear to increase after a thra in only 11 patients [6]. Lo et al. [11] observed urethral
TVT procedure [26]. No effect of TVT-O insertion on ure- kinking in five out of ten women with tapes implanted under
thral pressure profilometry has been observed [26, 38]. the proximal urethra [25]. It is probable that if the tape is
320 A. Hegde and G. W. Davila
the sling is placed precisely at the midurethral location, it is found to be significantly more in Group B when compared
more likely to remain in the desired position with respect to with Group A (OR, 2.21; 95% CI, 1.027–4.77, p = 0.04).
the urethral length. In order to understand whether the transobturator route of
Another iatrogenic reason for the displacement of the the surgery was a potential confounder to the study results,
sling may potentially be the placement of the sling through we expanded the study to include 40 patients who had under-
the same incision as that used for anterior vaginal wall repair gone TVT sling surgery in a third group (unpublished data,
in women undergoing concomitant anterior vaginal wall [11]). In the TVT group also, only 14 (35%) patients had the
repair and sling surgery. In a prospective cohort study of 100 sling in the desired midurethral location when compared to
women who underwent TOT sling surgery at Cleveland 31 (77.5%) in the pubovaginal sling group. When we looked
Clinic Florida [34], we found, using 3D endovaginal ultra- at tape percentile (the distance of the midpoint of the sling
sound, that 50% of patients who had undergone concomitant from the urethrovesical junction divided by the urethral
anterior vaginal wall repair (Group A) had the sling located length), the tape location in the patients who had undergone
proximally as opposed to only 23.8% of patients in whom TOT sling surgery was found to be more proximal than that
only sling surgery was performed (Group B; p < 0.05). in patients who had undergone TVT sling surgery; however,
Nineteen percent of the patients in Group A had the sling it was not statistically significant (p = 0.254). There may be
located proximal to the urethrovesical junction as opposed to other confounders that we have not accounted for, including
4.8% of patients in Group B (p < 0.05). All the patients who the difference in elasticity and flexibility of the slings; how-
had the sling located proximal to the urethrovesical junction ever, the study results do suggest that suture-fixating the tape
had suboptimal treatment outcomes following surgery. Thus in place during implantation is associated with desired sling
patients who undergo transobturator sling surgery, with con- location a year following surgery [11]. The ideal next step in
comitant anterior vaginal wall repair performed through the conclusively solving this piece of the puzzle may be a trial in
same incision, are more likely to have the sling located more which patients are randomized into a study group where
proximally when compared with patients who undergo tran- suture fixation is done and control group without suture fixa-
sobturator sling surgery alone. tion followed by determination of sling location using ultra-
sound a year after sling surgery.
suboptimal outcomes [9]. The deformability of the sling on Concordance of urethral movement with the sling during
Valsalva, the concordance of urethral movement with the maximal Valsalva (Figs. 22.11 and 22.12) The 3D cube
sling, and the location of the sling were noted in each patient obtained over 30 s at rest was analyzed to determine the loca-
at 1-year follow-up point with the help of 2D and 3D trans- tion of the sling relative to the urethral length at rest. The
perineal ultrasound. Two-dimensional dynamic assessment sling location at rest was compared to that on maximal
of sling function was performed during cough, Valsalva, and Valsalva. If the sling location on maximal Valsalva relative to
squeeze maneuvers. Three-dimensional cubes of the anterior the urethral length was identical to that at rest, the urethra
pelvic compartment were obtained in each patient, over 6 s was considered to move concordant with the sling [9]. If the
across the midsagittal plane in maximal Valsalva and over sling location on maximal Valsalva relative to the urethral
30 s at rest.
Fig. 22.9 Transperineal ultrasound. Midsagittal view. TVT sling (S) Fig. 22.11 Transperineal ultrasound. Midsagittal view. Transobturator
flat at both rest and on cough/Valsalva. B bladder, SP symphysis pubis, sling (S), located midurethrally at rest. B bladder, SP symphysis pubis,
T transducer, U urethra T transducer, U urethra
324 A. Hegde and G. W. Davila
the sling was c-shaped along its width at rest and on strain- Is sling location at rest correlated with de novo and persis-
ing, the failure rate was 10%. tent overactive bladder symptoms following sling surgery?
Kociszewski et al. hypothesized that a sling that remains We conducted a prospective cohort study in 104 patients
c-shaped both at rest and on straining is likely to have been with urodynamic stress or mixed incontinence who under-
placed too tightly [10]. While it is conceivable that for proper went sling surgery: 64 patients underwent transobturator
functioning the tape should remain at a certain distance from sling surgery, and 40 patients underwent retropubic midure-
the urethral lumen, there is no clear understanding of what thral sling surgery [46]. All patients answered the UDI-6 and
that optimal distance is. The risk of failure has been found to the OAB-sf validated questionnaires at 1-year follow-up
be increased fivefold if this distance is greater than 5 mm, visit. The location of the sling (as determined on 3D endo-
and when it is shorter than 3 mm, the risk of developing post- vaginal ultrasound) was not found to be associated with
operative voiding dysfunctions or overactive bladder development of de novo urgency incontinence, persistence,
symptoms due to bladder outlet obstruction is significantly or resolution of urgency symptoms in patients who under-
increased [38]. went transobturator sling surgery. However, in the patients
who underwent retropublic sling surgery, though the location
of the sling had no association with the development of de
22.7 T
ape Position and Postoperative novo urgency incontinence, persistence of urgency symp-
Complications toms was significantly more in those patients in whom the
sling was not placed midurethrally (p = 0.005). Similarly,
A subset of patients will develop voiding dysfunction or de resolution of urgency symptoms in patients who underwent
novo overactive bladder symptoms following midurethral retropubic sling surgery was significantly more in those
sling procedures [38]. Hypothetically, the risk of these com- patients in whom the sling was placed midurethrally as
plications is higher when the tape is positioned too close to opposed to altered locations (p = 0.034). The transformed
the bladder neck, but it remains controversial if this really symptom severity score and the transformed HRQL subscale
plays a critical role [38]. Ducarme et al. [42] showed that the scores of OAB-sf were not associated with development of
tape was located closer to the bladder neck in patients with de novo urgency incontinence, persistence, or resolution of
postoperative voiding dysfunction. However, they found that urgency symptoms in patients who underwent transobturator
in patients who developed de novo urgency incontinence, the sling surgery (p > 0.05). However, in patients who under-
tape was located closer to the external urethral meatus [42]. went retropubic sling surgery, the transformed symptom
These observations have been disputed by others [7, 29]. It is severity score was significantly lower, and the quality of life
much more likely that the risk of voiding dysfunction and de subscales were significantly better when the sling was placed
novo urgency increases when the tape is inserted too tightly. midurethrally (p < 0.05).
In the study by Dietz et al. [7], the incidence of these compli-
cations correlated with more cranial positioning of the tape.
Kociszewski et al. [10] only observed complications in 22.8 Future Directions
patients with a distance of less than 3 mm between the tape
and the urethral lumen. Furthermore, as described above, There is increasing evidence being generated regarding
they contend that if the tape has a c-shaped appearance, it sling function and the influence of tape positioning on surgi-
indicates that it was not placed in a tension-free manner. cal outcomes. However, the need of the hour is standardiza-
They found that it was associated with sixfold higher risk of tion of terminology and technique of sonographic assessment
postoperative complications [10]. Similarly, after a TVT-O that forms the backbone of much of the evidence. The evi-
procedure, signs of tight tape placement, such as urethral dence is also quite fragmented, and the quality of the studies
encroachment at rest and a distance at rest of less than 12 mm is debatable. There is, hence, a need to conduct if not ran-
between the tape and the symphysis pubis, were found to be domized controlled trials, then prospective cohort studies, at
associated with development of voiding dysfunction [20]. least, to conclusively prove the impact of sling location on
Postoperative complications after TVT-O may also be outcomes following sling surgery. Multicenter trials are
related to inadequate repositioning of the tape arms. If, on necessary. More robust studies are also necessary to conclu-
Valsalva maneuver, the arms are too close to each other (too sively understand dynamic sling behavior and whether it
narrow of a suburethral angulation), the risk of voiding dys- may prove useful to suture-fixate the sling. The influence of
function substantially increases. Closer angulation at retain- retropubic direction of sling placement on sling location
ing is associated with de novo urge incontinence [43]. when compared with the more horizontal transobturator
It is also apparent that voiding dysfunction may develop sling placement needs to be better delineated in the future.
in cases of intraoperatively unrecognized urinary tract perfo- Clinicians managing patients with stress incontinence
ration or urethral erosion by the tape [44, 45]. should familiarize themselves with the value of sonographic
326 A. Hegde and G. W. Davila
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namic evaluation after tension free vagina tape procedure (TVT). 40. Hegde A, Nogueiras M, Aguilar V, Davila GW. Should a subure-
Acta Obstet Gynecol Scand. 2001;80:65–70. thral sling be suture-fixated in place at the time of implantation? Int
25. Lo T-S, Horng S-G, Liang C-C, et al. Ultrasound assessment of Urogynecol J. 2013;24(Suppl 3):S60.
mid-urethra tape at three-year follow-up after tension free vaginal 41. Hegde A, Nogueiras M, Aguilar V, Davila GW. Dynamic assess-
tape procedure. Urology. 2004;63:671–5. ment of TVT sling function on transperineal ultrasound: is it cor-
26. Long CY, Hsu CS, Lo TS, et al. Clinical and ultrasonographic com- related with outcomes one year following surgery? Int Urogynecol
parison of tension-free vaginal tape and transobturator tape pro- J. 2014;25(Suppl 4):S34.
cedure for the treatment of stress urinary incontinence. J Minim 42. Ducarme G, Rey D, Ménard Y, Staerman F. Échographie endovagi-
Invasive Gynecol. 2008;15:425–30. nale et troubles mictionnels après TVT (tension free vaginal tape).
27. Foulot H, Uzan I, Chopin N, et al. Monarc transobturator sling sys- Gynecol Obstet Fertil. 2004;2:18–22.
tem for the treatment of female urinary stress incontinence: results 43. Chene G, Cotte B, Tardieu A-S, et al. Clinical and ultrasonographic
of a postoperative transvaginal ultrasonography. Int Urogynecol J correlations following three surgical anti-incontinence procedures
Pelvic Floor Dysfunct. 2007;18:857–67. (TOT, TVT and TVT-O). Int Urogynecol J. 2008;19:1125–31.
28. Dietz HP, Wilson PD. The ‘iris effect’: how two-dimensional
44. Tunn R, Gauruder-Burmester A, Kolle D. Ultrasound diagnosis of
and three-dimensional ultrasound can help us understand intra-urethral tension-free vaginal tape (TVT) position as a cause of
anti-
incontinence procedure. Ultrasound Obstet Gynecol. postoperative voiding dysfunction and retropubic pain. Ultrasound
2004;23:267–71. Obstet Gynecol. 2004;23:298–301.
29. de Tayrac R, Deffieux X, Resten A, et al. A transvaginal ultrasound 45. Vassallo BJ, Kleeman SD, Segal J, Karram MM. Urethral erosion
study comparing transobturator tape and tension free vaginal tape of a tension-free vaginal tape. Obstet Gynecol. 2003;101:1055–8.
after surgical treatment of female stress urinary incontinence. Int 46. Hegde A, Hurezeanu G, Nogueiras V, Aguilar V, Davila GW. Is sling
Urogynecol J Pelvic Floor Dysfunct. 2006;17:466–71. location at rest correlated with denovo and persistent overactive
30. Viereck V, Nebel M, Bader W, et al. Role of bladder neck mobil- bladder symptoms following transobturator and retropubic midure-
ity and urethral closure pressure in predicting outcome of tension- thral sling surgery? Int Urogynecol J. 2014;25(Suppl):S151–2.
Colposuspension and Fascial Sling
23
Fiona Reid
a b
Fig. 23.3 (a) Delayed perforation of bladder by ethibond suture over 10 years after colposuspension. (b) Ethibond sutures removed from bladder
after delayed perforation
Obturator internus
muscle and fascia
Obturator
canal
bite”. Most surgeons insert two sutures either side of the palpating the catheter balloon whilst applying gentle down-
urethra, hence four in total; however some only insert one ward traction on the urethral catheter. At this level the sutures
suture on each side and others up to three or four each are placed as far lateral as possible in the vagina (Fig. 23.4).
side. There is no evidence to support or refute these varia- The sutures are then passed laterally through Cooper’s
tions in practice. ligament (iliopectineal ligament). However, care should be
Some surgeons prefer to fill the bladder with approxi- taken not to extend the lateral dissection too far due to risk of
mately 200 mL of diluted methylene blue to aid identifica- injury to the obturator bundle.
tion of its lateral margins and demonstrate any inadvertent The vagina should be elevated to “just enough” to support
cystotomy. Some surgeons advocate cystoscopy following the bladder neck. It is important not to over elevate the
the insertion of the sutures to exclude sutures in the bladder vagina. Usually there is some bow stringing of the sutures
or ureteric injury. The incidence of which is unknown but between the vagina and Cooper’s ligament, which is a con-
probably rare. siderable difference between the modern colposuspension
Tanagho recommends placing the suspension sutures as and that described by Burch (Fig. 23.5a, b).
far lateral as possible in the vagina, with two sutures on each The variation in the type, number and the placement of
side. The first suture is placed at the level of the mid-urethra sutures and degree of elevation may account for variation in
and the second at the urethra-vesical junction, identified by outcome between surgeons performing colposuspension.
332 F. Reid
a b
Fig. 23.5 (a) Normal position colposuspension sutures with bow stringing. (b) Space of Retzius: Colposuspension sutures lateral to previous TVT
The development of the shorter sling on a string placed in that in both arms of the intervention, the surgeons are trained
a similar manner to a TVT has lead more clinicians to offer and have completed enough cases to ensure their learning
women a fascial sling as a primary procedure. curve is complete.
Also both arms of the study should use the same number
and type of sutures.
23.3.5 Contraindications An economic review from three RCTs found that tension-
free vaginal tape (TVT) may be more cost-effective than
A patient who has a high risk of retropubic bowel adhesions laparoscopic colposuspension which in turn may be more
should probably not be considered for a fascial sling expect cost-effective than open retropubic colposuspension [21].
a patient who has a high risk of bowel adhesions in the retro-
pubic space.
If the woman has had extensive previous abdominal sur- 23.6 D
o the Sutures Used
gery or a previous abdominal hernia, this will make it techni- for a Colposuspension Affect
cally difficult to harvest a sling from the abdominal wall, and Outcome?
fascia lata may be more appropriate.
Obesity will make the surgery more challenging and may There is only one study comparing different numbers of sus-
increase the risk of haemorrhage and hernia. pension sutures, one each side compared to two [22]. The
study found subjective cure rates of 89% women randomized
to two sutures compared with only 65% in those randomize
23.4 Outcomes of Colposuspension to one suture. There are no trials comparing the type of
and Fascial Sling sutures, whether absorbable sutures are as effective as
non-absorbable.
Assessing the outcome of surgery for stress urinary inconti-
nence is complex.
Most commonly, researchers report cure as “the dry rate”, 23.7 I s Colposuspension as Effective
the resolution leakage from SUI. The “dry” rate for a proce- as an Autologous Fascial Sling?
dure does not reflect the potential impact that other compli-
cations can have such as voiding difficulties and overactive The most recent Cochrane review of colposuspension in 2017
bladder. A patient global impression score is useful; however included 55 trials involving a total of 5417 women [23].
this can probably be influenced by other factors such as pre- A subgroup analysis of studies comparing “traditional
operative counseling. slings” and open colposuspension showed better effectiveness
The best evidence available is from multicentre RCTs with with traditional slings, than open colposuspension, in the
long-term follow-up using multiple outcome measures. Long- medium and long term (RR 1.35; 95% CI 1.11–1.64 from 1 to
term outcomes, over 5 years, are required as surgical success 5 years follow-up, RR 1.19; 95% CI 1.03–1.37). Voiding diffi-
of some procedures is known to decline with time [17, 18]. culties were more common following a sling procedure; how-
The NICE guidance (2013) for Urinary Incontinence in ever the incidence of posterior compartment prolapse was
Women contains a comprehensive summary of both random- greater following colposuspension. The term “traditional fas-
ized trials, cohort and case series of all continence surgery cial sling” covers a significant group of procedures. In the
including fascial slings, in Appendix H (https://www.nice.org. recent Cochrane review, trials using autologous slings placed at
uk/guidance/cg171/evidence/appendix-h-pdf-191581167). the mid-urethra and those placed at bladder neck were included
in a common analysis. They also included allograft, xenograft
and synthetic slings. From this heterogenous collection of pro-
23.5 I s Laparoscopic Colposuspension cedures, it is difficult to draw useful clinical conclusions.
as Effective as Open? The most recent International Consultation on
Incontinence (ICI), in 2017, concluded that the autologous
Up to 2 years after surgery, high-quality RCT evidence has fascial sling (AFS) is the most widely evaluated biological
shown that the subjective and objective outcome laparo- sling and is an effective and durable treatment for SUI (Level
scopic colposuspension is comparable to open colposuspen- 1 Evidence). They added the caveat that there was some evi-
sion [19, 20]. dence (Level 2) that autologous slings may be superior to
Burch, himself, was the ultimate pragmatist and said “the other biological materials [24].
present operation, like all operations, will probably not go The ICI stated that AFS is more effective than colposus-
too smoothly on the first few attempts but, once learn it goes pension at mid-long term (EL = 1/2) however AFS is associ-
much better”. It is important when reviewing trials to ensure ated with a higher rate of early postoperative voiding
336 F. Reid
dysfunction. Very limited data suggest that the overall rates Table 23.2 Different lengths of fascial sling
of late surgical complications are similar after sling and col- Cure rates
posuspension; however, the pattern of complications may Long detached fascial Short sling on fascial
vary. sling string
6 months 76–82% 77–83%
AFS were found to be as effective as polypropylene MUS
Over 29–62% 44–57%
in the short term (Level 1); however the operating time and 5 years
length of stay was significantly short for the MUS [24].
The SISTEr trial was a large high-quality multicentre
RCT of Burch and Sling on a String; 655 women were ran- 23.10 I s an Autologous Sling Better at the
domized, 326 to a sling and 329 to a colposuspension. Mid-Urethra or the Bladder Neck?
Success rates were higher for women who underwent the
sling procedure than for those who had a colposuspension There has been a move to use a modified TVT introducer to
(66% vs. 49%, p < 0.001). However, more women who insert an autologous sling on a string at the level of the mid-
underwent the sling procedure had urinary tract infections, urethra rather than the bladder neck. This also avoids the
difficulty voiding and postoperative urge incontinence [25]. need to perform the formal retropubic dissection of the Cave
of Retzius [14, 15].
There are no trials comparing AFS at UVJ versus mid-
23.8 I s the Sling on a String as Effective urethra; however there is one trial which demonstrates that
as the Traditional Aldridge Sling? AFS at the mid-urethral which some are calling aTVT
(autologous TVT) is as effective as synthetic polypropylene
Since the millennium most “traditional slings” reports in the TVT. The multicentre study recruited 79 women to undergo
literature are for detached slings made from autologous rec- the “autologus TVT” and 72 to polypropylene TVT. At 1
tus sheath. There are no randomized trials comparing an year there was no statistically significant difference in sub-
attached sling (Aldridge) to the detached (Blaivas) version. jective cure rates between the “autologus TVT” (90%) and
Hence it is not possible to determine if cure, incisional her- polypropyleneTVT (93%) [14].
nia, pain, detrusor overactivity or voiding dysfunction are
affected by either technique. However the attached (Aldridge)
sling requires greater dissection of rectus sheath and may 23.11 I s Fascia Lata as Effective as Rectus
theoretically have a greater risk of incisional hernia but pro- Sheath Fascia?
ponents suggest it has a lower incidence of voiding
difficulties. Fascia lata can be harvested from the lateral thigh. There are
no randomized trials or cohort studies comparing fascia lata
to rectus fascia slings.
23.9 I s a Shorter Sling on a String
as Effective as a Full Length
Detached Sling? 23.12 A
re Allografts as Effective
as Autologous Slings?
There is one RCT which compared two detached autologous
rectus sheath fascias, a long sling (20 cm × 1.5 cm) to a There are no RCT data to compare cadaveric slings to autol-
shorter sling on a string (8–10 cm × 1.5 cm). The study ran- ogous slings.
domized 165 women, 81 to the long sling and 84 to the short
sling on a string. Long-term follow-up, between 61 and
89 months (average 6 years), was achieved in 56/81 and 23.13 A
re Xenograft Slings as Effective
69/84 for the long and shorter sling, respectively [26]. as Autologous Slings?
Women were followed up at five regular time intervals.
At the last recorded long-term follow-up, there was still a There is a multicentre RCT which at 1 year found that the
trend towards baseline for the IIQ-7 and UDI-6 scores. subjective success of TVT, AFS and Pelvicol® were 93%,
However there was no difference between the two groups 90% and 61% respectively. The trial stopped the recruitment
(Table 23.2). to Pelvicol due to poor outcomes. One in seven patients in
One woman in the 20 cm sling and four in shorter sling the Pelvicol group underwent repeat sling surgery for early
group had the sling surgically released. At long-term follow- failures. At a median follow-up of 10 (range 6.6–12.6) years,
up, three women from each group performed regular self- subjective success rates for TVT and AFS were 73% and
catheterization. There were no reported incisional hernias. 75% respectively [17].
23 Colposuspension and Fascial Sling 337
23. Lapitan MCM, Cody JD, Mashayekhi A. Open retropubic colpo- nary incontinence in women: short, medium and long-term follow-
suspension for urinary incontinence in women. Cochrane Database up. Int Urogynecol J. 2007;18(11):1263–70.
Syst Rev. 2017;(7):CD002912. 27.
Abdel-Fattah M, Barrington JW, Arunkalaivanan
24. Rovner E. Surgery for urinary incontinence in women. In:
AS. Pelvicol((TM)) pubovaginal sling versus tension-free vagi-
Incontinence. 2017, ICUD ICS. Bristol: ICS. p. 1741–855. nal tape for treatment of urodynamic stress incontinence: a
25. Albo ME, et al. Burch colposuspension versus fascial sling to reduce prospective randomized three- year follow-up study. Eur Urol.
urinary stress incontinence. N Engl J Med. 2007;356(21):2143–55. 2004;46(5):629–35.
26. Guerrero K, et al. A randomised controlled trial comparing two
autologous fascial sling techniques for the treatment of stress uri-
Injectable Biomaterials
24
Tomi S. Mikkola
Stress urinary incontinence (SUI) affects millions of women 24.2 Safety of Urethral Bulking Agents
worldwide, and many are surgically treated with a lifetime
risk of SUI surgery being approximately 15% [1]. The cur- An ideal UBA should be biocompatible, hypoallergenic,
rent gold standard treatment of SUI is either retropubic or nonmigratory, and durable. Currently it is difficult to get an
transobturator midurethral sling. However, midurethral overview of the safety of the different products. Systematic
slings have recently become under scrutiny due to mesh reviews are based on low numbers of randomized controlled
complications including erosion, pain, and voiding difficul- trials (RCTs) that are moreover of moderate quality. A recent
ties [2]. These concerns have increased the interest in inject- extensive review show that UBAs have an overall complica-
able biomaterials as urethral bulking agents (UBAs) that tion rate of 32%; however, majority of these are non-severe
increase the central filler volume and thereby the power of and transient [8]. Despite this, more severe complications
the urethral sphincter [3]. Although UBAs are considered to such as periurethral abscesses and granulomas are seen. This
be particularly helpful in women with a low urethral closing appears to be strongly associated to the injectable biomate-
pressure (intrinsic sphincter deficiency), bulking is equally rial, mostly related to mini-particles suspended in a carrier
effective in both urethral hypermobility and intrinsic sphinc- gel such as dextranomer hyaluronic acid [9] but also to sili-
ter deficiency [3, 4], likely since often both are present to con elastomer such as cross-linked vinyl dimethyl
some extent in SUI patients. Various injectable biomaterials polydimethylsiloxane [8]. The mini-particles are not bio-
compatible and may elicit a chronic inflammatory response
that results in tissue hardness and in some patients leads to
Electronic Supplementary Material The online version of this calcification, erosion, and migration of the particles. In con-
chapter (https://doi.org/10.1007/978-3-030-40862-6_24) contains trast, non-particulate gels including cross-linked collagen
supplementary material, which is available to authorized users. (bovine collagen) and homogenous hydrogel (polyacryl-
amide hydrogel, PAGH) are biocompatible and not associ-
T. S. Mikkola (*) ated with chronic inflammation. Since bovine collagen
Department of Obstetrics and Gynecology, Helsinki University (Contigen) has been withdrawn from the market, at present
Central Hospital, Helsinki, Finland
e-mail: tomi.mikkola@hus.fi
PAGH is the only non-particulate gel with very good safety and thus, the literature lacks information about repeated
data [10–12]. injections or about the cost-effectiveness aspects of both first
The safety of UBA depends on the product itself, as well and repeated treatments.
as on the physician skills on performing the procedure. The When choosing the treatment of SUI, also patient’s goals
latter could be best managed by appropriate training and and expectations should be considered. It has been demon-
standardized methods. However, there are no standardized strated that women tend to be pragmatic in their overall
injection techniques that could be generalized to all UBAs. expectations regarding treatment outcome [18]. Furthermore,
When comparing paraurethral and transurethral injection when asked about attitudes and expectations with different
routes, lower complication rate and a trend towards better treatments, 57% of women preferred minor procedure with
subjective and objective outcomes favor transurethral injec- low risk of complications and are prepared to accept lower
tion [13, 14]. Furthermore, transurethral injections, such as success rate [18]. For this reason, the effectiveness of a pro-
PAGH, may be performed under visual control in order to cedure should be balanced with its invasiveness.
more accurately place the bolus of the material and confirm
the urethral coaptation. This also allows to determine the
used technique more precisely, and ideally the injection tech- 24.4 Future Directions
nique could be standardized and visually verified for studies
as well as for clinical training. The current technique for Majority of currently available UBA treatments appear safe;
PAGH is to inject under visual control approximately 1.5 cm however, the long-term efficacy particularly as primary treat-
from bladder neck four cushions that meet at midline (see ment remains to be determined. Since the current gold stan-
Video 24.1). Also after training it is important that surgeons dard treatment of SUI is either retropubic or transobturator
carry out a sufficient case load to maintain their skills and midurethral sling, UBAs should be compared to these treat-
recommended annual number is at least 20 cases [15]. ments in the typical SUI population. This is particularly
Although these numbers come mainly from SUI sling sur- important due to the recent concern about the mesh complica-
gery, they likely apply also for bulking procedures. tions affecting also midurethral slings. Currently one RCT
comparing PAGH and TVT sling is conducted (www.clinical-
trials.gov). A total of 224 women with primary SUI were ran-
24.3 Efficacy of Urethral Bulking Agents domized for TVT (n = 111) or PAHG (n = 113) treatment [19].
Primary outcomes were patient satisfaction, effectiveness, and
The Cochrane review from 2012 [13] on urethral injection complications at 1-year follow-up. Data were analyzed with
therapy for SUI concluded that the review of 14 trials, which an intention-to-treat basis. At 1-year follow-up, the median
included 2004 women, found some limited evidence that (IQR 25–75 percentile) satisfaction score (0–100) for TVT
UBA therapy can relieve SUI in women. However, before was 99 and for PAHG 85 (p < 0.001), and thus, PAHG did not
UBA therapy can be recommended as a standard first-line meet the non-inferiority criteria. Similarly as with objective
treatment for temporary or partial relief of symptomatic SUI, cure rates, the cough stress test was negative in 95% of TVT
further comparative RCTs are required [13]. Since 2012 new patients versus 66% of PAHG patients (p < 0.001). However,
studies have been conducted, particularly with more modern most perioperative complications (hematoma, bladder perfo-
and safe UBA, such as PAGH [12]. In a randomized, pro- ration, or urinary retention) and all reoperations due to compli-
spective, multicenter study, 345 women with SUI were cations were associated with TVT. Furthermore, at 1-year
treated with either PAGH or collagen gel [12]. At 12 months erosions, pelvic/implantation site pain and difficulty to empty
47.2% of patients with PAGH and 50% with collagen gel bladder were associated only with TVT.
were cured, and 77.1% and 70%, respectively, considered This trial will help to determine also the subjective and
themselves cured or improved. These 1 year results with objective long-term efficacy and if PAGH treatment could
PAGH are similar as in previous studies [16, 17]. With simi- have potential to become a more prominent first-line treat-
lar results in reviews assessing efficacy of different UBAs ment for SUI. In addition, more studies comparing the differ-
and particularly polydimethylsiloxane and PAGH [6, 7], ent UBA treatments, particularly with new products, are
66–89% subjective success rates at 12 months were detected. needed. Lastly, given the likely decline in efficacy of UBAs
In contrast, the objective success rates were less well docu- over time, follow-up periods in all future studies should be
mented ranging from 25% to 73% [7]. Furthermore, the 2–5 years to describe long-term outcomes and the need for
long-term efficacy of UBA treatments is not well determined, repeated injections.
24 Injectable Biomaterials 341
• The inflatable cuff (Fig. 25.1): The cuff surrounds the ure-
thra/bladder neck circumferentially. They range from 4 to
11 cm increasing by 0.5 cm. In women and children, the
25.1 Introduction cuff is placed around the bladder neck. In men, the cuff is
placed around the bulbar urethra.
Artificial urinary sphincter (AUS) is a surgical device that • Pressure-regulating balloon reservoir (Fig. 25.2): The
is implanted to restore continence control in men, women balloon is placed usually in the suprapubic region. It acts
and children. In women, AUS is usually considered as the both as a reservoir and also a pressure-regulating system.
last resort to restore continence after failure of other anti- Different pressure pre-set balloon reservoirs are available
incontinence procedures, albeit there are indications for (41–50, 51–60, 61–70, 71–80, 81–90 cm water). The bal-
the primary insertion of AUS. The procedure requires loon with the lowest pressure required to occlude the
appropriate patient selection with proper counselling, bladder neck is selected. This can vary from patient to
operated upon by a surgeon who is well versed with the patient.
anatomy of the pelvis and possesses sound knowledge of • Control pump (Fig. 25.3): The control pump is placed
reconstructive techniques. The patient should be followed below the labia majora in women. The pump has a unidi-
up to detect any possible complications and manage them rectional valve, refill-delay resistor and a deactivation
accordingly. We outline in this chapter the device, indica- button. Squeezing and releasing the soft part of the pump
tions, contraindications, operative technique and a brief releases the pressure in the cuff by pushing the fluid to the
review of the current literature on the laparoscopic balloon-reservoir allowing the patient to void. The refill-
approach to the insertion of AUS.
A. R. Rao
American Hospital, Dubai, UAE
e-mail: amrithrao@yahoo.com
P. Grange (*)
King’s College Hospital, London, UK
e-mail: pgrange@nhs.net Fig. 25.1 AMS 800™ inflatable cuff
25.3 Indications
25.4 Contraindications
25.5 Operation
is then carried out to free the bladder neck from the underly-
ing vaginal wall. The operation can be difficult in women
who have had previous pelvic operations or have had anti-
incontinence procedures, as the scar tissue can be quite dense
and adherent. Careful dissection with control of haemostasis
is essential to avoid injuring the urethra, the bladder or
indeed the vagina. The risk of infection and erosion is higher
if the vaginal wall or the urethra is injured. Combined
transvaginal and transabdominal approach has also been
described for difficult cases.
Patient Preparation
The patient is in a supine position preferably on an anti-slip
gel mattress. DVT prophylaxis includes TEDS® stockings
and the Flowtron® pump during the procedure and in the
immediate post-operative period. Unless contraindicated, we
routinely administer low molecular weight heparin in the
post-operative period. The pressure areas of the body are
protected with gel pads.
The abdominal wall, genitals and the perineum are
cleaned thoroughly with iodine-based solution. Sterile access
to the vagina is also required during surgery. A combination
of antibiotics (depending on the local microbiological resis-
tance) to cover gram-positive, gram-negative and anaerobic Fig. 25.5 Laparoscopic approach using the Freehand robotic camera
organisms is administered at induction and continued for holder
48 h after the operation.
A 16-Fr Foley catheter with 10 mL in the balloon is above the upper border of the symphysis pubis. Once the soft
inserted through the urethra into the bladder and emptied connective tissue of the space of Retzius is identified, CO2
completely. The patient is in a moderately head-down posi- gas insufflation is started. In our experience, a pressure of
tion with arms alongside the body (Fig. 25.4). The burden of 9 mmHg is sufficient enough to give adequate space to carry
holding a camera by the assistant is eased by using a robotic out the procedure. This space is developed using smooth
camera holder: Freehand® (Prosurgics Ltd), which maintains movements of the 10 mm zero degree telescope initially fol-
a stable picture throughout the operation (Fig. 25.5) [3]. A lowing the contour of the upper border of the symphysis
11 mm clear vision port (e.g. Visiport™) is inserted with a pubis and the pubic rami. There is an advantage of clarity
10 mm telescope in the midline about five fingers breadth with the newer HD stacks and a deflectable tip video-
346 A. R. Rao and P. Grange
PS
LA
BI
Fig. 25.6 Exposure of the vagina and the anatomical landmarks. Bl,
bladder; LA, levator ani; PS, pubic symphysis
Fig. 25.10 Creation of the space for the pump in the labia majora
should be carried out to rule out detrusor overactivity, and redo procedures were six (11.2%) mechanical problems
the screening would indicate the position of the cuff and the and one vaginal erosion (2%) [14].
emptying and filling of the cuff (if contrast-based solution
was used to fill the components at the time of implantation).
Urethrocystoscopy should be carried to rule out cuff 25.7.3 Robot-Assisted Artificial Urinary
erosion. Sphincter Insertion
around the bladder neck was loose, which was rectified 3. Sharma D, Brown C, Kouriefs C, Sood H, Grange P, Patel H. Initial
experience with The FreeHand robotic camera holder in laparo-
by using a smaller cuff. They postulated that insufficient scopic urology. J Endourol. 2009;23(1):A249.
tightness of the cuff could be due to inability of the sur- 4. Hussain M, Greenwell TJ, Venn SN, Mundy AR. The current role
geon to feel the force while pulling the cuff around the of the artificial urinary sphincter for the treatment of urinary incon-
urethra due to the absence of haptic sensation in robotic tinence. J Urol. 2005;174:418–24.
5. Ratan HL, Summerton DJ, Wilon SK, Terry TR. Development and
surgery [18]. current status of the AMS 800 artificial urinary sphincter. EAU-
EBU Update Ser. 2006;4:117–28.
6. Webster GD, Perez LM, Khoury JM, Timmons SL. Management of
25.8 Conclusion type III stress urinary incontinence using artificial urinary sphinc-
ter. Urology. 1992;39(6):499–503.
7. Thomas K, Venn SN, Mundy AR. Outcome of the artificial urinary
AUS is an option to restore continence in women, most often sphincter in female patients. J Urol. 2002;167(4):1720–2.
following failed anti-incontinence procedure. The success 8. Light JK. Abdominal approach for implantation of the A.S.
rate of achieving continence is quite high, although patient 800 artificial urinary sphincter in females. Neurourol Urodyn.
2005;7(6):603–11. (Special issue).
selection is of paramount importance to avoid any disap- 9. Costa P, Mottet N, Rabut B, Thuret R, Ben Naoum K, Wagner L. The
pointment. Insertion of AUS should be performed by sur- use of an artificial urinary sphincter in women with type III incon-
geons who have adequate experience as the procedure can be tinence and a negative Marshall test. J Urol. 2001;165(4):1172–6.
difficult due to previous surgeries and can carry a significant 10. Petero VG Jr, Diokno AC. Comparison of the long-term outcomes
between incontinent men and women treated with artificial urinary
morbidity. Post-operative follow-up should be diligent to sphincter. J Urol. 2006;175:605–9.
pick up complications and managed accordingly. 11. Diokno AC, Hollander JB, Alderson TP. Artificial urinary sphincter
Traditionally, open abdominal approach has been used to for recurrent female urinary incontinence: indications and results. J
implant the AUS; however, recently laparoscopic insertion is Urol. 1987;138:778–80.
12. Grange P, Mignot H. Laparoscopic artificial sphincter implantation
gaining popularity with the advantages attributed to mini- in multioperated women. In: 2nd International Consultation on
mally invasive surgery. Incontinence, Paris, France; 2001.
13. Rouprêt M, Misraï V, Vaessen C, Cardot V, Cour F, Richard F,
Chartier-Kastler E. Laparoscopic approach for artificial urinary
sphincter implantation in women with intrinsic sphincter deficiency
incontinence: a single-centre preliminary experience. Eur Urol.
Take-Home Messages 2010;57(3):499–504.
• Artificial urinary sphincter is a good option to 14. Ferreira C, Brychaert PE, Menard J, Mandron E. Laparoscopic
restore continence when other methods have been implantation of artificial urinary sphincter in women with
unsuccessful. intrinsic sphincter deficiency: mid-term outcomes. Int J Urol.
2017;24(4):308–13.
• Insertion of AUS should be undertaken by special- 15. Fournier G, Callerot P, Thoulouzan M, Valeri A, Perrouin-Verbe
ists who are well versed with pelvic anatomy and MA. Robotic-assisted laparoscopic implantation of artificial uri-
reconstructive techniques. nary sphincter in women with intrinsic sphincter deficiency incon-
• Success rate is high; however, long-term follow-up tinence: initial results. Urology. 2014;84(5):1094–8.
16. Biardeau X, Rizk J, Marcelli F, Flamand V. Robot-assisted lapa-
is needed to identify and treat complications. roscopic approach for artificial urinary sphincter implantation in
11 women with urinary stress incontinence: surgical technique and
initial experience. Eur Urol. 2015;67:937–42.
17. Peyronnet B, Vincendeau S, Tondut L, Bensalah K, Damphousse
M, Manunta A. Artificial urinary sphincter implantation in women
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1. www.AmericanMedicalSystems.com. 18. Hervé F, Lumen N, Goessaert AS, Everaert K. Persistent uri-
2. Appell R. Technique and results in the implantation of the artificial nary incontinence after a robot-assisted artificial urinary sphinc-
urinary sphincter in women with Type III stress urinary inconti- ter procedure: lessons learnt from two cases. BMJ Case Rep.
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Pharmacological Treatment of Urinary
Incontinence and Overactive Bladder: 26
The Evidence
Dudley Robinson and Linda Cardozo
urodynamically proven detrusor overactivity and that 83% 26.3.2 Neurogenic Hypothesis
of female patients with detrusor overactivity have symptoms
suggestive of OAB [8]. The pathophysiology of detrusor overactivity remains
unclear. In vitro studies have shown that the detrusor muscle
in cases of idiopathic detrusor overactivity contracts more
26.2.1 Muscarinic Receptors than normal detrusor muscle. These detrusor contractions are
not nerve mediated and can be inhibited by the neuropeptide
Molecular cloning studies have revealed five distinct genes vasoactive intestinal polypeptide [22]. Other studies have
for muscarinic acetylcholine receptors in rats and humans, shown that increased α adrenergic activity causes increased
and it has been shown that five receptor subtypes (M1–M5) detrusor contractility [23].
correspond to these gene products [9]. In the human bladder, There is evidence to suggest that the pathophysiology of
the occurrence of mRNA encoding M2 and M3 subtypes has idiopathic and obstructive overactive bladder is different.
been demonstrated although not for M1 [10]. The M3 recep- From animal and human studies on obstructive overactiv-
tor is thought to cause a direct smooth muscle contraction ity, it would seem that the detrusor develops postjunctional
[11]. Whilst the role of the M2 receptor has not yet been clari- supersensitivity, possibly due to partial denervation [24],
fied, it may oppose sympathetically mediated smooth muscle with reduced sensitivity to electrical stimulation of its
relaxation [12] or result in the activation of a non-specific nerve supply but a greater sensitivity to stimulation with
cationic channel and inactivation of potassium channels. In acetylcholine [25]. If outflow obstruction is relieved, the
general it is thought that the M3 receptor is responsible for detrusor can return to normal behaviour and reinnervation
the normal micturition contraction although in certain dis- may occur [26].
ease states, such as neurogenic bladder dysfunction, the M2
receptors may become more important in mediating detrusor
contractions [13]. 26.3.3 Urethral Reflex
is a fundamental abnormality at the level of the bladder Table 26.1 Common causes of frequency and urgency of micturition
wall with evidence of altered spontaneous contractile Urological
activity consistent with increased electrical coupling of Urinary tract infection
cells, a patchy denervation of the detrusor and a supersen- Detrusor overactivity
Small-capacity bladder
sitivity to potassium [31]. Charlton et al. [32] suggest that
Interstitial cystitis
the primary defect in the idiopathic and neuropathic blad- Chronic urinary retention/chronic urinary residual
ders is a loss of nerves accompanied by hypertrophy of Bladder mucosal lesion, e.g. papilloma
the cells and an increased production of elastin and col- Bladder calculus
lagen within the muscle fascicles. Urethral syndrome
Urethral diverticulum
Urethral obstruction
Gynaecological
26.3.5 Urothelial Afferent Hypothesis
Pregnancy
Stress incontinence
More recently the role of afferent activation in the urothe- Cystocoele
lium and suburothelial myofibroblasts has been investigated Pelvic mass, e.g. fibroids
as a factor in the pathophysiology of detrusor overactivity. Previous pelvic surgery
C-fibre afferents are known to have nerve endings in the sub- Radiation cystitis/fibrosis
urothelial layer of the bladder wall as well as in the urothe- Postmenopausal urogenital atrophy
Sexual
lium. Studies have revealed that ATP is released from the
Coitus
urothelium by bladder distension [33], and this may lead to Sexually transmitted disease
activation of purinergic receptors on afferent nerve terminals Contraceptive diaphragm
which in turn evokes a neuronal discharge leading to bladder Medical
contraction. Diuretic therapy
Prostanoids [34] and nitric oxide [35] are synthesised Upper motor neuron lesion
locally in the urothelium and are also released by bladder Impaired renal function
Congestive cardiac failure (nocturia)
distension. It is probable that a cascade of stimulatory (ATP,
Hypokalaemia
prostanoids, tachykinins) and inhibitory (nitric oxide) medi-
Endocrine
ators are involved in the activation of sensory pathways dur- Diabetes mellitus
ing bladder filling [36]. The role of C-fibres in the Diabetes insipidus
pathophysiology of detrusor contractions is also supported Hypothyroidism
by the use of intravesical vanilloids (capsaicin and resinifera- Psychological
toxin) in patients with idiopathic detrusor overactivity and Excessive drinking
hypersensitivity disorders [37]. Habit
Anxiety
24-h period can be calculated as well as the diurnal and noc- their fluid intake to between 1 and 1.5 L/day [44] and to
turnal volumes. Urgency is now generally regarded as being avoid tea, coffee and alcohol if these exacerbate their prob-
the driving symptom of OAB and is known to play an impor- lem. In addition there is also increasing evidence to suggest
tant role in the development of daytime frequency, nocturia that weight loss may improve symptoms of urinary inconti-
and urgency incontinence. Several validated urgency scoring nence [45].
systems (Patient Perception of Intensity of Urgency Score
(PPIUS) [38], Urgency Perception Score (UPS) [39], Indevus
Urgency Severity Scale (IUSS) [40]) have been developed to 26.6.1 Bladder Retraining
attempt to measure urgency severity, and these may be used
in conjunction with frequency volume charts in clinical Bladder retraining was first described by Jeffcoate and
practice. Francis [46], and both inpatient and outpatient therapy can
Quality of life (QoL) is assessed by the use of question- be effective. A meta-analysis has concluded that bladder
naires completed by the patient alone or as part of the consul- retraining is more effective than placebo and medical therapy
tation and allows the quantification of morbidity and the although there is insufficient evidence to support the effec-
evaluation of treatment efficacy as well as measuring how tiveness of electrical stimulation and too few studies to eval-
lives are affected and coping strategies adopted. uate the effect of pelvic floor exercises and biofeedback in
Generic questionnaires, such as the Short Form 36 [41], women with urgency urinary incontinence [47]. Nevertheless
are general measures of QoL and are therefore applicable to the National Institute of Clinical Excellence (NICE) [48] and
a wide range of populations and clinical conditions, whilst the International Consultation on Incontinence (ICI) [49]
disease-specific questionnaires, such as the Kings Health recommend that bladder retraining should be considered as
Questionnaire (KHQ) [42], are designed to focus on lower first-line treatment in all women with OAB.
urinary tract symptoms. More recently the International Antimuscarinic therapy may be a useful addition to non-
Consultation on Incontinence has now developed and vali- drug therapy in the management of patients with OAB. In a
dated a number of disease-specific questionnaires for use in Cochrane review of 23 trials including 3685 patients, symp-
lower urinary tract dysfunction [43]. tomatic improvement was more common amongst those on
antimuscarinic therapy compared to bladder retraining (RR
0.74; 95% CI: 0.61–0.91), and combination treatment was
26.5.1 Urodynamic Investigations also associated with more improvement than bladder training
alone (RR 0.57; 95% CI: 0.38–0.88). Similarly there was a
Whilst a number of women complaining of symptoms sug- trend towards greater improvement with a combination of
gestive of OAB can be managed following the basic assess- antimuscarinic therapy with bladder retraining compared to
ment, those women with refractory or complex symptoms antimuscarinic therapy alone (RR 0.80; 95% CI: 0.62–1.04)
may benefit from urodynamic investigations. Basic urody- although this was not statistically significant [50].
namic investigations include uroflowmetry, filling cystome-
try and pressure/flow voiding studies, but when these tests do
not replicate the patient symptoms, video urodynamics or 26.7 Medical Management
ambulatory urodynamics may be more informative.
Whilst a conservative approach is justified initially, drug
therapy remains integral in the management of women with
26.5.2 Cystourethroscopy OAB, and there are currently a number of different antimus-
carinic drugs available as well as the newer β3 agonist,
Although endoscopy is not helpful in diagnosing OAB, it mirabegron.
may be used to exclude other causes for the symptoms asso-
ciated with OAB such as a bladder tumour or calculus. In
addition cystourethroscopy should be considered in all 26.8 Antimuscarinics
women complaining of haematuria, painful bladder syn-
drome and recurrent incontinence. Traditionally tolerability, compliance and persistence have
limited the usefulness of many of the antimuscarinic agents
although with the introduction of newer bladder selective
26.6 Conservative Management drugs, once-daily dosing and differing routes of administra-
tion, it is possible that persistence with therapy may increase.
All women with OAB benefit from advice regarding simple There are now a number of different licensed antimusca-
measures which can help to alleviate their symptoms. Many rinic drugs available on the market within the United
patients drink too much, and they should be told to reduce Kingdom. These have all been recently reviewed by the
26 Pharmacological Treatment of Urinary Incontinence and Overactive Bladder: The Evidence 355
Table 26.2 Drugs used in the treatment of overactive bladder In order to improve tolerability, a controlled release oxy-
Antimuscarinic drugs Level of evidence butynin preparation using an osmotic system (OROS) has
Grade of recommendation
Darifenacin 1 A been developed which has been shown to have comparable
Fesoterodine 1 A efficacy to immediate-release oxybutynin although associ-
Oxybutynin 1 A
Propiverine 1 A ated with fewer adverse effects [57]. In order to maximise
Solifenacin 1 A efficacy and minimise adverse effects, alternative delivery
Tolterodine 1 A systems have been evaluated. An oxybutynin transdermal
Trospium 1 A delivery system was compared to extended-release toltero-
dine in 361 patients with mixed urinary incontinence. Both
International Consultation on Incontinence [51] (Table 26.2), agents significantly reduced incontinence episodes, increased
and all have Level 1 evidence [52] and a Grade A recom- volume voided and led to an improvement in quality of life
mendation [53]. when compared to placebo. The most common adverse event
A systematic review and meta-analysis of 83 studies, in the oxybutynin patch arm was application site pruritus in
including 30,699 patients and six different drugs (fesotero- 14% although the incidence of dry mouth was reduced to
dine, oxybutynin, propiverine, solifenacin, tolterodine and 4.1% compared to 7.3% in the tolterodine arm [58].
trospium), support the efficacy of antimuscarinic therapy in A large prospective multicentre, randomised, double-
the management of OAB. Overall there was a significantly blind placebo-controlled study has also been reported inves-
higher return to continence favouring active treatment over tigating the use of oxybutynin gel in the management of
placebo; the pooled RR across different studies and different overactive bladder in 704 patients [59]. Overall there was a
drugs is 1.3–3.5 (p < 0.01). Antimuscarinic therapy was also significant reduction in urge incontinence episodes in the
shown to be statistically significantly more effective in the gel arm compared to placebo, a significant reduction in day-
reduction of incontinence episodes per day, reduction in time frequency and increase in volume voided. Dry mouth
number of micturitions per day and reduction of urgency epi- was more common in the treatment arm when compared to
sodes per day [54]. placebo (6.9% vs. 2.8%), and skin site reactions were infre-
quent in both arms—5.4% and 1.0%, respectively.
Consequently oxybutynin gel may represent an important
26.8.1 Oxybutynin development over the oxybutynin patch in terms of patient
acceptability, but this formulation is currently only available
Oxybutynin is a tertiary amine that undergoes extensive first- in North America.
pass metabolism to an active metabolite, N-desmethyl oxy- In summary, the efficacy of oxybutynin is well docu-
butynin, which occurs in high concentrations and is thought mented although very often its clinical usefulness is limited
to be responsible for a significant part of the action of the by adverse effects. Alternative routes and methods of admin-
parent drug. It has a mixed action consisting of both an anti- istration may produce better patient acceptability and
muscarinic and a direct muscle relaxant effect in addition to compliance.
local anaesthetic properties. Oxybutynin has been shown to
have a high affinity for muscarinic receptors in the bladder
and has a higher affinity for M1 and M3 receptors over M2. 26.8.2 Tolterodine
The effectiveness of oxybutynin in the management of
patients with detrusor overactivity is well documented. A Tolterodine is a competitive muscarinic receptor antagonist
double-blind placebo-controlled trial found oxybutynin to with relative functional selectivity for bladder muscarinic
be significantly better than placebo in improving lower receptors. Whilst it shows no specificity for receptor sub-
urinary tract symptoms although 80% of patients com- types, it does target the bladder muscarinic receptors rather
plained of significant adverse effects, principally dry than those in the salivary glands. Several randomised,
mouth or dry skin [55]. double-blind, placebo-controlled trials have demonstrated
The antimuscarinic adverse effects of oxybutynin are well a significant reduction in incontinent episodes and micturi-
documented and are often dose limiting, with 10–23% of tion frequency [60], whilst the incidence of adverse effects
women discontinuing medication [56]. Using an intravesical has been shown to be no different to placebo. When com-
route of administration, higher local levels of oxybutynin can pared to oxybutynin in a randomised double-blind placebo-
be achieved whilst limiting the systemic adverse effects. controlled parallel-group study, it was found to be equally
Intravesical administration of oxybutynin is an effective and efficacious and to have a lower incidence of side effects,
useful alternative for patients with neurogenic detrusor over- notably dry mouth [61].
activity who need to self-catheterise or who suffer from Tolterodine is also available as an extended-release once-
‘bypassing’ an indwelling catheter. daily preparation. A double-blind multicentre trial of 1235
356 D. Robinson and L. Cardozo
women has compared extended-release tolterodine to tinuation were dry mouth and constipation. These were also
immediate-release tolterodine and placebo. Whilst both for- found to be dose related.
mulations were found to reduce the mean number of urge In order to assess the long-term safety and efficacy of
incontinence episodes per week, the extended-release prepa- solifenacin, a multicentre open-label long-term follow-up
ration was found to be significantly more effective [62]. study has been reported. This was essentially an extension
Extended-release oxybutynin (ER) and extended-release of two previous double-blind placebo-controlled studies in
tolterodine (ER) have also been compared. In the OPERA 1637 patients [68]. Overall the efficacy of solifenacin was
(Overactive bladder: Performance of Extended Release maintained in the extension study with a sustained
Agents) study, which involved 71 centres in the United improvement in symptoms of urgency, urge incontinence,
States, improvements in episodes of urge incontinence were frequency and nocturia over the 12-month study period.
similar for the two drugs although oxybutynin ER was sig- The most commonly reported adverse events were dry
nificantly more effective than tolterodine ER in reducing fre- mouth (20.5%), constipation (9.2%) and blurred vision
quency of micturition [63]. (6.6%) and were the primary reason for discontinuation in
In summary, the available evidence would suggest that 4.7% of patients.
tolterodine is as effective as oxybutynin since although it has Solifenacin has also been compared with tolterodine
fewer adverse effects patient tolerability and compliance are ER in the solifenacin (flexible dosing) od and tolterodine
improved. ER as an active comparator in a randomised trial (STAR)
[69]. This was a prospective double-blind, double-dummy,
two-arm, parallel-group, 12-week study of 1200 patients
26.8.3 Trospium Chloride with the primary aim of demonstrating non-inferiority of
solifenacin to tolterodine ER. Solifenacin was non-inferior
Trospium chloride is a quaternary ammonium compound to tolterodine ER with respect to change from baseline in
which is non-selective for muscarinic receptor subtypes and the mean number of micturitions per 24 h. In addition soli-
shows low biological availability. It crosses the blood-brain fenacin resulted in a statistically significant improvement
barrier to a limited extent and hence would appear to have in urgency, urge incontinence and overall incontinence
few cognitive effects [64]. A placebo-controlled, randomised, when compared with tolterodine ER. The most commonly
double-blind multicentre trial has shown trospium to increase reported adverse events were dry mouth constipation and
cystometric capacity and bladder volume at first overactive blurred vision and were mostly mild to moderate in sever-
contraction, leading to significant clinical improvement ity. The number of patients discontinuing medication was
without an increase in adverse effects over placebo [65]. similar in both treatment arms (3.5% in the solifenacin arm
When compared to oxybutynin, it has been found to have vs. 3.0% in the tolterodine arm).
comparable efficacy but was associated with a lower inci-
dence of dry mouth and patient withdrawal from the study
[66]. At present trospium chloride would appear to be equally 26.8.5 Darifenacin
effective as oxybutynin although it may be associated with
fewer adverse effects. Darifenacin is a tertiary amine with moderate lipophilicity
and is a highly selective M3 receptor antagonist which has
been found to have a fivefold higher affinity for the human
26.8.4 Solifenacin M3 receptor relative to the M1 receptor.
A review of the pooled darifenacin data from the three
Solifenacin is a potent M3 receptor antagonist that has selec- phase III, multicentre, double-blind clinical trials in patients
tivity for the M3 receptors over M2 receptors and has much with OAB has been reported in 1059 patients [70].
higher potency against M3 receptors in smooth muscle than it Darifenacin resulted in a dose-related significant reduction
does against M3 receptors in salivary glands. in median number of incontinence episodes per week.
The clinical efficacy of solifenacin has been assessed in Significant decreases in the frequency and severity of
a multicentre, randomised, double-blind, parallel-group, urgency, micturition frequency and number of incontinence
placebo-controlled study of solifenacin 5 and 10 mg once episodes resulting in a change of clothing or pads were also
daily in patients with overactive bladder [67]. The primary apparent, along with an increase in bladder capacity.
efficacy analysis showed a statistically significant reduc- Darifenacin was well tolerated. The most common treatment-
tion of the micturition frequency following treatment with related adverse events were dry mouth and constipation,
both 5 and 10 mg doses when compared with placebo although together these resulted in few discontinuations. The
although the largest effect was with the higher dose. The incidence of CNS and cardiovascular adverse events were
most frequently reported adverse events leading to discon- comparable to placebo.
26 Pharmacological Treatment of Urinary Incontinence and Overactive Bladder: The Evidence 357
Propiverine has both antimuscarinic and calcium channel- 26.10 β-Adrenoceptors and OAB
blocking actions. Open studies have demonstrated a benefi-
cial effect in patients with OAB [75] and neurogenic detrusor Adrenoceptors are members of a family of seven transmem-
overactivity [76]. Dry mouth was experienced by 37% in the brane receptors, with two main groups, α and β, with a num-
treatment group as opposed to 8% in those taking placebo, ber of subtypes comprising each group. β1-, β2- and
with dropout rates being 7% and 4.5%, respectively. Overall β3-adrenoceptors have been identified in human urothelium
propiverine was found to have comparable efficacy to oxybu- and detrusor muscle, with β3 being highly expressed in the
tynin but was better tolerated in terms of adverse effects. urinary bladder [83, 84].
More recently propiverine extended release has been intro- β3-adrenoceptors have been demonstrated as the predom-
duced and been shown to be as effective as the immediate- inant subtype, with 95% of all β-adrenoceptor mRNA in the
release preparation in the management of OAB [77]. human bladder relating to this β3 subtype; this receptor is
thought to be important for mediating human detrusor relax-
ation [85, 86]. This is supported by animal studies in which
26.9 Anticholinergic Burden β3-adrenoceptor agonists have been demonstrated to cause
dose-dependent detrusor relaxation during the storage phase
Whilst antimuscarinic therapy remains integral in the man- of the micturition cycle and to inhibit neurogenic detrusor
agement of women with OAB, there is an increasing body of overactivity during in vitro studies [87, 88].
evidence to suggest that these drugs may act on the central
nervous system and may lead to a long-term reduction in
terms of cognitive function and dementia [78]. 26.10.1 Mirabegron
A systematic review of 46 studies including 60,944 par-
ticipants has demonstrated a significant decline in cognitive Mirabegron is the first commercially available selective
ability with increasing anticholinergic load in addition to an β3-agonist for the treatment of OAB and has now been
increasing trend in terms of mortality although this was not approved for use in Japan, the United States, Canada and
significant [79]. These findings are supported by a 2-year Europe.
358 D. Robinson and L. Cardozo
Mirabegron has been investigated in a comprehensive 25 mg to 26.3 mL (95% CI 12.0–41.0) for solifenacin 10 mg
programme of phase II and phase III studies. In a randomised plus mirabegron 50 mg. Micturition frequency was signifi-
double-blind placebo-controlled North American trial in cantly reduced in patients treated with solifenacin 5 mg plus
1329, patients with OAB [89] mirabegron 50 and 100 mg mirabegron 50 mg, solifenacin 10 mg plus mirabegron 25 mg
demonstrated significantly greater efficacy than placebo for and solifenacin 10 mg plus mirabegron 50 mg groups
the co-primary endpoints of incontinence episodes and mic- (p < 0.05) compared with solifenacin 5 mg monotherapy.
turition frequency. Since mirabegron is an adrenoceptor ago- All combinations were well tolerated with the incidence
nist, it does not have the typical adverse effects associated and type of treatment-emergent adverse events similar
with antimuscarinic agents, and dry mouth rates were 1.5%, between patients treated with monotherapy and combination
0.5% and 2.1% in the placebo, 50 mg and 100 mg group, therapies. This study demonstrated that combination therapy
respectively. Reassuringly there were no differences in the significantly improved efficacy compared with solifenacin
incidence of hypertension between the mirabegron arm and 5 mg monotherapy. The lack of additive effects of these two
the placebo arm. treatments on safety parameters is important, with no new
The efficacy and tolerability of mirabegron have also clinically relevant safety concerns arising.
been reported in a large multicentre randomised double- The efficacy and safety of combination therapy with solif-
blind, parallel-group, placebo- and tolterodine-controlled enacin and mirabegron in patients with an inadequate
phase III trial in 1978 patients with OAB [90]. Overall mira- response to solifenacin monotherapy has also been investi-
begron 50 and 100 mg were found to be significantly supe- gated in the BESIDE study [93]. This was a prospective ran-
rior to placebo in the co-primary endpoints of incontinence domised double-blind study of 2174 patients refractory to
episodes and micturition frequency although tolterodine was solifenacin 5 mg od monotherapy who were randomised to
not shown to be significantly better than placebo, and this combination therapy (solifenacin 5 mg and mirabegron
was supported by a significant improvement in QoL in the 50 mg) or solifenacin monotherapy (5 or 10 mg). Overall the
mirabegron arm. Rates of dry mouth (2.8% and 2.6%) and efficacy of combination therapy was superior to solifenacin
constipation (1.6% and 1.4%) in the mirabegron groups were 5 mg with significant improvements in incontinence episodes
no different to placebo. (p = 0.001) and micturition frequency (p < 0.001). In addition
The long-term safety of mirabegron has also been investi- combination was non-inferior to solifenacin 10 mg for mictu-
gated in a 12-month randomised double-blind phase III study rition frequency and incontinence episodes over 3 days.
in 2444 patients with mirabegron 50 and 100 mg and toltero- Whilst the evidence from the BESIDE study clearly dem-
dine ER 4 mg as an active comparator [91]. Dry mouth was onstrates the efficacy of combination therapy in women with
reported in 2.8%, 2.3% and 8.6% of patients, respectively, refractory symptoms, the use of primary combination ther-
whilst mean changes in systolic blood pressure were apy is less clear. The SYNERGY study was a prospective,
0.2 mmHg, 0.4 mmHg and −0.5 mmHg, respectively. double-blind randomised trial investigating the use of com-
Given the results from both the phase II and phase III pro- bination therapy (solifenacin 5 mg and mirabegron 25 or
grammes, the licensed dose of mirabegron in Europe is 50 mg) compared to monotherapy in 3398 patients in 435
50 mg od although this should be reduced to 25 mg od in sites in 42 countries [94]. Overall combination therapy with
patients with renal or hepatic impairment. solifenacin 5 mg and mirabegron 25 mg and solifenacin
5 mg and mirabegron 50 mg provided consistent improve-
ments in efficacy compared with monotherapy. Interestingly,
26.10.2 Combination Therapy: Mirabegron whilst, the solifenacin 5 mg and mirabegron 50 mg groups
and Solifenacin did not achieve a statistically significant effect when com-
pared to mirabegron 50 mg in the primary analysis of reduc-
In order to examine whether combining mirabegron with tion in daily incontinence episodes the other co-primary
antimuscarinic treatments could improve efficacy in patients endpoints were met. Furthermore patient-reported outcome
with OAB, a randomised, double-blind, phase II trial measures and HRQoL have shown a clear benefit of combi-
(SYMPHONY) evaluated the efficacy of combination of nation therapy as compared to monotherapy demonstrating a
solifenacin (2.5, 5 and 10 mg) with mirabegron (25 and meaningful effect to patients [95].
50 mg) compared to solifenacin and mirabegron monother- The subtle differences between the BESIDE study and the
apy (n = 1306) [92]. The mean volume voided per micturi- SYNERGY study would perhaps suggest that combination
tion was significantly improved in patients treated with therapy is more useful as a second-line therapy as compared
combination therapy with the adjusted difference compared to primary therapy and may maximise efficacy and minimise
with solifenacin 5 mg monotherapy ranging from 18.0 mL the side effects of antimuscarinics resulting in improved per-
(95% CI 5.4–30.0) for solifenacin 5 mg plus mirabegron sistence and adherence.
26 Pharmacological Treatment of Urinary Incontinence and Overactive Bladder: The Evidence 359
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Intravesical Botulinum Toxin
for the Treatment of Overactive Bladder 27
Pawel Miotla and Tomasz Rechberger
another study the number of P2X3-immunoreactive and However, in a comparative study conducted by Liao et al.,
TRPV1-immunoreactive fibres decreased at 4 and 16 weeks patients with refractory detrusor overactivity were randomly
after BTX-A administration, and this correlation was associ- assigned into three groups. BTX-A (100 U) was dissolved in
ated with improvements in subjective and objective parame- 10 mL, and then patients received 10, 20 or 40 intravesical
ters such as the number of urgency episodes and urodynamic onabotulinumtoxinA injections. The authors did not observe
findings. Therefore, the authors concluded that this attenua- differences between the groups in both therapeutic effects
tion in sensory receptors could be responsible for a decreased and adverse events’ rates. Therefore, they have concluded
sensation of urgency. The administration of onabotulinum- that ten injections (each with 1 mL of solution) are adequate
toxinA resulted in afferent innervation of the bladder, as well to achieve an optimal therapeutic effect for refractory OAB
as in the efferent innervation of the detrusor, with patients [16].
accompanied changes in afferent nerves. The clinical results The other researchers have decided to significantly
of BTX-A treatment in patients with detrusor overactivity decrease the number of BTX-A injections, and in a prospec-
may be consider as consequences of decreased levels of sen- tive study on BTX-naïve patients with neurogenic detrusor
sory receptors P2X3 and TRPV1 [10]. All these subsequent overactivity or idiopathic detrusor overactivity, they man-
changes result in suppression of pain transmission and aged patients with one, two or three injections. The dosage of
desensitisation as well as show an anti-inflammatory effect. BTX-A (Botox, Allergan) ranged from 100 to 300 U, and it
In this chapter are summarised the main studies consider- was dissolved in sodium chloride to achieve the concentra-
ing the usage of onabotulinumtoxinA, which is still the only tion of 20 U/1 mL. The dose of 100 U was administered in
one officially registered botulinum toxin A for the treatment one injection site in the midline of the posterior bladder wall.
of idiopathic OAB and neurogenic bladder. Patient injected with two or three sites received 160 U and
300 U, respectively. The authors did not observe the differ-
ences between the number of injections and treatment
27.2 Recommendation for Practice response rates when compared these results to randomised
clinical trials with the standard number of performed injec-
27.2.1 Injection Procedure tions, 10 or 30 for idiopathic OAB and for neurogenic blad-
der, respectively. For idiopathic detrusor overactivity and
OnabotulinumtoxinA is administered into the detrusor mus- neurogenic bladder, the authors achieved subjective improve-
cle during rigid or flexible cystoscopy. ment rate, which was comparable to positive treatment
The practice considering the usage of antibiotics before, response reported in the randomised trials. Therefore, the
during or post-procedure varies between practices; however, authors have postulated that neural migration of the BTX-A
such prophylaxis is recommended by onabotulinumtoxinA did not require multiple injection sites to occur [17].
manufacturer [11]. The procedure can be conducted in local, The injections are conducted in two or three horizontal
spinal or general anaesthesia. For local anaesthesia the blad- lines sparing the trigone. For practical reasons it is recom-
der is instilled with 2% lidocaine solution for 20–30 min mended to start from the bottom horizontal line and then
before the procedure. Schurch et al. recommend local anaes- move up to the top line. Such strategy protects from unde-
thesia, which contains a mixture of 30–50 mL 2% lidocaine sired poor visualisation in case of unexpected bleeding from
and 8.4% bicarbonate sodium solution infused into the blad- the bladder wall. In some countries it is recommended to
der for 10 min [12]. Then the bladder is emptied by natural stop an intake of antiplatelet therapy or anticoagulants with
micturition or catheterisation and rinsed with 0.9% sodium sufficient time window before injections to prevent unde-
chloride solution. sired, excessive bleeding during the procedure [11]. The tip
For the treatment of idiopathic OAB, onabotulinumtox- of needle should be inserted 3–5 mm depth. In a prospective
inA (100 U) can be dissolved in 10 mL of 0.9% sodium chlo- study, 45 patients with refractory idiopathic detrusor overac-
ride solution and administered in 20 injections (each contains tivity received onabotulinumtoxinA (100 U) after randomi-
0.5 mL of solution) [13]. Patients with neurogenic bladder sation into three groups. Then participants were injected into
can be injected with 200 or 300 U of onabotulinumtoxinA detrusor, suburothelial and bladder base. The therapeutic
dissolved in 30 mL of saline at 30 different sites (10 U of efficacy was significantly longer in patients treated with sub-
BTX-A per milliliter and per site) sparing the trigone [14, urothelial and detrusor injections in comparison with bladder
15]. OnabotulinumtoxinA should be reconstituted directly base administration [18].
before the procedure; however, it is possible to store the Patients must be informed that routinely onabotulinum-
reconstituted drug even for 24 h in the refrigerator at 2–8 °C toxinA shows a therapeutic effect after approximately
with preservation of sufficient effectiveness for such time 1–2 weeks and the duration of improvement is estimated for
interval [11]. 4–10 months [11] (Fig. 27.1).
27 Intravesical Botulinum Toxin for the Treatment of Overactive Bladder 367
nent during the visit and did not require retreatment with ated the efficacy and safety of onabotulinumtoxinA (200 or
BTX-A injections. A significant increase in mean reflex vol- 300 U) in comparison with placebo in patients presented
ume and mean maximum cystometric and a significant with NDO due to spinal cord injury (at T1 level or lower)
decrease in maximum detrusor voiding pressure after ona- (n = 121) or multiple sclerosis (n = 154). Patients were not
botulinumtoxinA injections were noticed. Worse results were oblige to conduct clean intermittent catheterisation (CIC) at
observed in patients treated with 200 U of onabotulinumtox- the baseline; however, they had to be willing to start CIC in
inA. Interestingly, the authors did not report any side effects case of significant increase of post-void residual. The study
of this therapy. Additionally, hypersensitive crisis during drug (BTX-A 200 U or BTX-A 300 U or placebo) was dis-
voiding disappeared after treatment in three patients. This solved in 30 mL of saline and administered during cystos-
study proved that onabotulinumtoxinA bladder injections are copy in 30 intradetrusor injections avoiding the trigone.
valuable treatment options for patients with neurogenic blad- Patients completed a 7-day bladder diary before the treat-
der after spinal cord injuries, and successfully treated patients ment and then for each scheduled visit. Moreover, urody-
became continent for at least 9 months. A higher dose (300 U) namic studies were conducted before treatment and at week
of onabotulinumtoxinA seemed to be more effective [24]. 6 of follow-up. The change of number of urinary inconti-
Fifty-nine patients with neurogenic detrusor overactivity nence episodes was considered as a primary study endpoint.
were enrolled in the study comparing the safety and efficacy The authors also analysed the changes in maximum cysto-
of different doses of onabotulinumtoxinA (200 or 300 U metric capacity, maximum detrusor pressure and quality of
Botox) vs. placebo injected intradetrusorally. All participants life assessed with Incontinence Quality of Life total score. At
required CISC and demonstrated urinary incontinence before baseline visit patients reported similar number of urge uri-
treatment. Most of the included patients presented NDO due nary incontinence per week in all groups (Table 27.1).
to spinal cord injury (n = 53); however, multiple sclerosis
(MS) was responsible for the development of detrusor over- Table 27.1 Mean baseline and changes from baseline in urinary
activity in six participants. The results of therapy were moni- incontinence episodes, some urodynamic parameters and volume per
tored with bladder diary, dedicated the Incontinence Quality void up to week 12 (adopted from [15])
of Life (I-QOL) questionnaire and urodynamic assessment, Placebo
as well. The investigated groups did not significantly differ at group OnabotulinumtoxinA OnabotulinumtoxinA
Parameter (n = 92) 200 U (n = 92) 300 U (n = 91)
baseline in the mean daily frequency of urinary incontinence
Urinary episodes/week; mean (SD)
episodes, and the incidence of urinary leakage among the Baseline 36.7 32.5 (18.4) 31.2 (18.1)
300 U BTX-A, 200 U BTX-A and placebo groups was 2.8, (30.7)
1.9 and 3.0, respectively. The number of incontinence epi- Week 2 −9.7 −18.8 (16.7)∗ −15.8 (25.8)∗∗
sodes significantly decreased after the injections in both (17.9)
actively treated groups, and it was represented as a reduction Week 6 −13.2 −21.8 (18.1)∗∗ −19.4 (25.7)∗∗
(20.0)
in incontinence episodes of approximately 50% baseline val-
Week 12 −12.2 −20.5 (18.9)∗∗ −19.8 (18.6)∗
ues. Patient included in placebo group did not report signifi- (22.2)
cant improvement. These observations consisted of Volume/void, mL; mean (SD)
maximum cystometric capacity (MCC), reflex detrusor vol- Baseline 147.4 158.8 (113.0) 167.9 (118.4)
ume (RDV) and maximum detrusor pressure (MDP) during (94.2)
bladder contraction assessed by urodynamics. A significant Week 2 12.7 55.3 (117.6)∗∗ 62.6 (140.6)∗∗
(71.4)
improvement in I-QOL scores was reported by patients in Week 6 16.7 109.1 (120.1)∗ 101.8 (155.4)∗
both BTX-A groups throughout the 24-week follow-up vis- (80.3)
its. Urinary tract infections (UTIs) were the most commonly Week 12 21.5 105.2 (122.5)∗ 100.3 (140.8)∗
reported adverse event (AE) in this study and were observed (73.2)
in four (21.1%), six (31.6%) and three patients (14.3%) in Maximum cystometric capacity, mL; mean (SD)
Baseline 249.4 247.3 (147.6) 246.8 (149.1)
the 300 U BTX-A, 200 U BTX-A and placebo groups,
(139.3)
respectively. Pain in injection site, even was observed, disap- Week 6 6.5 157.0 (164.8)∗ 157.2 (185.2)∗
peared within 1 h after injections. Based on these results, the (144.8)
authors concluded that intradetrusor onabotulinumtoxinA Maximum detrusor pressure during first involuntary detrusor
injections are effective and well-tolerated treatment options contraction, cm H2O; mean (SD)
Baseline 41.5 51.7 (41.0) 42.1 (33.2)
for patients with neurogenic detrusor overactivity during a
(31.2)
24-week study period [25]. Week 6 6.4 −28.5 (47.8)∗ −26.9 (33.2)∗
In the first large, randomised, placebo-controlled trial (41.1)
conducted at 63 centres in Europe, North America, Latin ∗
p < 0.001
America, South Africa and Asia-Pacific, the authors evalu- ∗∗
p < 0.01
27 Intravesical Botulinum Toxin for the Treatment of Overactive Bladder 369
Patients, independently of recognition (MS or SCI), et al. assessed the outcomes of switching to abobotulinum-
declared improvements in decreasing number of urinary toxinA (Dysport, Ipsen Biopharmaceuticals) in NDO patients
incontinence incidences after the treatment since week 2 of who were not adequately treated with onabotulinumtox-
follow-up. The similar effect in reduced number of UI epi- inA. In this retrospective multicentre study, patients were
sodes as well as improvements in urodynamic studies was switched to intradetrusor abobotulinumtoxinA injections in
observed at week 6 in both BTX-A groups. Most of the case of primary or subsequent Botox treatment. Most of the
patients needed retreatment after 42 weeks from primary included patients had received 750 U of abobotulinumtox-
procedure in both onabotulinumtoxinA groups, which was inA, which was dissolved in 20 mL of 0.9% sodium chloride
significantly longer when compared to placebo group solution and administered in 20 sites. As a major result out-
(13 weeks, p < 0.001). During the first cycle of treatment, come, the authors assessed data in bladder diary and urody-
urinary tract infection and urine retention were the most namic parameters. More than half of participants observed a
commonly occurring adverse events. Urinary tract infections significant decrease in the number of urinary incontinence
were recognised in 27.5% and 38.2% of participants treated episodes. The urodynamic study showed an increase in max-
with 200 U and 300 U of onabotulinumtoxinA, respectively. imum cystometric capacity and a decrease in maximum
Due to significant increase in post-void residual, 30% and detrusor pressure. The authors observed that more than 56%
42% of patients initiated de novo CIC in 200 U and 300 U of patients refractory to Botox can be effectively treated with
subgroups, respectively. Despite these undesired adverse Dysport. However, it should be mentioned that abobotu-
events, onabotulinumtoxinA (200 or 300 U) significantly linumtoxinA remains not officially registered by the FDA for
decreased the number of urinary incontinence episodes and NDO treatment [28].
improved quality of life with no significant differences in Denys et al. investigated whether response to first treatment
efficacy between doses [15]. cycle with onabotulinumtoxinA can affect long-term retreat-
The analysis of long-term study assessed the efficacy and ment outcome in NDO patients. All patients (n = 195) included
safety of repeated onabotulinumtoxinA injections in NDO in this study received 200 U of onabotulinumtoxinA in retreat-
patients and showed no clinically relevant differences in effi- ment cycles, and majority of them (83.1%) achieved at least
cacy or duration of therapeutic effect between 200 and 300 U 50% reduction in the number of urinary incontinence episodes
of onabotulinumtoxinA. Patients observed significant relief after first treatment. Interestingly, in patients who achieved a
in detrusor overactivity symptoms for 9–10 months. Patients low response after first treatment, more than 37% experienced
were observed till five retreatments cycles, and they reported ≥50% UI reduction in further subsequent treatment cycles.
consistently reduced number of urinary incontinence as well Therefore, the authors concluded the importance of perform-
as improvements in quality of life when compared to base- ing at least a second treatment with onabotulinumtoxinA in
line values. As it was described in previous study, urinary NDO patients before matching patients as non-responders for
tract infection and urine retention were the most commonly onabotulinumtoxinA therapy [29].
observed adverse events after BTX-A injections, indepen-
dently of the number of retreatments [26].
Mehnert et al. evaluated whether 100 U onabotulinum- 27.2.3 Overactive Bladder Treatment
toxinA could effectively treat OAB symptoms in patients with OnabotulinumtoxinA
with multiple sclerosis. The main reason for a decrease of
routinely administered doses (200 or 300 U) was the need to In the multicentre study, a dose response across a range of
reduce the incidence of urinary retention after BTX-A treat- doses of onabotulinumtoxinA in refractory OAB patients
ment. Twelve MS patients were included in this study and was assessed. Patients were randomly assigned into six sub-
received ten intradetrusor injections. After treatment a sig- groups (placebo and onabotulinumtoxinA at doses of 50,
nificant increase of maximum bladder capacity (from 352 to 100, 150, 200 or 300 U). Demographics characteristics
538 mL) and significant decrease in maximum detrusor pres- between groups were comparable at the baseline. Three hun-
sure, as well as frequency and urgency, were observed. dred and thirty-one female and male patients, aged
Reinjections were conducted approximately after 8 months 18–85 years, with refractory OAB were included in this
from primary treatment due to recurrence of OAB symp- study. After randomisation patients received 20 injections
toms. It seems that in MS patients presenting overactive (0.5 mL per site) with preceding local anaesthesia into the
bladder symptoms, the dose of 100 U of onabotulinumtox- detrusor muscle, sparing the trigone. Patients completed a
inA may be sufficient to improve quality of life without sig- 7-day bladder diary before treatment and all participants
nificant impact on increase of post-void residual [27]. underwent urodynamic testing. The primary efficacy out-
It has been also reported that switching to abobotulinum- come was defined as the change in a weekly number of
toxinA may be useful in the treatment of neurogenic detrusor urgency urinary incontinence, whilst within the scope of sec-
overactivity in non-responder to onabotulinumtoxinA. Bottet ondary outcomes were frequency, urgency and nocturia per
370 P. Miotla and T. Rechberger
week as well as changes of volume voided per micturition. The primary endpoints of the study included the change
Almost 87% of the participants completed the study accord- in the number of UUI and proportion of patients with
ing to the protocol. After 3 months of follow-up, a decrease improvement after treatment when compared to baseline val-
from baseline in UUI episodes per week was observed as ues. The authors assessed also the changes in frequency,
follows: −17.4, −20.7, −18.4, −23.0, −19.6 and −19.4 and 50 urgency, nocturia, volume voided, proportion of continent
U, 100 U, 150 U, 200 U and 300 U for the placebo and ona- patients and the quality of life as secondary study endpoints.
botulinumtoxinA subgroups, respectively. The major differ- The necessity of conducting CIC was defined as PVR in the
ence in differentiation from placebo was observed in the range of 200–350 mL with co-existing voiding difficulties or
proportion of incontinence-free patients. At week 12 com- ≥350 mL independent of other symptoms. Finally, 280
plete reduction in UUI episodes was reported as 15.9%, patients had received injections with onabotulinumtoxinA
29.8%, 37.0%, 40.8%, 50.9% and 57.1% in the placebo and 100 U, whilst 277 patients were injected with placebo.
50, 100, 150, 200 and 300 U dose groups. The analysis of At week 12 of follow-up, patients treated with BTX-A
adverse event incidence showed the highest rate of increased reported significant relief in OAB symptoms, a decrease in
residual volume, necessity of CIC conduction and urinary daily UUI was −2.65 and this reduction was significantly
tract infection in subgroups treated with at least 200 U ona- higher when compared to placebo (−0.87). The proportion
botulinumtoxinA. Based on these results, the authors have of decrease in daily UUI was almost 48% in BTX-A group in
concluded that 100 U of BTX-A seems to be the dose that comparison with baseline values. Moreover, at this visit
appropriately compromises between clinical efficacy and 22.9% and 6.5% became completely continent in onabotu-
undesired side effects [30]. linumtoxinA and placebo groups, respectively.
In the dose-ranging study conducted at 40 sites, 288 OAB More than 60% of the participants in BTX-A group
female patients with OAB, who presented ≥8 UUI episodes reported positive treatment response, which was significantly
per week, were injected intradetrusorally with placebo or higher than in placebo group (29.2%). Patients treated with
different doses of onabotulinumtoxinA (50, 100, 150, 200 or onabotulinumtoxinA reported significantly higher daily
300 U). The major aim of this study was to assess disease- decrease in other OAB symptoms such as frequency (−2.15)
specific and quality-of-life outcomes after BTX-A treatment. or urgency (−2.93) when compared to placebo −0.91 and
Patients were assessed with dedicated questionnaires, such −1.21, respectively. Based on the bladder diary results,
as the Incontinence-Specific Quality-of-Life Instrument patients in BTX-A group also reported an increase in voided
(I-QOL), the King’s Health Questionnaire (KHQ) and the volume (+41 mL per micturition). Moreover, patients in ona-
36-Item Short-Form Health Survey. After the treatment with botulinumtoxinA group declared a significant improvement in
onabotulinumtoxinA at doses ≥100 U, patients reported sig- the quality-of-life questionnaires during consecutive visits.
nificant improvements in all analysed quality-of-life param- More than 15% of patients in BTX-A group had uncom-
eters when compared with placebo subgroup. The authors plicated UTI in the first 12 weeks of observation, whilst this
had concluded that after single cycle of treatment with BTX- AE was observed in only 5.9% of participants assigned into
A (doses ≥100 U), patients were able to perceive significant placebo subgroup. Only patients assigned in BTX-A group
improvement in the quality of life even for 9 months [31]. had to perform CIC (n = 17, 6.1%) during the first treatment
In the third phase of RCT, 557 patients with OAB with no cycle. In most of the cases, the duration of CIC did not
response to anticholinergics were enrolled. Patients had to be exceed 6 weeks. In this study onabotulinumtoxinA was sig-
at least 18 years old and had experienced three or more urgency nificantly superior to placebo in improvement objective and
UI episodes and 8≥ micturitions daily documented in the subjective endpoints of analysis. Patients reported clinically
3-day bladder diary. Post-void residual was checked before relevant relief in OAB symptoms, and what is more BTX-A
treatment, and only patients with PVR ≤100 mL were allowed therapy was well tolerated [32].
to enter the study. During randomisation they were assigned It has been also observed that intravesical onabotulinum-
into placebo or a dose of 100 U of onabotulinumtoxinA toxinA injections can improve nocturia and urgency urinary
groups. OnabotulinumtoxinA 100 U or placebo was dissolved incontinence at night in refractory OAB women. Participants
in 10 mL of saline and administered in 20 intradetrusor injec- treated with 100 U of Botox perceived a significant improve-
tions. Follow-up visits were scheduled for weeks 2, 6 and 12 ment in reduction of nocturia episodes (−0.98) as well as in
and then every 6 weeks till week 24. Patients could also night-time urgency urinary incontinence episodes (−0.37)
request for retreatment after first cycle; however, it was possi- when compared to baseline. Therefore, the authors con-
ble at least 3 months from previous BTX-A injections, and cluded that intravesical onabotulinumtoxinA injection sig-
they had to experience ≥2 urgency urinary incontinence epi- nificantly decreased the burdensomeness of nocturia in OAB
sodes in 3-day bladder diary. Participants had to complete the patients without nocturnal polyuria [33].
bladder diary before all consecutive visits as well as they rated One of the most discussed side effects after intravesical
their perception of treatment during each visit. onabotulinumtoxinA injections is urinary retention with spe-
27 Intravesical Botulinum Toxin for the Treatment of Overactive Bladder 371
cial caution in case requiring clean intermittent catheterisa- analysis. Based on the results achieved after 12 weeks of
tion. The rate of urine retention as well as indication to therapy, they concluded that patients who received onabotu-
initiate CIC varies between published studies. However, the linumtoxinA had the greatest reduction in urge urinary
incidence of CIC in previous RCTs considering the usage of incontinence episode, frequency and urgency. Moreover,
100 U of onabotulinumtoxinA to treat refractory OAB symp- onabotulinumtoxinA treatment had the highest odds of
toms was estimated as 6.1–6.9% [32, 34]. achieving completely dryness, as well as ≥50% decrease in
In the analysis conducted in 299 patients (mean age of number of urge urinary incontinence. Therefore, the authors
participants was 66.4 years), who were treated with 100 U of concluded that at 3 months of follow-up, onabotulinumtox-
onabotulinumtoxinA, the CIC was necessary to initiate in inA produced greater improvement for OAB when compared
2.7% of patients after first treatment cycle. Even in the to other pharmacotherapies [39]. This observation may sup-
retreatment cycles (two and three), the incidence of de novo port an idea to initiate OAB pharmacotherapy in elderly
CIC remained relatively low (3.2%), which was smaller than patients with onabotulinumtoxinA as a prevention of poly-
in previously mentioned RCTs. The range of duration of CIC pharmacy and undesired drug interactions. It has been also
was from 4 days to a maximum of 122 days [35]. hypothesised that usage of liposomes with BTX-A might
The authors did not find the potential influence of comor- prevent an undesired influence on the bladder such as detru-
bidities, age or parity on the incidence of CIC; however, sor underactivity after onabotulinumtoxinA injections. This
other authors had reported that elderly or multiparous women strategy might be very important for the treatment of elderly
are at increased risk of urinary retention after intradetrusor patients with low detrusor contractility, because it could help
BTX-A injections. The duration of CIC in this study ranged in keeping balance between the desired therapeutic efficacy
from 20 to 83 days [23]. and undesired side effects [40].
Patel et al. reported that in the group of 99 OAB female
patients, CIC was required only in 1.6% of participants, and in
all cases the necessity for CIC disappeared within 4 weeks [36]. 27.4 Conclusion
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Sacral Nerve Stimulation for Overactive
Bladder and Voiding Dysfunction 28
Philip E. V. Van Kerrebroeck
28.2 Mode of Action SNM is not approved by the FDA for the pain that is a
prevalent component of interstitial cystitis (IC) or other
The different elements of the mode of action in sacral neuro- forms of bladder pain. For some symptoms of IC such as
modulation (SNM) are still a topic of ongoing research, but urinary urgency and frequency, and some forms of nocturia,
the global mechanisms have been documented with modern SNM can be a potential beneficial treatment modality.
investigational techniques. The stimulation of afferent nerve SNM has been used in conditions of chronic genitouri-
fibers modulates reflex pathways involved in the filling and nary pain; the results have shown a dramatic reduction in
evacuation phase of the micturition cycle, through spinal cir- visual analog pain scores, but evidence is only available from
cuits mediating somato-visceral interactions within the small series or case reports with short-term follow-up. The
sacral spinal cord [11]. Two mechanisms are important: few available long(er)-term follow-up studies in general
show a significant decline of results over time [16].
1. Activation of afferent fibers causes inhibition at a spinal
and/or supraspinal level.
2. Reflex activation of efferent fibers to the striated urethral 28.4 Selection Criteria
sphincter that causes detrusor relaxation.
Basic patient selection consists of history taking, physical
The S3 sacral nerve is the preferential site of lead implan- examination, urinalysis (and eventually urine culture), void-
tation because it is the site of 60.5% of the overall pudendal ing diaries, and other simple diagnostic tests such as pelvic
afferent activity [12], although obviously supraspinal path- ultrasound and cystoscopy to exclude specific causes of
ways are also involved. lower urinary tract dysfunction.
Positron emission tomography (PET) and functional Urodynamic examination is used to detect detrusor over-
magnetic resonance imaging (fMRI) have been used to activity with or without urgency incontinence, to evaluate the
study brain activity in patients with detrusor overactivity or degree of detrusor underactivity or to diagnose detrusor
urinary retention. Detrusor overactivity is associated most acontractility. Ambulatory monitoring allows for more reli-
prominently with differences in activity in the orbitofrontal able clinical decision-making, as it is associated with void-
cortex [13] and cerebellum [14]. Furthermore, neuromodu- ing diary improvement during the SNM test period. Using
lation in women with urinary retention changed activity in ambulatory UDS to confirm success could in the future even-
the midbrain, cerebellum, cingulate gyrus, and prefrontal tually justify the shortening of the test period [17].
cortex [15]. However the most important element of patient selection
Brain activity has also been investigated in patients with for SNM is a successful trial stimulation. This test is per-
urgency incontinence during acute and chronic sacral neuro- formed with placement of a temporary or permanent (two-
modulation, and it is possible that some of the beneficial stage implant technique) electrode under local or general
effects observed originate from supraspinal brain areas, anesthesia.
which are inhibited or activated via the caudal spinal cord.
a b c d
Fig. 28.1 Percutaneous implantation of the sacral lead electrode. (a) removal of the introducer. (d) Testing of the electrode after introduction
The test needle in the sacral foramen. (b) The lead introducer and sheet in the sacral foramen through the introducer
that allow for positioning the sacral electrode. (c) The sheet after
Some patients who fail a PNE test are still good candi-
dates for SNM therapy; for this reason a two-step implant
technique was developed. Under local anesthesia, a perma-
nent tined lead electrode (Fig. 28.2) is implanted and con-
nected to an external stimulator. This tined lead electrode has
four sets of self-anchoring tines, allowing minimally inva-
sive percutaneous placement. This technique is widely used
in Europe and the USA.
A group of experienced European implanters proposed a
clinical consensus on a standardized and optimal electrode
placement technique based on data from the literature and
clinical experience [18]. The principles as indicated should
allow for a minimal stimulation threshold (<2 V) and a maxi-
mum of active contact (minimal two out of four). The opti-
mal setting will offer maximal programming possibilities
and reduce energy consumption. This should increase effi-
cacy, as well the percentage of successful patients but also
the maximal global effect that can reached in individual
patients [19]. It can also be expected that adverse events
Fig. 28.2 The self-anchoring electrode (tined lead) for implantation in should be minimized. Moreover low-amplitude stimulation
the sacral foramen will extend the battery life and reduce the re-intervention
rate for battery change.
the physician evaluates the bladder symptoms for 7–14 days. Stimulation with an external stimulator is performed for a
For the initial test, a test needle is inserted into the third maximum of 2 weeks following instructions of the company
sacral foramen to stimulate the sacral root. This procedure is (Medtronic Inc.) that produces the equipment. Sometimes
used during an acute phase to test neural integrity. A typical the test period is extended up to 4 weeks to allow for addi-
S3 motor response is an inward movement of the pelvic tional observation or diagnostic procedures. However it is
floor, plantar flexion of the big toe, and tingling sensation in not certain when the onset of the therapy effect can be
the anal area, perineum, scrotum, or vagina. Fluoroscopy can expected. Recently results of a prospective study were pub-
be used for S3 localization in anterior/posterior and lateral lished that evaluated the average onset time of sacral neuro-
imaging. The temporary electrode is connected to an external modulation in patients with lower urinary tract symptoms
stimulator. This temporary electrode is prone to dislocation, [20]. Of the 45 patients included, 29 (64%) were successful.
not allowing sufficient time for proper evaluation and also Mean time to success was 3.3 days (range 1–9). There was
does not mimic completely the situation with a permanent no significant difference in mean time to success between
electrode. Nevertheless if the patient’s symptoms improve by patients with overactive bladder and nonobstructive urinary
at least 50%, then they are a candidate to undergo step 2, in retention (3.25 days and 3.5 days, respectively). If these
which a permanent implantable pulse generator is implanted results can be confirmed, a test stimulation of >9 days would
into the soft tissue of the patient’s buttock. not be necessary to estimate the results in a reliable fashion
378 P. E. V. Van Kerrebroeck
In 1999, Schmidt et al. [23] published the results of the first 28.7 Predictive Factors
prospective randomized study in which the results of SNM
therapy for urgency incontinence were evaluated. Overall, 76 Many papers reported on predictive factors for a successful
patients were treated in a multicenter trial: 34 patients were result with SNM. In 2002 Scheepens et al. tested 212 patients
implanted, and 42 patients were treated with standard con- with a PNE test and found that intervertebral disk prolapse
servative therapy. After 6 months of treatment, there was a and urgency incontinence were found to be significant posi-
significant difference in results between two groups: in the tive predictive factors, while duration of complaints and neu-
first group, 47% of patients were completely dry, and 29% rogenic bladder dysfunction were negative predictive factors
showed a greater than 50% reduction in incontinence epi- [31]. Currently, no useful predictive factors have been
sodes. In the control group, the results were significantly described in electing successful patients with voiding dys-
worse. During evaluation of therapy after 6 months, the stim- function. However Bertapelle et al. performed a study that
ulation group returned to baseline symptoms when stimula- demonstrated lower success rates in patients who showed a
tion was stopped. lack of detrusor response to acute stimulation of the sacral
28 Sacral Nerve Stimulation for Overactive Bladder and Voiding Dysfunction 379
nerve [32]. Another study concluded that patients with absent 28.8 Complications
contractility on ambulatory urodynamics have a consider-
ably lower chance of SNM success [33]. Hence, ambulatory Siegel et al. reported on complications in a series of 914
urodynamics could be used to select patients with a con- stimulation test procedures [42]. In total 181 adverse events
firmed acontractile bladder and predict SNM failure. More occurred (19.8%): lead migration (11.8% of procedures),
recently, Rademakers et al. were able to predict SNM treat- technical problems (2.6%), and pain (2.1%) represent the
ment outcome in men with impaired bladder emptying [34]. main adverse events. For the 219 patients who underwent
They showed that pre-assessment of bladder outlet resistance implantation of the permanent system, adverse events were
and bladder contractility by pressure-flow studies and, after- pain at the stimulator site (15.3%), new pain (9%), suspected
ward plotting the results in the Maastricht–Hannover nomo- lead migration (8.4%), transient electric shock (5.5%), pain
gram, can potentially predict SNM success. at the lead site (5.4%), and adverse change in bowel function
Most patients who are eligible for SNM have had com- (3%). Surgical revision of the implanted neurostimulator was
plaints for many years and have been shown to be refractory performed in 2.2% of patients.
to conservative treatment such as bladder training, pelvic Hijaz et al. [43] described the complications of 161
floor exercise, behavioral therapy, and antimuscarinics or a patients implanted with the tined lead. In these series eight
beta-3-adrenergic receptor agonist before SNM is offered. explants were necessary due to infection and seven due to
Considering the time frame of duration of specific voiding or loss of effect. In 26 patients, a revision was performed due to
storage symptoms, and the subsequent chance of success of a decrease in clinical response.
SNM, very little is known. Most studies reported on duration In 2006, van Voskuilen et al. [27] described 194 adverse
of complaints before SNM treatment only as a secondary events in 149 patients undergoing SNM after testing with a
outcome measure, while other possible predictive factors in wire electrode and after the former open procedure. In total
SNM outcome were investigated primarily [31, 35–39]. 129 reoperations were performed (repositioning of the
These studies mostly consisted of small groups of patients implanted pulse generator, revision of electrode), and 21
with a variable range of duration of complaints (up to patients had their system explanted. Additionally van
5 years). The results of these studies are contradictory and Voskuilen reported data on complications in 39 patients
hence no final conclusions can be drawn. implanted with the tined lead: there were seven severe
It has been proposed that the incidence and degree of adverse events, of which three needed reoperations. Three
psychological problems might influence treatment outcome patients had a reoperation to reposition the IPG because of
of SNM and psychiatric comorbidity has previously been persistent pain at the level of implanted pulse generator not
indicated as a negative predictor. Marcelissen et al. prospec- linked to stimulation [38]. In US study, the most common
tively studied the role of a broad spectrum of psychological device-related adverse events were an undesirable change in
factors related to SNM treatment by using validated psycho- stimulation in 60 of the 272 subjects (22%), implant site pain
logical screening questionnaires [40]. They also assessed in 40 (15%), and therapeutic product ineffectiveness in 36
the relationship between psychiatric history and the out- (13%) [44].
come of chronic SNM treatment and concluded that there Based on the available literature and our own clinical
was no evidence that psychological screening can predict experience, there is a decrease in reoperation rate with the
the outcome of SNM treatment. However patients with a tined lead implantation, and overall SNM has an acceptable
medical history of psychiatric disease appear to be more safety profile, even with a follow-up of 5-years.
likely to encounter adverse events with permanent SNM The life span of the actual implantable pulse generator
treatment. The same results were confirmed in a study by (InterStim II) varies between 5 and 7 years after which a bat-
Drossaerts et al. that concluded that although it is known tery replacement is necessary with an open procedure.
that psychological factors play a role in the severity of Recently a new rechargeable device (Axonics r-SNM
LUTS, they do not predict SNM outcome [33]. They con- System™, Fig. 28.4) has been tested in a European clinical
cluded that SNM should not be withheld from complex trial [45]. In this procedure a similar electrode is placed in
patients with affective conditions but should be offered in the sacral foramen and connected to a rechargeable battery
the framework of an integrated care. that should last for at least 15 years and can be charged with
Recently the Maastricht neuromodulation group found an external device. A total of 51 OAB patients were implanted
that QoL and affective symptoms can significantly improve in a single-stage implant procedure. A total of 31 of 34
in LUTS patients who are successfully treated with SNM patients (91%) that responded during an initial trial period
[41]. However when divided per indication, a significant continued to benefit from therapy at 1-year based on bladder
improvement in affective symptoms together with QoL was diary criteria, and 84% were satisfied with the therapy. Of the
only reported in successful patients with OAB and not in total group, 98% found their charging experience acceptable
successfully treated patients with NOR. [46]. No serious device-related adverse events occurred, but
380 P. E. V. Van Kerrebroeck
19.6% of patients experienced device-related adverse events, IPG and recharger may change significantly between
most notably discomfort due to stimulation, which was recharging sessions, thus making the recharge more cumber-
resolved with reprogramming. This miniaturized, recharge- some. Furthermore, the stability of the IPG inside the subcu-
able system is expected to provide clinical and cost benefits taneous tissue could be compromised, and the patient might
over current non-rechargeable systems by eliminating be more likely exposed to twiddler’s phenomenon.
replacement surgeries. Currently a US–European trial is An important aspect of rechargeable systems relates to the
ongoing with this device in order to apply for FDA approval. requirement for IPG changes. The battery life of rechargeable
devices has been estimated at 15 years compared to the lon-
gevity of the current InterStim II, which is about 5–7 years. As
28.9 Newer and Investigational a result, rechargeable IPGs will be associated with a reduced
(Experimental) Neuromodulation need for reoperation. Hence, life expectancy of patients will be
Techniques an important factor when considering rechargeable devices,
besides cognition and patient’s dexterity. Additionally, the
With more than 300,000 patients implanted worldwide, recent adoption of an optimized tined lead placement tech-
SNM with the recharge-free device (InterStim™ II, nique allows for lower amplitudes, and hence, longer battery
Medtronic, Minneapolis, MN) is the standard approach, but life can be expected also with recharge-free systems.
is only approved for magnetic resonance imaging (MRI) There are also some potential additional pitfalls associ-
head scans. However, recently, two commercialized recharge- ated with rechargeable devices. Patients must be compliant
able devices that are conditional MRI-safe received CE mark and should have the cognitive capability and the manual dex-
and FDA approval. These devices provide full-body MRI terity to recharge their IPG. Although the recharging process
safety for both 1.5 and 3 T, and the clinical effectiveness can be done at home without being connected to a power
appears to be similar to that of the current recharge-free socket, the therapeutic noncompliance of patients can be an
device. The need for full-body MRI-safe implants is obvi- issue. Since a lack of compliance will lead to a loss of effec-
ous, since about 50% of patients with neurostimulators will tiveness and/or an increased burden for the healthcare pro-
have an indication for an MRI over their lifetime, and up to fessionals, careful screening of candidates for a rechargeable
23% of SNM explantations are currently due to the need for device is imperative. Recharge-free devices require no regu-
MRI. Therefore, it is expected that these new technologies lar or frequent interactions with the patient programmer, and
will enable more patients to choose SNM as the preferred patients with a poorer compliance may better qualify for
therapeutic option. recharge-free devices. Another factor is disease awareness as
Rechargeable batteries result in a smaller volume implant- the psychological and patient perception of their problem
able pulse generator (IPG) and potentially allow more com- will be experienced differently between individuals with a
fort for patients. Currently available SNM systems include rechargeable or a recharge-free system. One of the greatest
the recharge-free InterStim II system (14 cm3), the recharge- benefits that patients describe is their ability to forget about
able Axonics system (5.5 cm3), and the InterStim Micro their medical condition once an SNM device is implanted. A
technology (2.8 cm3) that reduces the size by about 80% recharge-free system allows the patient to set and forget the
when compared with the InterStim II (Fig. 28.5). However, treatment, but with a rechargeable system, patients are
smaller devices will not be a benefit to all patients because actively reminded of their condition every 1–2 weeks.
about 40% of the global adult population is obese. A correct Good indications for rechargeable devices are therefore
implantation of a small rechargeable device with the neces- available in technology-savvy, compliant, and highly moti-
sity for recharges may be challenging in obese patients, since vated patients or in patients who are in need of high-energy
the angle and distance between the superficially implanted stimulation with expected reduction of battery life, slim patients
28 Sacral Nerve Stimulation for Overactive Bladder and Voiding Dysfunction 381
28.10 Conclusions
Fig. 28.5 The Medtronic InterStim Micro system battery for sacral Sacral nerve modulation procedures can deliver objective
neuromodulation compared to the InterStim II battery
and subjective benefit in patients with voiding dysfunctions
as the overactive bladder syndrome, with or without urgency
incontinence, but also in nonobstructive urinary retention. In
a group of patients with highly therapy-resistant lower uri-
nary tract dysfunction, SNM is safe, minimally invasive, and
reversible. The minimally invasive percutaneous approach
for SNM with a tined lead is easy to perform, and the com-
plication rate is low. SNM does not carry the risk of systemic
side effects encountered in pharmacologic therapy or the
potential morbidity that open surgical procedures may cause.
Therefore SNM should be considered in any patient with
chronic voiding dysfunction resistant to conservative therapy
and proposed as an alternative to treatment with onabotuli-
num toxinA injections. Technical ameliorations such as the
rechargeable battery will allow to reduce surgical revisions
Fig. 28.6 The AHLeveeS System (Neuspera Medical Inc., San Jose, and increase cost efficacy, and MRI compatible pulse gen-
CA, USA) for sacral neuromodulation
erators will reduce the limitations in patients in whom total
body MRI examination is anticipated. New implant develop-
with insufficient fat tissue at the implant site, patients with a ments will further limit the amount of implanted material
history of pain, or patients with significant infection risks for and will allow for other anatomical stimulation sites as the
device replacements. When assessing patient compliance for tibial nerve but still will have to find their exact place in the
rechargeable SNM, it is recommended to look at all factors that neuromodulation algorithm.
may impact therapeutic noncompliance. These include demo-
graphic factors (age, gender, education, available caregivers);
psychosocial factors (motivation, attitude), health literacy, Take-Home Messages
patient knowledge, physical difficulties, forgetfulness, or his- • Sacral nerve stimulation allows for successful neu-
tory of good compliance; complexity of therapy maintenance romodulation of lower urinary tract dysfunctions as
(finding the right spot to recharge); potential side effects of overactive bladder (with or without urinary urgency
therapy maintenance (potential discomfort due to mild heating incontinence) and voiding dysfunction, refractory
depending on battery technology); compatibility with lifestyle to maximal conservative therapy.
(frequent travelling); lack of accessibility for therapy mainte- • The actual sacral nerve stimulation technique pro-
nance (frequent travelling, easy access in case of lost recharger, duces sustained efficacy in non-neurogenic patients
helpline in case of technical questions); cost issues (insurance and has an acceptable safety also in the long term,
in case of lost recharger); and patient motivation. with adverse events that can be treated effectively.
A shared decision-making process between patient and • New techniques for neuromodulation of the lower
physician is recommended by making the patient aware of urinary tract will allow for a more cost-effective
all advantages and disadvantages of each system. therapy with lower morbidity and limited re-inter-
Recently, a new approach to sacral nerve stimulation has vention rate.
been developed, consisting of a miniature implantable stimu-
382 P. E. V. Van Kerrebroeck
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28 Sacral Nerve Stimulation for Overactive Bladder and Voiding Dysfunction 383
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Part V
Anal Incontinence
Overview: Epidemiology and Aetiology
of Anal Incontinence 29
Alison J. Hainsworth, Andrew B. Williams,
and Alexis M. P. Schizas
age (15–34 years, 5.7%; >90 years, 15.9%). Only six studies nence, use cross-sectional studies to minimise bias and use
were considered high quality, and the median for prevalence self-validated questionnaires which account for impact on
in these studies was 11.2% (range 8.3–13.2%) [6]. quality of life, then there may be less variation in the estima-
An earlier systematic review in 2004 found that preva- tion of prevalence [12].
lence of anal incontinence varied from 0.4% to 18% (2–24%
including flatus incontinence). The prevalence in studies
which minimised significant bias was 11–15% [7]. 29.2.3 Incidence
Table 29.2 Causes of anal incontinence [14, 15] and 49 years and 11.6% aged 80 years and older suffered
Mechanism for anal incontinence with more frequent and severe symptoms
Action anal incontinence
Risk factors in older patients [19].
Delivery to Rapid transit Inflammation (inflammatory bowel Although an increase in prevalence with age is well docu-
the rectum disease, ischaemic colitis,
microscopic colitis)
mented, the physiological effect of age on continence is still
Infection not clear. Studies with endoanal ultrasound and MRI have
Irritable bowel syndrome shown that the external anal sphincter becomes thin and atro-
Malignancy phic with age [20–23] and faecal incontinence relates to atro-
Post-cholecystectomy diarrhoea
Polypharmacy
phy of the external anal sphincter [24]. However, anal
Tube feeds squeeze pressures may [25, 26] or may not [27, 28] decrease
Sports such as running with age. Rectal sensation may decrease [29].
Constipation with Nursing home residents Other risk factors seen in the elderly population such as
faecal impaction Behavioural, lifestyle factors
polypharmacy (which can cause loose and frequent stool),
Medication
Rectal Rectal compliance Ulcerative colitis urinary incontinence, impaired mobility and dementia are
storage and capacity Crohn’s disease additive risk factors for anal incontinence [30].
Radiation proctitis
Rectal tumour 29.3.3.2 Nursing Home Residence
Spinal cord injury
Rectal surgery The most prominent and common association with anal
Anal Sphincter muscle Obstetric trauma incontinence is with nursing home residence [2]. If preva-
sphincter injury Surgical trauma (lateral lence of anal incontinence in the community is considered
mechanism sphincterotomy or anal stretch, 7–8% and prevalence in the elderly around 10%, then the
anorectal surgery for haemorrhoids
or anal fistula)
prevalence in nursing homes may approach 50% [31]. A sur-
Accidental trauma vey of 18,000 nursing home residents in Wisconsin found
Puborectalis Obstetric trauma causing 47% had anal incontinence [32]. Interestingly, this survey
dysfunction denervation so that anorectal angle found no association between age and anal incontinence
is not maintained
(mean age 84 years), but rather the risk factors for faecal
Pelvic floor dyssynergia leading to
incomplete evacuation and incontinence were primarily urinary incontinence followed
subsequent soiling by the loss of ability to perform personal daily living activi-
Injury to anal Obstetric trauma ties, tube feeding, physical restraints, diarrhoea, dementia,
mucosal folds Surgical trauma impaired vision and constipation with faecal impaction.
which maintain
tight seal
Prevention of Mucosal or full-thickness rectal 29.3.3.3 Gender
closure of the anal prolapse Most attention has been focused on anal incontinence in
canal women, and although prevalence may be higher in women in
Nerve Pudendal nerve Obstetric trauma younger age groups, community-based studies show that
supply injury Idiopathic
Peripheral neuropathy
prevalence in men is essentially comparable to women [12,
Loss of sensation Obstetric trauma 19, 33–35]. Women seek medical treatment for faecal incon-
to the anorectum Idiopathic tinence more readily than men which is why there may be a
Peripheral neuropathy perceived increase in females [33].
Central nervous system injury (spina
The risk factors and aetiologies for anal incontinence are
bifida, spinal cord injury, stroke)
Nerve supply to Obstetric trauma different between the sexes, but more work is needed to
external anal examine the aetiology of anal incontinence in men. In
sphincter and younger women childbirth is the main risk factor for anal
puborectalis incontinence. The effects of obstetric trauma may not be
Physical Inability to reach Immobility
mobility toilet in time Dependence on others for
noticed until after the menopause; some propose that the
activities of daily living menopause is an independent risk factor for anal inconti-
Nursing home residents nence, but this is difficult to prove. There are oestrogen and
progesterone receptors in the internal and external anal
sphincter, but the role of hormone receptors and late-onset
29.3.3 Risk Factors for Incontinence incontinence is not yet known.
In older patients the risk factors also differ. In a study
29.3.3.1 Age where 1345 older subjects were interviewed, age, depres-
The prevalence of anal incontinence increases with age [18]; sion, heart disease, urinary incontinence and polypharmacy
a study of 10,116 found 4% of men and women between 40 were risk factors in women and malnutrition a risk factor in
29 Overview: Epidemiology and Aetiology of Anal Incontinence 391
men. Increased dependence for activities of daily living were techniques for and the benefits of repair to a damaged exter-
a risk factor for both [36]. Sphincter defects, low resting and nal anal sphincter) [12].
squeeze pressures and pelvic organ prolapse are more com- Neurogenic trauma includes pudendal neuropathy and
mon in women (i.e. the silique of childbirth), and rectal denervation of the striated pelvic floor muscles, particularly
hypersensitivity and evacuatory disorders with normal rest- the external anal sphincter and puborectalis muscles.
ing and squeeze pressures are more often seen in men [12]. Pudendal nerve damage is associated with multiparity, for-
ceps delivery, increased second stage of labour, third-degree
29.3.3.4 Childbirth tears and increased birth weight. However, pudendal nerve
conduction studies in up to 60% of women may return to
Mechanisms for Anal Incontinence After Childbirth normal within 2 months of delivery [39].
Obstetric trauma is an important and common cause of anal Other obstetric factors including damage to the levator ani
incontinence [12]. Obstetric trauma includes mechanical muscle are also being investigated.
trauma (obstetric anal sphincter injuries (OASIs)) and neuro- There are modifiable risk factors which can affect obstet-
genic trauma. ric trauma; ventouse delivery is less likely to cause perineal
OASIs is classified according to Table 29.3 (see Fig.13.2). and anal sphincter trauma compared to forceps, mediolateral
The incidence of OASIs has increased due to increased recog- episiotomy reduces the risk of a third- or fourth-degree tear
nition and the advent of imaging with endoanal ultrasound compared to a midline episiotomy, liberal use of episiotomy
and MRI (see Chap. 32). Prior to endoanal ultrasound, unless is not beneficial, a prolonged second stage of labour leads to
a woman presented with an obvious third- or fourth-degree denervation and should be avoided, caesarean may be benefi-
tear, it was assumed that any anal incontinence symptoms cial if there is prior anal sphincter damage, or previous pro-
were due to neurogenic injuries. Sultan et al. were the first to lapse surgery without symptoms and appropriate perineal
identify ‘occult’ obstetric anal sphincter injuries which were support during delivery may reduce perineal and anal sphinc-
not recognised at the time of injury. They performed endoanal ter trauma [12].
ultrasound before and after delivery in 150 women. There
were only two women who had a recognised obstetric anal Epidemiology of Anal Incontinence After Childbirth
sphincter injury during delivery, but 35% of primiparous A survey of 8774 American women in the first 3–6 months
women and 44% of multiparous women demonstrated an anal post-partum found that 29% reported anal incontinence
sphincter injury on endoanal ultrasound 6 weeks post-partum. (46% of these women experienced incontinence to stool and
There was a strong association between a defect on ultra- 38% to flatus) [40]. A prospective Canadian study of 949
sound and symptoms [37]. women found that 3.1% complained of faecal incontinence
As our understanding of the anal sphincter anatomy and and 25.5% of flatus incontinence in the 3 months following
mechanism has improved, so has the rate of recognised birth [41].
obstetric anal sphincter injuries (increased from 1.8% to Obstetric anal sphincter injury can cause long-term anal
5.9% for first vaginal deliveries) [38]. This provides opportu- incontinence in up to 50% of patients [42–45]. A study of
nity for obstetricians to perform immediate sphincter repair 304 women 10 years after their first delivery showed that
(there is evidence that repair of the internal anal sphincter is 57% of women with a sphincter tear and 28% of all women
beneficial; more research is needed to determine the repair had anal incontinence. Severe anal incontinence at baseline
and 5 years after delivery were independently strong predic-
tors of severe anal incontinence at 10 years [42].
Table 29.3 Classification of OASIs Factors thought to be associated with anal incontinence
Obstetric anal following childbirth include higher BMI, longer second
sphincter injury Description stage, forceps-assisted delivery and anal sphincter tears. A
First degree Laceration of the vaginal epithelium or systematic review in 2008 examined 18 studies with a total
perineal skin only of 12,237 participants. The risk of anal incontinence doubled
Second degree Involvement of the perineal muscles but not
the anal sphincter
with a forceps delivery and increased by a third with a spon-
Third degree Disruption of the anal sphincter muscles taneous vaginal delivery compared with caesarean section.
which are subdivided into: Instrumental deliveries resulted in more symptoms than
3a <50% thickness of the external anal spontaneous vaginal delivery (significant for forceps deliver-
sphincter is torn
ies but not ventouse). When only considering liquid or solid
3b >50% thickness of the external anal
sphincter is torn anal incontinence, the same trends were observed, but they
3c internal anal sphincter also torn were not statistically significant [46]. A systematic review in
Fourth degree Third-degree tear with disruption of the anal 2010 found that third- or fourth-degree rupture was the only
epithelium aetiological factor which was strongly associated with post-
392 A. J. Hainsworth et al.
partum anal incontinence. There were no associations which within the stool, such as in the case of bile salt malabsorp-
other postulated risk factors, for example, birth weight or tion, can lead to the rapid accumulation of gas and liquid
instrumental delivery. However, it was acknowledged that stool which can overwhelm continence mechanisms [14].
the potential coexistence of different risk factors impedes the
interpretation of the influence of a single delivery-related Diarrhoea
risk factor [45]. Diarrhoea may be caused by infection, inflammation, irritable
There have been questions surrounding the safest mode of bowel syndrome, malignancy, medications and some sports
delivery for a second birth if a first delivery is complicated including running (Table 29.2). It is an important cause of
by anal sphincter injury. The aim is to reduce risk of recur- anal incontinence; a survey of 2800 US woman identified
rent anal sphincter injury and long-term anal incontinence. A diarrhoea as the most important independent risk factor for
population-based questionnaire study of women whose first anal incontinence [52]. A case series of 76 patients with diar-
delivery had been complicated by anal sphincter injury and rhoea found that 51% suffered with incontinence [53].
had then undergone second delivery via vaginal delivery Diarrhoea is also an additive risk factor in those with another
(1472 women) or caesarean section (506) found that mode of risk factor, such as obstetric anal sphincter injury [54].
second delivery did not significantly affect the risk of long-
term anal incontinence symptoms. However, those who had Rectal Urgency
undergone a second vaginal delivery were at risk of further Rectal urgency is a risk factor for anal incontinence; it also
deterioration of long-term anal incontinence symptoms [47]. contributes to anal incontinence in those with other risk fac-
It is not fully understood why some women with anal tors [12]. The function of the rectum as a storage facility and
sphincter injury only develop symptoms of anal incontinence the reasons behind rectal urgency are still poorly understood
later in life. Symptoms may only occur many years after and require further research. Rectal urgency may lead to
delivery (this may be due to the contributory effects of the incontinence either by rapid transit into the rectum which
menopause or progression of neuropathy) [12]. overwhelms its function as a reservoir or by hypersensitivity
or a combination [55, 56]. Rectal urgency may be seen in
29.3.3.5 Urinary Incontinence irritable bowel syndrome [12].
Urinary incontinence and anal incontinence commonly coex-
ist. This probably represents the fact that both arise from Constipation/Faecal Impaction
similar aetiologies rather than one causes the other. Constipation and anal incontinence coexist as frequently as
urinary incontinence and anal incontinence do [12]. Factors
29.3.3.6 Diabetes which contribute to constipation include depression, immo-
Up to 20% of people with diabetes mellitus suffer anal incon- bility, inadequate dietary fibre or fluid intake, metabolic dis-
tinence [48]. orders such as hypothyroidism, neurological conditions and
Microvascular changes may cause damage to the nerves medications.
and muscles of the pelvic floor, and anal incontinence may Prolonged retention of stool within the rectum, particu-
be caused by decreased rectal sensation or reduced function larly in the elderly, causes faecal impaction. Reduced peri-
of the external anal sphincter or both [49]. One study anal and rectal sensation means that the patient does not have
showed that rectoanal inhibitory reflex recovery time cor- the desire to defaecate when the rectum has reached a normal
related with anal incontinence in 31 type I diabetics (19 full capacity [57]. Faecal impaction causes prolonged relax-
with incontinence) and 42 type II diabetics (26 with incon- ation of the internal anal sphincter, but the lack of sensation
tinence); the authors hypothesised that this may be due to and perception stops the normal contraction of the external
decreased sympathetic nerve innervation [48]. However, anal sphincter. Liquid stool from above the stool bolus seeps
two epidemiological studies of 190 and 114 diabetic around the impacted faeces and leaks out of the anus.
patients, respectively, showed no association between neu- Symptoms may be aggravated by laxatives [14, 57, 58].
ropathy and anal incontinence, questioning this hypothesis
[50, 51]. Irritable Bowel Syndrome
Irritable bowel syndrome may comprise of alternating con-
29.3.3.7 G astrointestinal Disorders and Stool stipation and diarrhoea leading to a chaotic bowel habit and
Consistency rectal urgency.
Stool consistency, volume and frequency of stool as well as
irritants in the stool can contribute towards incontinence. It is 29.3.3.8 Neurological/Psychiatric Disorders
only possible to maintain continence in the presence of high Stroke, multiple sclerosis, Parkinson’s disease, systemic
volume, liquid stool if there is good anal sensation, a compli- sclerosis, myotonic dystrophy, amyloidosis, spinal cord
ant rectal reservoir and strong anal sphincters. Irritants injury, Hirschsprung’s disease, retarded or interrupted toilet
29 Overview: Epidemiology and Aetiology of Anal Incontinence 393
training, dementia and depression can all cause anal inconti- cle function [69]. However, any association between vitamin
nence. Many of these affect patient mobility, ability to per- D deficiency and anal incontinence may simply represent the
form activities of daily living, diarrhoea or faecal impaction fact that both occur in the elderly.
[12]. Altered mental state and acute delirium secondary to
hospitalisation, surgery and medications can also cause 29.3.3.10 Physical Mobility
problems with continence [12, 59]. Impaired mobility may prevent someone from reaching the
toilet on time following the urge to defaecate and is an inde-
Dementia pendent risk factor for anal incontinence [55]. Causes for
The influence of dementia on anal incontinence was exam- impaired mobility include musculoskeletal (e.g. arthritis,
ined in a random sample of 85-year-olds from Gothenburg, fracture) and neurological (stroke) disorders.
Sweden (485 subjects). Anal incontinence was seen in 34.8% A study of long-term patients found that immobility was
of demented subjects and only 6.7% of non-demented sub- the most important predictor for anal incontinence [59].
jects [60]. In nursing home residents, although diarrhoea was However, toilet access and mobility may be modifiable. Up
found to be the strongest risk factor for anal incontinence, to 30% of patients suffer an episode of incontinence within
dementia actually played a stronger role in the development the first week of having a stroke, with rehabilitation this
of anal incontinence [61]. decreases to 15% at 3 years [70].
External rectal prolapse may be the result of pudendal tion, but a significant number of patients can still suffer with
neuropathy and pelvic floor weakness or can lead to damage anal incontinence to the point where a stoma may be prefer-
to the internal anal sphincter. Chronic straining and constipa- able [83, 84].
tion with or without a history of vaginal childbirth can lead For rectal cancer, restorative rectal resection and radio-
to pelvic floor weakness and pudendal neuropathy and sub- therapy affect the ability of the rectum to act as a reservoir.
sequent perineal descent, sensory loss of the anorectum and The position of the tumour and the level of the anastomosis
motor deficiency of the external sphincter, rectal prolapse affect the risk of anal incontinence; low tumour height and
and anal incontinence. Conversely, rectal prolapse may pre- the use of neoadjuvant therapy are key risk factors for poorer
vent closure of anal canal, cause damage to the internal anal outcomes [85]. A reduction in rectal sensation and a change
sphincter by repetitive stretching and may lead to anal incon- in colonic motility are also seen post-operatively which indi-
tinence. Alternatively, damage to the internal anal sphincter cates that nerve damage may also contribute.
by some other mechanism (e.g. obstetric anal sphincter Various methods exist to attempt to replace the rectal stor-
injury) can result in persistent rectal prolapse and anal incon- age reservoir including the formation of an ileoanal pouch
tinence [14]. and the colonic J pouch. There is a paucity of data examining
Though internal rectal prolapse (intussusception) mani- long-term outcomes, but at 18 months, the risk of faecal
fests primarily as incomplete evacuation, over 50% of incontinence is less with a colonic J pouch compared to a
patients also complain of anal incontinence [77]. This may straight anastomosis [84].
either be due to chronic straining secondary to incomplete
evacuation resulting in a stretch injury and consequent neu- Other Surgeries
ropathy of the pudendal nerve or the infolding rectal folds
leading to rectal distention and initiation of the rectoanal Ureterosigmoidostomy
inhibitory reflex. As our understanding of intussusception Mixing stool with urine produces loose stool which can
improves, the pathophysiology behind its role in anal incon- affect anal continence [2].
tinence will also improve.
Hysterectomy
29.3.3.13 Surgery There is conflicting evidence regarding the association
Anorectal surgery including sphincterotomy, fistulectomy, between hysterectomy and anal incontinence [54]. Nerve
fistulotomy, haemorrhoidectomy, ileoanal pouch and rectal injury is thought to be a possible cause though this has not
resection are risk factors for anal incontinence. Other surger- been proven.
ies include ureterosigmoidostomy after urinary bladder
resection, hysterectomy and cholecystectomy. Cholecystectomy
Cholecystectomy is an independent risk factor for anal
Anorectal Surgery incontinence [54]. The reasons may be due to post-
Damage to the internal anal sphincter during anorectal sur- cholecystectomy diarrhoea or rectal irritation and therefore
gery can cause anal incontinence. Up to 8% of patients rectal urgency secondary to bile salt malabsorption.
undergoing lateral sphincterotomy and 52% of patients
undergoing fistulotomy may have anal incontinence [78, 79]. 29.3.3.14 Smoking
Newer techniques which preserve the anal sphincter for the Smoking is an independent risk factor for anal incontinence
treatment of these pathologies have decreased the risk [78, in patients over 40 years [54]. There is also an association
80]. The anal sphincter may also be damaged during haemor- between smoking and anal incontinence and smoking in
rhoidectomy though there may be other causes for anal post-partum patients [86]. Possible mechanisms for include
incontinence such as division of the anoderm. One study fast transit secondary to nicotine and the anti-oestrogen
found that 40 out of 418 patients undergoing Milligan haem- effect of nicotine [12].
orrhoidectomy suffered with anal incontinence—19 of these
agreed to investigation to find out why and only four were
found to have an anal sphincter injury [81]; anal inconti- 29.3.4 Future Directions
nence has been found to be as high as 33% following haem-
orrhoidectomy without anal sphincter injury [82]. • It is now clear that anal incontinence occurs in men to the
same degree as women, and so future research will likely
Rectal Resection concentrate on pathophysiology in males.
Indications for rectal resection include rectal cancer and • Modifications in delivery techniques and education of
inflammatory bowel disease. In the majority of patients, it is doctors and midwifes are needed to reduce to rate of
possible to preserve the anal sphincters during rectal resec- obstetric trauma.
29 Overview: Epidemiology and Aetiology of Anal Incontinence 395
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Patient-Reported Outcome Assessment
in Anal Incontinence 30
Toshiki Mimura
scope of this chapter, it is briefly described so that the char- To demonstrate validity, content validity and construct
acteristics and significance of each PROM and the difference validity consisting of convergent validity and discriminant
between them can be understood. validity as well as criterion validity should be performed
For a formal development of a PROM, candidate items [13, 14].
for relevant questions are generated by a panel of experts and Content validity is a qualitative assessment of whether the
preferably with patients. After they are administered to a questionnaire evaluates the content it is intended to measure.
group of patients, the final PROM is formed by removing To obtain content validity, patients review the measure and
redundant questions and is grouped into subscales by princi- provide feedback as to whether the questions are clear,
pal component analysis (namely, exploratory factor analy- unambiguous, and comprehensive.
sis). At the same time, their wordings and expressions are Convergent validity is a quantitative assessment of
refined so that patients can understand them more clearly and whether the questionnaire measures the theoretical construct
easily. Ideally, it is to be evaluated by confirmatory analysis it is intended to measure. It indicates whether a questionnaire
in another group of patients to confirm that the grouping of has stronger relationships with similar concepts or variables.
the subscales is appropriate. In the development of FIQL [9], To demonstrate convergent validity, stronger relationships
for example, a 41-item questionnaire was generated by an should be seen with the most closely related constructs with
expert panel including colorectal surgeons and health service Spearman’s correlation coefficient of at least 0.70.
researchers, and it was reduced into a final 29-item question- Discriminant validity indicates whether the questionnaire
naire by principal component analysis. The number of sub- can differentiate between known patient groups (e.g., those
scales was also reduced from 6 to 4 by confirmatory with mild, moderate, or severe disease). To demonstrate dis-
analysis. criminant validity, the scores of the questionnaire should be
significantly different among the known patients’ groups
divided depending on the severity of disease or symptom
30.3 Evaluation of Reliability, Validity, using some established score or test.
and Responsiveness of PROMs Criterion validity reflects the correlation between the new
questionnaire to be evaluated and an accepted reference or
All PROMs must demonstrate reliability, validity, and gold standard. One difficulty in demonstrating criterion
responsiveness, although their demonstration is not easy to validity is that a gold standard measure might not be avail-
perform due to variations in scale construction, data report- able. When criterion validity can be established with an
ing, and validity testing [12]. existing measure, the correlation should be between 0.40 and
0.70; correlations approaching 1.0 indicate that the new
Reliability refers to the ability of a measure to produce questionnaire may be too similar to the gold standard and
similar results when assessments are repeated. Two methods therefore is not worthy to be developed.
should be performed to demonstrate the reliability. One is the
questionnaire’s internal consistency, which indicates how Responsiveness indicates whether the measure can detect
well individual items within the same subscale correlate. To change (for better or worse) in a patient’s condition. To dem-
assess internal consistency, Cronbach’s alpha coefficient is onstrate responsiveness, the score should be significantly dif-
used and should be greater than 0.70 to demonstrate good ferent before and after some intervention.
internal consistency reliability [13, 14]. The other is test-
retest reliability, or reproducibility, which indicates how
well the results can be reproduced with repeated question- 30.4 A
nal or Fecal Incontinence Symptom
naire. To assess test-retest reliability, the same patient com- Severity Scales
pletes the questionnaire twice at baseline and again after
some interval, usually 2–4 weeks while the conditions of More than 20 scales have been reported for rating the sever-
patients remain almost the same. Too short interval could ity of anal or fecal incontinence [1]. Among them, the most
cause recall bias, while too long interval may question the widely used has been Cleveland Clinic Florida Fecal
stability of patients’ conditions including their symptoms. Incontinence Score (CCFIS, namely, Wexner score) [4],
The intraclass correlation coefficient is used to demonstrate which was published in 1993. The scales that were reported
reproducibility and should be 0.70 or over to demonstrate before CCFIS are now rarely used and were reviewed by
good test-retest reliability [13, 14]. Pescatori et al. [15]. Eight scales that are currently used are
summarized in Table 30.1 with their characteristics as well
Validity refers to the ability of a questionnaire to measure as the presence or absence of confirmation regarding reli-
what it is intended to measure. ability, validity, and responsiveness. Among them, the
Table 30.1 Anal/Fecal Incontinence Symptom Severity Scale
Inclusion Inclusion
Inclusion of of amount of
Published gas Inclusion of fecal HRQOL Internal Test-retest Content Convergent Discriminant Criterion
year Content included in score incontinence of urgency leakage items consistency reliability validity validity validity validity Responsiveness
CCFIS [4] 1993 Frequency of leakage of Yes No No Yes: 1 No [16] Yes [5, – Yes [5, 16] Yes [17] Yes [17] Yes [5, 18]
flatus, liquid stool, and item 16]
solid stool, pad use, and
lifestyle alteration
SMIS [5] 1999 Frequency of leakage of Yes Yes No Yes: 1 No [16] Yes – Yes Yes [19] Yes [19] Yes [18, 19]
flatus, liquid stool, and item
solid stool, pad use and
lifestyle alteration,
urgency, use of
constipating medication
FISI [6] 1999 Frequency of leakage of Yes No No No Yes Yes – – Yes Yes Yes [28]
flatus, mucus, liquid
stool, and solid stool
Weighting of each
symptom and frequency
was made
FISS [7] 2004 Frequency of FI, type/ Yes Yes Yes No Yes Yes – Yes Yes Yes Yes
30 Patient-Reported Outcome Assessment in Anal Incontinence
CCFIS, St Mark’s Incontinence Score (SMIS) [5], and Fecal Table 30.3 St. Mark’s Incontinence Score (SMIS) (Ref [5])
Incontinence Severity Index (FISI) [6] are the most widely Never Rarely Sometimes Weekly Daily
used in clinical studies at present. Incontinence for solid 0 1 2 3 4
stool
Incontinence for 0 1 2 3 4
Cleveland Clinic Florida Fecal Incontinence Score liquid stool
(CCFIS) (Table 30.2) was introduced in a paper published Incontinence for gas 0 1 2 3 4
in 1993, including the frequency of leakage of flatus and liq- Alteration in lifestyle 0 1 2 3 4
uid and solid stool as well as the frequency of pad usage and No Yes
lifestyle alteration [4]. It has been called “Wexner score” Need to wear a pad or 0 2
after the name of Dr Steven D. Wexner, who is a worldwide plug
Taking constipating 0 2
famous surgeon and the last author of the CCFIS paper, medicines
although its first author is J. Marcio N. Jorge. Nowadays, it Lack of ability to defer defecation for 0 4
tends to be called CCFIS rather than Wexner score following 15 min
the public trend to use a general term rather than a proper Never, no episodes in the past 4 weeks; rarely, 1 episode in the past
name. Besides, at the time of its publication, CCFIS was not 4 weeks;
validated as a PROM and was just introduced as one of the Sometimes, >1 episode in the past 4 weeks but <1 a week; weekly, 1 or
more episodes a week but <1 a day;
instruments used in clinical practice at Cleveland Clinic Daily, 1 or more episodes a day
Florida. One of the important roles of PROMs is that the Add one score from each row: minimum score = 0 = perfect continence;
same scale is widely used in many studies so that the results maximum score = 24 = totally incontinent
can be easily and reliably compared among them even if the
scale itself is not perfect, and CCFIS has achieved that role. Table 30.4 Fecal Incontinence Severity Index (patient’s perspective)
Later on, the reliability [5, 16], validity [5, 16, 17], and (Ref [6])
responsiveness [5, 18] of CCFIS were confirmed by other Two or Two or
studies, most of which used it to compare with their scales in One to more more
their validation studies. three times Once a times a Once times a
Never a month week week a day day
Gas 0 4 6 8 11 12
St Mark’s Incontinence Score (SMIS) (Table 30.3) was Mucus 0 3 5 7 10 12
created on the basis of CCFIS and added two new items Liquid 0 8 10 13 17 19
including an assessment of fecal urgency and the use of con- stool
stipating medication [5]. SMIS is sometimes called “Vaizey Solid 0 8 10 13 16 18
stool
score” after the name of Ms. Carolynne J. Vaizey, who is the
first author of the SMIS paper. Fecal urgency is obviously an The question asked “For each of the following, please indicate on aver-
age how often in the past month you experienced any amount of acci-
important symptom in patients with fecal incontinence (FI) dental bowel leakage: Check only one box per row”
even if it does not result in actual FI because they cannot help
staying near the toilet to avoid FI due to their fear of fecal urgency, which is an extremely distressing symptom. It is
questionable, however, whether fecal urgency can be cor-
Table 30.2 Cleveland Clinic Florida Fecal Incontinence Score rectly evaluated with the item used in SMIS, which is “Lack
(CCFIS) (Ref [4]) of ability to defer defecation for 15 min.” Even some people
Frequency who have no symptoms of FI in their daily life might find it
Type of incontinence Never Rarely Sometimes Usually Always difficult to defer defecation for 15 min. Therefore, a lower
Solid stool 0 1 2 3 4 threshold, perhaps 5 min, might be more appropriate.
Liquid stool 0 1 2 3 4 However, it has been demonstrated that SMIS correlates
Gas 0 1 2 3 4 moderately well with patients’ subjective perception and is
Wears pad 0 1 2 3 4
suitable for the severity assessment of FI and the evaluation
Lifestyle alteration 0 1 2 3 4
of a treatment outcome [19].
0 = perfect
20 = complete incontinence
Never = 0 (never) Fecal Incontinence Severity Index (FISI) (Table 30.4) is
Rarely = <1/month based on the frequency of leakage of gas, mucus, and liquid
Sometimes = <1/week, ≥1/month and solid stool [6]. FISI has two distinct characteristics com-
Usually = <1/day, ≥1/week
Always = ≥1/day pared with CCFIS and SMIS. One of them is that FISI purely
The continence score is determined by adding points from the above evaluates the severity of anal incontinence (AI) without any
table, which takes into account the type and frequency of incontinence component of QOL. Both CCFIS and SMIS include usage of
and the extent to which it alters the patient’s life
30 Patient-Reported Outcome Assessment in Anal Incontinence 403
pad and lifestyle alteration with the former reflecting of gastrointestinal symptoms, particularly FI, constipation,
patients’ degree of fastidiousness and the latter being influ- and irritable bowel syndrome [7]. FISS is a part of FICA and
enced by their degree of anxiety for AI. Even if patients contains only four questions regarding frequency of FI, usual
become completely continent to feces by some therapy, most type of bowel incontinence, number of protective pads
of them are still worried about the possibility of bowel acci- changed per day, and urgency. FISS evaluates the amount of
dents and keep wearing pads and staying near the toilet. This fecal leakage dividing it into three degrees, although it is a
is why FI is called a symptom of “anxiety.” The scores of subjective and gross classification of “Gas only or only
CCFIS and SMIS, therefore, do not become zero for a long enough to stain your underwear (size of quarter),” “Small
time even when AI itself is completely cured until patients amount of stool,” and “Moderate to large amount of stool.”
become sufficiently confident. From this aspect, CCFIS and
SMIS are not just scales to evaluate AI symptom severity Revised Faecal Incontinence Scale (RFIS) (Table 30.6)
alone, reflecting AI-specific QOL to some extent. On the was developed examining the psychometric properties of
other hand, FISI evaluates only AI symptoms, and its score many fecal incontinence items including CCFIS, which were
becomes zero if the AI is completely cured by some therapy included in a large community survey of 2915 subjects [21].
no matter how much patients are still worried about it. RFIS does not contain gas incontinence purely evaluating FI,
whereas all the other scales include gas incontinence result-
The other characteristic of FISI is that each score of AI
type and frequency combination has weightings in FISI, Table 30.5 Fecal Incontinence Symptom Severity Scale (FISS) (Ref [7])
whereas gas and liquid and solid stool incontinence have the 1 2 3
same score from 0 to 4 depending on its frequency in CCFIS Frequency of Up to once/month <2/week ≥2–3/week
and SMIS. In other words, solid stool incontinence is regarded incontinence
as indicating the same severity as gas incontinence in CCFIS Usual type of Gas only/only Small Moderate to
and SMIS, which might not be realistic nor acceptable to bowel enough to stain amount of large amount
incontinence your underwear stool of stool
patients. The weightings like in FISI were proposed by Miller (size of quarter)
et al. [20] in 1988, in which, however, each score from 1 to 9 Number of None One >1
was simply given to three types of incontinence (flatus, fluid, protective pads
and solid stool) × three kinds of frequency combination in changed/day
order. In FISI, its weightings were performed with more sci- Urgency Never Sometimes Often/usually
entific way, and each of AI type and frequency combination Maximum total score = 12. Scores of 1–4, 5–8, and 9–12 were catego-
rized as mild, moderate, and severe fecal incontinence, respectively
was weighted by colorectal surgeons and patients with AI,
which resulted in Table 30.4 from patients’ perspective.
Surgeons and patients had very similar weightings for each of Table 30.6 Revised Faecal Incontinence Scale (RFIS) (Ref [16])
the type and frequency combination, but interestingly in the Often or
frequency of “once a day” and “two or more times a day,” the Never Rarely Sometimes usually Always
scores of liquid stool incontinence were higher than those of Do you leak, have 0 1 2 3 4
accidents, or lose
solid stool incontinence (17 vs. 16 and 19 vs. 18, respectively)
control with solid
from patients’ perspective, whereas the scores of liquid stool stool?
incontinence were lower than those of solid stool inconti- Do you leak, have 0 1 2 3 4
nence (16 vs. 17 and 18 vs. 19, respectively) from surgeons’ accidents, or lose
perspective. This is probably because surgeons tend to think control with liquid
stool?
that solid stool incontinence is a more severe symptom than Do you leak stool if 0 1 2 3 4
liquid stool incontinence assuming that FI is mainly caused you don’t get to the
by poor anal function. On the other hand, some patients might toilet in time?
have had the experience of liquid stool incontinence inflicting Does stool leak so 0 1 2 3 4
that you have to
more severe impact on their QOL than solid stool inconti-
change your
nence, because leaked liquid stool is more difficult to handle underwear?
compared with solid stool. Does bowel or stool 0 1 2 3 4
leakage cause you
Fecal Incontinence Symptom Severity Scale (FISS) (Table to alter your
lifestyle?
30.5) was developed as a part of Fecal Incontinence and
Rarely, less than once in the past 4 weeks; sometimes, less than once a
Constipation Assessment (FICA) [7] and was separately val- week, but once or more in the last 4 weeks;
idated as a symptom severity scale for AI [8]. The FICA, Often or usually, less than once a day but once a week or more; always,
which contains 98 questions, is a reliable and valid measure once or more per day or whenever you have a bowel movement
404 T. Mimura
ing in AI scales. In the large community survey, the flatus however, mainly troubled by difficulty evacuating in consti-
item of CCFIS had a low item-total correlation, suggesting pation which is not included in LARS score.
redundancy. Besides, the internal consistency of CCFIS was
low (Cronbach’s alpha = 0.58) but improved if the flatus item
was deleted [21]. RFIS also effectively evaluates the amount 30.5 A
nal or Fecal Incontinence-Specific
of leakage by asking “Does stool leak so that you have to Quality of Life Questionnaire
change your underwear?”. The reliability, validity, and
responsiveness of RFIS were confirmed, being compared AI can have a devastating impact on QOL [2], which can be
with CCFIS and SMIS [16]. RFIS was demonstrated to have evaluated by generic or symptom-specific instruments. Most
superior internal consistency and test-retest reliability to symptom severity scales also include one or two questions
CCFIS and SMIS. related to impact of AI on QOL including lifestyle alteration
[4, 5, 7, 16]. AI-specific QOL questionnaires have more
Low Anterior Resection Syndrome (LARS) Score questions that provide a refined assessment of the impact of
(Table 30.7) was developed specifically to evaluate the bowel AI on QOL, including Fecal Incontinence Quality of Life
disorders including FI in patients after rectal resection [22]. Scale (FIQL) [9], Modified Manchester Health Questionnaire
Each question has weightings depending on the frequency of (MMHQ) [10], and International Consultation on
symptoms or bowel movements. One of the characteristics of Incontinence Questionnaire Bowels (ICIQ-B) [11]. The
patients with LARS is that they have frequent bowel motions MMHQ and ICIQ-B provide a combination of symptomatic
in a short period of time called “clustering,” which is evalu- evaluation as well as an assessment of QOL, whereas FIQL
ated in LARS score. Besides, a constipation symptom is is the only one dedicated FI-specific QOL questionnaire that
evaluated by giving a score of 5 to the infrequent bowel is widely used in clinical studies. These three questionnaires
motion of “less than once per day.” Patients with LARS are, are summarized in Table 30.8.
[10] Physical/social
limitations
Personal
relationships
Emotions
Sleep/energy
Sexual activity
Lifestyle
adaptation
ICIQ-B 2011 6 Sexual impact Yes Yes Yes Yes – – Yes Yes
[11] Quality of life
FIQL, Fecal Incontinence Quality of Life Scale; MMHQ, Modified Manchester Health Questionnaire; ICIQ-B, International Consultation on Incontinence Questionnaire Bowels
– indicates no validation study found
405
406 T. Mimura
used as is [33]. The low internal consistency for the embar- test-retest reliability for the two-telephone administration of
rassment domain (Cronbach’s alpha = 0.68) was also reported FISI was high (r = 0.75).
by Ogata et al. [28], and it was proposed to remove the item
Q2-1 from the embarrassment domain because its question is Regarding the AI-specific QOL evaluation, MMHQ has
about a symptom only asking “I leak stool without even 24 questions consisting of seven subscales including role
knowing it,” which has no association with the feeling of limitations, physical/social limitations, personal relation-
embarrassment. ships, emotions, sleep/energy, sexual activity, and lifestyle
Another problem of FIQL is a simple typo in the original adaptation in addition to seven general questions about
paper of FIQL [9]. In its table of “scale scoring,” item of Q3d bowel habits, sexual activity, and medical history. Kwon
is included in both Scale 2 and Scale 3. The Q3d in Scale 2 et al. [10] concluded that the telephone-administered version
is a simple typo and should be changed to Q3c. This simple of the MMHQ showed good-to-excellent validity, internal
mistake was formally pointed out by Pares et al. [34], which consistency, and test-retest reliability.
was acknowledged by Rockwood [35].
International Consultation on Incontinence
Questionnaire Bowels (ICIQ-B) The International
30.6 C
ombined Questionnaire of Anal Consultation on Incontinence Questionnaire (ICIQ) modular
Incontinence Severity Scale and Anal questionnaire was developed to meet the need for a univer-
Incontinence-Specific Quality of Life sally applicable standard guide for the selection of question-
Questionnaire naires for use in clinical practice and clinical research for
pelvic dysfunction including urinary tract, vaginal, and
In order to assess the severity of AI and to evaluate the effi- bowel symptoms [37]. The three aims of ICIQ include (1)
cacy of treatment, particularly in clinical research, both recommendation of high-quality self-completion question-
symptomatic severity and its impact on QOL must be naires according to evidence of validation, (2) promotion of
assessed as accurately and objectively as possible. It is wider use of questionnaires to standardize assessment of
because the purpose of the therapies for AI is the improve- lower urinary tract and pelvic dysfunction and its impact on
ment of patients’ QOL through their symptomatic ameliora- patients’ lives, and (3) facilitation of communication in dif-
tion. Symptom severity and its impact on QOL can be ferent patient settings and different patient groups both in
evaluated separately, for example, with FISI and FIQL, clinical practice and wider clinical research. Sixteen ICIQ
respectively. The CCFIS, SMIS, and RFIS include one ques- modules/questionnaires are currently available for use, and
tion about QOL but cannot evaluate AI-specific QOL from the bowel module (ICIQ-B) [11] is one of them. Besides,
sufficient aspects and are usually used as instruments to more than 50 language versions of various modules have
assess symptomatic severity. On the other hand, Modified been validated according to established protocol.
Manchester Health Questionnaire (MMHQ) and International
Consultation on Incontinence Questionnaire Bowels ICIQ-B is a 21-item questionnaire to evaluate AI symp-
(ICIQ-B) have enough items to evaluate both symptomatic toms and their impact on QOL. To evaluate AI symptoms, it
severity and AI-specific QOL in patients with AI. Similar has 15 questions comprising three subscales of bowel pat-
evaluation can be performed with Comprehensive Fecal tern, bowel control, and other bowel symptoms, while six
Incontinence Questionnaire (C-FIQ), which is a combina- questions are used to assess AI-specific QOL consisting of
tion of FISI and FIQL [36]. Therefore, the usage of C-FIQ is two subscales including sexual impact and quality of life.
practically the same as using both FISI and FIQL. After all, ICIQ-B contains 17 questions arranged in three
scored subscales of bowel pattern, bowel control, and quality
Modified Manchester Health Questionnaire of life. Besides, a question of “How much does this bother
(MMHQ) was developed to evaluate AI symptom severity you?” is asked in 20 items combined with questioning the
and its impact on QOL with telephone interview [10]. For frequency of each symptom. It has been demonstrated that
the symptomatic severity, it has five questions comprising ICIQ-B has acceptable validity, good-to-very-good reliabil-
four items from FISI and one item of fecal urgency. In the ity, and reasonable responsiveness [11]. Cotterill et al. [11]
validation study of MMHQ, the telephone-administered FISI concluded that ICIQ-B is a psychometrically robust, self-
scores were significantly lower than those yielded by the report instrument for the evaluation of anal incontinence and
self-administered FISI, probably due to the embarrassment its impact on QOL. Moreover, the committee of the 5th
of patients who were reluctant to discuss their symptoms of International Consultation on Incontinence recommends
AI with interviewers. The correlation between the telephone ICIQ-B as the highest Grade A+ of recommendation to evalu-
and self-administration of FISI was also not high (r = 0.5), ate both symptomatic severity of anal incontinence including
reflecting the individual difference of embarrassment. The fecal urgency and its impact on QOL [37].
30 Patient-Reported Outcome Assessment in Anal Incontinence 407
and validation of Rockwood et al.’s (2000) Fecal Incontinence 35. Rockwood T. Are you worried about bowel accidents? Quality of
Quality of Life Scale (FIQLS). Z Gastroenterol. 2012;50:661–9. Life in Fecal Incontinence. Dis Colon Rectum. 2008;51:1434.
31. Dehli T, Martinussen M, Mevik K, et al. Translation and validation 36. Macmillan AK, Merrie AEH, Marshall RJ, et al. Design and vali-
of the Norwegian version of the fecal incontinence quality-of-life dation of a comprehensive fecal incontinence questionnaire. Dis
scale. Scand J Surg. 2011;100:190–5. Colon Rectum. 2008;51:1502–22.
32. ‘t Hoen LA, Utomo E, Schouten WR, et al. The fecal inconti- 37. Diaz D, Robinson D, Bosch R. Chapter 5B. Patient-reported out-
nence quality of life scale (FIQL) and fecal incontinence severity come assessment. In: Abrams P, Cardozo L, Wagg A, Wein A, edi-
index (FISI): validation of the Dutch versions. Neurourol Urodyn. tors. Incontinence, vol. 1. 6th ed. Bristol: International Consultation
2017;36:710–5. on Urological Diseases - International Continence Society; 2017.
33. Peterson AC, Sutherland JM, Liu G, et al. Evaluation of the Fecal p. 544–98.
Incontinence Quality of Life Scale (FIQL) using item response 38. Bordeianou L, Rockwood T, Baxter N, et al. Does incontinence
theory reveals limitations and suggests revisions. Qual Life Res. severity correlate with quality of life? Prospective analysis of 502
2018;27:1613–23. consecutive patients. Colorectal Dis. 2008;10:273–9.
34. Pares D, Vial M, Grande L. Are you worried about bowel acci-
dents? Quality of life in fecal incontinence. Dis Colon Rectum.
2008;51:1432–3.
Anorectal Manometry
31
Filippo Pucciani and Iacopo Giani
Fig. 31.2 Rectoanal
inhibitory reflex (RAIR). (a)
Control. RAIR is elicited by
balloon inflation (arrow:
40 mL): relaxation (measured
by relaxation time—RT) is
followed by contraction
(measured by contraction
time—CT). (b) Fecal
incontinence: contraction time
(CT) is prolonged
31 Anorectal Manometry 413
• Monitoring of rectal compliance. Rectal compliance, as mal transient IAS relaxation may lead to fecal soiling and
determined by the pressure/volume ratio at several dif- pruritus ani [17]. The duration of RAIR is also longer in
ferent distending volumes, reflects tonic adaptation of patients affected by idiopathic fecal incontinence than in
rectal wall (rectum distensibility) to the incoming fecal controls; a prolonged contraction time (CT), with a slow
load [8]. return to the pre-stimulation values, is the typical sign [18].
A longer RAIR impairs the fecal continence mechanism.
When small amounts of stool elicit RAIR with a prolonged
31.3 A
norectal Manometry and Fecal CT in patients with a poor external anal sphincter recruit-
Incontinence ment and in the presence of a conscious rectal sensitivity
threshold which is higher than that of the RAIR threshold,
Thanks to these intrinsic features, anorectal manometry is fecal passive incontinence may occur.
capable of providing objective information about the mecha- A significant decrease or loss of rectal sensation (>CRST,
nisms of fecal continence. When used in incontinent patients, >CS) may contribute to fecal incontinence by impairing the
manometric data suggest which continence mechanisms may recognition of impending defecation. When stool enters the
be malfunctioning. However, manometric findings in incon- rectum, the perception of rectal distension gives the con-
tinent patients are aspecific and must be completed with data scious stimulus to contract the anal sphincter for the preser-
obtained using other diagnostic techniques, both morpho- vation of continence; if stool is not perceived, the contractive
logic (clinical evaluation and anoscopy, MRI, endoanal voluntary response is not elicited and fecal incontinence may
ultrasound) and functional (anal neurophysiologic tests), to occur. Diabetes mellitus [19] and multiple sclerosis [20] may
obtain a correct pathophysiological profile of incontinence. exhibit this pathophysiological mechanism of incontinence,
Anal resting pressure may be reduced in fecal inconti- but some other types of patients have the same dysfunction.
nence [9]. Dysfunction of the internal anal sphincter may be Some studies suggest that biofeedback training improves
suspected in these patients, especially if they have passive sensory thresholds [21, 22]. Normalization or reduction of
fecal incontinence [10], and endoanal ultrasound will con- the first detectable sensation (CRST) correlates with thera-
firm the suspicion. A positive correlation between ARP and peutic success, and it is considered of value in the biofeed-
the presence of sphincter defects on endoanal ultrasound back training of patients with fecal incontinence [3].
[11] has been proven. Incontinent patients with sphincter The compliance of the rectum, as with the maximum tol-
defects had significantly lower mean ARP than those without erated volume, may contribute to fecal incontinence. A
sphincter defects. It should be noted that the discriminative reduction of rectum distensibility decreases rectal capacity,
power of ARP data between continent and incontinent as testified by simultaneous impairment of MTV, and sub-
patients is poor, with low sensitivity and specificity [12] stantial decreases in compliance are associated with an
because of the wide range of normal pressures. However, increased frequency of stool, rapid transit of stool through
manometry is more precise than a digital examination for the the rectum, and urge fecal incontinence [3]. Rectal inflam-
evaluation of anal tone [13]. mation, fibrosis of the rectum, and radiotherapy and replace-
Maximal voluntary contraction is frequently impaired in ment of the rectum, as with sphincter-saving operations, are
patients affected by fecal incontinence. Amplitude and dura- all factors that decrease rectal compliance.
tion of squeeze tone are lower than in healthy controls, with
high sensitivity (92%) and specificity (97%) [14]. This sign
is related to external anal sphincter dysfunction, and often 31.4 A
norectal Manometry and Pelvic
patients have urge incontinence with loss of stool because of Floor Rehabilitation
inability to suppress defecation [10]. Endoanal ultrasound
will be able to detect EAS lesions, and neurophysiologic Anorectal manometry is a diagnostic testing, but above all, it
anal tests (EMG, pudendoanal reflex) could be useful in provides information that can guide management of fecal
diagnosing pudendal nerve injury [3, 15]. incontinence and even a rehabilitation program.
Rectoanal inhibitory reflex, the transient decrease in rest- Rehabilitative treatment is the first-line conservative ther-
ing anal pressure in response to rapid inflation of a rectal apy of incontinence after failure of medical treatment. A sys-
balloon, often cannot be elicited when anal pressures are tematic review has shown that rehabilitation cures up to half
very low (<10 mmHg). Therefore, in some incontinent and improves up to two-thirds of patients [23]. Multimodal
patients with low ARP, it is not possible to judge if the reflex rehabilitation may be used as rehabilitative protocol [24].
is present or absent, if normal or not. However, there are The algorithm for this rehabilitation management is based on
some reports on RAIR modifications in patients affected by manometric reports. Biofeedback and pelviperineal kinesi-
fecal incontinence. A longer RAIR duration has been showed therapy are indicated by low anal resting pressures or weak
in patients with fecal soiling and pruritus ani than in controls maximal voluntary contraction. Volumetric rehabilitation
[16]. An ambulatory manometric study confirmed that abnor- (sensory retraining) is indicated for disordered rectal sensa-
414 F. Pucciani and I. Giani
Fig. 31.4 RAIR (rectoanal inhibitory reflex) is elicited by balloon inflation (30–40–50 mL): relaxation (measured by relaxation time—RT) is
followed by contraction (measured by contraction time—CT)
24. Pucciani F, Iozzi L, Masi A, et al. Multimodal rehabilitation for fae- fecal incontinence: a systematic review. Rev Esp Enferm Dig.
cal incontinence: experience of an Italian centre devoted to faecal 2018;110(9):577–88.
disorder rehabilitation. Tech Coloproctol. 2003;7:139–47. 29. Simillis C, Lal N, Qiu S, et al. Sacral nerve stimulation versus
25. Pucciani F, Ringressi MN, Redditi S, et al. Rehabilitation of fecal percutaneous tibial nerve stimulation for faecal incontinence:
incontinence after sphincter-saving surgery for rectal cancer: a systematic review and meta-analysis. Int J Colorectal Dis.
encouraging results. Dis Colon Rectum. 2008;51:1552–8. 2018;33(5):645–8.
26. Ternent CA, Shahidaran M, Blatchford GJ, et al. Transanal ultra- 30. Michelsen HB, Buntzen S, Krog K, et al. Rectal volume tolerability
sound and anorectal physiology findings affecting continence after and anal pressures in patients with fecal incontinence treated with
sphincteroplasty. Dis Colon Rectum. 1997;40:462–7. sacral nerve stimulation. Dis Colon Rectum. 2006;49:1039–44.
27. Yoshioka K, Hyland G, Keighley MRB. Anorectal function after 31. Basilisco G, Bharucha AE. High-resolution anorectal manometry:
abdominal rectopexy: parameters of predictive value in identifying an expensive hobby or worth every penny? Neurogastroenterol
return of continence. Br J Surg. 1989;76:64–8. Motil. 2017;29(8):10.1111/nmo.13125.
28. Arroyo Fernández R, Avendaño Coy J, Ando Lafuente S,
et al. Posterior tibial nerve stimulation in the treatment of
Endoanal Ultrasonography in Anal
Incontinence 32
Giulio Aniello Santoro, Luigi Brusciano, and Abdul H. Sultan
Anal incontinence (AI) is a complex disorder with a multifacto- (previously believed to be occult tears), reported in up 33% of
rial etiology. Childbirth and anorectal surgery (hemorrhoidec- primiparous females after vaginal deliveries [4, 12, 13].
tomy, lateral internal sphincterotomy, fistulotomy, and transanal Specific scores have been reported to define the severity
stapling) are the main causes why the anal sphincters and the of the sphincter damage [14–16]. Starck et al. [14] used a
pudendal nerve may be damaged [1–4]. A systematic evaluation score from 0 to 16 to describe the extent of the endosono-
is fundamental for revealing the underlying pathophysiology and graphic defects, with a score of 0 indicating no defect and a
lead to adequate treatment. As previously reported in Chap. 8, score of 16 indicating a defect of >180° involving the whole
endoanal ultrasonography (EAUS) has been recommended by length and depth of the sphincter (Table 32.1). Tears are
the 6th International Consultation on Incontinence (ICI, Tokyo defined by an interruption of the fibrillar echotexture.
2017) as the “gold standard” technique for the assessment of Scarring is characterized by loss of normal architecture,
anal sphincters integrity [5]. Features shown by EAUS can help with an area of amorphous texture that usually has low
differentiate between incontinent patients with intact anal reflectiveness. The operator should identify if there is a
sphincters and those with sphincter lesions (defects, scarring, combined lesion of the internal (IAS) and external (EAS)
thinning, thickening, and atrophy) [6–11]. In addition, a major anal sphincters, and of the puborectalis muscle (PR), or if
impact of EAUS has been to detect undiagnosed sphincter tears the lesion involves just one muscle. The number, circumfer-
ential (radial angle in degrees or in hours of the clock site)
and longitudinal (proximal, distal, or full length) extension
G. A. Santoro (*)
of the defect, presence of scarring, differences in echo-
Tertiary Referral Pelvic Floor and Incontinence Center,
IV°Division of General Surgery, Regional Hospital, Treviso, genicity and thickness of the sphincters, and other local
University of Padua, Padua, Italy alterations should be carefully assessed and should always
e-mail: giulioasantoro@yahoo.com be described. However, finding a sphincter defect does not
L. Brusciano necessarily mean that it is the cause of AI [17]. Indeed,
Division of General and Obesity Surgery, Master of Coloproctology, patients with AI may have intact anal sphincters and puden-
University of Campania “Luigi Vanvitelli”, Napoli, Italy
dal neuropathy [3] or primary degeneration of the internal
e-mail: luigi.brusciano@unicampania.it
sphincter [18]. The size of the defects appears to correlate
A. H. Sultan
with the severity of AI, as reported by Thakar and Sultan
Urogynaecology and Pelvic Floor Reconstruction Unit Croydon
University Hospital, St George’s University of London, London, UK [9]; however, Voyvodic et al. [19] failed to demonstrate a
e-mail: asultan29@gmail.com relationship between muscle injuries and the severity of
clinical symptoms. Ultrasonography should, therefore, inte- ric trauma is associated with combined IAS and EAS
grate with anorectal manometry, neurophysiologic tests, or injuries (Fig. 32.4) [14, 16]. A thinning of the IAS of less
other imaging modalities [20, 21]. than 2 mm in a patient more than 50 years old is abnormal,
and the term “primary degeneration of the IAS” has been
a b
Fig. 32.1 Endoanal ultrasound performed with 2052 rotating trans- retraction phenomenon (half-moon sign). (b) Internal sphincter lesions
ducer (BK Medical). (a) Complete division of the internal anal sphinc- between 3 o’clock and 9 o’clock. Reproduced with permission from
ter between 12 o’clock and 4 o’clock following a left lateral internal Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders.
sphincterotomy for fissure. The remaining muscle appears thicker for a Springer-Verlag Italy, 2010
32 Endoanal Ultrasonography in Anal Incontinence 419
a b
Fig. 32.3 Endoanal ultrasound performed with 2052 rotating trans- (90°). (b) Three-dimensional reconstruction in the coronal plane allows
ducer (BK Medical). Internal anal sphincter lesions following hemor- to measure the length of the defect (arrow). Reproduced with permis-
rhoidectomy. (a) Two defects (arrows) can be demonstrated between 2 sion from Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor
o’clock and 6 o’clock (120°) and between 7 o’clock and 10 o’clock Disorders. Springer-Verlag Italy, 2010
a b
Fig. 32.4 Endoanal ultrasound performed with 2052 rotating transducer (half-moon sign). (b) Reconstruction in the longitudinal plane shows the
(BK Medical). (a) Combined anterior internal and external anal sphincter complete loss of both sphincters anteriorly and the presence of scar.
damage due to obstetric trauma between 10 o’clock and 2 o’clock. The Reproduced with permission from Santoro GA, Wieczorek AP, Bartram
remaining internal sphincter appears thicker for a retraction phenomenon CI (eds) Pelvic Floor Disorders. Springer-Verlag Italy, 2010
used to describe it. Vaizey et al. [18] reviewed the EAUS tivity, and pudendal latency. Incontinent patients with IAS
examinations of 38 patients with passive AI and intact anal degeneration were found to be older than those with obstet-
sphincter. The IAS appeared thinner than normal and hyper- ric trauma. An apparently opposite EAUS condition is an
echoic, and these conditions were combined with reduced abnormal thickening of the IAS (Fig. 32.5), typical of older
resting pressure and normal squeeze pressure, rectal sensi- ages [7], and also seen in patients suffering from myotonia
420 G. A. Santoro et al.
a b
Fig. 32.5 Endoanal ultrasound performed with 2052 rotating trans- Axial plane; (b) coronal plane. Reproduced with permission from
ducer (BK Medical). Abnormal thickness of the internal anal sphincter Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders.
(4.1 mm) (arrows) in a 42-year-old female with intra-anal prolapse. (a) Springer-Verlag Italy, 2010
dystrophica. Ultrasonographic imaging helps to assess All obstetric trauma affects the sphincters anterior to a
results after treatment [28] (Figs. 32.6, 32.7, and 32.8). In a horizontal line through the mid-canal. Any tear of the anal
study by de la Portilla et al. [29], 3D-EAUS evaluation of sphincters posterior to this line is usually due to some other
injectable silicone biomaterial (PTQ) implants to treat fecal etiology. External sphincter tears from obstetric trauma can
incontinence due to IAS damage demonstrated that all the involve any part or thickness of the sphincter and quite often
implants were properly located at 3 months. At 24 months, extend to the full length of the sphincter [4, 9–11]. The ultra-
75% (33/37) of implants were still properly located. The sonographic appearance of an EAS defect is a break in the
authors found that the continence deterioration suffered by circumferential integrity of the mixed hyperechoic band. A
most patients after the first year from the injection was not defect can have either a hypoechoic or hyperechoic density
related to the localization and number of the implants. pattern. This corresponds to replacement of the normal stri-
ated muscle with granulation tissue and fibrosis. The major-
ity of OASIS are associated with a single, large defect in the
32.3 E
xternal Anal Sphincter anterior EAS but can be associated with a defect of the IAS
Abnormalities (Figs. 32.9, 32.10, 32.11, and 32.12). In examining a female,
it is important to remember the ultrasonographic differences
The most frequent cause of AI is childbirth injury to the between the natural gaps (hypoechoic areas with smooth,
EAS. Obstetric anal sphincter injuries (OASIS) is a term regular edges, occurring in the upper part of the anal canal)
used to define trauma to the perineum during vaginal deliv- and the sphincter ruptures (mixed echogenicity due to scar-
ery that includes third- (injury to perineum involving the anal ring, with irregular edges and loss of symmetry) occurring at
sphincter complex—EAS and IAS) and fourth-degree tears the upper anterior part of the anal canal. There is some evi-
(injury to perineum involving the anal sphincter complex and dence to suggest that EAUS performed after vaginal birth
anal epithelium). When the diagnosis of OASIS is obtained and before the tear has been repaired could lead to improved
from EAUS evaluation within 2 months of delivery, the inci- primary repair of the IAS and EAS resulting in reduced rates
dence of any degree of anal sphincter defect in primiparous of AI and improved quality of life for women. One random-
women is reported to be as high as 27–35%. Between 4% ized trial of 752 primiparous women compared clinical
and 8.5% of multiparous women have a new sphincter defect examination (routine care) to the use of EAUS prior to peri-
[30]. When women sustain an OASIS, they are at increased neal repair. EAUS was associated with a reduction in the rate
risk of developing AI either immediately following c hildbirth of severe AI at greater than 6 months postpartum (risk ratio
or later in life. The true prevalence of AI related to OASIS RR 0.48) (Level of Evidence 2) [31]. More high-quality ran-
may be underestimated. The reported rates of AI following domized controlled trials are needed before the routine use
primary repair of OASIS range between 15% and 61%, with of EAUS on the labor ward can be supported. Cost and train-
a mean of 39% [30]. ing required to implement EAUS should be considered.
32 Endoanal Ultrasonography in Anal Incontinence 421
a b
Fig. 32.6 Endoanal ultrasound performed with 8838 linear transducer sphincter lesion after sphincterotomy for fissure. Reconstructions in the
(BK Medical). (a) Bulking agent injection (PTQ), seen as three hyper- coronal (b) and sagittal planes (c) allow evaluation of the correct posi-
echoic round-shape areas into the intersphincteric space at 5, 7, and 11 tion and extent of the material injected
o’clock position, in a female with fecal incontinence due to internal
Endoanal US has an important role in detecting clinically ter defects in 28 (35%), of whom 9 (32%) reported altered
occult anal sphincter injuries after a vaginal delivery [4, 9– continence to stool. Sphincter defects were not identified in
13]. Using EAUS, Donnelly et al. [32] found anal sphincter those women who delivered by caesarean section. Deen et al.
injury in 35% of primiparous vaginal deliveries. Sultan et al. [33] studied 46 patients with postpartum AI and found that
[4] reviewed EAUS findings in 79 primiparous women 87% had a recognizable anal sphincter defect on EAUS. In a
before and after vaginal delivery and identified anal sphinc- prospective study, de Parades et al. [13] did not confirm
422 G. A. Santoro et al.
a b
Fig. 32.7 Endoanal ultrasound performed with 8838 linear transducer The internal sphincter is interrupted from 6 to 9 o’clock position due to
(BK Medical). Gatekeeper implants into the intersphincteric space at 2, 7, fistula surgery. The remaining muscle appears thicker for a retraction phe-
and 11 o’clock position, at the middle level of the anal canal (asterisks). nomenon (half-moon sign) (a) axial plane; (b) multiplanar reconstruction
p revious observations that anal sphincter injury is common Distinguishing isolated tears of the EAS from those
after forceps delivery. In a large population of 93 healthy involving the support structures is often difficult, as these
females, anal sphincter injury was identified by ultrasonog- structures are an integral part of the sphincter [37]. Tears of
raphy in <13% of cases after forceps delivery, and the devel- the puboanalis create asymmetry of the low reflective trian-
opment of FI was not related to these defects. The only factor gular area just inside the PR that extends down into the lon-
with significant predictive value for anal sphincter injury was gitudinal layer (Fig. 32.13). Tears to the transverse perinei
perineal tear. Pinta et al. [34] analyzed possible risks factors are seen as asymmetrical to these structures just below and
associated with sphincter rupture during vaginal delivery. A lateral to the PR (Fig. 32.14). A limitation of EAUS is the
total of 52 females with a third- or fourth-degree perineal definition of EAS atrophy in patients with idiopathic AI
laceration were compared with 51 primiparous females with because of the vague contours of the muscle ring [38]. The
no clinically detectable perineal laceration. EAUS found a reason for this is that fat replacement and loss of muscle
persistent defect of the EAS in 39 females (75%) in the rup- fibers reduce the clarity of the outer interface reflection, so
ture group, compared with 10 females (20%) in the control that the outer border of the EAS is not visible and therefore
group (P < 0.001). An abnormal presentation was the only it is impossible to measure its thickness. Endoanal magnetic
risk factor for anal sphincter rupture during vaginal delivery. resonance imaging (MRI) is more accurate in detecting atro-
Anal incontinence related to anal sphincter defects is likely phy as there is a thinner EAS, with replacement of muscle by
to occur even in an elderly population of women who expe- fat [38–40]. High-resolution multiplanar ultrasonography
rienced vaginal deliveries earlier in life [10]. Oberwalder may help to detect sphincter damage [41–45]. Three-
et al. [35] reported that 71% of women with late-onset AI dimensional reconstruction offers the possibility of measur-
had occult sphincter defects on EAUS results. The onset of ing EAS length, thickness, area, and volume. The relationship
AI was at a median age of 61.5 years. Data are controversial between the radial angle and the longitudinal extent of a
for the routine use of EAUS in asymptomatic patients after sphincter tear can be assessed and graded. The length of the
vaginal delivery [5]. There are no cost-benefit studies of remaining intact sphincter muscle can also be evaluated,
EAUS in this setting, nor any data on whether asymptomatic improving the selection of patients for surgical repair of the
patients could benefit from it. Currently, there is no recom- anal sphincter complex and helping the surgeon to judge how
mendation about screening women later after vaginal deliv- far the repair should extend. A rendering technique can be
ery for occult sphincter defects. Sioutis et al. [36] highlighted particularly useful in evaluating anal sphincter lesions [42].
the risk of over diagnosis of third-degree tears, which By using a combination of different postprocessing display
occurred in 7% of cases. parameters, the rendered image provides better visualization
32 Endoanal Ultrasonography in Anal Incontinence 423
a b
c d
Fig. 32.8 Endoanal ultrasound performed with 2052 rotating trans- Gatekeeper at 9 and 11 o’clock was implanted into the muscular fibers
ducer (BK Medical) in a 56-year-old male, with persisting incontinence of the external sphincter; (c) the Gatekeeper at 5 o’clock was implanted
after Gatekeeper implants. Ultrasound shows that the Gatekeeper outside the external sphincter into the ischioanal space; (d) the
(arrows) was not implanted in the correct position: (a) the Gatekeeper Gatekeeper at 3 o’clock position was implanted at the lower level of the
at 7 o’clock was implanted at the puborectalis muscle level; (b) the anal canal, into the subcutaneous space
performance when there are minor degrees of difference of and the intensity data of muscular fibers and fat tissue
echogenicity between lesions and surrounding tissues. replacement [39].
Compared with normal mode, a rupture of the EAS in the EAUS also serves as a surveillance tool to monitor results
anal canal can be better visualized by setting the render mode after sphincteroplasty or graciloplasty (Figs. 32.16 and
with high-opacity, normal-thickness, and high-luminance 32.17) [46–48]. EAUS may have a role after perineal repair
parameters (Fig. 32.15). An EAS tear will appear as a low- in the evaluation of residual injury and in the management
intensity defect in the context of the brightest segments of of subsequent pregnancies (Figs. 32.18, 32.19 and 32.20)
this striated muscle. It is also possible to detect EAS atrophy [49]. There are no systematic reviews or randomized con-
by using render mode with a normal-opacity, high-thickness, trolled trials to suggest the best method of follow-up after
and high-luminance setting, in order to separate the color OASIS. Studies show a high frequency of endosonographic
424 G. A. Santoro et al.
a b
Fig. 32.9 Endoanal ultrasound performed with 8838 linear transducer (BK Medical). Obstetric anal sphincter injuries grade 3A. At 12 o’clock
position, there is a damage (arrows) involving lesser than 50% of the external sphincter. (a) Axial plane; (b) axial plane; (c) coronal plane
sphincter defects after primary repairs in between 54% and the ultrasonographic defects demonstrated by 3D-EAUS
93% of women [50–52]. These data emphasize the impor- (Fig. 32.20) [55]. In a prospective study that assessed at
tance of adequate repair of OASIS and demonstrate that long term the function and morphology of the anal sphinc-
repair can be difficult or underestimated. The current guide- ters and the pelvic floor after primary repair of OASIS,
lines of the UK Royal College of Obstetricians and women who experienced deterioration of continence over
Gynecologists (RCOG) do not make recommendations time following repair had a significantly shorter anterior
about using EAUS for confirming a complete primary repair EAS at 3D-EAUS (Fig. 32.20). EAS length correlated with
[53]. According to this guidelines, if a woman is experienc- increased severity of AI [56]. Savoye-Collet et al. [46] noted
ing AI at follow-up after repair, referral to EAUS should be improvement in AI in 18/21 (86%) of patients in whom
considered. A persistent ultrasound-detected defect in the EAUS documented closure of the EAS defect after overlap-
anal sphincter muscles after OASIS is associated with AI ping anterior sphincter repair. In contrast, eight of the ten
[54]. Reconstruction of the entire length of the EAS is cru- patients who had a persistent defect in the EAS still had
cial. Incontinence after primary repair of OASIS is related significant AI. Dobben et al. [47] also found that patients
to relative length of reconstructed EAS and to the extent of with a persistent ultrasonographic EAS defect had a worse
32 Endoanal Ultrasonography in Anal Incontinence 425
clinical outcome than those without an EAS defect EAUS has been used to select the surgical treatment in
(P = 0.003). Starck et al. [48] reported that the extent of patients with AI and to assess the clinical efficacy of the
endosonographic EAS defects after primary repair of OASIS treatment. In a multicenter observational study on the
increased over time and was related to AI. implantation of prostheses in patients with AI, EAUS was
Hemorrhoidectomy, fistulectomy or fistulotomy, anal used preoperatively to select cases (either intact sphincters
dilatation, or lateral internal sphincterotomy can cause AI, or IAS lesions extending for less than 60° of the anal cir-
due to anal sphincter injury. This is more likely to occur cumference), intraoperatively to perform the implants into
during treatment of complex, high fistulas or in patients the intersphincteric space, and postoperatively to evaluate
who have undergone multiple operations for a recurrent or the results of surgery and complications (prostheses dis-
persistent fistula. Clinical severity of AI after anorectal sur- lodgement) [58, 59]. 3D-EAUS can be used to quantify
gery is related to EAUS features. More frequently, in how much sphincter can be safely divided during fistulot-
patients with higher clinical severity score, the IAS is omy. In a prospective, consecutive study, a strong correla-
always affected and thicker [57] (Level of Evidence 3). tion was found between preoperative 3D-EAUS
measurements of fistula height with intraoperative and
postoperative 3D-EAUS measurements of IAS and EAS
division. Fistulotomy limited to the lower two thirds of the
EAS is associated with excellent continence and cure rates
[60] (Level of Evidence 3).
a b
Fig. 32.11 Endoanal ultrasound performed with 8838 linear transducer (BK Medical). Obstetric anal sphincter injuries grade 3C. At 12 o’clock
position, there is a damage (arrows) involving both the external and the internal sphincters. (a) Axial plane; (b) coronal plane
426 G. A. Santoro et al.
a b
Fig. 32.12 Endoanal ultrasound performed with 2052 rotating trans- Damage from 10 to 2 o’clock position replaced by a mixed echogenic
ducer (BK Medical). Obstetric anal sphincter injuries grade 4, involving tissue (scar); (b) damage from 9 to 3 o’clock position; (c) coronal plane
both the external and the internal sphincters and the anal mucosa. (a) reconstruction showing the anterior loss of the anal sphincters
formation of hematoma and edema [61]. At long-term, an has been supported by surgical findings. Gold et al. [8]
increased echogenicity of the PR may be due to the replace- reported that sensitivity and specificity in locating the defect
ment of muscular fibers with scar tissue or fibrosis [62]. were 100%, and accuracy in the topographic detection of the
defect was 90%. Deen et al. [64] investigated 44 incontinent
patients with EAUS. All sonographically detected EAS
32.5 Accuracy and Reliability defects were confirmed at operation, and 21 of 22 IAS
defects were also confirmed at surgery. The sensitivity and
The main indication for EAUS in patients with AI is to detect specificity of EAUS were 100% for EAS defects and 100%
anal sphincter defects and damage to the pelvic floor mus- and 95.5%, respectively, for IAS lesions. Sultan et al. [10]
cles. Dobben et al. [63] found that anal inspection and digital compared preoperative ultrasonographic findings with intra-
rectal examination were not appropriate to detect IAS defects operative findings in 12 consecutive patients who underwent
and inaccurate (true positive rate 36%) for determining EAS surgical repair for AI. Endoanal ultrasound correctly identi-
defects <90°. Therefore, in daily clinical practice, a suffi- fied all sphincter defects (confirmed histologically) at the
cient diagnostic work-up in evaluating AI should include time of surgery. Sentovich et al. [65] examined the accuracy
EAUS [5]. The accuracy of EAUS in the assessment of AI and reliability of EAUS. In 22 incontinent women with
32 Endoanal Ultrasonography in Anal Incontinence 427
a b
Fig. 32.13 Endoanal ultrasound performed with 2052 rotating trans- three-dimensional reconstruction in the coronal plane. Reproduced
ducer (BK Medical). (a) Axial endosonographic image showing a tear with permission from Santoro GA, Wieczorek AP, Bartram CI (eds)
of the left puboanalis (PA) appearing as a scar in the medial aspect of Pelvic Floor Disorders. Springer-Verlag Italy, 2010
the puborectalis (PR). BS bulbospongiosus, TP transverse perinei; (b)
a b
Fig. 32.14 Endoanal ultrasound performed with 2052 rotating trans- nal sphincter ring (EAS). Reproduced with permission from Santoro
ducer (BK Medical). (a) Axial endosonographic image showing a tear GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders. Springer-
of the left transverse perinei (TP). (b) In the coronal plane, the lesion of Verlag Italy, 2010
the transverse perinei appears as a hypoechoic band lateral to the exter-
known anal sphincter injury, the accuracy was 100%. interpretation of the ultrasound results between experienced
However, in nulliparous women, EAUS falsely identified ultrasonographers (interobserver reliability) was good (81%
sphincter injury in 5–25% of normal anal sphincters. In this agreement). Agreement was significantly better for the IAS
group, an intact IAS was more accurately predicted than an (74%, fair) than the EAS (61%, poor; P = 0.0002) and in
intact EAS (95% vs. 85%). Overall clinical agreement in the evaluating the distal anal canal (0–1.5 cm) (78%) than the
428 G. A. Santoro et al.
a b
Fig. 32.15 Endoanal ultrasound performed with 2052 rotating trans- thickness, and high-luminance setting provides a better visualization of
ducer (BK Medical). A 57-year-old female with a large anterior exter- the anterior defect of the external sphincter and of the mixed echo-
nal anal sphincter tear between the 9 o’clock and 3 o’clock position, genicity scar tissue (b). Reproduced with permission from Santoro GA,
combined with an internal sphincter defect between the 7 o’clock and Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders. Springer-
11 o’clock position as a consequence of an obstetric trauma. Compared Verlag Italy, 2010
with normal mode (a), volume render mode with high-opacity, normal-
a b
Fig. 32.16 Endoanal ultrasound performed with 2052 rotating trans- confirms that the repair was extended to the whole length of the anal
ducer (BK Medical). (a) Anterior external sphincter repair by overlap- canal (anterior thickness of the external sphincter: 15.7 mm)
ping technique (arrows). (b) The reconstruction in the coronal plane
proximal anal canal (2.0–2.5 cm from the anal verge) (48% with respect to combined or isolated IAS tears, although
agreement; P < 0.0001). However, Gold et al. [8] found a there was some disagreement regarding isolated EAS tears.
very good (kappa = 0.80) interobserver agreement for diag- Abramowitz et al. [12] demonstrated interobserver concor-
nosis of sphincter disruption. There was no disagreement dance in 98.9% of cases. Benefits of 3D-EAUS in the evalu-
32 Endoanal Ultrasonography in Anal Incontinence 429
a b
c d
Fig. 32.18 Endoanal ultrasound performed with 8838 linear transducer (BK Medical). (a, b) Failed anterior external sphincter repair by end-to-
end technique. (c, d) The reconstruction in the coronal plane confirms that discontinuation of the anterior repair
major clinical and functional parameters; elastography does EVUS to 50% for TPUS, these modalities can be used in
not seem to provide additional information in the diagnostic combination with EAUS, to provide additional information
work-up of AI [73]. on pelvic floor muscles and levator hiatus damage. In a pro-
spective, observational study, defects of the pubovisceral
muscle (PVM) were identified with 3D-EVUS in 27% of
32.6 EAUS Versus EVUS and TPUS women with AI who had undergone vaginal delivery. Severity
of incontinence was related to the extent of damage of the
TPUS and EVUS have been recently evaluated as alternative PVM and to the enlargement of the levator hiatus [81]. These
imaging modalities for the investigation of sphincter integ- findings were not confirmed in a retrospective study where
rity in AI [74–78] (Level of Evidence 3). Advantages of these worsening of levator ani deficiency among patients with
procedures include the availability of commonly used trans- major AI did not reach statistical significance [82]. TPUS
ducers, absence of distortion of the anal canal, better patient may be used as screening modality for the detection of undi-
acceptability, and possibility for functional studies [77]. agnosed anal sphincter injuries after vaginal delivery (Level
Currently there are limited studies that directly compare of Evidence 2, Recommendation Grade B). 3D-TPUS has
these techniques with EAUS [79, 80]. Although the sensitiv- shown good agreement with the gold standard 3D-EAUS and
ity for the detection of sphincter defects ranges from 44% for a high sensitivity in detecting residual defects [83]. In a pro-
32 Endoanal Ultrasonography in Anal Incontinence 431
a b
c d
Fig. 32.19 Endoanal ultrasound performed with 8838 linear transducer (BK Medical). (a, b) Residual defect after anterior external sphincter
repair by end-to-end technique. (c, d) The reconstruction in the coronal plane shows that the external sphincter was not repaired in the upper part
of the anal canal
spective, randomized controlled trial, the undiagnosed tear agreement (kappa = 0.24) between both imaging techniques
rate increased from 3.5% (clinically detected) to 11.5% by in a multicenter study with a large cohort of patients with
ultrasound [84]. Future studies should focus on technique AI. Malouf et al. [87] evaluated 2D-EAUS and endoanal
standardization and method as well as on the predictive value MRI prospectively in 52 patients with AI and reported that
of both EVUS and TPUS compared with EAUS in the detec- both techniques are comparable in diagnosing EAS defects.
tion of sphincter defects. However, 2D-EAUS appeared to be superior in demonstrat-
ing IAS lesions. Rociu et al. [88] retrospectively compared
2D-EAUS and endoanal MRI to surgery in 22 patients with
32.7 EAUS Versus MRI AI and found MRI to be the most accurate for depicting IAS
and EAS defects. They also found that EAS atrophy can
Several studies have compared the diagnostic accuracy of only be accurately depicted at endoanal MRI and not at
EAUS and endoanal or external phased-array MRI in assess- 2D-EAUS. Williams et al. [41] found that patients with a
ing anal sphincter integrity [38, 85]. The results of these thin IAS (<2 mm) and/or a poorly defined EAS at EAUS
studies vary, with some of the variability attributable to dif- were more likely to have EAS atrophy and endoanal MRI
ferences in study design, patient population, and the level of should be considered to determine whether the sphincter is
experience of readers [38, 85]. Dobben et al. [86] found fair grossly atrophic. West et al. [44] evaluated whether
432 G. A. Santoro et al.
a b
c d
Fig. 32.20 Endoanal ultrasound performed with 8838 linear transducer (BK Medical). Short anterior reconstruction of the external sphincter
visualized in the coronal (a–c) and longitudinal planes (d)
a b
Fig. 32.21 Endoanal ultrasound performed with 2052 rotating trans- right branch of the puborectalis. Reproduced with permission from
ducer (BK Medical). Puborectalis muscle damage (arrows). (a) Partial Santoro GA, Wieczorek AP, Bartram CI (eds) Pelvic Floor Disorders.
lesion of the right branch of the puborectalis; (b) Complete loss of the Springer-Verlag Italy, 2010
Compared with clinical examination (routine care), the use 1. Jorge JM, Wexner SD. Etiology and management of fecal inconti-
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Transperineal Ultrasonography
in the Assessment of Anal Incontinence 33
and Obstetric Anal Sphincter Injuries
Cristina Ros-Cerro, Eva Maria Martínez-Franco,
and Montserrat Espuña-Pons
The optimal timing for postnatal imaging using TPUS is 33.2 Recommendations for Practice
considered at 10–12 weeks postpartum, similar to
3D-EAUS. Since TPUS is non-intrusive, it may be performed 33.2.1 Endovaginal Ultrasound (EVUS)
immediately postpartum [14]; however, oedema, suture
material and haematoma may alter the image leading to As mentioned previously, in the beginning, EVUS was first
inconclusive results [13]. performed using rotating probes, which were first two-
dimensional and later three-dimensional [8]. Today several
Table 33.1 Advantages and disadvantages of the endoanal ultrasound probes have been specifically designed for the vaginal route,
and the exoanal routes (endovaginal, 2D and 3D transperineal ultra- having a variable sensitivity and specificity for detecting
sound) to visualise the anal sphincter complex OASI [10]. According to some studies, EVUS can reliably
Advantages Disadvantages detect normal anatomy of the anal sphincter [10–15]
EAUS High resolution Not easily available (Fig. 33.1). However, the correlation with EAUS is not good,
Standardised classificationIntrusive making images and volumes difficult to interpret [10, 16].
of defects Distend anal canal
Some studies have reported a percentage of volumes which
EVUS Less intrusive Volumes difficult to interpret
Not easily available and non evaluables are non-evaluable due to poor image quality of up to 47%
2D-TPUS Non-intrusive Low sensitivity and [16]. Therefore, this approach is currently not considered the
Available specificity technique of choice for evaluation of the anal sphincter com-
Low resolution plex (Table 33.1).
No visualisation of the
deepest part of the anal
canal
Non-standardised 33.2.2 Transperineal Ultrasound (TPUS)
classification of defects
3D-TPUS Non-intrusive Distortion of the upper
To visualise the anal sphincter complex, TPUS may be per-
Good correlation with quadrant of the EAS
EAUS to detect the defects Non-standardised formed using a convex multi-frequency probe or an endo-
Available classification of defects cavitary probe. In the latter case, it is also called introital
EAS external anal sphincter, EAUS endoanal ultrasound, EVUS endo- ultrasound. The advantage of introital ultrasonography is
vaginal ultrasound, TPUS transperineal ultrasound that the endocavitary probe works at a higher frequency than
a b
Fig. 33.1 Axial plane of the anal sphincter complex obtained by arrow), whereas the external anal sphincter is defined as a mixed echo-
3D-rotational probe (type 2050, Ultraview 800, BK Medical). (a) genic circular structure surrounding the IAS (red arrow). No defects are
Endovaginal approach; (b) endoanal approach. Internal anal sphincter visible in the image
(IAS) is identified as a homogeneous hypoechoic circular band (yellow
33 Transperineal Ultrasonography in the Assessment of Anal Incontinence and Obstetric Anal Sphincter Injuries 439
a b
Fig. 33.2 Position of the probes to obtain the axial plane of the anal sphincter complex by transperineal approach. (a) Convex multi-frequency
probe inclined in the posterior compartment. (b) Endocavitary probe perpendicular to the horizontal compartment (perineal body)
the convex multi-frequency probe, thereby providing a This approach can also evaluate lesions in the sphinc-
higher quality of image in the evaluation of superficial struc- ters (interruption of the route), although the correlation
tures such as the anal sphincter in the introital zone. Probes with 2D-EAUS is controversial. Some studies have found
with 3D and 4D technology can be used in both routes a good correlation while others have not [9, 17]. Compared
(Table 33.1). with 3D EAUS, 2D-TPUS has a good sensitivity for
The probe should be inserted into the introitus using a defects in the EAS but a low sensitivity for defects of the
large quantity of gel and with little pressure to avoid distort- IAS.
ing the image. The convex probe should be inclined in the According to the literature available on this technique, it
posterior compartment while the endocavitary probe should is not the best exoanal technique for evaluating the anal
be perpendicular to the horizontal compartment (perineal sphincter.
body) (Fig. 33.2).
33.2.2.2 3D-TPUS
33.2.2.1 2D-TPUS The addition of 3D technology provides better definition of
It has been demonstrated that with the use of 2D-TPUS, it is the anatomical structures and visualisation of the deepest
possible to correctly identify the sphincters [9, 11, 16, 17] in part of the anal canal. This approach provides volumes which
both asymptomatic women and in those with dysfunction of may be digitally stored and reviewed and discussed offline
the pelvic floor, despite the deepest part of the anal canal by different interpreters, including multiplanar images and
being difficult to evaluate (Fig. 33.3). more precise measurements.
440 C. Ros-Cerro et al.
a b
Fig. 33.3 Axial plane of the anal sphincter complex obtained by echogenic circular structure surrounding the IAS (red arrow). (a) No
2D-transperineal ultrasound (2D-TPUS). Internal anal sphincter (IAS) tears are visible; (b) Defects are visible in both IAS and EAS. Arrows
is identified as a homogeneous hypoechoic circular band (yellow show the ends of the defect
arrow), whereas the external anal sphincter (EAS) is defined as a mixed
a b
c d
Fig. 33.4 3D acquisition of the anal sphincter complex. Mid-sagittal (a), coronal (b) and axial plane (c) are shown. (d) is the 3D reconstruction
in the axial plane. No defects are visible in the external anal sphincter (red arrow) nor the internal anal sphincter (yellow arrow)
3D-TPUS is able to describe normal anatomy, evaluating disruption or discontinuity in the ultrasonographic texture of
the whole route of the sphincter complex [14] and measuring the sphincters (Fig. 33.4). Defects of the IAS include the
the normal thickness of the sphincters [18]. half-moon sign which is translated into retraction of the ends
Criteria of abnormality have been established based on of the IAS: the image shows a reduction in IAS thickness at
anatomical normality. Sphincter defects are identified as a the ends with an increase in thickness in the central zone in
33 Transperineal Ultrasonography in the Assessment of Anal Incontinence and Obstetric Anal Sphincter Injuries 441
Fig. 33.5 Methodology to describe the sphincters tears as proposed by length of the anal canal is analysed by placing the cranial slice (slice n°
Dietz [13], using the tomographic ultrasound imaging technique (TUI). 1) at the level of the anorectal junction and the last slice (slice n° 8) at
After obtaining the longitudinal slice of the entire anal canal, 3D–4D the level of the anal verge, assessing the six central slices. Significant
technology is applied, and the option of eight slices is used. The top left external anal sphincter trauma is considered when visible defects of at
image shows the mid-sagittal plane, whereas the remaining eight least 30° in circumference are present in at least 4/6 tomographic slices.
images represent coronal slices through the anal canal. The whole No tears are visible in the image
the shape of a half-moon [19]. Defects are usually described recommended to obtain the image with the pelvic floor mus-
according to clock face positions, with defects located at the cle in contraction, although this does not provide any advan-
position between 9 and 12 o’clock being the most frequent tage in terms of validity [13]. After obtaining the longitudinal
localisations of OASI. The star shape is lost when there are slice of the entire anal canal, 3D–4D technology is applied.
rectal mucosa lesions. In addition, the thickness of the EAS If TUI is available, the option of eight slices is used. The top
may increase after surgery repair providing a heterogeneous left image shows the mid-sagittal plane, whereas the remain-
image [19]. ing eight images represent coronal slices through the anal
To evaluate the presence or not of EAS defects, the cor- canal. The whole length of the anal canal is analysed by plac-
relation with 3D-EAUS is very good [16], improving the ing the cranial slice (slice n° 1) at the level of the anorectal
results of 2D-TPUS and showing a high sensitivity for recog- junction and the last slice (slice n° 8) at the level of the anal
nising a defect in both sphincters (95% and 73%, verge, assessing the six central slices (Fig. 33.5). The dis-
respectively). tance between the slices depends on the length of the anal
Different classification systems of the lesions used in the canal, and therefore varies and is adjusted in each patient. As
EAUS, such as the Starck or Norderval [20], have been mentioned previously, significant EAS trauma is considered
attempted to classify a defect detected by TPUS. Neither sys- when visible defects of at least 30° in circumference are
tem has demonstrated to be useful on comparing the trans- present in at least 4/6 tomographic slices. It is important to
perineal with the endoanal route. Therefore, the group of add that this definition was obtained on analysing a total of
H.P. Dietz [21] proposed the definition of ‘significant exter- 78 women with FI of different aetiologies and severities. In
nal anal sphincter trauma’ as visible defects of at least 30° in this population the method presented a good correlation with
circumference in at least 4/6 tomographic slices using the the presence of clinical manifestations. However, in a later
tomographic ultrasound imaging (TUI) technique in study by the same group, a good correlation was not found
3D-TPUS. This definition attempts to adapt the definition of between the number of affected slices and the severity of the
Sultan for 3D-EAUS (defect of >30° in 2/3 of the length of symptomatology [22]. It is known that FI is a complex mech-
the anal canal) to 3D-TPUS. Methodologically, acquisition anism that involves the anatomy of the anal sphincter com-
and aperture angles should be reduced to 60–70°, being less plex as well as proper functioning of the levator ani muscle,
than pelvic floor imaging for levator ani morphology. It is pudendal nerves and central nervous system [23]. Therefore,
442 C. Ros-Cerro et al.
Fig. 33.6 Anal sphincter complex visualised using tomographic ultra- because defects (red arrow) of at least 30° in circumference are present
sound imaging technique (TUI) by 3D-transperineal approach, follow- in at least 4/6 tomographic slices (defect in 6/6 in the image)
ing Dietz’s method. Significant external anal sphincter trauma is visible
we cannot define what a clinically relevant lesion is only tak- better sensitivity and specificity for the detection of
ing into account the anatomy of the EAS and the IAS. sphincter defects than 2D-TPUS or EVUS.
If TUI technology is not available, it is also possible to –– There is currently no valid system to classify sphincter
evaluate the anal canal using the sweeping technique similar defects observed by TPUS.
to the analysis of volumes obtained with 3D-EAUS. The –– 3D-TPUS could be proposed as a tool for the initial evalu-
sweeping technique consists in dragging the render box fol- ation or screening of women with symptoms of FI or to
lowing the anal canal, from the anal verge to the level of the identify residual defects following primary repair of an
anorectal junction, in the longitudinal plane and looking at OASI, to thereby decide which women have indications
the volume rendered to evaluate the anal sphincter and define to undergo an endoanal study to more clearly define the
the defect (Fig. 33.6). characteristics of the lesion.
–– However, routine use of exoanal routes (TVUS, TPUS)
for the visualisation of the anatomy of the anal sphincter
33.3 Conclusions complex is not recommended [1].
References 12. Meriwether KV, Hall RJ, Leeman LM, Migliaccio L, Qualls C,
Rogers RG. The relationship of 3-D translabial ultrasound anal
sphincter complex measurements to postpartum anal and fecal
1. Khullar V, Amarenco G, Doumouchtsis SK, Derpapas A, Fernando
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R, Sekido N, Shobeiri SA, Tubaro A, Vodusek DB. Imaging, neu-
13. Dietz HP. Exoanal imaging of the anal sphincters. J Ultrasound
rophysiological testing and other tests. In: Wein A, Abrams P,
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Cardozo L, Wagg A, editors. Sixth international consultation on
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Hochner-Celnikier D, Yagel S. Postpartum evaluation of the anal
2. Cazemier M, Terra MP, Stoker J, de Lange-de Klerk ESM,
sphincter by transperineal three-dimensional ultrasound in primipa-
Boeckxstaens GEE, Mulder CJJ, Felt-Bersma RJF. Atrophy
rous women after vaginal delivery and following surgical repair of
and defects detection of the external anal sphincter: comparison
third-degree tears by the overlapping technique. Ultrasound Obstet
between three-dimensional anal endosonography and endoanal
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magnetic resonance imaging. Dis Colon Rectum. 2006;49(1):20–7.
15. Ghazaleh R; White D; Quiroz L; Shobeiri SA. 3-Dimensional
3. Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter
endovaginal ultrasound can reliably detect normal anal sphincter
injuries-myth or reality? BJOG. 2006;113(2):195–200.
anatomy. Neurourol Urodyn. 2013;32(6):507–932.
4. De Leeuw JW, Vierhout ME, Struijk PC, Hop WC, Wallenburg
16. Ros C, Martínez-Franco E, Wozniak MM, Cassado J, Santoro
HC. Anal sphincter damage after vaginal delivery: functional out-
GA, Elías N, López M, Palacio M, Wieczorek AP, Espuña-Pons
come and risk factors for fecal incontinence. Acta Obstet Gynecol
M. Postpartum two- and three-dimensional ultrasound evaluation
Scand. 2001;80(9):830–4.
of anal sphincter complex in women with obstetric anal sphincter
5. Sultan AH, Thakar R. Lower genital tract and anal sphincter trauma.
injury. Ultrasound Obstet Gynecol. 2017;49(4):508–14.
Best Pract Res Clin Obstet Gynaecol. 2002;16(1):99–115.
17. Cornelia L, Stephan B, Michel B, Antoine W, Felix K. Trans-
6. Starck M, Bohe M, Valentin L. The extent of endosonographic anal
perineal versus endo-anal ultrasound in the detection of anal sphinc-
sphincter defects after primary repair of obstetric sphincter tears
ter tears. Eur J Obstet Gynecol Reprod Biol. 2002;103(1):79–82.
increases over time and is related to anal incontinence. Ultrasound
18. Lee JH, Pretorius DH, Weinstein M, Guaderrama NM, Nager
Obstet Gynecol. 2006;27(2):188–97.
CW, Mittal RK. Transperineal three-dimensional ultrasound in
7. Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu
evaluating anal sphincter muscles. Ultrasound Obstet Gynecol.
A, Goldman HB, Huser M, Milani AL, Moran PA, Schaer GN,
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Withagen MIJ. An International Urogynecological Association
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(IUGA)/International Continence Society (ICS) joint report on
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endosonography for detecting damage to the anal sphincter. AJR
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Magnetic Resonance Imaging
34
Jeroen A. W. Tielbeek and Jaap Stoker
cated coil is the high signal to noise ratio (SNR) close to the
Learning Objectives coil. This high SNR can be used for obtaining images with
• Recognize the imaging features of fecal high spatial resolution. As the anal sphincter muscles are
incontinence. only a few millimeters thick, optimal spatial resolution is
• Describe the accuracy, advantages and disadvan- advantageous. The distension caused by the coil could be
tages of EAUS and MRI. considered a disadvantage, as the anal sphincter components
• Identify sphincter defects and atrophy on MRI. are stretched. Although some thinning will occur which
might be disadvantageous, the information obtained by the
high spatial resolution of an endoanal coil will more than
compensate for this. Subtle changes in the architecture of
anal sphincter components and in signal intensity are visible.
34.1 Introduction It is possible that some distension might be beneficial to
visualize a sphincter defect. This will occur as overlapping
The workup of patients with fecal incontinence primarily com- torn sphincter parts are displaced, which may help in identi-
prises clinical history, physical examination, anofunctional tests fying the defect.
(e.g., manometry), and endoanal ultrasound (EAUS). Magnetic Our experience is based on a 17 mm cylindrical coil with
resonance imaging (MRI) was introduced in the 1990s as an a length of 8 cm. The coil is protected by a 19 mm outer
alternative for EAUS. The primary reason was the difficult diameter coil holder, which has a length of 10 cm [1]. The
delineation of the external sphincter at EAUS. MRI has a high diameter of the endoanal coil is comparable to the diameter
intrinsic contrast resolution, which has proved to be beneficial of an endosonography transducer, facilitating comparison of
for delineating the external sphincter. In this chapter the role of findings.
MRI in patients with fecal incontinence is described. As treat-
ment is primarily aimed at the external sphincter, the emphasis
is on evaluation of the external sphincter. 34.2.2 Preparation
a b
Fig. 34.2 Endoanal coronal (a) and axial (b) T2-weighted turbo spin- ischioanal space (arrowhead). There is also atrophy of the internal
echo in a 56-year-old female patient with fecal incontinence show sphincter (IS) and moderate atrophy of the puborectal muscle (PR) and
severe atrophy of the external sphincter (ES) and scar tissue of the left levator ani (LA). Compare to Fig. 34.3
anterolateral external sphincter (arrows) with adjacent scar tissue in the
with a thickness less than 2 mm, in a middle-aged or elderly These findings were not confirmed in a prospective study
individual, is considered atrophied (Fig. 34.2). in a larger number of patients. In this study, findings at EAUS
and endoanal MRI in 52 patients were compared to the final
diagnosis made by an expert panel, based on all available
34.4 Accuracy for Sphincter Defects information [12]. Complete agreement between endoanal
MRI and EAUS and the final diagnosis was found in 62%.
In the more than 20 years since the introduction of endoanal Findings at EAUS were more frequently confirmed by the
MRI, several studies have been published on the accuracy of expert panel than findings at endoanal MRI. Discordant find-
endoanal MRI in detecting anal sphincter defects. Initial ings primarily concerned internal sphincter lesions. The
studies concerned rather small series, demonstrating that authors concluded that MRI is inferior in diagnosing internal
accuracy is good (up to 95%) for demonstrating external anal sphincter injury. The differences between both studies
sphincter defects [9, 10]. As EAUS is the standard technique are probably related to differences in experience with either
for demonstration of anal sphincter defects, a comparison of technique and differences in the disease spectrum and refer-
endoanal MRI and EAUS is important. Two single-center ence standard.
studies and one larger multicenter comparative study have The third study compared EAUS and endoanal MRI for
been performed. detection of external sphincter defects [13]. This multi-
The first comparative study retrospectively compared center study concerned 237 patients (214 women). There
both techniques to findings at surgery. The study concerned was agreement between endoanal MRI and EAUS in 146
22 patients with fecal incontinence undergoing anterior anal patients (61%; κ = 0.24: fair agreement). A selection of
sphincter repair [11]. There was better agreement of endo- patients (n = 36) underwent anterior anal sphincter repair.
anal MRI with surgical results for external sphincter defects In these patients there was no significant difference in the
compared to findings at EAUS for diagnosing lesions of the detection of external anal sphincter defects between endo-
external anal sphincter (к MRI 0.85 vs. EAUS 0.53) and anal MRI and EAUS (P = 0.23). The sensitivity and posi-
internal anal sphincter (к MRI 0.64 vs. EAUS 0.49). tive predictive value of endoanal MRI were 81% and 89%,
448 J. A. W. Tielbeek and J. Stoker
a b
Fig. 34.3 Endoanal coronal (a) and axial (b) T2-weighted turbo spin- architecture of the complete inferior internal sphincter ring and scar tissue
echo in a 46-year-old male patient with anal pain demonstrates normal of the internal sphincter left posterolateral (black arrow in a; white arrow
anatomy of the external sphincter (ES) and puborectalis muscle (PR) at in b) after previous surgery. BS bulbospongiosus muscle, G gluteus mus-
the right side. The inferior part of the internal sphincter (IS) is abnormal culature, IC ischiocavernosus muscle, LA levator ani (white arrow in a);
(best seen in the axial plane (a); compare to Fig. 10.5), with disturbed TPM transverse perineal muscle, R coil with tip in distal rectum
34.5 Accuracy for Sphincter Atrophy Abnormal thinning (<2 mm) of the internal anal sphincter
can be found in patients with idiopathic degeneration [22].
External sphincter atrophy was a finding known from elec- Atrophy of the internal anal sphincter is most easily appreci-
tromyography. This entity had become somewhat neglected ated at an axial image, and a cutoff of 2 mm thickness is used
following the widespread replacement of electromyography to identify internal sphincter atrophy in older individuals.
by EAUS. Internal sphincter atrophy is nicely demonstrated at both
As the external sphincter is very well delineated at endo- endoanal MRI (Fig. 34.2) and EAUS.
anal MRI, detection of atrophy was an easy task (Fig. 34.2).
A study with histopathological verification in 25 patients
demonstrated that endoanal MRI is accurate in detecting 34.6 M
RI in the Management
external sphincter atrophy [16]. Endoanal MRI had a sensi- of Fecal-Incontinent Patients
tivity of 89%, specificity 94%, positive predictive value 89%,
and negative predictive value 94% for external sphincter The results of EAUS and endoanal MRI in the detection of
atrophy. external sphincter defects are comparable. The widespread
External sphincter atrophy is a finding related to sphincter experience and availability, and lower costs and time effi-
function. In a prospective series of 200 patients, external anal ciency, favor EAUS as the first-choice technique for detect-
sphincter atrophy was present in 123 patients (62%) at endo- ing external sphincter defects. Endoanal MRI can be used as
anal MRI [17]. The atrophy was severe in 44 patients (22%) an alternative. In experienced hands, external phased array
and mild in 79 (40%). Maximal squeeze pressure and squeeze MRI can replace endoanal MRI. This is a time-efficient
increment pressure were significantly decreased in individu- alternative, which lacks the discomfort associated with the
als with external sphincter atrophy. Patients with severe atro- introduction of an endoanal device, a drawback of both
phy had a significantly lower maximal squeeze and squeeze endoanal MRI and EAUS.
increment pressure than patients with mild atrophy. This is The principal role of endoanal MRI is in demonstrating
concordant with an earlier study in which 16 patients with and grading external sphincter atrophy. This finding is a neg-
fecal incontinence and decreased squeeze pressure, and 9 ative predictor of the outcome of anterior anal repair. With
controls with normal squeeze pressures, were studied [18]. current knowledge, MRI is the preferred method to demon-
Anal squeeze pressure correlated with external sphincter vol- strate external sphincter atrophy. Data on EAUS are sparse
ume and fat content. and conflicting. Therefore, in patients considered for anterior
Two studies have evaluated the role of endoanal MRI in anal repair, MRI should be performed to identify individuals
predicting the outcome of anterior anal repair. One study with external sphincter atrophy. The use of external phased
performed endoanal MRI in 20 female patients scheduled for array MRI is a valuable alternative in experienced hands.
anterior anal repair. Eight of these patients had external Neither EAUS nor endoanal MRI play a role in selecting
sphincter atrophy. The outcome was significantly better in patients for pelvic floor rehabilitation. In a series of 250
those patients without external sphincter atrophy [19]. A fur- fecal-incontinent patients, neither technique had substantial
ther study in 30 patients demonstrated that baseline measure- predictive value for the outcome of pelvic floor rehabilitation
ment of preserved external anal sphincter bulk correlated [23]. More research into this area is needed.
with a better outcome [15]. These studies demonstrate that
external sphincter atrophy at endoanal MRI is a negative pre-
dictor of outcome of anterior sphincter repair. 34.7 Conclusions
Studies on EAUS and detection of external sphincter atro-
phy are sparse and have limited patient numbers and conflict- The evidence on the role of endoanal MRI in fecal inconti-
ing results. In a comparative study of 20 female patients, nence is considerable but not extensive. Endoanal MRI can
external sphincter atrophy was identified in 8 patients at be used as an alternative to EAUS for detecting external
endoanal MRI and in no patients with EAUS [19]. In a study sphincter defects. Current evidence indicates that endoanal
of 18 patients, three-dimensional (3D) EAUS and endoanal MRI should be used in patients considered for anterior anal
MRI showed no difference in the assessment of external anal repair because of external sphincter atrophy identification.
sphincter atrophy, but there was a substantial difference in The role of MRI in other surgical treatment options is an
grading [20]. However, another study with 18 fecal- obvious topic for future research. One can speculate that
incontinent patients showed that correlation between EAUS external sphincter atrophy at MRI could be an important
and endoanal MRI for external anal sphincter thickness, finding for sacral neuromodulation. However, one study
length, and area was poor [21]. The decreased delineation of reports that sacral nerve stimulation can be effective in
the external anal sphincter border in external sphincter atro- patients with fecal incontinence related to atrophy of the
phy probably impairs accurate evaluation. external anal sphincter, regardless of the severity of atrophy
450 J. A. W. Tielbeek and J. Stoker
detected by MRI [24]. Technical developments in MRI, such 10. deSouza NM, Hall AS, Puni R, et al. High resolution magnetic
resonance imaging of the anal sphincter using a dedicated endo-
as diffusion weighted imaging, diffusion tensor imaging, and anal coil. Comparison of magnetic resonance imaging with surgical
fiber tracking [25], could be of value in patients with fecal findings. Dis Colon Rectum. 1996;39:926–34.
incontinence. 11. Rociu E, Stoker J, Eijkemans MJ, et al. Fecal incontinence: endo-
anal US versus endoanal MR imaging. Radiology. 1999;212:453–8.
12. Malouf AJ, Williams AB, Halligan S, et al. Prospective assess-
ment of accuracy of endoanal MR imaging and endosonogra-
Take-Home Messages phy in patients with fecal incontinence. AJR Am J Roentgenol.
• In patients with fecal incontinence, MRI is well tol- 2000;175:741–5.
13. Dobben AC, Terra MP, Slors JFM, et al. External anal sphincter
erated and comparable to EAUS. defects in patients with fecal incontinence. Comparison of endoanal
• The widespread experience and availability, and MR imaging and endoanal US. Radiology. 2007;242:463–71.
lower costs and time efficiency, favor EAUS as the 14. Terra MP, Beets-Tan RGH, Vervoorn I, et al. Pelvic floor muscle
first-choice technique for detecting external sphinc- lesions at endoanal MR imaging in female patients with faecal
incontinence. Eur Radiol. 2008;18:1892–901.
ter defects. 15. Dobben AC, Terra MP, Deutekom M, et al. The role of endoluminal
• Endoanal and external coil MRI are both accurate imaging in clinical outcome of overlapping anterior anal sphincter
in detecting external sphincter atrophy. repair in patients with fecal incontinence. AJR Am J Roentgenol.
2007;189:W70–7.
16. Briel JW, Zimmerman DDE, Stoker J, et al. Relationship between
sphincter morphology on endoanal MRI and histopathologi-
cal aspects of the external anal sphincter. Int J Colorectal Dis.
2000;15:87–90.
References 17. Terra MP, Deutekom M, Beets-Tan RG, et al. Relationship
between external anal sphincter atrophy at endoanal magnetic
1. Stoker J, Rociu E, Zwamborn AW, Laméris JS. Endoluminal MR resonance imaging and clinical, functional, and anatomic charac-
imaging of the rectum and anus: technique, applications, and pit- teristics in patients with fecal incontinence. Dis Colon Rectum.
falls. Radiographics. 1999;19:383–98. 2006;49:1149–59.
2. Deutekom M, Terra MP, Dijkgraaf MG, et al. Patients’ percep- 1
8. Williams AB, Bartram CI, Modhwadia D, et al. Endocoil magnetic
tion of tests in the assessment of faecal incontinence. Br J Radiol. resonance imaging quantification of external anal sphincter atro-
2006;79:94–100. phy. Br J Surg. 2001;88:853–9.
3. Kessels IM, Fütterer JJ, Sultan AH, et al. Clinical symptoms related 19. Briel JW, Stoker J, Rociu E, et al. External anal sphincter atrophy
to anal sphincter defects and atrophy on external phased-array MR on endoanal magnetic resonance imaging adversely affects conti-
imaging. Int Urogynecol J. 2015;26:1619–27. nence after sphincteroplasty. Br J Surg. 1999;86:1322–7.
4. Terra MP, Beets-Tan RG, van der Hulst, et al. Evaluating anal 2
0. Cazemier M, Terra MP, Stoker J, et al. Atrophy and defects
sphincter defects in patients with fecal incontinence: endoanal MR detection of the external anal sphincter: comparison between
imaging versus external phased array MR imaging. Radiology. three-dimensional anal endosonography and endoanal magnetic
2005;236:886–95. resonance imaging. Dis Colon Rectum. 2006;49:20–7.
5. Terra MP, Beets-Tan RG, van der Hulst VPM, et al. MR imaging 2
1. West RL, Dwarkasing S, Briel JW, et al. Can three-dimensional
in evaluating atrophy of the external anal sphincter in patients with endoanal ultrasonography detect external anal sphincter atrophy?
fecal incontinence. Am J Roentgenol. 2006;187:991–9. A comparison with endoanal magnetic resonance imaging. Int J
6. Malouf AJ, Halligan S, Williams AB, et al. Prospective assessment Colorectal Dis. 2005;20:328–33.
of interobserver agreement for endoanal MRI in fecal incontinence. 2
2. Vaizey CJ, Kamm MA, Bartram CI. Primary degeneration of the
Abdom Imaging. 2001;26:76–8. internal anal sphincter as a cause of passive faecal incontinence.
7. Rociu E, Stoker J, Eijkemans MJC, Laméris JS. Normal anal sphinc- Lancet. 1997;349:612–5.
ter anatomy and age- and sex-related variations at high-spatial- 23. Terra MP, Deutekom M, Dobben AC, et al. Can the outcome of
resolution endoanal MR imaging. Radiology. 2000;217:395–401. pelvic-floor rehabilitation in patients with fecal incontinence be
8. Frudinger A, Halligan S, Bartram CI, Price, et al. Female anal predicted? Int J Colorectal Dis. 2008;23:503–11.
sphincter: age-related differences in asymptomatic volunteers with 2
4. Santoro GA, Infantino A, Cancian L, et al. Sacral nerve stimula-
high-frequency endoanal US. Radiology. 2002;224:417–23. tion for fecal incontinence related to external sphincter atrophy. Dis
9. deSouza NM, Puni FR, Zbar A, et al. MR imaging of the anal Colon Rectum. 2012;55:797–805.
sphincter in multiparous women using an endoanal coil: correlation 25. Zijta FM, Froeling M, Nederveen AJ, et al. Diffusion tensor imag-
with in vitro anatomy and appearances in fecal incontinence. AJR ing and fiber tractography for the visualization of the female pelvic
Am J Roentgenol. 1996;167:1465–71. floor. Clin Anat. 2013;26:110–4.
Neurophysiological Evaluation:
Techniques and Clinical Evaluation 35
Mitul Patel, Kumaran Thiruppathy, and Anton Emmanuel
the puborectalis muscle and the EAS have separate neuro- canal. Further large propulsive contractions of the rectum
logical innervation. This is evident from pudendal blocks occur until the rectum is empty.
which does not abolish voluntary contraction of the pelvic A sensory input from the anus maintains this propulsive
floor. Blocking of the pudendal nerve results in loss of sensa- activity until the rectum is fully voided. This seems to be a
tion in the perianal and genital skin and weakness of the anal reflex mediated at spinal cord level since even spinally
sphincter muscle, but does not affect rectal sensation [4]. injured patients can void a complete stool from the rectum,
Additionally, pudendal nerve blocks eliminate rectoanal once initiated.
contractile reflexes (RACR) which suggests that pudendal As the stool passes through the anal canal, it stretches the
neuropathy may affect the rectoanal contractile reflex external anal sphincter generating a traction force upon it.
response. The RACR is either a subconscious effort or a pri- After the last stool is passed, the “closing reflex” of the exter-
mordial reflex that prevents accidental release of rectal con- nal sphincter is stimulated by the release of traction [6].
tents, for example, when the intraabdominal pressure is A number of reflexes have been described in addition to
raised when coughing or sneezing. The RACR is mediated the aforementioned RACR that play a fundamental role in
by both pelvic splanchnic and pudendal nerves and is inde- neural control of the anorectum.
pendent of rectal sensation [5]. The rectoanal inhibitory reflex (RAIR) is initiated result-
The somatic innervation does not fully dictate bowel and ing in decent of rectal contents into the upper anal canal
anorectal function. The autonomic nerve supply of the pelvic which allows the discrimination of solid, liquid or gaseous
viscera travels within the pelvic plexus anterior to the pelvic luminal contents. After rectal filling sensation reaches con-
muscles. sciousness, the parasympathetic-driven defecation reflex is
Furthermore, the gastrointestinal system has a unique initiated unless voluntarily inhibited. The absence of this
nerve supply known as the enteric nervous system (ENS). reflex is pathognomonic of Hirschsprung’s disease and after
The ENS is an integrated system of neurons with structural low anterior resection (Fig. 35.1).
complexity and functional heterogeneity similar to those of There are a number of neurophysiological tests that are per-
the brain and the spinal cord. The ENS’s role within the gut formed within tertiary centres to evaluate the anorectum. These
includes control of gut motor function, mucosal blood flow, tests can be used in conjunction with other modalities to provide
mucosal transport and secretion and modulation of immune an improved understanding of the pathophysiology of disorders
and endocrine function. of the anorectum and allow for their better management.
The anorectum is innervated by somatic (sensory and
motor), autonomic nerves and the enteric nervous system
creating a complex interplay of mechanisms to allow for the 35.3 Nerve Conduction Studies
intricacy of gut function and defecation.
Defaecation commences with rectal sensory awareness The unique anatomical character of the pelvis means neuro-
at a threshold level of filling which is conveyed to the cere- physiological testing produces its own challenges; however,
bral cortex as the perception of the need to evacuate the before approaching specific tests, a basic understanding of
rectum. The threshold volume of the rectum is dependent the principles and techniques used is essential for the pelvic
on the nature of the contents (gas, liquid or solid) and the floor surgeon.
physical properties of the rectum itself in terms of compli- With any neuromuscular disorder, the first step in diagnos-
ance and sensitivity of the mucosal lining. These physical tic evaluation is to determine which portions of the nerve and
properties, in turn, depend on the individual’s autonomic muscle are intact. Symptoms can arise from insult at the neu-
tone and mood. ron, the axon, the neuromuscular junction or the muscle fibres.
When the subject is in a socially appropriate setting for The second step is to determine the exact location of the injury.
defaecation, determined by learned higher cortical functions, Three common tests are frequently used to evaluate neu-
a position is adopted to flex the hips to permit straightening romuscular disorders:
of the rectal angle and allows a more effective anatomical
position to expel the contents. The rectal contents stimulate 1. Nerve conduction studies, which evaluate the velocity of
reflex relaxation of the anal sphincters and puborectalis. The propagation of an action potential along different nerve
subject then performs a Valsalva manoeuvre by breathing segments.
against a closed glottis, to raise the abdominal pressure and 2. Repetitive nerve stimulation, which tests the consistency
the muscles of the anterior abdominal wall contract to funnel of transmission across the neuromuscular junction. The
the pressure down to the pelvis. The relaxation of the pelvic aforementioned test is not routinely used for pelvic floor
floor then allows some stool to enter the lower rectum. This studies.
in turn tends to initiate the spontaneous giant rectosigmoid 3. Electromyography, which evaluates the intramuscular
contractions which pushes stool through the relaxed anal response to inherent neuronal signals [7].
35 Neurophysiological Evaluation: Techniques and Clinical Evaluation 453
Pressure (cmH2O)
Duration of reflex
Thiruppathy K, Roy A,
Preziosi G, Pannicker J,
Emmanuel A. Morphological
abnormalities of the rectoanal Maximum
inhibitory reflex reflects stimulation
symptom pattern in
neurogenic bowel. Dig Dis
Sci. 2012;57(7):1908–1914)
Resting
pressure
Amplitude
reduction
2/3 recovery
Time (seconds)
Nerve conduction studies introduce an action potential in Amplitude is measured from the baseline to the maximal
the peripheral nervous system, and the subsequent recording point of the waveform and provides the number of axons and
of the neural impulse at a location distant from the site of stim- muscle fibres being tested. This gives an estimate of the amount
ulation is taken. The velocity of the action potential and the of functional tissue. The area under the waveform above the
size of the response can allow for an assessment of the health baseline provides a better estimate of functioning tissue; how-
of the tested nerve. Three different types of response can be ever, even this can be unreliable for the pelvic floor as the dis-
measured—pure sensory nerve action potential (SNAP), com- tance between the electrode and the muscle can significantly
pound nerve action potential (CNAP) for mixed sensory and attenuate the signal. Duration of the action potential is mea-
motor nerves and pure motor nerve evaluations by measuring sured from the onset latency to when it crosses the baseline.
compound muscle action potentials (CMAPs). CMAPs have Nerve conduction velocities can be measured by dividing
been traditionally used to evaluate pelvic floor disorders. the distance the action potential has travelled by the time
A CMAP is the biphasic waveform obtained from stimu- taken. For motor nerve conduction, the latencies between
lating a nerve proximal to a muscle and recording the poten- two different sites of stimulation are subtracted to account
tial directly over the muscle. The CMAP response is a for the delay at the neuromuscular junction. Due to the
summation of all the muscle fibres that are depolarized by a unique anatomical path of the pudendal nerve and the inabil-
single stimulated nerve. ity to stimulate it at two defined anatomical points, nerve
The CMAP has a number of parameters. Onset latency conduction velocities are difficult to obtain [7, 8].
represents the arrival time of the fastest conducting nerve
fibres at the recording electrode over the muscle. This time
reflects neural activation from the stimulus, propagation of 35.4 P
udendal Nerve Terminal Motor
the action potential along the nerve and transmission across Latency (PNTML)
synapses at the neuromuscular junction. Disruption at any of
these sites will result in a prolonged latency. The largest, The pudendal nerve terminal motor latency (PNTML) mea-
heavily myelinated, fastest conducting axons in a nerve will sures neuromuscular integrity between the terminal portion
be those evaluated by the latency. Normal onset latency can of the pudendal nerve and the anal sphincter. An injury to the
be seen despite there being a significant loss of axons as only pudendal nerve leads to denervation of the anal sphincter
a few healthy myelinated axons are required to produce the muscle and muscle weakness.
first stimulus to the muscle. Prolonged onset latency how- Thus, measurement of PNTML can help identify if a
ever can allow one to assume there is significant loss of neu- weak sphincter muscle is due to nerve injury rather than
romuscular function. muscle injury. This can be useful in the assessment of
454 M. Patel et al.
patients with faecal incontinence prior to anal sphincter PNTML can be used to predict the outcome of sphincter
repair and helpful in predicting the outcome of surgery. repair surgery post-obstetric injury one study showed that
Furthermore, its value in assessing perineal decent and con- surgical repair produced a good to excellent result in 80% of
stipation has also been described [5]. women with faecal incontinence but without pudendal neu-
The commonest method of measuring PNTML is with a ropathy compared with 11% of women with neuropathy
disposable St. Mark’s electrode. This specially designed [10]. However, the utility of PNTML in patient management
electrode consists of two stimulating electrodes and two has been questioned with studies suggesting it does not have
recording electrodes which can be attached to a gloved index bearing on patient selection for surgical intervention and that
finger. The stimulating electrode is found at the tip of the even those with unilateral or bilateral prolonged pudendal
finger and the recording electrode at the base. The pudendal nerve terminal motor latency should be offered surgery as
nerve is then stimulated at the ischial spine with the record- there is still a significant functional improvement [11, 12].
ing electrode located at the EAS (Fig. 35.2). The utility of PNTML has been disputed. The American
The nerve inside the rectum is stimulated with a low elec- Gastroenterology Association does not recommend the use of
trical current which should cause the sphincter muscle to con- PNTML for the use of faecal incontinence as it correlates
tract. A CMAP is generated and from this the latency can be badly with clinical and histological finding as well as having
calculated. The normal range is of the order of 2.0–2.5 ms with poor sensitivity and specificity and being user-dependent
prolonged times being associated with pudendal neuropathy. [13]. Additionally, a normal PNTML does not exclude puden-
The primarily tools used in research and clinically to dal neuropathy as only a few patent nerve fibres are required
determine neuropathy are pudendal nerve terminal motor to provide a normal result. PNTMLs measure conduction of
latencies (PNTMLs) and single-fibre or concentric needle thick well-myelinated nerve fibres which is not an accurate
electromyography (EMG). As EMG is not routinely per- representation of integrated pudendal nerve function.
formed due to associated morbidity, patient discomfort and It is also usual to get unilateral prolonged PNTML; how-
need for experienced specialist to perform the tests, PNTMLs ever, both nerves anatomically cross over and are thought to
have been the favoured choice till recently. cross innervate [14, 15]. This in part may explain discrepan-
Women who deliver vaginally with a prolonged second stage cies between PNTML and inconsistent correlation with
of labour or forceps delivery have been found to have prolonged symptoms [14]. Such inconsistencies have been further
PNTML. Furthermore, after a birth injury, women who develop shown in a recent study where PNTML was only associated
faecal incontinence have been shown to have both pudendal with median maximum anal squeeze pressure and was not
neuropathy and anal sphincter defects. In one study, women associated with patient-reported severity of symptoms of
with obstetric injury developed faecal incontinence only when faecal incontinence, changes in quality of life attributable to
there was associated pudendal neuropathy [9]. This highlights faecal incontinence, median mean resting anal pressure or
the multifactorial nature of faecal incontinence, and a combina- median maximum resting anal pressure suggesting its rou-
tion of investigations is required to determine aetiology. tine use should be questioned [16].
35.5 Electromyography (EMG) tative information about muscle behaviour and may there-
fore be used in constipated patients to determine defecation
Electromyography (EMG) refers to the study of the pattern dyssynergia in the laboratory. In one study using surface
of electrical activity moving along the muscle fibres. The EMG techniques, the dyssynergia pattern correlated with
electrical activity originating from a nerve can be determined inability to expel a balloon filled with 50 mL of water from
and give an indication of a nerve function. In its complete the rectum in 83% of patients studied [18].
utility, EMG can discriminate between normal, denervated Surface EMG with the advent of vaginal and anal devices
and reinnervated as well as myopathic muscle. has shown to be useful during biofeedback pelvic floor
EMG allows for assessment of individual motor unit retraining to provide a visual or audible signal when the
action potentials (MUAPs). Motor units consist of a neu- appropriate contraction of the pelvic floor is undertaken.
ron, its axon and the multiple muscle fibres it serves. At
the level of the muscle, the axon branches to innervate
muscle fibres scattered throughout the muscle in a mosaic 35.6 Developments Neurophysiological
pattern. For the majority of pelvic floor sphincter mus- Investigations
cles, the neuronal cell bodies from which the action
potential is relayed lie in the anterior horn of the spinal Most current neurophysiological tests have focused on the
cord known as Onuf’s nucleus. rectum, anus and surrounding nerves, but newer tests are
Kinesiologic EMG assesses the presence or absences of emerging. We know the neuronal pathways between the
muscle activity during certain manoeuvers. Surface elec- brain and gut are intimately involved in negotiating sensa-
trodes are placed on the skin over the muscle being tested, tions and reflexes that control anal and rectal function. These
and a summation of electrical muscle activity can be evalu- bidirectional pathways from the anus, rectum, pelvic floor,
ated. This method does not allow for assessment of individ- spinal cord and brain can be assessed using various tech-
ual MUAPs and so is not used to diagnose or quantify niques. The afferent pathways can be assessed using a multi-
neuropathy. Alternatively, needle EMG provides a more tude of novel tests functional MRI (fMRI), examining PET,
accurate picture to diagnose neuropathy or myopathy and cortical evoke potentials and magnetic encephalography.
still remains the gold standard EMG test.
Needle EMG can be performed using a multitude of nee-
dle electrodes—monopolar, single-fibre and concentric each 35.7 Cortical Evoked Potentials (CEP)
with their own distinctive properties. The commonest used
remains the concentric needle electrode which consists of a Cortical evoked potentials have been used for over 60 years
bevelled needle with a platinum wire (active electrode) at the to study somatosensory, visual, auditory and pain pathways.
tip surrounded by a steel cannula. The uptake area for the This technique involves a brief sensory stimulation, which is
needle is equivalent to approximately 20 muscle fibres [7, 8]. time- and phase-locked to the electroencephalogram record-
EMG of the pelvic floor can be performed to identify ing via surface electrodes placed on the scalp. The event-
areas of sphincter injury by mapping the EAS, to determine related signal is small in amplitude but occurs at the same
whether the muscle contracts or relaxes (by the number of moment in time following each stimulus, while the large
motor units firing) and to identify denervation-reinnervation amplitude background electroencephalogram occurs ran-
potentials indicative of nerve injury. domly. In order to extract the desired signal, repeated stimuli
EMG of the striated pelvic floor muscles can be per- are given, and the subsequent brain activity is averaged. The
formed using a needle electrode, a surface electrode on the resultant waveform represents the brain’s response to a stim-
perianal skin or an anal plug. ulus as it changes with each millisecond. CEP responses of
The needle electrode can be a concentric which can sam- the GI tract (oesophagus, stomach, duodenum, and sigmoid
ple a number of motor units or single-fibre electrode which colon) have been mapped for pain stimuli to create the
has a smaller recording surface and detects single motor “human visceral homunculus” [19].
units. Needle EMG can be used to map the striated muscle Furthermore, it has been used in the anus and rectum to
fibres of the EAS and when compared to anal ultrasound study irritable bowel syndrome. Twenty-two pairs of age-
assessment for sphincter injury show agreement; however, matched healthy females and IBS patients had CEP recorded
anal ultrasound was more sensitive and as expected better in response to rhythmic rectal distensions. IBS patients dem-
tolerated with a lower risk of infections [17]. Needle elec- onstrated higher prevalence of cerebral evoked potential early
trode EMG is therefore not recommended at the current time peaks postprandially and uniformly shorter cerebral evoked
outside of research use. potential latencies, both before and after a meal. Another
Surface EMG is an alternative mechanism of assessing study, patients with IBS had shorter latency and increased
sphincter activity but is less reliable due to the inconsistent amplitude compared with controls. The outcomes of these two
contact with the anal canal. Surface electrodes provide quali- studies offer evidence for hypersensitivity of visceral afferents
456 M. Patel et al.
with effects at a cortical level [5]. CEPs are reliable and repro- bowel itself. An attraction of SNS is that, unlike direct surgery
ducible measures of early sensory processing and have been to the sphincter or colon, they have the potential to modify all
used to subcategories IBS into four pathophysiological groups. aspects of the coordinated neuromuscular functions [27].
This highlights the syndrome’s heterogeneous nature and how SNS involves direct, chronic, low-voltage electrical stimu-
personalised treatment may be beneficial in the future [20]. lation of the sacral nerve roots using an electrode placed via a
sacral foramen usually S3. Though the technology has evolved
over time, the commonest current form utilises a percutane-
35.8 Motor Evoked Potentials ously sited, commercially manufactured quadripolar electrode
lead system connected to an implanted pulse generator
The efferent motor pathways can be assessed using stimula- (InterStim® Therapy, Medtronic Inc., Minneapolis, US)
tion of the motor cortex using transcranial magnetic stimula- placed within the subcutaneous fat. A temporary percutaneous
tion (TMS). Magnetic flux is created when a current is nerve evaluation (PNE) system is also available which allows
rapidly discharged through a conducting coil. This magnetic for a trial period before permanent implantation [28].
flux can be used to stimulate neural tissue in a non-invasive For FI patients in whom the primary aetiology appears to
and painless method. Cortical mapping with transcranial be neurogenic and in whom a sphincter defect is not found at
magnetic stimulation suggests that rectal and anal responses investigation, SNS is now considered the first-line surgical
are bilaterally represented on the superior primary motor intervention when conservative treatments have failed [29].
cortex—Brodmann area 4 [21]. A large number of case series studies have shown the ben-
efit of SNS in reducing faecal incontinence. Systematic
review has shown favourable mid- and long-term positive
35.9 M
ucosal Blood Flow: Laser Doppler outcomes for SNS of approximately 80% based on a greater
Flowmetry (LDF) than 50% reduction in FI episodes, although this figure is
reduced to approximately 60% when all available partici-
Gastrointestinal mucosal blood flow is thought to be regu- pants who start therapy are included (comparable with
lated at least in part by the enteric nervous system; it has intention-to-treat principles) [28, 30].
been postulated that assessment of mucosal blood flow may The most recent Cochrane systematic review on the topic
provide a surrogate, sensitive, quantitative measure of the analysed six trials concluding that SNS can improve continence
level of activity of the extrinsic autonomic nerves innervat- in a proportion of patients with faecal incontinence. However, it
ing the gut. Mucosal blood flow is influenced by local neural did not improve symptoms in patients with constipation [28].
and endocrine factors, but given a steady-state situation, the The exact mechanism of how SNS improve incontinence
variation in blood flow may be accounted for by differences is not known. The initial hypothesis that the mechanism of
in extrinsic nerve activity. Measurement of the mucosal SNS was primarily peripheral motor neurostimulation is not
blood flow can be performed using laser Doppler flowmetry supported by the majority of studies. Due to the large body of
(LDF) a technique which has been previously used in assess- evidence demonstrating effects outside of the anorectum, it
ing perfusion in skin grafts, Raynaud’s phenomenon and appears likely that the influence of SNS on anorectal function
cerebral hypoperfusion [22]. Within the gut this technique occurs at a pelvic afferent or central level [31]; however, stud-
has been validated to measure extrinsic autonomic hind gut ies in patients with tenesmus failed to show changes in ano-
function and though is not used clinically has been used to rectal sensory function. Though investigations continue, it is
research gut dysfunction in spinal cord injury (SCI), multiple well recognised that the lack of understanding of the exact
sclerosis and diabetic patients. The use of LDF has been used mechanism of action of SNS limits the current potential of
to show reduced mucosal blood flow in SCI patients with this treatment option in terms of better patient selection,
constipation and thus altered autonomic innervation [23, 24]. improved technology, patient outcomes and healthcare costs.
Neuromodulation of the anorectum to improve incontinence Our knowledge of neuroanatomy and neurophysiology of the
has shown recent promise. The origins of electrical stimula- colo-rectum has been based on classical descriptions with
tion of the anorectum date back to the 1960s [25]. Sacral nerve few advances in recent years. Studying neural control of
stimulators (SNS) and neuromodulation originally were first colorectal function is difficult as there are:
used for those with urinary dysfunction; however, this has now
been adopted for faecal incontinence [26]. The advent of SNS • Few studies
has allowed for a bridge between conservative management of • Poor animal models to extrapolate to human neuro-gut
incontinence and surgical interventions to sphincters or the function
35 Neurophysiological Evaluation: Techniques and Clinical Evaluation 457
• Difficulty extrapolating from neurological disease 5. Remes-Troche JM, Rao SSC. Neurophysiological testing in anorec-
tal disorders. Expert Rev Gastroenterol Hepatol. 2008;2:323–35.
(because of co-factors related to disease) 6. Bajwa A, Emmanuel A. The physiology of continence and evacua-
• Poor reproducibility of physiological measures to date tion. Best Pract Res Clin Gastroenterol. 2009;23:477–85.
• Dependence on assessment of reflexes 7. Gregory WT, Kenton K. Clinical neurophysiology of the pelvic
floor. In: Pelvic floor disorders. Milan: Springer; 2010. p. 43–55.
8. Weiss JM, Weiss L, Silver JK. Easy EMG: a guide to perform-
Recently opportunities have been improving; however, ing nerve conduction studies and electromyography. 2nd edition,
the majority of tests are used for research purposes. In part Elsevier; 2015.
this has been due to emerging physiological investigational 9. Tetzschner T, Sørensen M, Lose G, Christiansen J. Anal and urinary
methods. In vivo studies have also focused on the role of incontinence in women with obstetric anal sphincter rupture. Br J
Obstet Gynaecol. 1996;103:1034–40.
anorectal sensory function and how it complements motility, 10.
Felt-Bersma RJ, Klinkenberg-Knol EC, Meuwissen
while in vitro organ culture models have evaluated histologi- SG. Investigation of anorectal function. Br J Surg. 1988;75:53–5.
cal change. The better classification of neuro disease 11. Cooper EA, De-Loyde KJ, Young CJ, Shepherd HL, Wright
subtypes—i.e. homogenous groups with narrower
C. Pudendal nerve testing does not contribute to surgical decision
making following anorectal testing in patients with faecal inconti-
“ranges”—has allowed for pure study groups and reducing nence. Int J Colorectal Dis. 2016;31:1437–42.
cofounding factors. New treatment techniques (SNS, puden- 12. Chen AS, Luchtefeld MA, Senagore AJ, Mackeigan JM, Hoyt
dal nerve stimulation) allow pre- and post-treatment com- C. Pudendal nerve latency. Does it predict outcome of anal sphinc-
parisons in function, physiology and clinical outcome. Thus ter repair? Dis Colon Rectum. 1998;41:1005–9.
13. Diamant NE, Kamm MA, Wald A, et al. AGA technical review on
we can begin to understand the neurophysiology of anal con- anorectal testing techniques. Gastroenterology. 1999;116:735–60.
tinence and potentially better understand pathophysiology in 14. Wunderlich M, Swash M. The overlapping innervation of the two
both neurological and idiopathic patients. sides of the external anal sphincter by the pudendal nerves. J Neurol
Sci. 1983;59:97–109.
15. Sultan AH, Kamm MA, Hudson CN, Thomas JM, Bartram
CI. Anal-sphincter disruption during vaginal delivery. N Engl J
Take-Home Message Med. 1993;329:1905–11.
16. Saraidaridis JT, Molina G, Savit LR, Milch H, Mei T, Chin S, Kuo
Though neurophysiology tests have their limitations J, Bordeianou L. Pudendal nerve terminal motor latency testing
and play a bigger role in the research setting currently, does not provide useful information in guiding therapy for fecal
they can be beneficial in evaluating specific aspects of incontinence. Int J Colorectal Dis. 2018;33:305–10.
patients’ pathological process leading to symptoms. 17. Law PJ, Kamm MA, Bartram CI. A comparison between electro-
myography and anal endosonography in mapping external anal
Pelvic floor neurophysiological tests should be per- sphincter defects. Dis Colon Rectum. 1990;33:370–3.
formed by trained neurophysiologists in dedicated 18. Chiarioni G, Kim SM, Vantini I, Whitehead WE. Validation of
units, with quality control of the results. The useful- the balloon evacuation test: reproducibility and agreement with
ness of these tests must be decided on an individual findings from anorectal manometry and electromyography. Clin
Gastroenterol Hepatol. 2014;12:2049–54.
basis and overall clinical picture to explain the correla- 19. Drewes AM, Dimcevski G, Sami SAK, Funch-Jensen P, Huynh
tion between neurophysiological findings and pelvic KD, Le Pera D, Arendt-Nielsen L, Valeriani M. The “human vis-
floor dysfunction. ceral homunculus” to pain evoked in the oesophagus, stomach, duo-
denum and sigmoid colon. Exp Brain Res. 2006;174:443–52.
20. Arebi N, Bullas DC, Dukes GE, Gurmany S, Hicks KJ, Kamm MA,
Hobson AR. Distinct neurophysiological profiles in irritable bowel
syndrome. Am J Physiol Liver Physiol. 2011;300:G1086–93.
21. Turnbull GK, Hamdy S, Aziz Q, Singh KD, Thompson DG. The cor-
tical topography of human anorectal musculature. Gastroenterology.
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1983;98:378–84. A. Gut symptoms in diabetics correlate with components of the rec-
2. Coggrave M, Norton C CJ (2014) Management of faecal inconti- toanal inhibitory reflex, but not with pudendal nerve motor laten-
nence and constipation in adults with central neurological diseases - cies or systemic autonomic neuropathy. J Dig Dis. 2015;16:342–9.
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Online Library. In: Cochrane Collab. Publ. by John Wiley Sons, A. Morphological abnormalities of the recto-anal inhibitory
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and constipation in adults with central neurological diseases - 2012;57:1908–14.
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Online Library.htm. nence. Lancet (London, England). 1966;1:297–8.
3. Wiesel PH, Norton C, Glickman S, Kamm MA. Pathophysiology 26. Brindley GS. Emptying the bladder by stimulating sacral ventral
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4. Rao SS. Pathophysiology of adult fecal incontinence. tion on anorectal dysfunction. Colorectal Dis. 2011;13:5–9.
Gastroenterology. 2004;126:S14–22.
458 M. Patel et al.
feces or flatus” [2]. The term AI is used for incontinence for urgency complaints, and urinary incontinence (level 3)
solid and liquid feces and flatus, while the term fecal incon- [3–5]
tinence (FI) refers only to incontinence for liquid and solid 4. Older people in residential homes
feces. Here, AI is used as an umbrella term, and it is explic- • FI: advanced age (level 1) [9]
itly indicated where the specific symptoms of flatal inconti- • FI: urinary incontinence, limited mobility, having a neu-
nence or FI are meant. rological disorder, cognitive decline, dementia, problems
A summary of recommendations for the diagnostic and of trunk control, non-Caucasian ethnicity and difficulties
therapeutic process is presented at the end of the chapter. with general activities of daily living (level 2) [9]
(Table 36.1).
C: Non-comparative study
D: Expert opinion, for instance, the members of the guideline
development team
Level of conclusions
Conclusion based on: Recommendation based on the level of the conclusion:
Level 1: one study at A1-level or at least two independent It has been demonstrated that…
A2-level studies
Level 2: one study at A2-level or at least two independent B-level It is plausible that…
studies
Level 3: one B- or C-level study There are indications that…
Level 4: expert opinion In the opinion of the evidence statement development team, …
36 Behavioral Therapies and Biofeedback for Anal Incontinence 461
Fig. 36.2 Anocutaneous
reflex is the reflexive
contraction of the external
anal sphincter by lightly
touching the skin around the
anus. A normal reaction is a
rapid contraction of the anal
sphincter
• Supplementary functional examination: rectal balloon group of experts in the field, has distinguished four problem
and electromyography (EMG). Filling a rectal balloon categories for patients with AI (for further subdivision, con-
intrarectally with air allows the therapist to measure and sult the full-text Evidence Statement of the original docu-
the patient to become aware of initial sensory perception ment and flowchart at www.fysionet-evidencebased.nl [14]):
of filling, the rectoanal inhibitory reflex (RAIR), the ini-
tial feeling of urgency, and the maximum tolerable vol- 1. AI with pelvic floor dysfunction and awareness of loss of
ume. In addition, EMG can be used to measure the stools (urgency). The treatment plan is developed based
activity at rest and during contraction and relaxation, as on the presence or absence of a neurological problem,
well as the response of the pelvic floor muscles to filling anorectal sensation, voluntary or involuntary control, and
and Valsalva and straining with an inflated balloon. factors that adversely affect pelvic floor function.
2. AI with pelvic floor dysfunction without awareness of
loss of stools (passive). The treatment plan is developed
36.5 Physiotherapy Analysis/Diagnosis based on the presence or absence of a neurological prob-
lem and anorectal sensation.
It is very important to analyze whether and to what extent 3. Al without pelvic floor dysfunction.
there is sufficient balance between strain and physical condi- 4. AI with or without pelvic floor dysfunction, in combina-
tion. The physical condition may be affected by dysfunctions tion with general factors impeding the recovery or adjust-
of the continence mechanisms: ment processes. The treatment plan is developed based on
the presence or absence of comorbidity.
• Damage to or weakness of the pelvic floor muscles (exter-
nal anal sphincter and m. levator ani) The nature and severity of any pain symptoms must be
• Damage to or weakness of the internal anal sphincter taken into consideration for all four problem categories, as
• A neurological problem: nuclear/infranuclear dysfunc- these represent a complicating factor.
tion, peripheral innervation, spinal cord, brainstem or
lack of awareness.
36.6 Therapeutic Process
The physical condition partly depends on other factors,
such as general mobility, diet, intestinal system (peristalsis The therapeutic process includes the actual treatment, evalu-
or fecal composition), medication, problematic history ation, and conclusion of treatment. The treatment plan relates
(e.g., adverse sexual experiences, physical violence), and to the identified problem category, and the objective is to
comorbidity. The patient’s physical condition (at local, per- improve one or more of the following components of conti-
sonal, and participation level) determines how much they nence: muscle function, reservoir function, consistency of
can bear. stools, awareness and acknowledgement of the health prob-
The analysis process is used to determine the nature, lem, or interactions between these components. No adverse
severity, and modifiability of the problem. The Dutch guide- effects or worsening of symptoms have been reported for any
line development team, in consultation with a feedback of the forms of therapy discussed below.
36 Behavioral Therapies and Biofeedback for Anal Incontinence 463
Fig. 36.3 Correct position to defecate. Mobile applications, like iPelvis, that show exercises and life hygiene advices on coloproctological dys-
functions, may be useful to improve long-term adherence
The following therapeutic interventions can be preferences, and expectations, the pelvic physiotherapist
identified: explains any relevant aspects, using visual aids where
necessary, and discusses the normal function of the conti-
1. Providing education and advice: a patient-specific educa- nence mechanism and defecation (level 4) (Fig. 36.3).
tion plan is used for each problem category (problem cat- 2. Electrostimulation: ES is applied in various ways, using
egories I–IV). Taking account of the patient’s views, different stimulation parameters and combining it with
464 B. Berghmans et al.
other therapies (like BF or PFMT). The precise mecha- treatment of patient with AI (level 1) [11]. Supported by
nism of action of ES is unknown, but the main mechanism the recommendations of the “International Consultation
may be based on an increased awareness of the anal on Incontinence” and based on the low costs and the
sphincter. It has been demonstrated that there is insuffi- absence of adverse effects of the therapy, PFMT can be
cient evidence to recommend ES for the treatment of AI, part of an integrated approach, which involves education/
based on only few studies, which were heterogeneous in advice, training the patient’s awareness of the way in
terms of patient sample, treatment protocol, and outcome which and the extent to which the pelvic floor muscles
measures (level 1) [25]. There have also been uncon- can be used, where necessary with the help of BF and/or
trolled studies that repeatedly mention that “the interna- rectal balloon training (for problem categories IC, ID, II–
tional literature, as well as our own research findings, IV) (level 4) (Fig. 36.5).
confirm that ES is effective and that ES plays an impor- Besides, exercises to reduce the anorectal angle, focus-
tant role as a component of conservative treatment for ing on the m. puborectalis (similar to “the knack”
some patients with AI” [25]. Therefore, it is recom- described for the inward movement of the urethra), can be
mended that ES is useful for a specific group of patients, used to improve the patient’s voluntary control of their
to improve the voluntary control of the pelvic floor in pelvic floor (for problem category IB) (level 4).
patients who lack this voluntary control (problem cate- 4. Biofeedback can be used in various ways for patients
gory IA) (level 4). with AI:
A specific type of ES is tibial nerve stimulation (TNS). • To reduce or increase rectal sensation using a rectal
This is a form of ES in which a surface electrode is placed balloon
on the skin over the tibial nerve on one ankle and refer- • Strength training (EMG (activity of motor units) or
enced to another electrode on the ipsilateral foot (transcu- pressure (anal manometry or probe)): BF is used to
taneous, TTNS) or a needle inserted beneath the skin visualize the activity of a patient’s anal sphincter and/
close to the tibial nerve on one side and is referenced to an
electrode on the ipsilateral foot (percutaneous, PTNS)
[26]. Typical TTNS stimulation parameters are 250 μs
pulses at a frequency of 10 Hz and current of up to
30 mA. Typical PTNS stimulation parameters are 200–
250 μs pulses at a frequency of 10–20 Hz and up to 9 mA.
3. Pelvic floor muscle training: PFMT consists of repeated
voluntary contractions and relaxations of the pelvic floor
muscles in order to improve muscle strength, voluntary
control of muscle relaxation, endurance, repeatability,
coordination, and correct position of the pelvic floor.
Where necessary, PFMT aims to train the patient’s aware-
ness regarding the way in which and the extent to which
the pelvic floor muscles can be used (Fig. 36.4).
It has been demonstrated that some elements of PFMT
Fig. 36.5 Rectal balloon—Rectal balloon training as an adjunctive
have a therapeutic effect, but no definitive conclusion can method for pelvic floor muscle training in conservative management of
be drawn about the role of anal sphincter exercises in the fecal incontinence
or pelvic floor muscles, such as the m. puborectalis, contraction must be long and powerful enough to allow
and to enable awareness of contraction and relaxation. the resting pressure to return to its initial value.
As the patient sees or hears the signal, they are encour-
aged to increase their contraction strength and keep up It has been demonstrated that some BF elements have a
the contraction longer or to put more attention to therapeutic effect. PFMT with BF appears to be more effective
proper relaxation (Figs. 36.6 and 36.7). than PFMT alone, and BF with ES appears to be more effec-
• Coordination training (triplet): a balloon is inserted into tive than ES alone. However, the available literature does not
the rectum. Two other, smaller, pressure-recording bal- allow any definitive conclusions to be drawn on the role of BF
loons are introduced into the upper and lower parts of in the treatment of patients with AI (level 1) [11]. However, in
the anal canal. As the rectal balloon is filled, it elicits the the opinion of the evidence statement development team, BF
RAIR. This causes anal relaxation, which is visualized can be used when there is doubt about the ability of a patient
by the two recording balloons and which the patient without voluntary control of the pelvic floor to perform pelvic
must become aware of and must learn to counteract by floor contractions (problem category IA) or if a patient shows
means of a voluntary anal sphincter contraction. This insufficient progress, in order to accelerate progress in the
context of an integrated approach (e.g., education and advice,
voluntary control, PFMT) based on all modifiable components
(problem categories IC, ID, II, and IV) (level 4) (Fig. 36.8).
followed up again at 12 months, whereas patients not report- The 2010 Schwandner study (29) compared 3T to EMG
ing adequate relief at 3 months were assumed to be non- BF alone and found that the 3T group improved significantly
responders at 12 months. Patients treated with BF + PFMT more than the group treated with EMG BF at 9 months but
were significantly more likely than patients treated with not at 3 months. However, this study had limitations: Some
PFMT alone to report adequate relief (76% vs. 41%). patients had only mild FI and 15% were only incontinent for
Continence (zero FI episodes in the previous month) was flatus. In addition, the dropout rate was high: Only 24% of
achieved by 44% of biofeedback-treated patients compared the EMG BF-only group completed the 9 month trial, and
to 21% of PFMT-only patients. Scores on the validated Fecal only 54% of the combined ES plus BF group completed the
Incontinence Severity Index also showed significantly trial. However, these limitations do not explain the findings
greater improvement in the biofeedback patients compared because the data were analyzed by intention to treat.
to the PFMT-only patients at 3 months and again at 12 A second study from this group of investigators compared
months follow-up [32]. Biofeedback-treated patients 3T to low-frequency (100 Hz, 50 μV) ES, with both treat-
increased their anal canal squeeze pressures and decreased ments provided twice a day for 20 min each for a total of 6
their abdominal wall tension significantly more than PFMT- months [30]. There were few dropouts: 92% of the 3T group
only patients when squeezing to prevent stool leakage. This and 84% of the EMG BF group completed the 6 month trial.
study showed that BF + PFMT was superior to PFMT alone The 3T group showed significant improvement by 3 months,
in patients with moderate to severe FI. It also showed that whereas the low-frequency ES group showed no change
treatment benefits for both biofeedback and PFMT were not from baseline at 3 or 6 months. A limitation of this study was
explained by non-specific effects of conservative treatment. the lack of blinding.
The updated Cochrane review surveyed the literature through Two other studies tested low-frequency ES alone [34] or
January 2012 and identified 21 studies for analysis [11]. combined ES with BF [35]. The aim of the first study was to
Unlike the previous Cochrane review [33], this one yielded a compare daily home ES to standard BF training in six weekly
qualified endorsement of biofeedback for the treatment of sessions provided in the clinic. There was no difference
FI: “We found some evidence that biofeedback and electrical between these two treatments in overall improvements in FI,
stimulation may enhance the outcome of treatment com- although there was a significant decrease in FI frequency
pared to electrical stimulation alone or exercises alone… from baseline to the end of treatment for the ES group. Home
While there is a suggestion that some elements of biofeed- ES was less costly than BF provided in the clinic [34].
back therapy and sphincter exercises may have a beneficial In the second study, ES was combined with BF but only in
effect, this is not certain.” half of patients (28/62, and then only if, in the opinion of the
investigators, ES was needed to “help the patient identify and
contract their sphincter.” There was no difference in FI sever-
36.9 U
pdate: Review of Evidence ity or FI quality of life between the BF/ES group and the
from January 2012 to May 2016 dextranomer-injected group at the 6-month assessment [35].
Tibial nerve stimulation: This variant of ES is to stimu-
Electrical stimulation: Two RCTs evaluated the efficacy of a late through electrodes attached to the skin overlying the
Triple Therapy (3T) protocol in which medium frequency tibial nerve of one ankle (transcutaneous stimulation, abbre-
electrical stimulation (3000 Hz, 500 μV) plus EMG BF was viated TTNS) or to stimulate through a needle inserted
compared to either EMG BF alone [29] or to low-frequency through the skin and into the region of the tibial nerve (per-
ES (100 Hz, 50 μV) alone [30]. (These two studies were pub- cutaneous stimulation, abbreviated PTNS). A systematic
lished prior to 2012 but were inadvertently missed in the previ- review of tibial nerve stimulation published in 2014 [26]
ous review. Triple therapy is a complex protocol in which reviewed two RCTs of TNS and PTNS published up to 2013
patients are directed to practice during two 20-min sessions and multiple uncontrolled studies of both percutaneous and
each day at home. In the morning session, they received EMG transcutaneous TNS [36, 37]. This review concluded that
BF and alternately contracted their pelvic floor muscles volun- transcutaneous TNS was not superior to sham electrical
tarily or stimulated contractions with medium frequency stimulation and that no adequate RCT of percutaneous TNS
ES. In the afternoon session, they received EMG BF and were was available by 2013. A pilot study published by Thin in
also provided with medium frequency ES contingent on vol- 2015 compared sacral nerve stimulation to PTNS and found
untary contractions that exceeded an individually determined support for the efficacy of PTNS [38]. Subsequently, a rigor-
threshold. The threshold required to trigger ES was progres- ous RCT of PTNS was reported by the same group [39].
sively raised as performance improved in an effort to encour- They randomized 227 patients with FI from 17 clinical sites
age stronger contractions. Triple therapy was provided by to receive 12 weekly sessions of percutaneous PTNS or sham
battery-operated devices at home. A minimum of 6 months of PTNS. There were no significant differences in the primary
twice-daily sessions was required to improve FI. outcome measure, which was the proportion achieving at
468 B. Berghmans et al.
least a 50% reduction in FI episodes (38% in PTNS, 31% in medical care or three sessions of EMG BF in phase 1 and the
sham). However, some of the secondary outcomes showed combination of standard medical care and BF in phase 2
differences: The average number of FI episodes decreased [40]. There was no evidence of differential effects in phase 1,
significantly more in the PTNS group than in the sham group, but the combined treatment was associated with significant
and this was found to be due to a greater reduction in urgency- improvement compared to baseline. Since most patients had
related FI episodes but not in the number of passive FI epi- tried standard medical care prior to the study and the BF
sodes. Thus, this well-conducted study failed to show a training was less than is usually employed in phase 1, this
significant benefit of PTNS on the a priori selected primary study may also be seen as supporting the efficacy of BF.
outcome measure, but it leaves doubt about whether PTNS The Pelvic Floor Disorders Network, which is a consor-
may be an effective treatment for urgency-related FI. Further tium of eight academic surgical divisions supported by the
research is needed in groups stratified at the outset between National Institute for Child Health and Human Development,
urgency and passive FI [39]. is conducting a multicenter trial of biofeedback and/or loper-
PFMT studies: Daily pelvic floor muscle exercises are amide for the treatment of FI. Results are not yet available,
often combined with clinic-based BF [40]. Three studies but the study design and methods have been published [47].
published since 2012 evaluated PFMT as the primary treat- This study uses a factorial design which compares four
ment [41–43]. Glazener and colleagues reported the long- groups: biofeedback plus loperamide, loperamide plus edu-
term follow-up of a study comparing PFMT to standard cation (control for biofeedback), biofeedback plus placebo
medical care [42]. All 747 women included in this study had tablets, and patient education plus placebo tablets. A detailed
urinary incontinence 3 months after vaginal delivery, and protocol for conducting biofeedback training using new soft-
15.7% of them also reported FI. PFMT had a significantly ware which provides the therapist with prompts to help stan-
greater impact on FI than standard medical care at 1-year dardize the biofeedback intervention across sites as well as
follow-up but not at 12 years. Limitations to this study are individualizing biofeedback to the patient’s specific deficits
that comparisons at 12 years are confounded by some has been published [48].
patients undergoing additional treatments, especially if they Home biofeedback training: The efficacy of home-
had an inadequate response to the initial treatment, and pro- based BF, which allows for more frequent BF training and
gression of underlying disease. Peirce and colleagues (2013) reduces the amount of professional time required, was the
compared PFMT alone to PFMT supplemented by clinic- focus of six studies. Two studies in which 3T was provided
based BF in 120 women with a third-degree sphincter lacera- twice daily for 6–9 months were described above; both sup-
tion during vaginal delivery, to determine whether ported the efficacy of 3T [29, 30]. (1) Dehli compared intra-
supplemental BF is more effective at preventing FI [41]. No anal injections of a bulking agent to 6 months of twice-daily
differences were seen, but the study was underpowered to BF and found that both treatments improved FI severity and
detect a difference in incident cases of FI. Lin and colleagues quality of life with no significant difference between treat-
(2016) tested whether PFMT instructional DVD pamphlet ments [35]. (2) Damon compared 4 months of home-BF to
were more effective than the pamphlet alone in reducing FI standard medical care and reported that significantly more
following low anterior resection for cancer [43]. (This very patients in the BF group were responders [46]. (3) Bartlett
low dosage) PFMT, taught by a research assistant prior to tested whether the addition of home BF to clinic BF improved
discharge from the hospital, was associated with lower rates outcomes compared to clinic BF alone: For the whole group,
of FI at 1, 3, and 6 months follow-up. An unanswered ques- supplementation with home BF did not significantly improve
tion remains whether PFMT taught by digital palpation of outcomes, but a post hoc analysis showed that the youngest
pelvic floor muscles rather than by verbal or printed instruc- half of the patients (below the median age of 61) did benefit
tions, is as effective as BF augmented by PFMT, as some significantly more when clinic-based BF was augmented by
earlier studies suggested [44, 45]. home BF [49]. (4) A study by Peirce et al. (2013) compared
Biofeedback compared to standard medical care: Two daily home BF to daily PFMT for 3 months to determine
new RCTs followed a traditional design by comparing BF to whether either treatment could prevent FI in women with a
standard medical care, defined as dietary counseling and use third-degree sphincter laceration sustained during childbirth
of antidiarrheal drugs or laxatives to normalize stool consis- [41]. There was no evidence that home-based biofeedback
tency. Damon and colleagues (2014) randomized patients to training prevented the development of FI, but the study was
receive either standard medical care alone or standard medi- underpowered to show a difference in incident cases of FI.
cal care plus 20 sessions of BF and found that significantly The six studies of home biofeedback described above
more of the BF-treated patients met the responder definition suggest that home practice 1–2 times daily with a battery-
compared to the standard medical care only group [46]. operated BF device is more beneficial than either ES or BF
Sjodahl et al. (2015) used a crossover design in which in the clinic or standard medical care. Home BF may also be
patients were initially randomized to receive either standard less costly to provide. However, these studies also suggests
36 Behavioral Therapies and Biofeedback for Anal Incontinence 469
that home BF has possible limitations: (1) longer periods of ency and visibility on the important role of pelvic physio-
BF training may be required (at least 6 months according to therapy throughout the field of clinicians that are involved
one investigator); (2) on average, younger patients benefit (often in a multidisciplinary context) in continence care.
more than older patients; and (3) daily practice is a burden Moreover, efforts should be undertaken to work toward evi-
which may increase the dropout rate. dence statements or guidelines for the other treatable
Systematic reviews and meta-analyses: Table 16-5, domains of pelvic physiotherapy. Irrespective of the limited
pp. 2045–2046, 6th edition of ICI Incontinence [28] lists the evidence base, conservative treatment is unanimously rec-
systematic reviews and guidelines documents published ommended, singly or in combination, for the majority of
since January 2012 that addressed the use of BF, ES, TNS, patients with AI [1, 14]. Clinicians should keep in mind that
and PFMT for the treatment of AI [11, 26, 50–53]. The conservative treatment is a first-line approach and should be
Cochrane review [11] published in 2012 provided qualified considered before surgery mainly due to the low costs and
evidence for the efficacy of biofeedback as summarized in its absence of side effects [14, 28].
conclusion: “While there is a suggestion that some elements Our recommendations will raise discussion and future
of biofeedback therapy and sphincter exercises may have a research questions, which will ultimately result in advance-
therapeutic effect, this is not certain. Larger well-designed ments in the area of pelvic physiotherapy in AI. Future chal-
trials are needed to enable safe conclusions.” The other lenges are to conduct further high-quality RCTs (with
reviews and guidelines documents that addressed BF adequate training intensity, sample size, methodological
(Table 16-5 ICI Incontinence [28]) were consistent in recom- quality, and consistent use of consensus-based terminology)
mending it, alone or in combination with PFMT or ES, for and to perform studies to get insight into adequate stimula-
the treatment of FI. tion parameters and which methodologically sound measure-
ment instrument to choose.
36.10 Conclusions
36.12 Recommendations for Practice
This chapter reflects the current state of knowledge for a
methodic and systematic physiotherapeutic assessment and
treatment for patients with AI. Overall, evidence is (still) 1. Diagnostic process
(fairly) weak, and therefore the cited Dutch Evidence • Measurement instrument—in the opinion of the evi-
Statement reflects also consensus among experts. The benefit dence statement development team, the screening,
of this evidence statement is to improve quality and unifor- diagnostic, and treatment evaluation processes should
mity in care and increase transparency to the involved clini- involve a patient-reported outcome measure (level 4).
cians and patients. More high-quality research is needed to • Wexner score—in the opinion of the evidence state-
validate the consensus-based recommendations. ment development team, the Wexner score is a suitable
instrument to assess the severity of AI as a health prob-
lem and how well the patient is coping (level 4).
36.11 Spin Off • GPE—in the opinion of the evidence statement devel-
opment team, the GPE is a suitable instrument to evalu-
The Royal Dutch Society for Physiotherapy (KNGF) decided ate patient-perceived changes in health status (level 4).
to publish an evidence statement instead of a guideline as • Defecation diary—in the opinion of the evidence state-
this enabled the society, by combining evidence, expert judg- ment development team, a defecation diary should be
ment, and consensus, to support health-care providers to used to assess the defecation frequency and the sever-
methodically approach their patients, notwithstanding the ity of the AI (level 4).
paucity of published evidence [14]. • Bristol Stool Scale—in the opinion of the evidence
AI covers only one important domain of symptoms that statement development team, the BSS is a suitable
pelvic physiotherapists are able to treat. Other important instrument to assess the consistency of a patient’s
domains are among others stress and urgency urinary incon- stools (level 4).
tinence, prolapses (bladder, uterus or intestines), sexual • ICIQ-B and FIQL—the evidence statement develop-
problems, constipation, pelvic pain, and support before and ment team recommends the ICIQ-B to assess bowel
after surgery (gynecologic, urologic, and gastrologic). Pelvic symptoms and impact of these symptoms on quality of
physiotherapists are musculoskeletal experts and well- life and the FIQL to assess disease-specific quality of
trained and well-utilized to assess and treat the consequences life (level 4).
of the various health problems mentioned earlier. The KNGF 2. Therapeutic process
Evidence Statement AI [14] contributes to more transpar- Providing education and advice
470 B. Berghmans et al.
• Patient-specific education plan—in the opinion of the before a cough or lifting a heavy object, to prevent the
evidence statement development team, a patient-spe- loss of urine or stools.
cific education plan should be used for each individual Biofeedback
problem category (level 4). • It has been demonstrated that some BF elements have
Electrostimulation a therapeutic effect. PFMT with BF appears to be more
• It has been demonstrated that low-frequency ES is effective than PFMT alone, and BF with electrostimu-
weakly effective or not effective when used alone or in lation appears to be more effective than ES alone, but
combination with BF for the treatment of FI. The 3T no definitive conclusion can be drawn regarding the
involving electrical stimulation at a frequency of role of BF in the treatment of patients with AI (level 1).
3000 Hz combined with BF, when practiced twice • There are indications that a combination of manome-
daily for at least 6 months, may be more effective than try BF or rectal balloon training and PFMT is more
BF alone or low-frequency (100 Hz) ES alone (level effective than PFMT alone if previous conservative
2). Based on only limited studies, which were hetero- treatments have failed (level 3).
geneous in terms of patient sample, treatment proto- • In the opinion of the evidence statement development
col, and outcome measures, it is unclear on what basis team, BF can be used when there is doubt about the
patients should be selected for ES and what ES modal- ability of a patient without voluntary control of the
ity would be optimal (level 1). pelvic floor to perform pelvic floor contractions (prob-
• In the opinion of the evidence statement development lem category IA) or if a patient shows insufficient
team, ES is useful for a specific group of patients, to progress, in order to accelerate progress in the context
improve the voluntary control of the pelvic floor in of an integrated approach (e.g., education and advice,
patients who lack this voluntary control (problem cat- voluntary control, PFMT) based on all modifiable
egory IA) (level 4). components (e.g., for problem categories IC, ID, II
• It is plausible that PTNS has a possibly effective and IV) (level 4).
approach to the treatment of FI (level 2), but PTNS
remains an investigational treatment protocol currently
not (yet) recommendable for clinical practice 36.13 Future Directions
Pelvic floor muscle training
• It has been demonstrated that some elements of PFMT Further RCTs of ES, PTNS, PFMT, and BF are needed to
have a therapeutic effect and therefore is recommended define the most optimal physiological parameters to improve
as an early intervention in the treatment of AI. However, or restore anorectal function and bowel control.
no definitive conclusion can be drawn yet about the Protocols of pelvic floor rehabilitation for AI need to be
role of anal sphincter exercises in the treatment of standardized.
patients with AI (level 1).
• In the opinion of the evidence statement development
team, PFMT can be recommended as part of an inte-
grated approach, which involves education/advice,
training the patient’s awareness of the way in which Take-Home Messages
and the extent to which the pelvic floor muscles can be • Based on adequate patient selection and nature and
used, where necessary with the help of BF and/or rec- severity of AI, pelvic floor rehabilitation should be
tal balloon training (for problem categories IC, ID, II– considered as a first-line treatment for patients with
IV) (level 4). This evidence is supported by the AI, taking into account degree of modifiability of
recommendations of the International Consultation on the patient’s health problem (general and local
Incontinence and is partly based on the low cost and impeding factors).
the absence of adverse effects of the therapy. • Using the ICF, the physiotherapeutic diagnostic
• In the opinion of the guideline development team, process serves to identify the nature and severity of
exercises to reduce the anorectal angle, focusing on AI and its degree of modifiability by pelvic floor
the m. puborectalis (similar to the “knack” described rehabilitation.
for the inward movement of the urethra), can be used • Pelvic floor rehabilitation aims to improve and
to improve the patient’s voluntary control of their pel- restore anorectal dysfunction and bowel control
vic floor (for problem category IB) (level 4). The and has its place in the multidisciplinary treat-
“knack” is a voluntary contraction which a person can ment of AI.
use to learn to contract their pelvic floor muscles just
36 Behavioral Therapies and Biofeedback for Anal Incontinence 471
36. Leroi AM, Siproudhis L, Etienney I, et al. Transcutaneous elec- or pelvic floor retraining with digital guidance alone in the treat-
trical tibial nerve stimulation in the treatment of fecal inconti- ment of mild to moderate fecal incontinence 7. Dis Colon Rectum.
nence: a randomized trial (CONSORT 1a). Am J Gastroenterol. 2003;46:703–10.
2012;107:1888–96. 46. Damon H, Siproudhis L, Faucheron JL, et al. Perineal retraining
37. George AT, Kalmar K, Sala S, et al. Randomized controlled trial of improves conservative treatment for faecal incontinence: a multi-
percutaneous versus transcutaneous posterior tibial nerve stimula- centre randomized study. Dig Liver Dis. 2014;46:237–42.
tion in faecal incontinence. Br J Surg. 2013;100:330–8. 47. Jelovsek JE, Markland AD, Whitehead WE, Barber MD, Newman
38. Thin NN, Taylor SJ, Bremner SA, et al. Randomized clinical trial of DK, Rogers RG, Dyer K, Visco A, Sung VW, Sutkin G, Meikle SF,
sacral versus percutaneous tibial nerve stimulation in patients with Gantz MG. Controlling anal incontinence in women by performing
faecal incontinence. Br J Surg. 2015;102:349–58. anal exercises with biofeedback or loperamide (CAPABLEe) trial:
39. Knowles CH, Horrocks EJ, Bremner SA, et al. Percutaneous
design and methods. Contemp Clin Trials. 2015;44:164–74.
tibial nerve stimulation versus sham electrical stimulation for 48. Markland AD, Jelovsek JE, Whitehead WE, Andy UU, Newman
the treatment of faecal incontinence in adults (CONFIDeNT): a DK, Dyer K, Harm-Ernandes I, Cichowski S, McCormick J, Rardin
double-blind, multicentre, pragmatic, parallel-group, randomised D, Sutkin G, Shaffer A, Meikle S, on behalf of the Pelvic Floor
controlled trial. Lancet. 2015;386:1640–8. Disorders Network. Improving biofeedback treatment of fecal
40. Sjodahl J, Walter SA, Johansson E, et al. Combination therapy with incontinence in women: Implementation of a multi-site manometric
biofeedback, loperamide, and stool-bulking agents is effective for biofeedback protocol. Neurogastroenterol Motil. 2017:29(1).
the treatment of fecal incontinence in women - a randomized con- 49. Bartlett L, Sloots K, Nowak M, et al. Supplementary home biofeed-
trolled trial. Scand J Gastroenterol. 2015;50:965–74. back improves quality of life in younger patients with fecal inconti-
41. Peirce C, Murphy C, Fitzpatrick M, et al. Randomised controlled nence. J Clin Gastroenterol. 2015;49:419–28.
trial comparing early home biofeedback physiotherapy with pel- 50. Vonthein R, Heimerl T, Schwandner T, et al. Electrical stimulation
vic floor exercises for the treatment of third-degree tears (EBAPT and biofeedback for the treatment of fecal incontinence: a system-
Trial). BJOG. 2013;120:1240–7; discussion 1246. atic review. Int J Colorectal Dis. 2013;28:1567–77.
42. Glazener CM, MacArthur C, Hagen S, et al. Twelve-year follow-up 51. Rao SS, Benninga MA, Bharucha AE, et al. ANMS-ESNM position
of conservative management of postnatal urinary and faecal incon- paper and consensus guidelines on biofeedback therapy for anorec-
tinence and prolapse outcomes: randomised controlled trial. BJOG. tal disorders. Neurogastroenterol Motil. 2015;27:594–609.
2014;121:112–20. 52. Rao SS, American College of Gastroenterology Practice Parameters
43. Lin YH, Yang HY, Hung SL, et al. Effects of pelvic floor muscle Committee. Diagnosis and management of fecal incontinence.
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closure. Eur J Cancer Care (Engl). 2016;25:449–57. Committee. Am J Gastroenterol. 2004;99:1585–604.
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Sphincter Repair and Postanal Repair
37
Adam Studniarek, Johan Nordenstam,
and Anders Mellgren
Learning Objectives cles. Surgeons frequently see patients who have developed
After completing this chapter, the reader should be able to: FI after obstetric trauma or anorectal procedures. Anal
incontinence secondary to sphincter tears is mainly found in
• Describe the diagnostic workup and indications for female patients after third- or fourth-degree tears [2].
sphincteroplasty Previous anorectal surgeries, such as fistula surgery [3],
• Discuss the technique of overlapping sphinctero- hemorrhoidectomy [4], manual dilatation (Lord’s proce-
plasty and associated technical pearls dure) [5], or lateral internal sphincterotomy for the treatment
• Present short-term and long-term results of of anal fissure [6], have all been described as causes of
sphincteroplasty in different patient populations FI. With midline episiotomies and/or operative vaginal
• Discuss the quality of life for patients who undergo delivery, the incidence of anal sphincter injuries can reach
sphincteroplasty based on most recent fecal 50% [7].
incontinence grading scales Anal sphincter damage sustained during childbirth is one
• Describe the indication for postanal repair and of the most common causes in middle-aged women [8].
associated success rates after the procedure Occult sphincter defects during vaginal deliveries have been
diagnosed by anal ultrasound in up 35.4% of primiparous
women and 43.8% of multiparous women and are especially
common after forceps deliveries [9]. Prospective studies
have confirmed a high rate of injuries after vaginal deliveries
37.1 Introduction [10]. More recent meta-analysis demonstrates that the inci-
dence of occult anal sphincter disruption after vaginal deliv-
Fecal incontinence (FI) significantly affects patients’ social, ery is higher than previously estimated [11]. However, at
personal, and occupational life, and in severe cases FI symp- least two-thirds of postpartum occult defects are asymptom-
toms can lead to social isolation and depression in otherwise atic. Damon et al. found that if signs of clinical FI and a his-
healthy individuals. FI prevalence ranges from 2.2% to 17%, tory of vaginal delivery were present, an anal sphincter
depending on the study population and the criteria use for defect could be seen upon endoanal ultrasound (EAUS) in
defining FI [1]. 62% of patients, and clinical symptoms were related to the
Several factors are considered to produce symptoms of size of these defects [12].
FI, including consistency and amount of stool (e.g., diar- Recent technological advances in imaging techniques
rhea), damage to the mucosa of the colon and rectum (e.g., allow for improved diagnostic evaluation. Ultrasound allow
colitis), neurologic factors (e.g., diabetes, Parkinson’s dis- for incorporating measurements of defects in the anal sphinc-
ease), and injuries to the anal sphincter and pelvic floor mus- ters and the pubovisceral muscles [13].
A Cochrane review from 2006 showed that there was no gut, silk, and PDS. Evaluation of 40 case series of women
statistically significant difference in perineal pain, dyspareunia, who underwent overlapping anal sphincteroplasty with the
flatus incontinence, and FI between the two repair techniques use of either permanent or absorbable sutures demonstrated
at 12 months. At the same time, the overlap group had, statisti- decreased FI severity scores with permanent sutures, but
cally significant lower incidence in fecal urgency and lower the overall patient-reported degree of FI symptoms was
anal incontinence score. The overlap technique was also asso- similar [43].
ciated with a statistically significant lower risk that anal incon-
tinence symptoms will worsen over a 12-month period. There
was, however, no significant difference in quality of life [36]. 37.5.5 Diverting Stoma
The results of overlapping anal sphincter repair seem to
deteriorate with time. Patients should be counseled that a In patients with a severe trauma to the perineum other than
majority will have improved FI after the procedure, but after delivery, a proximal diverting colostomy is often con-
continence is rarely perfect, and function may deteriorate structed to decrease the risk for infectious complications
with time [37]. A few studies have reported more promis- and to facilitate nursing management. Patients undergoing
ing results, with lasting improvement and satisfactory elective anal sphincteroplasty are, however, usually oper-
long-term functional results [38]. ated without diverting stoma. The presence of a stoma has
In a comparison between the two techniques, Tjandra not proven to improve the rate of wound healing and a
et al. [39] found no significant difference in functional out- diverting stoma also adds the risk for stoma-related compli-
come of overlapping vs. apposition of the sphincter ends. cations [44].
This prospective, randomized controlled trial demonstrated
that the outcomes were similar. Although, the population
size was relatively small, there is little additional data pub- 37.6 Other Considerations
lished comparing the two techniques.
Overlapping sphincteroplasty has remained the standard 37.6.1 Primary Repair vs. Sphincteroplasty
at surgical repair, with supporting short-term and long-term
results. A direct relationship between the size of the tear and A third- or fourth-degree perineal tear at child delivery is
the degree of dysfunction has not been confirmed [40]. usually repaired immediately with a “primary repair.” For
optimal outcomes, these injuries should be repaired under
optimal conditions. Persisting sphincter defects are reported
37.5.2 Separate Suturing of External in up to 66% [45, 46], and up to 40% of these women eventu-
and Internal Sphincters ally develop FI symptoms [47].
In situations when there is no available surgical specialist,
A modified surgical approach, with separate suturing of the primary repair can be delayed 8–12 h without worse out-
external and internal anal sphincters, has been suggested by comes at 1-year follow-up [48]. Delayed primary repair is
Lindqvist et al. [41]. Separate suturing technique resulted in usually not recommended routinely, but can be an alternative
significant improvement of anal incontinence symptoms at under special circumstances [49, 50].
1-year follow-up [42]. This has, however, not been replicated For secondary repair with sphincteroplasty after obstet-
in larger trials or with longer follow-up. ric injury, a delay of at least 6 months to 1 year has been
recommended to allow the tissue to recover [50]. Soerensen
et al. prospectively looked at sphincter repairs done as a
37.5.3 Scar Tissue delayed primary (within 72 h postpartum) or as an early
secondary reconstruction (within 14 days after delivery)
There seems to be an immediate benefit to overlap scar without a diverting stoma in women who had sustained a
over scar, which can be adequately evaluated and quanti- third-degree or fourth-degree obstetric tear. They found
fied with ultrasound. This may also facilitate repair of equal results with acceptable long-term functional out-
larger defects [42]. come in both groups [51].
In acute emergency trauma situations, the recommended
initial treatment is usually debridement of nonviable tissue,
37.5.4 Suture Material removal of foreign material, open drainage, and often proxi-
mal diversion with distal washout. Depending on the extent
Several different suture materials have been suggested by of injury and the associated trauma, reconstructive surgery
authors, including monofilament nylon, pullout wire, cat- may be deferred.
476 A. Studniarek et al.
37.6.2 Failed Primary Repair concluded that pelvic floor exercises are appropriate first-
line treatment options. Electrical stimulation was abandoned
There seems to be no difference in outcome in patients who in this study due to anal pain.
had an unsuccessful primary repair and those who had an Some studies [58] use technological devices to improve
occult injury (and thus no previous primary repair) [51]. results of home treatment with biofeedback, and there are
Recent data evaluating risk factors for primary repair con- smartphone applications used for the same purpose.
clude that repairs performed during on-call hours, with inex- Patients who have undergone sphincteroplasty are usually
perienced personnel, and often misdiagnosed at first, increase referred for postoperative pelvic floor exercises and biofeed-
the risk for a failed repair, while use of antibiotics and laxa- back [59].
tives may improve the outcome [52]. Patients undergoing
more than two previous repairs (including previous second-
ary sphincteroplasty) usually have poorer outcomes [52]. 37.6.6 Concomitant Perineal Operations
Pudendal neuropathy has been reported to be a predictive 37.6.7 Alternative Surgical Options
factor of failure following anterior overlapping sphinctero-
plasty, while other studies have not seen a difference in Different types of muscle transpositions/flaps have been sug-
patients with or without pudendal neuropathy [56]. gested to treat FI. Usually, the gracilis or gluteus muscles
Sphincteroplasty is usually considered even if there is a doc- have been used, but long-term results have not been encour-
umented pudendal neuropathy. The potential impact of this aging. Dynamic graciloplasty, transposition of a gracilis
should be discussed with the patient preoperatively. muscle that was stimulated with an electric stimulator, has
Some patients have an inability to volontarily contract the been tried but carried a high complication rate and is no lon-
sphincter muscles at preoperative clinical examination. This ger available [64–66].
may indicate a severe neurological injury and this may be a Artificial sphincters have also been tried [67]. An inflat-
predictor of possible failure after surgical repair. able device has been used, but carries a rather high complica-
tion rate (mainly infections), and is no longer available on
the market. More recently, a magnetic sphincter has been
37.6.5 Biofeedback tried with promising results [68], but it is unfortunately cur-
rently not available.
Biofeedback is used as a first-line therapy for FI. Several Another option is SNS, first proposed by Dr. Matzel in
studies demonstrate a positive effect of biofeedback in 1995 [69]. SNS treats FI successfully in a majority of patients
patients with sphincter defects. In a follow-up study by [69, 70]. Though SNS and sphincteroplasty have not been
Sander et al. [57], 48 patients were followed up after third- or directly compared prospectively in the literature, numerous
fourth-degree sphincter lacerations. After 1 month, ten studies have shown that patients with FI and sphincter defects
patients (21%) complained of anal incontinence with major- can have excellent outcomes with SNS [70–75]. The success
ity being incontinent only for gas. After 1 year, only three of SNS in these patients also does not appear to be correlated
patients (7%) had symptoms of incontinence. The authors to the degree of sphincter defect.
37 Sphincter Repair and Postanal Repair 477
100 37.9 S
exual Function After
Sphincteroplasty
Patient’s rating of improvement
Incontinence to Gas/Mucous
50
Continent
40
30
20
10
0
3* 40 * 63 77†
Months of follow-up
37 Sphincter Repair and Postanal Repair 479
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Dynamic Graciloplasty
38
Piotr Walega and Maciej Walega
intramuscularly into the gracilis muscle around the neuro- 38.2.1 Indications for Graciloplasty
vascular bundle, and not—as suggested by Williams—the
epineural bundle. • End-stage fecal incontinence (>35 points FISI)
Medtronic implanted stimulators with external stimula- • Lack of sphincter or extensive sphincter defect (more than
tion and extended battery life (up to 10 years) have come into 1/3 of the circumference of the muscle based on transanal
use. Although the price of such stimulators continues to be ultrasound or MRI)
high, the effectiveness of the therapeutic management, with • Previous unsuccessful treatments (sacral nerve
the patient returning to full social and professional activity, stimulation)
causes the method to gain popularity [9, 10]. • Sphincter innervation defect (verified by electrophysio-
logical examination)
Fig. 38.1 Thigh phase. Dissected gracilis muscle belly. Tendon tran-
sected from distal attachment
Fig. 38.3 Intact proximal neurovascular bundle visible in the surgical
field. End of thigh phase. At this height the gracilis muscle is transposed
through a subcutaneous tunnel to create a loop around the anus
dure, depending on its topical condition, neurological assess- free tendon end should be sutured using nonabsorbable
ment, and preferences of the patient. During the perineal sutures (monofilament 2/0) to the ischial tuberosity or skin.
stage, two blunt incisions are made on both sides of the anus The last stage of the procedure consists in implanting the
(approximately 2–3 cm from its margin), thus forming a tun- electrodes and stimulator (Fig. 38.6). In the region of the
nel to which the gracilis muscle is transposed (Fig. 38.5). identified major nerve bundle, two monopolar electrodes
Depending on the anatomical conditions and the preferences (model 4300 manufactured by Medtronic®) are sutured to the
of the operator, the incisions are horizontal or vertical. The muscle mass. The needle of the first electrode (anode) is
transposed muscle is fitted around the rectum, thus forming inserted distally to the nerve bundle, while the cathode is
the neosphincter [12, 13]. The preferred form is an alpha or inserted as close as possible to the bundle, at the site of the
gamma loop, but other configurations have also been maximum response during stimulation (Fig. 38.7). Using an
described. In the “split-sling” technique, the free end of the external stimulator (Medtronic, type 3051E®), one should
muscle is pulled through the approximately 1-cm-wide open- select the best stimulation parameters (Fig. 38.7). Usually, the
ing formed by separating the muscle mass into layer [14]. The said parameters are as follows: amplitude—0.5–1.0 V,
486 P. Walega and M. Walega
impulse width—0.210 ms, frequency from 10 to 20 Hz. In the tured by Medtronic® are pulled through from the groin to the
experience of the author, intraoperative manometric assess- formed pocket. After surgical wound closure and application
ment facilitates the selection of stimulation power [12, 14]. of dressing, one should check the stimulator operation using
Following the dissection of the skin and subcutaneous the console of the 7432 Medtronic® Itrel Programmer. The
layer in the hypogastrium, a 4 × 4 cm pocket should be thigh wounds are suction-drained and a double-layer closure
formed in order to place the stimulator (Fig. 38.8). Using the
guideways provided in the kit, the cables connecting the
electrodes with the IPG InterStim 3023 stimulator manufac-
Fig. 38.5 End of the thigh and perineal phase. (A) Dissection point of
the distal attachment of gracilis muscle. (B) Access to the distal tendon
of gracilis muscle to its safety removal. (C) Reverse gracilis muscle Fig. 38.6 Neuromuscular pacemaker implantated by dynamic gracilo-
with proximal neurovascular bundle. Two electrodes will be here plasty. (a) A patient programmer. (b) Implantable pacemaker placed in
inserted into the muscle using external stimulator. (D) Tendon of graci- abdominall wall. (c) Intramuscular electrode implantated in gracillis
lis muscle sutured to the skin. (E) Gracilis muscle wrapped around the muscle near the proximal neurovascular bundle
anus. In author’s center strength and tension of the muscle is adjusted
using intraoperative anorectal manometry
Fig. 38.7 Positioning of neurostimulation electrodes. (A) External electrodes inserted into the muscle near the neurovascular bundle. In
stimulator connected with the electrodes temporarily brought out the next step, they will be passed through the subcutaneous tunnel to the
through the abdominal wall during parameter optimization. (B) Two pacemaker in abdominal wall
38 Dynamic Graciloplasty 487
Fig. 38.9 Wounds are closed with Prolene 3-0 suture. In the author’s 38.5 Adynamic Graciloplasty
center, a suction drain is placed in thigh incision
Fig. 38.10 Transanal electrostimulation. In author’s center applied by patients without permanent stimulator (adynamic graciloplasty)
References 13. Madner JB, Williams NS. The electrically stimulated gracilis neo-
anal sphincter. Eur J Gastroenterol Hepatol. 1997;9:435–41.
14. Rosen HR, Novi G, Zoech G, Feil W, Urbarz C, Schiessel
1. Nelson R, Norton N, Cautley E, Furner S. Community based preva-
R. Restoration of anal sphincter function by single-stage dynamic
lence of anal incontinence. JAMA. 1995;274:559–61.
graciloplasty with modified (split-sling) technique. Am J Surg.
2. Thomas TM, Egan M, Walgrove A, Meade TW. The prevalence of
1998;175:187–93.
faecal and double incontinence. Community Med. 1984;6:216–20.
15. Herman RM, Walega P, Nowakowski M, Gryglewski A, Richter
3. Jorge JMN, Wexner SD. Etiology and management of faecal incon-
P, Popiela T. Dynamic gracilloplasty in Poland. Proktologia.
tinence. Dis Colon Rectum. 1993;36:77–97.
2001;2:179–85.
4. Muller C, Belyaev O, Deska T, et al. Fecal incontinence: an up-to-
16. Williams NS, Hallan RI, Koeze TH, Pilot MA, Watkins
date critical overview of surgical treatment options. Langenbecks
S. Construction of a neoanal sphincter by transposition of the graci-
Arch Surg. 2005;390:544–52.
lis muscle and prolonged neuromuscular stimulation for the treat-
5. Devesa JM, Vicente E, Enríquez JM, Nuño J, Bucheli P, de Blas
ment of faecal incontinence. Ann R Coll Surg. 1990;72:108–13.
G. Total fecal incontinence--a new method of gluteus maximus
17. Rosen HR, Urbarz C, Novi G, et al. Long-term results of modi-
transposition: preliminary results and report of previous experience
fied graciloplasty for sphincter replacement after rectal excision.
with similar procedures. Dis Colon Rectum. 1992;35:339–49.
Colorectal Dis. 2002;4:266–9.
6. Pickrell KL, Broadbent TR, Masters FW. Construction of a rec-
18.
Ruthmann O, Fischer A, Hopt UT, Schrag HJ.
tal sphincter and restoration of anal continence by transplant-
Schliessmuskelprothese vs. Ersatzmuskelplastik bei hochgradiger
ing the gracilis muscle in four cases of children. Ann Surg.
stuhlinkontinenz? Chirurg. 2006;77:926–38.
1952;135:853–62.
19. Walega P, Romaniszyn M, Siarkiewicz B, Zelazny D. Dynamic ver-
7. Cavina E, Seccia M, Banti P, Zocco G. Anorectal reconstruction
sus adynamic graciloplasty in treatment of end-stage fecal incon-
after abdominoperineal resection. Experience with double-wrap
tinence: is the implantation of the pacemaker really necessary?
graciloplasty supported by low-frequency electrostimulation. Dis
12-Month follow-up in a clinical, physiological, and functional
Colon Rectum. 1998;4:1010–6.
study. Gastroenterol Res Pract. 2015;698516, 5p.
8. Baeten C, Spaans F, Fluks A. An implanted neuromuscular stimu-
20. Cavina E, Seccia M, Evangelista G, Buccianti P, Tortora A, Chirico
lator for faecal continence following previously implanted gracilis
A. Perineal colostomy and electrostimulated gracilis “neosphinc-
muscle. Dis Colon Rectum. 1988;31:134–7.
ter” after abdominoperineal resection of the colon and anorectum: a
9. Chapman AE, Geerdes B, Hewett P, et al. Systematic review of
surgical experience nad follow up study in 47 cases. Int J Colorectal
dynamic graciloplasty in the treatment of faecal incontinence. Br J
Dis. 1990;5:6–11.
Surg. 2002;89:138–53.
21. Rullier E, Zerbib F, Laurent C, Caudry M, Saric J. Morbidity and
10. Adang EMM, Engel GL, Rutten FFH, Geerdes BP, Baeten
functional outcome after double dynamic graciloplasty for anorec-
CG. Cost-effectiveness of dynamic graciloplasty in patients with
tal reconstruction. Br J Surg. 2000;87:909–13.
faecal incontinence. Dis Colon Rectum. 1998;41:725–33.
22. Inglin RA, Eberli D, Brugger LE, Sulser T, Williams NS, Candinas
11. Romaniszyn M, Walega P, Nowakowski M, Nowak W. Can surface
D. Curent aspects and future prospects of Total anorectal recon-
electromyography improve burgery planning? Electromyographic
struction-a critical and comprehensive review of the literature. Int J
assessment and intraoperative verification of the nerve bundle entry
Colorectal Dis. 2015;30:293–302.
point location of the gracilis muscle. J Electromyogr Kinesiol.
23. Ho KS, Seow-Choen F. Dynamic graciloplasty for total anorectal
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Safety and efficacy of dynamic graciloplasty for fecal incontinence.
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Injectable and Implantable Biomaterials
for Anal Incontinence 39
Alex Hotouras and Pasquale Giordano
and can be considered for the treatment of FI refractory to 39.2 Types of Agents Used
conservative therapy.
The aim of this chapter is to describe the most com- Shafik was the first to describe the use of bulking agents in
monly used injectable and implantable biomaterials used 1993 [1]. He used polytetrafluoroethylene (Teflon or Polytef)
for incontinence and appraise the results of the various or autologous fat to treat patients with “partial faecal incon-
studies (Table 39.1). tinence” [1, 2]. The agent was injected without anaesthesia,
in the rectal neck submucosa, above the dentate line at each
Table 39.1 Injectable and implantable biomaterials for faecal of the 3 and 9 o’clock positions. Since then many other
incontinence injectable biomaterials have been used including silicone
• Autologous fat biomaterial (PTQ™), stabilized hyaluronic acid/dextrano-
• Silicone biomaterial (PTQ, Bioplastique) mer (NASHA/Dx), ethylene vinyl alcohol (EVOH), porcine
• Carbon-coated zirconium beads (Durasphere) dermal cross-linked collagen (Permacol®), glutaraldehyde
• Calcium hydroxylapatite microspheres (Coaptite)
bovine cross-linked collagen (Contigen), pyrolytic carbon-
• Hyaluronic acid (NASHA/Dx, Solesta, Zuidex)
• Glutaraldehyde cross-linked collagen (Contigen) coated zirconium beads (Durasphere), polydimethylsiloxane
• Polyacrylamide hydrogel (Bulkamid) elastomer, dextranomer in nonanimal stabilized hyaluronic
• Porcine dermal collagen (Permacol) acid, hydrogel cross-linked with polyacrylamide
• Ethylene vinyl alcohol copolymer (Enteryx) (Bioplastique), synthetic calcium hydroxylapatite ceramic
• Expandable silicone microballoons microspheres, and polyacrylonitrile in cylinder form
• Polyacrylonitrile (Hyexpan, Gatekeeper, SphinKeeper) (Hyexpan) (Gatekeeper™, SphinKeeper®) [Table 39.1].
a b
c d
Fig. 39.1 (a) Injectable silicone biomaterial (PTQ—Macroplastique); (b) schematic drawing of bulking agent injection into the submucosa; (c,
d) intraoperative images. Injections performed at 3 (left lateral) and 9 (right lateral) o’clock positions
39 Injectable and Implantable Biomaterials for Anal Incontinence 493
39.3 Technique tightening of the anal canal. Bulking agents could also tar-
get defective areas of the IAS, if present, to create canal
The technique may vary depending on the type of material symmetry and regular contour of the anus.
used. Injectable bulking materials are generally inserted The procedure is usually performed in an outpatient set-
into the submucosa of the distal rectum, while implant- ting under local anaesthesia with or without some degree of
able materials are normally placed into the proximal inter- sedation or under general anaesthesia as day case procedure
sphincteric space with the objective to increase the tissue depending on the type of material used. In many cases if the
volume in the high-pressure zone, especially in the proxi- response is not satisfactory or the improvement is lost over
mal portion of the anal canal, creating a tighter seal at rest time, a repeat injection can be administered. Although there
(Fig. 39.1). Currently the only injectable material placed is no need for specific bowel preparation, a phosphate enema
into the intersphincteric plane is EVOH, while both is often used just before the procedure is carried out.
implantable devices Gatekeeper™ and SphinKeeper® are Antibiotic prophylaxis (e.g. metronidazole) at induction of
delivered into the intersphincteric plane (Fig. 39.2). The anaesthesia is recommended. Intraoperative endoanal ultra-
number of injections and the volume of the injected bulk- sound (EAUS) is not compulsory but is thought to facilitate
ing agent are variable depending on the material used and the correct placement of the bulking agent into the submu-
the indication. Usually several injections in different parts cosa space (Fig. 39.3) or the implant in the intersphincteric
of the anal circumference are needed to optimize the plane (Fig. 39.4) [3].
a d
Dispenser
c Delivery system
e f
Fig. 39.2 Implantable Gatekeeper device. (a) Guide sheath assembly; (b) prosthesis in sheath; (c) prosthesis released from sheath; (d) delivery
system and dispenser; (e, f) intraoperative images
494 A. Hotouras and P. Giordano
a b
Fig. 39.3 Three-dimensional endoanal ultrasound performed by linear transducer (type 8838, BK Medical). Bulking agents (PTQ) are visualized
as hyperechoic volumes into the submucosa. (a) Axial plane; (b) coronal plane; (c) sagittal plane
39 Injectable and Implantable Biomaterials for Anal Incontinence 495
a b
Fig. 39.4 Three-dimensional endoanal ultrasound performed by linear transducer (type 8838, BK Medical). Polyacrylonitrile implants
(Gatekeeper) are visualized as hypoechoic cylinders (asterisks) into the intersphincteric plane. (a) axial plane; (b) coronal plane
39.4 Safety and Adverse Events (n = 1). Migration of the injectable bulking agent was
reported in 14 patients, 2 patients were injected with
Injection and implantation of biomaterials for the manage- Durasphere, and 12 had a PTQ injection. Two patients had
ment of FI appear safe as the risk of complications is small, leakage of Durasphere with stool.
and most adverse events are relatively minor that resolve In a small prospective RCT comparing silicone biomate-
within the first 2 postoperative weeks. The most common rial (PTQ) to saline injection, Siproudhis et al. [5] reported
adverse event is perianal pain or discomfort. Others included 18 adverse effects in 9 participants of their trial. Six out of
leakage of injected agents within the first few days, abscess 22 people injected with silicone biomaterial (PTQ) experi-
formation that may require surgical intervention, mucosal enced pain at the implant site compared to 2 out of 22 in the
erosion, hematoma, obstruction defecation, pruritus ani, and control group. Anal inflammation was found in two com-
urgency. pared to none in the control group. Overall the adverse
In a systematic review [4] of the 420 patients treated with events were not considered “serious”; however, the duration
bulking agents for passive FI, there were 52 reported adverse of events had not been reported in the outcome. In a study
events. The most common adverse events were minor and reported by Graf et al. [6] in 2011, 128 patients treated with
included pruritus ani (n = 16) and mild pain during injection NASHA/Dx experienced post-procedure adverse events
(n = 13). Other common events included mild proctalgia compared to 29 in the sham treatment group. The most com-
(n = 8) and anal inflammation and swelling (n = 6). More mon adverse event was proctalgia (19/136 vs. 2/70) fol-
serious events included persistent anal discomfort (n = 1), lowed by injection site bleeding (7/136 vs. 12/70) and rectal
infection requiring drainage (n = 1), and pain during defeca- haemorrhage (10/136 vs. 1/70). Two serious events were
tion (n = 1). Furthermore, one patient reported significant reported in the NASHA/Dx group: prostatic abscess treated
pain during the injection. Other events were anal bleeding conservatively with antibiotics and a rectal abscess requir-
(n = 2), anal soiling (n = 1), leakage (n = 1), and dermatitis ing surgical drainage [6]. The trial comparing PTQ and
496 A. Hotouras and P. Giordano
Durasphere [7] noted significantly more adverse events in FI. Adverse outcomes and complications were also noted.
the Durasphere group compared to PTQ group. The main During the first phase of the trial, 128 patients developed
post-procedural complaints in patients with PTQ were of treatment-related adverse events. The most common post-
bruising. In contrast, participants injected with Durasphere procedure complication was minor bleeding, pain, and dis-
complained of rectal pain (1/20), erosions (2/20), and type comfort. Two serious complications post-injection were
III hypersensitivity reaction (1/20) requiring hospital admis- noted: one patient developed a perianal abscess that required
sion for management. A systematic review by Hong et al. surgical intervention and one patient developed a prostatic
[8] looking at outcomes from injectable bulking agents for abscess that resolved on antibiotic treatment. In the long-
FI commented on adverse events following this procedure. term follow-up phase, 20 further treatment-related adverse
Twenty-three studies reported adverse events occurring in events were recorded, the most common being proctalgia
219 patients. The rate of adverse events was 18% (95% CI and injection site nodule. Kenalog injection and xylocaine
10.0–30.1). In majority of cases, adverse outcomes were ointment were used for this. None of these patients under-
considered minor and resolved in a few weeks. Adverse went surgery, and proctalgia eventually resolved in all cases.
events included perianal pain or discomfort (most com- Stephens et al. [7] looked at the impact of implantation of
mon), leakage of injected agents, abscess, mucosal erosion, EVOH for incontinence management. Thirteen subjects had
obstructed defecation, hypersensitivity reaction, hematoma, at least one adverse event; 11 were classified as mild and 2 as
diarrhoea, pruritus, and urgency. Fifteen patients experi- severe. Twenty-eight patients developed treatment-related
enced leakage of the injected agent, which self-resolved in a adverse events; 22/28 were classified as mild in nature. Two
few days. Seven out of 219 patients developed a perianal serious complications were recorded. One patient developed
abscess, two of which required surgical drainage. Bartlett faecal impaction and injection site anal abscess and required
et al. [9] performed a study looking at the efficacy of PTQ hospital admission. Another patient experienced severe chest
for FI. Nine complications were noted, all of which were pain following the procedure; patient was admitted, observed,
minor. Two patients needed antidiarrheal medication, and and discharged with no further intervention. Overall compli-
two patients required treatment for constipation. One patient cations post-procedures have been poorly reported. No stud-
developed a perianal abscess requiring removal of the ies available looking at adverse events alone following such
implant, surgical drainage of the abscess, and replacement procedures, but adverse events that have come to the atten-
of the PTQ. The patient achieved full continence following tion to the investigators during their trial have occasionally
this. One perianal abscess was treated conservatively with been stated. Three studies have used biological material as a
antibiotics alone. Three patients experienced anal irritation bulking agent for a total of 122 patients [13–15]. Overall,
and discomfort. Once the infection settled on antibiotics, the 105 patients received cross-linked porcine dermal collagen
patient had a replacement PTQ implant and achieved full paste (Permacol™) and 17 received Glutaraldehyde cross-
continence subsequently. Three patients had minor anal irri- linked (GAX) collagen, a highly purified bovine dermal col-
tation or discomfort; one patient had superficial mucosal. lagen. There were no complications reported in any of these
Similarly, Morris et al. [10] had one patient developing a three studies [13–15].
perianal abscess in the PTQ group, but no complications in
the Durasphere group. Dehli et al. [11] assessed the effec-
tiveness of NASHA/DX in the management of FI. Among 39.5 Efficacy
the ten patients who received the anal injection of NASHA/
DX, three were infected requiring treatment; one was treated Evidence on the efficacy of bulking agents is weak, and most
with oral antibiotics; and two required surgical drainage. All studies conducted for this treatment have been of poor qual-
three patients were treated effectively, and the incontinence ity and included small number of patients. A Cochrane
was unaffected. Due to the development of infection of review in 2016 found little evidence that perianal injection of
these patients, the remaining 54 patients in the trial were a bulking agent is effective in treating FI although patients
given prophylactic antibiotics. No further post-procedural did report an improvement in symptoms in the short-term
infections were noted. Seven patients (11%) reported leak- [15]. Long-term benefit on symptoms of passive FI remains
age of the injected agents, and three patients (5%) experi- still unclear.
enced prolonged defecation. Pain was well controlled with Shafik [2] first described the use of Teflon for the manage-
paracetamol alone in three patients. ment of FI by injecting the substance into the rectal neck
Similarly, Mellgren et al. [12] assessed the long-term effi- mucosa above the pectinate line. The study including 11
cacy of NASHA/Dx injection therapy for treatment of patients noted a long-term cure in 45.4% after the first injec-
39 Injectable and Implantable Biomaterials for Anal Incontinence 497
tion and in 63.6% after the second injection. 36.4% showed patient experienced a postoperative complication of a peri-
partial improvement, and therefore no failures were found. anal abscess requiring surgical drainage (PTQ group).
According to Shafik, improvement is secondary to an Furthermore a large prospective study [9] recruited 74
increase in rectal neck pressures produced by the cushion- patients who received PTQ implants in the intersphincteric
effect of the injection [2]. plane. At a median follow-up of 28 months, 52 patients
In a more recent analysis, with 637 patients from 19 stud- (70%) were continent and extremely satisfied with the result.
ies that used the CCF-FIS score, the improvement rate was The CCF-FIS in participants who remained incontinent was
close to 40% [8]. A univariate meta-regression analysis based reduced significantly from 12 before implant to 3.5 at
in change in CCF-FIS showed that the transphincteric or follow-up.
intersphincteric route was associated with greater improve- NASH/Dx or stabilized hyaluronic acid/dextranomer is an
ment in continence compared to submucosal injection through alternative bulking agent to PTQ and Durasphere, also injected
the transanal route. Similarly, a lower percentage of study into the intersphincteric plane. A large RCT by Graf et al. [6]
patients with missing or migrated implants was significantly compared injection of NASH/Dx to the injection of a sham
associated with greater improvement in continence. Patient agent. Two hundred and six patients were selected of which
age, severity of incontinence, number of injections or volume 136 were randomized to receive NASHA/Dx (n = 136) versus
of material, use of EAUS, and repeated injection were not 70 who were randomized to sham treatment. Success was con-
found to be impacting on the efficacy of the therapy [8]. sidered in patients with a 50% or more reduction in the num-
Two small similarly sized RCTs compared PTQ versus ber of incontinence episodes experienced. This study noted a
Durasphere [10, 16]. The first, with 40 patients, showed that statistically significant difference between the treatment and
at 12 months after injection, significantly more PTQ patients control groups. Participants in the treatment group had consid-
achieved greater than 50% improvement in CCF-FIS. In erably more incontinence free days at 6 months (3.1 days vs.
comparison to the Durasphere group, PTQ was shown to 1.7 in the sham group, MD 1.40 days, 95% CI 0.33–2.47).
have better outcome; with improved symptoms at 6 and However secondary endpoints including the number of FI epi-
12 months (at 12 months, RR 0.15, 95% CI 0.04–0.60 and sodes, CCF-FIS at 3 and 6 months, and Fecal Incontinence
better quality of life at 6 months (MD −0.56, 95% CI −1.01 Quality of Life (FIQOL) at 12 months did not show any statis-
to −0.011) [10]. There was also a significant improvement in tical difference. In another RCT, with 60 patients in each arm,
FI quality of life scale and the 12-month physical health comparing stabilized hyaluronic acid (NASHA/Dx) versus
scale of Short Form-12 health survey in the PTQ group but biofeedback, there was no statistical difference in the inconti-
not in the Durasphere group [16]. nence improvement rate after 24 months [11].
In the second RCT by Morris et al. [10] including 34 In the largest prospective study with 136 patients that
patients, the efficacy of PTQ and Durasphere were also com- received NASHA/Dx submucosally, Mellgren et al. [12]
pared. A significant improvement in mean continence scores reported a >50% reduction in incontinence episodes at 52%
in both the PTQ and Durasphere was demonstrated. These of patients after 36 months. The improvement in the pri-
effects persisted at all three points of follow-up; 6 weeks, mary endpoint was accompanied by improved quality of
6 months, and 12 months. In participants randomized to the life scores for all domains of the FIQOL scale with minor,
PTQ group, the CCF-FIS was reduced by 4.3 (P < 0.001), transient adverse events. In the second largest study [13]
4.2 (P < 0.001), and 1.1 (P = 0.24) at 6 weeks, 6 months, and with 100 patients that received intersphincteric injection of
12 months, respectively [10]. These differences were found collagen (Permacol®), 68% reported a subjective improve-
to be statistically significant (P = 0.001). In participants ran- ment in symptoms with 56 reporting improved CCF-FIS
domized to the Durasphere group, the CCF-FIS score was from a mean of 14 (range 9–18) to a mean of 8 (range 5–14)
reduced by 5.3 (P = 0.003), 4.1 (P = 0.002), and 1.8 after 36 months. Thirty-eight patients (38%) required a
(P = 0.19). These differences were again statistically signifi- repeat injection of collagen, and a further 15 patients
cant (P = 0.001) [10]. When the two groups (PTQ vs. required a third injection. Similarly Hussain et al. [14]
Durasphere) were compared, no significant differences in the investigated the efficacy of Permacol for the management
magnitude of effects were demonstrated at all three follow- of FI. Thirty-eight patients were followed up for a median
up points. Calculated differences in the CCF-FIS scores
period of 9 months. Response to treatment was recorded as
between PTQ and Durasphere groups were 1.0 (P = 0.52) at excellent, good, fair, and poor in 12, 5, 4, and 17 patients,
6-week follow-up (mean 4.3, SD ± 3.7 vs. 5.3 ± 5.1), 0.1 respectively; St. Mark’s score improved in 72% and 63% of
(P = 0.92) at 6 months (4.2 ± 3.5 vs. 4.1 ± 3.8), and 0.4 patients at 1 and 2 years, respectively [14]. All four domains
(P = 0.72) at 12 months (1.4 ± 2.6 vs. 1.8 ± 3.0) [10]. One of Rockwood Quality of Life Score improved on first and
498 A. Hotouras and P. Giordano
Fig. 39.5 Gatekeeper
consists of a thin and solid a b
cylindrical prosthesis (a) that
within 24 h of implantation in
contact with human tissue, it
expands and changes shape
and volume, becoming thicker
and shorter (b)
second year follow-up; however, only two domains, coping week with an improvement of CCF-FIS from 12.7 to 5.1
and embarrassment, were statistically significant. Maeda (P < 0.001). More recently, Trenti et al. [20] have investi-
et al. [17] compared injection of Bulkamid (hydrogel cross- gated the use of the Gatekeeper in treatment of FI as part of
linked with polyacrylamide) and Permacol (porcine dermal a multicentre, retrospective, and longitudinal study of 49
collagen). The hydrogel group incontinence scores patients with incontinence. In this study six implants were
improved from a median of 15–12 at 6 weeks, and this was inserted. The Vaizey score was used as a means of analysing
maintained at 6 months. Nonetheless there was an improve- improvement in symptoms over a period of time. Twenty-
ment in the collagen group as well with a median score three patients (48%) were classified as responders and 25
improvement from 16 to 14 over 6 weeks but deteriorated (52%) as nonresponders. The mean Vaizey score at baseline,
to 15 at 6 months. The numbers for the trial were too small 6 months, 12 months, and last visit post-surgery in the
to demonstrate a significant different in the two groups. In responder group was 13.3 (SD 3.8), 4.3 (SD 2.1), 4.2 (SD
a study by Kenefick et al. [18], six patients were injected 3.6), and 5.7 (SD 5.3), respectively. There were statistically
with silicone biomaterial for FI. Despite the small numbers significant differences noted in the mean baseline Vaizey
in the study, there was a marked improvement in symptoms score and scores at 6 and 12 months and last follow-up post-
and patient satisfaction in five out of six patients. Median procedure (P < 0.001). When considering long-term
incontinence scores improved significantly from 14 before improvement in symptoms, follow-up at 2.7 years noted that
the procedure to 8 after the procedure (P = 0.04). There was the initial responders maintained an improvement of more
a significant improvement in the FIQOL reported by than 50% of the baseline Vaizey score. A higher percentage
patients as demonstrated by the change in the SF-36 scores of prosthesis migration was found in the nonresponder
(worst score = 0, best score = 100). A marked improvement group compared to the responders (2.4 SD 2.5 vs. 1.0 SD
in physical function score was noted from a median of 26 1.6; P = 0.040) [20]. Similarly, Ratto et al. [21] led a multi-
(range 5–33) pre-procedure to 79 (range 25–100) post-pro- centre, observational study on the efficacy of the Gatekeeper
cedure (P = 0.02) and social function score from 10 (range [20]. In this study, 54 patients were implanted with six
5–37) to 100 (range 50–100) (P = 0.02). No post-procedure Gatekeeper implants positioned into the intersphincteric
complications were reported. place. At baseline and 1, 3, and 12 months after implanta-
Gatekeeper (polyacrylonitrile cylinder), is a relatively tion, the number of FI episodes and CCF-FIS, Vaizey,
novel material initially introduced as bulking agent in the FIQOL Scale, and SF-36 Health Survey scores were mea-
management for FI. It consists of a thin and solid cylindrical sured. All FI severity scores were significantly reduced fol-
prosthesis that is implanted into the proximal portion of the lowing implantation, and patients’ quality of life improved.
intersphincteric space of the anal canal (Fig. 39.2). Within At 12 months, 30 patients (56%) showed at least 75%
24 h of implantation in contact with human tissue, it expands improvement in all FI parameters, and 7 (13%) became fully
and changes shape and volume, becoming thicker, shorter, continent. At the final follow-up appointment at 1 year, 30
and softer consistency providing extrinsic compression of patients (56%) had improvement of at least 75% in all
the anal canal (Fig. 39.5). In the initial series of 14 patients incontinence parameters; however 24 patients have a less
[19], 4 prostheses were injected in each patient. At a mean than 75% improvement. All scores measuring FI severity
follow-up of 33 months, there were no complications, and reduced significantly during follow-up. Median CCF-FIS
there was a significant decrease in major FI episodes per varied from 12 to 5 (P < 0.001), median Vaizey from 14 to
39 Injectable and Implantable Biomaterials for Anal Incontinence 499
a SphinKeeper
prostheses
Mucosa/
Submucosa
Internal
shincter
Intersphincteric
space
External
sphincter
Fig. 39.6 Ten SphinKeeper implants can be placed into the inter- formed by mechanical rotating transducer (type 2052, BK Medical,
sphincteric plane to achieve a better encirclement of the anal canal. (a) frequency 13 MHz). Ten polyacrylonitrile implants (SphinKeeper) are
Schematic drawing; (b) three-dimensional endoanal ultrasound per- visualized as hypoechoic cylinders into the intersphincteric plane
6.5 (P < 0.001), and median AMS from 87 to 43.5 (P < 0.001) Ethylene vinyl alcohol (EVOH) is another alternative to
[21]. The Gatekeeper implant has now been replaced with a treatment for FI. A prospective study by Stephens et al. [7]
new-generation implant, the SphinKeeper, made of the same looking at 21 patients showed a statistically significant
material but just larger in size (Fig. 39.6) [22]. Up to ten decrease in CCF-FIS (P = 0.0005) and the FI Severity Index
SphinKeeper implants can be placed in each patients with score (P = 0.005) after treatment. Twelve months following
the idea to achieve a better encirclement of the anal canal treatment, the mean CCF-FIS had decreased by 37%
and optimize the functional outcome. With the evolution of (P = 0.0021), and 47% of subjects had >50% improvement
the prosthesis and the technique, the SphinKeeper is now in CCF-FIS. There was also a notable improvement in
used as a permanent implantable device rather than a bulk- embarrassment (P = 0.0455) and coping/behaviour
ing agent with the rational to introduce a kind of artificial (P = 0.0056). In a study [23] with the longest follow-up of
neosphincter rather than simply augmenting the IAS as the 7 years, 19 patients who received various bulking agents
injectable materials. (Durasphere, PTQTM, Solesta®) did not sustain the initial
500 A. Hotouras and P. Giordano
a b
Fig. 39.7 Three-dimensional endoanal ultrasound performed by (arrow) (a) and into the subcutaneous space (arrows) (b). PR puborec-
mechanical rotating transducer (type 2052, BK Medical, frequency talis muscle, ScEAS subcutaneous external anal sphincter
13 MHz). Migration of the prostheses into the supralevator space
21. Ratto C, Buntzen S, Aigner F, Altomare DF, Heydari A, Donisi treatment of fecal incontinence: clinical outcomes and ultrasound
L, Lundby L, Parello A. Multicentre observational study of the evidence. Tech Coloproctol. 2015;19:23–7.
Gatekeeper for faecal incontinence. Br J Surg. 2016;103:290–9. 24. Ullah S, Tayyab M, Arsalani-Zadeh R, Duthie GS. Injectable anal
22. Ratto C, Donisi L, Litta F, Campennì P, Parello A. Implantation of bulking agent for the management of faecal incontinence. J Coll
SphinKeeper(TM): a new artificial anal sphincter. Tech Coloproctol. Physicians Surg Pak. 2011;21:227–9.
2016;20:59–66. 25. Siproudhis L, Morcet J, Laine F. Elastomer implants in fae-
23. Guerra F, La Torre M, Giuliani G, Coletta D, Amore Bonapasta S, cal incontinence: a blind, randomized placebo-controlled study.
Velluti F, La Torre F. Long-term evaluation of bulking agents for the Aliment Pharmacol Ther. 2007;25:1125–32.
Sacral Neuromodulation for Fecal
Incontinence 40
Klaus E. Matzel and Birgit Bittorf
reach and facilitates placement along the natural path of the number of programming options for permanent stimulation
sacral spinal nerves in the pelvis. The positioning of the elec- with the least energy consumption—and thus battery longev-
trode is always determined by the pattern and intensity of a ity and the lowest likelihood of negative side effects [2].
motor or sensory response to stimulation, the intensity of The SNM procedure consists of a test phase to determine
applied stimulation, and the radiographic appearance of the clinical effectiveness and, in case of a successful test, chronic
implanted electrode. Ideally, all four contacts of the elec- therapeutic stimulation. The test phase entails percutaneous
trode should be positioned close to and parallel with the tar- nerve evaluation (PNE) with either temporary electrodes
get nerve, which runs in a caudolateral direction after exiting (one or more easily placed monopolar flexible electrodes
the ventral opening of the foramen. This offers the greatest (Medtronic InterStim® 3059, Medtronic Inc., Minneapolis,
MN, USA)) or the so-called quadripolar tined lead [2]
(Medtronic InterStim® 3889, Medtronic Inc., Minneapolis,
MN, USA). The first option offers the possibility of testing
more than one sacral spinal nerve and is less invasive and
expensive. These electrodes are easily removable; however,
if test stimulation is successful, insertion of a tined lead is
required for chronic stimulation. The latter option, the tined
lead, is less prone to dislodgement [3] and can remain and be
connected to the fully implantable pulse generator (Medtronic
InterStim® II, 3058, Medtronic Inc., Minneapolis, MN,
USA), which will be implanted if during the test phase a
50% symptom improvement is achieved. For the test stimu-
lation phase (typically 2 weeks), both types of electrode are
connected to an external pulse generator (Fig. 40.4), and the
patient documents bowel habits and incontinence frequency
by diary. The indication for chronic therapeutic stimulation
is based on the degree of symptom improvement.
For both test and chronic stimulation with the fully
Fig. 40.2 Intraoperative use of fluoroscopy with lateral imaging of
implanted system (Fig. 40.5), the parameters are set in coop-
sacrum after a.p. marking of distal edge of ileosacral junction and
medial edges of sacral foramina: “H“-sign foramen needle electrode eration with the awake patient. They are determined by the
inserted into S3 left perception of stimulation, the required intensity, and the
Fig. 40.3 Intraoperative imaging: (a) electrode introducer placement, (b) tined lead electrode placement
40 Sacral Neuromodulation for Fecal Incontinence 505
40.4 Indications
Fig. 40.5 Sacral neuromodulation system (electrode and pulse genera-
tor) implanted No physiological predictors of outcome exist. Thus, the indi-
cations for implantation of the permanent device are based
on the clinical outcome of test stimulation. Initially, SNM
presence of side effects. The temporary electrodes allow was limited to fecal incontinence in the presence of a mor-
only unipolar stimulation and the tined lead electrode only phologically intact anal sphincter. However, based both on
bipolar stimulation; chronic stimulation with an implanted the awareness that stimulation’s effect is not limited to the
tined lead and pulse generator can be uni- or bipolar. The sphincters and on the experience of a highly predictive posi-
stimulation setting should be comfortable and free of side tive test, a progressive broadening of the indications has
effects. Most commonly, suprasensory threshold stimulation occurred. Today a wide spectrum of causes of fecal inconti-
is used, although a subsensory threshold can also be effective nence is successfully treated with SNM. The procedure has
[4]. Patients are able to adjust the parameters within a preset also been extended to other pelvic organ/floor disorders,
range with a handheld programmer. Adjustments to the pro- such as constipation [13]. A pragmatic trial and error con-
gramming parameters may be required. cept—in which the indication for test stimulation is not
506 K. E. Matzel and B. Bittorf
based solely on specific pathophysiological or pathomorpho- transection, septic conditions in the field of operation (pilo-
logical criteria—has demonstrated that SNM may be effec- nidal sinus), pregnancy, mental or physical inability to adhere
tive for fecal incontinence caused by external anal sphincter to treatment, and the need for MRT (the current version of
damage [14–16], radiation [17], rectal prolapse repair [18], the implant is only conditionally safe for 1.5 T MRT head
Crohn’s disease [19], partial spinal lesions [20], and cauda coil).
equina [21], several neurological diseases (such as muscular
dystrophy and systemic sclerosis) [22, 23], and also low
anterior resection syndrome (LARS) [24, 25]. The associa- 40.5 Prognostic Factors of Outcome
tion of fecal incontinence with other pelvic floor dysfunc-
tions such as urinary incontinence or retention is a further Any attempt to identify factors statistically predictive of a
area for application [26, 27]. successful outcome to temporary and chronic stimulation
A placebo effect has been addressed in a double-blind has failed. At present no clinical factors (patient features, eti-
randomized crossover trial [28]. ology of incontinence, motor or sensory response to test
Multiple guidelines and recommendations (National stimulation) or preoperative laboratory investigations (anal
Institute for Health and Care Excellence [NICE] [29], manometry, electrophysiological tests, etc.) have convinc-
American Society of Colon and Rectal Surgeons [ASCRS] ingly demonstrated prognostic value [34–37], either for the
[30], International Consultation on Incontinence [ICI] test phase or for chronic stimulation [38]. Recently, a retro-
[31], French [32] and Italian [33]) confirm the clinical effi- spective study reported that patients with fecal incontinence
cacy of SNM and consider it to be one of the first-line sur- and concomitant high-grade internal rectal prolapse (Oxford
gical interventions for fecal incontinence of varied Grade 3 and 4) have a poorer clinical outcome to chronic
etiology. The positioning of SNM in the treatment algo- SNM [39].
rithm is central (Fig. 40.5 ICI Algo). A limited number of
surgical alternatives such as sphincteroplasty exist, but
they are suitable for a far more limited spectrum of etiolo- 40.6 Outcome
gies (Fig. 40.6).
The list of specific contraindications for SNM is limited Since the introduction of SNM in coloproctology [1], out-
to conditions not allowing adequate electrode placement, come reports have accumulated (Tables 40.1 and 40.2), some
such as anorectal/sacral malformations, complete spinal cord focusing on its long-term efficacy [40–44, 50, 61–63]. Most
Review Repeat
clinical, radiological and evaluation
physiological data
Rectal evacuation Sphincter defect > 180º or Sphincter defect Sphincter defect No sphincter
disorder significant perineal tissue loss 120º – 180º < 120º defect
Yes Symptom no
Follow up
improvement
Novel therapies:
• Magnetic anal sphincter
• Puborectal sling
ACE: antegrade continence enema, BI: biomaterial injection, • Radiofrequency energy treatment
SNS: sacral nerve stimulation; *not widely available • Stem cell therapy
• Vaginal pessary - EclipseTM
Fig. 40.6 Algorithm International Consultation on Incontinence (ICI): surgical treatment for fecal incontinence [31]
40 Sacral Neuromodulation for Fecal Incontinence 507
Table 40.1 Chronic sacral nerve stimulation (SNS) for fecal incontinence (FI): incontinence episodes, studies with at least 50 patients
Table 40.2 Chronic sacral nerve stimulation (SNS) for fecal incontinence (FI): Cleveland Clinic Incontinence Score, studies with at least 50
patients
Patients Median Median score
(n) Patients (n) follow-up Median score follow-up
Author Year (baseline) (follow-up) (months) baseline (range) (range) P-value
Tjandra et al. [43] 2008 53 53 12a 16 (1)b 1 (2)b <0.001
Altomare et al. [44] 2009 60 52 74b 15 (4)b 5 (5)b <0.001
Brouwer et al. [53] 2010 55 13 48a 15 (13–18) 6 (2–8) 0.008
Faucheron et al. [54] 2010 87 87 45 13 (6–19)b 8 (1–17)b n.a.
Michelsen et al. [45] 2010 126 10 72a 20 (12–20) 7 (2–11) <0.001
Gallas et al. [34] 2011 200 54 24a 14 (2–20) 7 (0–19) 0.001
Lim et al. [55] 2011 53 41 51§ 12 (9–15) 8 (5–11) 0.001
Wong et al. [56] 2011 61 61 31 14 (n.a.) 8 (n.a.) n.a.
Faucheron et al. [57] 2012 57 42 63 14 (4–19) 7 (1–16) <0.001
Damon et al. [58] 2013 102 101 48b 14 (3) 9 (1) <0.0001
Maeda et al. [59] 2014 108 101 60a 16 (6–20) 8 (0–19) <0.0001
Altomare et al. [50] 2015 272 228 84 16 (13–18) 7 (4–12) <0.001
Duelund-Jakobsen et al. 2016 164 n.a. 22 15 (3–20) 9 (0–20) <0.001
[60]
Modified after Thin et al. [56]
n.a. not available
a
Values at specific time point
b
Mean
patients treated with chronic SNM experience a sustained 40.7 Future Directions
clinical improvement regardless of the underlying etiology
[50], with reported follow-up of up to 18 years [61]. The SNM is a well-established treatment option for fecal inconti-
long-term results are favorable when compared with those of nence. Its role in the current treatment is central. Future
other surgical techniques such as sphincteroplasty. The clini- development will most likely include a modifications of the
cal benefit is not limited to symptom reduction or relief but applied stimulation device (miniaturization) and its handling
also to quality of life: a significant improvement has been (programming, interface). With the availability of a test stim-
repeatedly demonstrated in short-, mid-, and long-term out- ulation phase, which is highly predictive of the clinical effec-
come studies that used both general health (SF-36) and tiveness if it leads to a positive clinical outcome during the
disease-specific questionnaires such as the Fecal Incontinence test phase, the spectrum will of application will expand
Quality of Life Scale (FIQLS) [41, 44–46, 63–65]. further.
508 K. E. Matzel and B. Bittorf
16. Jarrett ME, Dudding TC, Nicholls RJ, et al. Sacral nerve stimula-
Take-Home Messages tion for fecal incontinence related to obstetric anal sphincter dam-
age. Dis Colon Rectum. 2008;51:531–7.
SNM develop to be the central treatment modality for 17. di Visconte MS, Munegato G. The value of sacral nerve stimulation
surgical therapy of fecal incontinence. A broad spectrum in the treatment of faecal incontinence after pelvic radiotherapy. Int
of etiologies leading to fecal incontinence can be treated J Colorectal Dis. 2009;24:1111–2.
18. Jarrett ME, Matzel KE, Stösser M, et al. Sacral nerve stimulation
successfully. The patient selection is pragmatic and
for fecal incontinence following surgery for rectal prolapse repair:
based on the outcome of a timely limited test stimulation a multicenter study. Dis Colon Rectum. 2005;48:1243–8.
phase. The chronic stimulation results in long- term 19. Vitton V, Gigout J, Grimaud JC, et al. Sacral nerve stimulation
symptom improvement and improved quality of life. can improve continence in patients with Crohn’s disease with
internal and external anal sphincter disruption. Dis Colon Rectum.
2008;51:924–7.
20. Jarrett ME, Matzel KE, Christiansen J, et al. Sacral nerve stimula-
tion for faecal incontinence in patients with previous partial spinal
injury including disc prolapse. Br J Surg. 2005;92:734–9.
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Posterior Tibial Nerve Stimulation
for Faecal Incontinence 41
Gregory P. Thomas, Carolynne J. Vaizey,
and Yasuko Maeda
41.1 Introduction
toms begin to deteriorate. At this point “top-up” treatments (p < 0.0001) after 12 sessions. After most recent top-up ther-
are given. This can then be continued in the longer term. This apy, the mean score was 10 (4.3) (p < 0.0001). The median
is usually administered in the outpatient clinic, although deferral time also improved significantly after 12 sessions (1
recent work has explored its use by the patient from home. (0–45) to 5 (0–60) min p < 0.0001). This improvement per-
Percutaneous PTNS has been described in a number of sisted after most recent top-up therapy (4 (0–60) min
single series. Shafik, in 2003 [3], described 32 patients, all p < 0.0001). The median FI episodes per week improved sig-
with idiopathic faecal incontinence, who had received percu- nificantly after 12 sessions (5 (0–35) to 1 (0–27) p < 0.0001).
taneous PTNS. All had an intactanal sphincter, had failed Again, this improvement was maintained at most recent top-
biofeedback and other conservative treatments. They up session (1 (0–24) p < 0.0001). The median (range) time
received 30 min of stimulation on alternate days for a period from completion of the 12 initial sessions of PTNS to top-up
of 4 weeks. This group was compared with 20 untreated con- therapy was 12 (1–40) months. Uni- and multivariate analy-
trol patients. The primary endpoint was >50% improvement sis showed that type of FI (urge or passive) and sphincter
in a faecal incontinence score, similar to the Cleveland Clinic morphology had no significant impact on outcome.
FI score [5]. A >50% improvement in the continence score
occurred in 27 (84%) of patients treated, 9 (29%) of whom
experienced a relapse during a mean period of 22.3 ± 4.6 41.3 Transcutaneous PTNS
[SD] months. Six of these patients benefitted from further
“top-up” therapy. It is unclear whether randomisation or This is less commonly used. It requires an electrode pad to
matching of the two groups were attempted, or how the con- stimulate the posterior tibial nerve (Fig. 41.2). Like the per-
trol group was managed or how they compared with the cutaneous version, a ground pad is placed nearby. The treat-
treatment group. The follow-up period ranged from 16 to ment regimen is similar to that used for percutaneous
30 months. PTNS. It is also more amenable to use by the patient from
De la Portilla [6] described 16 subjects treated by PTNS home. Stimulation of both left and right sides simultaneously
for 30 min once a week for 3 months. All had failed conser- [9] and the use of bespoke devices [10] have been described.
vative therapy, and all had an intact sphincter. A statistically
significant reduction in the Cleveland Clinic FI score [5] was
seen immediately after treatment, which was maintained at a
3-month assessment. The reduction in the number of incon-
tinent episodes was not statistically significant.
In a prospective multicentre study by Govaert and col-
leagues, 22 patients received twice-weekly 30-min PTNS for
6 weeks [7]. All had failed conservative treatment, and none
had a significant sphincter defect. Treatment was continued
weekly, then biweekly and finally monthly. At 6 weeks 14
(63%) had a greater than 50% reduction in incontinent epi-
sodes, but this was not statistically significant. If symptoms
reappeared or worsened, then treatment reverted to the last
effective treatment schedule and was continued for 1 year. At
1-year assessment, there was a significant reduction in incon-
tinence episodes in the 14 patients, who remained in the
study. There was a statistically significant reduction in the
Cleveland Clinic FI score [5] at 6 weeks, 3 months and 1 year
after PTNS. A significant improvement in the SF-36 health-
related quality of life score at 1 year was also seen. Anorectal
physiological parameters were not assessed.
The largest series to date is from The Royal London
Hospital, UK. Hotouras and colleagues [8] reported the out-
come of 150 patients who had undergone percutaneous
PTNS. 115 were available for analysis. The patients under-
went a course of 12 sessions of PTNS followed by “top-up”
sessions when required. A median (range) total of 26 (12–42)
months of follow-up was recorded. The mean Cleveland
Clinic FI score [5] improved from 12 (3.9) to 9.4 (4.6) Fig. 41.2 Transcutaneous PTNS
41 Posterior Tibial Nerve Stimulation for Faecal Incontinence 513
A significant improvement in symptoms has been reported in median (range) FI episodes per week was seen in both
around 60% of patients. groups, 1 hour (2 (0–16) to 0.5 (0–12)) and 4 h (4 (0–16) to
In a prospective uncontrolled study by Queralto [4], ten 1 (0–8)). Improvement was seen in the ability to defer defe-
patients received daily treatment for 20 min for 4 weeks. All cation, 1 h (2 (0.5–5) to 2 (0.5–10) min), and more signifi-
had an intact sphincter and had failed biofeedback. A statisti- cantly in the 4-h group (0.5 (0.5–5) to 5 (0.5–15) min). No
cally significant improvement of more than 60% in the detailed statistical analysis of the data was performed.
Cleveland Clinic FI score was reported, which was main-
tained at a 12-week assessment. It is unclear whether this
was statistically significant. There was no statistically sig- 41.4 Mechanism of Action
nificant change in anal canal pressures.
Vitton reported the outcome of 24 patients [11] who It is uncertain how PTNS works. It is thought to neuromodu-
received 20-min daily sessions for 3 months. All had failed late the sacral nerve plexus remotely via the posterior tibial
conservative therapy, but no data on the integrity of the anal nerve through to the sciatic nerve. This implies a similar
sphincter were given. There was no statistically significant mechanism of action to sacral nerve stimulation (SNS). The
difference in the Cleveland Clinic FI score before and after exact mechanism of action of SNS is uncertain. It is likely to
treatment. Those with evidence of improvement were offered be the result of multiple different physiological effects [16,
further treatment. On assessment at a mean of 15 months, 17], leading to alteration of local somato-visceral reflexes
this improvement was maintained. Anorectal manometry with subsequent changes in colonic motility, rectal sensitiv-
was not performed. ity and modulation of higher perception of afferent informa-
Eleouet reported on 32 patients, who were treated twice tion [18, 19]. One study attempted to determine if there are
daily for 1 month [12]. The primary endpoint was a visual any changes in anal sphincter function with PTNS. Lopez-
analogue score simply to assess percieved overall benefit. Delgado and colleagues [20] assessed anal resting and maxi-
Secondary endpoints included the Cleveland Clinic FI score mum squeeze pressures in a group of patients who had
and a faecal incontinence quality of life score [13]. Twenty received PTNS. They reported statistically significant
(62.5%) recorded a greater than 10% improvement in the increases in these measures in 24 patients after a 3-month
visual analogue score. There was also a statistically signifi- follow-up. Marti and colleagues [21] assessed rectal capacity
cant improvement in the mean Cleveland Clinic FI score in 46 patients who underwent PTNS. At follow-up, no sig-
(14.5 to 11), which was maintained at 3 and 6 months, fol- nificant change in rectal capacity was seen. It should be
lowing further top-up treatment. noted that there are no consistent changes in anorectal func-
Thomas and colleagues [14] randomised 30 patients to tion seen from SNS [22].
receive either daily or twice-weekly transcutaneous PTNS The acupuncture point, “Sanyinjiao” or “spleen 6”, over-
for 6 weeks. Three of the daily group achieved complete con- lies the posterior tibial nerve near the ankle. Chang et al. [23]
tinence at 6 weeks. None of the twice-weekly group man- reported the effects of acupuncture stimulation of this point
aged this. Only the daily group showed a significant in patients with lower urinary tract dysfunction. An improve-
improvement in median (IQR) FI episodes per week (5 ment was seen in the majority of the patients. A small study
(11.1) to 3.5 (4.3) p = 0.025). Deferral and Vaizey FI scores by Scaglia et al. [24] reported improvement in faecal conti-
[15] were not affected significantly in either group. A further nence using acupuncture. One of the acupuncture points
study by the same authors [9] looked at bilateral stimulation, used here corresponded to the position of the posterior tibial
or stimulation to both left and right posterior tibial nerves nerve. No work published to date has directly compared acu-
simultaneously. Here, a total of 20 patients underwent puncture with PTNS for FI.
6 weeks of daily bilateral transcutaneous PTNS. Two PTNS is usually delivered unilaterally, at the nerve’s most
achieved complete continence. Ten (59%) achieved a greater superficial position above and behind the medial malleolus.
than 50% reduction in FI episodes per week. The median It does not matter which leg is used. There has been no sug-
(IQR) FI per week improved significantly from 6 (8.3) to 2 gestion of dominance of either the left or right tibial nerve,
(7.3) (p = 0.03). The ability to defer defecation improved although work has been done in relation to dominance of the
significantly too from 3 (4) to 5 (8) min (p = 0.03). pudendal nerve and its effect on anal sphincter activity [25].
Rimmer [10] reported the outcome of a bespoke device A frequency of 10–20 Hz and a pulse width of 200 μs are
called the Geko (Firstkind Ltd., UK). This was a wearable usually used for PTNS; these are similar to the settings used
device which provided electrical transcutaneous stimulation for SNS. It has been [26] suggested that a shorter pulse width
to the posterior tibial nerve. It allowed ambulatory treatment. and a higher frequency may improve faecal incontinence in
The authors compared 1 h with 4-h unilateral treatment twice patients receiving SNS. There is no published work investi-
weekly for a total of 6 weeks. Twenty-two were randomised gating the effect of altering these parameters in PTNS. The
to the 1-h group and 21 to the 4-h group. Improvement in the optimum duration and frequency of treatment have yet to be
514 G. P. Thomas et al.
determined. The published literature describes a diverse this, and only one of the sham group achieved this outcome.
range of treatment and “top-up” schedules. The therapeutic The percutaneous group achieved statistically significant
effects of SNS are short-lived once treatment has stopped. superiority when compared to the others (p = 0.035). The
Much of the literature suggests that there is a residual thera- percutaneous group also showed an improvement in mean
peutic effect after PTNS treatment finished. It is unclear how deferral time from 1.9 to 6.7 min. The authors concluded that
long this can last for and how this is related to the initial percutaneous PTNS was superior to transcutaneous PTNS.
treatment regimen or modality of PTNS used.
cutaneous tibial nerve stimulation in patients with faecal inconti- sus sham electrical stimulation for the treatment of faecal incon-
nence. Br J Surg. 2015;102(4):349–58. tinence in adults (CONFIDeNT): a double-blind, multicentre,
28. Hotouras A, Murphy J, Allison M, Curry A, Williams NS, Knowles pragmatic, parallel-group, randomised controlled trial. Lancet.
CH, et al. Prospective clinical audit of two neuromodulatory 2015;386(10004):1640–8.
treatments for fecal incontinence: sacral nerve stimulation (SNS) 32. van der Wilt AA, Giuliani G, Kubis C, van Wunnik BPW, Ferreira I,
and percutaneous tibial nerve stimulation (PTNS). Surg Today. Breukink SO, et al. Randomized clinical trial of percutaneous tibial
2014;44(11):2124–30. nerve stimulation versus sham electrical stimulation in patients
29. George AT, Kalmar K, Sala S, Kopanakis K, Panarese A, Dudding with faecal incontinence. Br J Surg. 2017;104(9):1167–76.
TC, et al. Randomized controlled trial of percutaneous versus trans- 33. Altomare DF, Picciariello A, Ferrara C, Digennaro R, Ribas Y, De
cutaneous posterior tibial nerve stimulation in faecal incontinence. Fazio M. Short-term outcome of percutaneous tibial nerve stimula-
Br J Surg. 2013;100(3):330–8. tion for low anterior resection syndrome: results of a pilot study.
30. Leroi AM, Siproudhis L, Etienney I, Damon H, Zerbib F, Amarenco Colorectal Dis. 2017;19(9):851–6.
G, et al. Transcutaneous electrical tibial nerve stimulation in the 34. Vigorita V, Rausei S, Troncoso Pereira P, Trostchansky I, Ruano
treatment of fecal incontinence: a randomized trial (CONSORT Poblador A, Moncada Iribarren E, et al. A pilot study assessing the
1a). Am J Gastroenterol. 2012;107(12):1888–96. efficacy of posterior tibial nerve stimulation in the treatment of low
31. Knowles CH, Horrocks EJ, Bremner SA, Stevens N, Norton C, anterior resection syndrome. Tech Coloproctol. 2017;21(4):287–93.
O'Connell PR, et al. Percutaneous tibial nerve stimulation ver-
Radiofrequency
42
Luanne Force, Mariana Berho, and Steven D. Wexner
a b
Fig. 42.1 The SECCA procedure. (a) Anoscope wires are deployed in four levels within anal canal, both above and below the dentate line. (c)
three to four quadrants circumferentially and are meant to enter the The procedure leads to internal anal sphincter thickening (With permis-
internal anal sphincter. (b) Radiofrequency treatment is performed at sion © Springer 2016 [2])
Complications are minor and infrequent, the most common The earliest studies on radiofrequency augmentation were
complication being mucosal bleeding, which is usually mini- done by Takahashi et al. The first study by this group dem-
mal and resolves with conservative treatment [1]. In rare onstrated an improvement in the Cleveland Clinic Florida-
cases, a suture ligature may be required [9]. Some patients Fecal Incontinence Score (CCF-FIS) from 13.5 to 5 [1].
may develop mucosal ulceration, which generally improves They also found a significant improvement in quality of
over several weeks [9]. Some patients have experienced tran- life scores over 6 months. Improvement in initial and max-
sient worsening of their incontinence [9]. imal rectal distention volumes was demonstrated by
42 Radiofrequency 519
11. Efron JE. The SECCA procedure: a new therapy for treatment of 15.
Visscher AP, Lam TJ, Meurs-Szojda MM, Felt-Bersma
fecal incontinence. Surg Technol Int. 2004;13:107–10. RJF. Temperature-controlled delivery of radiofrequency energy in
12. Kim DW, Yoon HM, Park JS, Kim YH, Kang SB. Radiofrequency fecal incontinence: a randomized sham-controlled clinical trial. Dis
energy delivery to the anal canal: is it a promising new approach to Colon Rectum. 2017;60(8):860–5.
the treatment of fecal incontinence? Am J Surg. 2009;197(1):14–8. 16. Felt-Bersma RJ. Temperature-controlled radiofrequency energy in
13. Lam TJ, Visscher AP, Meurs-Szojda MM, Felt-Bersma RJ. Clinical patients with anal incontinence: an interim analysis of worldwide
response and sustainability of treatment with temperature-controlled data. Gastroenterol Rep (Oxf). 2014;2(2):121–5.
radiofrequency energy (Secca) in patients with faecal incontinence: 17. Kaiser AM, Orangio GR, Zutshi M, Alva S, Hull TL, Marcello PW,
3 years follow-up. Int J Colorectal Dis. 2014;29(6):755–61. et al. Current status: new technologies for the treatment of patients
14. Abbas MA, Tam MS, Chun LJ. Radiofrequency treatment for
with fecal incontinence. Surg Endosc. 2014;28(8):2277–301.
fecal incontinence: is it effective long-term? Dis Colon Rectum.
2012;55(5):605–10.
Other Surgical Options for Anal
Incontinence: From End Stoma 43
to Stem Cell
Zoran Krivokapić and Barišić Goran
ing since the introduction of SNS. In modern surgery indica- World War II, this technique was almost abandoned until in
tions include end stage severe fecal incontinence associated 1981 Bruining [15] reported modified technique of gluteus
with extensive anal sphincter loss or congenital anorectal muscle transposition in a 17-year-old female injured in a
malformation, as imperforate anus or spina bifida, or peri- traffic accident. He detached gluteus muscles from the femur
anal colostomy after abdominoperineal resection where the and wrapped them around the anus to create a “scissorlike”
only other option is a stoma [4, 5]. mechanism. In 1982 Hentz [16] modified the technique by
detaching gluteus muscles from the sacral and coccygeal ori-
gin and wrapped them around the anus in order to stabilize
43.3 Muscle Transposition Techniques spitted muscle slings at a proper resting tension and fiber
length. In order to minimize donor site morbidity (hip desta-
Muscle transposition techniques are usually used in the man- bilization), Orgel [17] proposed the technique of a double-
agement of end-stage incontinence where previous, less split gluteus maximus muscle flap, where he mobilized only
aggressive treatments have failed. Various skeletal muscles the inferior part of one muscle (usually the right side) at its
were used in the past as neosphincters in order to maintain insertion at the iliotibial band and femur. A number of case
fecal continence [6]. These muscles were typically in close reports or small series were reported since 1980, using dif-
proximity to the anus and were harvested and encircled ferent techniques with a proximally or distally based muscle
around the anus in order to substitute anal sphincters [6]. The flaps [18–23]. In 1996, Guelinckx et al. [24], encouraged by
earliest successful report ensued when Chetwood [7] per- reported results of dynamic cardiomyoplasty and dynamic
formed transposition of the gluteus muscle to restore conti- graciloplasty, presented results in seven patients treated by
nence in a patient who developed fecal incontinence after conventional and four patients treated by dynamic
trauma. gluteoplasty.
Gracilis muscle transposition (without electrical stimula- Theoretically, the use of the gluteus maximus muscle as a
tion) was first described by Pickrell et al. in 1952 [8] in order substitute for anal sphincters has advantages because it is
to restore continence in four children. Fedorov et al. [9] used normally used as an auxiliary muscle to maintain fecal con-
adductor longus muscle, while Hakelius et al. [10] utilized tinence and patients can be easily trained to use it. At the
free autogenous muscle transplant for the treatment of anal same time, it is a well-vascularized, large, and powerful mus-
incontinence in children. Some advocated smooth muscle cle, supplied by the superior and inferior gluteal artery, capa-
transplants [11], while Hallan [12] used electrically stimu- ble for forceful contraction. It is innervated by the inferior
lated sartorius neosphincter in a canine model. Sartorius gluteal nerve originating from the L5 and S1 nerve roots
neosphincter showed excellent results in animal model but which makes it functional even in cases of fecal incontinence
was not successful in humans. The main downside of all pas- due to the pudendal neuropathy. Active contraction and high
sive muscle transposition techniques was the inability of tonus of the muscle can be maintained for longer periods
patients to voluntarily contract the transposed muscle in an compared to the gracilis muscle which is of paramount
effective manner to maintain continence. Another problem importance for maintaining continence. Furthermore, its
was the inability of the transposed muscle to maintain tonic neurovascular structures can easily be preserved during dis-
contraction over prolonged periods of time. In practice, only section and detachment from the sacrum, and neurovascular
two muscles were used for this purpose: the gluteus and the pedicle has less traction compared to graciloplasty. In most
gracilis muscle. cases muscle wraps have sufficient length to reach the anal
canal without excessive tension. Several wrap configurations
are possible because the amount of the transferred muscle far
43.4 G
luteoplasty (Gluteus Maximus exceeds the amount of muscle tissue of a normal anal sphinc-
Plasty) ter. It enables enough of healthy and contractile muscle to
completely encircle the anus and form a muscle cuff even in
Since Chetwood reported the first transposition of the glu- cases when muscle atrophy occur, which is not uncommon
teus maximus muscle in order to treat fecal incontinence, after transposition. The best functional results were obtained
various modifications of the original technique were with a technique that uses caudal parts of both gluteus mus-
described. In 1930, Chittenden [13] used gluteal muscle cles to encircle the anus [25]. Unfortunately, there are impor-
flaps for anal reconstruction after abdominoperineal resec- tant drawbacks regarding to this technique. Gluteus maximus
tion, while Bistrom [14] transposed gluteus muscle and contains predominantly type II striated muscle fibers which
pulled the rectal stump through a previously created hole in make it prone to fatigue. It is not capable to sustain continu-
the muscle for treatment of fecal incontinence. After the ous contraction for a longer period of time. Furthermore, the
43 Other Surgical Options for Anal Incontinence: From End Stoma to Stem Cell 523
muscle after dissection is bulky, making it technically gluteoplasty. In most reports, continence improved after glu-
demanding to tunnel and wrap around the anus especially in teoplasty. There are a limited number of studies with objec-
patients with deficient perineal body or excessive scarring of tive assessment of long-term results. Guelinckx reported
the rectovaginal septum. There is also a problem with a continence for stool in 9 out of the 11 patients, while seven
higher donor site morbidity compared to gracilis muscle patients were also continent for liquids [24]. Christiansen
transposition. In gluteoplasty, in most cases, muscles from found improvement in continence in three out of seven
both sides should be harvested, while in graciloplasty only patients, while in four it remained unchanged [21]. Hultman
one muscle is taken. Gluteus maximus is a hip extensor, found that gluteoplasty was successful in restoring fecal con-
important for walking, running, standing up from sitting tinence in 72% and partially successful in 16% of patients
position, and walking upstairs, so patient may experience [23]. According to a review of the literature by Fleshner,
some difficulties in everyday life. In most cases, sport complete continence was achieved in 60% and partial conti-
activities are dramatically reduced after muscle transposi- nence in 36%, while total failure was observed in 4% of
tion. At the same time, this natural function of the muscle patients [28]. Combined data from 17 studies including 149
can make continence difficult to maintain when patient is patients with gluteoplasty showed successful or partially
running or climbing stairs [26]. Finally, surgical technique successful outcome in 73% of patients with an overall com-
for gluteoplasty is more complex and challenging because plication rate of 38%. Since the first report by Chittenden,
the access to its neurovascular bundle is less familiar com- anorectal reconstruction after abdominoperineal resection
pared to graciloplasty. Those may be the reasons why it never (APR) by gluteoplasty has received little attention, so only
gained the same popularity as the graciloplasty, even though few reports were published [20, 29, 31] (Fig. 43.1).
results of non-stimulated gluteoplasty were shown to be
superior [27] or at least equal [21] to the results of non-stim-
ulated graciloplasty. The best candidate for this procedure is 43.5 Dynamic Gluteoplasty
a young patient with severe sphincter defects or destroyed
sphincters not amenable to sphincteroplasty. It may be a Madoff [30] reported results of the prospective multicenter
good option for patients who may benefit from transposition study where electrostimulation of the transposed gluteus
of substantial muscle bulk but without excessive rectovagi- muscle was performed in order to improve results. He
nal scarring. The primary contraindication for this procedure achieved good results in all patients initially but maintained
is the presence of injured or nonfunctioning gluteus maxi- successful outcome in only 5 (45%) out of the 11 patients
mus muscles. Patients with fecal incontinence secondary to a and concluded that this procedure should be limited to inves-
spina bifida or myelomeningocele should not be treated with tigational purposes. Guelinckx [24] treated 11 patients, 7
gluteoplasty because the nerve supply of the muscle is with conventional and 4 patients with dynamic gluteoplasty.
derived from the inferior gluteal nerve, originating from L5 All patients who had satisfactory results and were continent
to S1. Conversely, patients with Leriche syndrome are not for both solid and liquid stool were in dynamic gluteoplasty
candidates for this procedure, since vascular supply for the group. However, dynamic gluteoplasty newer gained such a
muscle originates from the superior and inferior gluteal popularity as dynamic graciloplasty. It was probably because
artery. Complications after gluteoplasty are not uncommon. the gracilis was technically easier to use, had less variations
The most frequent complication is wound infection occur- in the nerve and blood supply, and had less donor site mor-
ring in almost one quarter of patients [28]. Other, less fre- bidity. Finally, electrostimulation threshold is much higher
quent complications include skin necrosis, anal canal in gluteoplasty resulting in shorter device battery life.
necrosis, anal canal stricture, fecal impaction, obstructive
defecation, chronic pain, and donor site morbidity such as
posterior thigh numbness, dysesthesia, and severe chronic 43.6 Graciloplasty
pain. Christiansen [21] reported wound infection in three out
of seven patients after bilateral gluteoplasty. Hultman [23] Passive gracilis muscle transposition (without electrical
reported donor site morbidity and perirectal complications in stimulation) was first described by Pickrell et al. in 1952
64% of patients in a retrospective analysis of 25 consecutive [8] after an attempt to restore continence function in four
patients undergoing gluteoplasty for fecal incontinence. children. More than 30 years after, Corman [32] reported
Puerta [29] reported a success rate of 70% using the gluteus good results with this technique, while Faucheron et al.
transposition technique in 22 patients with fecal inconti- [33] confirmed that significant proportion of patients
nence. Madoff [30] reported wound infection in 27% and may have satisfactory continence after passive gracilis
anal stricture in 9% out of 11 patients treated with dynamic transposition.
524 Z. Krivokapić and B. Goran
a b
Fig. 43.1 (a–c) Gluteoplasty. (a) Marks in the operative field. (b) L.E., Hultman C.S. Gluteoplasty for the Treatment of Fecal
Identifying the inferior gluteal nerve and vascular pedicle. (c) Incontinence. In: Ratto C., Doglietto G.B., Lowry A.C., Påhlman L.,
Transposition of the muscle. (Reprinted with permission from McPhail Romano G. (eds) Fecal Incontinence. Springer, Milano 2007)
The gracilis muscle is the most superficial adductor of continence making it very difficult for a patient to learn how
the thigh and has little impact on motion of the lower to contract and use the gracilis muscle as a neosphincter.
extremity. Its natural function is to assist the legs in adduc- Muscle fatigue and the inability of patients to voluntarily
tion and internal rotation, so when this muscle is used for a contract the transposed muscle were the main reasons why
neosphincter procedure, adjacent muscles take over its func- successful results of non- stimulated graciloplasty were
tion. As a result, there is minimal donor site morbidity, and achieved in less than 50% of patients. Moreover, most of the
patients can perform most of everyday activities including patients had severe constipation due to outlet obstruction
sports [34]. This superficial muscle has constant and proxi- produced by overtightening of the anus with the transposed
mal neurovascular supply, which enables effortless dissec- muscle [35].
tion and in most cases sufficient muscle length to overlap Finally, in many cases of fecal incontinence, there is an
around the anus. Unfortunately, like all skeletal muscles, adjacent pudendal nerve damage, which precludes this tech-
gracilis has a majority of type II, fatigue prone, fast-twitch nique. Results of non-stimulated graciloplasty were success-
muscle fibers and is incapable to sustain prolonged, forceful ful in less than 50% of cases, although some claimed that
contraction. At the same time, natural function of this mus- continence rate was improved in more than 80% [32, 35–37]
cle has nothing in common with muscles responsible for (Fig. 43.2).
43 Other Surgical Options for Anal Incontinence: From End Stoma to Stem Cell 525
a b
c
d
Fig. 43.2 (a) Dissection of the gracilis muscle. (b) Preserving of the neurovascular bundle. (c) Muscle transposition. (d) Muscle wrapped around
the anal canal
43.7 Dynamic Graciloplasty prone muscle fibers to a slow, fatigue-resistant fibers by con-
tinuous electrical stimulation. In Italy, Cavina [43] et al. used
A physiologic base for dynamic graciloplasty was the results graciloplasty for anal sphincter reconstruction after abdomi-
from experimental studies in muscle physiology in animals. noperineal resection. In England, group around N. Williams
They found that low-frequency electrical stimulation of the stimulated directly the nerve trunk using external device
muscle can change normal muscle fiber pattern and trans- periodically. In Maastricht, Beaten et al. used permanent
form fiber type II, fatigue prone muscles into fiber I, fatigue- implantable stimulator for electrostimulation of the muscle.
resistant muscles [12, 38]. This process can change skeletal Direct nerve stimulation is more physiological and requires
muscle-like gracilis into a muscle with properties of a lower stimulation level thus maximizing battery life, while
sphincter muscle. muscle electrodes are more secure, and there is less chance
Introduction of muscle electrostimulation techniques, of lead displacement. This procedure became the most popu-
based on research in using the latissimus dorsi muscle to lar form of a muscle neosphincter because of its simplicity,
assist a failing heart in dynamic cardiomyoplasty [39], the nature of neurovascular supply of the gracilis muscle,
renewed the interest in the gracilis muscle transposition. and minor donor site morbidity.
Although the first electrical stimulation for treatment of fecal Dynamic graciloplasty is a major procedure, and many
incontinence after operation for anorectal agenesis was complications have been reported. The most frequent were
reported by Dickson in 1968 [40], it was C. Beaten from wound complications. In a prospective multicenter study
Maastricht who in 1986 implanted the first neurostimulator including 139 patients from 12 centers, Madoff [30] reported
in a patient who already had conventional graciloplasty major wound complications in 32% of patients and minor
10 years earlier for anal atresia. wound complications in 29%. Tendon detachment was
The new technique, named dynamic graciloplasty, was recorded in 3%, pain in 22%, and device/stimulation prob-
attributed to Beaten [41] and Williams [42] who indepen- lems in 11% of patients. Necrosis of the neoanus as well as
dently developed the concept of transforming fast, fatigue the gracilis muscle was also reported. Moreover, 48% of the
526 Z. Krivokapić and B. Goran
138 reported complications in this study required one or more inflatable cuff that occludes the anal canal, a pressure-
reoperations [30]. Functional failure, which was not related to regulating balloon located in the retroperitoneal space, and
some specific complication, was recorded in 40% of all fail- a control pump placed in the scrotum or labia. It was
ures [30]. Constipation was reported after graciloplasty in designed as a sphincter replacement procedure for treat-
approximately 16% of patients, and in some cases it was due ment of an end-stage fecal incontinence in cases when all
to overtightening of the anus with the gracilis. Insufficient previous treatments failed in patients who wanted to avoid
contraction of the gracilis muscle is complication caused by colostomy. The first artificial bowel sphincter for fecal
muscular or stimulation problems. Dynamic graciloplasty is a incontinence was implanted by Christiansen in 1987 [53].
very complex procedure, and experience is very important in He used urinary sphincter (AMS 800), while Lehur [54]
order to reduce complication rate and improve results. It designed it specifically for fecal incontinence treatment in
should be performed only in high-volume centers. Madoff 1996. Since that time, the artificial bowel sphincter has
[30] reported significant differences in complication rate and been used mostly in specialized centers. However, most
outcome comparing high- and low-volume centers. The over- studies had a small number of patients, and it was difficult
all major wound complication rate was 17.4% in high-volume to assess the effectiveness of this device. One meta-analy-
centers compared to 33.1% in low-volume centers. sis included 21 studies with 541 patients and revealed that
In the literature, the success rates of dynamic graciloplasty ABS was implanted only in patients with severe end-stage
in treatment of fecal incontinence vary from 45% to 80% fecal incontinence [55]. The most common indication was
[44–49]. Most studies reported a small number of patients sphincter destruction followed by congenital malforma-
with an overall improvement of continence in about 50% of tions, while one study included perineal colostomy after
cases with follow-up ranging from 7 months to 4 years. abdominoperineal resection. There was no mortality, but
Again, high-volume centers did better than inexperienced complication rate was high. The pooled rate of surgical
ones. The reported overall success rate was 80% in experi- revision was 49%, and the most common reason was
enced centers compared to only 47% in inexperienced centers device malfunction, such as cuff rupture or balloon and
[30]. Large differences in success rates may be related to the pump leak and cuff unbuttoning. However, device mal-
learning curve associated with this complex procedure. It function did not appear to be a major cause of definite fail-
may also be related to the length of the follow-up and differ- ure. The pooled rate of permanent device removal was
ent tools and definitions used to measure outcomes. 24%. The most common reasons were device infection and
Although the results of dynamic graciloplasty are satis- erosion (pooled rates 56%). The pooled rate of retaining a
factory in general, the problem is very high complication functional device was 69%. Evacuatory difficulty was
rate, mostly wound infections, high rates of reoperation, and common, but it was severe in only 8% of patients. In cases
complications related to the implanted devices. There are when the artificial bowel sphincter is operational, without
also issues with obstructive defecation. In addition, the long- serious complications, patients might experience a signifi-
term consequences of chronic electrostimulation may cause cant improvement in continence and even in quality of life.
the problem because there are concerns that chronic electro- The pooled improvement rate of continence was between
stimulation may decrease muscle fiber diameter and lead to 55% and 75% depending on the method/scale used for
muscle degeneration and atrophy by affecting the collateral evaluating continence function. All studies revealed sig-
blood supply [50, 51]. Another important disadvantage is the nificant improvements in QOL after implantation, includ-
high cost of the procedure. However, studies showed that ing at long-term follow-up.
there is a considerable cost benefit of graciloplasty compared ABS is successful method for treating severe fecal incon-
to the costs of the colostomy in the long term [52]. tinence, but at the price of a very high complication rate,
Muscle transposition techniques continue to have its role frequently leading to subsequent explantation of the device.
in treatment of fecal incontinence although results are not The most frequent complication is infection which was
always predictable. Since they are major surgical procedures reported to be around 26% (in some series up to 76%) [56],
with lots of complications, they should be reserved only for followed by constipation that occurs in approximately 29%
selected cases, when all other options are not possible and of patients. Pain and technical failure are also common com-
when permanent colostomy is the only alternative. plications, in some cases necessitating device removal.
Patients should be well informed about the high rate of com-
plications before accepting this procedure.
43.8 Artificial Bowel Sphincter (ABS) As a result of technical challenges, device malfunctions
and high infection rates, followed by high rates of further
The ABS manages incontinence by imitating the natural surgery for complications, this device never became widely
action of the sphincter muscle. The device consists of an accepted (Fig. 43.3).
43 Other Surgical Options for Anal Incontinence: From End Stoma to Stem Cell 527
43.9 Magnetic Anal Ring Medical). This device was considered to add support of a
weakened anal sphincter through the magnetism of beads
Magnetic anal ring was first used for anal incontinence treat- placed around the anal canal (FENIX® Continence
ment by Lehur and colleagues in 2010 [57] although it was Restoration System, Torax Medical). Several small studies
originally developed for the treatment of gastroesophageal revealed that surgical procedure is straightforward, and the
reflux disease (LINX® Reflux Management System, Torax safety profile is acceptable. They reported promising short-
term outcomes with this technique, but long-term outcomes
still remain unknown. In general, therapeutic success rates
ranged between 53% and 66% at short-term follow-up. In
one study, long-term results with the median follow-up of
5 years were published [58]. This study included 35 patients
with severe fecal incontinence for ≥6 months, who had pre-
viously failed conservative therapy. During follow-up, device
had to be removed in seven patients due to complications.
Therapeutic success rates, including treatment failures
(device explantation or stoma creation), were 63% at year 1,
66% at year 3, and 53% at year 5 [58]. The most frequent
adverse events included defecatory dysfunction (20%),
“Sphincter” implant site pain (14%), device erosion (11%), implant site
infection (11%), and bleeding (9%) [58]. Authors concluded
Balloon
that magnetic anal sphincter augmentation may provide
excellent outcomes in patients with functioning device. This
technique may develop into a promising new treatment
Pump
option for fecal incontinence. The perfect indication has yet
to be determined, and more studies with larger numbers of
patients with a longer follow-up are necessary to determine
the role of magnetic anal ring in surgical treatment of fecal
Fig. 43.3 Artificial bowel sphincter (Reprinted with permission from
Herold A. Incontinence. In: Herold A, Lehur PA, Matzel KE, O Connell
incontinence. However, in 2017, Torax Medical announced
PR. European manual of medicine, Coloproctology. Springer-Verlag the discontinuation of sales and clinical studies of the
Berlin Heidelberg 2008) FENIX® Continence Restoration System (Fig. 43.4).
a b
Fig. 43.4 (a, b) FENIX® Continence Restoration System. (a) Fenix glamor closed. (b) Fenix glamor opened (Reprinted with permission from
Torax Medical)
528 Z. Krivokapić and B. Goran
ongoing in order to assess the safety of adipose-derived ble of reducing fecal incontinence-related problems.
mesenchymal stem cells after the injection into the anal Different types of anal plugs are commercially available.
sphincter. The secondary end point is to compare the efficacy Plugs are made of different materials (polyurethane, poly-
of ADRCs in patients with fecal incontinence [77]. vinyl alcohol) and come in different designs, shapes, and
Another strategy is to harvest stem cells directly from the sizes. First they were used in patients with fecal inconti-
striated skeletal muscle and culture them in vitro into the nence due to major neurological problems, such as spina
myoblasts. The advantage of this procedure is that after bifida. A limited data regarding this procedure exist in the
implantation these cells only differentiate into muscle cell literature. One prospective, randomized, controlled study
lines, regardless of the type of tissues in the vicinity. Skeletal evaluated the use of the anal plugs in children and adults
muscles have the capability to regenerate (at least partially) with fecal incontinence [81]. This study showed that the
and to repair damage. Special stem cells, called satellite cells, majority of patients gained some benefits, reflected in
located among the muscle fibers, became activated in response reduced soiling, and the small but quantifiable improve-
to muscle damage and transform into myoblasts, which are ments in the quality of life. The conclusion of this study
then capable of intense proliferation in order to repair dam- was that anal plug may be a good solution for selected
age. The technology of in vitro myoblast culturing is already patients. In a Cochrane review that included four studies
available and is continuously improving. The first study, with a total of 136 patients, they found that plugs may be
involving ten women with obstetric external anal sphincter helpful in alleviating problems caused by incontinence
disruption treated by injection of adult stem cells, autologous [82]. However, the available data suggest that anal plugs
myoblasts (AM), was published by Frudinger [78]. No can be difficult to tolerate because 48 participants (35%)
adverse events were observed. At 12 months the Wexner were excluded before the end of the study, suggesting poor
incontinence score had decreased by a mean of 13.7 units, compliance. Satisfying results were obtained in 77% of
anal squeeze pressures were unchanged, and overall quality users that achieved a ≥50% reduction in incontinence fre-
of life scores improved by a median of 30 points. Authors quency [82]. Selection of the type of plug can be very
concluded that treatment with autologous myoblasts was safe important for its performance. Intolerance of the device
and well tolerated and significantly improved symptoms of and failure of retention are the most frequently reported
anal incontinence due to obstetric anal sphincter trauma. adverse events. So far, anal plugs can be considered as
Recently, first randomized, placebo-controlled study of intra- relatively efficient, cheap, and acceptable symptomatic
sphincteric injections of autologous myoblasts in 24 patients fecal incontinence treatment option in a selected group of
with fecal incontinence was published [79]. This was a phase people, either as a substitute for other forms of manage-
2, double-blind, placebo-controlled study where administra- ment or as an adjuvant treatment option (Fig. 43.7).
tion of AM or placebo was performed with eight injections in
the existing residual external anal sphincter under endoanal
ultrasound guidance. At follow-up visits (6 and 12 months),
CCI and FIQL scores, anorectal manometry, perineal electro-
physiological tests, anal ultrasound, and MRI were per-
formed. Myoblast injection resulted in a significant reduction
in CCI scores and improvement in quality of life. The CCI
score at 6 and 12 months decreased from a median of 15 at
baseline to 9 and 6.5, respectively. After 12 months there was
a >30% reduction in the CCI score in 58% of patients in the
AM arm compared with 8% in the placebo arm. Excellent
results obtained in this and two other studies [78, 80] revealed
that the injection of AM in the anal sphincter may become a
standard treatment for FI and may change the treatment para-
digm of fecal incontinence in the near future.
43.12 Colostomy ter, when a permanent colostomy is the only other viable
alternative. ABS is successful method for treating severe
Although fecal diversion is usually the last choice in treat- fecal incontinence, but at the price of a very high complica-
ment of severe fecal incontinence, it has a 100% cure rate, tion rate, frequently leading to subsequent explantation of
but it is still unknown whether it truly improves QOL in the device. Magnetic anal sphincter augmentation may pro-
these patients in whom all previous treatments have failed. vide satisfactory outcomes in patients with functioning
The first study that addressed this issue was published by device, but Torax Medical announced the discontinuation of
Colquhoun [83]. It was a cross-sectional postal survey of sales of the FENIX® Continence Restoration System.
110 patients with fecal incontinence or an end colostomy. Promising initial results with different cell therapy options
QOL measures used in this study included the Short Form may change the treatment paradigm of fecal incontinence in
36 General Quality of Life Assessment (SF-36) and the the near future, but further research is needed in this area.
Fecal Incontinence Quality of Life (FIQOL) score. Analysis Anal plugs can be considered as a relatively efficient, cheap,
of the SF-36 revealed higher social function score in the and acceptable symptomatic fecal incontinence treatment
colostomy group, and analysis of the FIQOL revealed higher option in a selected group of patients, either as a substitute
scores in the coping, embarrassment, lifestyle, and depres- for other forms of management or as an adjuvant treatment
sion scales in the colostomy group compared to the FI option. At the end, colostomy may be a decent option in
group. The conclusion of this study was that colostomy patients with an end-stage, severe fecal incontinence, where
improves QOL in patients who suffer moderate-to-severe all previous treatment attempts have failed.
fecal incontinence. Finally, colostomy formation has accept-
able complication rate, offers 100% cure with no relapse,
results in better QOL, and may be a good option when all Take-Home Messages
previous treatments fail. However, creation of a permanent • Surgical treatment of fecal incontinence is often
stoma is a radical option and has a distinctive form of physi- complex and should be performed only in special-
cal impairment and QOL adjustment. One retrospective ized centers.
study [84] has examined patients’ views of a colostomy in • Patients with limited sphincter defects (less than
fecal incontinence and included 11 males and 58 females 50% of the circumference) may be offered sphinc-
with a median age of 64 years. The majority of patients had teroplasty as a first choice.
experienced a variety of problems with the stoma, while • Sphincter replacing therapy is indicated in patients
only ten patients reported no problems with their stoma. On with large sphincter defects or completely destroyed
the other hand, the majority (83%) felt that the stoma did not sphincters but with a price of high morbidity, com-
restrict their life, and nearly all felt that the stoma had plications, high rates of reoperation, and frequently
improved their quality of life. The overwhelming majority unpredictable results.
of patients in this study were positive about the stoma and • New and under investigation techniques such as
the difference it had made to their life. Although the litera- stem cell therapy may change the treatment para-
ture is sparse regarding colostomy in fecal incontinence digm of fecal incontinence in the near future, but
treatment, based on available studies, we can conclude that further research is needed.
colostomy may be a viable option in patients with an end-
stage, severe fecal incontinence, where all previous treat-
ment attempts have failed.
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E, Secco M, Suzuki MF, Camargo MM, Bartolini P, Brum PC, 82. Deutekom M, Dobben AC. Plugs for containing faecal inconti-
et al. SJL dystrophic mice express a significant amount of human nence. Cochrane Database Syst Rev. 2015;7:CD005086.
muscle proteins following systemic delivery of human adipose- 83. Colquhoun P, Kaiser R Jr, Efron J, Weiss EG, Nogueras JJ,
derived stromal cells without immunosuppression. Stem Cells. Vernava AM, Wexner SD. Is the quality of life better in patients
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Treatment of Anal Incontinence: Which
Outcome Should We Measure? 44
Alison J. Hainsworth, Alexis M. P. Schizas,
and Andrew B. Williams
Table 44.1 The questionnaires which can be used to assess faecal incontinence
Questionnaire Quality of Life
(authors) Type Purpose (QoL) Validation Pros Cons
Symptom severity scores
Pescatori score Self-assessment Diagnostic tool No Simple to use. Limited to a score
(Pescatori et al.) (frequency to for frequency and Sensitive to of only 6 points.
[57] flatus/mucous, type of anal frequency Does not take
liquid or solid incontinence amount in account
stool)
American Medical Self-assessment Designed to assess No Includes stool lost, Complex
Systems score [58] (retrospective outcomes after frequency and
review of artificial bowel effect on lifestyle
symptoms over sphincter
past 4 weeks)
Jorge and Wexner Designed to be Diagnostic tool, Yes Valid, responsive, Simple to use, Subtle assessment
Faecal Incontinence filled in by grade severity reproducible [26] easily understood of QoL. Does not
score/Cleveland physicians but by patients [6] include urgency,
Clinic Score (Jorge also used as leakage amount or
and Wexner) [5] self-assessment volume
(type and
frequency, pad
usage, lifestyle
alteration)
St Mark’s faecal Interview-based or Diagnostic tool, Yes Responsive [26], Includes urgency, Subtle assessment
incontinence score/ self-administered grade severity reproducible, high antidiarrhoeal of QoL
Vaizey score questionnaire clinical validity medication
(Vaizey et al.) [6] (about past and utility [6]
4 weeks)
The Revised Faecal Short 5-item For use in No Responsive, Short, reliable
Incontinence Scale assessment tool outcome and reliable
(Sansoni et al.) [9] epidemiological
research and
clinical practice
Faecal Incontinence Self-assessment Diagnostic tool No Criterion validity, Simple tool to Does not include
Severity Index (weighted scores test-retest assess severity urgency, leakage
(FISI) (Rockwood for four types of reliability and amount or volume
et al.) [10] leakage and five responsiveness to
frequencies) change have been
partly or
adequately
validated [7]
Cancer specific
LARS score Self-assessment Diagnostic tool No Valid, reliable Simple, quick Correlates to QoL
(Emmersten et al). evaluation
[15]
MSKCC bowel Self-assessment Diagnostic tool to No Reliable, valid Not routinely used Broad scope
function instrument survey (41 points) prospectively (length and
(Temple et al.) [12] which can be used evaluate scoring influence
via email/paper/by symptoms after its practicality)
interview in the sphincter
phone [16] preserving cancer
surgery
Quality of life scores
The Rockwood Self-assessment Assessment of Yes Reliable, valid, Does not measure
scale (FIQL) (29 items in 4 QoL specific to responsive [25, leakage. No single
(Rockwood et al.) domains: lifestyle anal incontinence 26] summary measure
[24] behaviour,
depression,
embarrassment)
44 Treatment of Anal Incontinence: Which Outcome Should We Measure? 535
Table 44.1 (continued)
Questionnaire Quality of Life
(authors) Type Purpose (QoL) Validation Pros Cons
Combined severity and quality of life
ICIQ-BS [29, 31] Self-assessment Assessment of Yes Robust, valid, Assessment of the Does not report on
(17 questions in 3 symptom severity, reliable, severity, the leakage amount or
scored domains: the bother of reasonable bother and volume. More
bowel pattern, symptoms and response to QoL. Can be work needed to
bowel control and QoL changes in applied across assess
quality of life) symptoms and international responsiveness to
QoL following populations change [7]
intervention
Rapid assessment Self-assessment Rapid assessment Yes Significant Fast assessment of Superficial
faecal incontinence (includes visual of both severity correlation both severity and assessment of
score (RAFIS) (De analogue scale) and QoL between RAFIS QoL both aspects.
La Portilla et al.) and Jorge-Wexner Sensitivity to
[27] score and change in
Rockwood scale. symptoms/QoL
Reliable after treatment
and test-retest has
not been assessed
Visual analogue scores
Visual analogue Self-assessment Rapid assessment No Not concordant Fast assessment Cannot replace
score severity of severity with other
(Devesa et al.) [33] Jorge-Wexner questionnaires
Visual analogue Self-assessment Rapid assessment Yes Only correlation Fast assessment Cannot replace
score QoL (Devesa of QoL with Rockwood other
et al.) [33] scale was for questionnaires
embarrassment
subscale
Table 44.2 Possible outcome measures for the treatment of anal incontinence
Outcome measure Assessment tools Importance Limitations
Symptom severity Questionnaires The aim of treatment is to improve – There may be poor correlation between
Bowel diaries symptoms and so these should be symptom severity and quality of life
Patient interviews assessed – As anal incontinence is multifactorial
symptoms may persist despite an
intervention which has solved one
aspect; this will not be apparent on
assessment of symptoms only
Bother Questionnaires The aim of treatment is to improve the – As above
Patient interviews bother of anal incontinence and so this
should be assessed
Quality of life Questionnaires The aim of treatment is to improve – Multiple contributing factors which are
Patient interviews quality of life and so this should be complex to assess
assessed
Patients’ perception Patient interviews Treatments must be acceptable to
and acceptability of patients
treatment
Anal sphincter Anorectal physiology Objective parameters useful to assess – Changes in function may not be
function change for research reflected in patient symptoms
Anal sphincter Endoanal ultrasound Useful in research – Changes in structure may not be
structure MRI Useful in clinical practice if symptoms reflected in patient symptoms
Volume vector manometry have failed to improve despite
treatment or if symptoms deteriorate
despite an initial improvement
536 A. J. Hainsworth et al.
Table 44.3 A summary of the tools which can be used to measure outcomes after treatment of anal incontinence
Tool Advantages Disadvantages
Questionnaires – Assess the patients’ symptoms, amount of bother – Not all are responsive to change after intervention
inflicted and quality of life which are the main outcome – Severity may be underestimated by patients due to
measures for any intervention avoidance behaviour or recall bias
– Few questionnaires assess all aspects of severity and
quality of life; multiple questionnaires may be required
Bowel diaries – Avoid recall bias for symptom severity – Although recommended by some societies, there are few
published examples of those which can be used in clinical
practice
Patient interviews – Allow qualitative assessment (e.g. patient perception – Time consuming
and the acceptability of treatments)
Anorectal physiology – Objective measure of change in anorectal function after – May not correlate with change in symptoms
treatment
Imaging (endoanal – Objective measure of change in anorectal structure after – May not correlate with change in symptoms
ultrasound/MRI) treatment
psychosocial factors [4]. There are also few questionnaires 44.2.1.2 The St Mark’s Incontinence Score
which are used to evaluate severity and treatment outcomes The St Mark’s incontinence score (also known as the Vaizey
that address all four aspects of severity simultaneously. score) is widely used to assess severity of anal incontinence
Moreover, some assess severity of symptoms of anal inconti- [6]. It combines elements of the Pescatori score, the Wexner
nence and others assess quality of life in relation to anal score and the American Medical Systems score with the
incontinence, but few assess both. There have also been addition of questions about urgency and the use of antidiar-
questionnaires designed to assess cancer-specific outcomes rhoeal medications. (The Pescatori score was one of the first
following the surgical treatment of rectal cancer. scores designed to assess anal incontinence and simply diag-
noses the frequency and type of anal incontinence. The
American Medical Systems score was designed to assess
44.2.1 Symptom Severity Questionnaires outcomes after an artificial bowel sphincter.)
The St Mark’s incontinence score was developed after cli-
Table 44.1 summarises the symptom questionnaires which nicians noticed that patients used avoidance behaviour
assess faecal incontinence. The International Consultation (remaining close to the toilet) to control their symptoms such
on Incontinence (ICI) has recommended the Jorge-Wexner, that severity may be underestimated if urgency is not
St Mark’s incontinence score and Revised Faecal accounted for. It also reduces the emphasis placed on pad
Incontinence Scale for use in both research and clinical prac- usage (compared to the Jorge-Wexner score) as pad usage
tice and the Faecal Incontinence Severity Index (FISI) for may simply reflect the fastidiousness of the patient or co-
use in research (optional in clinical practice). existing urinary incontinence rather than anal incontinence
severity. The St Mark’s incontinence score has shown the
44.2.1.1 The Jorge-Wexner Score greatest change after treatment compared to the Pescatori
The Jorge-Wexner score (also known as the Wexner score or the score, the Jorge-Wexner and the American Medical Systems
Cleveland Clinic Score) may be filled in by physicians or patients score and is a useful score for comparison of patients and
as a self-assessment tool [5]. It is simple to use and easily under- treatments.
stood by patients [6]. It is used to grade severity of faecal incon- A recent study of 390 patients by the team at St Mark’s hos-
tinence and to assess its impact upon lifestyle; it was the first pital compared patients’ subjective perception of bowel control
score to include usage of pads and lifestyle alteration as well as (scale 0–10) with the St Mark’s incontinence score (a change in
frequency and severity of episodes. However, it only allows a the score was documented in 131 patients who underwent bio-
subtle assessment of quality of life and does not include urgency, feedback). The St Mark’s incontinence score correlated moder-
leakage or volume. The International Consultation on Continence ately well with patients’ subjective perception of their symptoms
(ICI) has examined the score and found that construct and crite- and was reliable regardless of type of incontinence, age and
rion validity, internal consistency, test-retest reliability and gender. The authors reaffirmed that the St Mark’s score is suit-
responsiveness are partly or adequately validated [7]. able for the evaluation of treatment outcomes [8].
44 Treatment of Anal Incontinence: Which Outcome Should We Measure? 537
44.2.1.3 The Revised Faecal Incontinence Scale 44.2.2.1 T he Low Anterior Resection Syndrome
The Revised Faecal Incontinence Scale was developed to Score (LARS Score)
provide a short, psychometrically sound tool to assess sever- The low anterior resection syndrome (LARS) score has been
ity of faecal incontinence before and after treatment [9]. The specifically developed to assess bowel dysfunction after low
authors examined 61 people with faecal incontinence at anterior resection and is the most useful tool for rapid assess-
baseline and 38 at follow-up and found the score was able to ment. It is a simple tool for quick evaluation, and the results
discriminate between different levels of incontinence can be categorised as no LARS (score 0–20), minor LARS
severity, had superior internal consistency and test-retest
(score 21–29) and major LARS (score 30–42). It is highly
reliability to the Wexner and St Mark’s scores and was at sensitive and specific to ‘major’ LARS [15]. The authors
least as responsive to detecting a change in incontinence who developed this questionnaire invited all 1143 low ante-
after treatment as the Wexner and St Mark’s scores. rior resection patients identified in a national Colorectal
Cancer Database to complete the questionnaire, 961 partici-
44.2.1.4 T he Faecal Incontinence Severity pated. There were significant differences in groups with and
Index (FISI) without radiotherapy, tumour height above or below 5 cm
The Faecal Incontinence Severity Index is a diagnostic tool and total mesorectal excision/partial mesorectal excision.
based on a type x frequency matrix which includes four types The LARS score correlates with quality of life though qual-
of leakage (gas, mucus, liquid and solid) and five frequencies ity of life is not assessed by the questionnaire.
(1–3 times per month, once per week, twice per week, once
per day and twice per day). It was developed by surgeons 44.2.2.2 T he Memorial Sloan Kettering Cancer
(who suggested which aspects to include) and patients (who Center (MSKCC) Bowel Function
ranked each aspect) to assess severity of symptoms [10]. It Instrument
can be used to assess treatment outcomes in research; for The MSKCC instrument was developed to prospectively
example, Zutshi used it to assess 10-year outcomes after anal evaluate bowel function following sphincter preserving sur-
sphincter repair for faecal incontinence and found that conti- gery for rectal cancer [12]. The authors developed a 41-point
nence deteriorates in the long term following surgical repair bowel function survey after a literature review, expert opin-
[11]. Further work is needed for evaluating construct validity ion and patient interviews. They asked 184 patients to com-
and internal consistency [7]. plete the survey (70.1% response rate) and found that the
instrument was reliable and valid (radiation, coloanal anasto-
moses and handsewn anastomoses had significantly worse
44.2.2 Symptom Severity Questionnaires function).
Designed to Assess Outcomes This bowel function instrument can be used via the web/
for Rectal Cancer Treatment email, with paper or on the phone via interview [16]. The
scope of the MSKCC bowel function instrument is broader
Sphincter preserving surgery for rectal cancer is often possi- than the LARS score as it covers the consequences of the
ble, but functional results are not well understood [12], and symptoms as well as their severity reliable and is valid for
many patients suffer with low anterior resection syndrome assessment of outcomes after rectal cancer surgery. However,
(LARS). Questionnaires have been developed to assess symp- it is not routinely used as it is lengthy and its’ scoring system
toms and their contributing factors and to consolidate the treat- (which involves re-coding, three subscale scores, a global
ment of LARS and assess treatment outcomes [13]. The LARS score and a total score) may make it less practical [13].
score and MSKCC bowel function instrument (both discussed
below) are suitable for the comprehensive and in-depth assess-
ment of LARS although focused assessment with the Wexner 44.2.3 Diary Monitoring
score, St Mark’s score or FISI may also be used.
Experts recommend that the consistent use of the same Symptom questionnaires may be misleading, only provide a
questionnaires in order that different institutions can compare snapshot of bowel habits and fail to reflect day-to-day varia-
outcomes and interventions [13]. A systematic review in 2017 tions or the relationship between bowel symptoms and stool
found that there is still substantial variation in reporting of form [17]. Bowel diaries are recordings of bowel habits
functional outcomes following low anterior resection and a which are widely used in diagnostic and interventional stud-
consensus is still needed to improve and standardise research ies [18]. They may be more accurate than interviews or ques-
into low anterior resection syndrome and its treatment [14]. tionnaires with less recall bias [17, 19, 20]. For example,
538 A. J. Hainsworth et al.
Manning examined 150 patients and found a discrepancy 44.2.5 The Combined Assessment of Symptom
between recalled and recorded figures for bowel frequency Severity and Quality of Life
of three or more bowel actions per week in 16% of patients
[20]. Diary monitoring provides an objective assessment of There are different scores to measure the severity of and
severity if filled out correctly by patients. impact on quality of life, of faecal incontinence but often not
Although some societies advocate bowel diaries to together, and some authors recommend a combination of
assess bowel dysfunction and guide treatment, there are scores to allow thorough assessment [26]. Minguez (who
few published examples which can be used in clinical translated the Rockwood scale into Spanish) compared the
practice. The International Continence Society suggests Rockwood scale to the Jorge-Wexner score and found a
the following are included: urgency, flatus and faecal strong correlation between the two [25]. They also found that
incontinence (amount, consistency), passive staining/ pad usage is an independent factor which worsens quality of
soiling, pads (changes, degree of soiling), straining/dif- life scores. Bols examined the Vaizey score (St Mark’s faecal
ficulty/time in the toilet, unsuccessful attempts to defe- incontinence score), the Jorge-Wexner score and Rockwood
cate, assistive measures (e.g. digital stimulation, manual scale and concluded that although all total scores had ade-
evacuation, irrigation, laxative or rectal evacuant use), quate to excellent responsiveness and longitudinal construct
diet and fluids (type and/or timing) [18]. validity, there were psychometric limitations for each. They
Daily stool diaries have been frequently used to assess also found a strong correlation between some items (particu-
outcomes after treatment of faecal incontinence with larly between embarrassment and coping/behaviour sub-
sacral nerve stimulation. Improvements in both the num- scales). However, they still suggested a combination of the
ber of episodes of faecal incontinence per week (as Wexner score for severity assessment with the Rockwood
recorded in the diary) and summative symptom scores score for quality of life is required to enable a thorough and
(Cleveland score, St Mark’s score) have been seen in both complete evaluation [26]. Bordeianou performed a prospec-
the short and the long term [21]. tive analysis in 502 consecutive patients to examine the rela-
tionship between the Faecal Incontinence Severity Index
(FISI) and the Rockwood scale and SF-36. There was only
44.2.4 Quality of Life Questionnaires moderate correlation with embarrassment and coping/behav-
iour and no correlation with lifestyle/depression, stressing
There may be poor correlation between symptom severity the need to measure both variables (severity and quality of
and quality of life [22, 23]. Symptom scores alone do not life) to determine the true impact of treatment [23].
allow satisfactory evaluation of the impact of faecal inconti-
nence on quality of life, and therefore both aspects of faecal 44.2.5.1 T he Rapid Assessment Faecal
incontinence should be assessed [22]. Quality of life can be Incontinence Score (RAFIS)
assessed using generic scales such as the SF36 questionnaire The rapid assessment faecal incontinence score (RAFIS) was
or specific scales such as the Rockwood scale. developed to quickly assess faecal incontinence in both its
severity and impact upon quality of life. It consists of a visual
44.2.4.1 The Rockwood Scale (FIQL) analogue scale combined with the frequency of episodes of fae-
The Rockwood scale (the Rockwood faecal incontinence cal incontinence within the last month. The authors examined
quality of life scale (FIQL)) is a widely used tool to spe- 261 consecutive subjects and found a significant correlation
cifically assess the impact of faecal incontinence on qual- between RAFIS and the Jorge-Wexner score and the Rockwood
ity of life [24] (it has also been translated into Spanish) scale. They concluded that RAFIS is a valid and reliable tool to
[25]. It contains 29 different items to form four scales for assess both aspects of faecal incontinence [27] (severity and
the assessment of lifestyle, coping/behaviour, depression/ quality of life) although only superficially and has not been
self-perception and embarrassment, but there is no single routinely adopted for clinical or research practice.
summary measure. It was suggested by experts and then
proposed to patients for ranking. Psychometric evaluation 44.2.5.2 ICIQ-BS
has shown that this is a reliable and valid measurement The modular international consultation on incontinence
with significant correlations with the subscales in the questionnaire for bowel symptoms (ICIQ-BS) has been
SF-36 [24]. The International Consultation on Continence developed as a comprehensive, robust, condition-specific
recommend its use in research but as an optional tool in self-completion questionnaire to assess bowel symptoms, the
clinical practice [18]. amount of bother they cause and their impact on quality of
44 Treatment of Anal Incontinence: Which Outcome Should We Measure? 539
life [28, 29]. It is the top-rated questionnaire for evaluation sures in the treatment of anal incontinence. However, ano-
of symptoms severity and impact on health-related quality of rectal structure and function are also useful outcome
life [30]. It can be applied across international populations in measures, particularly in the context of therapeutic trials for
clinical practice and research and enables comparison of faecal incontinence. This is because:
findings from different settings and studies [31]. Online ver-
sions are also psychometrically robust, in men and women, 1. Symptom severity may be underestimated by day-to-day
including Veterans [32]. It shows a reasonable response to variation in symptoms and patient avoidance of certain
changes in symptoms and quality of life following an inter- activities to reduce incontinent episodes.
vention [29], but more work is needed in this domain [7]. 2. The pathophysiology of faecal incontinence is multifacto-
rial, and therefore there may be several contributing fac-
tors towards symptoms which may not all be solved with
44.2.6 Visual Analogue Scores a single intervention.
3. Objective parameters may be useful to determine out-
Visual analogue scores have also been developed to assess comes in uncontrolled studies.
the severity of faecal incontinence and its impact upon qual- 4. If faecal incontinence initially responds to treatment and
ity of life but have not been shown to be a suitable substitute then symptoms deteriorate, there may be failure of treat-
for other scoring systems. Devesa examined 103 consecutive ment or another contributing factor (e.g. recurrent incon-
patients affected by faecal incontinence to determine if a tinence after sacral nerve stimulation due to device
single score represented in a visual analogue scale (VAS) malfunction) [35].
could replace the Jorge-Wexner score and Rockwood faecal
incontinence quality of life scale. A VAS for quality of life Tests of anorectal structure and function include anal
could not substitute all four subscales of the Rockwood manometry, rectal compliance and sensation with either
score. A VAS for severity was not concordant with the Jorge- balloon studies or Barostat, saline continence tests, por-
Wexner score. The authors concluded that a VAS does not ridge enema, pudendal nerve terminal motor latency, nee-
assess the same issues for severity of symptoms and impact dle EMG of the external sphincter, endoanal ultrasound
upon quality of life for faecal incontinence as the Jorge- and endoanal MRI.
Wexner score and Rockwood scale. The only significant cor- Tests of anorectal structure and function in a research
relation was between the VAS for faecal incontinence and context can help to strengthen the argument for implementa-
the embarrassment subscale of the Rockwood scale [33]. tion of certain therapies and ensure treatments are more
widely available. Previously, although biofeedback treat-
ment was known to ameliorate symptoms in patients with
44.2.7 Interview Assessment faecal incontinence, it was not known if it also caused an
improvement in anorectal function. Rao examined anorectal
Interviews can be used for qualitative assessment and to manometry, saline continence tests, prospective stool dia-
assess patient acceptability of treatments and patient percep- ries and bowel satisfaction scores before and after biofeed-
tion of their symptoms and how they have changed following back for faecal incontinence and found a significant
an intervention. For example, Thin performed a randomised improvement in all parameters in both the short and long
clinical trial of sacral versus percutaneous tibial nerve stimu- term [36, 37]. The examination of anorectal function as well
lation in patients with faecal incontinence and qualitative as patient symptoms in these studies helped to highlight the
interview data suggested both treatments had high accept- effectiveness of biofeedback therapy for faecal inconti-
ability amongst patients [3]. nence. Norton performed a randomised control study which
Symptom severity questionnaires can also be used in an examined conservative treatment in 171 patients. All ver-
interview scenario. For example, the St Mark’s score can be sions of conservative treatment (from standard advice to
used as both an interview-based and a self-administered hospital biofeedback plus a home electromyogram biofeed-
incontinence score [34]. back device) improved continence, quality of life, psycho-
logical well-being and anal sphincter function (measured
with a diary, symptom questionnaire, continence score,
44.3 Anorectal Structure and Function patient’s rating of change, quality of life, hospital anxiety
and depression score and anorectal manometry). The assess-
Patients’ symptoms, the amount of bother experienced by ment of anorectal manometry showed subjective and objec-
the symptoms and their impact upon quality of life may be tive improvement in faecal incontinence following all types
considered the most important and relevant outcome mea- of conservative measures.
540 A. J. Hainsworth et al.
44.3.1 Anorectal Physiology volume) and compliance. Progress after treatment with either
pelvic floor rehabilitation or rectal sensitivity training with bal-
Anorectal physiology includes anorectal manometry, sen- loon distension (the subject is trained to feel the distension and
sory measurements and neurophysiology. to tolerate progressively lower or larger volumes depending on
if there is rectal hyper- or hyposensitivity present) can be docu-
mented according to the volumes tolerated. However, although
44.3.1.1 Anorectal Manometry there may be an improvement in rectal capacity, this may not be
Anorectal manometry includes conventional anal manome- reflected by patients’ symptoms. For example, Terra examined
try, high-resolution manometry, high-definition manometry, 281 patients and found a moderate improvement in maximal
vector volume manometry and ambulatory manometry. tolerated volume and severity of faecal incontinence, but only a
Anorectal manometry measurements include functional anal few patients had a substantial improvement in the St Mark’s
canal length, maximum resting pressure, maximum squeeze faecal incontinence score [47]. The authors have done further
pressure, involuntary squeeze pressure, endurance squeeze work which concludes that additional tests (including anal sen-
pressure and resting pressures. sitivity testing, anal manometry and endoanal ultrasound) only
Manometry may be useful to evaluate treatment outcomes have a limited role in assessing treatment outcomes after pelvic
[38]. For example, in patients with low anterior resection floor retraining and will not necessarily predict any improve-
syndrome (LARS), there is reduced anal pressure after sur- ment in symptoms [48].
gery which can be treated with biofeedback. The level of
incontinence correlates with reduced resting pressure levels 44.3.1.3 Neurophysiology
[39, 40], and a recovery in anorectal function can be moni- Neurophysiology includes EMG (electromyography) and
tored with anorectal manometry [41]. Improvements in fae- pudendal nerve terminal motor latency. Measurements
cal incontinence and quality of life are also associated with a include assessment of activity in the external sphincter and
significant increase in maximal anal resting pressure follow- puborectalis. EMG can be used for strength training during
ing artificial sphincter reimplantation for faecal incontinence biofeedback and be used to quantify the reinnervation of the
[42], and some have observed reduced anal pressures in external anal sphincter by detecting a prolongation in the
patients with persistent incontinence despite surgical repair motor unit potential [18].
obstetric anal sphincter injury [43].
However, some have found no association between
improvement of symptoms and anal manometry pressures 44.3.2 Saline Continence Tests or Porridge
following treatment of faecal incontinence. Sorensen Enema
found no correlation between anal pressures and severity
of symptoms after primary obstetric injury repair [44]. Following a sphincter repair with defunctioning colostomy or
Grey examined 85 patients following anal sphincter low anterior resection with a defunctioning loop ileostomy, a
repair, and whilst there were significant improvements in water holding procedure provides a simple examination for
quality of life, there were no changes in anal manometry the evaluation of the anal sphincter function prior to stoma
[45]. This may be explained by a systematic review of reversal. Saline or another liquid (e.g. porridge) is inserted into
long-term outcomes after anal sphincter repair for faecal the rectum via a catheter and the patient asked to walk around
incontinence which analysed data from 16 studies com- with a pad in for 20 min to assess continence [38, 49].
prising nearly 900 repairs. There was poor correlation
between severity of symptoms and quality of life, and the
authors concluded that despite worsening results over 44.3.3 Imaging
time, most patients remain satisfied with their sphinctero-
plasty [46]. This may be due to the variety of techniques 44.3.3.1 Endoanal Ultrasound
used; as more advanced manometric techniques are used Endoanal ultrasound may be used pre- and post-surgical
more widely (e.g. high-definition anal manometry) and as sphincter repair to assess the effect of the operation on the
a consensus emerges regarding normal values, changes in sphincter defect and to investigate unsatisfactory results after
anal manometry may reflect changes in symptoms more surgery [50] (Fig. 44.1).
frequently. Some have found a good correlation between patient
symptoms and post-operative appearances on endoanal
44.3.1.2 Sensory Measurements ultrasound. Felt-Bersma examined 18 patients before
Sensory measurements are made with rectal balloon distention, and after anal sphincter repair. There was not only good
Barostat and rectal impedance studies. Measurements include correlation between the clinical effect of sphincter repair
rectal sensation (first and urge sensation and maximal tolerated and changes on endoanal ultrasound and anal manome-
44 Treatment of Anal Incontinence: Which Outcome Should We Measure? 541
Take-Home Messages
1. Treatment of anal incontinence may be assessed by
subjective or objective outcomes.
2. It is important to assess outcomes to:
Fig. 44.1 Endoanal ultrasound. A sagittal view of the anal sphincter
–– Check that treatments are successful in the short,
complex. The white arrow shows the internal anal sphincter, the dashed medium and long term.
arrow shows the longitudinal muscle and the black arrow the external –– Understand why a treatment has or has not
sphincter worked.
–– Allow improvement in treatments.
try, but post-operative persistent incontinence could be –– Increase the adoption of treatments by multiple
attributed to remaining sphincter defects [51]. Norderval units.
found improved St Mark’s scores correlated with the –– Check patient acceptability of treatments.
length of the external anal sphincter defect following 3. Subjective outcomes:
primary repair of obstetric anal sphincter tears in 63 Symptoms (severity, bother and quality of life) may
women (61 controls) (the integrity of the internal anal be assessed with patient questionnaires, stool dia-
sphincter did not differ) [52]. Sorensen examined 59 ries and patient interviews.
women (29 cases after primary obstetric injury repair Often a combination of questionnaires is
and 30 controls) and found that anterior sphincter length required for the complete evaluation of both symp-
correlated with severity of incontinence (though there tom severity and impact upon quality of life. The
was no correlation between anal pressures and severity ICIQ-BS is the only questionnaire at present which
of incontinence) [44]. assesses symptoms, quality of life and bother of
Endoanal ultrasound can also be used to assess the safety symptoms simultaneously.
of new treatments, for example, to ensure that there is no Patients may use avoidance behaviour which
migration of an artificial bowel sphincter [53] or inter- leads to underestimation by the clinician of symp-
sphincteric bulking agents such as the Gatekeeper™ [54]. tom severity.
4. Objective outcomes:
44.3.3.2 MRI Anorectal structure and function may be assessed
MRI is equivalent to endoanal ultrasound for the assessment with anorectal physiology, saline or porridge conti-
of external sphincter defects but not internal sphincter defects nence tests, endoanal ultrasound and endoanal MRI.
[55]. Research has shown that external anal sphincter atro- The pathophysiology of anal incontinence is
phy following sphincteroplasty (for obstetric injury causing multifactorial and so the assessment of the anorec-
incontinence) can only be visualised on endoanal MRI but tal structure and function may explain why symp-
not ultrasound and that atrophy affects continence post- toms are not solved with a single intervention.
operatively [56]. However, the quality of ultrasound has Assessment of anorectal structure and function
improved since this study, and although imaging the sphinc- may explain a recurrence of symptoms despite initial
ter post-operatively may be useful for research purposes, it is success (e.g. recurrent incontinence after sacral nerve
often not available for routine post-operative assessment in stimulation due to device malfunction) and may be
clinical practice. useful to determine outcomes in uncontrolled studies.
542 A. J. Hainsworth et al.
37. Ozturk R, Niazi S, Stessman M, Rao SSC. Long-term outcome and 48. Terra MP, Deutekom M, Dobben AC, Baeten CGMI, Janssen
objective changes of anorectal function after biofeedback therapy for LWM, Boeckxstaens GEE, et al. Can the outcome of pelvic-floor
faecal incontinence. Aliment Pharmacol Ther. 2004;20(6):667–74. rehabilitation in patients with fecal incontinence be predicted? Int J
38. Witte M, Schwandner F, Klar E. Before and after anorectal surgery: Colorectal Dis. 2008;23(5):503–11.
which information is needed from the functional laboratory? Visc 49.
Parés D, Duncan J, Dudding T, Phillips RKS, Norton
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39. Rasmussen OO, Petersen IK, Christiansen J. Anorectal function reversal of a defunctioning stoma (porridge enema test). Colorectal
following low anterior resection. Colorectal Dis. 2003;5(3):258–61. Dis. 2008;10(4):379–85.
40. Lee SJ, Park YS. Serial evaluation of anorectal function follow- 50. Nielsen MB, Dammegaard L, Pedersen JF. Endosonographic
ing low anterior resection of the rectum. Int J Colorectal Dis. assessment of the anal sphincter after surgical reconstruction. Dis
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41. van Duijvendijk P, Slors JFM, Taat CW, van Tets WF, van
51. Felt-Bersma RJ, Cuesta MA, Koorevaar M. Anal sphincter repair
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tal function after total mesorectal excision for rectal carcinoma spective clinical study. Dis Colon Rectum. 1996;39(8):878–85.
with or without preoperative radiotherapy. Am J Gastroenterol. 52. Norderval S, Røssaak K, Markskog A, Vonen B. Incontinence after
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42. Lehur P-A, Zerbib F, Neunlist M, Glemain P, Bruley-des-Varannes tive length of reconstructed external sphincter: a case-control study.
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44. Soerensen MM, Pedersen BG, Santoro GA, Buntzen S, Bek K, 54. Al-Ozaibi L, Kazim Y, Hazim W, Al-Mazroui A, Al-Badri F. The
Laurberg S. Long-term function and morphology of the anal gatekeeper™ for fecal incontinence: another trial and error. Int J
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2006;49(8):1149–59.
Part VI
Pelvic Organ Prolapse
Epidemiology and Etiology of Pelvic
Organ Prolapse 45
Stefano Salvatore, Sarah De Bastiani, and Fabio Del Deo
tvl
American Urogynecologic Society (AUGS), and the
Society of Gynecologic Surgeons (SGS) [6]. The American gh
pb
College of Obstetricians and Gynecologists has also rec-
ommended its use [7]. It has proven interobserver and
intraobserver reliability [8] and is the system used most POP-Q PROLAPSED
COMPARTMENT SITE ORGAN VAGINAL WALL SITE
commonly in the medical literature [9]. The POP-Q is an
Anterior Aa Urethra Distal anterior vaginal
objective, site-specific system for describing and staging (urethrocele) wall
POP in women [10]. In the POP-Q system, the topography Ab Bladder Proximal and distal
of the vagina is described using six points (two on the ante- (cystocele) anterior vaginal wall
Middle C Cervix Cervix
rior vaginal wall, two on the superior vagina, and two on D Small bowel Uterosacral scar
the posterior vaginal wall) and several other measurements (enterocele)
Posterior Ap Small bowel Proximal posterior
[10]. Taken together, these measurements can be used to vaginal wall
(enterocele)
produce a sagittal diagram of the prolapse and a detailed Bp Rectum Proximal and distal
description of vaginal anatomy. For the purposes of simple (rectocele) posterior vaginal
wall
clinical communication or grouping patients for research Perineal body Perineal body
purposes, an ordinal staging system using the POP-Q mea-
surements was developed:
A simplified version of the POP-Q system, which was
–– Stage 0—No prolapse. developed by an international group of investigators, has
–– Stage I—The requirements for stage 0 are not met, but the been proposed [11, 12]. Like the standard POP-Q examina-
most distal portion of the prolapse is >1 cm distal to the tion, the Simple POPQ (S-POPQ) measures the anterior,
level of the hymenal plane. posterior, and up to two measurements of the apex, including
–– Stage II—The most distal portion of the prolapse is both the cervix and posterior cul-de-sac. The S-POPQ
between ≤1 cm proximal to the hymenal plane and ≥1 cm records the ordinal stage of the four measurements by esti-
distal to the hymenal plane. mating the distances involved.
–– Stage III—The most distal portion of the prolapse is While not recommended by leading societies, the Baden-
between >1 cm distal to the hymenal plane, but no further Walker Halfway Scoring System is another commonly used
than 2 cm less than the total vaginal length in. In other POP staging system. The degree, or grade, of each prolapsed
words, the maximum prolapse is more than 1 cm outside structure is described individually (e.g., grade 1 anterior
the hymenal plane, but it is 2 cm less than the maximum vaginal wall prolapse or grade 3 uterine prolapse). The
possible protrusion. grade/degree is defined as the extent of prolapse for each
–– Stage IV—Eversion of the total length of the vagina. structure noted on examination while the patient is strain-
45 Epidemiology and Etiology of Pelvic Organ Prolapse 549
ing. Because there are no clear demarcations among the cut- POP do not seek medical attention. The distinction between
off stages, the Baden-Walker system lacks the precision and symptomatic and asymptomatic POP is clinically relevant,
reproducibility of the POP-Q system. The system has five since treatment is generally indicated only for women with
degrees/grades [13]. symptoms. However, there are few high-quality data regard-
ing the prevalence of symptomatic POP.
Rates of asymptomatic POP are probably even higher.
45.2 Prevalence and Incidence Several studies have used clinical examination to assess the
prevalence of POP in a community-based setting. One study
Pelvic organ prolapse is one of the most frequent disorders included 497 women who were seen in an outpatient clinic
connected with age that makes women visit their gynecolo- for routine gynecologic care and were assessed using the
gist. The worldwide prevalence of POP has recently been Pelvic Organ Prolapse Quantification (POP-Q) system. The
reported to be around 9% [14]. If the diagnosis is based on overall distribution of POP-Q system stages was as follows:
clinical evaluation, the prevalence ranges from 41% to 56% stage 0, 6.4%; stage 1, 43.3%; stage 2, 47.7%; and stage 3,
as compared to 3–7% when the diagnosis is based on symp- 2.6%. No subjects examined had POP-Q system stage 4 pro-
toms or complaints from women [15, 16]. In a study done in lapse. The distribution of the POP-Q system stages in the
the United States, the prevalence of POP was lower in population revealed a bell-shaped curve, with most subjects
African American women 1.9% as compared to Caucasian having stage 1 or 2 support. Few subjects had either stage 0
women 2.8% and Hispanic women 5.1% [17]. The differ- (excellent support) or stage 3 (moderate to severe pelvic sup-
ence in prevalence of POP between Africans residing in the port defects) [28].
United States and those living in Africa could be explained If we analyze a Sliwa et al. work, we found that the most
by a comparatively higher number of deliveries, difficult frequent pelvic disorder reported in their group of patients
access to skilled delivery attendance, and heavier physical was the defect connected with both cystocele and rectocele.
workload among African living in sub-Saharan Africa. In the This may lead to the conclusion that cystocele is the most
United States, this problem may affect even 24% of the common type of dysfunction throughout the whole group of
women’s population, whereby the percentage depends women with pelvic organ disorders [24]. Similar results were
mainly on age. Among women between 20 and 39 years of obtained by Hendrix et al. on a large group where the most
age, it concerns 10% of the population, whereas it involves frequently observed disorder was also cystocele [29].
up to 50% of women in their 80s [18]. With regard to the
aging process of the society, this problem will involve a
higher rate of the total women’s population. One estimates 45.3 R
isk Factors and Pathophysiological
that in 2050 it will concern over 30% of women over 20 years Mechanisms
old [19]. In the United States, the incidence of women sub-
mitted to surgical procedures connected with one of the types 45.3.1 Ethnicity
of prolapse is 11.8%, which constitutes the most common
indication for surgical procedure. There are approximately Several studies showed that Hispanic and European women
300,000 POP surgeries each year in the United States [20, seem to have a higher risk of developing POP compared to
21]. In developed countries, approximately 20% of surgical Asian or African women [30–34]. In Zacharin’s cadaveric
procedures among women are carried out due to pelvic organ study, pubourethral ligaments, endopelvic fascia, and endo-
prolapse [22–24]. It is also worth mentioning that the prob- pelvic attachment to the obturator fascia were reported to be
lem is probably more frequent, because only 10% of the stronger and thicker in Chinese compared to Caucasian
population struggling with pelvic organ prolapse in their women [35]. A significantly less pelvic organ mobility in
everyday life seeks help from a gynecologist and the major- Asian women was shown also by Dietz et al. using perineal
ity never ask for it [25]. Population-based studies report an ultrasound [34]. The reasons for these ethnic discrepancies
11–19% lifetime risk in women undergoing surgery for pro- are still unclear.
lapse or incontinence [26, 27].
The exact prevalence of POP is difficult to ascertain, for
several reasons: (1) different classification systems have 45.3.2 Familiarity and Other Genetic Risk Factors
been used for diagnosis; (2) studies vary by whether the rate
of prolapse reported is for women who are symptomatic or It is generally recognized that POP has an inheritable predis-
asymptomatic; and (3) it is unknown how many women with position. In a case-control study, Chiaffarino et al. showed
550 S. Salvatore et al.
that the risk of urogenital prolapse was higher in women with 45.3.3 Obstetric Factors
mother or sister reporting this condition: the odds ratios
(ORs) were 3.2 (95% CI 1.1–7.6) and 2.4 (95% CI 1.0–5.6), Pelvic floor tissue trauma that occurs during childbirth is
respectively, in comparison with women whose mother or sis- universally considered the main risk factor for developing
ters reported no prolapse [36]. The reason why some females POP later in life [50–56]. Pregnancy itself has been widely
with little to no risk factors develop POP while other females accepted as a risk factor for pelvic floor dysfunction. This
with multiple risk factors do not is clearly that some women association is strongest for stress urinary incontinence
have a genetic predisposition to prolapse. Analyzing young (SUI), whereas for POP it has been less well established. In
women with stage III and IV POP, Jack et al. showed that the the study by O’Boyle et al., all 21 nulliparous nonpregnant
risk of prolapse among their siblings was five times higher women had a POP-Q stage 0–I, while out of 21 nulliparous
than that of the risk for the general population [37]. The pregnant women, 47.6% had a stage II POP (p < 0.001)
authors concluded that POP has a dominant pattern of inheri- with POP-Q stage increasing from the first to the third tri-
tance with incomplete penetrance. Buchsbaum et al. found a mester [57].
high concordance in the POP stage between nulliparous As confirmed by several studies, a woman’s parity is
women and their parous sisters, thus supporting the hypothe- strongly associated with her risk of developing POP. The
sis of a familial basis for this condition [38]. Nevertheless, Women’s Health Initiative showed that having one childbirth
they highlighted the importance of vaginal delivery that determined a twofold risk increase for prolapse compared to
appeared to confer a risk for more advanced prolapse. nulliparity, and each additional childbirth added a 10–20%
Some genetic variants have been found in families with an risk increase [32]. Another case-control study found that in
increased incidence of POP. In the genome-wide association women with a parity of four, the risk for symptomatic POP
study conducted by Allen-Brady et al., results from associa- was 3.3 times higher compared to those with a parity of one
tion analysis identified five single-nucleotide polymorphisms [53]. In a population-based study by Rortveit et al., authors
significantly associated with POP [39]. More recently the found that the risk of prolapse progressively increased from
same authors performed a genome-wide linkage analysis one to three or more vaginal deliveries [31].
using a resource of high-risk POP pedigrees and results The potential protective effect of caesarean section still
showed that loci on chromosomes 10q and 17q may predis- remains controversial. However, nowadays it has been well
pose to POP development [40]. demonstrated that elective caesarean section has a protective
Further studies investigated the role of specific genetic role on the pelvic floor, and therefore it may decrease the risk
polymorphisms in increasing the susceptibility to early onset of developing POP [36, 50–56, 58–60]. Comparing women
of POP, such as polymorphism in the promoter of LAMC1 who delivered by caesarean section only with vaginal deliv-
gene or of COL1A1 gene [41, 42]. Although results were eries only, the incidence rate for prolapse surgery was sig-
encouraging, their clinical application cannot be recom- nificantly lower in the first group, whereas in the vaginal
mended based on current evidence. delivery cohort, it progressively increased reaching its peak
Women with genetic disorders of the connective tissue, about three decades after first childbirth. This interesting
such as Marfan or Ehlers-Danlos syndrome, have high rates result was shown in a register-based cohort study [59] in
of POP [43–47]. It is well-known that the vaginal wall is which authors included 33,167 women having all their preg-
composed of connective tissue in its subepithelial layer and nancies terminated by caesarean section and an age-matched
adventitia and also vaginal and uterine supportive tissues are sample of 63,229 women only having spontaneous births in
mainly made of collagen and elastin. Therefore in these the decade 1973–1983. Gyhagen et al. reported that the prev-
women, the connective tissue disorder may occur also in alence of POP was not significantly different comparing
terms of pelvic organ descent. women who had undergone emergency or elective caesarean
Apart from these genetic diseases, numerous data show section [55].
that women with POP have an abnormal pelvic extracellular Controversy remains with regard to the risk of developing
matrix metabolism with an increased collagen turnover. POP related to specific obstetrical events and interventions.
Connective tissue remodeling throughout the body is con- Several studies found that instrumental delivery significantly
trolled by matrix metalloproteinases (MMP), a family of increase the risk of prolapse when compared with non-
calcium-dependent zinc-containing endopeptidases. An operative vaginal birth, with no differences between forceps
overexpression of MMP-1 and 2 has been observed in women and vacuum delivery [60, 61]. On the other hand, a case-
with prolapse with a concurrent decrease in their inhibitor control study observed no significant association between
TIMPs [48, 49]. The consequences are an excessive tendency instrumental delivery, maternal age, length of delivery, and
toward connective tissue degradation and a decrease in the POP [53]. Similar results were found by Uma et al. with
amount of collagen in pelvic tissue that has been reported regard to forceps delivery, episiotomy, infant birthweight,
from women with POP. and prolonged labor [52].
45 Epidemiology and Etiology of Pelvic Organ Prolapse 551
45.3.4 Age and Hormonal Status factory workers compared to other job categories (p < 0.001).
They also showed that an annual household income of
It is well-known that both incidence and prevalence of Dollars 10,000 or less was associated with severe POP [67].
POP increase with increasing age. Through a large cross- According to Chiaffarino et al., housewives had an OR of
sectional study in menopausal clinics in Italy, members of urogenital prolapse of 3.1 (95% CI 1.6–8.8) in comparison
Progetto Menopausa Italia Study Group showed that in with professional/managerial women [36].
comparison with women aged ≤51 years, the OR of uter-
ine prolapse was 1.3 and 1.7, respectively, for women
aged 52–55 and ≥56 years [62]. Similar findings came out 45.3.6 General Medical Conditions
from a cross- sectional analysis of American women
enrolled in the Women’s Health Initiative [32]. The life- Through a chronic increase of the pressure on the pelvic
time risk of undergoing a single operation for prolapse or floor, obesity may be intuitively associated to global pelvic
incontinence by age 80 is 11.1% according to Olsen et al. floor dysfunction and therefore to more severe prolapse [69,
[63]. This surgery is uncommon in people younger than 70]. However, this association is not as strong for prolapse as
30 years. for stress urinary incontinence [71, 72].
Although it would seem intuitive that the decrease of According to Swift et al., the OR for developing POP is
estrogen levels observed with menopause might predispose 2.51 and 2.56 for overweight and obese women, respec-
to POP, current evidence on this topic is controversial. Some tively [30]. Similarly, women with a body mass index of
studies support the role of estrogen in the development of more than 26 kg/m2 are more likely (OR 3.0 95% CI 1.6–
pelvic floor disorders. In a cross-sectional study by Lara 5.7) to undergo surgery for prolapse compared to those with
et al., postmenopausal women with POP were reported to a lower value [73].
have a lower expression of estrogen receptor α on the vaginal Kudish et al. evaluated the relationship between change in
wall and a smaller number of vessels in the lamina propria of weight and POP progression/regression in women during a
the vagina compared to premenopausal controls [64]. On the 5-year period [74]. Analyzing 16,608 postmenopausal
other hand, according to Trutnovsky et al. the pelvic organ women with an intact uterus, aged 50–79 years, they
support and levator ani function do not appear to be substan- observed that the risk of prolapse progression in overweight
tially influenced by hormone deficiency following meno- and obese women as compared with participants with healthy
pause. The same applies for local or systemic hormone BMIs increased by 32% and 48% for cystocele, by 37% and
replacement therapy [65]. 58% for rectocele, and by 43% and 69% for uterine prolapse,
respectively. The authors also showed that weight loss does
not appear to be significantly associated with regression of
45.3.5 Socioeconomic Factors POP, suggesting that damage to the pelvic floor related to
weight gain might be irreversible.
A low socioeconomic status, intended as low educational Although not convincingly, chronic obstructive pulmo-
level and yearly income, is a demographic factor associated nary disease has been associated with the development of
with an increased risk of developing POP [66, 67]. POP causing increased intra-abdominal pressure during
Considering the 21,449 non-hysterectomized women around chronic cough [75].
menopause analyzed by the Progetto Menopausa Italia Study The same pathophysiological mechanism might be the
Group, the OR of uterine prolapse was 0.8 (95% CI 0.7–0.9) basis of an increased risk for prolapse among patients with
and 0.8 (95% CI 0.6–0.9), respectively, for women with chronic constipation implying repetitive straining at stool.
intermediate or high school/university degree compared to Spence-Jones et al. reported that the presence of this condi-
women with none/primary education [62]. tion already in the youth was significantly more common in
In a review study on prevalence and risk factors for pelvic women who then developed uterovaginal prolapse (61% vs.
floor dysfunction in 16 developing countries, Walker et al. 4%, p < 0.001) compared with controls [76]. At the time of
observed that the mean prevalence of POP was 19.7% (range consultation, 95% of the women with prolapse were consti-
3.4–56.4%) but risk factors were similar to those in industri- pated, compared with only 11% of control women. Many of
alized countries, particularly increased age and parity. In these women also needed to digitate to achieve rectal
low-income countries additional risk factors for pelvic floor evacuation.
disorders were poor nutrition and heavy work [68]. In a recent study, Rogowski et al. showed that the diagno-
Jobs involving heavy lifting have been reported to increase sis of metabolic syndrome and the presence of elevated tri-
the risk for POP. In a multicenter cross-sectional study, glycerides increased with the overall POP-Q stage and
Woodman et al. showed that the prevalence of severe POP therefore they may be associated with the severity of POP in
was significantly higher among women who were laborers/ urogynecological patients [77].
552 S. Salvatore et al.
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35. Zacharin RF. Abdominoperineal urethral suspension: a ten-year 58. Quiroz LH, et al. Vaginal parity and pelvic organ prolapse. J Reprod
experience in the management of recurrent stress incontinence of Med. 2010;55(3–4):93–8.
urine. Obstet Gynecol. 1977;50(1):1–8. 59. Leijonhufvud Å, et al. Risk of surgically managed pelvic floor dys-
36. Chiaffarino F, et al. Reproductive factors, family history, occupa- function in relation to age at first delivery. Am J Obstet Gynecol.
tion and risk of urogenital prolapse. Eur J Obstet Gynecol Reprod 2012;207(4):303.e1–7.
Biol. 1999;82(1):63–7. 60. Volløyhaug I, et al. Pelvic organ prolapse and incontinence
37. Jack GS, et al. Familial transmission of genitovaginal prolapse. Int 15–23 years after first delivery: a cross-sectional study. BJOG.
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38. Buchsbaum GM, et al. Pelvic organ prolapse in nulliparous women 61. Handa VL, et al. Pelvic floor disorders 5–10 years after vaginal or
and their parous sisters. Obstet Gynecol. 2006;108(6):1388–93. cesarean childbirth. Obstet Gynecol. 2011;118(4):777–84.
39. Allen-Brady K, et al. Identification of six loci associated with pel- 62. [No authors listed]. Risk factors for genital prolapse in non-
vic organ prolapse using genome-wide association analysis. Obstet hysterectomized women around menopause. Results from a large
Gynecol. 2011;118(6):1345–53. cross-sectional study in menopausal clinics in Italy. Progetto
40. Allen-Brady K, et al. Evidence for pelvic organ prolapse predis- Menopausa Italia Study Group. Eur J Obstet Gynecol Reprod Biol.
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2015;212(6):771 e1–7.
554 S. Salvatore et al.
above and 1 cm below, and ≤1 cm below but at least 2 cm
Learning Objectives less than the total vaginal length, respectively).
• The assessment of POP should involve objective Clinical evidence of POP does not always correlate with
and subjective measures. the presence of POP symptoms, as up to 80% of women may
• Subjective measurements of POP are the patient- be asymptomatic [4]. The level of hymen has been estimated
reported outcomes (PROs). to be an important “cutoff point” for symptom manifestation,
• PROs should be used in the day-to-day clinical as women with POP below the hymen are more likely to
practice as they provide a better understanding of have bulging symptoms and more PFD symptoms, as well
patients’ perceptions regarding their situation and [2, 5–7]. However, the symptoms of POP are diverse and
their thoughts for the therapeutic management. often non-condition specific as they may be the result of a
• PROs should be used in research for the assessment coexisting PFD and not directly attributing to the POP itself.
of therapeutic outcomes and comparison of the var- Thus, it is of importance to acknowledge which symptoms
ious therapeutic modalities. reflect the POP and which is a coexisting PFD before choos-
ing the best therapeutic approach. Additionally, the latter
allows a thorough patients’ counselling aiming to provide
information of what to expect (i.e., which symptoms may
46.1 Introduction disappear or persist, etc.) after an intervention. POP in par-
ticular and PFD in general rarely result in severe morbidity
Pelvic organ prolapse (POP) is “primarily a definition of or mortality but can influence negatively women’s quality of
anatomical change” [1]. It refers to a falling, slipping, or life (QOL) and their daily (physical and social) activities and
downward displacement of the uterus and/or vaginal com- sexual function.
partments and neighboring organs such as the bladder, rec- Furthermore, management of PFD involves conservative
tum, or bowel [1]. Thus, POP along with urinary incontinence, treatment including vaginal pessaries, behavioral therapy
voiding dysfunction, fecal incontinence, and defecatory dys- (such as lifestyle modification, bladder training, etc.), phar-
function belongs in an interrelated group of conditions macotherapy, and surgical interventions. Definition of treat-
named pelvic floor disorders (PFD) [2]. ments’ success rates has not been standardized yet. Surgical
The diagnosis of POP includes clinical evidence of POP interventions aim to restore the anatomical changes to an
and symptoms related to the “downward displacement” of a optimum or at least satisfactory result. Objective measures
pelvic organ [1]. The clinical evidence of POP is evaluated such as “optimal anatomic outcome” (stage 0 according to
using the Pelvic Organ Prolapse Quantification (POP-Q) the Pelvic Organ Prolapse Quantification (POP-Q) System
System [3]. POP-Q includes four stages (stage 0 to stage IV). [8]) used to define “cure” which was the priority of surgeons
Stages 0 and IV define the absence of POP and the complete [3]. However, anatomy does not always correlate with the
eversion, respectively. Stages I, II, and III define the distance severity or presence of symptoms. POP symptoms may not
between the most distal portion of the prolapse from the level be present in 75% of patients without an optimum postsurgi-
of hymen (≥1 cm above the level of hymen, between 1 cm cal anatomic result and in 40% of patients with a satisfactory
one [9]. As a step forward, recommendations of reporting
S. Athanasiou (*) surgical outcomes suggest evaluation not only of objective
National and Kapodistrian University of Athens, Athens, Greece but also of subjective and quality of life measures [10].
e-mail: stavros.athanasiou@gmail.com
This chapter reviews the currently available patient- tying/urinary retention, slow urine stream, rectal urgency,
reported outcome (PRO) measures that can be used by clini- digitation/splinting, dyspareunia, and vaginal laxity [1].
cians and researchers in patients with POP. Specifically, PROs The presence of POP symptoms may increase from an
assessing pelvic floor symptoms, their effect on patient’s qual- average of 0.5 symptoms in stage I prolapse to 2.1 symptoms
ity of life and sexual function, and what the patients actually in women with the leading edge of prolapse extending
think and feel for their condition and what they expect from beyond the level of hymen [11]. However, weak correlations
their therapy will be presented. The aim of this chapter is to have been found between prolapse and individual symptoms
present available evidence of research studies and to provide [12, 13]. Although bladder, bowel, and sexual symptoms are
an appropriate patient-oriented clinical practice and a repro- more common in women experiencing POP than those with-
duction of comparable results for the research studies. out, there is a weak correlation between specific prolapsed
compartments and individual symptoms [13, 14]. The only
symptom that is consistently reported by the patients with
46.2 Recommendations for Practice severe POP is the vaginal bulge that can be seen or felt [2].
Furthermore, women with mild prolapse may have stress uri-
46.2.1 POP Symptomatology nary incontinence (SUI) [15], while those with an advanced
one may experience voiding difficulties due to obstruction,
All symptoms that may be directly or potentially associated needing a manual assistance to urine [13]. Nevertheless, in
to POP as described by the International Urogynecological some cases, SUI may be occult, appearing only after reduc-
Association (IUGA) and the International Continence tion of prolapse, and a combined prolapse and anti-
Society (ICS) are presented in Table 46.1 [1]. The most com- incontinence surgical procedure should be considered [16].
monly described symptoms are the bulge sensation/visual- In addition, data regarding the appearance of urgency and
ization, feeling of pelvic pressure, bladder storage symptoms urge incontinence (UUI) in relation to POP stage are in dis-
(i.e., frequency, urgency, and nocturia), urinary incontinence cordance [13, 15]. Specifically, Romanzi et al. found that
(UI), recurrent UTIs, and incomplete defecation [1]. Other urgency and UUI may occur in patients with advanced POP
common symptoms are the low backache, incomplete emp- [15], while Burrows et al. demonstrated that patients with
Table 46.1 Prolapse symptoms as defined by the International Urogynecological Association (IUGA) and the International Continence Society
(ICS) [1]
Prolapse symptoms
Vaginal prolapse symptoms Urinary tract prolapse symptoms Anorectal prolapse symptoms
Vaginal bulging (complaint of a” bulge,” “lump,” Urethral prolapse (complaint of a (a) Anorectal prolapse (complaint of a “bulge” or
or “something coming down” or “falling out”) “lump” at the external urethral “something coming down”)
Pelvic pressure meatus) (b) Rectal prolapse (complaint of external protrusion
Bleeding, discharge, infection of the rectum)
Splinting/digitation
Low backache
Potential prolapse symptoms
Related to lower urinary tract symptoms Related to anorectal dysfunction Related to sexual dysfunction symptoms
symptoms
Hesitancy Constipation Dyspareunia
Slow stream Feeling of incomplete bowel Obstructed intercourse
Intermittency evacuation Vaginal laxity
Straining to void Straining to defecate Libido loss or decrease
Spraying (splitting) of urinary stream Sensation of anorectal blockage
Feeling of incomplete (bladder) emptying Splinting/digitation
Need to immediately re-void Fecal (rectal) urgency
Post-micturition leakage Post-defecatory soiling
Position-dependent micturition
Splinting to micturate
Dysuria
Urinary retention
Urinary frequency
Urgency
Other possible associated symptoms
Urinary incontinence symptoms
Bladder storage symptoms
Bladder sensory symptoms
Lower urinary tract infection
46 Patient-Reported Outcomes and Pelvic Organ Prolapse 557
less advanced POP are more likely to experience urgency Table 46.2 Grade of recommendations according to the International
and UUI than those with an advanced one [13]. Consultation on Incontinence [23]
All the above indicate that the presence or severity of POP Grade Criteria
may not attribute to specific POP symptoms, while POP A. Highly Valid and reliable and responsive to change on
recommended psychometric testing (published data)
symptoms may be experienced by women with adequate pel-
B. Recommended Valid and reliable to change on psychometric
vic support. Therefore, a detailed documentation of the testing (published data)
symptomatology is essential prior to the initiation of any C. With potential Valid or reliable or responsive to change on
therapy in order to assess its efficacy. psychometric testing (published data or
abstracts)
46.2.2 Patient-Reported Outcome on certain factors such as population, culture, the baseline
Questionnaires from which the patients start, etc. [21]. Thus, it should not be
overestimated but applied judiciously to clinical practice or
The PFD symptoms can be assessed during the clinical inter- research [21].
view. However, the clinical interview relies on the physi-
cian’s time and knowledge. Usually, there is not enough time
to review all problems that may affect patients, while clinical 46.2.4 Categories of PROs
histories do not assess patients’ perception regarding their
condition neither how their quality of life is impaired by their PRO measures are divided into two large categories [22]: (1)
condition. Generic measures are multidimensional and have been
Subjective and quality of life measures can be assessed by designed to attribute to a broad range of populations as they
psychometrically robust, preferably self-administered ques- tend to assess physical, social, and emotional dimensions of
tionnaires known as patient-reported outcomes (PRO). PRO life. However, they may not detect MIDs as they do not focus
“is any report of the status of a patient’s health condition that on specific effects of the evaluated therapeutic approach.
comes directly from the patient, without interpretation of the And (2) condition-specific measures are more specific to a
patient’s response by a clinician or anyone else” [11]. They certain disease or population and thus may be more precise
represent the most important clinical review of patient’s at evaluating the efficacy of the treatment. Grade of recom-
experience, disease, or set of symptoms. Thus, PROs are mendations and their criteria according to the International
used to assess effectiveness and quality of treatment, as they Consultation on Incontinence [22, 23] are presented in
evaluate presence and severity of symptoms and their impact Table 46.2.
in the everyday life [17, 18]. In addition, PRO questionnaires may be divided into five
other categories: (1) screeners, (2) symptom questionnaires
(measure the presence, intensity, discomfort, and impact of
46.2.3 Selecting PRO Instruments specific symptoms), (3) quality of life questionnaires, (4)
sexual function questionnaires, and (5) measures of patient’s
The choice of which PRO instrument to use should be based satisfaction, expectations, and goal achievements [2, 22].
on three steps: (1) seeking its relativity and consistency to Some questionnaires may be mixed assessing symptoms,
the clinical purpose and objectives of the study, (2) determi- quality of life, and sexual function of the patients.
nation of the length and construct of the questionnaire
because long questionnaires may be difficult to be completed
by the patients, and (3) assessment of the reliability (ability 46.3 PRO Instruments for POP
to reproduce similar results after repeated assessments),
validity (ability to measure of what it is expected to), and Many PRO instruments for POP are used, aiming to cover all
responsiveness of the questionnaire (ability to detect POP symptoms (directly, potentially, or possibly associated
changes) [2, 19]. to POP), their impact on patient’s quality of life and sexual
The smallest change in PROs that patients perceive as function, as well as patients’ expectations and satisfaction
important defines the minimum clinically important differ- (Table 46.3, Further Reading). Patients initially may not be
ence (MCID). The statistically important differences do not able to recognize issues associated with bladder or bowel or
always correlate to what is clinically important. Thus, MCID sexual function. Thus, in research and in clinical practice,
helps physicians to interpret the outcome measures and to these issues should be acknowledged before proceeding to
decide of whether to continue or modify their management. therapy and medical counselling.
In addition, it helps researchers to calculate the sample size PROs for POP may be administered by mail in order to be
of clinical trials [20]. However, MCID can vary depending completed prior the patient’s visit or online or via phone or by
558 S. Athanasiou
a member of the medical team or self-administered in the an inter-observer variability. Computerized questionnaires
healthcare setting. The method of administration will affect were also suggested and were found to be comparable to paper
both the response rate and the accuracy of the response. Self- questionnaires in reliability and validity with superior response
administered questionnaires are the most robust and accurate rates, efficiency, and economic advantages [24–27]. In addi-
for assessing patients’ perspectives as they are not affected by tion, patients may find them easier and more enjoyable to
46 Patient-Reported Outcomes and Pelvic Organ Prolapse 559
complete [27] provided they have technological skills. When ory. Thus, recall bias may be introduced [22]. Furthermore,
patients are elderly, as many POP patients, such skills are parts or certain questions from PROs should not be used alone
doubtful resulting in no completion of the questionnaires or or in modification or changing the order or content because
needing help from outer observers that may introduce biases. the psychometric properties may alter, and the scoring is
All PROs for POP are presented in Table 46.3 [28–161] invalidated [22]. If someone wishes to modify, a validated
and extensively reviewed in Further Reading. Below, some questionnaire should perform a new validation. In addition,
PROs for POP, as well as considerations and tips for their some questionnaires are considered companion to others (i.e.,
selection and interpretation, will be discussed. PROs evaluating symptoms with PROs evaluating QoL and
PROs evaluating sexual function). The advantage of compan-
ion questionnaires is that they add the one to another without
46.3.1 Screeners duplicating questions.
Urogenital Distress Inventory (UDI-6), Pelvic Floor
The beginning of screeners in POP lies in 1989 when WHO Distress Inventory-20 (PFDI-20, respectively), and Pelvic
conducted a meeting to establish specific questions about Organ Prolapse Distress Inventory long and short form
chronic obstetric comorbidities [28]. Seven questions were (POPDI and POPDI-6, respectively) are PROs for POP with
chosen that could identify 80–90% of moderate to severe Grade A recommendation and wide coverage of symptoms
prolapses. Since then many screening tools have been devel- [22, 23]. The International Consultation on Incontinence
oped [28]. Screeners may be used to detect patients who Modular Questionnaire on Female Lower Urinary Tract
might have POP or PFD before a clinical examination. Symptoms (ICIQ-FLUTS) and ICIQ-UI SF, as well as the
Nevertheless, they should not be misinterpreted as diagnostic Colorectal-Anal Distress Inventory long and short form
tools even when cutoff scores have been determined. They (CRADI and CRADI-8, respectively), are Grade A PROs
usually include few and specific-oriented questions (i.e., focusing on LUTS and bowel function, respectively [22, 23].
“feeling or seeing a bulge in vagina?” etc.). Responsiveness PFDI-20 is the synthesis of the UDI-6, POPDI-6, and
of screeners has not been assessed. However, sensitivity and CRADI-8. It has been derived from the PFDI (its long form
specificity are extremely important for their interpretation that consists of 46 questions) a questionnaire designed spe-
[22]. Sensitivity provides information regarding how likely a cifically for women with POP. PFDI-20 is the most com-
patient with a certain condition is to score positive in screen- monly used questionnaire in studies assessing therapies
ers, while specificity is how likely a patient without a certain (surgical or conservatives) for POP as it includes urinary,
condition is to score negative [22]. colorectal, and POP scales and is reliable, valid, and respon-
sive to change. Its flexibility due to the wide coverage of
symptoms allows the postsurgical evaluation of POP inter-
46.3.2 Symptom Questionnaires ventions with subgroup comparisons of POP women with
and without UI or with and without bowel dysfunction. This
Symptom questionnaires aim to assess the presence, severity, is of importance because postsurgical complications (i.e., de
and bothering of particular POP symptoms or groups of POP novo appearance of UI) can be assessed, while modifications
symptoms. Ideally, they should be valid, reliable, and respon- of certain types of surgical techniques may be introduced
sive, with the MCID being of importance especially for the when POP coexist with UI or bowel dysfunction.
studies assessing surgical strategies. Questionnaires with a Furthermore, its recall period of 3 months is considered
wide coverage of POP symptoms are preferable, but when appropriate for the recollection of symptoms and events [63,
specific symptoms are indicative (such as UI), specific condi- 65]. UDI-6, POPDI-6, and CRADI-8 they all can be used
tion questionnaires may be used. Nevertheless, before decid- separately because they have been validated and designed to
ing which or how many questionnaires to use, it should be be used individually. However, their synthesis forbids possi-
kept in mind that the goal is to obtain accurate answers from ble duplication of concepts or items, offers less patient bur-
the patients without making it difficult or confusing for them. den, and takes less time to be administered.
In addition, the administration of longer questionnaires may
result in more missing data than the short ones. Usually for
research studies, many features have to be evaluated; thus the 46.3.3 Quality of Life Questionnaires or
long ones may be more appropriate, whereas for the everyday Health-Related Quality of Life
clinical practice, the short ones are considered more user- Questionnaires
friendly. Furthermore, the most frequently used PROs are not
always the most reliable ones [22]. Another aspect that should “Quality of Life is defined as an individual’s perception of
be considered before deciding which questionnaire to use is their position in life in the context of the culture and value
the recall period that allows factors to affect patients’ mem- systems in which they live in relation to their goals,
560 S. Athanasiou
expectations, standards and concerns” [162]. “Health- with POP [63–66]. Thus, it can be used by researchers and
Related Quality of Life (HRQOL) is defined as an indi- clinicians. It encompasses the Incontinence Impact
vidual’s or a group’s perceived physical and mental health Questionnaire (IIQ), the Pelvic Organ Prolapse Impact
over time” [163]. Questionnaire (POPIQ), and the Colorectal-Anal Impact
Usually, QoL or HRQOL is evaluated with multi-item Questionnaire (CRAIQ) [63–66]. It has a 3-month recall
questionnaires aiming to assess various aspects of patients’ period that is considered appropriate to recollection of symp-
life such as sleep, energy, physical health, emotions, work toms’ impact in the quality of life [63, 65]. The PFIQ-7
life, sex life, and social life. The terms QoL questionnaires or includes the IIQ-7, POPIQ-7, and CRAIQ-7 and is a com-
HRQoL questionnaires are used interchangeably in the lit- panion questionnaire to the PFDI-20 [22]. PFIQ-7 and PFDI-
erature. However, the QoL questionnaires include domains 20 have been translated and validated in many languages
such as personal safety, community connectedness, and reproducing its reliability and validity [165–171].
future security that usually are not found in HRQoL ques- Moreover, many mixed questionnaires have been devel-
tionnaires, although these domains may be affected by ill- oped aiming to offer evaluation of symptom bothering and
nesses [164]. HRQoL measures a broad description of simultaneously how this bothering interfere with the
self-perceived health status using functioning and well-being patient’s everyday life. Such questionnaires are the follow-
and not of QoL as it is widely known [164]. ing: the Australian Pelvic Floor Questionnaire, Electronic
QoL or HRQoL questionnaires may be interpreted differ- Personal Assessment Questionnaire-Pelvic Floor (ePAQ-
ently by the patients depending on their personality, social PF), ICIQ-VS, ICIQ-FLUTS, and Overactive Bladder
and economic status, psychology, etc. In addition, individual Questionnaire (OAB-q) are mixed questionnaires. The
symptoms have distinct impact on QoL. For example, women Australian Pelvic Floor Questionnaire and the ePAQ-PF also
with POP may stop participating in physical or social activi- include a sexual function domain, while ePAQ-PF is the only
ties, while women with UI, even though still participating in electronic prolapse specific questionnaire. Moreover,
such activities, usually declare less satisfied than they used to ICIQ-VS and ICIQ-FLUTS include a 10-cm VAS for the
before the condition occurred [7]. In addition, improvements determination of patients’ QoL. However, VAS for measur-
of objective measurements following a POP surgery do not ing HRQOL in POP patients has not found to be valid [91].
always reflect improvements in the patients QoL. Thus, QoL
questionnaires are important outcomes for urogynecological
interventions. 46.3.4 Sexual Function
As mentioned above PROs assessing QoL or HRQoL
are divided into two categories, the generic and condition Female sexuality is complex, as various aspects, such as psy-
specific. The condition-specific PROs are preferable, as chological, social, and physiological, are involved. Therefore,
they allow to estimate the impact of the specific condition female sexual dysfunction (FSD) is difficult to diagnose.
in patient’s life and to address changes following an However, it is very important to be identified and treated
intervention. appropriately, for establishing women’s well-being and qual-
Short Form Survey (SF) long and short form (SF-36 and ity of life. Two systems are considered “sanctioned with
SF-12, respectively), Pelvic Floor Impact Questionnaire international fluence” for the definition of sexual dysfunc-
long and short form (PFIQ and PFIQ-7, respectively), tion the ICD-10 and DSM-5 [172]. The combination of these
Incontinence Impact Questionnaire long and short form (IIQ two produced the ICD-11 which is currently in the process of
and IIQ-7, respectively), King’s Health Questionnaire, and modification. The ICD-10 includes sexual dysfunction not
International Consultation on Incontinence Questionnaire- caused by an organic disorder or disease, while DSM-5
Lower Urinary Tract Symptoms quality of life (ICIQ- includes the female sexual interest/arousal disorder, female
LUTSqol) are the most commonly used HRQOL with Grade orgasmic disorder, and genito-pelvic pain/penetration disor-
A level of recommendation [22, 23]. The SF is a generic der [172]. These systems are not familiar to gynecologists,
questionnaire that measures concepts such as physical and and screening for FSD in women with PFDs is not consis-
social functioning, role limitations due to physical or emo- tently performed [173].
tional problems, bodily pain, vitality, and mental health and However, 50–60% of women with PFD are sexually
general health perception. The SF short form is frequently active [13, 174]. Data regarding the presence of dyspareu-
used as a gold standard for health-related QoL question- nia, decreased orgasmic capacity, and libido in women with
naires [165, 166]. However, apart from its social functioning POP are controversial. Studies have demonstrated that
scale, it is not responsive to change in women with POP symptomatic POP and UI increase the risk of FSD (due to
undergoing surgery. reduced sexual arousal, infrequent orgasm, and dyspareu-
PFIQ is prolapse specific with excellent validity, reliabil- nia) while UI women are more likely to avoid sexual inti-
ity, and responsiveness that assesses the impact of urinary, macy due to their fear of urine leakage [123, 129]. In
prolapse, and bowel function in the everyday life of women addition, the negative impact of POP in sexual functioning
46 Patient-Reported Outcomes and Pelvic Organ Prolapse 561
may be improved or remained unchanged following a PFD therapeutic goal has been fulfilled. Patient’s perceptions of
surgery [175]. Nevertheless, measures of sexual function outcomes associated with urogynecologic health are greatly
have been found to be similar between women with and influenced by their personal beliefs about their condition and
those without POP [129]. Moreover, FSD was found to be their understanding of the availability of various treatments.
related to the presence of POP and not the grade of POP and Patients’ expectations and satisfaction are two separate sub-
can be explained only partly by the presence of POP [176]. jective instruments. Specifically, patients’ expectations may
Other factors such as aging/menopause or problems with the be positive (goals) or negative (fears) [177]. Important goals
partner may be involved. prior to POP surgery are symptom release and improved life-
As sexuality is a multi-complex issue, it is essential for style (including physical capabilities and improved sexual
the gynecologists to screen and accurately evaluate the pres- life), while the most important fears are de novo symptoms,
ence of FSD in POP patients taking into account all sexuality POP recurrence, and surgical complications [177]. However,
aspects in order to provide a better patient counselling. The goals are not always in alignment within what reasonably
PROs evaluating women’s sexuality and its deviations may expected in terms of efficacy. For example, disagreement
help them identify the problem without embarrassing neither between the patients’ goals and the objectively demonstrated
the gynecologist nor the patients. PROs for sexual function, success of the surgical procedure may cause patient’s dis-
as PROs for quality of life, are divided into two large catego- satisfaction. Thus, it is of great importance for the clinicians
ries: the generic and the condition specific. during the pretreatment counselling to identify and under-
The Golombok Rust Inventory of Sexual Satisfaction and stand what the patient regard as the main problem and what
the Brief Index of Sexual Functioning for Women are generic they actually expect as a feedback from their therapy in order
questionnaires with Grade A level of recommendation [22, to suggest the optimum therapy for them.
23]. Condition-specific questionnaires with Grade A level of The Goal Attainment Scaling (GAS) is the oldest PRO that
recommendation are not available. However, the most com- is widely used in the medicine aiming to identify the therapeu-
monly used condition-specific PROs for sexual function in tically goals of each patient. In urogynecology it can be used
women with POP are the Pelvic Organ Prolapse/Urinary to evaluate treatment outcomes following surgery for PFD
Incontinence Sexual Function Questionnaire short form [139, 140]. The Goal Attainment Scaling (GAS) is a PRO
(PISQ-12), with a Grade B level of recommendation, and the evaluating the extent to which patient’s individual goals are
Female Sexual Function Index (FSFI) with a Grade C level met by thepeutic interventions. (1) It augments information
[22, 23]. In particular, the PISQ-12 is a companion question- received from standardized outcomes. A disadvantage of stan-
naire to the PFDI-20 and the PFIQ-7 [127–131]. It was dardized outcomes is that patients answer questions that are
designed to evaluate the sexual function of heterosexual not adjusted for the individual or a particular situation. In con-
women with POP or UI. It is a valid, reliable, and responsive trast, GAS is specifically tailored for individuals and evaluates
to change questionnaire. However, it cannot assess the part- only what is important to the patient. (2) Patients’ expectations
ner perception of POP and cannot identify the post-surgery- are central for GAS, providing all the information needed for
specific negative effects on sexual function. Recently, IUGA the physician to know what is regarded as treatment benefit to
revised PISQ-12 to PISQ-IR aiming to attribute in both sexu- the patients. Thus, unrealistic goals may be separated from the
ally and nonsexually active women [132, 133]. PISQ-IR cor- realistic ones, and physicians can explain to the patients what
relates with PFDI-20 and FSFI [132, 133]. their treatment can actually achieve. In this way, patients may
FSFI, although with Grade C level of recommendation, is understand that their goals are unrealistic and determine new
often used in the assessment of POP patients, especially ones, more realistic, while physicians may select an alternative
when undergoing surgical approaches. It may detect patients therapeutic option instead of their initial plan. (3) It may be
with hypoactive sexual desire disorder (HSDD), female used in clinical trials. Its individualized approach may be over-
orgasmic disorder (FOD), and female sexual arousal disor- come using a summary score of all goals of patients utilizing
der (FSAD) [120]. It has also a particular threshold discrimi- standardized z-based scoring.
nating patients with from those without FSD [121]. Thus, it Disadvantages of GAS may include [178] the following:
may help clinicians and researchers understand whether POP (1) risk of bias at setting goals because physicians may lead
or another factor contributes to the FSD and identify sexual the patients to easy achievable goals; (2) success depends on
problems arising de novo postsurgical. physician to select appropriate goals and accurately predict
outcomes, while observable changes may not correspond to
the pre-defined outcomes; (3) it’s time-consuming, espe-
46.3.5 Patients’ Expectations and Satisfaction cially the initial step; (4) difficulties performing double-
blind trials; and (5) unresolved statistical issues regarding
PROs for patients’ expectations and satisfactions have been the calculation of the summary score. Thus, some research-
developed to evaluate directly the patients’ perceptions ers suggest being a complementary outcome and not a pri-
regarding the effectiveness of their therapy and whether their mary one [179].
562 S. Athanasiou
specificity when objective signs of prolapse in clinical exam- tively. Questions 1–9 are targeted to stress urinary inconti-
ination were not present. nence (SUI) with a maximum total score of 27, while
Single-question screening [30]: The question is: “Do questions 10–15 to urge incontinence with a maximum total
you usually have a bulge or something falling out that you score of 18 (UUI). However, data regarding its sensitivity
can see or feel in your vaginal area?” Affirmative answer to and specificity are not available.
this question has 96% sensitivity and 79% specificity for 3-Incontinence Questionnaire (3IQ) [39]: It has been
prolapse beyond the level of hymen. designed to distinguish patients with SUI and UUI. It includes
Pelvic Organ Prolapse Simple Screening Inventory three questions, with the first one being “During the last 3
(POPSSI) [31]: It is based on Pelvic Floor Disorder Inventory months, have you leaked urine (even a small amount)?”
(PFDI) and includes the following four questions: Affirmative answer leads to the other two questions. The type
of UI is defined based on the third question. The classification
• “Urinary incontinence following laughing, sneezing or of UUI has a 75% sensitivity and 77% specificity, while the
coughing?” classification of SUI has 86% sensitivity and 60% specificity.
• “Urinary urgency?” However, due to low specificities the 3IQ should not be used
• “Feeling pain during defecation?” as a diagnostic tool, as many as 23% and 40% of women may
• “Feeling or seeing bulge in vagina?” be treated inappropriately for UUI and SUI, respectively.
• In the general population, POPSSI has 45.5% sensitivity OAB-V8/OAB Awareness Tool [40, 41]: It includes eight
and 87.4% specificity. questions, based on OAB Questionnaire (OAB-q), involving
frequency, nocturia, urgency, and UUI with bothering scores
Epidemiology of Prolapse and Incontinence ranging from 0 to 5. A score greater of 8 may indicate pres-
Questionnaire (EPIQ) [32]: It is a validated screener that ence of bothersome OAB symptoms. It has a 98% sensitivity
may detect women at high risk to develop PFD (POP, SUI, and an 82.7% specificity. However, OAB-V8 in comparison
OAB, and anal incontinence). Its positive and negative pre- to B-SAQ is worst in detecting SUI symptoms.
dictive value for POP is 76% and 97%, respectively, while Pelvic Pain and Urgency/Frequency (PUF) [42, 43]: It
for SUI 88% and 87%, respectively, for OAB 77% and 90%, includes eight questions addressing to frequency, nocturia,
respectively, and for AI 61% and 91%, respectively. symptoms related to sexual intercourse, and pain in the blad-
der or the pelvis. Each answer may receive a score from 0 to
4. A cutoff score ≥13 has been found to provide the best
Detection of Patients with LUTS sensitivity-specificity ratio for PUF. The sum of scores
defines the total score. It correlates directly with the likeli-
Bladder Control Self-Assessment Questionnaires hood of the intravesical positive potassium results that have
(B-SAQ) [33, 34]: It has been developed to identify patients been estimated in about 80% of patients with bladder pain
with general LUTS and not solely symptoms of specific con- syndrome and interstitial cystitis. However, it should not be
dition. Thus, it assesses presence and bothering of urgency, used as a diagnostic tool. In addition, it has been designed by
frequency, nocturia, and incontinence. Bothering scoring has clinicians without patient input. It includes medical terms
a range between 0 (not at all) and 3 (a great deal). The final that may not be adequately comprehended by the patients.
score is calculated by the sum of scoring of each symptom. It Thus, its validity as a PRO instrument is questionable.
is quick and easy to complete, with 98% sensitivity and 79% Bladder Pain/Interstitial Cystitis Symptom Score
specificity for bothersome LUTS. (BPIC-SS) [44]: It is an eight-item questionnaire designed to
Interstitial Cystitis Symptom Index (ICSI) [35–37]: It select BPS/IC patients for clinical trials. A cutoff score ≥19
includes four questions assessing the severity of day-time has a 72% sensitivity and 86% specificity for clinical trial
frequency, nocturia, urgency, and bladder pain over the past inclusion. However, it should not be used as a diagnostic tool.
month. Severity scoring ranges from 0 to 20. A score of 0–6, Questionnaire for Urinary Incontinence Diagnosis
7–14, and 15–20 are indicative for mild, moderate, and (QUID) [45–47]: It may distinguish accurately patients with
severe symptoms, respectively. It has a good test-retest reli- SUI or UUI with only six questions, and it is considered as one
ability, internal consistency, validity, and responsiveness. It of the few available questionnaires that may add to office diagno-
may be used to distinguish which patients should be further sis of UI type. Each item may receive scores from 0 to 5. Items
examined for interstitial cystitis, as it has not a sufficient 1–3 and 4–6 correspond to stress and urge score, respectively.
specificity to be used as a diagnostic tool. Thus, the minimum and maximum scores for both stress and
Medical, Epidemiological, and Social Aspects of Aging urge are 0 and 15, respectively. The diagnosis of SUI or UUI is
Questionnaire (MESA) [38]: It includes 15 questions with proposed when stress score is ≥4 or urge score ≥6, respectively.
four possible answers: “rare,” “rarely,” “sometimes,” and Its sensitivity and specificity for SUI are 85% and 71%, respec-
“often,” applying to “0,” “1,” “2,” and “3” scoring, respec- tively. For UUI both sensitivity and specificity are 79%.
564 S. Athanasiou
Detection of Patients with Sexual Dysfunction Visual Analogue Scale [56, 57]: It is a valid, repeatable,
single-item continuous scale, usually with a length from 0 to
Three questions [48]: The following specific questions have 10 cm, that assesses bothering of each POP symptom using a
been found to be as effective as detailed interview: sliding indicator. The highest the score, the more intense are
the symptoms. Initially, it was validated for the assessment
• “Are you sexually active?” of quality of life in urogynecologic research. Lately, an asso-
• “Are there any problems?” ciation between VAS and POP grade on clinical and ultra-
• “Do you have any pain with intercourse?” sound examination was found. However, studies performing
comparisons between VAS and other standard validated POP
Sexual Function Questionnaire (SFQ) [49, 50]: It con- questionnaires, or studies evaluating its sensitivity to change
sists of 34 questions detecting the presence or absence of following therapeutic interventions, currently are not avail-
hypoactive sexual desire disorder (HSDD), female sexual able. Additionally, MID has not yet been determined.
arousal disorder (FSAD), female orgasmic disorder (FOD), Urogenital Distress Inventory (UDI) (Grade B) [58–
and dyspareunia. It has an excellent internal consistency and 61]: It is a reliable, valid, and sensitive 19-item questionnaire
validity (discriminant and longitudinal) and moderate to including irritative symptoms, obstructive/discomfort symp-
good reliability. toms, and stress symptoms. Answers assess the presence of
Sexual Function Questionnaire 28 [49–51]: It includes symptoms and the degree of bother on a four-point scale
six domains and 28 questions for recognition of HSDD, (“not at all,” “a little bit,” “moderately,” and “greatly” apply-
FSAD, FOD, dyspareunia, enjoyment, and partner issues ing to 0, 1, 2, and 3, respectively). Initially, it was designed
using a five-point Likert scale. It has a good test-retest reli- to assess women with UI but has also been used for the
ability and validity and excellent internal consistency. A cut- assessment of lower urinary tract function in women with
off score of 5 determines the arousal cognitive domain. POP. However, the validity in women with UI without uro-
Sexual Function Questionnaire 15 [49, 50]: It includes dynamic diagnosis is questionable. MID for the UDI and
four domains and 15 questions for recognition of HSDD, UDI-stress, in women with stress-predominant UI, is consid-
FSAD, FOD, and dyspareunia using a five-point Likert scale. ered reasonable at −11 and −8 points, respectively. MID for
HSDD [52]: It is a four-item questionnaire with a five- the UDI and UDI-irritative, in women with urge-predominant
point Likert scale designed to detect presence or absence of UI, is −35 and −15, respectively.
HSDD. Urogenital Distress Inventory-6 (UDI-6) (Grade A)
Brief Profile of Female Sexual Function (B-PFSF) [62]: It is the short form of UDI. It has a high correlation
[53]: It is a seven-item instrument based on the Profile of with the long form, but it is patient friendlier as it includes
Female Sexual Function and Personal Distress Scale. Each only six questions. The total score is calculated using the fol-
item has a six-point Likert scale (“always” to “never”). Sum lowing algorithm: sum of scores/6 × 25. As with the long
of scores results in a final score ranging from 0 to 35. A cut- form, UDI-6 has a questionable validity for women with UI
off score ≤20 defines the presence of HSDD with 97% sen- without a urodynamic diagnosis.
sitivity and 96% specificity. Pelvic Floor Distress Inventory (PFDI) (Grade B) [63]:
It is based on two validated questionnaires the UDI and the
Incontinence Impact Questionnaire (IIQ) and assesses symp-
Symptom Questionnaires tom distress in women with PFD. Overall it includes 52
items (19, 17, and 16 for UDI, Colorectal-Anal Distress
PROs with Wide Coverage of POP Symptoms Inventory (CRADI), and Pelvic Organ Prolapse Distress
Inventory (POPDI), respectively). It is reliable, valid, and
Pelvic Organ Prolapse Symptom Score (POP-SS) [54, condition-specific. However, it is time-consuming as it takes
55]: It is a seven-item questionnaire that patients report how an average of 23 min to be completed. It may be used to pre-
often they experience POP symptoms. Possible answers dict the outcome of pelvic reconstructive surgery [64]. In
apply to a five-point Likert scale: “never,” “occasionally,” particular, a cutoff value of 62/300 pre-surgery, in women
“sometimes,” “most of the time,” and “all the time” receiving with pelvic organ prolapse that was repaired with synthetic
scores of 0, 1, 2, 3, and 4, respectively. Thus, the total score mesh, may predict a failure to improve quality of life at 36
ranges from 0 to 28. It has a good internal consistency, con- months post-surgery. The positive predictive value and spec-
struct validity, and sensitivity to change. In particular, it was ificity of the latter cutoff value were 83.6% and 62.1%,
able to detect changes when surgical or pelvic floor muscle respectively.
training (PFMT) was applied, with a different magnitude of PFDI-20 (Grade A) [63]: It is the short-form of PFDI
changes depending on intervention. An MID of 1.5 has been with 20 items and three scales (UDI-6, POPDI-6, and
considered to correspond better to patients’ satisfaction. CRADI-8). It is reliable and responsive to change and has an
46 Patient-Reported Outcomes and Pelvic Organ Prolapse 565
excellent correlation with the long form of PFDI. Total score Electronic Personal Assessment Questionnaire-Pelvic
is calculated by adding the scores of the three scales with a Floor (ePAQ-PF) [69–72]: It is reliable, valid, and web-
possible range from 0 to 300. Each scale item could receive based questionnaire consisting of urinary (12 questions),
values from 0 to 4 applying to a score ranging from 0 to bowel (20 questions), vaginal (11 questions), and sexual (15
100 for each scale. The higher the score, the more intense questions) domains. All domains evaluate quality of patients’
are the symptoms. A change of ≥45 points (15%) was life. Moreover, urinary domain assesses pain, overactive
determined as MID. PFDI-20 correlates well with the PFDI bladder and SUI, bowel domain constipation, evacuation,
[66]. Additionally, PFDI-20 can be converted using a certain and incontinence, while vaginal domain sensation and pro-
formula to PFDI [66]. lapse. Sexual domain includes aspects of urinary, bowel, and
Pelvic Organ Prolapse Distress Inventory (POPDI) vaginal symptoms in relation to sex. The time for its comple-
long and short form (Grade A) [63, 65]: It is a specific tion has been estimated between 12–103 min providing
condition questionnaire and has been included in PFDI. Its medians of 26 and 33 for the “non-interactive” version and
short version has six questions and it is part of PFDI-20: “Do primary care, respectively. Additionally, its responsiveness
you usually experience pressure in the lower abdomen?”, to change has been indicated in the relative domains of pro-
“Do you usually experience heaviness or dullness in the pel- lapse and quality of life, in women undergoing POP surgery.
vic area?”, “Do you usually have a bulge or something fall- The electronic over paper administration of PROs is consid-
ing out that you can see or feel in your vaginal area?”, “Do ered to offer many advantages. However, patients should
you ever have to push on the vagina or around the rectum to have technological skills, but the vast majority of POP
have or complete a bowel movement?”, “Do you usually patients are elderly, and such skills are doubtful.
experience a feeling of incomplete bladder emptying?”, and Birmingham Bowel and Urinary Symptoms
“Do you ever have to push up on a bulge in the vaginal area Questionnaire (BBUS-Q) (Grade B) [73, 74]: It is a valid,
with your fingers to start or complete urination?”. Negative reliable, and responsive, 22-item questionnaire assessing
answers receive 0 score, while affirmative ones’ score ranges constipation (Q1 and 2), evacuation (Q7–13 and 15), incon-
from 1 to 4 depending on degree of bothering. Each scale tinence (Q3–6), and urinary symptoms (Q16–22). Question
score ranges from 0 to 100. 14 is not encompassed in any domain. Responses apply to a
International Consultation on Incontinence four-level scale, while scores range from 0 to 100 for each
Questionnaire-Vaginal Symptoms (ICIQ-VS) (Grade C) domain. Cutoff scores to define abnormal domains are
[67]: It is a valid, reliable, consistent, and responsive ≥64%, ≥17%, ≥17%, and ≥20%, for constipation, evacua-
PRO. Initially it included 27 items for vaginal symptoms (14 tion, incontinence, and urinary symptoms score,
items and 13 subquestions (corresponding to the degree of respectively.
bother)), sexual matters (ten items and nine subquestions
corresponding to the degree of bother)), and quality of life
(one item). Responses of vaginal symptoms and sexual mat- PROs Focusing on LUTS
ters have 4–5 points, while the quality of life question and
the subsequent questions of vaginal symptom and sexual Incontinence Severity Index (ISI) [75]: It is a valid, reli-
matters a 10 VAS. The short form includes 14 items corre- able, sensitive measure with only two questions (“how often
sponding to the evaluation of vaginal symptoms, sexual mat- do you experience urine leakage” and “how much urine do
ters, and quality of life. Vaginal symptoms and sexual matters you lose each time”). The total score is calculated by multi-
are calculated separately using specific algorithms. plying the score of the first question (from 0 to 4) by the
Australian Pelvic Floor Questionnaire [68]: It is a score of the second question (from 1 to 2). It can be used in
reproducible and valid questionnaire with a wide coverage, routine clinical practice.
as it assesses presence, bothering, and impact on quality of Bristol Female Lower Urinary Tract Symptoms
life of all pelvic floor symptoms (bladder, bowel, and sexual Questionnaire (BFLUTS) [76, 77]: It is a valid and reliable
function) and prolapse symptoms. It has 42 items and four questionnaire that includes 6 domains involving frequency,
sections (bladder, bowel, prolapse, and sexual function cor- voiding, incontinence, sex, and quality of life with scores
responding to questions 1–15, 16–27, 28–32, and 33–42, ranging from 0 to 15, 0 to 12, 0 to 20, 0 to 6, and 0 to 18,
respectively). Scores are calculated separately for each sec- respectively. However, it has been found that women may
tion giving values from 0 to 10 for each section. Thus, the score higher on self-completion than interview [65].
maximum global dysfunction score is 40. The bladder, International Consultation on Incontinence Modular
bowel, prolapse, and sexual function domains correlate with Questionnaire-Female Lower Urinary Tract Symptoms
the UDI-6, established bowel questionnaire, International (ICIQ-FLUTS) (Grade A) [78]: It is the short form of
Continence Society Prolapse Quantification, and McCoy BLUTS. It is a valid, reliable, and responsive, 12-item ques-
Female Sexuality Questionnaire, respectively. tionnaire evaluating nocturia, urgency, bladder pain, fre-
566 S. Athanasiou
quency, hesitancy, straining, intermittency, UI (urge, stress, has three scored domains involving bowel pattern, bowel
and unexplained), frequency of urinary incontinence, and control, and quality of life with scores ranging from 1 to 21,
nocturnal enuresis. Filling, voiding, and incontinence symp- 0 to 28, and 0 to 26, respectively. Additionally, it includes
tom subscales range from 0 to 15, 0 to 12, and 0 to 20, four unscored items for the assessment of clinical or patient
respectively. Additionally, it evaluates impact of individual perspective.
symptoms with bothering scales that are not incorporated in Wexner Scores (Grade C) [86, 87]: It is a scoring system
the overall scores. for both fecal incontinence and constipation. The inconti-
ICIQ-UI SF (Grade A) [79, 80]: It is a valid, reliable, nence score ranges from 0 to 20, while the constipation score
responsive questionnaire with four items, including fre- from 0 to 30 with values >15 defining constipation’s pres-
quency, prevalence and cause of UI, and impact on everyday ence. Zero defines absence of symptoms while 20 and 30
life. The cause of UI is not included in the total score calcula- severe ones.
tion. The total score ranges from 0 to 21. The recommended Rapid Assessment Fecal Incontinence Score (RAFIS)
MIDs for women undergoing surgery due to SUI are −5 and [88]: It is a valid and reliable two-item tool for assessing
−4 at 12 and 24 months postoperatively, respectively. fecal incontinence. The total score ranges from 0 to 20.
Questionnaire for Urinary Incontinence Diagnosis Fecal Incontinence Severity Index (FISI) [89]: It
(QUID) [45–47]: It is a valid, reliable, and responsive to includes four items involving incontinence to gas, mucus,
change with 6-item UI symptom questionnaire. It may dis- liquid stool, and solid stool with scores ranging from 0 to 12,
tinguish accurately the type of UI and may be offered as a 0 to 12, 0 to 19, and 0 to 18, respectively.
screener, as presented above. It correlates strongly with the Cleveland Clinic Fecal Incontinence Score [90]: It is a
UDI as it assesses symptoms’ intensity and bothering. In five-item questionnaire assessing leakage of solid, liquid,
addition, it may detect differences following a non-surgical and gas, the use of pads, and the lifestyle restriction.
intervention. Thus, it may be used in research as UI outcome Responses apply to “never,” “rarely,” “sometimes,” “usu-
measure of clinical trials. ally,” and “always.”
Overactive Bladder Questionnaire (OAB-q) [81–83]: It
is a valid, reliable, and responsive symptom bother and qual-
ity of life questionnaire attributable in both continent and Quality of Life Questionnaires
incontinent patients. Initially, 62 items (13 symptom items, 4
general, and 44 health-related quality of life (HRQL)) were Generic Questionnaires
included, while a reduction to 33 items (8 symptom items
and 25 HRQL) was performed in order to become user- Health Utilities Index (HUI)-3 [91–95]: It includes eight
friendlier and more accurate. It includes scales of symptom attributes (vision, hearing, speech, ambulation, dexterity,
bother (frequency, nocturia, urgency, and urge incontinence), emotion, cognition, and pain) with five or six levels. The
coping, concern/worry, sleep, social interaction, and scoring attribute to morbidity scale is from 0.00 (worst level)
HRQL. Each question corresponds to a six-point Likert to 1.00 (best level). It can receive negative scores represent-
scale, from “none of the time” to “all the time,” applying to ing health states worse than death. Difference in mean HUI
1–6, respectively. The total score for each domain ranges total score ≥0.03 has been suggested as MID. It is a valid
from 0 to 100, with MID recommended at ≥10 points. In tool of HRQOL in women with POP or other PFDs (i.e., UI).
addition, two versions of 4- and 1-week recall period with EuroQol (EQ-5D) [91, 92, 96]: It includes five attributes
similar factor structures are available. (mobility, self-care, usual activities, pain/discomfort, and
pain) with five or six levels. The score of EQ-5D ranges from
−0.59 to 1.00. Difference in utility score of 0.03 has been
PROs Focusing on Bowel Function suggested as MID. It is a valid measure of HRQOL in women
with POP and UI (urge, stress, and mixed).
Colorectal-Anal Distress Inventory (CRADI) long and Sort Form Survey (Grade A) [91, 93, 94, 97, 98]: It has
short (CRADI-8) form (Grade A) [63, 84]: The long form various versions including 36 (SF-36), 12 (SF-12), and 6
has 17 items and is included in the PFDI, while CRADI-8 (SF-6) items. SF-36 measures eight concepts: physical and
has eight items and is included in the PFDI-20. However, social functioning, role limitations due to physical or emo-
they can be used apart from the PFDI and PFDI-20 as inde- tional problems, bodily pain, vitality, mental health (psycho-
pendent questionnaires for women with fecal incontinence. logical distress and well-being), and general health
MIDs for the long and short form are 11 and 5, respectively. perception. The number of response levels varies between 4
International Continence Consultation-Bowels and 21, depending on domain. The MID for the physical
(ICIQ-B) [85]: It is a valid, reliable, and responsive 35-item functioning scale is 2 and 3 points for functioning scores <40
questionnaire (25 symptom items and 10 HRQL items). It and >40, respectively. SF-12 also includes eight concepts,
46 Patient-Reported Outcomes and Pelvic Organ Prolapse 567
while SF-6 is derived from SF-12 with six concepts (physical study evaluating these long forms of PFIQ in women under-
and social functioning, role limitation, pain, mental health going pelvic floor reconstructive surgery (PFR) or receiving
and vitality). SF-6 is scored on a scale from 0.29 to 1.00, andvaginal pessary resulted in different MIDs in the respective
each of the six attributes has five or six levels of responses.subscales depending on type of intervention. In particular,
In addition, SF-6, as with HUI-3 and EQ-5D, is valid and MID for POPIQ is −40 to −27 and −29 for PFR and vaginal
reliable for women with POP or UI of any type, with MID of pessary, respectively. MID for CRAIQ is −34 to −6 and −29
0.03. for PFR and vaginal pessary, respectively.
Activities Assessment Scale (AAS) [98]: It is a valid, Prolapse Quality of Life Questionnaire (P-QOL) [100–
reliable, and responsive measure for the assessment of physi- 104]: It is a simple, valid, and reliable measurement that
cal activities following vaginal reconstructive surgery for includes nine domains (general health perceptions; prolapse
POP and SUI. It includes 13 items for the evaluation of the impact; role; physical, social, and personal limitations; emo-
ability regarding lying in bed, sitting, getting in or out of bed
tions; sleep/energy; and severity measures) with responses
or chair, reaching or stretching, lifting 3–5 pounds, walking having a four-point scoring system. This scoring attributes to
around inside, climbing up or down stairs, walking outside how much the POP symptoms are affecting women’s life
or at work, engaging in sedentary activities (i.e., typing, talk-
ranging from “none/not at all” to “a lot.” Each domain ranges
ing on the phone, playing cards, watching TV), engaging in from 0 to 100. Higher score indicates greater negative impact
light physical activities (i.e., cooking, dusting, clerical work,
on women’s life. Thus, it is a reliable and valid tool for the
visiting friends), engaging in moderate physical activities recognition of women who need a therapeutic intervention,
(i.e., sweeping, washing the car, dancing, playing golf, hik- as symptom severity and their impact on quality of women’s
ing), engaging in vigorous physical activities (i.e., construc-life can be defined. Additionally, P-QOL has been used in
tion work, shoveling, playing tennis or basketball, weight surgical studies, detecting significant improvement of the
lifting), and engaging in sexual intercourse. Responses may quality of life of women undergoing a pelvic reconstructive
receive scores from 1 “no difficulty” to 6 “did not do it for surgery, such as vaginal mesh implantation. In particular,
other reasons.” The total score is calculated using a transfor-MID difference was met in all domains. Nevertheless, the
mation algorithm to produce a range from 0 to 100. Higher latter MID was defined only by a statistical model using the
total score indicates greater physical functioning. “half standard deviation,” as studies with the recommended
methods for determining MID have not been published [94].
Incontinence Impact Questionnaire long (IIQ) and
Condition Specific short form (IIQ-7) (Grade A) [63, 99, 105–107]: The long
form includes 30 items with 4 subscales (physical activity,
Pelvic Floor Impact Questionnaire (PFIQ) long and short travel, social relationships, and emotional health) and a pos-
form (PFIQ-7) (Grade A) [60, 63–66, 84, 91, 99]: It is a sible score of 0–400. Mild, moderate, and severe levels of UI
valid, reliable, and responsive measurement assessing the are defined when IIQ is <50, 50–70, and >70, respectively. In
impact in HRQOL of related, possibly related, and poten- addition, MID for women undergoing continence surgery or
tially related POP symptoms. The short form correlates well PFR or receiving vaginal pessary is −28 to −14 or −37 to
with the long one, while a conversion formula from the short −31 or −17, respectively [88]. IIQ-7 consists of seven ques-
to the long form, with an excellent goodness of fit, has been tions and a possible score of 0–100. Good, moderate, and
published. The long form includes three domains poor QoL is indicated when IIQ-7 is <50, 50–70, and >70,
(Incontinence Impact Questionnaire (IIQ), Pelvic Organ respectively.
Prolapse Impact Questionnaire (POPIQ), and Colorectal- Incontinence Quality of Life Questionnaire (I-QOL)
Anal Impact Questionnaire (CRAIQ)) with 93 items (31 [108–110]: It is a valid and reproducible measure of UI that
items in each domain). The PFIQ-7 includes three domains is more closely related to overall well-being of patients than
(IIQ-7, POPIQ-7, and CRAIQ-7) with 21 items (seven items bodily pain. Initially, it was designed for use in clinical trials
in each domain). The total score of PFIQ-7 ranges from 0 to and in-patient care centers. It has 22 items with three sub-
300 (each domain may receive scores from 0 to 100). A scales (avoidance and limiting behavior, psychosocial
change of ≥36 points (12%) has been suggested as MID for impact, and social embarrassment). MID for patients with
PFIQ-7. In addition, the generic questionnaires of HUI-3, SUI has been proposed to be 2.5 and 6.3 points for between
EQ-5D, and SF-6D correlated significantly but moderately and within treatment, respectively. MID for patients with
with the prolapse subscale of PFIQ-7. The long and short neurogenic bladder ranges from 4 to 11 points.
forms of IIQ, POPIQ, and CRAIQ can also be used individu- King’s Health Questionnaire (KHQ) (Grade A) [101,
ally from the PFDI long and short form, respectively. MID 102]: It is a valid, reliable, and responsive measure of UI
for IIQ has been estimated at −16 points. MID for CRAIQ regardless of type. It has three sections: (1) general health
long and short form is −18 and −8, respectively. However, a and overall health related to urinary symptoms with two
568 S. Athanasiou
questions; (2) incontinence impact, role limitations, physical women, and it was able to quantify the nature and degree of
limitations, social limitations, personal limitations, emo- impaired sexual function in surgically menopausal women.
tions, sleep and energy, and severity coping measures with Changes in Sexual Functioning Questionnaire long
19 questions; and (3) bother or impact of urinary symptoms form (CSFQ) and short form (CSFQ-14) (Grade C) [118,
with 11 questions. MID is indicative when change from 119]: It is a 35-item questionnaire that evaluates changes
baseline to posttreatment is ≥5 in each domain. related to sexual function with an underlying cause (such as
International Consultation on Incontinence medications for illness). It encompasses five domains (sex-
Questionnaire-Lower Urinary Tract Symptoms quality ual desire/frequency, sexual desire/interest, sexual plea-
of life (ICIQ-LUTSqol) (Grade A) [111, 112]: It is a valid, sure, sexual arousal, and orgasm) with scoring of
reliable, and responsive measurement that has been derived individuals’ domains and an overall CSFQ score. It may be
from KHQ, with 22 items. The total score of all items ranges used in both clinical and nonclinical patients (i.e.,
from 0 to 76, and the overall impact on everyday life sub- depressed ones) with responsiveness. A short form with 14
scale from 0 to 10 that is not incorporated in the overall items and three scales has been suggested as a global mea-
score. The MID has been suggested to be 3.71. sure of sexual dysfunction. It addresses desire, arousal,
Fecal Incontinence Quality of Life Scale (FIQL) and orgasm but also the scales of the long form with a
(Grade B) [113, 114]: It includes 29 items with four scales strong internal reliability.
(lifestyle, coping/behavior, depression/self-perception, and
embarrassment). It may distinguish patients with fecal incon-
tinence from patients with other gastrointestinal problems. Condition-Specific PROs
Additionally, it has significant correlations with the SF-36
subscales. However, limitations have been found, and Female Sexual Function Index (FSFI) (Grade C) [120,
suggestions for revisions have been made. In particular, there 121]: It is a valid and reliable 29-item questionnaire with six
is a lack of contrast validity, a highest reliability in patients domains (desire, arousal, lubrication, orgasm, satisfaction, and
with low QoL, and a minimal differential functioning. Thus, pain). It may detect patients with HSDD, FOD, and FSAD. In
it has been suggested formatting, scoring, and instructions to addition, a cutoff value of 26.55 may distinguish patients with
be simplified, items with higher difficulty to be developed, sexual dysfunction from those without. However, a possible
and embarrassment domain to be revised. Furthermore, it has disadvantage is that the evaluation refers in the last 4 weeks.
not been tested in asymptomatic controls. Thus, its capability Cases where sexual intercourse has not been performed for
as a screening tool is unknown. reasons other than sexual dysfunction cannot be detected, as
the response of “not having sexual intercourse” does not
include the possible reasons. Furthermore, the partner’s sexual
Sexual Function problems cannot be addressed.
McCoy Female Sexuality Questionnaire (MFSQ)
Generic PROs (Grade C) [122]: Various versions have been tested using 7,
9, 10, or 17 items that were all valid, reliable, and consistent.
Golombok Rust Inventory of sexual satisfaction (Grade Responses are retrieved with seven-point Likert scales. It is
A) [115]: It is a valid, reliable, and responsive measure that able to identify levels of sexual interest and response in rela-
has 56 items (28 for women and 28 for men) for the assess- tion to levels of estrogens and androgens. In particular, a dif-
ment of heterosexual couples’ sexual relationship and indi- ferentiation of sexual response between women with
vidual’s functioning, as well. It includes 12 domains that are hormone replacement therapy (HRT), oral contraceptives,
divided in five domains for women (anorgasmia, vaginismus, and presence or absence of ovaries may be detected by cer-
avoidance, nonsexuality, and dissatisfaction), five for men, tain items of MSFQ.
and two non-gender oriented (frequency of sexual contact Short Personal Experiences Questionnaire (SPEQ)
and non-communication). [108, 123–126]: It includes nine items with eight of them
Brief Index of Sexual Functioning for Women being adapted from the MSFQ. The first half attributes to all
(BISF-W) (Grade A) [116, 117]: It includes 22 items ini- women irrespectively to partner status, while the second one
tially covering levels of sexual functioning (interest/desire to women with partners (females or males). Sexual desire
and sexual activity) and satisfaction suitable for both clinical (one item), arousal (two items), orgasm (one item), dyspa-
and nonclinical samples. However, a new scoring algorithm reunia (one item), passion for the partner (1 item), and diffi-
was created for clinical trial use, encompassing seven domains culties of partner in sexual performance (one item) are
(thought/desire, arousal, frequency of sexual activity, recep- evaluated. A cutoff score of ≤7 detects women with sexual
tivity/initiation, relationship satisfaction, pleasure/orgasm, dysfunction (79% sensitivity and specificity). In addition,
and problems affecting sexual function). This scoring was SPEQ scores correlate with estradiol levels and, thus, meno-
compared between normative and surgically menopausal pausal status, indicating that from early to late menopause,
46 Patient-Reported Outcomes and Pelvic Organ Prolapse 569
sexual dysfunction may rise from 42% to 88%. Furthermore, lated using a mean value with the intention to automatically
SPEQ may detect the arousal, orgasm, and dyspareunia account of missing data. Better body image is indicated
changes in relation to PFDI scores. Thus, it has been found when BIPOP is scored higher.
that POP is associated with decreased sexual arousal, infre- ICIQ-VS [67], Australian Pelvic Floor Questionnaire
quent orgasm, and dyspareunia. [68], and Electronic Personal Assessment Questionnaire-
Pelvic Organ Prolapse/Urinary Incontinence Sexual Pelvic Floor (ePAQ-PF) [69–72]: They are mixed question-
Function Questionnaire long (PISQ) and short form naires as they address symptoms, sexual functioning, and
(PISQ-12) (Grade B) [127–131]: It has been developed to quality of life of women with POP, as presented above.
evaluate sexual functioning in heterosexual women with UI
or POP and discriminate patients with sexual dysfunction
from those without. Two versions (long form and short form) Patients’ Expectations PROs
have been published. The long form measures 31 items,
while the short one (PISQ-12) only 12 items. PISQ-12 scores Goal Attainment Scaling (GAS) [135–141]: GAS is a mul-
may predict the PISQ-31 scores. For both versions the items tistep approach which begins with the identification of goals
correspond to behavioral-emotive, physical, and partner- by the patients. Initially, patients list their goals and the
related. Likert scale ranging from always (0 score) to never importance of each goal to them (fairly important, very
(4 score) is encompassed. Scores are obtained for all domains important, and extremely important). Afterward, anticipated
individually. The sum of all scores creates a total PISQ score. or expected outcome levels are discussed with the urogyne-
PISQ total score ranges from 0 to 125. Higher values indi- cologist. Thus, unrealistic goals may be eliminated. After the
cate better sexual functioning, while MID is set at 6 points. completion of therapy, assessment of goal attainment is
Furthermore, it has a sensitivity of 78% and specificity of rated. The scores may be “0” when the goal is achieved as
72% for the detection of women with depression. However, predicted, “+1” or “+2” when achievement is above the level
PISQ has defaults. The partner-related domain does not eval- predicted (“somewhat better than expected or predicted” or
uate the response of partners to POP and UI but the women’s “much better than expected or predicted,” respectively),
perception regarding her partners’ response. In addition, its “−1” when achievement is below the expected level, and
capability to address sexual function following a pelvic sur- “−2” when there is worsening of the target function.
gery is inadequate, because it cannot identify most surgery- Self-Assessment Goal Achievement (SAGA) [141]: It is
specific negative effects on sexual function. a patient-completed questionnaire designed to assess goal
PISQ-International Urogynecological Association attainment in behavioral or pharmacologic treatment of
(IUGA) Revised (PISQ-IR) [132, 133]: It is a valid, reli- LUTS/OAB. It is a comprehensive and easy-to-understand
able, and responsive measure of sexual function that devel- questionnaire. At baseline, SAGA includes nine fixed treat-
oped from the PISQ-12 and attributes to both sexually and ment goals and up to five additional treatment goals specified
nonsexually active women. It includes 42 items evaluating by the patients. The five most important goals are ranked,
both sexual activity status and sexual function. It is the only and the criteria for successful achievement of the most
PRO for sexual function that has been validated not only in important goals are identified. At follow-up, the degree of
women with POP and/or UI but also in women with anal achievement of each individual (fixed and additional) goal,
incontinence (AI). It has been found to correlate with the as well as the overall goal, is rated.
PFDI-20, ISI, and EPIQ question 35, for both sexually and Expectations, Goal Setting, Goal Achievement, and
nonsexually active women, and for the sexually active ones Satisfaction (EGGS) [138, 143]: It combines all patient-
additionally correlate with FSFI and POPQ. Results of the centered outcomes (expectations, goal setting, goal achieve-
PISQ-IR may be calculated using the transformed summa- ment, and satisfaction). It has been suggested to become the
tion or the mean calculation. Guidelines for both methods fourth dimension for the assessment of PFD along with the
have been published. In addition, a summary score is not rec- physical findings, symptoms, and QoL outcomes. Specifically,
ommended, as explaining or understanding relationships it was found that women who did not chose surgical interven-
between items is not feasible. tion had as primary goal information seeking, while patients
Body Image in the Pelvic Organ Prolapse Questionnaire with a primary goal other than the symptom goal were more
(BIPOP) [134]: It is a valid, consistent, and reliable 21-item likely to choose alternative to surgery interventions.
questionnaire developed to identify the impact of POP on
body image. It has two versions, one for women with a sex-
ual partner and one for those without. In particular, this mea- Patients’ Satisfaction PROs
surement aims to identify how women feel or might have felt
regarding their attractiveness, confidence, femininity, and Patient Global Impression (PGI) Scales [144–148]: Valid and
sexual intimacy due to their anatomical changes when they reliable measurements for LUTS and POP that include a single
have or have not a sexual partner, respectively. It is calcu- item aiming to evaluate a certain condition overall and not sepa-
570 S. Athanasiou
rately its components. Thus, patients may rate the severity (PGI- with UI and/or OAB. It is a single-item questionnaire with
S) or bothering (PGI-B) of their condition and the change six possible responses evaluating the problems (from “none”
(PGI-C) or improvement (PGI-I) following a therapeutic inter- to “many severe”) due to the bladder condition. PPBC cor-
vention. Depending on type of PGI, responses may involve relates with the bladder diaries, OAB-q, and KHQ.
four- to seven-point scales. PGI-S and PGI-I correlate signifi- Specifically, higher PPBC improvement indicates greater
cantly with number of UI episodes, stress pad test, and QoL reductions in frequency, urgency episodes, and symptom
questionnaires. Moreover, PGI-C and PGI-I are valid, reliable, bother and significantly greater improvement in HRQL in
and sensitive to change measures that can be used following a comparison to a minor PPBC improvement.
prolapse surgery. Furthermore, PGI-I is a single question that is Benefit, Satisfaction, and Willingness (BSW) [130,
answered post-surgery with an excellent positive correlation 155]: It is a three-item questionnaire designed to evaluate the
with POP-Q and pQoL and a negative correlation with self- perception of patients regarding the benefit, satisfaction, and
documentation in goal achievement. Thus, it may be considered willingness to continue with the therapy. It was validated by
a tool for the definition of surgery “success” for POP, as it three randomized controlled trials for the assessment of tolt-
reflects the objective, subjective, QoL, and patients’ goal. erodine in OAB patients. In these studies correlations
However, it may score higher than ICIQ in women undergoing between BSW and the improvements of OAB-q, KHQ, and
surgery for UI or POP, overestimating the surgical results. bladder diaries were evident.
Surgical Satisfaction Questionnaire (SSQ-8) [149, Treatment Satisfaction with Medicines Questionnaire
150]: It is a valid and reliable tool for the patient satisfaction (SATMED-Q) [156, 158]: It is a valid, reliable, and respon-
following pelvic surgery. It includes eight items with five- or sive 17-item questionnaire with six domains (treatment
six-point scale responses (from “very satisfied” to “very effectiveness, convenience of use, impact on daily activities,
unsatisfied” or “very satisfied” to “N/A” or “yes” to “never”). medical care, global satisfaction, and undesirable side effects
In women with advanced POP that underwent reconstructive that have been evaluated in chronically ill patients). The
or obliterative surgery, the postoperative answers of SSQ-8 MID has been suggested at 13.4 for total score. For domains
are comparable with the improvements from preoperative to the MID ranges from 10.3 (medical care) to 20.6 (impact on
postoperative IIQ and UDI. daily living/activities) points.
Global Perception of Improvement (GPI) [61, 151], Treatment Satisfaction Questionnaire for Medication
Patient Satisfaction Questionnaire (PSQ) [151], and (TSQM) [158, 159]: It is a sound and valid measure for
Estimated Percent Improvement (EPI) [151]: GPI is simi- patients’ satisfaction with two versions, an initial long with
lar to the PGI-I, but it includes five-point scale responses 55 items and a second shorter with 31 items. Both versions
(from “much better” to “much worse”) instead of seven-point include four scales: side effects, effectiveness, convenience,
scale responses. PSQ is a single-item questionnaire that eval- and global satisfaction.
uates the level of satisfaction following a therapeutic inter- Overactive Bladder Satisfaction (OAB-S)
vention. It may receive responses using a five-point scale Questionnaire [160, 161]: It is a valid questionnaire with
(from “very satisfied” to “very dissatisfied”). GPI, PSQ, and five scales involving OAB Control Expectations (ten items),
EPI are valid measurements for outcomes of behavioral treat- Impact on Daily Living with OAB (10 items), OAB Control
ment for UI. They all correlate positively with the reduction (ten items), OAB Medication Tolerability (six items), and
of the number of UI episodes in the bladder diary and the Satisfaction with Control (ten items). In addition, it includes
change in the IIQ. They all correlate negatively with the five single-item overall assessments of patient’s fulfillment
desire of another treatment. In addition, GPI along with the of OAB medication expectations, interruption of day-to-day
PSQ and the incontinence episodes (IE) has been used for the life due to OAB, overall satisfaction with OAB medication,
determination of the MID of UDI and OAB-q. willingness to continue OAB medication, and improvement
Patient Perception of Treatment Benefit Questionnaire in day-to-day life due to OAB. OAB-S has better test reli-
(PPTBQ) [130, 152]: It evaluates whether patients perceive ability than TSQM, discriminating patients by severity level
a benefit from the treatment. Responses vary from “no ben- and detecting change in satisfaction levels in OAB patients.
efit,” “little benefit,” and “much benefit”). PPTBQ along
with bladder diaries, PPBC, OAB-q, and IIQ-7 has been used
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Integrated Imaging Approach to Pelvic
Organ Prolapse 47
Giulio A. Santoro, Andrzej P. Wieczorek,
Magdalena Maria Woźniak, Jonia Alshiek,
Abbas Shoebeiri, and Abdul H. Sultan
68
Evident
66
Occult
13
Functional 44 Organic
10
Rectal intussusception
Innternal mucosal prolapse
Anxiety, depression
Rectocele
28
15
33
Cystocele - prostatism
Pudendal neuropathy
28
Peritoneo-entero-sigmoidocele
Rectal hyposensation
13
Slow transit, IBS
urogynecologist or the colorectal surgeon [9, 10]. Moreover, imaging as magnetic resonance imaging (MRI) or evacua-
a single symptom such as obstructed defecation can be due tion proctography (EP) may be indicated.
to a variety of “occult” conditions often underestimated, This chapter aims to review the various imaging tech-
rather than to what is clinically evident, as reported in the niques and to demonstrate why and how they should be used
“iceberg diagram” by Pescatori et al. [11] (Fig. 47.1). These in combination to overcome the fractured unidisciplinary
causes, if present, are not uppermost in patients’ conscious- approach, providing a comprehensive assessment of the ana-
ness and must be searched for by the clinician, before rec- tomic damages and dysfunctions of the PF.
ommendation for treatment.
Imaging plays an important role to visualize abnormali-
ties undetected by the clinicians and/or to confirm clinical 47.2 Review of Imaging Techniques
findings to correlate with symptoms [12–15]. Although, in
recent years, new techniques have dramatically improved the 47.2.1 Evacuation Proctography (EP)
diagnostic accuracy in patients with POP, there is still no
single modality that can provide a comprehensive overview Evacuation proctography is the traditional modality used by
of the PF. In order to obtain as much information as possible, colorectal surgeons to assess the causes of obstructed defeca-
it is therefore fundamental an integration of different tech- tion syndrome (ODS): rectal prolapse, rectocele, intussus-
niques to overcome the limitations of each method. Routine ception, and anismus. It is also used by urogynecologists to
use of ultrasound techniques is a useful adjunct to clinical evaluate posterior compartment prolapse and to confirm or to
investigation and allows to assess multicompartmental disor- exclude an enterocele. This examination requires meticulous
ders. In most cases ultrasound imaging is adequate to select preparation of the patient consisting of laxatives and enemas,
a correct management, reducing the number of unnecessary with subsequent rectal administration of various contrast
surgeries and thus minimizing the risk of failures, as well as mediums, most often a combination of barite suspension
faster and more effective treatment of postoperative compli- with an appropriate proportion of potato paste, similar to the
cations. In difficult cases or when there is no agreement stool consistency. In the urogynecology setting, it is fre-
between clinical and ultrasound findings, the second level of quently used in a modification called cysto-urethro-colpo-
47 Integrated Imaging Approach to Pelvic Organ Prolapse 579
defecography, and it requires the administration of contrast symphysis) and the β angle/retrovesical angle (RVA: the
medium per os and in the bladder, vaginal lumen, and distal angle between the line extending through the lumen of the
colon. The movement of pelvis organs at rest, during evacu- proximal urethra and the line extending across the surface
ation phase, and squeezing is referred to the pubococcygeal of the bladder base). Normal values for bladder neck
line (PCL). descent (BND) have not been established; however, 20 mm
Evacuation proctography has the following disadvan- is considered as the limit value, above which urethral
tages: embarrassing for the patient, difficult to perform, low hypermobility is defined. It has been shown that this mea-
availability, and X-ray exposure in young females. surement strongly correlates with symptoms of stress uri-
nary incontinence (SUI) [17–20]. According to Al-Saadi
et al. [21], urethral hyper-rotation is more often observed in
47.2.2 Ultrasonography (US) SUI. Cystocele severity is usually evaluated by determining
the maximal descent of the bladder (MDB) relative to the
In a recent document to standardize the terminology for PF symphysis pubis during Valsalva maneuver [12]. Ni et al.
ultrasound (PFUS), a joint committee of international scien- [22] proposed an automatic cystocele severity grading by
tific societies (AIUM/AUGS/IUGA/ACR/AUA) proposed spatiotemporal regression. 2D TPUS also allows to assess
the practice parameter for the performance of urogyneco- the position of implanted tapes or meshes, as described by
logic US examinations [16]. The terminology for PFUS was Wlazlak et al. [23].
standardized as “perineal PFUS,” “introital PFUS,” “endo- For the middle compartment, the distance of the cervix
vaginal US” (EVUS), and “endoanal US” (EAUS). For the from the lower edge of the pubic symphysis [17] is mea-
purposes of this chapter, the perineal PFUS and the introital sured, and for the posterior compartment, measured the ano-
PFUS are grouped together under the old term of transperi- rectal angle (ARA: it is formed by the line running along the
neal US (TPUS). posterior wall of the rectum and the central axis of the anal
canal) is measured. An additional tool enabling the assess-
47.2.2.1 Two-Dimensional Transperineal ment of biomechanical properties of pelvic structures is the
Ultrasound (2D TPUS) “motion tracking” technique (vectors reflecting the displace-
The most frequently used US technique in urogynecology is ment of pelvic organs and muscles). It proved to be effective
TPUS. This term is synonymous with different applications in evaluating the functionality of the puborectal muscle dur-
of the US transducer: introital, translabial, or transperineal. ing contraction and relaxation [24].
This access enables visualization of the pelvic organs in the Limitations of 2D TPUS are the low frequencies
sagittal, oblique, and transverse section [12, 17]. It is usually (2–6 MHz) used that may result in poor resolution and lack
performed by convex transducers with 2–6 MHz frequency of detailed information of the examined structures. An addi-
range routinely used for abdominal US or by endovaginal tional limitation is the difficulty to perform correct measure-
end-fire transducers with 6–10 MHz frequency range used ments in patients with IV° degrees prolapse, because of the
for endovaginal and endorectal examinations or also by lin- displacement of transducer from the perineum. Hence the
ear transducers. Examination is performed in a lying posi- translabial approach should be preferred to the introital
tion, no gynecological chair is required, no special approach.
preparation for the patient is needed, and no contrast medium
is used. 47.2.2.2 Three-Dimensional Transperineal
In the midsagittal section, 2D TPUS shows the anatomi- Ultrasound (3D TPUS)
cal relationships of the three PF compartments at rest and Three-dimensional US was introduced at the end of the
during dynamic maneuvers. Its main aim is to assess the 1990s. Supplementing the 2D images with the third plane
contraction and relaxation of the levator ani/puborectalis allows a very accurate evaluation of the PF. By using trans-
muscle, the dimension of the levator hiatus, the mobility of ducers with a higher frequency than 2D probes (3–8 MHz),
the urethra and bladder neck, and the displacement of the it is possible to assess more accurately the morphology of
pelvic organs during maximal squeezing and straining [12, pelvic structures.
17]. The reference line to evaluate the position and mutual Volumetric 3D data can be stored and analyzed after the
relations of these organs is a plane/line running parallel to examination (off-line), also performing post-processing
the lower edge of the pubic bones in the caudal, dorsal analysis such as surface and volume render mode (SRM,
direction (H line). The distance between the bladder neck VRM), multiplanar reconstructions (MPR), or tomographic
and the H line is termed bladder symphysis distance (BSD) ultrasound imaging (TUI). 3D TPUS allows accurate visual-
[18]. The position and mobility of the urethra are also ization of the pelvis at selected levels after prior definition of
assessed by measuring the γ angle (the angle between the the region of interest (ROI). Assessment includes position of
line running through the pubic symphysis and the line con- the urethra, vagina, and anus in the axial plane, symmetry
necting the bladder neck and the lower edge of the pubic between each other and compared to pubic symphysis, eval-
580 G. A. Santoro et al.
uation of levator ani muscle and its attachment to the inferior anal canal provide excellent resolution. Automatic 3D acqui-
pubic rami, and measurement of biometric indices of levator sition reduces to a minimum the probability of artifacts com-
hiatus [18, 25, 26]. This modality is mainly used to visualize pared to “freehand” modality.
defects of the levator muscle components and to measure the EAUS has become the first step of imaging in proctology
urogenital hiatus in both nulliparous and multiparous women for the assessment of perianal fistulas and for the preopera-
with pelvic floor disorders. 3D TPUS has high repeatability tive staging of anorectal cancers [33]. In urogynecology, the
and reproducibility between operators [27, 28], and it is con- main indication of EAUS is the evaluation of obstetric anal
sistent with MRI [29]. Multiplanar and tomographic TPUS sphincter injuries (OASIS) [34]. According to the latest rec-
give access to the axial plane and allow to assess both levator ommendations of the International Consultation on
ani avulsion and hiatal ballooning which are correlated to Incontinence (ICI), the International Continence Society
organ prolapse severity and are risk factors for recurrence (ICS), and the International Urogynecological Association
after surgery [30–32]. Dietz et al. [31] described the minimal (IUGA), it has been defined as the “gold standard” investiga-
criteria for the diagnosis of avulsion of the puborectalis mus- tion of anal sphincter integrity [35–37]. Ultrasound anatomy
cle by TUI. of the anal canal and differences in its morphology between
The limits of 3D TPUS are similar to 2D TPUS: low reso- males and females are well known [12]. The anal canal is
lution and low penetration and difficulty to assess patients divided into three levels: in the upper part, there is the
with IV° degrees prolapse. Moreover, the position of the puborectal muscle; in the middle part, the external (EAS)
volumetric transducer at the introitus does not allow to visu- and internal anal sphincters (IAS); and in the lower part, only
alize the perineal body and the perineal muscles (e.g., bulbo- the subcutaneous EAS [12]. High-frequency EAUS allows
spongiosus, ischiocavernosus, and superficial transverse accurate measurements of anal sphincters and differentiation
perinei muscles) [18]. of abnormalities (thickening, thinning, atrophy, scars,
defects) [12]. 3D dynamic endorectal US may also be used to
47.2.2.3 Four-Dimensional Transperineal perform echodefecography [38]. This method allows to iden-
Ultrasound (4D TPUS) tify dysfunctions of the posterior compartment such as recto-
The simultaneous assessment of three perpendicular planes celes, intussusception, mucosal prolapse, and paradoxical
can also be performed real time (4D US). This technique can contraction (anismus) as well as of the middle compartment
be used for live 3D evaluation of pelvic organs, levator ani, (enterocele/sigmoidocele). The advantage of echodefecogra-
and levator hiatus during Valsalva maneuver and maximal PF phy is the ability to visualize causes of ODS without irradiat-
contraction (MPFC). However, in patients with IV° degrees ing the patient [39].
prolapse, accurate assessment of anatomical structures is
very difficult, as confirmed by Majida et al. [25] who reported 47.2.2.5 Three-Dimensional Endovaginal
that the visualization of the anterior and posterior borders of Ultrasound (3D EVUS)
the urogenital hiatus was possible only in 29% of cases. Axial images of the pelvis with high-frequency 3D EVUS
These results show that the 4D TPUS requires further (9–16 MHz) are similar to those with 3D TPUS; however, the
improvements before routinely use in clinical practice [25]. higher frequency provides better resolution of the examined
structures. EVUS examination is performed with the same
47.2.2.4 Three-Dimensional Endoanal 360° rotational transducers used for 3D EAUS. Patient is in
Ultrasound (3D EAUS) the lying position with the pelvis raised on her fists. No spe-
At the end of the 1990s, technological progress in the field of cial preparation is required, and no contrast medium is used.
endosonographic transducers resulted in the introduction of The probe must be inserted into the vagina in a neutral posi-
high multifrequency 360° rotational probes allowing high- tion so that it does not cause pressure on the surrounding tis-
resolution US. They were initially used to perform 2D EAUS sues, which could distort the anatomy [40]. In axial cross
and then replaced with new probes with 3D automatic acqui- section, pelvic structures are assessed in four levels: Level 1,
sition. These transducers (radial electronic transducer, at the highest level, the bladder base can be visualized on the
Hitachi Medical Systems, Japan, and mechanical rotating screen at 12 o’clock position and the inferior third of the rec-
transducer, types 2052, 8838, 20R3, BK Medical Herlev, tum at 6 o’clock position; Level 2, corresponds to the bladder
Denmark) differ in acquisition of 3D data (freehand or auto- neck, the intramural region of the urethra and the anorectal
matic). When using a mechanical transducer (type 2052), 3D junction; Level 3, corresponds to the midurethra and to the
is collected in the axial plane for a maximum of 60 mm in upper third of the anal canal; and Level 4, at the outer level,
60 s and consists of 300 consecutive images, where the num- the superficial perineal muscles, the perineal body, the distal
ber and thickness of layers can be individually selected by urethra, and the middle and inferior third of the anal canal can
the operator during the examination [33]. The 3D volume be evaluated [40]. High-resolution 3D EVUS allows an accu-
can be archived for off-line analysis. The high frequency of rate evaluation of the symmetry urethra/anal canal, the mor-
the transducer (9–16 MHz) and the direct contact with the phology of the urethra (rhabdosphincter, lisosphincter) and of
47 Integrated Imaging Approach to Pelvic Organ Prolapse 581
the supporting ligaments and fascia [41], the levator ani mus- dynamic MRI defecography replaced EP, enabling not only
cle subdivisions [42] and the indices of levator hiatus (area, to reduce exposure to radiation but also to obtain a much
length, and width) [43], and the integrity of the perineal body larger dose of information compared to the traditional X-ray
and the rectovaginal fascia [44]. 3D EVUS showed high study [57–59]. There are also reports on 3.0 T resonance for
interobserver reproducibility [43], which is important from defecographic tests, which provides images of such high
the perspective of using this modality on a larger scale in resolution that it is possible to identify undiagnosed clini-
clinical practice. 3D EVUS with automatic volumetric acqui- cally silent abnormalities [60]. Diffusion and tractographic
sition provides high-resolution images in all reconstructed techniques allow to assess in great details the distribution of
planes. This technique is also helpful in the postoperative levator ani fibers and their damages [51, 52].
evaluation of tapes and meshes. MPR allows to visualize The reference line used for the evaluation of pelvic organs
implanted elements and to identify displacement, shrinkage, at rest and during MPFC and maximal Valsalva maneuver is
fluid collections, abscesses, or hematomas. the PCL [50], which is defined on midsagittal images as the
line joining the inferior border of the symphysis pubis to the
47.2.2.6 Dynamic Endovaginal Ultrasound last or second last coccygeal joint. The anorectal junction
EVUS performed with electronic biplane transducer (type (ARJ) is defined as the cross point between a line along the
8848 BK Medical) or linear electronic transducer (type 8838 posterior wall of the distal part of the rectum and a line along
BK Medical) allows a dynamic assessment of the anterior the central axis of the anal canal. ARA is defined as the angle
and posterior compartment [12]. The biplane probe has both between the posterior wall of the distal part of the rectum and
convex and linear arrays which provide acquisition in the the central axis of the anal canal and can be measured at rest,
longitudinal and axial cross sections. it allows precise visual- during squeezing and straining. In normal condition, the
ization of the urethra (intramural part, mid-urethra, and dis- upper edge of the levator plate should run parallel to the PCL
tal urethra) and the rectum (anorectal junction, ARA, perineal line. The H line measures the distance between the lower part
body). It also provides information of urehtral vascularity by of the pubic symphysis and the posterior part of the ARA. The
using the color Doppler [45–47]. It is also possible a dynamic M line is perpendicular to the P line to the farthest point of
assessment by asking the patient to squeeze and to strain, in the H line, indicating the degree of PF descent [61]. Comiter
order to detect urethral hypermobility, cystocele, rectal pro- et al. [62] described the correct values for H and M lines,
lapse, rectocele, intussusception, enterocele, and anismus which are approximately 5 and 2 cm, respectively. Nardos
[12]. The linear electronic transducer type 8838 also enables et al. [63] showed that the measurements of the urogenital
automatic 3D data acquisition, providing accurate assess- hiatus obtained in the sagittal plane with MRI were signifi-
ment of urethral pathology, congenital abnormalities, and cantly higher compared to the measurements obtained with
postoperative complications. TPUS in nulliparas, both at rest, Valsalva, and squeeze.
According to the authors, this can be due to a different inter-
pretation of the reference anatomical points.
47.2.3 Magnetic Resonance Imaging (MRI)
Magnetic resonance allows simultaneous imaging of all pel- 47.3 Review of the Literature
vic compartments, making them visible in a very compre- and Recommendations
hensive way. Static MRI assesses the anatomy, morphology,
and relationships between organs as well as their abnormali- In 2010, an IUGA/ICS joint report on the terminology for
ties. A limit of this technique is the difficulty to visualize female pelvic floor dysfunction [36] stated that US has
tapes and meshes and to evaluate postoperative results [48]. become an increasingly frequent adjunct investigation in
In urogynecology, MRI can also be performed using the vag- urogynecology and female urology both in the office and in
inal coil to obtain better resolution in the assessment of the the urodynamic laboratory allowing assessment of postvoid
urethra and periurethral structures. However, the invasive- residuals, intercurrent pelvic pathology, uterine version, and
ness of this examination results in low compliance and very bladder or urethral abnormalities. Six years later, an IUGA/
limited application [49]. Recently, dynamic studies [50–53] ICS joint report on the terminology for female POP [37]
and diffusion and tractography MRI techniques [54, 55] have stated that imaging may assist the clinical assessment of POP
been introduced in the diagnosis of PFD. Dynamic pelvic or intercurrent PFD. The use of any of the different imaging
MRI is a helpful adjunct to physical examination and urody- modalities is, however, entirely optional. MRI provides the
namic testing, particularly when patient’s symptoms do not opportunity to examine the supporting structures of the PF
correspond to physical examination findings. It can guide and evaluate POP, levator ani defects, and postoperative
preoperative and postoperative surgical management in most results [36]. In 2017, an IUGA/ICS joint report on the termi-
patients, especially in the setting of multicompartmental dis- nology for female anorectal dysfunction defined the role of
orders [56]. In highly specialized urogynecological centers, imaging in the diagnosis and management of posterior
582 G. A. Santoro et al.
c ompartment disorders [64]. Ultrasound has been increas- Lone et al. [71] found a good to excellent agreement between
ingly incorporated as a useful investigation in patients with two examiners in the evaluation of all three compartments
anal incontinence, anal pain, and ODS. The sixth ICI, based and suggested that multicompartment PFUS should be con-
on the concept that pelvic organ dysfunction includes multi- sidered as a systematic integrated approach to assess the PF.
ple conditions, proposed integrated PFUS with a combina- Static MRI provides a comprehensive visualization of all
tion of different modalities (2D, 3D, 4D, dynamic, as well as pelvic structures. It is performed at a magnetic field strength
EVUS, EAUS, TPUS) for a global and multicompartmental of 1.5 T, using pelvic or phased-array coils and T2-weighted
perspective (Fig. 47.2). However, the values of this approach fast-spin echo (FSE) sequences. The spatial resolution can
in routine assessment of PFD are yet to be evaluated [65]. be enhanced by using endoluminal (endorectal, endovaginal)
Ultrasound has several advantages (low cost, wide acces- coils. In combination with T2-weighted FSE sequences,
sibility and availability, office procedure performed by clini- endoluminal coils provide improved signal-to-noise ratio
cians, intraoperative technique, less time-consuming, good (SNR) and high-resolution images. The prominent pelvic
compliance) and should be performed as first-line assess- floor structures of the posterior compartment visualized at
ment in PFD [66]. Dynamic US (TPUS/EVUS/echodefecog- MRI are the perineal body, the superficial perineal muscles,
raphy) has the potentiality to replace EP in the evaluation of the anal sphincters, the puborectalis muscle and levator ani,
ODS, allowing to differentiate enterocele, rectocele, internal the rectum, and the rectal support. With the development of
intussusception, mucosal rectal prolapse, and paradoxical fast multi-slice sequences, MRI has gained increasing accep-
anal sphincter and puborectalis contraction (anismus) [12]. tance for dynamic imaging of the posterior compartment
Electronic transducers with Color Doppler mode provide (MR defecography) [64]. Piloni et al. [59] described the
information on the vascularity of the urethra, which is char- methodology of this technique, the diagnostic criteria, and
acterized by different flow parameters [46, 67–69]. Vascular grading for ODS. The proposed system in five grades of
abnormalities may be related to urinary incontinence. combination of abnormalities seen at MR defecography was
Ultrasound has also been demonstrated useful in the postop- correlated to therapeutic options.
erative assessment of the position of mesh and sling. MRI provides a comprehensive evaluation of the pelvic
Transobturator (TOT) or transvaginal (TVT) tapes posi- floor; however it still has limited accessibility and high cost
tioned between 50 and 80 percentile of urethra length and requires highly specialized equipment and qualified
resulted in a success rate of 91% in patients with SUI [70]. medical staff. It should be considered as a second-line assess-
Clinicians are increasingly adopting a more holistic ment tool after ultrasound.
approach with a combination of different US modalities for Van Gruting et al. [72] evaluated the diagnostic accuracy
a multicompartmental assessment of PFD [12] (Fig. 47.2). of EP, MRI, TPUS, and EVUS for detecting posterior com-
2D: Two-dimensional; 3D: Three-dimensional; EAUS: Endoanal ultrasound; EVUS: Endovaginal ultrasound; LA: Levator ani; LH: Levator
hiatus; PR: puborectalis mucle; TPUS: Transperineal ultrasound; UGH: urogenital hiatus
Fig. 47.2 Combination of different US modalities for the integrated, multicompartmental assessment of PFD [12]
47 Integrated Imaging Approach to Pelvic Organ Prolapse 583
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Urogynecol J Pelvic Floor Dysfunct. 2002;13:236–52.
Transperineal Ultrasound: Practical
Applications 48
Hans Peter Dietz
Chapter 6 introduced normal pelvic floor anatomy as imaged 48.2 Instrumentation and Indications
by translabial/ transperineal or ‘pelvic floor’ ultrasound. This
chapter will cover the use of this modality in clinical prac- Instrumentation and basic examination technique are cov-
tice. To date, urogynaecology as taught in textbooks remains ered in Chap. 6 which also provides information on the tech-
largely uninformed by imaging; as a result it is permeated by nique of 3D ultrasound. Figure 48.1 shows the standard
multiple misconceptions and misunderstandings. Even most orientation for 3D/4D pelvic floor ultrasound, obtained by
recent publications and teaching materials produced by placing an abdominal 3D/4D transducer on the perineum.
learned societies contain information that is contradicted by The A plane on the left conventionally shows the midsagittal
functional anatomy as seen on simple 2D translabial ultra- plane, with the symphysis pubis in the top left-hand corner of
sound since the mid- eighties. that image as traditionally seen on 2D translabial imaging
The growing interest in pelvic floor imaging in recent since 1986. B and C planes are often omitted for convenience
years is attributable to several distinct factors. Pelvic floor but are available at the touch of a button. The right-hand
dysfunction includes a number of conditions that are increas- image shows a rotated, semitransparent representation of all
ingly prevalent in our ageing populations. The estimated life- pixels contained in a ‘region of interest’, that is, the ‘box’
time risk for prolapse or urinary incontinence surgery is seen in Image A. This method of representing volume ultra-
sound data was originally developed to enable visualization
of the foetal face, but, rather fortuitously, it is eminently suit-
H. P. Dietz (*) able for imaging of the entire levator hiatus, including the
Sydney Medical School Nepean, University of Sydney,
symphysis pubis, urethra, bladder base, vagina, anorectum
Sydney, NSW, Australia
e-mail: hpdietz2@bigpond.com and levator plate.
a b
Fig. 48.1 Standard orientation of translabial 4D pelvic floor ultrasound. The transducer is placed midsagittally. The midsagittal plane is repre-
sented in (a), a rendered volume in the axial plane in (b). The images represent findings on maximal Valsalva in a patient with stress urinary
incontinence and mild anterior compartment descent. A anus, B bladder, L levator ani, R rectal ampulla, S symphysis pubis, U urethra
Table 48.1 Indications for pelvic floor ultrasound imaging regarded as abnormal, although both lower and higher cut-
Clinical indications for pelvic floor ultrasound offs have been proposed. Abnormal volume measurements
(a) Anal incontinence should be confirmed after at least one more void. Occasionally,
(b) Assessment of synthetic implants (slings, meshes and bulking incidental foreign bodies or bladder tumours may be detected
agents) (Fig. 48.2). Detrusor wall thickness of > = 5 mm (detrusor
(c) Defecatory dysfunction hypertrophy) seems associated with urge urinary inconti-
(d) Levator ani muscle assessment after childbirth
nence and detrusor overactivity [13]. Detrusor hypertrophy
(e) Obstructed defecation
(f) Obstetric perineal injury can be variable depending on location, with the dome often
(g) Obstetric anal sphincter injury thicker than the posterior bladder base beyond the trigone,
(h) Pelvic or vaginal pain after pelvic floor surgery especially in women with cystocele (Fig. 48.3). As a result,
(i) Pelvic organ prolapse DWT is not in fact a good test [14, 15]. Unlike the situation
(j) Pelvic pain and dyspareunia in the male bladder, DWT may not be predictive of voiding
(k) Perineal cyst or mass difficulty in women [16, 17]. Occasionally, a trigonal cystic
(l) Symptoms of voiding dysfunction
structure may be observed, the differential diagnosis being
(m) Urinary incontinence
(n) Vaginal cyst or mass such as a urethral diverticulum ureterocele and Nabothian follicle (Fig. 48.4).
(o) Vaginal discharge or bleeding after pelvic floor surgery
(p) Voiding dysfunction 48.3.1.1 T he Anatomy of Stress Urinary
Incontinence
In women suffering from stress urinary incontinence or uro-
Indications for pelvic floor ultrasound include virtually dynamic stress incontinence, the proximal urethra commonly
all conditions seen in an urogynaecological clinic and are rotates postero-inferiorly on Valsalva manoeuvre as the ure-
listed in Table 48.1. thra and anterior vaginal wall are tethered to the symphysis
pubis and the pelvic sidewall. In essence, the symphysis acts
as a fulcrum around which the entire anterior compartment
48.3 Anterior Compartment Pathology rotates. Points of reference for measurements of bladder neck
mobility are either the central axis of the symphysis pubis
48.3.1 Residual Urine and Bladder Wall [18] or its inferior-posterior margin [19]. The former may be
more accurate, providing measurements that are independent
Ultrasound is commonly utilized to determine postvoid of transducer position or movement. However, obtaining the
residual urine. Using the transperineal route, the residual central axis of the pubis can be difficult in postmenopausal
volume in millilitres may be estimated by using the formula women due to calcification of the interpubic disc, and visual-
X cm × Y cm × 5.6 [12], with X and Y denoting the largest ization of the entire interpubic disc makes inclusion of the
dimensions of the bladder, obtained perpendicular to each posterior compartment and anorectal angle in the resulting
other, in the midsagittal plane. Volumes over 50 ml are image or volume difficult to impossible.
48 Transperineal Ultrasound: Practical Applications 589
a b
Fig. 48.2 Bladder stone (long arrow, left) and transitional cell carcinoma (TCC; short arrow, right). (a) The stone is hyperechogenic and shows
distal acoustic shadowing; (b) the TCC is iso-echoic and produces no shadowing
a b
Fig. 48.4 Cystic structures in the anterior compartment, seen in the vesico-ureteric junction. Ureteroceles fill and empty with ureteric peri-
midsagittal or parasagittal planes. (a) Ureterocele, i.e. a sacculation of stalsis. (b) Nabothian follicle which is part of the cervix and moves with
the intravesical part of the ureter, which is due to a stenosis of the it on Valsalva
a b
c d
Fig. 48.5 Determination of bladder neck descent and retrovesical demonstrate the measurement of distances between inferior symphy-
angle: ultrasound images show the midsagittal plane at rest (a, c) and on seal margin and bladder neck (vertical, x and horizontal, y) and the ret-
Valsalva (b, d). A anal canal, B bladder, L levator ani, R rectal ampulla, rovesical angle at rest (rva-r) and on Valsalva (From [19], with
S symphysis pubis, U urethra, Ut uterus, V vagina. The lower images permission)
48 Transperineal Ultrasound: Practical Applications 591
a b
Fig. 48.6 Marked funnelling of the bladder neck (arrows) on Valsalva in the midsagittal plane (a) and a rendered volume (b). Such appearances
are suggestive of a low-pressure urethra (‘intrinsic sphincter deficiency’) and urodynamic stress incontinence
a b
c d
Fig. 48.7 Gartner cyst (Mullerian remnant; large arrows) as seen in the the circular urethral rhabdosphincter, confirming the diagnosis. The pri-
midsagittal plane (a), coronal plane (b), axial plane (c) and axial ren- mary differential diagnosis, a urethral diverticulum, grows from inside
dered volume (d). The small arrows in the bottom right panel indicate the rhabdosphincter and tends to destroy its ring structure
592 H. P. Dietz
a b
d
c
e f
h
g
Fig. 48.8 Varying appearances of urethral diverticula. Images of the mid- (a, b) Hyperechogenic foci and distortion; (c, d) Small cystic structure; (e,
sagitta (a, c, e, g) and coronal plane (b, d, f, h) obtained from 4 different f) Simple posterior urethral diverticulum; (g, h) Circumferential complex
patients with a confirmed urethral diverticulum on urethroscopy are shown. urethral diverticulum. Arrows indicate the diverticulum
48 Transperineal Ultrasound: Practical Applications 593
a b c
Aa
Ba
Bp D
Ap tvl
Fig. 48.9 Cystocele on clinical examination (a). ICS POPQ diagram and coordinates (b) and pelvic floor ultrasound in the midsagittal plane (c).
A anus, B bladder, L levator ani, S symphysis pubis, U uterus
a b
Fig. 48.10 Cystocele types as seen on maximal Valsalva in the midsagittal plane. (a) Cystocele with open retrovesical angle of over 180° (RVA,
indicated by lines placed through the trigone and the proximal urethra). (b) Typical large cystocele with intact retrovesical angle of about 110°.
A anus, B bladder, L levator ani, S symphysis pubis
firmed urethral diverticula. A urethral diverticulum usually pathogenesis for cystourethrocele [28]. Occasionally, a
arises dorsal to the urethra and may develop by surrounding severe cystocele may result in inversion of the bladder neck,
the organ, initially within the confines of the fascia of the that is, rotation of the bladder neck up to 180° on Valsalva
urethral rhabdosphincter, explaining the horseshoe shape of and marked urethral kinking. Fig. 48.11 shows quantification
larger diverticula (Fig. 48.8d). Occasionally, they may also of pelvic organ descent in a patient with three-compartment
be found ventral to the urethra, i.e. in the space of Retzius. prolapse.
Most often, however, excessive descent of the anterior
vaginal wall is indeed a ‘cystocele’ or prolapse of the bladder 48.3.1.3 Central Compartment
as shown in Fig. 48.9. Historically, two types of cystoceles The uterus can be difficult to identify because of its iso-
have been described, and they seem to have rather different echoic nature, similar in echotexture to the vagina, especially
functional implications (Fig. 48.10) [27]. A cystourethrocele in women with small, atrophic uteri. In women with signifi-
or Green type II cystocele is associated with stress urinary cant uterine descent, a specular (mirror-like) echo indicates
incontinence and normal voiding, while a cystocele with the leading edge of the cervix. Nabothian follicles may help
intact retrovesical angle or Green type III cystocele tends to distinguish the cervix from vaginal wall (Figs. 48.4 and
be found in women with voiding dysfunction and symptoms 48.12). Occasionally, imaging will show a retroverted uterus
of prolapse rather than stress incontinence. The former is not compressing the urethra and/or bladder neck, explaining
associated with avulsion of the levator ani, as opposed to the symptoms of voiding difficulties. Even more impressively, a
Green type III cystocele, which argues against a traumatic low anteverted uterus may result in rectal intussusception in
594 H. P. Dietz
women with symptoms of obstructed defecation, which is physiological and therapeutic implications, even if, on clini-
termed a ‘colpocele’ on defecation proctography (Fig. 48.13). cal assessment of surface anatomy, those conditions are
generally subsumed under the term ‘rectocele’. Many gynae-
48.3.1.4 Posterior Compartment cologists are unaware of this fact since they never see any-
Descent of the posterior vaginal wall can be due to a number thing but surface anatomy. Even digital rectal examination
of different anatomical abnormalities with different patho- (which needs to be performed on Valsalva to demonstrate
true rectocele and intussusception) is not routinely employed.
The link between anatomical abnormalities and defeca-
tory dysfunction, mostly in the sense of obstructed defeca-
tion (incomplete bowel emptying, straining at stool and
digitation) [29], is frequently not fully appreciated by both
gynaecologists and colorectal surgeons. The ‘gold stan-
dard’ diagnostic method, defecation proctography, is inva-
sive, expensive and not commonly available. Pelvic floor
ultrasound is cheaper, non-invasive and much better
accepted by the patient and seems to yield similar findings
[30–32], even without 3D/4D imaging. It is poised to
replace defecation proctography for the initial investigation
for women with posterior compartment prolapse and
obstructed defecation [33].
Clinical posterior compartment descent is most com-
monly found to be due to a ‘true’ or radiological rectocele on
imaging: a defect of the rectovaginal septum that results in
Fig. 48.11 On Valsalva in the midsagittal plane, prolapse is quantified
herniation of the anterior wall of the rectal ampulla into the
against a horizontal line placed through the inferoposterior symphyseal
margin, as in this patient with three-compartment prolapse. There is vagina [34]. On translabial ultrasound the rectovaginal sep-
descent of the bladder neck to 16 mm below the symphysis, of the blad- tum (RVS) is often not easy to visualize (see Fig. 6.15, for an
der to 19 mm below, of the uterus to 21 mm below, of an enterocoele to exception) unless one uses endovaginal imaging, but direct
26 mm below and of the rectal ampulla to 31 mm below the reference
assessment of the RVS on static ultrasound seems to be of
line. B bladder, E enterocoele, R rectal ampulla, S symphysis pubis,
U uterus very limited clinical utility [35].
a b
Fig. 48.12 A Nabothian follicle (arrow) can provide a convenient ing axial plane rendered volume in (b) is not suitable for hiatal mea-
marker of the cervix, as in this patient with third-degree cystocele and surement since the line of minimal dimensions (oblique line in a) lies
second-degree uterine prolapse. The green line of the region of interest partly outside the box. This manifests in an overestimate of hiatal depth
(the ‘box’ in a) serves as the line of reference here; however, the result- posteriorly. A anal canal, B bladder, S symphysis pubis, U uterus
48 Transperineal Ultrasound: Practical Applications 595
a b
Fig. 48.13 A colpocele, i.e. a rectal intussusception propelled by the wall are shown by the dotted line, (a) with the cervix inverting the ante-
cervix of a prolapsing uterus. This usually is due to the cervix (as in this rior wall of the rectal ampulla. A anal canal, B bladder, Cx cervix,
patient), but very occasionally an acutely retroverted uterus can result in S symphysis pubis, Ut uterus. The dotted line in (b) shows hiatal area
a colpocele caused by the fundus. The anal canal and anterior rectal
a b c
Aa
Ba
Bp D
Ap tvl
Fig. 48.14 Rectocele on clinical photograph (a), representation on POP-Q (b; Ba = −3, C = −4, Bp = +1) and appearances on imaging (c; A anal
canal, B bladder, L levator ani, R rectocele, S symphysis pubis) (From [109], with permission)
Diagnosis of a ‘true’ rectocele does not rely on identifica- Both rectocele and perineal hypermobility are associated
tion of the RVS itself but rather on demonstration of a pocket with symptoms of prolapse, i.e. of a vaginal lump or a drag-
or diverticulum, i.e. a discontinuity of the anterior anal mus- ging sensation, but obstructed defecation is more likely with
cularis on Valsalva (Fig. 48.14). A rectocele is defined by its a true, radiological rectocele, that is, a defect of the RVS
depth and descent relative to the symphysis pubis (Fig. 48.15). [37]. Other causes of posterior compartment prolapse
Another manifestation of posterior compartment descent is include a combined rectoenterocele, an isolated enterocele,
perineal hypermobility where the RVS is intact but may be rectal intussusception or a deficient perineum giving the
abnormally distensible (Fig. 48.16), synonymous with impression of a ‘bulge’ [38, 39]. Rectal intussusception is
‘descending perineum syndrome’ and associated with exces- an early stage of rectal prolapse where rectal mucosa and
sive distensibility of the levator hiatus [36]. The latter is not muscularis enter the proximal anal canal, changing it to a
surprising since the levator plate distends not just laterally ‘martini glass’ configuration. This condition, not uncom-
but downwards as well. mon but rarely diagnosed by gynaecologists, is strongly
596 H. P. Dietz
a b
c d
Fig. 48.15 Translabial ultrasound images in the midsagittal plane. (a) reference line placed through the ventral aspect of the internal anal
and (c) are images at rest; (b) and (d) are obtained on maximal Valsalva. sphincter. A anal canal, B bladder, R rectal ampulla, S symphysis pubis,
(b) Rectocele descent against a reference line placed through the infero- V vagina (From [110], with permission)
posterior symphyseal margin; (d) Rectocele depth measured against a
a b c
Fig. 48.16 Anatomical abnormalities of the posterior vaginal compart- of the rectal ampulla without rectocoele (‘perineal hypermobility’) and
ment associated with symptoms of obstructed defecation, showing a (c) rectal intussusception (From [111], with permission)
‘true rectocoele’, i.e. (a) defect of the rectovaginal septum, (b) descent
48 Transperineal Ultrasound: Practical Applications 597
associated with abnormalities of the levator ani muscle and between the vagina and anorectum, distorting and compress-
hiatus [40]. ing a true rectocele, enterocoele or intussusception, without
Current ultrasound data do not support the classification addressing the actual underlying abnormality. Even the use
of defects originally described by Cullen Richardson [34], of posterior compartment mesh may not be truly curative as
suggesting that some of the defects described were artefac- shown in Fig. 48.17 where a true rectocele is prevented from
tual, i.e. produced on dissection. This is plausible given the developing into the vagina by an Apogee mesh. While the
technical challenges inherent in separating the vaginal mus- posterior vagina now looks normal, neither the patient’s
cularis from the RVS proper. symptoms of obstructed defecation nor the anatomical
A competent assessment of posterior compartment pro- abnormality are cured, since her rectocele now develops into
lapse by imaging can have substantial therapeutic conse- the perineum.
quences. The overwhelming majority of women with If a patient suffers from a symptomatic true rectocele,
posterior compartment descent are treated with a simple pos- then clearly a defect-specific rectocele repair should be the
terior colporrhaphy, a procedure that creates a scar plate surgical treatment of choice [41]. Figure 48.18 shows find-
a b
Fig. 48.17 Posterior mesh repair (a, small arrows) usually ‘cures’ the large to cause symptoms, developing into the perineum rather than the
vaginal manifestation of rectocele. However, sometimes the rectocele vagina (b, big arrow outlined by dots)
itself, i.e. the diverticulum of the rectal ampulla, is still sufficiently
a b
Fig. 48.18 Sonographic appearances on Valsalva, before (a) and 6 months after (b) defect-specific rectocele repair. A anal canal, B bladder,
R rectocele/rectal ampulla, S symphysis pubis (From [112], with permission)
598 H. P. Dietz
ings before and 3 months after repair of a transverse RVS aspects indicating bowel wall. Peristalsis is commonly
defect. On the other hand, if posterior compartment descent observed on real-time scanning.
is due to a hyper-distensible fascia or perineal descent, plica- The treatment of rectal intussusception (Fig. 48.20) is even
tion of this fascia or even a levatorplasty may be a better more controversial, although this is a controversy that gynae-
surgical option. Needless to say, it seems to make little sense cologists are rarely exposed to since they are unlikely to diag-
to remove portions of rectal wall as in the STARR (stapled nose the condition. Intussusception is even more strongly
transanal rectal resection) procedure in someone who has a associated with symptoms of obstructed defecation than recto-
herniation of the rectal wall due to a defect of the RVS, since cele [42] and is often associated with other manifestations of
one would expect neither the rectocele nor the patient’s prolapse. In the author’s unit, it has a prevalence of about 1:25.
symptoms to be cured. A further complication may be the development of a lateral or
Figure 48.19 demonstrates typical appearances of an iso- posterior rectocele due to severe damage to the levator plate;
lated enterocoele which tends to manifest clinically as post- this may also be considered a buttock hernia and is palpable on
hysterectomy vault prolapse. This is less common than a digital rectal examination during Valsalva manoeuvre.
combination of recto- and enterocoele. Both may also occur The standard approach to rectal intussusception is a recto-
in women with intact uterus. The contents of an enterocoele pexy, either via a laparotomy or laparoscopically. This usu-
are usually the small bowel and/or omentum which appears ally involves mesh and can be combined with a vault
iso-echoic and homogeneous, less often the sigmoid colon suspension procedure. Another approach implemented in the
which tends to be more inhomogeneous with hypo-echogenic unit of the author is to utilize the RVS for an anterior vaginal
a b c
Aa
Ba
Bp D
Ap tvl
Fig. 48.19 Vault prolapse/enterocele on clinical photograph (a), representation on POP-Q (b; Ba = −3, D = +2.5, Bp = −1) and appearances on
imaging (c; B bladder, E enterocele, R rectal ampulla, S symphysis pubis) (From [109], with permission)
a b
Fig. 48.20 Intussusception with unusual posterior rectocele (arrow) in patient with severe obstructed defecation, bilateral avulsion and severe
ballooning. The distended ampulla with posterior sacculation is outlined in all three orthogonal planes in the midsagittal plane (a) and a rendered
volume showing the axial plane (b)
48 Transperineal Ultrasound: Practical Applications 599
rectopexy to the sacrospinous ligaments. This can conve- Figure 48.21 contrasts tomographic imaging (TUI) of a
niently be combined with a vault suspension and avoids normal anal sphincter on the left with the same sphincter
denervation of the rectum, a common consequence of open 3 months after a vaginal delivery when it showed a signifi-
or laparoscopic rectopexy procedures. cant defect that had been overlooked immediately postpar-
tum; in the delivery suite, a second-degree perineal tear
48.3.1.5 The Anal Sphincter had been diagnosed by the attending midwife. Even after
The external and internal anal sphincters are usually imaged accurate diagnosis and primary repair of a major perineal
with endo-anal ultrasound [43] and MRI [44], which is particu- tear, a significant defect of the external anal sphincter
larly useful in women with faecal incontinence and after obstet- remains visible in 30–40% of patients [50], both in the
ric anal sphincter injury (OASI). These techniques are intrusive, short term and many years later when over 50% of patients
involving endo-anal placement of an ultrasound probe or are symptomatic [53].
endocoil. Distortion of the anatomy is inevitable, which may be Sonographically detected defects are associated with anal
one explanation why our textbook illustrations often seem so incontinence, both after OASI repair [50, 53] and later in life
different from observed anatomy on real-time ultrasound. [51]. To quantify the extent of trauma, we determine the
For different reasons, neither MRI nor endo-anal ultra- number of abnormal slices, with > = 4/6 slices required for
sound allow dynamic assessment on manoeuvres, e.g. on the diagnosis of a ‘residual defect’ [52]. Another method is
sphincter contraction. Exo-anal ultrasound imaging on the to measure the defect angle as in Fig. 48.22; a cut-off has
other hand does not have these disadvantages. It was first empirically been set at 30°, although attempts at validating
described by Peschers et al. in 1997 [44] and is now widely defect angle have not been successful to date [54].
used to image the anal sphincter using either endo-vaginal or Translabial ultrasound of the anal sphincter is increasingly
transabdominal probe [45–48]. This method has been shown used in research. Its simplicity and superior acceptance by
to have good correlation with 2D endo-anal imaging [48] and patients [55] will, much more so than in the case of more intru-
recently has been developed further using modern 4D trans- sive methods, allow incorporation into clinical practice. While
ducers [49–53]. For a detailed overview of this novel tech- pain, oedema and the presence of suture material make imag-
nique, see [52]. ing difficult shortly after childbirth, exo-anal imaging is emi-
For imaging of the anal canal, we use a standard curved nently feasible within a very few days. Follow-up after
array volume transducer in the transverse or coronal plane, 2–3 months, once the effect of potential neuropathy has sub-
i.e. perpendicular to the anal canal. The probe is inclined sided, allows a final assessment of the quality of both diagno-
quite steeply from ventrocaudal to dorsocranial to obtain a sis and treatment in the delivery suite. Establishment of
coronal view of the anal canal (Fig. 6.3). Additional appli- postnatal imaging services in the context of ‘perineal clinics’
cation of gel in the midline is often beneficial to fill the is overdue as third-degree tears are frequently overlooked after
gluteal fold. Imaging is performed on sphincter contraction childbirth, with the experience of the personnel involved being
which seems to enhance the definition of muscular defects. one of the main factors in the diagnosis [56], and as primary
Figures 6.15–6.18 describe the basic methodology. repair is clearly insufficient in many cases [50, 53].
Fig. 48.21 Tomographic imaging of the anal sphincters. This is a comparison of (a) antenatal and (b) postnatal imaging, showing a 3b perineal
tear (asterisk) that was overlooked in the delivery suite
600 H. P. Dietz
Fig. 48.22 Overlooked, unrepaired 3b tear with well-repaired episiotomy. The angle measurements illustrate quantification of this tear which
measures well over 30° in 5/6 slices
Figures 48.21–48.25 show different forms of residual anal incontinence. However, it has to be mentioned that such
anal sphincter defects after vaginal delivery. In Fig. 48.22 abnormalities of the internal anal sphincter can at times be
there is evidence of a 3b tear that was not recognized at the observed in women without a history of surgical intervention.
time of postnatal suturing of an episiotomy (see arrow).
Figure 48.23 demonstrates a poor result after end-to-end 48.3.1.6 Synthetic Implants
repair, while Fig. 48.24 shows equally poorly reconstructive Synthetic implants have become popular for the surgical
results after an overlap repair. Even worse, Fig. 48.25 repre- treatment of stress urinary incontinence and since the
sents a rectovaginal fistula after a poorly repaired fourth- mid-2000s also for POP. Over the last 5 years. There has
degree tear. Due to increasing medicolegal and public been a backlash due to novel complications such as
pressure, maternal trauma will likely become a key perfor- chronic pain and erosion, with substantial adverse public-
mance indicator of obstetric services [57]. As regards ante- ity on social media and in the lay press. This is increas-
natal and intrapartum research, future perinatal intervention ingly leading to referrals for imaging of slings and meshes,
trials should include imaging of maternal trauma as an out- a task for which few imaging services are equipped or
come measure since maternal trauma is a common adverse trained.
consequence of vaginal childbirth. While biological materials such as Surgisis or Permacol
On a final note, occasionally one will encounter other tend to degrade over time and may not remain visible on any
abnormalities which may at times interfere with identification imaging modality, this is not the case for implants made of
of the caudal margin of the internal anal sphincter. The latter polypropylene and similar synthetic materials. Synthetic
is, as mentioned in Chap. 6, important for reproducible slice sling and mesh implants are virtually invisible on MR, CT
placement. Figure 48.26 is an inflamed, symptomatic haemor- and conventional X-ray but highly echogenic on sonographic
rhoid, while Fig. 48.27 shows what is likely an iatrogenic imaging. Ultrasound can confirm the presence of suburethral
defect of the internal anal sphincter after haemorrhoidectomy slings (Figs. 48.28–48.34) and distinguish different types of
repair, a not uncommon cause of post- haemorrhoidectomy implants (see Fig. 48.29 for a transobturator sling) [58].
48 Transperineal Ultrasound: Practical Applications 601
Fig. 48.23 Poor reconstructive result after end-to-end repair of a 3c tear after forceps delivery
Fig. 48.24 Status after unsuccessful overlap repair of a 3c tear, showing substantial distortion and a marked perineal scar (arrows). The patient
was faecally incontinent
602 H. P. Dietz
Fig. 48.25 Small rectovaginal fistula 3 months after insufficiently repaired 3c tear. The fistula is a small filiform echogenic line, indicated by
arrows in two central slices. The two arrows in the top left-hand image indicate the longitudinal extent of the internal anal sphincter defect
Fig. 48.26 Inflamed haemorrhoid on tomographic imaging, indicated by arrows. Haemorrhoids can obscure the distal aspect of the internal anal
sphincter and sometimes even the external anal sphincter, interfering with the assessment
48 Transperineal Ultrasound: Practical Applications 603
Fig. 48.27 Status after haemorrhoidectomy in a 60-year-old patient with mild anal incontinence. The internal anal sphincter is invisible between
4 and 7 o’clock in most slices and thickened over the remaining circumference, possible iatrogenic trauma
a b
Fig. 48.28 Appearance of a typical suburethral sling (arrow) in the midsagittal plane at rest (a) and on maximal Valsalva (b). The line in (b)
demonstrates measurement of the sling- pubis gap. B bladder, R rectum, S symphysis pubis
604 H. P. Dietz
a b
Fig. 48.29 Suburethral slings are generally hyperechoic and easily wall to the other is clearly shown, demonstrating that the mesh remains
identified posterior to the urethra. On this image a Monarc transobtura- well outside the donut-shaped urethral rhabdosphincter (From [113],
tor tape is shown in the midsagittal plane (a) and in an axial rendered with permission)
volume (b). In the axial plane, the course of mesh from one pelvic side-
a b
Fig. 48.30 TFS (tissue fixation system) slings as seen in the midsagit- lapse. In (a) there is an implant under the trigone, and in (b) another is
tal plane in two different patients. The TFS has been used not just for found in the perineum. The latter is the most prone to erode and cause
urinary incontinence as a suburethral sling, which appears highly echo- chronic pain
genic and nondeformable (as seen in both a and b), but also for pro-
Standard polypropylene slings have a rather typical sono- Suburethral slings all seem to act by direct, dynamic com-
graphic appearance that changes under load as the implant is pression under load, which is apparent on imaging, with the
deformed by interaction with surrounding tissues. More sling changing from a linear to a c-shape [59]. Complications
densely woven tapes such as the IVS may be smaller and due to excessive tensioning such as voiding dysfunction or
harder to visualize or wider and less deformable, such as the de novo symptoms of urgency and/or urge incontinence
TFS (Fig. 48.31). commonly have a sonographic correlate in a tightly rolled-up
48 Transperineal Ultrasound: Practical Applications 605
a b
Fig. 48.31 ‘Tethered’ suburethral sling (TVT) in the midsagittal plane metry is perforation of the urehral rhabdosphincter on the patient’s left.
(a), the coronal plane (b) and the axial plane (c). The tape (arrows) The longitudinal smooth muscle does not seem to be affected. Such
seems unremarkable in (a), but in (b) it is apparent that it does not run placement is due to surgical error and may be asymptomatic. Its natural
symmetrically. In (c) it becomes obvious that the cause of this asym- history is unclear
a b
c d
Fig. 48.32 A TVT that has perforated the urethra as imaged in the midsagittal plane (a), the coronal plane (b), the axial plane (c) and a rendered
volume in the axial plane (d). Part of the tape on the patient’s right hand side has been removed
606 H. P. Dietz
a b
c d
Fig. 48.33 Patient after TVT division due to de novo urgency, urge and axial views, with the two free tape ends indicated by arrows. The
incontinence and chronic mild obstruction. (a) shows the midsagittal gap between the two tape ends is also evident in the axial plane ren-
plane (A anal canal, B bladder, R rectal ampulla, S symphysis pubis, dered volume (d), with a gap between the cut ends of about 5–7 mm at
U urethra). The arrow indicates the most likely location for a TVT, but rest (Adapted from [114], with permission)
the tape is invisible in the midsagittal plane. (b) and (c) shows coronal
band that leaves only a small gap between the implant and widely, but some materials such as Macroplastique (TM) are
symphysis pubis, especially on Valsalva. This ‘sling-pubis echogenic and easily identified para-urethrally or under the
gap’ (Fig. 48.28) seems to be the most consistently useful bladder neck (Fig. 48.35). However, appearances on imaging
measure of ‘sling tightness’, with a gap of 8–14 mm on max- are not predictive of treatment success.
imal Valsalva being rated as ‘normal’ [60]. An implant that is Mesh implants used in prolapse surgery are another o bvious
seen as too close to the urethra, rigid and compressive, with indication for translabial ultrasound, and 3D/4D imaging with
a low sling-pubis gap of less than 8 mm, will prompt the sur- sectional plane and rendering capabilities is particularly useful
geon either to attempt dilatation/stretching of the sling if in identifying polypropylene mesh implants (Figs. 48.36–
identified within the first week or 10 days, or to undertake 48.42) [61–63]. In the anterior compartment, mesh is com-
sling division at a later stage. monly situated posterior to the bladder neck, caudal to the
In some instances slings are shown to be ‘tethered’, i.e. trigone and the posterior bladder wall, visible as an echogenic
placed deep to the fascia of the urethral rhabdosphincter and linear or curvilinear structure. Mesh can be identified in the
therefore through the muscle rather than outside it, as shown three orthogonal planes (Fig. 48.36) and also in rendered vol-
in Fig. 48.31. Occasionally, imaging will suggest perforation umes (Fig. 48.37).
and/or stenosis (Fig. 48.32). Sling division, a minor proce- A Valsalva manoeuvre often helps visualization and
dure that may be performed under local anaesthetic, tends to shows mesh rotating around the fulcrum of the symphysis
result in a 5–10 mm gap between mesh arms documenting pubis. More caudally placed transobturator meshes can act
successful division as shown in Fig. 48.33. Rarely, faulty like an oversized trigonal sling, rotating dorsocaudally.
sling placement will result in perforation and even transec- Persistent prolapse of the central or posterior compartment
tion of the urethra, and ultimately the implant may be found and distance from the transducer can impair visualization by
in the space of Retzius (Fig. 48.34). Injectables are not used translabial imaging. While mesh shrinkage, contraction or
48 Transperineal Ultrasound: Practical Applications 607
Fig. 48.34 The final outcome of urethral tape erosion may not necessar- This transobturator tape (arrow), 7 years after implantation, is now situ-
ily be surgical removal. Occasionally the tape may erode through the ated in the space of Retzius. (b–c) An orthogonal representation of imag-
entire urethra to eventually be found in the space of Retzius, as in this ing shown here is particularly useful to define the spatial extent of
patient who had symptoms of the overactive bladder, voiding dysfunc- unusual para-urethral findings
tion and recurrent UTIs for years without being assessed or treated. (a)
a b
c d
Fig. 48.35 Macroplastique silicone macroparticles used in inconti- (a–c) and in a rendered volume (d). The implant is visible as a donut
nence surgery are very echogenic and found surrounding the urethra shape in c and d
both anteriorly and posteriorly, as shown both in the orthogonal views
608 H. P. Dietz
a b c
Fig. 48.36 Identification of anterior compartment mesh on Valsalva der, L levator ani, R rectum, S symphysis pubis (Modified from [59],
(a, midsagittal plane; b, coronal plane; and c, axial plane). Arrows show with permission)
mesh length in the midsagittal (a) and the coronal plane (b–c). B blad-
a b c
Fig. 48.37 Ultrasound images showing anterior mesh failure: (a) at the bladder neck, leading to dislodgement of the mesh from the bladder
rest; (b) on submaximal Valsalva manoeuvre; (c) on maximum Valsalva. base. B bladder; BN bladder neck, L levator ani muscle, R rectum, S
Cystocele recurrence ventral and caudal to a well-supported mesh sug- symphysis pubis, U urethra (From [60], with permission)
gests that the caudal aspect of the implant was insufficiently secured to
a b
Fig. 48.38 Translabial imaging of a transobturator anterior compartment mesh. The mesh (arrows) is seen posterior to proximal urethra and blad-
der neck in the midsagittal plane (a) and in a rendered volume in an oblique axial plane (b) (From [115], with permission)
48 Transperineal Ultrasound: Practical Applications 609
a b c
Fig. 48.39 Ultrasound images showing apical mesh failure: (a) at rest; nial mesh aspect suggests dislodgement of apical attachment. B blad-
(b) on submaximal Valsalva manoeuvre; (c) on maximum Valsalva. der, S symphysis pubis, U urethra (From [60], with permission)
Cystocele recurrence dorsal to the mesh with high mobility of the cra-
a b c
Fig. 48.40 Ultrasound images showing global mesh failure: (a) at rest; of the entire mesh on Valsalva, suggesting dislodgement of both lateral
(b) on submaximal Valsalva manoeuvre; (c) on maximum Valsalva. and apical attachments. B bladder, L levator ani muscle, R rectum, S
Cystocele recurrence behind the mesh is associated with high mobility symphysis pubis (From [60], with permission)
a b
Fig. 48.41 Midsagittal view (a) and axial plane rendered volume (b) despite severe levator ballooning evident in the axial plane (b) in this
in a patient after successful Perigee (P) and Apogee (A) implantation. patient with bilateral avulsion injury (Modified from [59], with
The midsagittal plane (a) demonstrates absence of prolapse on Valsalva, permission)
retraction is often considered as one of the causes of pelvic likely due to poor surgical technique and/or an excess of
pain after mesh repairs [64], this has been refuted by longitu- material, resulting in mesh folds during implantation or
dinal studies [62, 65]. The so-called mesh shrinkage is very immediately after closure [65].
610 H. P. Dietz
a b
Fig. 48.42 (a) Suburethral sling (‘Monarc’) and posterior compart- tal intussusception (I), which is due to an enterocele barred from devel-
ment mesh repair (‘Apogee’) in a patient with clinical prolapse cure and oping into the vagina (A anal canal, L levator ani, R Rectum, S symphysis
symptoms of obstructed defecation 6 months postoperatively. (b) A rec- pubis)
Prolapse recurrence after mesh use can be a particularly other hand, the evidence suggests that they are no more
vexing problem. In a recent study of recurrence after anterior effective and clearly more likely to lead to complications
mesh repair [63], we identified three distinct anatomical situ- than native tissue repair in the posterior compartment. They
ations: (1) anterior failure, cystocele ventral and caudal to a may be encountered sonographically as hyperechogenic cur-
mesh with intact anchoring; (2) apical failure, cystocele/ vilinear structures in the posterior vaginal wall (Figs. 48.41
anterior enterocele/uterine prolapse dorsal and caudal to a and 48.42). Figure 48.42 shows an unusual complication in a
mesh with failure of apical anchoring and finally (3) global patient with post- hysterectomy vault prolapse who was
failure, cystocele with high mesh mobility due to failure of ‘cured’ by a posterior compartment mesh. Postoperatively
both apical and lateral anchoring mechanisms she developed de novo obstructed defecation which on imag-
(Figs. 48.38–48.40). ing turned out to be an intussusception. Her enterocoele, pre-
Most prolapse recurrence in this series was global or api- vented from passing through and everting the vagina, now
cal (i.e. failure of apical and lateral anchoring). Only a small inverts the rectal ampulla, trying to pass through the alternate
minority showed anterior failures which suggest dislodg- passage of the anal canal.
ment of the mesh from the bladder base, likely due to faulty
surgical technique [63]. This implies that most cases of cys-
tocele recurrence are ‘engineering’ problems rather than 48.3.2 The Levator Ani
issues of surgical technique. This is supported by the obser-
vation that dislodgment of mesh-anchoring structures is Axial plane imaging 3D/4D ultrasound has allowed the intro-
associated with hiatal area on Valsalva [63]; the larger the duction of axial plane imaging into clinical practice. This is
hiatus, the higher the loads placed on anchoring structures particularly useful for the assessment of the pelvic floor in the
such as transobturator arms and the higher the probability of narrower sense: the levator ani muscle and hiatus. Translabial
mechanical failure of load-bearing structures [66]. It should ultrasound has confirmed 60-year old, forgotten clinical data
not be difficult to come up with engineering solutions to the [69, 70] and recent MRI studies [71] showing that major struc-
problem of anchor dislodgment; unfortunately, research and tural abnormalities of the levator ani muscle are common in
development in this field seems to have come to a halt due to women who have given birth vaginally [3]. Most recent studies
poor patient selection and unscrupulous marketing which use the methodology described in this chapter for the assess-
has provoked widespread medicolegal action. As a result, ment of such trauma and show a prevalence of 10–15% after
many women have suffered complications such as chronic normal vaginal delivery, 10–20% after vacuum and 40–60%
pain and erosion without any conceivable benefit. after forceps delivery, with the highest prevalence after rota-
Unfortunately, ultrasound is largely useless in the evaluation tional forceps; for an overview of prevalence, see [72].
of these two main mesh complications. Reproducible assessment of the levator ani muscle on
Anterior compartment meshes, as long as they are translabial 3D/4D ultrasound requires identification of the
anchored effectively, result in superior anatomical outcomes, plane of minimal dimensions, i.e. the minimal distance
especially in women with major levator tears [67, 68]. On the between the interpubic disc ventrally and the anorectal angle
48 Transperineal Ultrasound: Practical Applications 611
dorsally (Fig. 48.43). This provides the reference plane for taken clinical obstetrics so long to realize how common
standardized assessment both of the levator hiatus, the larg- major maternal trauma truly is, and how important for the
est hernia portal in the human body, and of the insertions of future life of the affected mother: avulsion is the primary
the puborectalis muscle on the inferior pubic ramus, the modifiable etiological factor in the pathogenesis of female
commonest location of major maternal birth trauma. pelvic organ prolapse [72].
A defect of this muscle insertion is defined as ‘avulsion’, Figure 48.44 illustrates a comparison of clinical examina-
due to the caudal aspects of the levator ani muscle, the tion, axial plane rendered volume and MR imaging in a
‘puborectalis’ or ‘pubococcygeus/pubovisceralis’ muscle, patient with unilateral right-sided levator avulsion after a
being separated from the bone on which it inserts in a direct normal vaginal delivery at term. The levator can in fact be
muscle-bone ‘enthesis’. The only known mechanism for imaged with a 2D ultrasound—either with the help of a side-
such trauma is excessive distension of the muscle during firing endocavitary probe or with an abdominal curved array
vaginal delivery at the time of crowning of the foetal head. placed in a parasagittal orientation (Fig. 48.45) [73].
This trauma is most commonly occult as the vaginal skin and However, it is more convenient and much more reproducible
muscularis layer tend to fail in a different location, together to use standard 3D/4D abdominal/obstetric probes placed on
with the perineal body. This frequently leaves the site of the perineum in the midsagittal plane (Fig. 6.1). Using set-
avulsion covered by intact vagina, preventing discovery of an tings similar to those for imaging a baby’s face, a rendered
avulsion, even if a vaginal haematoma may at times signal volume, with the rendering direction set from distally to
major hidden trauma. It is not surprising therefore that it has proximally, results in images that rival MRI (Fig. 48.46).
a b c d
Fig. 48.43 Measuring hiatal dimensions as shown in an oblique single (approx. 1.8 cm deep) is located between the symphysis pubis and the
axial plane (a, b) and in a rendered volume (c, d). The determination of levator ani posterior to the anorectal angle. Image (d) represents a semi-
hiatal dimensions using a single oblique axial plane is shown in (a) and transparent view of all pixels in the ROI box on the left. The dotted line
(b). The midsagittal plane on the left (a) demonstrates a line indicating in (b) and (d) represents hiatal area measurements (23.05 cm2 in (b),
the minimal sagittal diameter of the hiatus, i.e. the location of the 21.77 cm2 in (d)) (From [115], with permission)
oblique axial plane shown in (b). The region of interest (ROI) box in (c)
a b c
Fig. 48.44 Typical right-sided levator avulsion injury was diagnosed partum. This patient was asymptomatic apart from deep dyspareunia
in the delivery suite after a normal vaginal delivery at term, (a) on 3D (From [115], with permission)
ultrasound (b) and on magnetic resonance imaging (c) 3 months post-
612 H. P. Dietz
a b
caudal
dorsal
Symphysis
pubis
Puborectalis muscle
Pelvic
sidewall
Fig. 48.45 Parasagittal view of the insertion of the puborectalis mus- transducer placement; (b) schematic line drawing of the principal struc-
cle on the pelvic sidewall. The image in (c) shows a normal insertion of tures seen in (c) (From [74], with permission)
the muscle, with the hyperechogenic muscle fibres clearly visible. (a)
Fig. 48.46 Right-sided avulsion in a patient with third-degree cysto- muscle contraction, showing a right-sided complete avulsion (asterisk).
cele and first-degree uterine prolapse. The midsagittal plane (a) shows A anal canal, B bladder, L levator ani, S symphysis pubis, U uterus. The
descent of bladder and uterus on Valsalva. (b) Tomographic representa- patient’s right side is represented on the left side of the slices
tion of the puborectalis muscle in the patient obtained on pelvic floor
Standardized evaluation of the levator ani is made possi- rently near impossible with other diagnostic modalities.
ble (and very simple) by the acquisition of volume data, i.e. Avulsion can be diagnosed in several different ways includ-
fan-shaped blocks of volume pixels or ‘voxels’, which is cur- ing palpation [74], but multislice or tomographic imaging
48 Transperineal Ultrasound: Practical Applications 613
(TUI) is probably the most reproducible and valid, [75–78], omission of this step in the generation of a set of TUI slices
and it correlates well with MR for the diagnosis of levator may result in false-positive findings in caudal slices. This
trauma [79]. particularly affects women with a strong levator contraction
Figure 48.46 shows a typical right-sided complete avul- in whom warping of the levator plate from ventrocaudal to
sion of the puborectalis on tomographic imaging in a patient dorsocranial may be quite marked.
with cystocele and stage 1 uterine descent, while Fig. 48.47 If the appearance of muscle insertions on TUI is equivo-
demonstrates a bilateral defect on TUI, complete on the right cal due to partial trauma, scar tissue, limited image quality
and partial on the left. Incomplete defects do not seem to be or artefact, the ‘levator-urethra gap’ (LUG) (Fig. 48.48)
associated with prolapse or prolapse recurrence [80], which can be very useful in establishing a diagnosis, even if any
means that the distinction between incomplete and complete biometric measurement is of course subject to interethnic
trauma, i.e. the definition of a ‘full avulsion’, is crucial. and interindividual variation. It is therefore not surprising
Given the generally accepted 2.5 mm interslice interval for that different cut-offs for a ‘normal’ LUG have been estab-
pelvic floor tomography, the minimal criterion for a full lished for Caucasians (2.5 cm) [81] and East Asians
avulsion requires the three central slices in Figs. 48.46 and (2.36 cm) [79]. The LUG has an equivalent on MRI [82]
48.47 to be abnormal [76]. This implies that slice location is and can be used as the only criterion for the diagnosis of
of the essence, and it is fortunate that the appearance of the avulsion [83]. Usually, imaging for levator assessment is
symphysis pubis allows standardization of slice location to performed on pelvic floor muscle contraction as this
within 1 mm (Fig. 48.47). Care has to be taken, however, enhances tissue discrimination, but TUI at rest seems to be
with identification of the plane of minimal dimensions, as equally valid [84, 85].
Fig. 48.47 Tomographic imaging of the puborectalis, showing a com- the central slice and closed (invisible) on the right-central slice) is
plete right-sided and partial left-sided avulsion. The required appear- shown by the arrows
ance of the symphysis pubis (open on the left-central slice, closing on
614 H. P. Dietz
Fig. 48.48 Illustration of the measurement of the levator-urethra gap (LUG) in the three central slices of a tomographic representation of the
puborectalis muscle. All measurements on the left (the patient’s right) are clearly abnormal, indicating a complete right-sided avulsion
Major delivery-related levator injury plays a substantial [95] and since extensively validated against MRI [96] and
role in the aetiology of female pelvic organ prolapse. Very clinical examination [97, 98]. Repeatability is clearly excel-
likely there are other factors, such as altered biomechanics of lent [78, 99, 100].
intact muscle, fascial trauma and neuropathy. However, it is In childbirth, the levator hiatus has to undergo a very sub-
clear that avulsion enlarges the levator hiatus [86], reduces stantial degree of distension [102, 103], which may result in
contractile strength [87] and is associated with prolapse, macroscopic trauma (avulsion) (see above) or irreversible
especially in the anterior and central compartments [72, 88]. over-distension of the puborectalis muscle, i.e. ‘micro-
Levator defects seem to be the single strongest risk factor for trauma’ [72]. Hiatal enlargement to 25 cm2 on Valsalva or
prolapse recurrence after reconstructive surgery [89–91], higher is defined as ‘ballooning’ on the basis of receiver
which is not surprising since enlargement of the levator hia- operator characteristics statistics [105] and normative data in
tus through whatever mechanism will necessarily result in young nulliparous women [95].
increased strain on any load-bearing structure [66]. Hiatal area can be assessed both in axial plane slices at the
Axial plane imaging of the levator ani muscle has not plane of minimal hiatal dimensions or in rendered volumes
just led to a rediscovery of avulsion as a central factor in the (see Fig. 48.43 for a comparison of the two methods). Since
pathogenesis of pelvic floor disorders; it has also made us the hiatal plane is non-Euclidean (warped rather than flat),
realize that prolapse is truly a hernia: a hernia of pelvic hiatal area measurements obtained in rendered volumes may
organs through the largest potential hernia portal in the be more valid and more reproducible as well as easier to
human body, the levator hiatus. This triangular structure is obtain [105]. The degree of distension is strongly associated
the most complex ‘defect’ in the abdominal wall as it is with prolapse and symptoms of prolapse [106], and both
crucial for the function of three vital organ systems: the avulsion and ‘ballooning’ seem to be independent risk fac-
reproductive tract (intercourse and childbirth), the lower tors of female POP and POP recurrence after reconstructive
urinary tract (elimination of liquid waste) and the lower surgery [107, 108]. Most recently, it has become clear that
gastrointestinal tract (elimination of solid waste). Not sur- hiatal distensibility is the pathophysiological correlate of
prisingly, the pelvic floor in women is a compromise ‘vaginal laxity’ [109], a common and often misunderstood
between competing priorities. From an evolutionary point complaint that can result in substantial bother, mainly
of view, reproduction is of course the top priority, and it is through its impact on sexual function [110].
not surprising that pelvic floor disorders are common and
sometimes very difficult to treat.
The current functional anatomy of the female pelvic floor 48.4 Conclusions
is the result of rapid evolutionary change, with major differ-
ences in bony and soft tissue anatomy between our nearest Pelvic floor ultrasound imaging is a highly useful diagnostic
relatives, the simian primates and Homo sapiens. Over the tool for physicians and researchers dealing with pelvic floor
last 15 years, it has become evident that there are major inter- disorders, especially since the introduction of 3D/4D ultra-
individual and interethnic variations in dimensions and bio- sound which allows simple, cheap and highly reproducible
mechanical properties of the levator hiatus [92–94]. Such assessment of the axial plane, and multislice or tomographic
international comparisons have become possible due to the imaging. The increasing ubiquity of such systems, new soft-
standardization of the assessment of hiatal dimensions by ware options, and the increasing availability of training will
axial plane pelvic floor ultrasound, first described in 2005 likely lead to a more general acceptance of imaging as an
48 Transperineal Ultrasound: Practical Applications 615
integral part of the investigation of women with pelvic floor 9. Dietz HP, Wilson PD. The influence of bladder volume on the posi-
tion and mobility of the urethrovesical junction. Int Urogynecol J.
disorders. 1999;10(1):3–6.
The issue of levator trauma, one of the most significant 10. Oerno A, Dietz H. Levator co-activation is a significant con-
developments in pelvic floor medicine, is taking pelvic floor founder of pelvic organ descent on Valsalva maneuver. Ultrasound
ultrasound into the mainstream of urogynaecology and will Obstet Gynecol. 2007;30:346–50.
11. Orejuela F, Shek K, Dietz H. The time factor in the assess-
enhance communication between the different clinical spe- ment of prolapse and levator ballooning. Int Urogynecol J.
cialties dealing with such patients, such as urologists, gynae- 2012;23:175–8.
cologists, colorectal surgeons, physiotherapists and imaging 12. Dietz HP, Velez D, Shek KL, Martin A. Determination of post-
specialists. The method has great potential to improve not void residual by translabial ultrasound. Int Urogynecol J.
2012;23:1749–52.
just diagnostic but also therapeutic skills, and this is becom- 13. Khullar V, Cardozo LD, Salvatore S, Hill S. Ultrasound: a nonin-
ing increasingly obvious. vasive screening test for detrusor instability. Br J Obstet Gynaecol.
Tomographic imaging of the anal sphincter and levator 1996;103(9):904–8.
ani will enable obstetricians to assess maternal birth trauma 14. Yang JM, Huang WC. Bladder wall thickness on ultrasonographic
cystourethrography: affecting factors and their implications. J
with unprecedented ease and accuracy and at a minimal cost. Ultrasound Med. 2003;22(8):777–82.
This will likely result in the establishment of maternal trauma 15. Lekskulchai O, Dietz H. Detrusor wall thickness as a test for
as a key performance indicator of obstetric services, a devel- detrusor overactivity in women. Ultrasound Obstet Gynecol.
opment that is long overdue and likely to substantially 2008;32:535–9.
16. Lekskulchai O, Dietz H. Is detrusor hypertrophy in women associ-
change obstetric practice. ated with symptoms and signs of voiding dysfunction? Aust NZ J
Obstet Gynaecol. 2009;49:653–6.
17. Titus J, Blatt A, Chan L. Ultrasound measurement of bladder
wall thickness in the assessment of voiding dysfunction. J Urol.
2008;179:2275–9.
Take-Home Messages 18. Schaer G. The clinical value of sonographic imaging of the ure-
throvesical anatomy. Scand J Urol Nephrol. 2001;207:80–6.
• Translabial ultrasound is the imaging method of 19. Dietz HP. Pelvic floor ultrasound in incontinence: What’s in it for
choice in the evaluation of pelvic floor disorders the surgeon? Int Urogynecol J. 2011;22(9):1085–97.
such as urinary incontinence, defecation disorders, 20. Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-
anal incontinence and pelvic organ prolapse. dimensional aspects. [Review] [86 refs]. Ultrasound Obstet
Gynecol. 2004;23(1):80–92.
• 3D/4D imaging using volume transducers allows the 21. Pirpiris A, Shek KL, Dietz HP. Urethral mobility and urinary
assessment of distinct abnormalities such as implants incontinence. Ultrasound Obstet Gynecol. 2010;36:507–11.
or urethral diverticula in the orthogonal planes. 22. Masata J, Martan A, Svabik K, Drahoradova O, Pavlikova M.
• Tomographic or multislice imaging has revolution- Ultrasound imaging of the lower urinary tract after successful
tension- free vaginal tape (TVT) procedure. Ultrasound Obstet
ized the assessment of maternal birth trauma in the Gynecol. 2006;2006:221–8.
form of levator avulsion and anal sphincter tears. 23. Dietz H, Nazemian K, Shek KL, Martin A. Can urodynamic
stress incontinence be diagnosed by ultrasound? Int Urogynecol
J. 2012;23(24):1399–403.
24. Naranjo-Ortiz C, Shek K, Dietz H. What is normal bladder neck
anatomy? Int Urogynecol J. 2016;27(6):945–50.
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Three-Dimensional and Dynamic
Endovaginal Ultrasonography for Pelvic 49
Organ Prolapse and Levator Ani
Damage
A B C D E F G H I J
PV
PR
IC
PP
STP
PA
Fig. 49.5 BK Flex Focus ultrasound machine with a 2052 probe (BK
Medical, Analogic, Peabody, MA, USA)
Fig. 49.9 The most caudad muscle seen by 3D endovaginal ultrasound Fig. 49.11 The puboanalis (PA) lies just lateral to the puboperinealis
imaging is the superficial transverse perinei muscle, which is high- (PP), and they are part of the same functional groups. Anus (A), pubic
lighted. Anus (A), external anal sphincter (EAS), pubic symphysis (PS), symphysis (PS), transducer (T) (© Shobeiri)
transducer (T) (© Shobeiri)
a b
Fig. 49.10 (a) The scant fibers of the puboperinealis muscles (PP) are highlighted. (b) The perineal body (PB) is highlighted in the same axial
view as (a). Anus (A), perineal body (PB), puboperinealis (PP), pubic symphysis (PS), transducer (T) (© Shobeiri)
vations in the total number of subjects. There was 98%, 96%, In addition to visualization of the muscle subdivisions,
and 92% agreement for level 1, 2, and 3 muscles, respec- the interobserver and the interdisciplinary repeatability of
tively. Cohen’s kappa index/standard error were calculated (1) levator hiatus length; (2) levator hiatus width; (3) levator
for individual muscles as follows: STP and puborectalis hiatus area; (4) LAM attachment to the pubic rami, on both
were seen by both raters 100%, puboperinealis 65%, pubo- sides; (5) anorectal angle (ARA); and (6) urethral thickness
vaginalis, and puboanalis 65% (95% confidence interval measurements using 3D EVUS have been established [7]. A
0.1–1), and iliococcygeus 90% (95% confidence interval team of six investigators in three different specialties (urogy-
0.6–1). necology (UGN), radiology (RAD), colorectal surgery
624 J. Alshiek et al.
(CRS)) was formed. Each discipline included two investiga- were performed. For the training session, an expert 3D reader
tors: UGN #1 and UGN #2; RAD #1 and RAD #2; and CRS demonstrated to each of the readers the technique to be used
#1 and CRS #2. Prior to study initiation, a dedicated training for measurements, including bony and soft tissue landmarks.
session was completed, and preliminary trial measurements Readers discussed and refined the measurement technique
for each parameter until all readers were in agreement
regarding measurement methodology. In order to minimize
the effect of imaging variations on the final measurements, a
standardized protocol for review of the study data sets was
strictly defined and jointly approved by all investigators.
Each ultrasound volume was displayed in a symmetrical
orientation in the coronal, sagittal, and transverse planes and
assessed in standardized sequences. The overall interobserver
repeatability for levator hiatus dimensions was good to excel-
lent (ICC, 0.655–0.889), for urethral thickness was good (ICC,
0.624), and for ARA was moderate (ICC, 0472) (Table 49.1).
The interdisciplinary repeatability for levator hiatus indices
was good to excellent (ICC, 0.639–0.915), for urethral thick-
ness was moderate to good (ICC, 0.565–0.671), and for ARA
was fair to moderate (ICC, 0.204–0.434) (Table 49.2) [7].
Table 49.1 Overall means and standard deviations (SD) of various measurements of individual readers
Urethral thickness
Observer LH length (mm) LH width (mm) LH area (cm2) (mm) ARA (degrees)
UGN #1 50.42 (SD: 4.18) 35.03 (SD: 3.50) 10.48 (SD: 1.51) 12.82 (SD: 1.6) 133.1 (SD: 12.3)
UGN #2 48.62 (SD: 4.87) 34.21 (SD: 3.30) 10.60 (SD: 1.31) 13.06 (SD: 1.41) 144.2 (SD: 7.03)
RAD #1 48.71 (SD: 4.84) 33.76 (SD: 3.50) 10.72 (SD: 1.70) 12.86 (SD: 1.73) 143.04 (SD: 12.5)
RAD #2 47.55 (SD: 5.62) 33.54 (SD: 3.32) 11.76 (SD: 1.35) 12.61 (SD: 1.32) 141.1 (SD: 7.99)
CRS #1 47.95 (SD: 4.20) 34.52 (SD: 3.38) 10.82 (SD: 1.60) 12.23 (SD: 1.77) 143.8 (SD: 9.97)
CRS #2 47.20 (SD: 4.05) 34.06 (SD: 2.96) 10.14 (SD: 1.60) 12.30 (SD: 1.44) 136.1 (SD: 5.94)
From Santoro et al. [6], with permission
ARA anorectal angle, CRS colorectal surgeon, LH levator hiatus, RAD radiologist, UGN urogynecologist
Table 49.2 Interobserver, intra- and interdisciplinary repeatability of three-dimensional endovaginal ultrasound parameters
LH length LH width LH area Urethral thickness ARA
Repeatability ICC 95% CI ICC 95% CI ICC 95% CI ICC 95% CI ICC 95% CI
Overall 0.655 0.509–0.794 0.889 0.822–0.940 0.810 0.707–0.894 0.624 0.472–0.772 0.331 0.179–0.528
Intradisciplinary
UGN #1 vs. UGN #2 0.643 0.359–0.819 0.889 0.773–0.948 0.857 0.713–0.932 0.660 0.385–0.829 0.035 −0.339–0.402
RAD #1 vs. RAD #2 0.717 0.473–0.860 0.981 0.958–0.991 0.893 0.781–0.950 0.601 0.298–0.795 0.569 0.252–0.777
CRS #1 vs. CRS #2 0.883 0.761–0.945 0.910 0.815–0.958 0.887 0.770–0.947 0.735 0.501–0.869 0.216 −0.167–0.544
Interdisciplinary
RADs vs. CRSs 0.677 0.514–0.815 0.915 0.855–0.956 0.831 0.724–0.909 0.651 0.482–0.798 0.434 0.241–0.639
RADs vs. UGNs 0.639 0.467–0.790 0.897 0.826–0.946 0.851 0.755–0.921 0.565 0.380–0.739 0.327 0.139–0.549
UGNs vs. CRSs 0.694 0.536–0.826 0.874 0.790–0.934 0.783 0.656–0.882 0.671 0.506–0.811 0.204 0.032–0.431
From Santoro et al. [6], with permission
ARA anorectal angle, CI confidence interval, CRS colorectal surgeon, ICC interclass correlation coefficient, LH levator hiatus, RAD radiologist,
UGN urogynecologist
49 Three-Dimensional and Dynamic Endovaginal Ultrasonography for Pelvic Organ Prolapse and Levator Ani Damage 625
visible major LAM damage compared to 15% of women ratios for LASR indicated positive and statistically signifi-
with normal support, making it the strongest known factor to cant associations with all obstetric outcomes examined. The
be associated with both vaginal birth and POP [9]. The abil- probability of the LASR correctly classifying those with the
ity to diagnose injury to the LAM relies on advancements in adverse obstetric outcome, as estimated by the area under the
imaging. Levator ani avulsion as imaged by transperineal curve, ranged from 0.64 to 0.80 with the strongest discrimi-
ultrasound appears to double the risk of any significant ante- natory ability observed for severe LAM trauma. We con-
rior and central compartment prolapse [10]. cluded that fetal head circumference/mother MLHC ratio
(HISR) is associated with longer length of second stage of
labor, assisted delivery, and increased severity of perineal
49.2.1 Prevalence of Pelvic Floor Injury trauma. Similar associations were observed for LASR, but in
Following Vaginal Delivery addition, LASR had good discriminatory ability to identify
severe LAM trauma (Table 49.7.) [17].
During parturition, the levator ani muscle (LAM) stretches
beyond its limits in some women [11] in order to allow pas-
sage of a term infant [12]. Researchers have calculated maxi- 49.2.2 Levator Ani Injury and Hematomas
mum stretch ratios of 2.28–3.26 of the levator muscle.
However, striated muscle in nonpregnant animals allows a There are various definitions of levator ani injury, according
maximum stretch ratio of only 1.5 [13]. Interestingly, as all to mode of assessment and imaging modality. Most authors
women sustain overstretching of the pelvic floor, only have used avulsion of the muscles as the end point of the
some will have levator trauma. Alperin et al. studied study. However, more recent publications using 3D EVUS
pregnancy-induced adaptations in the pelvic floor muscles of have found that up to 50% of women may have hematoma
rat models [14]. They demonstrated that the changes in pel- formation after their first delivery (Fig. 49.13). Assessment
vic floor muscles occur by adding sarcomeres to increase
muscle fiber length. The largest change in muscle fiber length
occurred in the muscle known to have the shortest fibers,
namely, the coccygeus muscle of the levator ani. Furthermore,
they found a substantial increase in extracellular matrix. This
increase in extracellular matrix is thought to provide addi-
tional support to the coccygeus muscle [14].
Studies have shown that LAM injury occurs in 13–36% of
women who deliver vaginally [15]. There are various defini-
tions of levator ani injury, according to mode of assessment and
imaging modality. Furthermore, timing of ultrasound assess-
ment following delivery can impact on the incidence of LAM
injury. Most authors have used avulsion of the muscles as the
end point of the study. However, (3D) EVUS has found that up
to 35% of women may have hematoma formation shortly after
their first vaginal delivery [16]. Assessment of the levator mus-
cles is essential for a complete understanding of pelvic floor
anatomy abnormalities, as well as of pelvic floor dysfunction.
There have been many studies that have investigated pre-
dictive modeling of vaginal birth-induced LAM injury. In
our study of the predictive role of obstetric variables for
obstetric outcomes and birth-related levator ani muscle
(LAM) trauma, we evaluated minimal levator hiatus circum-
ference (MLHC) and the ratio of fetal head circumference to
MLHC = head-induced stretch ratio (HISR) as an indicator
of the discrepancy between passage and passing canal. To
derive the true impact of baby’s mass on the levator ani mus-
culature, we devised the levator ani stretch ratio (LASR),
which was calculated by multiplying the HISR and the Fig. 49.13 Schematic representation of the 3D endovaginal ultrasound
image in the axial plane of the minimal hiatal dimensions. The landmarks
baby’s weight. Mean HISR and LASR values were
are visible: pubic bone (PB), urethra (U), vagina (V), anal canal (A), leva-
statistically different across all binary outcome categories, tor ani muscle (L). The asterisk represents a right levator ani muscle hema-
with one exception for HISR and levator ani injury. The odds toma in the immediate postpartum (© Shobeiri)
626 J. Alshiek et al.
of the levator muscles is essential for a complete understand- there was 100% agreement between the investigators for the
ing of pelvic floor anatomy abnormalities, as well as of pel- presence of a hematoma. Hematomas away from the LAM
vic floor dysfunction. attachment zone to the pubic bone resolved. Hematomas that
It has been accepted that obstetric trauma is the main etio- were found at the area of attachment of the pubococcygeus
logical factor in the development of LAM avulsion. As part of the LAM to the pubic bone manifested as pubococ-
stated, trauma can occur by stretching of the inner part of the cygeus avulsions 3 months postpartum. Hematomas were
LAM (namely, the pubococcygeus part of the muscle), and significantly associated with episiotomy, instrumental deliv-
by disconnection of its insertion from the inferior pubic ery, and increased hiatal measurements. Palpation of LAM
ramus and the pelvic side wall [11]. A recent review found a avulsion, according to a previously described protocol [20],
13–36% incidence of LAM avulsion following the first vagi- was unreliable early postpartum, as only seven avulsions
nal delivery [18]. Overall, the highest incidence (39.5%) was were diagnosed using the finger as an instrument.
found in a prospective study where women were seen in the In an additional, smaller, group of women, the investiga-
early postpartum period, using transperineal ultrasound. The tors did not find hematomas but avulsion of the pubococ-
authors attributed this higher incidence to the difficulty in cygeus part of the LAM in the early postpartum period. The
differentiating fluid collections from LAM avulsion [19]. In overall incidence of LAM avulsion was 12.0% 3 months
our opinion, they used transperineal ultrasound, which is less postpartum. The authors therefore concluded that hemato-
discriminatory for the different parts of the LAM. Another mas in the pubococcygeus part of LAM, where it is sup-
more recent study evaluated the LAM shortly after childbirth posed to be attached to the pubic bone, always result in
using EVUS in a prospective study [16]. A total of 114 avulsion diagnosed 3 months postpartum. On the other
women underwent EVUS early postpartum. In 27 women hand, one third of avulsions confirmed at 3 months postpar-
(23.7%), the investigators found well-delineated, hypoechoic tum are not preceded by a hematoma at the site of LAM
areas consistent with hematomas (Fig. 49.14). Importantly, attachment to the pubic bone but could be seen as an avul-
Fig. 49.14 Schematic representation of the 3D endovaginal ultrasound bone remain intact within a few hours following vaginal delivery. Part
image in the axial plane of the minimal hiatal dimensions. The land- 2: the asterisk represents a bilateral postpartum defect where the levator
marks are visible: pubic bone (PB), urethra (U), vagina (V), anal canal ani muscle hematomas used to be, in the same patient, 3 months follow-
(A), levator ani muscle (L). Part 1: the asterisk represents a bilateral ing delivery (From van Delft [16])
hematoma in the muscles. Please note that the attachments to the pubic
49 Three-Dimensional and Dynamic Endovaginal Ultrasonography for Pelvic Organ Prolapse and Levator Ani Damage 627
sion in the early postpartum period [16]. The authors specu- the development of pelvic muscle weakness or changes in
lated that a hematoma is formed when muscle is torn away hiatus size in the absence of levator avulsion [25]. In the same
from the tendinous attachment. However, no hematoma is cohort of patients estimating the cumulative incidence of pro-
formed when the tendon or pubovisceral enthesis is avulsed lapse and other pelvic floor disorders (PFDs), comparing
from the pubic bone, due to the avascular nature of the vaginally parous women with and without levator avulsion,
trauma [21]. The resolution of hematomas at or away from levator avulsion was strongly associated with prolapse beyond
the attachment zone of LAM to the pubic bone directs to the the hymen (odds ratio, 2.7; 95% confidence interval, 1.3–5.7)
body’s ability to heal itself [22]. and with symptoms of prolapse (odds ratio, 3.0; 95% confi-
dence interval, 1.2–7.3). These associations persisted after
controlling for forceps-assisted delivery. In contrast, the odds
49.2.3 Levator Ani Avulsion of stress incontinence, overactive bladder, and anal inconti-
nence were marginally (but not significantly) increased
Levator ani avulsion injury was originally defined as “a dis- among women with levator avulsion in this cohort. The
continuity between the inferior pubic rami and the puborecta- authors concluded that the relationship between levator avul-
lis muscle” by perineal pelvic floor ultrasound. A complete sion and other PFDs may not be significant [26].
defect was diagnosed if the reference slide and slices 2.5 mm
and 5 mm cranial to it showed a sonographic defect [10]. The
authors also described a scoring system where defects were 49.2.4 LAD: Levator Ani Deficiency Score
scored according to the number of slices in which a disconti- as a Measure of Levator Ani Atrophy
nuity of the muscle with the pelvic side wall was documented,
with a minimum score of 0 and a maximum score of 16 in a Unlike the terms “defect” and “avulsion,” which may imply
patient with complete bilateral avulsion [23]. Levator avul- an all-or-none phenomenon, the term “LAD” implies a mea-
sion diagnosed by transperineal ultrasound appears to double surable gradient. While documenting the presence or absence
the risk of significant anterior and central compartment pro- of injury is important, LAM damage after childbirth, leading
lapse, with less effect on posterior compartment prolapse to symptomatic pelvic floor disorders or a decrement in mus-
[10]. Using MRI, DeLancey et al. described levator ani cle strength, may depend on the location and severity of the
defects and scored left and right muscle defects separately. A injury. Identifying the specific location and severity of
score of 0 was assigned if no damage was visible, 1 if less defects in LAM subdivisions may help to correlate specific
than half of the muscle was missing, 2 if more than half, and defects to corresponding clinical findings, providing further
3 if the complete muscle bulk was lost. The total score was insight into the form and function of this complex muscle
the sum of both sides, ranging from 0 to 6 and categorized as group. Recent imaging has pointed to the pubococcygeus
follows: 0, normal or no defect; 1–3, minor defect; and 4–6, insertion of the levator ani as the most often avulsed portion
major defect [9]. Miller et al. described a muscle tear if fibers of the LAM group (Fig. 49.5) [27]. Besides avulsion that in
were absent in at least one 4 mm section or two or more adja- average occurs in 15% of women, another 28.5% suffer from
cent 2 mm sections in both the axial and coronal planes, rated irreversible overdistention [28].
for both sides separately. They also distinguished between
subtle (equivocal muscle fiber loss), low-grade (muscle fiber
loss of <50%), and high-grade tears (muscle fiber loss >50%) 49.2.5 Scoring System
[24]. Obstetric levator avulsion is an important risk factor for
prolapse. In a study of vaginally parous women with or with- A LAD scoring system to grade levator injury has been
out levator avulsion, 5–15 years after delivery, using perineal developed according to the morphology and clarity of each
three-dimensional pelvic floor ultrasound, levator avulsion subdivision’s origin-insertion points, scored unilaterally.
was identified in 15% (66/453) patients. A history of forceps- This is analogous to the scoring system used in MRI [29].
assisted delivery was strongly associated with levator avul- Subgroups were evaluated and were scored (0, no defect; 1,
sion (45% vs. 8%; p < 0.001). Levator avulsion was also minimal defect with ≤50% muscle loss; 2, major defect with
associated with a larger levator hiatus area (+7.3 cm; 95% >50% muscle loss; 3, total absence of the muscle) on each
confidence interval [CI], 4.1–10.4, with Valsalva), wider gen- side based on thickness and detachment from the pubic bone
ital hiatus (+0.6 cm; 95% CI, 0.3–0.9, with Valsalva), and (Table 49.3). Each muscle pair score ranged from 0, indicat-
poorer muscle strength (−14.5 cm H2O; 95% CI, −20.4 to ing no defects, to maximum score of 6, indicating total mus-
−8.7, peak pressure). Among those with levator avulsion, cle absence. For the entire LAM group, a cumulative LAD
forceps-assisted birth was associated with a marginal increase score that ranged between 0 and 18 was possible. Scores
in levator hiatus size but not genital hiatus size or muscle were categorized as 0–6, mild (Fig. 49.15); 7–12, moderate
strength. Forceps-assisted birth was an important marker for (Fig. 49.16); and >13, severe deficiency (Fig. 49.17) [30]. All
levator avulsion but may not be an independent risk factor for the correlation coefficients at the individual sites as well as
628 J. Alshiek et al.
Table 49.3 Endovaginal ultrasound validated scoring system for levator ani muscle deficiency (LAD)
0 (no muscle 1 (mild 2 (moderate 3 (complete Subtotal Total
Score damage) abnormality) abnormality) muscle loss) 0–3 0–18
(L) Puboanalis (PA + PP)
(R) Puboanalis (PA + PP)
(L) Puborectalis
(R) Puborectalis
(L) Pubovisceralis (IC + PC)
(R) Pubovisceralis (IC + PC)
IC iliococcygeus, L left, PA puboanalis, PC pubococcygeus, PP puboperinealis, R right
tus (mild, moderate, severe) was also significantly different those with severe LAD have 6.44 times the odds of signifi-
between stages of prolapse (Table 49.5). A moderate positive cant POP than those with minimal deficiency. Thus, worsen-
correlation was demonstrated between LAD score and stage ing LAD scores as identified by 3D EVUS is a predictor of
of prolapse (rs = 0.44, p < 0.0001). When trying to find a clinically significant POP [30]. From a biomechanical per-
threshold of LAD above which vaginal prolapse developed, spective, these data are important, since pelvic floor support
no subjects with stage 3 prolapse had a score lower than 6, provided by these muscles will be weak, and the load will
and no subjects with stage 4 prolapse had a LAD score lower shift from the deficient muscles to the supportive connective
than 9 (Fig. 49.18). While all patients with stage 3 and 4 pro- tissues and cause their failure [13]. However, two women
lapse had moderate to severe LAD, in the group of patients with identical levator ani defects may present with different
with no prolapse, there were 15.2% with moderate and 9.2% POP presentations. Finite element modeling has demon-
with severe LAM deficiency. The frequency of severe LAD strated that, in addition to LAM deficiency, development of
increased progressively with increasing stage of POP-Q prolapse, such as a cystocele, also requires an increase in
(Fig. 49.19). Final adjusted logistic regression demonstrated abdominal pressure and apical and paravaginal support
a significant relationship between LAD score and the pres- defect [32].
ence of clinically significant POP (Table 49.6). Likelihood
ratio, c-statistics, and Hosmer-Lemeshow goodness of fit
tests each indicated excellent model fit (Table 49.6, Mild Moderate Severe
3
Stage of Prolapse
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Cumulative LA Score
630 J. Alshiek et al.
49.2.6 Changes of Levator Ani with Aging pelvic floor structures and function in the absence of child-
birth trauma [34]. The role of age as a factor impacting pos-
Injuries to the LAM after a vaginal delivery are associated sible age-related abnormalities in nulliparous women is
with difficult vaginal birth and with older age [32, 33]. Age understudied (Table 49.7.).
is commonly cited as a risk factor for developing prolapse; It is not known whether atrophic changes related to age
however, few studies have examined the effect of aging on will affect the visualization of the LAMs, or mimic defects.
This is important because the thickness of normal muscles
Table 49.6 Severity of LA deficiency by clinically significant varies among nulliparous women [35]. We performed a study
prolapse to evaluate the visibility of LAMs in 80 community-dwelling
Minimal Moderate Severe nulliparous women. Unilateral and bilateral levator ani
defect defect defect subdivisions were scored according to the LAD scoring sys-
n (%) n (%) n (%) p Valuea tem described above (Fig. 49.21). Two observers read all the
Stage 0–1 54 (71.1) 36 (45.6) 17 (26.2) <0.0001 ultrasound cubes. The resulting exact agreement for bilateral
Stage 2–4 22 (29.0) 43 (54.4) 48 (73.9) scoring of each levator ani subdivision ranged from 82 to
From Rostaminia et al. [30], with permission 84% [36]. There was no correlation between increasing age
Based on chi-square test
a
and total LAM scores (r = 0.20, p = 0.072). We found high
levels of agreement among observers in assessing 3D EVUS
Model (defect, age, parity, scans of LAM subdivisions of nulliparous women of differ-
menopausal status): 0.8388 ent ages, suggesting that age alone does not significantly
Levator ani defect: 0.7165 impact reliable visualization of the LAM on 3D EVUS
Age by decade: 0.7804 (Fig. 49.22).
Defect, age, parity: 0.8371
0.50 tor plate angle (LPA), iliococcygeal angle, and ARA have
been used for assessing the impact of levator damage on
static and dynamic MRI imaging features [38, 39]. The
puborectalis muscle is recognized as one of the compo-
0.25
nents of the levator ani that forms the vaginal high pressure
zone [40].
The puborectalis muscle is commonly thought to undergo
0.00 injury during vaginal childbirth, in the form of avulsion from
its insertion on the pubic ramus [33, 41, 42]. There had been
0.00 0.25 0.50 0.75 1.00 no argument on what constitutes an avulsion, mainly because
1-Specificity it was thought that the puborectalis is the muscle injured.
Avulsion of muscles from the pubic bone is known to have a
Fig. 49.20 Receiver operating characteristic (ROC) curve for com-
marked effect on levator dimensions [43]. The MLH, which
parison (From Rostaminia et al. [30], with permission)
Table 49.7. AUC and 95% CIs for measures assessed as predictors of delivery outcomes and severe pelvic floor trauma
HISR AUC LASR AUC Head circumference, MLHC AUC Birth weight
Delivery outcome (95% CI) (95% CI) AUC (95% CI) (95% CI) AUC (95% CI)
Second stage of labor 0.70 (0.61–0.79) 0.68 (0.60–0.77) 0.60 (0.50–0.71) 0.65 (0.56–0.75) 0.57 (0.48–0.67)
>90 min
Assisted delivery 0.68 (0.60–0.76) 0.66 (0.57–0.74) 0.62 (0.53–0.70) 0.63 (0.55–0.72) 0.57 (0.49–0.66)
Third-/fourth-degree 0.75 (0.64–0.86) 0.75 (0.64–0.86) 0.61 (0.48–0.75) 0.70 (0.58–0.82) 0.65 (0.51–0.78)
laceration
Episiotomy 0.69 (0.61–0.77) 0.67 (0.59–0.75) 0.61 (0.53–0.70) 0.63 (0.55–0.72) 0.58 (0.49–0.66)
Extreme LAD 0.67 (0.48–0.87) 0.80 (0.66–0.94) 0.62 (0.34–0.90) 0.66 (0.40–0.92) 0.74 (0.51–0.99)
HISR head induced stretch ratio, LASR levator ani stretch ratio, MLHC minimal levator hiatus circumference
49 Three-Dimensional and Dynamic Endovaginal Ultrasonography for Pelvic Organ Prolapse and Levator Ani Damage 631
LDA 0 1 2 3
No muscle loss
Muscle loss
<50% thickness
Muscle loss
>50% thickness
The score for left PA + Right PA + Left PR + Right PR + Left PV + Right PV = Total score 0-18
10
(-7,5 to 8,3)
-5
-10
-15
-5 0 5 10 15 20 25
Mean of All
is the smallest fibromuscular dimension of the pelvic floor Due to variations in terminology, the borders of the MLH
outlet, is thought to be made of levator fibers. had not been consistently defined in the literature. The bor-
ders of the MLH have been described in detail using 3D
632 J. Alshiek et al.
Fig. 49.26 The midsagittal plane was expanded to make the whole
volume visible. Levator ani muscle (LAM), pubic symphysis (PS), rec-
tum (R), transducer (T), urethra (U) (© Shobeiri)
Fig. 49.29 Puborectalis hiatus in the same patient of Fig. 49.28. Axial
view by transvaginal 360° ultrasound. Anterior-posterior (AP) line of
minimal levator hiatus, latero-lateral (LR) line, puborectalis (PR),
pubic symphysis (PS) (From Shobeiri et al. [44]; © Shobeiri)
Fig. 49.31 Cadaver dissection of the right hemipelvis with the pelvic floor
muscles visible. The planes of minimal levator hiatus and puborectalis hia-
tus are outlined. Anus (A), anterior-posterior line (AP) of minimal levator
hiatus (blue line), arcus tendineus fascia pelvis (ATFP), coccyx (CX), ilio-
coccygeus, (IC), ischial spine (IS), levator plate (LP), levator plate descent
angle (LPDA), obturator vessels (OB), pubic levator ultrasound reference
assessment line (PLURAL) (green line), plane of minimal levator hiatus
(P-MLH) (blue line), plane of puborectalis hiatus (P-PRH) (purple line),
perineal body (PB), pubococcygeus (PC), puborectalis (PR), pubic sym-
physis (PS), vagina (V) (From Shobeiri et al. [44]; © Shobeiri)
a b
PLURAL
PS B
LPDA
ML
H-A
EAS
EAS LP
Fig. 49.32 (a) The right midsagittal view of the levator plate descent Schematic drawing of a right midsagittal view of the levator plate and
angle in a healthy patient without levator ani deficiency. The levator levator plate descent angle in a healthy woman. A anal canal, B bladder,
plate position relative to the perineum is shown. The green line signifies EAS external anal sphincter, MLH-A minimal levator hiatus area, PS
the anorectal angle (ARA). The levator plate (LP) descent angle relative pubic symphysis, V vagina. (From Rostaminia [50] with permission)
to the reference line (PLURAL) is −16 ° (above the reference line). (b)
muscles involved in the anterior attachment of the MLH after surgery [47]. Interestingly, they found that women
would constitute what has been called levator avulsion in the who had surgical repair of prolapse had a 10° more cepha-
literature. A levator avulsion, which is a total detachment of lad-oriented LPA as well as a larger levator hiatus during
the levator entheses at the level of the pubic bone, would straining even without recurrence of prolapse. Ozasa and
result in widening of the levators and the ARA. To our colleagues compared the levator plate of 14 women with
knowledge, the contribution of the puboanalis muscle to this prolapse and 19 women without prolapse [48]. They found
area has not been documented previously. The injury to the that a best fit line through the levator plate always crossed
puboanalis fibers alone can potentially result in perineal and the pubic bone in women with normal support but never
anal protrusion. The current repair methods for perineal and crossed the pubic bone in those with prolapse. Hsu and col-
anal protrusion do not involve the investigation or repair of leagues showed that in women with normal support, the
the puboanalis muscle. The inner border of the MLH is levator plate has a mean angle of 44.3° relative to a hori-
mostly pubococcygeus, and the posterior border is the leva- zontal reference line during Valsalva, and women with pro-
tor plate that forms the ARA. lapse have a 9.1° more vertically oriented LPA, which was
The LPA as studied by the MRI investigators measured statistically different [49]. In our study, we measured the
the AP movement of the levator plate relative to the hori- LPDA, which is the position of the levator plate along the
zontal reference line. Berglas and Rubin used levator caudad-cephalad plane relative to the PLURAL plane as
myography to demonstrate that with straining, women with measured by EVUS not MRI. This angle quantifies the
prolapse have greater inclination of the levator plate [46]. levator plate position in reference to pubic bone and peri-
Goodrich et al. quantified the difference in the LPA of ten neal body at rest. LPDA is potentially useful as a separate
normal volunteers and five prolapse patients before and marker of levator function [44].
636 J. Alshiek et al.
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30. Rostaminia G, White D, Hegde A, Quiroz LH, Davila GW, Shobeiri 46. Berglas BRI. Study of the supportive structures of the uterus by
SA. Levator ani deficiency and pelvic organ prolapse severity. levator myography. Surg Gynecol Obstet. 1953;97(6):677–92.
Obstet Gynecol. 2013;121:1017–24. 47. Goodrich MA, Webb MJ, King BF, Bampton AE, Campeau NG,
31. Rostaminia G, Manonai J, Leclaire E, Omoumi F, Marchiorlatti Riederer SJ. Magnetic resonance imaging of pelvic floor relaxation:
M, Quiroz LH, et al. Interrater reliability of assessing levator ani dynamic analysis and evaluation of patients before and after surgi-
deficiency with 360° 3D endovaginal ultrasound. Int Urogynecol J. cal repair. Obstet Gynecol. 1993;82(6):883–91.
2014;25(6):761–6. 48. Ozasa HMT, Togashi K. Study of uterine prolapse by mag-
32. Chen LA, Ashton-Miller JA, DeLancey JOL. A 3D finite element netic resonance imaging: topographical changes involving the
model of anterior vaginal wall support to evaluate mechanisms levator ani muscle and the vagina. Gynecol Obstet Investig.
underlying cystocele formation. J Biomech. 2009;42(10):1371–7. 1992;34:43–8.
33. Kearney R, Miller JM, Ashton-Miller JA, DeLancey JO. Obstetrical 49. Hsu Y, Summers A, Hussain HK, Guire KE, Delancey JOL. Levator
factors associated with levator ani muscle injury after vaginal birth. plate angle in women with pelvic organ prolapse compared to
Obstet Gynecol. 2006;107(1):144. women with normal support using dynamic MR imaging. Am J
34. Jundt K, Kiening M, Fischer P, Bergauer F, Rauch E, Janni W, et al. Obstet Gynecol. 2006;194(5):1427–33.
Is the histomorphological concept of the female pelvic floor and 50. Rostaminia G, White DE, Quiroz LH, Shobeiri SA. Levator plate
its changes due to age and vaginal delivery correct? Neurourol descent correlates with levator ani muscle deficiency. Neurourol
Urodyn. 2005;24(1):44–50. Urodyn. 2013;34(1):55–9.
Magnetic Resonance Imaging, Levator
Ani Damage, and Pelvic Organ Prolapse 50
John O. L. DeLancey
50.2 F
unctional Anatomy: Levator Ani
Muscle and Connective Tissue Work
50.1 Introduction Together to Provide Pelvic Organ
Support
If the floor of a box fails, then all its contents will fall down.
Over 100 years ago, Halban and Tandler suggested that pel- Understanding the role that the levator ani muscle plays in
vic floor failure due to levator damage is the cause of pelvic preventing pelvic organ prolapse requires a consideration of
organ prolapse [1]. As logical as this basic mechanical fact how this muscle fits into the overall picture of pelvic organ
is, this issue was hotly disputed by many authors, especially support. Although whether muscle or connective tissue is the
Fothergill [2], who felt that support was provided exclusively most important in supporting the pelvic organs has been a
by the cardinal and uterosacral ligaments and fascial attach- long-standing point of contention, modern biomechanical
ments. Proof that levator ani muscle injury was associated analysis has shown that asking this question is like trying to
with pelvic organ prolapse, however, was made possible decide which scissors blade is most important. The muscles
when magnetic resonance imaging (MRI) allowed these and connective tissues work together to provide support in
muscles to be seen in living women [3, 4]. This allowed direct much the same way that the ventricles and valves are both
comparison of the levator ani muscle between women with needed for the heart to propel blood forward.
and without pelvic organ prolapse. One such study revealed Normal pelvic organ support is provided by the interac-
that 55% (83/151) of women with prolapse had major injury, tion between the levator ani muscles that close the pelvic
floor and the connective tissues that attach the uterus and
vagina to the pelvic sidewalls. The levator ani muscles hold
J. O. L. DeLancey (*) the pelvic floor closed and provide lifting and closing forces
Norman F. Miller Professor of Gynecology, Female Pelvic to prevent descent (Fig. 50.2) [7]; in this situation, the pres-
Medicine and Reconstructive Surgery, Department of Obstetrics sures in the anterior and posterior compartments are equal
and Gynecology, University of Michigan Medical School,
and balanced, canceling each other out. When the levator
Ann Arbor, MI, USA
e-mail: delancey@umich.edu muscles are weakened or damaged, the levator hiatus can
a b
Fig. 50.1 (a) Anterior predominant prolapse. Note tipped perineal visceral muscle (arrowheads) attaching to the pubic bone but complete
body that appears as if a structure normal holding the left side up had loss of that muscle on the left (L). This would explain failure of the
failed. (b) MRI of that subject showing an intact right-sided (R) pubo- hiatus to be closed. U uterus, V vagina ©DeLancey 2018
a b c
CL
Ligament
Tension
USL
Balanced Unbalanced
Pressures Pressures
Pulls on
Uterus
Pressure
©DeLancey
Fig. 50.2 Diagrammatic representation of interactions between levator anced. Levator damage (b) results in a hiatal opening, and the vagina
ani muscle, anterior vaginal wall prolapse, and cardinal/uterosacral becomes exposed to a differential between abdominal and atmospheric
ligament suspension. With normal levator function (a), the vaginal pressures. This pressure differential (c) creates a traction force on the
walls are in apposition, and anterior and posterior pressures are bal- cardinal ligament (CL) and uterosacral ligament (USL). ©DeLancey
be pushed open and cause the pelvic organs to descend so sures generated in the mouth force bubble gum to expand.
that one or both vaginal walls protrude through the opening. In the pelvis, this pressure differential creates a downward
In this situation, the vagina comes to lie between abdominal force that places abnormal loads on the connective tis-
and atmospheric pressure; the resulting pressure differential sues that attach the uterus and vagina to the pelvic walls.
acts on the vaginal wall in much the same way that pres- Conversely, if the connective tissues cannot adequately hold
50 Magnetic Resonance Imaging, Levator Ani Damage, and Pelvic Organ Prolapse 641
the organs in alignment above the closed hiatus, the same ceral [9]), the puborectal, and the iliococcygeal (Fig. 50.3).
pressure imbalance can occur. Therefore, both connective In this chapter, the term pubovisceral muscle will be used
tissue and muscle must work together to provide normal instead of pubococcygeal, because it describes the inser-
support. Understanding levator ani muscle anatomy and its tions better than the latter term, which was coined over a
subdivisions is essential to understanding how they provide century ago on evolutionary rather than anatomical grounds.
support and how injuries to specific portions of the muscle These subdivisions of the levator ani muscle can each be
affect function. seen in MR images (Fig. 50.4) [10]. There are also three
portions of the pubovisceral muscle: the pubovaginal, the
puboperineal, and the puboanal. These terms represent the
50.2.1 Levator Ani Muscle Anatomy pubovisceral muscle’s three points of insertion: the vagina,
the perineal body, and the anal sphincter complex. (Note the
Terminologia Anatomica [8]—the international gold similarity of the terms puborectal and puboanal. These are
standard for anatomy terms—has long-recognized that different muscles; the puborectal forms a sling behind the
the levator ani muscle consists of three subdivisions rectum that helps create the anorectal angle, while the pubo-
(Table 50.1): the pubococcygeal (also called the pubovis- anal inserts into the anal sphincter complex and elevates
Table 50.1 Overview of the nomenclature and functional anatomy of the levator ani
Terminologia Anatomica Origin Insertion Function
Pubococcygeal (pubovisceral)
– Pubovaginal Pubis Vaginal wall at the level of the mid-urethra Elevates vagina in region of mid-urethra
– Puboperineal Pubis Perineal body Tonic activity pulls perineal body ventrally toward
pubis
– Puboanal Pubis Intersphincteric groove between internal Inserts into the intersphincteric groove to elevate the
and external anal sphincter to end in the anus and its attached anoderm
anal skin
Puborectal Pubis Sling behind rectum Forms sling behind the rectum forming the anorectal
angle and closing the pelvic floor
Iliococcygeal Levator Two sides fuse in the iliococcygeal raphe The two sides form a supportive diaphragm that spans
Arch the pelvic canal
a b
PVa
PPM
ATLA
PAM ATLA
PRM
ICM
EA
PVaM S
PPM
PAM
©DeLancey
Fig. 50.3 (a) shows a schematic view of the levator ani muscles from transected just above the hymenal ring. (b) shows the levator ani muscle
below after the vulvar structures and perineal membrane have been seen from above looking over the sacral promontory (SAC) showing the
removed showing the arcus tendineus levator ani (ATLA); external anal pubovaginal, puboperineal, and puboanal muscles, as well as arcus ten-
sphincter (EAS). The three portions of the pubovisceral muscle are dineus levator ani and iliococcygeal muscle. The urethra, vagina, and
shown: pubovaginal (PVaM), puboperineal muscle (PPM), and pubo- rectum have been transected just above the pelvic floor, and the internal
anal muscle (PAM), as well as the iliococcygeal muscle (ICM) and obturator muscles have been removed to clarify levator muscle origins.
puborectal muscle (PRM). Note that the urethra and vagina have been ©DeLancey. (Modified after Kearney[11])
642 J. O. L. DeLancey
a b
Fig. 50.4 (a) is a 3D model of levator ani subdivisions, including the muscle. Inferior, left three-quarter view. (b) is the same model without
pubic bone and pelvic viscera. This model was created by using the the pubic bone. B bladder, EAS external anal sphincter, IC iliococcy-
magnetic resonance images. The pubovaginal, puboperineal, and pubo- geus muscle, PB pubic bone, PR puborectal muscle, PVi pubovisceral
anal muscles are all combined into a single structure—the pubovisceral muscle, U uterus, Ur urethra, V vagina ©DeLancey 2006
the anus.) The three portions of the pubovisceral muscle 50.2.2 Levator Ani Muscle Lines of Action
are not three muscles, however, but rather one muscle with
three points of insertion. Although the muscles of the leva- MRI has allowed the lines of action of the different aspects
tor ani are relatively simple and are described consistently of the levator ani muscle to be measured. This is impor-
by authors who have personally studied the muscle, a pro- tant, because the action of the pelvic floor muscles is deter-
fusion of conflicting terms that have historically applied to mined by the direction of these muscle fibers, the shape of
this region makes it somewhat complicated for readers to the muscle, and the points of attachment. Therefore, injury
interpret the literature by Kearney et al. [11]. to one component may have mechanical effects that are
The pubovisceral and puborectal muscles arise ventrally different than those caused by damage to another compo-
from the inner surface of the pubic bones (Fig. 50.5). The nent. As shown in Fig. 50.6, the pubovisceral muscle fibers
puborectal muscle lies lateral to the pubovisceral muscle and course 41° above the horizontal in the standing posture, in a
forms a sling behind the rectum at the anorectal junction. direction close to the iliococcygeal muscles (33°) [12]. By
While the puborectal muscle creates an angulation in the rec- contrast, the puborectal muscles actually act below the hori-
tum, the pubovisceral muscle elevates the vagina, perineal zontal (−19°).
body, and anus. The iliococcygeal muscle is thin and sheet- The significant difference (60°) in mean fiber angle
like, spanning the pelvic canal from the tendinous arch of between the pubovisceral and the puborectal muscles shows
the pelvic fascia to the midline iliococcygeal raphe, where that they have two different mechanical actions. These can be
it interdigitates with the muscle of the other side and con- understood within the context of the standing position (Fig.
nects with the superior surface of the sacrum and coccyx. It 50.6b). The diagonal vectors of the muscles can be resolved
forms a relatively flat horizontal portion that spans the dis- into two physiological vectors. The first—a vertically ori-
tance between the more medial pubic portions and the lateral ented “lifting” vector—acts against gravity by lifting the
pelvic wall. The area behind the rectum has been called the perineal structures and can be attributed to the pubovisceral
levator plate [1]. muscle. Descent of the perineal structures is found in women
50 Magnetic Resonance Imaging, Levator Ani Damage, and Pelvic Organ Prolapse 643
a b
Fig. 50.5 (a): Left mediolateral view of the anterior pelvic sidewall, 50-year-old nulliparous fresh cadaver showing the pubovisceral attach-
with pelvic organs removed, showing the characteristic features of the ments to the pubic bone. The fascial arch lies across the pubovisceral
origin of the pubovisceral muscle. The dotted rectangle shows the ana- muscle, and the levator arch forms the lateral margin of the pubovisceral
tomic area of study (Reproduced from Halban and Tandler, Fig. 50.2, muscle as it attaches onto the pelvic sidewall. ICM iliococcygeal muscle,
p. 34 [1]). (b): a similar view of the right anterior pelvic sidewall of a LA levator ani, PVM pubovisceral muscle. ©DeLancey
+S IC
M D M
x
3°
−4 horizontal to These Visible Abnormalities?
b
PVM PRM MRI studies have been done to help understand injury mech-
anisms after birth. This involves obtaining scans early (7
0.95N weeks) and late (6 months) after vaginal deliveries. At each
of these time points, both standard anatomical scans (proton
0.33N
−19°
0.67N
1N
a b
c d
Fig. 50.7 Mid-urethral axial MR images, early and late, in the region adjacent internal obturator (open arrowhead). (b) is a fluid-sensitive scan,
where the pubococcygeal muscle is normally seen lateral to the vagina where this difference is more apparent. In (c), a normal pubococcygeal
(Vag). (a) is a proton density scan where the solid arrowheads mark the muscle (black arrow) is seen between the vagina and internal obturator
pubococcygeal muscle and the open arrowheads show the obturator inter- (IO) (black arrow), while it is absent on the left (L). This pattern persists
nus. Signal intensity is lower in the pubococcygeal (arrowhead) than the in the late scan (d). PS pubic symphysis ©DeLancey
50.2.4 Location and Types of Levator Injury tent. Although it has become customary in the ultrasound
literature to refer to this as the puborectal muscle, in MRI,
While we have seen that levator ani muscle injury is highly where the puborectal muscle as defined in Terminologia
associated with prolapse, it is not the entire levator that is Anatomica can be distinguished from the pubovisceral
damaged. The portion of the muscle that is damaged was muscle, it is actually the pubovisceral and not the puborec-
established by studying women who had a unilateral leva- tal muscle that is injured [20].
tor muscle defect, where a normal side could be compared However, not all pubovisceral muscle injuries are alike.
with one that is intact [19]. This comparison revealed that MRI has revealed that there are two distinct types of pubo-
it is the pubovisceral portion of the muscle that is miss- visceral injury (Fig. 50.10): (a) loss of part of the pubovis-
ing in injured women (Fig. 50.8). While these injuries vary ceral muscle fibers with the overall attachment of the muscle
somewhat in appearance (Fig. 50.9), the location is consis- remaining intact (“Type I” injury) and (b) detachment of the
50 Magnetic Resonance Imaging, Levator Ani Damage, and Pelvic Organ Prolapse 645
a b
c d
Fig. 50.8 Upper panels: Axial MR scans of an exemplary 42-year-old lateral views, similar to the dorsal lithotomy position, are shown. In
female with a right-sided complete unilateral levator defect are shown. these panels, the pubic bone is semitransparent, and the obturator inter-
The intact levator ani muscle is traced (dashed line, labeled LA). The nus muscle is not shown. (c, d) Oblique right and left views peering
missing muscle is denoted (asterisk). Each panel is labeled with a num- over the pubic bone and down to the pelvic floor are shown. The ure-
ber indicating the level of scan in centimeters relative to the arcuate thra, vagina, and rectum have been truncated so as not to obscure the
pubic ligament; positive numbers indicate slices cephalad to the liga- views of the levator muscles. EAS external anal sphincter, LA levator
ment. Lower panels (a–d): 3D model generated from the axial MR ani, MM mirror image of the missing muscle, OI obturator internus, P
scans shown in the upper panels. (a, b) Oblique right and left infero- pubis, PB perineal body, R rectum, U urethra, V vagina. ©DeLancey
646 J. O. L. DeLancey
a b
c d
Fig. 50.9 Axial MR scans of four different women with complete uni- missing muscle is denoted (asterisk). In (a–c), the defect is shown on
lateral levator defects are shown. Note the variations in morphology. the right side and in (d), on the left side. ©DeLancey. EAS external anal
The intact levator ani muscle is traced (dashed line) and labeled LA. The sphincter, LA levator ani, P pubis, R rectum, U urethra, V vagina
muscle from its origin and of the levator arch from the pubic of the muscle in this injury zone [22]. When the muscle
rami (“Type II” injury). This detachment occurs because of detaches from the pubic bone, the anatomy of the entire pel-
the extreme stretching of the pubovisceral muscle that occurs vic sidewall is altered—causing a distortion in the normal
during birth [21] and the relatively thin, aponeurotic origin architecture of the vagina and surrounding tissues [23].
50 Magnetic Resonance Imaging, Levator Ani Damage, and Pelvic Organ Prolapse 647
a b c
Fig. 50.10 Illustrations of the right inner pelvic sidewall showing the tor internus muscle (OIM) in a Type II injury. Since there is only a sin-
fascial arch (F Arch) and levator arch (L Arch) originating from the gle point of pubic origin at the L Arch for the lateral margin of the
pubic bone (a). The pubovisceral muscle (PVM), pubic symphysis PVM, detachment of that point will result in complete offloading of that
(PS), urethra (U) and bladder can also be seen. In (b), atrophy in a por- region of the PVM. (Figure modified from Fig. 50.2a of DeLancey
tion of the PVM is shown; a Type I injury. In (c), the levator arch and 2002) ©DeLancey
PVM have become detached from the pubic bone exposing the obtura-
Fig. 50.11 Demonstration of the steps used in building 3D model. (a) and red marks, the levator arch (LA). The normal side (right side of the
is an axial image showing fascial arch (FA) and levator arch (LA). 3D image) can be compared with the abnormal side (left). Note the lower
models made from MRI showing arches with (b) and without (c) adja- location of both arches showing how these arches have moved caudally
cent structures. A reference line from the pubic bone to the ischial spine with to loss of the muscle origin. LAM levator ani, OI obturator inter-
P-IS acts as the X axis in local pelvic sidewall coordinate system visible nus, PS pubic symphysis, R rectum, U urethra, V vagina. From Larson
in (c) on defect side. Note that blue marks indicate the fascial arch (FA) et al. 2012 [24]. ©DeLancey
50.2.5 Injury Distorts the Pelvic Sidewall lie in this region. Since the fascial arch lies on the medial por-
Supports tion of the pubovisceral muscle (Fig. 50.5), detachment of the
levator ani from its origin causes the pelvic wall architecture
Loss of the pubovisceral muscle’s connection to the pel- to change. When the levator’s pubic attachment is lost, both
vis causes the pelvic sidewall structures (fascial and levator the fascial and levator arches fall downward. The most pro-
arches) to fall downward (Fig. 50.11) [24]. It is therefore nounced downward displacement occurs in the ventral region
important to consider the different mechanical consequences near the pubic bone—close to where the muscle originates.
of Type I injury, where there is a loss of a portion of the muscle This distortion has two effects: (1) it impairs the muscle’s abil-
tissue but the levator arch remains intact, and Type II injury, ity to close the urogenital hiatus due to loss of attachment to
where the levator arch and pubovisceral muscle become the pubic bone, and (2) it redirects the vectors of the fascial
detached from their origin. Both the fascial and levator arches connections to the tendinous arch of the pelvic fascia.
648 J. O. L. DeLancey
Fig. 50.12 Examples of grades of defects in the pubovisceral portion side is indicated on the figure, and the black arrows indicate the location
of the levator ani muscle in axial MR images at the level of the mid- of the missing muscle. (a) = a grade 1 defect; (b) = a grade 2 defect; and
urethra. These were selected to illustrate degrees of defects in individu- (c) = a grade 3 defect. ©DeLancey
als with a normal contralateral pubovisceral muscle. The score for each
250
50.2.6 The Amount of Injured Muscle Matters Normal Support
Prolapse
200
As one might expect with muscle injury, the amount of mus-
Number of subjects
Vakili and colleagues found that 44% of women with a 50.2.9 Levator Ani Injury and Fascial Failure
genital hiatus of 5 cm or greater had recurrent prolapse, com-
pared with 28% of those with a smaller hiatus (p = 0.034). The central tenant of our disease model maintains that the
In addition, increasing levator contraction strength was fascial tissues attaching the organs to the pelvic sidewall
associated with a decreased reoperation rate for pelvic floor and the levator ani muscles work together to maintain pelvic
disorders [26]. In women who had MRI for research pur- organ support. So, what evidence is there that this is true?
poses before an operation, a statistical model evaluating fac- Recent studies using stress 3D MRI comparing women with
tors that were predictive of recurrence revealed that levator and without anterior vaginal wall prolapse have allowed both
defects and increased hiatus size were key factors in estimat- the status of the connective tissue supports and the levator
ing the risk of anatomical cystocele recurrence—in addition ani muscle to be assessed at maximal Valsalva [35, 36]. In
to assisted vaginal delivery, which is known to cause levator this way, the relative contributions of these two factors of
damage [27]. Increased operative failure has also been iden- prolapse development can be assessed.
tified in women who have a deepening of the levator “bowl.” This analysis shows a strong relationship between three
Women with operative failures were more likely to have a factors that form a “collinear triad” consisting of (1) api-
large levator bowl compared to those with successful surgery cal descent, (2) paravaginal descent of the lateral vaginal
(84.6% vs. 39.6%; p = 0.005) [28]. wall, and (3) hiatal enlargement. From the strong correlation
between the apical and paravaginal descent and their similar
mechanistic roles of attaching the uterus and vagina to the
50.2.8 Muscle Injury Reduces Force pelvic walls, it is clear that these two factors are essentially
measurements of the same phenomenon. Conversely, the
The disease model presented at the beginning of this chapter role of hiatus size occurs in a different domain. The relation-
maintains that the connective tissue supports of the uterus ship between fascial attachment failure and enlarged hiatus
and vagina are only needed when the urogenital hiatus is size attests to the important interactions between these two
open. The levator ani is one important aspect of this closure. factors that relate to the pressure differential created when
The tonic activity of the levator ani muscle creates a high- the levators do not hold the hiatus closed and the vagina
pressure zone [16]—such as those created by the urethral becomes the barrier between abdominal and atmospheric
and anal sphincter muscles in their respective organs. In nul- pressure. These interactions are at the heart of our mechanis-
liparous women, a high vaginal resting pressure is correlated tic understanding of pelvic organ prolapse from the theoreti-
with a small levator hiatus area at rest (r = −0.451, p < 0.001) cal model presented at the beginning of this chapter.
[29]. As one might expect, injury to the muscle reduces the
force that it can generate. In women with levator defects,
the muscle generates 40% less force than in women without 50.2.10 Exposed Vaginal Length,
defects. Muscle injury is also associated with a widening of Pressure Differentials,
the levator hiatus [30] and caudal displacement of the entire and Symptomatic Prolapse
pelvic floor [31, 32]. Mechanistically, this failure to close the
hiatus results in the pelvic organs moving downward, posi- It is important to understand the strong relationship that exists
tioning them between abdominal and atmospheric pressure between the levator ani muscle’s ability to close the pelvic
and placing excessive forces on the suspending ligaments, floor and fascial failure, which involves the forces that result
as will be discussed. While it has been established that leva- from exposure of the vaginal wall to abnormal pressure dif-
tor injury is associated with an enlarged hiatus, it is impor- ferentials when the levators fail to hold the hiatus closed. The
tant to recognize that it is only one factor associated with force that results from pressure being applied to the vaginal
hiatal enlargement—explaining only about 10% of the phe- wall is directly proportional to the amount of vaginal wall
nomenon [33]. It is not completely understood what factors that is exposed to atmospheric pressure. MRI has shown that
are responsible for the remainder. There is also a significant there is a strong relationship between exposed vaginal wall
deepening of the “pelvic bowl” formed by the levator ani. length and how far the bladder descends (R2 = 0.91) [37]
The degree to which this bowl deepens is greater than that (Fig. 50.14). Initial descent while the vaginal wall is still in
of the protrusion of the pelvic organs below this level [32]. contact with the posterior vaginal wall does not increase the
This means that the abdominal organs move downward into amount exposed to a pressure differential, but when the blad-
this deepening bowl—a phenomenon that is not addressed der descends 4 cm below its normal position (approximately
by surgical correction. It has also been traditional to discuss at the introitus), the length of exposed vaginal wall subjected
the levator plate angle [34], but this is likely just a reflection to the difference in pressure increases significantly, with a
of the loss of forward pull on the plate caused by loss of force 2 cm increase for every additional 1 cm drop in bladder loca-
associated with the enlarged levator hiatus. tion. Exposed vaginal wall length is also highly correlated
650 J. O. L. DeLancey
a b c
8
8
8 7
Exposed Vaginal Length (cm)
1 1
0 0 0
0 2 4 6 8 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7
Most dependent Bladder Location Below Normal (cm) Apex Location Below Normal (cm) Hiatus Size (cm)
Fig. 50.14 The relationships between the exposed vaginal length and A bilinear relationship between exposed vaginal wall length and apex
most dependent bladder location, apex location, and hiatus size are location was also seen (b). Correlation coefficient R2 = 0.78. The esti-
shown. A bilinear relationship was used to describe the relationship mated transition point is at the apical descent at 5.0 cm below the nor-
between the position of the most dependent bladder point below normal mal position with a 95 % confidence interval (3.4–6.5 cm). Hiatus size
and the length of exposed vagina (a). Correlation coefficient R2 = 0.91. had a strong linear relationship between hiatus diameter and exposed
The estimated transition point is when the bladder location is 4.4 cm vaginal wall length (c), with correlation coefficient R2 = 0.85, but it is
below the normal position with a 95 % confidence interval (3.9, 4.9 cm). not bilinear. ©DeLancey
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Dynamic Magnetic Resonance Imaging
of Pelvic Floor Pathologies 51
Cäcilia S. Reiner and Khoschy Schawkat
51.3 Anterior Compartment small cystocele), bladder base 0–2 cm below the H line;
grade 2 (moderate), bladder base 2–4 cm below the H line;
The anterior compartment contains the bladder and urethra. and grade 3 (severe or large cystocele), bladder base 4 cm or
Frequent dysfunctions of the anterior compartment are stress more below the H line [9] (Fig. 51.2).
urinary incontinence (SUI) [9, 10] and overactive bladder
which is likely induced by bladder outlet obstruction [9]. Recommendations for Practice
Bladder outlet obstruction is most commonly caused by sur- • The measurements to assess pelvic floor descent are per-
gical repair of SUI or by urethral hypermobility, cystocele formed in the images with greatest straining effort, which
with kinking of the bladder outlet, outlet compression of the are displayed side by side with the rest images.
bladder by a prolapsing uterus, or rectocele [11]. • Avoid overdistension of the urinary bladder as it is associ-
SUI is caused by urethral hypermobility (80–90% of ated with underestimation of pelvic organ prolapse and
patients) [12] or intrinsic sphincter dysfunction (10–20% of may obscure findings in other compartments.
patients) [4]. Urethral hypermobility is caused by a defect in • Enteroceles are best detected at the end of the defecation
the urethral support system, e.g., due to vaginal delivery, phase as a consequence of the increased intra-abdominal
hysterectomy, or after surgical cystocele repair. pressure.
A cystocele develops due to tears in the endopelvic fascia • Functional abnormalities such as loss of urine during
and is defined as abnormal descent of the bladder at rest or straining should also be reported (Fig. 51.1) as well as
under stress (at straining and during defecation) [13]. incidental findings of the pelvic floor soft tissue
Cystocele is defined as a bladder base descent below the bor- structures.
der of the pubic symphysis and represents organ prolapse of
the anterior pelvic compartment through its respective hia-
tus. In dynamic pelvic floor MRI or MR defecography
(MRD) a cystocele is diagnosed on dynamic sequences when 51.4 Middle Compartment
the inferior border of the bladder descends >1 cm below the
pubococcygeal line (PCL) [9] (Fig. 51.1). A severe cystocele The middle compartment contains the uterus and vagina and
can mask symptoms of SUI as the urethra becomes kinked at therefore is only present in female patients. Uterine and vaginal
the bladder neck and through bulging of the anterior vaginal vault prolapse caused by levator ani trauma (e.g., after vaginal
wall patients can present with dyspareunia [4]. On MRD cys- childbirth) or damage to the supporting connective tissue due
toceles are measured from the bladder base perpendicularly to aging or congenital collagen defects may cause nonspecific
to the PCL and are graded according to their size as small complains. A variety of symptoms are described that range
(<3 cm below the PCL), moderate (3–6 cm below the PCL), from pelvic pain and pressure to urinary or fecal incontinence
and large (>6 cm below the PCL) [14]. Using the HMO sys- as well as dyspareunia [13]. The most common cause of pelvic
tem, cystoceles are graded based on the distance of the blad- floor dysfunction arising in the middle compartment is
der base relative to the H line as follows: grade 0 (no explained with an avulsion of the pubovisceral muscle at its
prolapse), bladder base above the H line; grade 1 (mild or inferior aspect after vaginal delivery [15]. Complete tear of the
a b c
Fig. 51.1 54-year old female patient with urinary incontinence and (3.8 cm) is seen with a horizontal orientation of the urethra (white
slight outlet obstruction. Midsagittal T2-weighted trueFISP MR image arrow). During defecation (c) the urinary bladder is emptied uninten-
at rest (a) shows a normal position of the pelvic floor. At straining (b) a tionally and an intrarectal intussusception develops (white arrowheads).
pathologic descent of the bladder (2.2 cm) and anorectal junction PCL pubococcygeal line
51 Dynamic Magnetic Resonance Imaging of Pelvic Floor Pathologies 655
Fig. 51.2 64-year old female patient with a large cystocele. MR image Fig. 51.3 76-year old female patient with an enterocele and anterior
obtained during defecation shows a large cystocele (C, white line) with rectocele. Midsagittal T2-weighted trueFISP MR image during defeca-
the bladder base >4 cm below the H line according to the HMO-system. tion shows protrusion of a moderate enterocele (5 cm) (E) into the
The H (5.5 cm) and M line (2 cm) are normal. H H line, M M line, PCL extended perineum leading to compression of the distal rectum result-
pubococcygeal line ing in outlet obstruction. The large anterior rectocele shows retention of
contrast medium due to compression by the enterocele. The extension
of the anterior rectocele is measured as the maximum wall protrusion
suspensory ligaments (uterosacral ligaments) causes uterine beyond the expected margin of the normal anterior rectal wall (white
arrow). PCL pubococcygeal line, E enterocele
descent into the vaginal introitus and with severe uterine pro-
lapse complete vaginal eversion can occur [16]. Patients may
present with a vaginal mass in case of uterine prolapse and
progressive ureteral obstruction can occur. abnormal descent of the anterior and middle compartment [18].
Vaginal prolapse is defined as descent of the vaginal vault The main cause for anorectal descent is excessive and repetitive
below the PCL. In cases of uterine prolapse, on axial images, straining leading to weakening of the pelvic floor musculature.
the cervix is often at the level of the pubic symphysis and Other conditions leading to weakening of the pelvic floor mus-
there is loss of the normal H shape of the vagina, often with culature are trauma due to vaginal delivery with pudendal nerve
posterior displacement of the fornix on the affected side. A impairment as well as neuropathies of other etiologies.
vaginal vault or uterine prolapse is diagnosed if the vaginal
vault or external cervical canal is located >1 cm below the
PCL at rest or straining. For grading vaginal vault or uterine 51.5.2 Rectocele
prolapse the same reference values are used as for grading of
cystoceles. Vaginal vault prolapse is often associated with A rectocele is a bulging of the anterior rectal wall and less
prolapse of other pelvic floor organs. frequently the posterior or lateral wall. Anterior rectocele is
caused by weakening of the supporting rectovaginal fascia
above the anal canal [19] (Fig. 51.3). Posterior rectoceles are
51.5 Posterior Compartment rare and due to levator plate damage [20]. On clinical exami-
nation an anterior rectocele can be seen as an outpouching of
51.5.1 Anorectal Descent the posterior vaginal wall with sensitivity between 30 and
80% [2, 21]. Most rectoceles only become apparent during
The landmark of the posterior compartment is the position of defecation. Related symptoms include dyspareunia, sensa-
the anorectal junction with respect to the PCL [17]. On MRD tion of incomplete evacuation, and constipation. For measur-
anorectal descent is defined as an abnormal descent of the ano- ing an anterior rectocele the expected location of the anterior
rectal junction more than 3 cm below the PCL. A descent below anorectal wall serves as posterior border of the rectocele in
the PCL between 3 and 6 cm is considered moderate and severe anterior posterior dimension. On MRD rectoceles are mea-
when greater than 6 cm (Fig. 51.1). It is often combined with an sured during maximal straining and evacuation. Small
656 C. S. Reiner and K. Schawkat
r ectoceles (<2 cm) are a very common finding in asymptom- intraanal intussusception may experience incomplete defeca-
atic subjects, are more frequently found in women, and are tion due to severe outlet obstruction. The intussusception can
considered normal [14, 22]. A bulge of 2–4 cm is considered be seen anterior, posterior, or circumferential. Small invagi-
moderate and >4 cm large; both are considered pathologic nations of the rectal wall are considered normal during def-
findings. Besides objective information about the size of a ecation, observed in nearly 80% of healthy subjects.
rectocele MRD displays the dynamics of its emptying and However, an intussusception can be missed in pathologic
possibly entrapment of the rectal gel [17]. The retention of conditions as it is commonly only visible at the end of the
rectal gel may serve as a surrogate for retention of stool in defecation phase. Therefore, the evacuation phase is manda-
the rectocele, which may lead to a sensation of incomplete tory to evaluate the full extent of pathologies [24]. The dif-
evacuation. The clinical relevance of a rectocele is defined by ferentiation between a mucosal intussusception and a
size, retention of contrast material (Fig. 51.3), need for evac- full-thickness intussusception is possible with dynamic pel-
uation assistance, and symptoms. vic MRI (Fig. 51.4), which is of clinical relevance, because
the two different forms entail different treatment strategies
[25, 26]. In up to 30% of patients with intussusception, asso-
51.5.3 Intussusception and Rectal Prolapse ciated anterior or middle pelvic floor compartment descent
has been shown [21], underlining the importance of a com-
Rectal prolapse is defined as an infolding of the rectal wall. plete pelvic floor evaluation.
An inner rectal pro-lapse (intussusception) is distinguished
from an external rectal prolapse, corresponding to the widely 51.5.3.2 External Rectal Prolapse
used clinical term “rectal prolapse” [23]. If parts of the rectal wall protrude through the anal canal
outward, this condition is referred to as “rectal prolapse”
51.5.3.1 Intussusception (Fig. 51.5). Women are more commonly affected than
Invagination or infolding of the rectal wall toward the anal men (6:1) with an incidence of 4:1000. Symptoms range
canal during defecation is called intussusception. It can from constipation, sensation of incomplete evacuation,
involve mucosal or mural components. Depending on the fecal incontinence to rectal ulcerations with bleeding.
extension of the invagination the intussusception may remain Although it is a clinical diagnosis patients are referred to
in the rectum (intrarectal) (Figs. 51.1 and 51.4) or extent into MRD to diagnose associated pathologies and for surgical
the anal canal (intraanal intussusception). Patients with planning.
a b
Fig. 51.4 41-year old female patient with full-thickness intrarectal rectum (intraarectal, full- thickness intussusception) (arrowheads).
intussusception. MR image (a) shows an anterior rectocele at the begin- Associated anterior and posterior rectoceles are seen (large arrows). In
ning of defecation. MR image (b) during defecation shows the develop- addition, a small cystocele evolves during defecation (small arrow)
ment of a circumferential mural intussusception, which extends into the
51 Dynamic Magnetic Resonance Imaging of Pelvic Floor Pathologies 657
Fig. 51.5 63-year old female patient with external rectal prolapse. MR Fig. 51.6 78-year old female patient with descending perineum syn-
image obtained during defecation shows an external rectal prolapse drom (pelvic floor relaxation). Midsagittal balanced steady state free
(arrow) and an additional moderate anterior and small middle compart- precession T2-weighted MR image obtained during maximal straining
ment descent. PCL pubococcygeal line shows a bulging of the whole pelvic floor with a large descent of the
anterior compartment (1: 6.5 cm), small descent of the middle compart-
ment (2: 2 cm) and a large descent of the posterior compartment (3:
51.5.4 Enterocele 7.5 cm). B bladder, P symphysis pubis, PCL pubococcygeal line, R rec-
tum, U uterus
An enterocele is a generic term for herniation of the perito-
neal sac, which contains omental fat (peritoneocele), small is measured in a perpendicular fashion in order to measure the
bowel (enterocele), or large bowel (sigmoidocele) which size. Depending on the size enteroceles are graded as small
extents below the PCL into the rectovaginal or retrovisceral (<3 mm), moderate (3–6 mm), and large (>6 mm) [14].
space (Fig. 51.3). Women are more frequently affected espe-
cially if they have a history of vaginal or abdominal hysterec-
tomy as a hysterectomy causes a separation of the anterior 51.6 Pelvic Floor Relaxation
(pubo-cervical) and posterior (rectovaginal) wall fascia. As a
result of the widespread use of hysterectomy the incidence of Pelvic floor relaxation (also known as descending perineal
enteroceles has markedly increased. In patients with pelvic syndrome) is defined as a pathologic descent of the pelvic
floor disorders the prevalence ranges between 17 and 37% floor at rest or at straining caudal to the PCL (Fig. 51.6).
and they are frequently associated with rectoceles [17] Usually all three compartments of the pelvic floor are
(Fig. 51.3). As clinical examination misses 50% of entero- involved. It is initially characterized by perineal pain and
celes and therefore is insufficient for its detection, imaging in constipation. Prolonged and excessive straining lead to
cases of suspicion is indispensable. MR imaging being supe- denervation and thereby in the chronic stage the patients
rior to conventional cystocolpoproctography is the best suited develop fecal incontinence [28]. Most commonly affected
imaging modality for diagnosis of enteroceles [27] and often are women, aged 50 or older, with multiple vaginal deliver-
allows the differentiation between peritoneocele, enterocele, ies, gynecological operations, and chronic constipation [29].
and sigmoidocele. Enteroceles are often concomitant findings Although it can be already seen at rest, the maximus exten-
of other pelvic floor pathologies and are best detected at the sion of the pelvic floor relaxation is seen at straining and
end of the defecation phase. Especially in patients planned for defecation. The descent is defined as the maximum distance
surgical pelvic floor repair the additional diagnosis of an between the PCL and the lowest point of the anterior (blad-
enterocele influences the surgical approach. Large entero- der base), middle (vaginal vault), and posterior pelvic floor
celes may follow the sacral curve and lead to compression of compartment (ARJ). A distance <3 cm below the PCL is
the ano-rectum, resulting in outlet obstruction. The distance graded as mild, 3–6 cm is moderate, and >6 cm is considered
from the most inferior point of the e nterocele to the PCL line a large descensus.
658 C. S. Reiner and K. Schawkat
a b
Fig. 51.7 60-year old female patient (s.p. hysterectomy and surgical evacuation a pathologic decrease of the anorectal angle (48°) is seen (c).
repair of an enterocele) with clinical suspicion of dyssynergic defeca- Paradoxical sphincter contraction is noted with impression of the dorsal
tion. On MR images obtained at rest (a) the anorectal angle measures anorectal wall during evacuation (arrowhead in c). The patient was able
103°, whereas the anorectal angle during squeezing is 81° (b). During to evacuate only less than two thirds of the contrast agent
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Pelvic Floor Muscle Training
in Prevention and Treatment of Pelvic 52
Organ Prolapse
Kari Bø and Ingeborg H. Brækken
plausible that PFMT can prevent POP in women. However, There are two main hypotheses for mechanisms as to how
to date there is no evidence for this proposal. Based on an PFMT may be effective in prevention and treatment of stress
understanding of functional anatomy and exercise science, urinary incontinence [46, 47], and the same theories may
we recommend that general exercise programs for women apply for a possible effect of PFMT to prevent and treat POP.
should include PFMT. The two hypotheses are as follows: (1) women learn to
consciously contract before and during increases in abdomi-
nal pressure (also termed “bracing” or “performing the
52.3.4 PFMT in Combination with Surgery Knack”) and continue to perform such contractions as a
behavior modification to prevent descent of the pelvic organs
PFMT has shown to be effective in reducing symptoms and and pelvic floor muscles; and (2) women are taught to per-
improve stage of POP. Women should be offered PFMT as a form regular strength training in order to build up “stiffness”
first choice treatment for prolapse, before surgery [17]. Most and structural support of the pelvic floor over time [45].
surgeons would also recommend to continue to do PFMT
after surgery to prevent relapse and to improve PFM func-
tion. To date there are only few RCTs assessing the effect 52.4.1 Conscious Contraction (Bracing or
of PFMT in combination with surgery [38–42]. Only one of “Performing the Knack”) to Prevent
these studies showed a positive additional effect [42]. and Treat POP
However, this is a feasibility study with a small sample
size, and the results must be interpreted with caution. Recent Research on basic and functional anatomy supports conscious
systematic reviews have concluded that there is insufficient contraction of the PFM as an effective maneuver to stabilize the
evidence to conclude whether PFMT has any additional pelvic floor [48, 49]. However, to date, there are neither studies
effect to surgical repair of POP [17, 42, 43]. One reason for on how much strength or which neuromotor control strategies
the lack of effect may be that the follow-up period has been are necessary to prevent descent during cough and other physi-
too short to show effect on relapse. And in addition, such cal exertions nor how to prevent gradual descent due to activi-
expected long-term effects involve that the women continue ties of daily living. Brækken et al. (2010) found that advice to
to perform PFMT regularly for many years. do “the Knack” and not to strain on defecation improved stage
of POP in 4% [24], but no morphological changes of the PFM
were found after this training modality [25].
52.3.5 Long-Term Effect An interesting, but difficult, hypothesis to test is whether
women at risk for POP can prevent development of prolapse
To date, there is only one abstract reporting long-term effect by performing bracing or “the Knack” during a rise in intra-
of PFMT for POP. Hagen et al. [44] reported a 2-year fol- abdominal pressure. Since it is possible to learn to hold a
low-up after PFMT. Unfortunately, only 40% of the original hand over the mouth before and during coughing, one would
447 participants responded. There was no longer any differ- expect that it is possible to learn to precontract the PFM
ence between the training and control group in Pelvic Organ before and during simple and single tasks such as coughing,
Prolapse Symptom Score, but fewer women in the PFMT lifting, and isolated exercises such as performing abdominal
group opted for further treatment and 6% in the PFMT group exercises. However, multiple task activities and repetitive
had surgery vs. 13% in the control group. Further and lon- movements such as running, playing tennis, aerobics, and
ger follow-up trials are needed in this area. However, long- dance activities cannot be conducted with intentional co-
term studies imply strict adherence to the training program to contractions of the PFM.
allow for meaningful interpretations of results.
As described by DeLancey [50] in the “boat in dry dock” 4. Slieker-Ten Hove MC, Pool-Goudzwaard AL, Eijkemans MJ, et al.
Symptomatic pelvic organ prolapse and possible risk factors in a
theory, the connective tissue support of the pelvic organs general population. Am J Obstet Gynecol. 2009;200:184–7.
fails if the PFM relax or are damaged, and organ descent 5. Lawrence JM, Lukacz ES, Nager CW, et al. Prevalence and co-
occurs. This underpins the concept of elevation of the PFM occurrence of pelvic floor disorders in community-dwelling
and closure of the levator hiatus as important elements in women. Obstet Gynecol. 2008;111:678–85.
6. Mouritsen L. Classification and evaluation of prolapse. Best Pract
conservative management of POP. All the RCTs in this area Res Clin Obstet Gynaecol. 2005;19:895–911.
have used strength training principles in the treatment proto- 7. Miedel A, Tegerstedt G, Maehle-Schmidt M, et al. Symptoms and
cols. However, Brækken et al. [24] measured PFM strength pelvic support defects in specific compartments. Obstet Gynecol.
increase in both randomized arms. They found a significant 2008;112(4):851–8.
8. Haylen BT, de Ridder D, Freeman RM, et al. An International
and huge increase in strength in the PFMT group only. They Urogynecological Association (IUGA)/International Continence
also found statistically significant increases in muscle vol- Society (ICS) joint report on the terminology for female pelvic
ume, shortening of the muscle length, narrowing of the leva- floor dysfunction. Int Urogynecol J. 2010;21(1):5–26.
tor hiatus, and lifting of the bladder neck and rectal ampulla 9. Bo K, Frawley HC, Haylen BT, Abramov Y, et al. An International
Urogynecological Association (IUGA)/International Continence
[25], factors that may be essential in prevention and rever- Society (ICS) joint report on the terminology for the conservative
sion of POP. and nonpharmacological management of female pelvic floor dys-
Readers may learn more about how to perform an effec- function. Int Urogynecol J. 2017;28(2):191–213.
tive PFMT program by watching www.Corewellness. 10. Maher C, Baessler K, Barber M, et al. Pelvic organ prolapse sur-
gery. In: Abrams PH, Cardoza L, Khoury AE, Wein A, editors.
Incontinence, vol. 2. 6th ed. International Consultation on Urinary
Incontinence, Plymbridge United Kingdom: Health Publication
52.5 Conclusions Ltd; 2015. p. 1855–992.
11. Thakar R, Stanton S. Management of genital prolapse. BMJ.
2002;324:1258–62.
To date there is strong evidence that PFMT can significantly 12. Wu JM, Matthews CA, Conover MM, et al. Lifetime risk of stress
reduce symptoms and improve stage of POP. Further studies urinary incontinence or pelvic organ prolapse surgery. Obstet
are needed to address which women respond to training and Gynecol. 2014;123(6):1201–6.
if POP can be prevented. A suggested primary prevention 13. Maher C, Feiner B, Baessler K, et al. Surgery for women with
anterior compartment prolapse. Cochrane Database Syst Rev.
strategy for the general female population would be to avoid 2016;(11):CD004014.
straining, to learn to contract the PFM during an increase 14. Whiteside JL, Weber AM, Meyn LA, Walters MD. Risk factors
in intra-abdominal pressure, and to conduct regular strength for prolapse recurrence after vaginal repair. Am J Obstet Gynecol.
training of the PFM. 2004;191:1533–8.
15. Handa VL, Garrett E, Hendrix S, et al. Progression and remission of
pelvic organ prolapse: a longitudinal study of menopausal women.
Am J Obstet Gynecol. 2004;190:27–32.
Take-Home Message 16. Miedel A, Ek M, Tegerstedt G, et al. Short-term natural history
in women with symptoms indicative of pelvic organ prolapse. Int
PFMT has 1A evidence to be effective in treating POP
Urogynecol J. 2011;22(4):461–8.
and there are no known side effects or complications. 17. Hagen S, Stark D. Conservative prevention and management of
Women with POP stage I, II, and III should be offered pelvic organ prolapse in women. Cochrane Database Syst Rev.
PFMT as first-line treatment. 2011;(12):CD003882.
18. Dumoulin C, Hay-Smith EJ, Mac Habée-Séguin G. Pelvic floor
muscle training versus no treatment, or inactive control treatments,
for urinary incontinence in women. Cochrane Database Syst Rev.
2014;(5):CD005654.
19. Dumoulin C, Bradley C, Burgio K, et al. Adult conservative man-
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3. Tegerstedt G, Maehle-Schmidt M, Nyren O, Hammarstrom Assos Thail. 2003;86:509–15.
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Use of Pessaries for Pelvic Organ
Prolapse 53
Dimos Sioutis and Rohna Kearney
Pessary management is the most commonly used conserva- 53.2 Types of Pessaries
tive treatment of pelvic organ prolapse. Vaginal pessaries are
passive mechanical devices designed to provide support to the There are two categories of pessaries in common use: sup-
pelvic organs to improve symptoms of pelvic organ prolapse. port pessaries and space-filling pessaries.
The concept of inserting a device into the vagina to relieve
prolapse symptoms is not a recent idea. The Kahun Papyrus
from ancient Egypt, in approximately 2000 BC, reports that 53.2.1 Support Pessaries
standing over specific burning ingredients could move pro-
truding pelvic organs back to normal position [1]. Ancient Ring pessaries are the most frequently used pessary. They
Greek physicians developed some of the earliest pessary-like are available in rigid polythene or flexible vinyl or silicone
devices to reduce prolapse. Polybus suggested the insertion (Figs. 53.1 and 53.2). A variety of size options are available
of half a pomegranate into the vagina and Soranos used a from 50 to 110 mm. Polythene and vinyl are designed for
linen tampon soaked in vinegar or a piece of beef meat. The single use whereas silicone pessaries can be used for up to
word “pessary” derives from the Greek word “peso”, which 5 years provided there is no visible damage. The advantages
refers to the oval-shaped stone used in an Ancient Greek of ring pessaries are that they are easy to fit and the woman
game, similar to modern checkers. Such stone pessaries were can have sex with the pessary in place. They are also amena-
ble to self-management. Shaatz pessaries, rings with support,
Gehrung or Falk sieve pessaries may provide better support
D. Sioutis
Third Department of Obstetrics and Gynaecology, Attikon when the uterus is prolapsing (Figs. 53.3 and 53.4).
Hospital, National and Kapapodistrian University of Athens,
Athens, Greece
R. Kearney (*) 53.2.2 Space-Filling Pessaries
Warrell Unit, St Mary’s Hospital, Manchester University Hospitals
NHS Trust, Manchester Academic Health Science Centre,
Gellhorn and shelf pessaries are the most commonly used
Manchester, UK
space-occupying pessaries (Figs. 53.5 and 53.6). They are
School of Medical Sciences, Faculty of Biology, Medicine and
inserted with the concave surface against the prolapsed
Health, University of Manchester, Manchester, UK
e-mail: rkearney@nhs.net cervix or vaginal cuff and the stem posteriorly towards the
introitus. Their size varies from 38 to 114 mm. They are 53.2.3 Incontinence Pessaries
more difficult to insert and replace than the ring pessaries
and are not compatible with vaginal intercourse. Cube and There are a range of pessaries which may be of benefit for
inflatable pessaries require the woman to be able to self- women with incontinence as well as prolapse. They have a
manage. Donut pessaries can be used for severe prolapse knob on the anterior portion to compress the urethra or blad-
with lax perineal support. der neck and reduce leakage (Fig. 53.7).
53 Use of Pessaries for Pelvic Organ Prolapse 669
Figs. 53.8 and 53.9 Demonstrating method of preparing pessary for insertion
or strain as the pessary is checked for repositioning or expul- survey of members of the American Urogynecologic Society
sion. The woman should be advised to void before leaving (AUGS) reported a variation in pessary follow-up. Over half
clinic and she should not feel any discomfort if the pessary is of all physicians taught their patients to self-manage their
fitted correctly. Further advice should be given regarding the pessary [11]. A survey of IUGA members on practice regard-
possibility of the pessary falling out particularly when opening ing shelf and Gellhorn pessaries reported that most members
the bowels and she should also be advised of pessary compli- follow up their patients every 6–12 months [12]. It would
cations including discharge and bleeding. The woman should appear that the most common follow-up period is 6 monthly
receive contact details in case she experiences problems with but this is not based on high-quality evidence. A pilot study
her pessary prior to her next scheduled appointment. has reported greater patient satisfaction with care with self-
Some studies have looked at predictors of success- management of ring pessaries compared with standard care
ful fitting and identified that failure to retain a pessary is but this needs to be robustly investigated [13]. In this self-care
associated with higher parity and previous hysterectomy [7]. study some women used a pessary only when they felt it was
Retrospective studies suggest the use of local HRT in meno- required, for example, exercising, and therefore reduced the
pausal women is associated with a higher rate of pessary amount of time that a pessary was in place. Some women pre-
retention and reduced vaginal discharge [4, 8]. A prospec- ferred to remove it before intercourse or defecating. Routine
tive observational trial of 100 women identified that a short practice in the UK is a 6 monthly follow-up clinic visit at
vaginal length (<6 cm) and a wide vaginal introitus (4 finger- which the pessary is removed and a speculum examination is
breadths) were risk factors for unsuccessful pessary fitting performed to assess for evidence of granulation or ulceration.
[9]. In some women fitting two pessaries at the same time The pessary is then replaced if the examination is normal.
may be required for optimal reduction of prolapse.
A review of 61 articles reporting pessary complica- vinyl pessary; however many practitioners prefer silicone
tions between 1952 and 2014 classified the complications pessaries as they can be used for up to 5 years, feel softer
according to the Clavien-Dindo classification of complica- and are easier to self-manage. If a pessary results in vaginal
tion severity [14, 15]. This review included 25 case studies excoriation or ulceration it may be necessary to remove the
and 36 case reports. The most frequently reported compli- pessary for 2–4 weeks to allow the vagina to heal. If there
cations were pain and discomfort, vaginal discharge, ero- is a contraindication to using oestrogen cream an antibiotic
sion, vesicovaginal fistula, bleeding and foul odour. As most cream such as clindamycin may be helpful.
of the included studies were case reports it is not possible
to report the frequency of complications as the denomina-
tor is unknown. Vesicovaginal and rectovaginal fistulas are 53.5 Evidence of Effectiveness
the most serious complications and are usually related to
a neglected pessary. Several reports suggested that a pes- There are no randomized trials comparing pessary use to sur-
sary was the cause of a vaginal or cervical cancer due to gery; however prospective studies have shown that pessaries
chronic inflammation; however the exact risk is unclear. are an effective intervention to reduce prolapse, urinary and
Complications were found in all Clavien-Dindo levels with bowel symptoms [7, 18]. There are several prospective stud-
deaths being recorded due to pyelonephritis with hydrone- ies following women with pessaries. A 5-year prospective
phrosis and erosion of pessary into upper rectum. UK study of 246 women reported that 76% of women suc-
A prospective UK study comparing surgery and pes- cessfully retained a pessary 4 weeks after insertion and that
sary treatment of prolapse followed 133 women after pes- 86% of the 151 women followed up over 5 years continued
sary insertion at 12 months and 12 women discontinued with pessary use. Most failures of pessary treatment occurred
pessary use by 6 months due to difficulty retaining the pes- within the first 4 weeks [16]. The same research group com-
sary, discomfort and discharge. Vaginal oestrogen was only pared the outcomes of 287 women undergoing prolapse
prescribed if there was evidence of vaginal atrophy [16]. A surgery or using pessaries with questionnaires at 1 year and
Spanish prospective study of 94 postmenopausal women reported similar outcomes in vaginal, bowel, urinary and
using a ring pessary with a median follow-up of 27 months quality of life scores [19]. Women who chose pessaries were
reported a continuation rate of 81%. Most discontinuations older (67 vs. 59 years), less likely to be sexually active, and
occurred in the first week and reasons included discomfort, 76% of the pessary group used a ring pessary. Of the 133
extrusion during daily activities, bleeding and dislike by hus- women who opted for pessary use first line, 12 women (9%)
band. All women were prescribed oestrogen cream in this discontinued pessary use within 6 months. Reasons for dis-
study unless there was a contraindication. For women con- continuation included difficulty retaining pessary, discom-
tinuing with pessary use the most common complication was fort and vaginal discharge. There was an improvement in
extrusion during daily activities or defecation (18%), bleed- vaginal soreness, bowel evacuation and sexual symptoms in
ing or excoriation (10.5%) and pain or discharge (2.6%). In the surgery group compared with the pessary group but these
contrast to the review of complications discussed above all symptoms were not bothersome as assessed by validated
complications were classed as Clavien-Dindo 1 [17]. This questionnaires.
may reflect the fact that prospective studies are poor at iden- A prospective Dutch study reported that at 1 year 72%
tifying rarer complications such as fistulae. of women using pessaries did not opt for surgery and that
Many women who are motivated to find a pessary solu- women choosing surgery had less severe symptoms [20].
tion to improve their prolapse symptoms are happy to try A US study looking at patient-reported goal attainment in
more than one type or size of pessary, if it is explained to 160 women undergoing surgery or using a pessary found
them that it typically takes more than one fitting to achieve a higher proportion of women in the surgery arm reported
a successful pessary solution. It is important that they are achieving symptom and function goals although both groups
made aware that if it is a correct fit they should feel no dis- experienced an improvement in symptoms and functioning.
comfort and be unaware that the pessary is in place. They Interestingly women who discontinued pessaries or crossed
should also be advised that a pessary may fall out and how over to the surgery arm had worse goal attainment whereas
to push it back in if it comes down during defecation. If sig- those who continued pessary use had similar goal attainment
nificant vaginal atrophy is present at initial assessment, it to the surgery arm [21].
is the author’s approach to pretreat with vaginal oestrogen The most recently published Cochrane review in 2013
for 2 weeks prior to inserting a pessary provided there are found only one randomized controlled trial comparing ring
no contraindications. Women should be advised that they to Gellhorn pessaries [22, 23]. However several other tri-
may develop a vaginal discharge and they should contact the als have been published since then comparing pessaries to
clinic if they experience excessive or foul smelling discharge, other treatment modalities. One trial compared pessary use
bleeding or discomfort. There is no evidence that discharge to pelvic floor muscle training in 162 women over the age of
is less with a silicone pessary compared to a polythene or 55 years recruited in primary care practices and reported on
672 D. Sioutis and R. Kearney
improvement in symptoms measured by the PFDI question- on the long-term outcome of pessary use including lifetime con-
naire [24]. This showed no significant difference between version to surgery [27]. Research in this area is required for us to
women randomized to pessary or pelvic floor muscle train- provide women with the knowledge that they require to make an
ing at 2 years; however the prolapse-specific symptom score informed decision regarding their treatment options.
(POP-DI) improved more in the pessary group. The cost of
pessary use was less than PFMT but there were more com-
plications with pessary use. Pessary use combined with Take-Home Messages
PFMT has been compared with PFMT alone in a random- Current evidence supports offering women the option
ized controlled trial of 276 women, again using the PFDI- of pessary management to control prolapse symp-
20 questionnaire to record symptom improvement. In both toms. Ring pessaries are the most successful option
the intention to treat and per protocol analysis there was a for women who wish to remain sexually active. Space-
statistically significant improvement in the prolapse sub- occupying pessaries are suitable for women who are
scale (POP-DI) in both groups with a greater improvement not sexually active or as a temporary measure prior to
in the pessary group [25]. One randomized trial compared surgery. Women should be advised:
134 women using either a ring with support or a Gellhorn
pessary and reported no difference in symptom improvement • More than one fitting may be required to achieve a
or quality of life measured by the PFDI and PFIQ question- successful pessary solution.
naires between these two types of pessary at 3 months [23]. • The pessary should be removed and reinserted at
least every 6 months.
• Of the risk of pessary complications including
53.6 Training of Pessary Practitioners expulsion, discomfort, discharge and bleeding.
• Advised that vaginal oestrogen may improve pes-
Currently there is no single recognized training programme sary retention in postmenopausal women.
for fitting and managing pessaries. In practice pessaries
are fitted by a variety of healthcare professionals includ-
ing nurses, doctors and physiotherapists. The James Lind
Alliance Priority Setting Partnership for pessaries in pro-
References
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53 Use of Pessaries for Pelvic Organ Prolapse 673
11. Cundiff GW, Weidner AC, Visco AG, Bump RC, Addison WA. A 20. Coolen AWM, Troost S, Mol BWJ, Roovers JPWR, Bongers
survey of pessary use by members of the American Urogynecologic MY. Primary treatment of pelvic organ prolapse: pessary use versus
Society. Obstet Gynecol. 2000;95:931–5. prolapse surgery. Int Urogynecol J. 2018;29:99–107.
12. Khaja A, Freeman RM. How often should shelf/Gellhorn pessaries 21. Sung VW, Wohlrab KJ, Madsen A, Raker C. Patient reported goal
be changed? A survey of IUGA gynaecologists. Int Urogynecol J. attainment and comprehensive functioning outcomes after surgery
2014;25:941–6. compared with pessary for pelvic organ prolapse. Am J Obstet
13. Kearney R, Brown C. Self-management of vaginal pessaries for pelvic Gynecol. 2016;215:659.
organ prolapse. BMJ Qual Improv Rep. 2014;3(1). U206180.w2533 22. Bugge C, Adam EJ, Gopinath D, Reid F. Pessaries (mechanical
14. Abdulaziz M, Stothers L, Lazare D, Macnab A. An integrative devices) for pelvic organ prolapse in women. Cochrane Database
review and severity classification of complications related to pes- Systematic Rev. 2013;(2):CD004010.
sary use in the treatment of female pelvic organ prolapse. Can Urol 23. Cundiff G, Amundsen CL, Bent AE, Coates KW, Schaffer JI,
Assoc J. 2015;9(5–6):E400–6. Strohbehn K, Handa VL. The PESSRI study: symptom relief out-
15. Dindo D, Demartines N, Clavien P-A. Classification of surgical comes of a randomized crossover trial of the ring and Gellhorn pes-
complications: a new proposal with evaluation in 6336 patients and saries. Am J Obstet Gynecol. 2007;196:405.e1–6.e8.
results of a survey. Ann Surg. 2004;240:205–9. 24. Panman CM, Wiegersma M, Kollen BJ, Berger MY, Lisman-
16. Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospec- van Leeuwen Y, Vermeulen KM, Dekker JH. Effectiveness and
tive study of vaginal pessary use for pelvic organ prolapse. Int J cost-effectiveness of pessary treatment compared with pelvic
Gynaecol Obstet. 2011;114:56–9. floor muscle training in older women with pelvic organ prolapse:
17. Duenas JL, Miceli A. Effectiveness of a continuous-use ring-
2-year follow-up of a randomized controlled trial in primary care.
shaped vaginal pessary without support for advanced pelvic Menopause. 2016;23:1307–18.
organ prolapse in postmenopausal women. Int Urogynecol J. 25. Cheung RY, Lee JH, Lee LL, Chung TK, Chan SS. Vaginal pessary
2018;29(11):1629–36. in women with symptomatic pelvic organ prolapse: a randomized
18. Clemons JL, Aguilar VC, Tillinghast TA, Jackson ND, Myers
controlled trial. Obstet Gynecol. 2016;128:73–80.
DL. Patient satisfaction and changes in prolapse and urinary symp- 26. http://www.jla.nihr.ac.uk/priority-setting-partnerships/pessaries-
toms in women who were fitted successfully with a pessary for pel- for-pelvic-organ-prolapse/top-10-priorities.htm.
vic organ prolapse. Am J Obstet Gynecol. 2004;190:1025–9. 27. Abdel-Fattah M, Familusi A, Fielding S, et al. Primary and repeat
19. Lone F, Thakar R, Sultan AH. One-year prospective comparison surgical treatment for female pelvic organ prolapse and inconti-
of vaginal pessaries and surgery for pelvic organ prolapse using nence in parous women in the UK: a register linkage study. BMJ
the validated ICIQ-VS and ICIQ-UI (SF) questionnaires. Int Open. 2011;1:e000206.
Urogynecol J. 2016;26:1305–12.
Anterior and Posterior Colporrhaphy:
Native Tissue Versus Mesh 54
Bernard T. Haylen
a b c
Fig. 54.1 (a) Anterior vaginal wall prolapse [11]. (b) Posterior vaginal wall prolapse [11]. (c) Vaginal vault prolapse [11]
vaginal vault fixation (and thus did not specifically address Vault support procedures to be described later will be
vaginal vault defects) though later ones involved attachment those achieved by a vaginal approach, as part of a compre-
of the prosthesis unilaterally or bilaterally to the sacrospi- hensive colporrhaphy. Those achieved by a laparoscopic or
nous ligament(s). other abdominal approach are acknowledged but not covered
Published rates for vault fixation in native tissue repairs in this chapter.
have been as low as 15% [18] and as high as 84% [15].
Published numerical “cutoff” for the performance of a
native tissue sacrospinous vaginal vault fixation is limited to 54.4 Anterior (Level II) Repair [11]
a posterior vaginal vault descent (PVVD—the level I defect
measurement from PR-Q) over 5.0 cm [15, 17]. The ratio- (a) Native tissue: the most common of these is as
nale for this arbitrary figure/colopexy (SSC) was stated as follows:
follows: for PVVD >5.0 cm, an SSC is more anatomically • Midline fascial plication: Involving midline incision,
and surgically desirable; for PVVD <5.0 cm, posterior wide exposure of the pubovesical fascia, midline fas-
vaginal vault support is less in question, while the approxi- cial plication, excision of redundant vaginal skin, and
mation of vaginal vault and sacrospinous ligament (SSL) midline re-suturing. See Fig. 54.4.
becomes more difficult. There are also as follows:
a b
Fig. 54.4 Anterior (native tissue) colporrhaphy [11]. (a) Preoperative. (b) Vesicovaginal fascial repair. (c) Anterior vaginal mucosal repair
678 B. T. Haylen
a b c
Fig. 54.5 Midline uterosacral plication anterior colporraphy combo (MUSPACC). (a) Suture needle starts to lift and expose intermediate section
of uterosacral ligament. (b) USL—left side exposed (under tension). (c) First suture completed, suture needle starts second suture on left side
54 Anterior and Posterior Colporrhaphy: Native Tissue Versus Mesh 679
(a) Posterior vaginal wall repair with native tissue: • Mesh or graft placement without additional vault/
The commonest of these is as follows: uterine support with or without concurrent fascial
• Midline fascial plication: involving midline incision plication
of full thickness of vaginal epithelium, wide expo- • Mesh or graft placement with additional vault/uter-
sure of the pre-rectal fascia, midline fascial plica- ine support, either:
tion, excision of redundant vaginal skin (care to –– Mesh kit with bilateral mesh fixation to the SSL
avoid stenosis/dyspareunia), and midline re-sutur- –– Mesh suspension kit with ischio-anal needle pass
ing. See Fig. 54.6. –– Posterior vaginal wall mesh/graft with concurrent
• Site-specific repair: lateral (uni- or bilateral), trans- vault/uterine suspension employing either bilat-
verse (upper and/or lower), combined. eral iliococcygeal fixation or fixation to the SSL
• Closure and/or excision of enterocele vaginally with –– Transperineal mesh/graft insertion
or without concurrent posterior wall repair.
(b) Posterior vaginal wall repair with mesh or graft rein-
forcement [11]: 54.6 Posterior (Level III) Repair [11, 19]
A structural addition or inclusion used to give additional
strength in function. It should be noted whether the graft The introital repair has traditionally been very subjective
is biologic, absorbable synthetic, or permanent synthetic. and empiric but can be made objective and relatively sim-
This may be further subclassified into: ple. Key aims are to (a) excise relevant defects and repair,
Fig. 54.6 Traditional posterior vaginal repair [11]. (a) Preoperative. (b) Rectovaginal fascial repair. (c) Posterior vaginal mucosal repair
680 B. T. Haylen
(b) improve posterior support for any anterior vaginal in the total posterior vaginal length (TPVL—Fig. 54.2) over
repairs, and (c) avoid creating dyspareunia which is a that if the PR was commenced at the hymen, (c) mean 31%
greater risk with a posterior repair compared to an anterior decrease in GH (Fig. 54.7b), (d) mean 28% increase in peri-
repair. neal length PL (Fig. 54.7c), and (e) mean 57% increase in
There is a positive relation between the size of the introi- mid-perineal thickness (MPT—Fig. 54.7d).
tal defects genital hiatus [20] (anteroposterior measure) and The case for any deeper perineal muscle suturing has not
perineal gap [21] (transverse) and the amount of vaginal been made. It may serve to increase patient discomfort
vault descent and thus the overall vaginal prolapse. There are including dyspareunia [23]. It has been recently shown that
anatomical advantages of commencing the repair at the pos- vaginal vault (level I) fixation significantly improves the
terior introitus. A simple excision of the perineal gap and vaginal introital (level III) repair [21], as judged by the
repair [19] (Figs. 54.7, 54.8) results in: (a) 100% excision of greater decreases in genital hiatus and perineal gap than if
thinned out perineal skin (gap—Fig. 54.7), (b) 24% increase there is no vaginal vault fixation.
a b
c d
Fig. 54.7 (a) Perineal gap (PG—cm): thinned out medial area (cm) (PL): distance from posterior margin of vestibule to anterior anal verge.
between Moynihan forceps placed bilaterally, where the labia minora (d) Mid-perineal thickness (MPT): thickness (cm) of the mid-perineum
meet the perineum. (b) Genital hiatus (GH—cm): from the external ure- in the midline (Fig. 54.8)
thral meatus to the posterior margin of the hymen. (c) Perineal length
54 Anterior and Posterior Colporrhaphy: Native Tissue Versus Mesh 681
a b c
Fig. 54.8 Perineal gap [22]. (a) Prior to excision. (b) After excision. (c) Reconstituted perineum
D
3 cm Ba
C
Aa
Bp
Ap
tvl
gh
pb
Mid-vaginal Laxity (MVL) (Undisplaced) [11, 15, 17]: Rectovaginal Fascial Laxity (RVFL) [11, 15, 17]: Laxity
Laxity of the vaginal mucosa (anterior traction) midpoint in of the rectovaginal fascia (anterior traction) midpoint in the
the vagina super-posteriorly and in the midline with the vagi- vagina super-posteriorly (mucosa opened) and in the midline
nal vault held in an undisplaced position (similar to that after with the vaginal vault held in an undisplaced position.
vault fixation).
22. Haylen BT, Vu D, Yang V, Tse K. Midline uterosacral plication 28. Silva WA, Pauls RN, Segal JL, Rooney CM, Kleeman SD, Karram
anterior colporrhaphy combo (MUSPACC): preliminary surgical M. Uterosacral ligament vaginal vault suspension: 5-year out-
report. Int Urogynecol J. 2011;22:69–75. comes. Obstet Gynecol. 2006;108:255–63.
23. Francis WFA, Jeffcoate TNA. Dyspareunia following vaginal oper- 29. Dwyer PL, Fatton B. Bilateral extraperitoneal uterosacral suspen-
ations. J Obstet Gynaecol Br Commonw. 1961;68:1–10. sion: a new approach to correct post-hysterectomy vaginal vault
24. McCall ML. Posterior culdoplasty: surgical correction of entero- prolapse. Int Urogynecol J. 2008;19:283–92.
cele during vaginal hysterectomy. Obstet Gynecol. 1957;10: 30. Haylen BT, Vu D, Birrell W, Vashevnik S, Tse K. A preliminary
595–602. anatomical basis for dual (uterosacral and sacrospinous ligaments)
25. Schull BL, Bachofen C, Coates KW, Kuehl TJ. A transvaginal vaginal vault support at colporrhaphy. Int Urogynecol J. 2012;23:
approach to repair of apical and other associated sites of pelvic 879–82.
organ prolapse with uterosacral ligaments. Am J Obstet Gynecol. 31. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N,
2000;183:1368–73. Brown J. Surgical management of pelvic organ prolapse in women.
26. Barber MD, Visio AG, Weidner AC, Amundsen CG, Bump
Cochrane Database Syst Rev. 2013;(4):CD004014.
RC. Bilateral uterosacral vaginal vault suspension with site specific 32. Mowat A, Maher D, Baessler K, Christmann-Schmid C, Haya N,
endopelvic fascial defect repair for treatment of pelvic organ pro- Maher C. Surgery for women with posterior compartment prolapse.
lapse. Am J Obstet Gynecol. 2000;183:1402–10. Cochrane Database Syst Rev. 2018;(3):CDC12975.
27. Karram M, Goldwasser S, Kleeman S, Steele A, Vassallo B, Walsh 33. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N,
P. High uterosacral vaginal vault suspension with fascial recon- Brown J. Surgical management of pelvic organ prolapse in women.
struction for vaginal repair of enterocoele and vaginal vault pro- 2016. www.Cochrane.org/CD012376.
lapse. Am J Obstet Gynecol. 2001;185:1339–43.
Apical Prolapse Surgery
55
Christopher Maher
55.1.1 Uterine Preservation study showed an almost 11-fold increased risk of failure in
patients with cervical elongation undergoing sacrospinous
In those wishing to retain fertility conservative management hysteropexy. Success rates were 96–100% after excluding
with a pessary is recommended for women with uterovaginal patients with severe prolapse and performing partial trache-
prolapse. If surgery is required, the data relating to the type lectomy for cervical elongation [22].
of hysteropexy and its impact on fertility, pregnancy and The 2017 International Collaboration on Incontinence
recurrence of prolapse is limited. (ICI) has developed an evidenced surgical pathway using the
Candidates for uterine conservation should be carefully Oxford grading system with guidance between the various
considered and strict selection criteria applied to decrease the surgical options for the management of uterine prolapse
likelihood of subsequent hysterectomy, which may be more (Fig. 55.1) [23]. The pathway points to obliterative surgery
technically challenging. Absolute and relative contraindica- such as colpocleisis in those happy to sacrifice vaginal inter-
tions to uterine preservation are listed in Table 55.1. Women at course and is usually performed with uterine preservation after
increased risk for endometrial, cervical or ovarian cancer and preoperative evaluation to minimise the risk of underlying
those with a personal history of estrogen receptor-positive malignancy. In these patients colpocleisis with uterine preser-
breast cancer, especially those taking tamoxifen, should have vation is a safe, effective and low-morbidity option. A large
their uterus, cervix and possibly ovaries removed at the time of publication following 153 women for 12 months demonstrated
prolapse repair. Hysteropexy should also be avoided in cases 95% of women being “satisfied” or “very satisfied” with the
of uterine abnormalities listed in Table 55.1. Patients with outcome. Continence surgery was performed in 40% and saw
recent postmenopausal bleeding even with a negative workup significantly improved bladder function with low morbidity
should probably undergo hysterectomy based on a 13% risk of [24]. Considering the surgery is usually performed in the
unanticipated endometrial cancer or hyperplasia [16]. elderly with significant comorbidities the procedure is well
During the consent process for postmenopausal women tolerated. Major complication unrelated to surgery (cardiac,
considering uterine preservation or hysterectomy, women pulmonary or cerebrovascular) occurred in 2% and major
should be informed of the lifetime risk of cervical (0.6%), complications specific to surgery (pyelonephritis, transfusion)
uterine (2.7%) and ovarian cancer (1.4%) [17, 18]. While in 4% [25]. The vast majority of women in the pathway will
ovarian cancer is uncommon, the general late presentation of elect reconstructive options for uterine prolapse which ini-
disease is associated with poor outcomes. Routine bilateral tially divide between hysterectomy and uterine preservation
oophorectomy demonstrated a tenfold decrease in the small with a wide variety of options available in each group.
risk of ovarian cancer without increased morbidity when
results were stratified by age [19, 20]. Furthermore in women
who have completed their family and considering prolapse 55.1.2 Uterine Prolapse: Hysterectomy or
surgery options, they should be informed that bilateral sal- Uterine Preservation
pingectomy may decrease the risk of ovarian cancer (OR
0.51, 95% CI 0.35–0.75) [21]. Vaginal options reviewed include sacrospinous /Manchester
Higher-risk women with hereditary conditions (BRCA hysteropexy with or without mesh and vaginal hysterectomy
mutations, Lynch syndrome) and obesity should consider with uterosacral or sacrospinous colpopexy with or without
hysterectomy with or without oophorectomy during prolapse mesh. Apical transvaginal mesh procedures were not prefer-
repair. Cervical elongation is included as a possible contrain- enced based on grade A evidence from the 2016 Cochrane
dication to uterine preservation as a prospective two-part review on the surgical management of prolapse that reviewed
six RCTs ( n = 548) comparing vaginal apical suspensions
Table 55.1 Relative contraindications to uterine-preserving surgery with and without permanent mesh. Maher et al. reported no
Uterine abnormalities benefit in the addition of the apical mesh in terms of recur-
Fibroids, adenomyosis, endometrial pathology sampling rent prolapse, awareness of prolapse or reoperation for pro-
Current or recent cervical dysplasia lapse was identified with increased morbidity associated
Abnormal menstrual bleeding with an 18% rate of mesh exposure. Hysterectomy performed
Postmenopausal bleeding via the abdominal or vaginal routes at the time of permanent
Cervical elongation mesh introduction increases the risk of mesh exposure by
Familial cancer BRAC1&2: ↑risk ovarian cancer and theoretical risk
two to three times as opposed to vaginal repair without mesh
fallopian tube and serous endometrial cancer
Hereditary non-polyposis colorectal cancer (Lynch syndrome): 60% and is usually avoided for this reason [26].
lifetime risk endometrial cancer Current abdominal options then include subtotal hyster-
Tamoxifen therapy ectomy and sacral colpopexy (SC), sacral hysteropexy with
Obesity: up to threefold increased risk endometrial cancer uterine preservation and native tissue uterosacral
Unable to comply with routine gynaecology surveillance hysteropexy.
55 Apical Prolapse Surgery 689
Bladder
function
Factors to Consider
Possible Pathway Pop Bowel
Preferred Option Surgery function
Further Data Required
Risk of
recurrent
prolapse
Reconstructive Obliterative
surgery surgery
Graft Suture
Vault Uterine
repair repair
Hysterectomy
Hysteropexy
± BSO
Sub-total
Vaginal ASC + Vaginal SS Sacral
hysterectomy
hysterectomy hysterectomy hysteropexy hysteropexy
ASC
Trying to sort thru all these options is challenging but anterior and posterior vaginal walls with the anterior leaf tun-
after establishing suitability for uterine preservation 31–60% nelling around the uterus in the broad ligament before being
of women preference for considering hysterectomy or uter- fixed to the sacral promontory as seen in Fig. 55.2. The vagi-
ine preservation is couched upon similar success rates being nal sacrospinous hysteropexy involves the posterior lip of the
obtained in each intervention [13–15]. cervix being fixed the right sacrospinous ligament as demon-
A variety of hysteropexy techniques have been described strated in Fig. 55.3. Comparative studies show short-term
to treat uterovaginal prolapse. The abdominal safety with decreased blood loss and shorter operating time
sacro-
hysteropexy involves mesh being suspended to the when vaginal sacrospinous hysteropexy was compared to
690 C. Maher
Left ureter
Uterine artery
Bladder
gina
Va
Rectum
Pudendal nerve
Central pilcation of
pubocervical fascia
Central pilcation of
rectovaginal fascia
vaginal hysterectomy; however efficacy results were mixed in comes. Gutman et al. reviewed randomised and non-
the two available RCTs [27, 28]. Dietz et al. [27, 28]demon- randomised trials comparing vaginal hysterectomy and
strated superior apical support in the hysterectomy group and hysteropexy and demonstrated no difference in anatomical
Detollenaere et al. found no difference in anatomical out- outcomes [26]. The only multicentre RCT conducted by the
55 Apical Prolapse Surgery 691
Pelvic Floor Disorders Network compared SSHP with ante- preferred. In those considering hysterectomy vaginal hyster-
rior graft (n = 88) using uphold to vaginal hysterectomy with ectomy with apical support was preferenced over abdominal
USLS (n = 87) at 3 years [29]. The primary composite out- options. The summary points include:
come of treatment failure (any reoperation or retreatment for
prolapse, any anatomic prolapse beyond the hymen and any • Significant relative contraindications exist to uterine pres-
bothersome prolapse symptoms) was observed in 21% of ervation surgery (GoE B).
hysteropexy compared to 27% of hysterectomy subjects. • Vaginal uterine preservation procedures have reduced
Failures were mostly anatomic and rarely by symptoms alone operating time and blood loss when compared to vaginal
(0% vs. 1%) with a total of 6% vs. 12% retreatments at 3 hysterectomy; however the anatomical results are con-
years. While there was a trend toward greater improvement in flicting in available RCTs and further evaluation is
the hysteropexy group, no significant differences were required to inform this outcome (GoE B).
observed in the composite outcome failure risk after perform- • Vaginal apical mesh interventions have similar outcomes
ing an adjusted hazard ratio of failure (0.62, 95% CI 0.38– when compared to native tissue vaginal repair but are
1.02). There were no differences in the overall satisfaction associated with high rates of mesh exposure and are nor
(90% vs. 89%), surgical pain, pelvic pain and body image. recommended (GoE A).
Mesh exposures occurred in 8% of hysteropexy (all related to • Vaginal hysterectomy and apical suspension had a lower
prolapse mesh, no sling exposures) and 5% of hysterectomy reoperation rate for prolapse when compared to sacral
(all from slings). More granulation tissue and suture expo- hysteropexy in a single RCT (GoE B).
sures were observed with hysterectomy (1% vs. 11% and 3% • In non-randomised trials the sacral hysteropexy was asso-
vs. 21%, respectively) although none of the mesh exposures, ciated with higher reoperation or pessary use when com-
suture exposures or granulation tissue required reoperation. pared to total hysterectomy and sacral colpopexy;
Sexual function, dyspareunia and pain improved for both the however the hysterectomy group suffered a significant
groups with low rates of de novo dyspareunia. rate of mesh exposure. In a single non-randomised trial
A single RCT compared mesh sacral hysteropexy (n = 41) the subtotal hysterectomy and sacral colpopexy had a
to vaginal hysterectomy with uterosacral colpopexy (n = 41) higher rate of recurrent prolapse as compared to total hys-
demonstrated that 21% required further surgical intervention terectomy and sacral colpopexy (GoE C).
for prolapse after the sacral hysteropexy as compared to • Further data is urgently required on efficacy of hystero-
none in the vaginal hysterectomy group suggesting an advan- pexy and hysterectomy and the various options for per-
tage with the vaginal hysterectomy and uterosacral suspen- forming the intervention
sion arm [30].
While there are no other RCTs comparing vaginal and or
abdominal interventions for uterine prolapse to inform the
decision pathway, the recent analysis of five non-randomised 55.1.3 Vault Prolapse
comparisons between sacral hysteropexy (n = 118) and
sacral colpopexy with hysterectomy (n = 165) demonstrated The surgical options that have comparative data for the
a higher rate of reoperation or pessary use after the sacral reconstructive management of post-hysterectomy include
hysteropexy as compared to sacral colpopexy and hysterec- vaginal uterosacral and sacrospinous colpopexy, vaginal api-
tomy (15% versus 0%). Unfortunately, the hysterectomy arm cal mesh or abdominal sacral colpopexy. A Cochrane meta-
suffered from a 7% rate of mesh exposure as compared to analysis of six RCTs demonstrated no benefit and significant
none after the sacral hysteropexy [23]. The subtotal hysterec- mesh morbidity when transvaginal apical mesh was com-
tomy and sacral colpopexy serves to minimise the risk of pared to native tissue vaginal apical repairs including sacro-
mesh exposure associated with hysterectomy but is fre- spinous and uterosacral colpoexy [32]. The majority of the
quently associated with the need for uterine morcellation transvaginal mesh kits evaluated have been removed from
which is controversial. A single retrospective review recently the market. The 2016 Cochrane meta-analysis of six RCTs
demonstrated when using the robotic approach the rate of compared abdominal sacral colpopexy (Fig. 55.4 and Video
recurrent stage 2 prolapse was significantly greater after sub- 55.1) to a variety of transvaginal procedures including trans-
total hysterectomy and SC as compared to total hysterec- vaginal mesh or uterosacral or sacrospinous colpopexy and
tomy and SC (42% vs. 20%) [31]. found that the sacral colpopexy had lower rates of awareness
So in summary, the ICI 2017 pathway for the surgical of prolapse, prolapse on examination and reoperation for
treatment of uterine prolapse makes the following recom- prolapse and lower rates of stress urinary incontinence and
mendations. Hysterectomy and hysteropexy are both suitable dyspareunia when compared to vaginal interventions [32].
options for uterine prolapse providing no contraindications On the basis of this data the 2017 ICI surgical management
to uterine prolapse exist. Regarding uterine preservation of prolapse points to sacral colpopexy as the preferred option
interventions, due to higher rates of recurrent prolapse after for vaginal vault prolapse. In recognition that not all women
sacral hysteropexy, the vaginal-based hysteropexies were are suitable for sacral colpopexy (morbidly obese, those with
692 C. Maher
prior radiation or multiple prior laparotomies) the pathway equivalence between the procedures, the pathway prefer-
also points to sacrospinous and uterosacral colpopexy as ences both interventions for vault or uterine prolapse equally.
viable options for vault prolapse. Following the 2-year data At 2-year review 60% in both groups had obtained primary
from the Optimal trial [33] that compared uterosacral and definition of success (no surgery or pessary for prolapse, no
sacrospinous colpopexy for apical prolapse and reported prolapse beyond the hymen on examination or symptoms of
prolapse). While the rate of serious complications was simi-
lar at 17% in both groups the complications experienced
with each colpopexy were distinctly different. The sacrospi-
nous colpopexy was associated with higher rates of neuro-
logical pain (12%) possibly relating to incorporation of
branches of the pudendal or sciatic nerves in the suspensory
sutures as seen in Fig. 55.5. Alternatively, at the uterosacral
colpopexy 4% experienced ureteric obstruction secondary to
incorporation or kinking of the ureter as it runs in close prox-
imity to the distal uterosacral ligament as demonstrated in
Fig. 55.5.
More recently the Pelvic Floor Disorders Network in the
USA retrospectively evaluated abdominal sacral colpopexy
as compared to a variety of native tissue vaginal repairs for
vault or uterovaginal prolapse in just over 1000 women at
1–2-year review [34]. The authors acknowledge that the two
groups were significantly different prior to evaluation with
those undergoing abdominal interventions being older, had
undergone more continence or prolapse interventions, have
greater prolapse on examination and more bother from the
prolapse than those undergoing vaginal interventions. Most
of these factors are clearly defined risk factors for recurrent
Fig. 55.4 At sacral colpopexy mesh secures the anterior and posterior prolapse and poor outcomes. The failure of the study meth-
vagina to the sacral promontory odology of the paper to match the two groups prior to evalu-
S2
Levator ani 3
(cut edge) S3
S4
Traditional
placement
Modification
(high uterosacral)
14. Korbly NB, Kassis NC, Good MM, et al. Patient preferences for vaginal hysterectomy with uterosacral ligament suspension on
uterine preservation and hysterectomy in women with pelvic organ treatment failure in women with uterovaginal prolapse: a random-
prolapse. Am J Obstet Gynecol. 2013;209(5):470e1–6. ized clinical trial. JAMA. 2019;322:1054–65.
15. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the per- 30. Rahmanou P, Price N, Jackson SR. Laparoscopic hysteropexy
formance of inpatient hysterectomy in the United States. Obstet versus vaginal hysterectomy for the treatment of uterovaginal
Gynecol. 2013;122(2 Pt 1):233–41. prolapse: a prospective randomized pilot study. Int Urogynecol J.
16. Frick AC, Walters MD, Larkin KS, Barber MD. Risk of unantici- 2015;26(11):1687–94.
pated abnormal gynecologic pathology at the time of hysterectomy 31.
Myers EM, Siff L, Osmundsen B, Geller E, Matthews
for uterovaginal prolapse. Am J Obstet Gynecol. 2010;202(5):507 CA. Differences in recurrent prolapse at 1 year after total vs supra-
e1–4. cervical hysterectomy and robotic sacrocolpopexy. Int Urogynecol
17. Pearce CL, Stram DO, Ness RB, et al. Population distribution J. 2015;26(4):585–9.
of lifetime risk of ovarian cancer in the United States. Cancer 32. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya
Epidemiol Biomarkers Prev. 2015;24(4):671–6. N, Brown J. Surgery for women with apical vaginal prolapse.
18. Siegel AL, Kim M, Goldstein M, Levey S, Ilbeigi P. High incidence Cochrane database Sys Rev. 2016;(10):Cd012376.
of vaginal mesh extrusion using the intravaginal slingplasty sling. J 33. Barber MD, Brubaker L, Burgio KL, et al. Factorial compari-
Urol. 2005;174(4 Pt 1):1308–11. son of two transvaginal surgical approaches and of perioperative
19. Jacoby VL, Grady D, Wactawski-Wende J, et al. Oophorectomy behavioral therapy for women with apical vaginal prolapse: the
vs ovarian conservation with hysterectomy: cardiovascular dis- OPTIMAL randomized trial. JAMA. 2014;311(10):1023–34.
ease, hip fracture, and cancer in the Women’s Health Initiative 34. Rogers RG, Nolen TL, Weidner AC, et al. Surgical outcomes after
Observational Study. Arch Intern Med. 2011;171(8):760–8. apical repair for vault compared with uterovaginal prolapse. Obstet
20. Parker WH, Feskanich D, Broder MS, et al. Long-term mortality Gynecol. 2018;131(3):475–83.
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in the nurses’ health study. Obstet Gynecol. 2013;121(4):709–16. trial of abdominal versus laparoscopic sacrocolpopexy for the treat-
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2016;55:38–46. comes for minimally invasive and open sacrocolpopexy. Neurourol
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Laparoscopic Pelvic Floor Surgery
56
Jan Deprest, Ann-Sophie Page, Albert Wolthuis,
and Susanne Housmans
Laparoscopy, has long been recognized to offer better expo- 56.2 Laparoscopic Colposuspension
sure and surgical detail, reduction in blood loss, and the need
for excessive abdominal packing and bowel manipulation. 56.2.1 Management of Stress Urinary
Next to the generic advantages of minimal access surgery all Incontinence
this leads to lesser morbidity. Laparoscopy has gradually
found its way in the field of urogynecology, with the intro- Continence is achieved by a combination of anatomical and
duction of a laparoscopic modification of colposuspension physiological properties of the bladder and urethra, the
by Vancaillie and sacrocolpopexy by Nezhat [1, 2]. Also sphincteric complex as well as other pelvic floor muscles and
other pelvic floor surgeries, such as paravaginal repairs [3], structures, including a normally functioning nervous system.
lateral “Kapandji” suspension [4], high uterosacral ligament Disruption of any of these components may lead to inconti-
suspension [5], or even sacrospinous fixation [6], and sal- nence. Stress Urinary Incontinence (SUI) is the complaint of
vage procedures such as the removal of mesh material [7], involuntary loss of urine through the urethra, synchronous
may benefit or are amenable for a laparoscopic approach. with an increase in intra-abdominal pressure. This typically
Herein, we will however focus on sacrocolpopexy and col- occurs when sneezing, laughing, coughing, or during physi-
posuspension, which are most commonly practiced. It has cal exercise. SUI occurs when the intra-abdominal pressure
taken quite some time before the laparoscopic modification exceeds the urethral closure pressure, for instance in the
of these procedures were shown to be equally effective as presence of urethral hypermobility or relative sphincter defi-
their open counterparts, but this is now reality. The generic ciency (or both). Urethral hypermobility occurs when there
limitations of laparoscopy are its steep learning curve and is insufficient support of the pelvic floor muscles and/or con-
long operation times, the limited number of degrees of free- nective tissue around urethra, bladder neck and to the vagina.
dom and its two-dimensional vision [8]. Those limitations In that case, on effort the urethra and bladder neck incom-
pletely close against the anterior vaginal wall. Leakage may
also occur when the urethral sphincter functions insuffi-
J. Deprest (*) · A.-S. Page · A. Wolthuis · S. Housmans ciently, yet “intrinsic sphincter deficiency” is no longer con-
Pelvic Floor Unit, University Hospitals Leuven, Leuven, Belgium
sidered as a separate entity [9]. Also the term “urodynamic
e-mail: jan.deprest@uzleuven.be
occurs in about 2% of tape insertions [14]. The tape is also often only procedure to be performed. The transperitoneal approach
blamed for causing pain during intercourse or even spontane- can be performed primarily, when concomitant intraperitoneal
ously. The efficacy and safety profile, the standardization of procedures are done, or secondary, after failure of the preperi-
technique and strong marketing have made this procedure toneal approach. First, the anterior peritoneum is incised about
extremely popular. Contemporary data comparing laparoscopic 3 cm above the symphysis. Then the urachus is coagulated and
colposuspension and MUS indicate equal subjective cure rates an incision from the left to the right obliterated umbilical artery
yet higher objective cure rates for MUS [12]. Moreover, placing is made. The dissection in the space of Retzius is first oriented
a MUS is less invasive, has a shorter learning curve and the toward the symphysis, hence keeping the midline. Lateral dis-
procedure is standardized and reproducible [12]. It is therefore section does not help the surgery and may cause laceration of
fair to say that MUS has become the gold standard for the surgi- more lateral venous structures. A thin fascial layer must be
cal management of SUI, leaving laparoscopic colposuspension, pierced to reach the posterior aspect of the rectus muscles to
at least in our unit, a procedure being offered only to patients avoid entering the dome of the bladder. In cases of previous
who either prefer the avoidance of graft material, or that undergo abdominal surgery, the top of the bladder may be attached to
simultaneously other procedures by laparoscopy [15]. the abdominal wall and peritoneal scar. In that case, filling the
The use of colposuspension may increase in the future, as bladder may help to identify the upper margin of the bladder
the use of synthetic durable materials in prolapse surgery is and locate the best place for peritoneal incision.
questioned or even banned, because of the risk for graft-related
complications, which may be difficult to treat. The lay public 56.2.3.2 Operative Technique
and certain authorities now question also the use of MUS, The symphysis pubis is used as a landmark. From there, the
including the National Health System Improvement in a letter dissection extends laterally to the ileopectineal ligaments and
to trust directors [16]. Indeed, in the U.K. “the government has downward along the midline into the retropubic area until the
announced a pause on the use of ... tape to treat SUI ... follow- Cooper’s ligaments can be identified. The bladder neck and the
ing a recommendation of the chair of an independent review vaginal vault are the next landmarks. Dissection of the Retzius
committee, who heard women and families [16].” This pause space is done by blunt dissection. When dissecting the vagina,
takes the form of a high vigilance restriction, and it was meant all fatty tissue is removed to allow perfect visualization and the
to lead to the postponement of any new cases, if it was clini- grasping of an appropriate bite of perivaginal tissue.
cally safe to do so, as communicated by NHS Improvement. The use of sutures now is considered more effective than
Conversely, the FDA affirmed that the concerns about vaginal clips or mesh and staples to approximate the vagina to the
mesh do not apply to the use of mesh for SUI [17]. ileopectineal ligaments. Two sutures are also more effective
than one [12] (Fig. 56.1). The sutures are placed after dissec-
tion and meticulous hemostasis. To facilitate proper placement
56.2.3 Technique of Laparoscopic of the sutures, the anterior vaginal wall is lifted with the aid of
Colposuspension two fingers in the vagina. The needle is inserted with the needle
holder 2 cm beyond the suture end of the needle. We use
We prescribe on a soft diet to reduce intra-operative bowel braided non-resorbable Ethibond 0 sutures (Ethicon,
distension, three days prior to the surgery. We use a single Johnson&Johnson, Zaventem, Belgium), which are 90 cm or
shot cefazolin 2 g administered intravenously 1 h prior to the more in length to allow extracorporeal suturing. Vancaillie pro-
first incision. After general anesthesia, the patient is posi- posed the use of Weston clinch knots [19]. The knots allow
tioned in a modified lithotomy position. After disinfection tightening the knot at any degree of elevation of the vagina, also
and sterile draping, a Foley catheter is introduced to empty without approximation to the ileopectineal ligament. We use at
the bladder to enable identification of the bladder neck. One least two single-bite sutures placed approximately 2.0 cm lat-
can use a three-way catheter to fill the bladder with dyed eral to each side of the urethra and 2.0 cm distal to the bladder
sterile water at any time during the operation. This allows neck, as described in the Tanagho modification [20].
easy recognition of an accidental bladder perforation. Four After checking hemostasis and bladder integrity, the perito-
trocars are used: one subumbilical primary port, two lateral neum is closed with a running suture. For that purpose we use
5 mm ports and one trocar of 7 mm or more halfway between a monofilamentary suture with large needle, such as Monocryl
the symphysis and the umbilicus, allowing needle passage. (Ethicon) 0 suture, because this one slides easily when tying
the knot. The large needle also facilitates quick closure of the
56.2.3.1 Preperitoneal or Transperitoneal peritoneum in a single run. We remove the catheter as early as
Approach possible following which the voided and residual volumes are
It is uncertain whether an extra-peritoneal approach has advan- checked. When preoperative residual bladder volume was nor-
tages over a transperitoneal approach [18]. The preperitoneal mal, we target for a residual volume <125 mL. If too large, the
approach is mainly performed when colposuspension is the catheter is reinserted temporarily, but intermittent self-cather-
698 J. Deprest et al.
ization is preferred. We empirically forbid heavy lifting or by the abdominal approach [4]. In sacrocolpopexy (SC) the
sports for 6 weeks postoperatively. vaginal vault and/or cervix is fixed by means of a graft to the
anterior longitudinal ligament over the sacrum. This opera-
56.2.3.3 Outcomes tion conserves vaginal length, hence should not compromise
Hemorrhage rarely occurs, and should be addressed appro- its function. Sacrocolpopexy by laparotomy (referred to as
priately. It rarely leads to discontinuation of the laparoscopic abdominal sacrocolpopexy (ASCP)) yields an over 90% suc-
procedure. Lower urinary tract injury is the most common cess rate, which is better than by sacrospinous fixation. This
complication of colposuspension, in particular bladder is however at the expense of longer operation times, higher
lesions. The majority of these lesions can be easily repaired morbidity, and increased hospital cost [4]. These shortcom-
endoscopically but may cause prolonged catheterization. ings are avoided by performing sacrocolpopexy by minimal
Even ureteral obstruction has been described but it is rare access, either by laparoscopy (LSCP) or by its RAS-
(<1%). Urinary tract infection is a common complication equivalent (RASC).
after this surgery. Other infectious complications such as Single incision vaginal mesh prolapse repair initially
wound infections or retropubic abscesses, although rare, are seemed to be a reasonable alternative to SCP, as it was sup-
a source of serious morbidity. Urinary retention, de novo uri- posed to combine the durability and comprehensiveness of a
nary urgency and voiding dysfunctions may occur. The later mesh repair, and the advantages of the vaginal route. In a
development of enterocele due to the anterior displacement randomized clinical trial (RCT), LSCP was associated with a
of the anterior vaginal wall is less documented for laparo- shorter hospital stay, earlier return to daily activity, better
scopic procedures, but there is no reason to believe these 2-year anatomical outcomes, less graft-related complications
would be less likely as earlier observed for open surgery. and, as a consequence less reinterventions as well as lower
Initially several case series and historical comparisons hospital costs, despite longer operation times [5, 6]. These
demonstrated outcomes comparable to those observed fol- findings, together with the global move away from vaginal
lowing open colposuspension. To our knowledge Kitchener prolapse mesh, have made that type of vaginal procedures
(2006) and Carey were the first to demonstrate equal objec- extremely unpopular, except in a country like France, where
tive and subjective cure rates for open and laparoscopic col- transvaginal mesh procedures were designed. However, also
posuspension [21, 22]. Since, this has been confirmed at the in that country, a recent randomized clinical trial again dem-
meta-analytic level [12]. Laparoscopic colposuspension is onstrated superiority of LSCP [23].
more expensive than its open counterpart and more expen-
sive than MUS.
56.3.2 Laparoscopic Versus Open
Sacrocolpopexy
56.2.4 Conclusion
Though the feasibility of LSCP was already demonstrated
Today there is level I evidence that the clinical outcomes from as in 1994, the procedure became only later embraced
laparoscopic colposuspension are comparable to those from widely than colposuspension, probably because vault
its open counterpart. Today the procedure is much less prac- prolapse occurs more rarely and LSCP needs extensive
ticed because of the popularity and outcomes of MUS. In dissection and advanced suturing skills, limiting this as
view of the increasing concerns about the use of synthetic a procedure within reach of the general gynecologist or
durable materials laparoscopic colposuspension may witness urologist [2, 24].
a revival. The challenge will then be to train a new generation Only by 2012 level I evidence became available support-
of urogynecologists who master this endoscopic operation. ing the hypothesis that a LSCP yields as good anatomic
(point C) and subjective (in that study the patient global
impression of improvement score) outcomes as the same
56.3 Laparoscopic Sacrocolpopexy operation by laparotomy. Moreover, LSC was associated
with less blood loss, less pain, and a shorter hospital stay.
56.3.1 Management of Level I Defects Conversely, operation time, return to normal activities, or
functional effects were similar for both modalities [25–28].
Whereas most patients with symptomatic Pelvic Organ At this moment, new trials rightfully compare the two mini-
Prolapse (POP) can be adequately managed by the vaginal mally invasive alternatives, i.e., vaginal sacrospinous fixa-
route, correction of apical descent or multi-compartment tion and LSCP, and this might change the landscape in the
prolapse including a so-called level I defect are better treated future [29].
56 Laparoscopic Pelvic Floor Surgery 699
56.3.3 Technique of Laparoscopic parietal peritoneum is incised and retroperitoneal fat is dis-
Sacrocolpopexy sected to allow exposure of the anterior vertebral ligament.
An area as large as required for fixing the mesh needs to be
There is at present no standardized technique. The dissected on the promontory just right from the midline.
International Urogynaecological Association Special Interest Pitfalls are the median sacral vessels, or when moving to
Group is currently drafting a review of techniques and the much laterally the ureter, or to the left the main vessels.
level of evidence for certain details. This report is at present Occasionally bipolar forceps is used for that purpose.
not available yet. Herein we describe our technique for
patients with symptomatic vault prolapse or uterine descent.
Patients have to present with minimally stage II prolapse of
the apex or upper posterior wall of the vagina according to
the Pelvic Organ Prolapse-Quantification system (POP-Q)
[30]. In case of associated rectal prolapse, a rectopexy may
be performed (Fig. 56.3). In our unit, patient preparation
involves bowel preparation for good exposure. We give
cefazolin (2 g) and metronidazole (1500 mg) prophylaxis.
After induction of general anesthesia, the patient is posi-
tioned in a modified lithotomy position with access to the
vagina and rectum. After disinfection and sterile draping a
3-way Foley catheter is inserted to empty the bladder. The
additional channels allow for bladder filling with dyed saline,
to exclude bladder lesions or identifying the bladder margins
during dissection and suturing. At least four trocars are nec-
essary: one primary umbilical 10 mm cannula, two lateral
5 mm trocars and one wider (10–12 mm) trocar halfway Fig. 56.4 Laparoscopic view from the umbilical port on the promon-
between the symphysis and the umbilicus. tory. The presacral venous structures are bluish and compressed by the
After careful identification of L5-S1, the inferior limit of pneumoperitoneum. The inferior border is the dashed red line. The iliac
arteries and bifurcation are indicated by the white dashed line. The
the left common iliac vein and the right ureter, the dissection promontory is indicated by the white interrupted line. Insert: view after
of the promontory is started (Fig. 56.4). First the prevertebral dissection. Copyright: UZ Leuven, Belgium
Fig. 56.3 Schematic drawing of a laparoscopic sacrocolpopexy (left) and sacrocolpopexy associated with a ventral rectopexy (right). The syn-
thetic mesh covers different aspects of the vagina and rectum. Drawing: Myrthe Boymans. Copyright: UZ Leuven, Belgium
700 J. Deprest et al.
Fig. 56.5 View after dissection of the prolapse vault, which is mobilized by a vaginal instrument; left anterior; right posterior and about two-thirds
along the posterior aspect of the vagina. Copyright: UZ Leuven, Belgium
The peritoneal incision at the promontory is then extended rin injections are administered as long as the patient is admit-
along the rectosigmoid to continue over the deepest part of ted, as well as a stool softener are continued for 6 postoperative
the cul-de-sac, opening the recto- and vesicovaginal space weeks to prevent heavy pushing. Also sexual inactivity is rec-
(Fig. 56.5). Some prefer to create a tunnel under the perito- ommended until the 3 months postop visit. All these measures
neum, avoiding later suturing. The lateral incision as well as were empirically determined.
the dissection downward toward the perineal body can be We try at all price not to open the vagina to avoid graft-
extended as far as required. This will be so when there is a related complications [34, 35]. For that reason, if hysterec-
large rectocele or when a concomitant rectopexy is required tomy is indicated, we would perform a laparoscopic
for rectal prolapse. cervicopexy following subtotal hysterectomy. We use non-
At this point in time we change gloves to prevent contami- resorbable mesh material, following our frustrating experience
nation of the mesh. Usually, two separate meshes are sutured with acellular collagen matrices—though other series had
to the posterior resp. anterior aspect of the vagina, using a equal outcomes after 1 year [36–38]. In Europe, the SCENIHR
knot pusher, needle holder, and assistant needle holder. As has recommended the use of polypropylene or polyester,
much as possible we try to avoid perforating the vagina while though without providing evidence whether for instance
suturing. Because this might not always be avoided, we hybrid materials (polypropylene with polyglecaprone) or
moved away from braided to monofilamentary resorbable polivinylidene fluoride would be less performant or cause
sutures (Fig. 56.6). Whether sutures need to be non-resorb- more complications [39].
able is questionable [31]. There is no agreement on how lat-
eral and deep one would dissect, neither the number or type of
sutures; there are already some reports on fixation with glue 56.3.4 Outcomes
[32]. One may need to palpate the rectum and vagina to define
their borders. Once this is finished, the vault is positioned by There are numerous reports on the successful outcome of
the rectal pusher (placed in the vagina) at the level of the LSCP, most of them retrospective in nature, monocentric or
ischial spines and then fixed in a tension-free position. We use from a single surgeon, often rather small, potentially including
either staples or sutures to fix the mesh to the promontory; the learning curve [40]. A somewhat dated review on 11 retro-
there is no true evidence for preferring one above the other in spective studies (n = 1197 patients at a mean follow-up of 24.6
terms of complications. It is at this time that one needs to be months) reported overall objective anatomical and subjective
alerted and avoid hemorrhage from the presacral vessels. We success rates of 92% and 94.4%, respectively [41]. Today
then close the peritoneum with both a running suture and the larger single center series have confirmed the efficacy of LSCP
staples left over from the sacral fixation. This will avoid adhe- and acceptable short-term complication rates [42–44]. We
sions to the mesh; however, some authors leave the perito- implemented LSCP in our unit in the late 1990s, and earlier
neum open [33]. At the end of the procedure we pack the reported on the medium-term outcomes [36, 45]. At a mean
vagina for 24 h. Postoperatively, low molecular weight hepa- follow-up of 12.5 months, we observed an anatomical cure
56 Laparoscopic Pelvic Floor Surgery 701
Fig. 56.6 Suturing of the mesh to the posterior aspect of the vagina staples is used to close the peritoneum, which is finished by a purse
(left, top) and anterior (right, top). Tension-free suspension of the mesh string (right, bottom). Copyright UZ Leuven, Belgium
by stapling it to the promontory (left, bottom). The remainder of the
rate approaching 95% and a functional cure rate of 92% [45]. experience, mainly for adhesions (Fig. 56.7). There were four
Since, we reported on a much larger consecutive series reactive conversions (0.7%) for anesthetic reasons or surgical
(n = 571) at a median age of 66.3 years (range: 27–91) [42] complications. In retrospect, there was an early (<60 cases)
(Table 56.1). 73.4% had a vault suspension, 24.2% a cervico- peak of strategic conversions, yet thereafter conversions were
pexy with concomitant laparoscopic-assisted subtotal hyster- rare and equally distributed along the experience (Fig. 56.1).
ectomy (LASH) and 2.8% a hysteropexy. Twenty-six were There were 20 patients (3.6%) with intraoperative complica-
redo-sacropexies (4.6%), and concomitant rectopexy, inconti- tion, their nature displayed in Table 56.2. The majority were
nence surgery or vaginal prolapse surgery was performed in lesions to the bladder (n = 10), vagina (n = 6) or epigastric
5.3%, 3.7%, and 3.0% respectively. arteries (n = 2), which were managed laparoscopically. The
Conversions were categorized into either a strategic con- postoperative complications were categorized according to the
version, i.e., instances where the surgeon as a precaution Clavien-Dindo classification system [48]. Eighty-four women
decided to open up the abdomen or to proceed vaginally, or (15.2%) had in total 95 postoperative Dindo grade II or higher
re-active, i.e., as a result of an intraoperative complication complications within 3 months (Table 56.3). Dindo II compli-
which the surgeon felt was better managed through open cations are those events that cause a deviation from the normal
abdomen [46, 47]. The overall conversion rate was 3.0% in 17 postoperative course, and that prompt the use of drugs other
patients, including 13 strategic conversions early on in the than analgesics, antipyretics, anti-emetics, diuretics, electro-
702 J. Deprest et al.
Table 56.1 Patient characteristics of our cohort and operative vari- Table 56.2 Rate and nature of complications in 554 consecutive
ables, for all patients and broken down by age category (under and patients who had their sacrocolpopexy completely by laparoscopy, also
above 70 years). broken down by age group
Baseline Median P
characteristics or % ≤70 years >70 years P Intra-operative n (%) ≤70 years >70 years value
Number of patients Total: 571 367 204 Number of patients 554 356 198
(100%) (64.3%) (35.7%) (64.3%) (36.7%)
Age (years) 66 (IQR 15) 61 (IQR 11) 75 (IQR 6) 0.000 Visceral injuries 16 (2.9%) 10 (2.8%) 6 (3.0%) 0.882
BMI (kg/m2) 25 (IQR 5) 25 (IQR 5) 25.5 (IQR 4) 0.917 Bladder 7 (1.3%) 5 (1.4%) 2 (1.0%) –
Menopausal 90.7% 87.2% 100% 0.000 Ureter 3 (0.5%) 3 (0.8%) 0 (0.0%) –
Diabetes mellitus (all 10.8% 9.5% 13.4% 0.344 Vaginal 6 (1.1%) 2 (0.6%) 4 (2.0%) –
types) Vascular injury 2 (0.4%) 0 (0.0%) 2 (1.0%) 0.127
Current smoker 12.2% 15.7% 3.9% 0.001 Epigastric artery 2 (0.4%) 0 (0.3%) 2 (1.0%) –
Prior hysterectomy 73.4% 70.3% 78.9% 0.025 bleeding
Prior POP surgery 72.1% 68.9% 77.8% 0.022 Anesthetic problems 1 (0.2%) 1 (0.3%) 0 (0.0%) 1.000
Prior LSCP 4.6% 5.7% 2.5% 0.072 Hypercapnia 1 (0.2%) 1 (0.3%) 0 (0.0%) –
Nature of procedures (index operation) Other 1 (0.2%) 1 (0.3%) 0 (0.0%) 1.000
Sacrocolpopexy 73.4% 70.3% 78.9% 0.025 Needle detachment 1 (0.2%) 1 (0.3%) 0 (0.0%) –
Concomitant 24.2% 27.0% 19.1% 0.036 Total number 20 (3.6%) 12 (3.3%) 8 (4.0%) 0.686
LASH + cervicopexy
–: not calculated because of low number per individual cell. P values
Hysteropexy 2.8% 3.0% 2.5% 0.705
are based on χ2 testing (Fisher exact)
Concomitant 5.3% 5.5% 4.9% 0.783
rectopexy
Concomitant 3.7% 3.6% 3.9% 0.814
incontinence surgery
Concomitant vaginal 3.0% 3.3% 2.5% 0.584
surgery
BMI Body Mass Index, LASH Laparoscopic Subtotal Hysterectomy,
LSCP Laparoscopic SacroColpoPexy. Absolute values not displayed;
missing values range prior surgery: 0%—certitude on menopausal sta-
tus 26.4%
10
Reactive conversions Strategic conversions Intra-operative complications
9
8
Absolute number of cases
7
6
5
4
3
2
1
0
60 120 180 240 300 360 420 480 540 571
Number of patients in blocks of 60
22% 43% 33% 28% 43% 48% 42% 37% 30% 26%
percentage of patients aged >70
Fig. 56.7 Effect of experience on (blue) the number of reactive con- 57]; Y axis: absolute number of cases. The number below each block
versions, (red) strategic conversions and (green) the number of intraop- refers to the percentage of patients above 70 years. (From Vossaert
erative complications. X axis: number of patients in blocks of 60 [40, et al., 2018, with permission of authors [42])
56 Laparoscopic Pelvic Floor Surgery 703
Table 56.3 Nature and number of 95 early postoperative complications in 83 patients, broken down according to the Dindo classification, and
categorized by age groups
Early postoperative complications n ≤70 years >70 years P value
Number of patients 554 356 198
Number of patients with complications (% of the population) 84 (15.2%) 57 (16.0%) 27 (13.6%) 0.455
Number of complications 95 61 34
Dindo II—any deviation from the normal postoperative course requiring pharmacological 77 53 (14.9%) 24 (12.1%) 0.372
treatment with drugs other than such allowed for grade I complications
Antibiotics for asymptomatic or symptomatic urinary tract infection 33 24 9
Antibiotics for postoperative fever and/or CRP rise 11 9 2
Treatment of vaginal infection 4 3 1
Antibiotics for umbilical/trocar wound infection 4 4 0
Antibiotics for Chronic Obstructive Pulmonary Disease exacerbation/pneumonia 2 2 0
Antibiotic prophylaxis after vomiting during extubation 1 1 0
Blood transfusion 11 6 5
Administration of (additional) drugs (amlodipine, perindopril, digoxin, bisoprolol, 7 1 6
haloperidol)
Low Molecular Weight Heparin for treatment of Deep Venous Thrombosis/Pulmonary 4 3 1
Embolism
Dindo III a—Complication requiring surgical, endoscopic or radiologic intervention not 4 1 (0.3%) 3 (1.5) 0.100
under general anesthesia
Infection with mesh extrusion, vaginally removed in the office 1 0 1
Urinary retention, catheterization 3 1 2
Dindo III b—Complication requiring surgical, endoscopic or radiologic intervention under 13 7 (2.0) 6 (3.0) 0.429
general anesthesia
Reoperation for prolapse 1 0 1
Reoperation for suspected hemorrhage 4 2 2
Reoperation for ureter reimplantation 1 1 0
Reoperation for mesh removal 2 1 1
Reoperation for exposure sling 1 1 0
Reoperation: cholecystectomy 2 2 0
Reoperation for bowel obstruction 2 0 2
Dindo IV—Life-threatening complication 1 0 (0.0%) 1 (0.5%) 0.357
ICU admission for cardiac decompensation and pulmonary edema 1 0 1
When several complications occurred, the patient was counted in the highest category applicable. CRP C-reactive protein. Statistics were done on
individual patient basis for each Dindo category
lytes, and physiotherapy. Among these, urinary tract infection 6CT2S4), from which she recovered after 9 weeks of antibi-
was the most common (5.9%), the majority identified on urine otic therapy, and in one patient we removed the mesh early
culture and asymptomatic. Other common Dindo II complica- on because of severe pelvic infection. She recovered and did
tions were the need for blood transfusion (1.9%) and the not develop recurrence. In retrospect, this patient had multi-
administration of antibiotics (1.9%). Dindo III and higher ple co-morbidities among which essential thrombocytosis,
were categorized as major. Interventions without the need for for which she was on the antitumoral agent hydroxy-
general anesthesia (Dindo IIIa) were for patients with urinary carbamide. Two patients had a reintervention for bowel
retention and in one patient in office mesh removal. obstruction. Four patients experienced complications away
Reintervention under general anesthesia (Dindo IIIb) and from the operation field. One had a reintervention for a
ICU admission (Dindo IV) are clinically very relevant com- symptomatic sling exposure. Two patients suffered from
plications. These were rare (2.3%). There were four early cholecystitis for which they were operated. One patient who
second look laparoscopies for suspected hemorrhage, though underwent simultaneous LASH was postoperatively diag-
despite a hemoperitoneum, no source could be identified. nosed with a ureteric obstruction at the level of the uterine
There were three directly prolapse surgery-related addi- artery and underwent reimplantation. We had 2.7% mesh-
tional surgeries. One patient with chronic coughing required related complications, most of them easy to manage, except
an immediate redo, one had a spondylodiscitis (IUGA for the above patient with discitis.
704 J. Deprest et al.
56.3.5 Outcomes in the Elderly (4) fixation of the implant to the promontory, (5) reperitone-
alization. We analyzed for each step the operation time, per-
In 2016, 19.2% of the EU-28-population was over 65 years formance, and complication rate. Taking operation time as
(5.4% >80 years), but by 2030 that segment will be 23.9% outcome measure, we found an apparent learning curve for
(7.2% >80 years) [49]. With increased activity and a health- all steps of the procedure, except for the dissection of and
ier population, POP surgery, hence also the demand for SCP fixation to the promontory. The most challenging step was
in the elderly will increase accordingly. In one study [50], the dissection of the vault. It took the trainee 31 procedures
the annual risk for POP surgery was 4.3/1000 women aged to achieve an operation time that was comparable to that of
71–73 years and in another one it was 5.0/1000 women aged an experienced surgeon. After a skills lab for suturing, the
65–69 years [51]. With age the prevalence of chronic ill- trainee could suture the implant as fast to the vault as the
nesses and comorbidities increases, including poor cardio- teacher.
pulmonary reserve, not to forget, the prevalence of prior
surgery [52]. Though complex operations seem risky in the
elderly, minimally invasive surgery may be particularly ben- 56.3.7 Conclusion
eficial in those patients [53]. The literature on the effect of
age is controversial [54–56]. Most studies show similar Laparoscopic sacrocolpopexy yields equally good objective
complication rates in younger and elder patients, yet occa- and subjective cure rates as by open surgery, but is associated
sionally higher complication rates are reported [54]. In that with less blood loss, less pain, and a shorter hospital stay.
study, age ≥65 years remained a significant predictor of The operation can be done by conventional “straight stick”
complications after correction for BMI, estimated blood laparoscopy as well as robotic assisted, though no benefits
loss and operating time (adjusted OR 2.28, 95% CI 1.21– have been demonstrated for the latter. The learning curve for
4.29, p = 0.01). In the above study on 571 consecutive LSCP, LSCP may be between 30 and 60 cases, depending on what
septuagenarians were not more likely to have intraoperative outcome measures are considered. At this moment, new tri-
(4.0% vs. 3.3% <70 years, p = 0.686) or early postoperative als are comparing LSCP to that of vaginal sacrospinous fixa-
complications (13.6% vs. 16.0% <70 years, p = 0.455) than tion and LSCP; the findings of these change the landscape in
younger patients. Mesh complications were also equally the future [29].
uncommon [42].
56.4.2 Associating Anterior Rectopexy sion. The procedure requires advanced dissection and sutur-
in Combined Middle and Posterior ing skills, which not many surgeons master today. Appropriate
Compartment Problems training programs will need to be designed to allow pelvic
floor surgeons to acquire the required skills and give colpo-
The choice for associating an anterior laparoscopic mesh- suspension back a place in their operative portfolio.
rectopexy as the preferred surgical procedure for associated Efforts are being done to document the impact of varia-
rectal prolapse by our colorectal colleagues in our unit has tion in techniques for laparoscopic sacrocolpopexy, such as
two reasons: (1) laparoscopic ventral rectopexy with mesh the nature and number of sutures, the extent of dissection, the
has been pioneered by our colorectal colleagues and out- nature of the implant, the impact of uterine conservation, etc.
comes are good [60, 61] and (2) it can be easily combined Though open sacrocolpopexy has been shown to be supe-
with a colpopexy. The procedure requires similar skills, dis- rior to vaginal sacrospinous fixation, new trials are being
section in the same anatomical spaces and for the technique conducted comparing minimally invasive sacrocolpopexy or
used (mesh anterior rectopexy) in our unit the same instru- laparoscopic hysteropexy and vaginal sacrospinous fixation
ments and devices are used. The symptomatology, diagnostic [29, 65].
assessment, and surgical management of ODS and perineal
descent is described in detail elsewhere in this book (Van
Geluwe & D’Hoore, Chap. 68). Occasionally we also treat Take-Home Messages
patients with an associated sigmoidocele together, for which Laparoscopic colposuspension is equally effective as
a partial bowel resection is done. open colposuspension, but is currently much less prac-
ticed because of the widespread embracement of
MUS. Slings are equally effective yet cheaper and are
56.4.3 Technique and Outcomes easier to learn.
of an Associated Anterior Rectopexy Laparoscopic and open sacrocolpopexy yield
equally good objective and subjective cure rates. The
In case of an associated rectopexy, the dissection of the recto- laparoscopic approach is associated with less blood
vaginal space along the rectal muscularis goes as far as the loss, less pain and a shorter hospital stay. The proce-
anal sphincter using monopolar dessication. Denervation or dure can be easily associated with a ventral rectopexy
damage to the inferior hypogastric nerve is to be avoided. The in selected cases.
peritoneal incision is started at the bottom of the pouch of The learning curve of laparoscopic sacrocolpopexy
Douglas and continued upward along the left side of the rec- is long and prior training on a simulator and on sutur-
tum. Redundant prerectal fat and when required part of the ing may shorten it. The benefit of robotic sacrocolpo-
pouch of Douglas may need to be resected, so that the mesh pexy has not been demonstrated; it may however
can cover directly the anterior aspect of the rectum. Sutures shorten the learning curve for physicians not familiar
will be placed on the front and alongside the rectum so that the with laparoscopy.
mesh eventually prevents the rectum from sliding downward
and bulging anteriorly, without true tension. The posterior,
middle, and anterior aspect that is covered by mesh is excluded
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The Robotic Approach to Urogenital
Prolapse 57
Claire M. McCarthy, Orfhlaith E. O’Sullivan,
and Barry A. O’Reilly
revolutionary gynaecologist, performed the first laparoscopic development of robot-assisted surgical systems, there are
appendicectomy [8]. However, the laparoscopic revolution opportunities to capitalize on the ergonomic and economic
began in earnest by the 1990s with the first laparoscopic hys- advantages of robot-assisted surgery, as well as increase
terectomy performed in 1990 by Nezhat and Reich [9]. access across all levels of healthcare. Thus, robot-assisted
surgery has the potential in the future to replace conventional
laparoscopy throughout many fields of surgery [16].
57.2.1 History of Robot-Assisted Surgery
As minimal access surgery continued to become widely uti- 57.2.2 Components of Robotic Surgery System
lized, it demonstrated superiority in areas such as reduced
perioperative morbidity and shorter length of hospital stay, The first da Vinci® System introduced in 1999 [12] was
in addition to being both more economical and reducing upgraded in 2003 from a three-armed to four-armed robot,
the exposure to adverse events. The development of robotic providing the fourth (retractor) arm. The system consists of
surgery was in part due to work by the Defense Advanced three main components:
Research Projects Agency (DARPA), which funded research
into the possibility to performing minimally invasive surgery 1. The console from where the surgeon controls the opera-
in a remote surgery programme, with surgeons controlling tion (Fig. 57.1)
the console and procedure remote from the battlefield [10]. 2. The patient side cart with four interactive robotic arms to
The role of robotic surgery has never been to replace the sur- which the operating instruments are attached (Fig. 57.2)
geon, but rather enhance his/her performance with highly 3. The vision system (Fig. 57.2)
advanced tools [11].
In 1999, Intuitive Surgical® developed and introduced The EndoWrist® instruments used during surgery com-
the first da Vinci® System to the market and in 2000 it was bine seven degrees of freedom, with 90° of articulation to
cleared by the FDA (Food and Drug Authority) [12] for provide a range of motion superior to the human hand [14].
minimally invasive surgery including urological procedures. It also combines intuitive motion and fingertip control with
Subsequently it was approved for gynaecological surgery in motion scaling and tremor reduction technology to provide
2005. In Europe, the da Vinci robot has full regulatory clear- instruments with greater capabilities and improved surgical
ance and has the CE (Conformité Européenne) mark since dexterity. The latest model in common usage, the da Vinci®
1999 [13]. Xi Surgical System (2014) [14], allows for more efficient
The success of the da Vinci system has been seen world- anatomical access with crystal clear three-dimensional and
wide, with availability in 66 countries and 44,000 surgeons high-definition visualization. Further modifications such
trained in the use of the da Vinci system [14]. Over five mil- as provision of a dual console facilitate training of the next
lion surgeries have been performed since their introduction generation of surgeons. Other adaptations include the capa-
under 20 years ago, which shows an unparalleled level of bility to identify key landmarks utilizing integrated fluores-
evidence in comparison to other non-robotic surgical system cence technology and single incision versatility minimizing
providers with over 15,000 peer-reviewed publications uti- port placement for common procedures such as the benign
lizing a single surgical system. hysterectomy. The principle of robot-assisted surgery is that
As the twenty-first century progresses, other companies the surgeon operates unscrubbed while seated at the con-
are beginning to venture into the field of robot-assisted sur- sole, from which they are able to view the operating field
gery. CMR Surgical Limited® is currently developing a sur- in three dimensions through a stereoscopic viewer. This has
gical robotic system called Versius® which will in theory be been further streamlined into the da Vinci SP [15], utiliz-
portable and transportable, with a footprint of 38 cm × 38 cm ing single port and arm access to the operative field, which
[15]. Medtronic® also plans to introduce a competitor to as well as being at the cutting edge of conventional laparo-
the market with Hugo®, as does TransEnterix®, Synaptive scopic surgery has rapidly been extrapolated to the arena of
Medical® and Titan Medical Inc.™. These continuous inno- robot-assisted surgery.
vations demonstrate that robotic surgery will continue to
evolve and adapt to maximize patient outcomes, as well as Recommendation for Practice
making the market more competitive and thus robot-assisted Surgeons should familiarize themselves with surgical equip-
procedures more cost-efficient. With further focus on the ment including troubleshooting minor technical issues.
57 The Robotic Approach to Urogenital Prolapse 711
57.2.3 Use of Robotic Surgery in Other Sub- Table 57.1 Comparison of laparoscopic versus robot-assisted surgery
specialties of Gynaecology and Surgical Conventional laparoscopic
Specialties surgery Robot-assisted surgery
Two-dimensional image Three-dimensional image
Straight, rigid instruments Enhanced dexterity
Since its introduction into clinical practice, robot-assisted
Surgeon fatigue Improved ergonomics and thus
surgery has expanded exponentially to include many surgical reduced fatigue
specialties such as gynaecology, general surgery, colorectal, Camera motion/tremor Camera controlled by primary
head and neck, cardiothoracic and urological surgery. The surgeon leading to improved
greatest volume of evidence for the use of robot-assisted sur- visualization and reduced tremor
Primary surgeon limited to two Primary surgeon can control up to
gery is in the area of urology, with cardiothoracic surgery
active instruments four instruments
the most recent speciality to benefit from robot-assisted Challenges of those at Overcomes complexities of obese
techniques. extremes of weight patients
The robotic telepresence technology is flourishing, and Increased incidence of Improved safety features to
opportunities have expanded to incorporate its use into physical and psychological minimize physical injury
sequelae for surgeons
specialties and procedures which have been previously
unattainable.
of physical symptoms or discomfort, supporting a more
favourable ergonomic environment in robotic surgery than
57.2.4 Laparoscopic Versus Robot-Assisted in laparoscopy [25]. Conventional laparoscopic surgery also
Surgery requires skilled assistants to carry out a range of activities,
such as manoeuvring the camera, obtaining the best pos-
Laparoscopic surgery has been an integral part of clini- sible image as well as anticipating future movements of the
cal practice much longer than robot-assisted surgery, and primary surgeon. In addition, assistants may need to utilize
its evolution was unprecedented during the late twenti- accessory instruments through additional ports, as the pri-
eth century. However, this innovation, development and mary surgeon is limited to utilizing two instruments at any
advancement has been capped, with its capabilities reach- one time in conventional laparoscopy. Table 57.1 summa-
ing a veritable glass ceiling. Surgeons are now primarily rizes these limitations of laparoscopic surgery and demon-
trained in minimally invasive surgery with the advantages strates how robot-assisted surgery surpasses the limitations
of minimally invasive surgery largely extrapolated to robot- of traditional minimal access surgery.
assisted surgery. These include reduced blood loss, fewer With the advances of laparoscopic surgery incorporated
complications, faster recovery, reduced length of hospital with the advances of robotic surgery, we have been able to
stay and improved cosmesis. However, conventional lap- overcome the limitations in the advancement of conventional
aroscopic surgery has a number of drawbacks which are laparoscopic surgery, allowing more complex procedures to
minimized by robot-assisted surgery, which have been be carried out to the same high standard as has been seen
described in the fields of urogynaecology [17], general and over the past century.
oncological gynaecology surgery [18] and in other surgical
specialties [19, 20]. Recommendation for Practice
Laparoscopically, surgeons operate exclusively with Surgeons intending on performing robot-assisted surgery
a two-dimensional image, which can limit depth percep- should have attained competency in at least one alternative
tion and also increase surgeon fatigue. Surgeons utilize approach in order to manage surgical complications.
straight, rigid instruments with decreased precision, which
is associated with reduced dexterity and control, culminat-
ing in poorer surgeon ergonomics and increased practitioner 57.3 Robotic Approach to Apical Prolapse
fatigue. In addition, operating in a small surgical field with
conventional laparoscopy can exacerbate tremor, which is Following the use of robot-assisted surgery in benign gynae-
reduced with robot-assisted surgery. It has been theorized cology, its use expanded to procedures that are the remit of
that the high-volume laparoscopic surgeon has the potential subspecialists in the field, such as in gynaecological oncol-
of causing irreparable strain injury leading to earlier retire- ogy and urogynaecology. Common procedures performed in
ment [21–23], as well as being associated with a more stress- the urogynaecological setting include robot-assisted sacro-
ful operative approach [24]. This could potentially impact on colpopexy (RASC), robot-assisted hysteropexy (RASH) as
the number of skilled surgeons treating us and our patients. well as mesh removal procedures and secondary repair pro-
Robot-assisted surgery has been shown to have a lower rate cedures, such as vaginal fistula repair.
57 The Robotic Approach to Urogenital Prolapse 713
The first case of RASC was reported in 2004 [26], and since
then, a number of authors have published case series of its
performance, suggesting alternative surgical techniques
and nuances to maximize clinical results. Despite this, there
remains a limited number of randomized controlled trials com-
paring laparoscopic-assisted sacrocolpopexy (LASC) with
RASC with the main endpoints of operation time, pain, func-
tional activity symptoms, cost, anatomical support and quality
of life [27, 28]. Overall, Paraiso demonstrated no significant
functional differences between laparoscopic and robot-assisted
procedures; however, the latter was associated with increased
pain scores and increased operative time. Increased pain fol-
lowing RASC however does not corroborate with other studies,
which typically show similar or reduced pain scores [29]. This
is potentially due to port insertion technique, and in view of the
fulcrum effect of robotic instrumentation, it is imperative that
ports are inserted at a 90-degree angle to the skin surface.
The rationale and surgical principles of RASC are simi-
lar to the laparoscopic approach, and when we examine Fig. 57.3 Diagram for port insertion sites: a routine approach. ©2019
Intuitive Surgical, Inc.
the inaugural operative RASC approach [26], we can see
adaptations from standard laparoscopy to maximize utiliza-
tion of the da Vinci robotic system. One camera port, two the instrument arms subsequently attached and instruments
robotic ports and two standard laparoscopic ports are placed. introduced under direct vision. The assistant port is the left
Standard laparoscopic dissection is used for initial anterior superio-lateral port to facilitate introduction of sutures and
and posterior vaginal mobilization and exposure of the sacral potentially mesh grafts. Dissection is then performed by the
promontory. The da Vinci robot is then docked and used to surgeon sitting at the console via the robot; to aid this vagi-
suture a silicone Y-shaped graft from the vagina to the sacral nal and rectal manipulators are introduced. The anterior and
promontory. Culdoplasty, with plication of the uterosacral posterior vaginal walls are mobilized and following this the
ligaments, is then performed, followed finally by retroperito- sacral promontory is exposed, and a track created to allow
nealization of the graft. the peritoneum to be closed over the mesh. The Y-shaped
As with all procedures, it is the natural evolution that as polypropylene mesh is then attached from the anterior and
more surgeons perform and undertake a procedure modifica- posterior walls of the vagina to the anterior longitudinal liga-
tions occur [30]. We describe one commonly used technique ment using permanent sutures, e.g. GORE-TEX®. Finally,
here. the peritoneum is then closed over the graft.
The patient is placed in moderate to steep Trendelenburg, Other surgical variations are in the number and calibre
with legs placed in the low lithotomy position. Once posi- of ports utilized, type of vaginal manipulator, deviations in
tioning is satisfactory, the ports are placed in a W shape suture material, mesh graft and additional techniques [31–
(Fig. 57.3) with the camera port (12 mm) cephalad to the 36]. Some of these techniques are highlighted in “Further
umbilicus (blue); the right instrument arm port (8 mm, yel- Reading” at the end of this chapter.
low) is placed 10 cm right of the umbilicus and ~30° inferior There are limited numbers of randomized controlled trials
to camera port. The left instrument arm port (8 mm, green) comparing robot-assisted, laparoscopic and open techniques,
is placed 10 cm left of the umbilicus and ~30° inferior to and those that do exist have different endpoints, outcome
camera port, the third instrument arm port (8 mm, red) is measures and follow-up times. Some of the most pertinent
placed on the left side ~3 cm from the iliac crest and >10 cm and notable papers are described in Table 57.2. However, we
from the left instrument port at the level of the camera port may never obtain high-quality evidence for robot-assisted
and, finally, the assistant port (8 mm, white) is placed far procedures such as this, due to firstly the heterogeneity in
right ~8 cm from the right instrument port, just below the published studies [37], as well as the belief that there are dif-
level of the camera port. The measurements for port place- ficulties performing randomized controlled trials with new
ment should be made after insufflation. The robot is then technologies, held by epidemiologists such as Professor Sir
docked, the camera arm attached to the camera port and Rory Collins [38].
714 C. M. McCarthy et al.
Table 57.2 Publications comparing robotic (RASC) versus laparoscopic (LASC) and/or abdominal (ASC) sacro-colpopexy
Patient
Paper RASC vs Operative time Length of stay Blood loss Cost Pain POP-Q score satisfaction
Paraiso [27] LASC Increased Increased Increased No difference
Anger [28] LASC No difference Increased No difference
White [29] ASC and No difference No difference No difference Increased No difference
LASC
Geller [32] ASC Decreased Decreased Improved
Hoyte [39] ASC Increased Decreased Increased
Lee [40] LASC Increased Increased Improved Increased
Pan [41] LASC Increased Increased Increased
Li [42] ASC Decreased Decreased Increased
To highlight some of the findings with respect to endpoints Recommendation for Practice
and outcome measures, there is little difference between Surgeons should be familiar with multiple approaches to
lengths of hospital stay between laparoscopic and RASC, surgical procedures to allow intraoperative adaptation as
yet the abdominal procedure is associated with a longer hos- required
pitalization [29]. The robotic approach is associated with
decreased blood loss while having little difference in func-
tional outcomes and recurrence rates. Complication rates are Case Box 57.1. Complex RASC
more difficult to stratify due to heterogeneity between stud- A 57-year-old woman was referred by her primary
ies, but overall are similar. case physician with a 3-year history of vault pro-
There are also advantages of RASC over laparoscopic lapse. She had three previous vaginal deliveries and
and open approaches, which are not as amenable to clinical a surgical history comprising of vaginal hysterectomy
study, such as ease of suture placement in the case of the performed 10 years previous for prolapse. This proce-
former, and increased risk of wound complications and pro- dure was complicated by a pelvic haematoma, requir-
longed length of stay owing to the latter. ing ultrasound-guided drainage in the post-operative
Anecdotally, when comparing robot-assisted surgery to period. Owing to a road traffic collision in recent
laparoscopic surgery, surgeons find dissection over the sacral years, she had limited abduction secondary to lower
promontory less problematic owing to an increased range of limb and pelvic injury.
movement of the instruments [43], which can also contribute These factors were considered when making an
to more efficient and facile suture placement and knot tying, operative decision, with her limited mobility com-
eliminating challenges of intra-corporeal dexterity. It also promising vaginal access, her wish to maintain sexual
allows the potential avoidance of surgical fixation products and function as well as the potential for further apical pro-
their associated risks [44]. The learning curve initially has also lapse given her young age. Following a full discussion,
been shown to be less steep, with as little as ten cases required this lady was admitted for a robot-assisted sacrocolpo-
to achieve surgical proficiency and competency [34, 45, 46]. pexy. Intraoperatively, it was evident that an excessive
Given the sparsity of research with focussed, concise amount of scarring was present between the vagina and
and consistent outcome measures reported, the PARSEC bladder, which impacted considerably on dissection.
(Prospective Assessment of Robotic Sacrocolpopexy: a The anterior and posterior vaginal walls were mobi-
European Multicentric Cohort) study is currently complet- lized and following this the sacral promontory was
ing recruitment of women who have undergone RASC in exposed, and a track created to allow the peritoneum
high-volume European institutions and is due for completion to be closed over the mesh. The Y-shaped mesh was
in 2022 [47]. Interim results have demonstrated successful then attached from the anterior and posterior walls of
anatomical outcomes at one year, with low intraoperative the vagina to the anterior longitudinal ligament using
complication rates, with console times as low as 53 min [48]. permanent sutures, e.g. GORE-TEX®. Finally, the
Additional work due to be published from the group demon- peritoneum is then closed over the graft. The patient
strates the largest prospective cohort study on robot-assisted was followed up and to date there is no evidence of
surgery having safe and durable results (van Zante et al. on recurrence.
behalf of PARSEC).
57 The Robotic Approach to Urogenital Prolapse 715
57.3.3 Other Procedures Amenable the right patient at the right time by the right surgeon. In
to Urogynaecological Robot-Assisted the case of pelvic surgery, a steep Trendelenburg position
Procedures is often adopted, in combination with CO2 pneumoperi-
toneum. This can increase upper airway resistance, caus-
As has been demonstrated in other chapters, continence uri- ing airway oedema and reduced lung compliance [69].
nary diversion is an appropriate surgical alternative in some Thus, the robot-assisted approach may not be suitable for
patients who are unable to perform clean intermittent self- patients with respiratory disease/compromise or morbid
catheterization (CISC). More commonly performed utilizing obesity. Other anaesthetic considerations that need to be
an open approach, there are reported case series which dem- evaluated and managed are reduced access to the patient
onstrate potential in the robot-assisted approach as being a owing to robot placement, which can delay patient man-
safe and feasible alternative that can be considered in appro- agement [70].
priate patients [57].
Similarly, fistula repair is an area that the robot-assisted
approach can offer significant advantages as both a primary 57.4.2 Education and Learning
repair method and a useful adjunct to vaginal surgery [58].
The increased dexterity, precision and control facilitate more As with the adoption of any new technique, there is a period
time-efficient and effective repairs to be achieved. Robot- of education and learning to reach satisfactory surgical
assisted procedures have been shown to have reduced blood ability and proficiency. With its exponential increase, there
loss, shorter length of stay and lower recurrence rates [59, have been successful robotic surgery fellowships, educa-
60], as well as facilitating complex dissection and recon- tional courses and curricula established to allow acquisition
struction that may be difficult to achieve utilizing open, lapa- of basic robotic skills, followed by more complex skills.
roscopic or open approaches. Structured curricula can allow the safe and stepwise accu-
In recent years, RASC has been combined with rectopexy mulation of these skills over a relatively short learning curve
to treat multi-compartment pelvic floor prolapse, with this [71]. Training programmes typically consist of patient side
first described by van Iersel et al. in 2016 [61], showing this training and console training and can involve the multidisci-
to be an effective technique with 12-month follow-up data. plinary team. Online modules have been provided by the da
Since their introduction, mid-urethral slings have been Vinci surgery community in basic concepts, and advanced
widely documented to be associated with vaginal extrusion console skills can be pursued in virtual reality simulators
[62] and urethral [63] and intra-vesical exposure [64], despite (which are evaluated for face, content and construct valid-
being curative for a significant number of women who previ- ity), dry labs or wet labs [72, 73].
ously suffered from stress urinary incontinence [65]. Over Education, training and support for all members of the
the past number of years, robot-assisted techniques have multidisciplinary team are essential when introducing new
also been utilized in mesh removal surgery, such as that technology to the operating environment. Teamwork is an
following mid-urethral sling surgery. Given robot-assisted essential component to success in all operative procedures,
systems’ greater dexterity, range of movement and access, it and focus should be placed on the provision of ongoing pro-
can be successfully performed in tandem with other surgical fessional development for all members of the operative team
approaches [66, 67]. These typically have included a vagi- in all phases of the patients’ operative journey (i.e. preopera-
nal approach combined with abdominal approaches [68], but tive assessment, intraoperative and post-operative care).
the use of robot-assisted procedures has reduced the need for Proctorship has also become an essential part of robot-
an open approach, providing equivocal outcomes in tandem assisted surgery training, providing efficient and rapid pro-
with reducing length of stay. Overall, this has the potential to gression of learning curve amongst surgeons [74].
be more time efficient, reducing patient risk. When we examine the learning curve with respect to api-
cal prolapse surgery, it has shown to be as short as 10–20
procedures [75], but more recently has been shown to be up
57.4 Considerations with Robotic Surgery 60 cases [76]. However, given that there is significant hetero-
geneity in what is reported as the learning curve, and who is
57.4.1 Preoperative Evaluation and Risk considered, it is difficult to secure a definite figure for spe-
Assessment cific procedures at this juncture without bias.
As newer models consist of additional consoles, this
As with other operative procedures, patient selection is allows training to be pursued in a formal clinical setting, an
imperative to ensure that the right procedure is chosen for essential adjunct to the operators.
57 The Robotic Approach to Urogenital Prolapse 717
Recommendation for Practice Both surgeon physical injury and stress have been
Self-audit including during the learning curve should be per- reported to be decreased by robotic surgery and have been
formed to examine outcomes. shown in both doctors and their non-medical counterparts
[83]. While initial reports of robot-assisted surgeons suffer-
ing from back pain [84], the console is now adjustable to sur-
57.4.3 Cosmesis geon-specific requirements, thus counteracting this potential
issue. An increased robot-assisted surgical workload has
Cosmesis is an important consideration for patients, and not been demonstrated to increase physical discomfort and
undoubtedly, successful robot-assisted surgery has improved symptoms [85]. This reduction in surgeon injury is signifi-
cosmesis versus open surgery. Even when compared with cant from a surgical point of view but also from an economic
multi-port laparoscopic surgery, robot-assisted surgery is point of view as surgical injury has a significant personal and
associated with improved cosmesis satisfaction and body institutional cost.
image perception [77].
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Concurrent Prolapse and Incontinence
Surgery 58
Annette Kuhn
Learning Objectives
• Aim of this chapter is to learn about the advantages
and disadvantages of concurrent prolapse and
incontinence surgery, to be able to inform patients
who suffer from prolapse and overt and masked
incontinence about surgical possibilities weighing
benefits and risks of concomitant surgery for pro-
lapse and for incontinence.
58.1 Introduction
Urinary stress incontinence (SUI) may develop after pel- Fig. 58.1 Uterine prolapse with cystocele and ulcerations
vic organ prolapse (POP) repair in approximately 25% of
patients (Fig. 58.1).
In women with stage II POP roughly 55% have concurrent 3. Patients who suffer from POP only without overt or
SUI, which decreases with increasing POP stages to 33% in masked incontinence.
patients with stage IV POP due to progressive kinking of the
urethra that protects the patient from leakage. Despite POP surgery leading occasionally to de novo
Reducing the prolapse may restore normal voiding func- incontinence, preoperative SUI might be treated by prolapse
tion or not depending on detrusor contractility and nerval repair only without additional continence procedures.
function. Although the majority of publications concentrate on de
Three groups of potentially incontinent patients may be novo SUI after prolapse repair, an analogue situation may
distinguished: occur after prolapse repair of the posterior compartment
resulting in de novo faecal incontinence. There is a paucity
1. Patients with concomitant POP and SUI, who suffer from of data analysing this issue, and general recommendations
SUI before their POP is treated; this type is defined as cannot be given.
overt incontinence. The following chapter will discuss what diagnostic tests
2. If the prolapse is surgically reduced and the vagina is put detecting occult urinary incontinence may be of help and
into the physiological position, patients who were conti- whether women with overt or occult incontinence should
nent before may experience de novo incontinence. This undergo concomitant continence surgery at the time of
type of SUI is defined as occult, masked or latent SUI. prolapse repair and what potential side effects are to
experience.
Additionally, the type of surgery for the treatment of SUI
A. Kuhn (*) will be discussed.
Department of Urogynaecology, University of Bern, Frauenklinik,
Inselspital, Bern, Switzerland
e-mail: annette.kuhn@insel.ch
58.2 Diagnostic Tests to Unmask Generally, the validity of urodynamics prior to surgical
Occult SUI prolapse repair remains unclear. An acontractile detrusor
may or may not remain acontractile after prolapse repair;
The Cochrane review on surgical interventions of POP residual urine may or may not disappear after restoring nor-
found that new SUI symptoms were described by 187 of mal anatomy.
1280 women [1]. Preoperative tests to determine the risk of In summary, no gold standard to examine bladder func-
postoperative SUI aim to mimic the postoperative anatomi- tion or to unmask occult SUI in patients with POP exists.
cal situation and reducing the prolapse manually, insertion Prolapse reduction methods in combination with stress tests
of speculum, sponge holder or pessary. The importance of may hint at lower risks for de novo SUI but are not entirely
these findings is ambiguous: these tests do not necessarily reliable.
predict postoperative incontinence and do not mimic pro- Table 58.1 summarizes the results of prolapse surgery
lapse surgery. The tests themselves may obstruct the urethra alone versus combination surgery from a meta-analysis [4].
or put undue tension on the urethra, thus preventing urinary The majority of study demonstrates benefits from combi-
leakage. No gold standard to determine occult SUI has been nation surgery.
developed, and none of these tests has acceptable positive
predictive values to determine who may and who may not
benefit from additional continence surgery. 58.3 P
atients with Concomitant POP
However, negative predictive values of pessary and spec- and SUI (Overt Incontinence)
ulum tests were 92.5% and 91.1%, respectively, meaning
that women with negative stress test during the insertion of a Preoperative SUI might be treated by prolapse repair alone
speculum or pessary are at low risk to suffer from SUI post- without an additional continence procedure alone [5].
operatively [2]. Therefore many clinicians prefer repairing the prolapse as
In clinical practice the use of a pessary prior to surgery initial step and later on address SUI in case of necessity.
is advisable (Fig. 58.2); if the patient reports de novo SUI Some patients find it unacceptable to undergo surgery twice.
during the use of the pessary, the patient should be informed Few studies have investigated prolapse surgery in women
about the possibility of postoperative SUI. with coexisting SUI symptoms prior to surgery. One study
Frigerio [3] determined a higher preoperative ICIQ-SF [6] investigated sacrocolpopexy with or without additional
score, a detrusor pressure at maximum flow rate less than Burch colposuspension in women with overt, masked and
30 cmH2O and urodynamically diagnosed SUI as inde- mixed incontinence and found no benefit in the group of
pendent risk factor for postoperative SUI. No additional patients with Burch colposuspension; two other studies
urodynamic values as independent risk factors could be investigated vaginal prolapse repair with additional midure-
determined. thral slings in women with coexisting SUI [7, 8] and showed
contradictory results. Pooled data [9] of these studies dem-
onstrated that in women with prolapse and coexisting SUI
one should combine vaginal prolapse repair with MUS in
2.5 women to prevent one woman needing subsequent MUS
after prolapse surgery only (number needed to treat 2.5). Not
surprisingly, the latter studies showed that concurrent con-
tinence procedures significantly increased the success rates
for SUI (RR 2.73 95% CI 1.66, 4.49; 9).
One third of patients with POP and overt SUI will be cured
of their SUI after prolapse repair only [8]. Unfortunately, we
have no tool to distinguish between the patients who will
benefit from an additional continence procedure and those
who will not.
A feasible strategy is to discuss the possibilities with the
patient during the preoperative visit and to let her choose.
Individual risk factors, ideas and personal timetables and
expectations may influence the patient’s choice of having
Fig. 58.2 Arabin pessary reposition test; a cube pessary (Arabin®) is a prolapse repair with or without concomitant incontinence
inserted into the vagina surgery.
58 Concurrent Prolapse and Incontinence Surgery 725
Table 58.1 Box plot analyses of prolapse surgery alone vs. prolapse surgery and incontinence surgery [4] SUI stress urinary incontinence
58.4 P
atients with POP and Masked 58.5 P
atients Who Suffer from POP Only
(Occult) Incontinence Without Overt or Masked Incontinence
Patients with prolapse and with the absence of SUI com- Women with POP only without symptoms of overt or masked
plaints may be tested for occult SUI. incontinence will be discussed in this paragraph; will they
Several randomized trials examined postoperative SUI in benefit from additional continence procedures?
women who were clinically continent prior to prolapse sur- The overall cumulative risk for de novo SUI after native
gery [9–13]. tissue anterior repair is 8% (44/559; 14). After anterior
The meta-analysis of these trials found that a concomitant armed mesh repair the overall cumulative de novo SUI rate
suburethral sling significantly improved postoperative SUI is significantly higher at 14% [14].
success rates (RR 3.04, 95% CI 2.12–4.37; 14). The CARE trial randomly allocated preoperatively
Therefore, a simultaneous sling insertion should be dis- continent women to undergo sacrocolpopexy either with
cussed in patients with clinical hints of occult SUI. or without colposuspension (157 vs. 165, respectively).
726 A. Kuhn
Colposuspension significantly reduced the risk of de novo The essential issue is that we do not have an excellent
SUI (26% vs. 41%, respectively; [15]). However, objec- preoperative clinical test to predict who exactly is at risk
tive testing demonstrated rather similar results (9% vs. 7%, for the development of postoperative SUI; therefore every
respectively). This study was terminated prematurely due to woman who undergoes an operation for vaginal prolapse
the high rate of postoperative SUI in the non-Burch group. is at risk for the development of de novo stress urinary
In another study, in which patients were included with incontinence.
preoperatively negative stress test with the prolapse reduced, The International Consultation on Incontinence [14]
44% developed de novo SUI [16]. (Page 1929) recommends the following flow chart:
Assessment:
Validated questionnaire
POP-Q
MUS midurethral sling, POP pelvic organ prolapse, POP-Q Pelvic Organ Prolapse Quantification, SUI stress urinary incontinence
58.6 S
ide Effects of Additional approach versus a single operation including prolapse repair
Incontinence Surgery in Patients Who and a simultaneous incontinence procedure. The latter
Undergo Prolapse Operations approach may result in more adverse events that may include
prolonged catheterization, increased operating time and uri-
Table 58.2 summarizes side effects of additional continence nary tract infections. The two-step approach may possibly be
procedures; data are obtained from a meta-analysis [4]. more difficult for patients who have comorbidities and who,
Overall, side effects compromising prolonged catheter- e.g., require bridging of anticoagulation, have an increased
ization, longer operating time and urinary tract infections anaesthetic risk or are under immunosuppressants.
(UTI) occurred more frequent in patients who underwent
simultaneous continence procedures.
58.8 Future Directions
58.7 Recommendations for Practice Future research should aim at diagnostic tests to identify the
women who are at risk for the development of postopera-
In order to get best informed consent from the patient before tive incontinence. A reliable test would help to predict who
surgery, we need to inform patients who suffer from pro- requires an additional incontinence procedure so that unnec-
lapse and incontinence about the possibility of a two-step essary additional operations could be avoided.
58 Concurrent Prolapse and Incontinence Surgery 727
Table 58.2 Side effects of additional continence surgery (SAE) in comparison to prolapse only procedures [4] SUI Stress urinary incontinence
4.2 Prolonged catherization (1 week or longer) after vaginal prolapse repair with or without midurethral sling
Borstad (1y) 5 87 2 94 49.7% 2.70 [0.54, 13.56]
Wei (OPUS trial 1y) 9 163 1 169 25.4% 9.33 [1.20, 72.83]
Schierlitz (6m) 3 25 1 27 24.9% 3.24 [0.36, 29.15]
Subtotal (95% CI) 275 290 100.0% 4.52 [1.54, 13.28]
Total events 17 4
Heterogeneity: Chi2 = 0.96; df = 2 (P = 0.62); I2 = 0%
Test for overall effect: Z = 2.74 (P = 0.006)
4.3 SAE after vaginal prolapse repair with or without midurethral sling
Wei (OPUS trial 1y) 28 165 20 172 77.2% 1.46 [0.86, 2.49]
Borstad (1y) 11 87 6 94 22.8% 1.98 [0.77, 5.13]
Subtotal (95% CI) 252 266 100.0% 1.58 [0.99, 2.51]
Total events 39 26
Heterogeneity: Chi2 = 0.30, df = 1 (P = 0.58); I2 = 0%
Test for overall effect: Z = 1.93 (P = 0.05)
Up to then patients need to be informed about the risk rior wall repair be predicted? Acta Obstet Gynecol Scand.
2011;90(5):488–93.
of de novo postoperative incontinence after vaginal prolapse 3. Frigerio M, Manodoro S, Palmieri S, Spelzini F, Milani R. Risk fac-
surgery and informed choice is advisable to make the choice tors for stress urinary incontinence after native-tissue vaginal repair
for a one-step or a two-step intervention keeping in mind of pelvic organ prolapse. Int J Gynecol Obstet. 2018;141:349–53.
that an additional incontinence procedure may produce addi- 4. Van der Ploeg JM, Van der Steen A, Oude Rengerink K, Van der
Vaart CH, Roovers JP. Prolapse surgery with or without stress
tional adverse events. incontinence surgery for pelvic organ prolapse: a systematic review
and meta-analysis of randomized trials. BJOG. 2014;121:534–47.
5. Colombo M, Vitobello D, Proietti F, Milani R. Randomized com-
parison of Burch colposuspension vs anterior colporrhaphy in
Take-Home Message
women with stress urinary incontinence and anterior vaginal wall
If additional continence procedures are performed prolapse. BJOG. 2000;107(4):544–51.
during vaginal prolapse surgery, less postoperative 6. Constatinini E, Lazzeri M, Bini V, Del Zingaro M, Zucchi A, Porena
stress urinary incontinence is expected; however, more M. Burch colposuspension does not provide any additional benefit
to pelvic organ prolapse repair in patients with urinary inconti-
adverse events will occur.
nence: a randomized surgical trial. J Urol. 2008;180:1007–12.
7. Van Der Ploeg JM, Oude Rengerink K, Van Der Steen A, Van
Leeuwen JH, Stekelenburg J, Bongers MY. Transvaginal prolapse
repair with or without the addition of a midurethral sling in women
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10. Meschia M, Pifarotti P, Buonaguidi A, Gattei U, Somigliana A. A prolapse repair with and without tension free vaginal tape (TVT) in
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AW. A prospective randomized controlled study comparing vaginal
Management of Pelvic Organ Prolapse:
A Unitary or Multidisciplinary 59
Approach?
David Ossin and G. Willy Davila
59.2 E
pidemiological Basis for Coexistence
Learning Objectives of Pelvic Floor Disorders
• What are the coexisting elements of the female pel-
vic disorders? Similar contributing risk factors, particularly injury to
• How were pelvic floor disorders managed in the pudendal nerve and levator ani muscles, likely influence
past and how has management evolved? developing coexisting pelvic floor conditions [3]. In
• What are the different multidisciplinary approaches Gonzalez-Argente et al., patients surgically treated for fecal
currently practiced? incontinence had a high prevalence of coexisting pelvic floor
conditions: 53% with urinary incontinence and 18% with
pelvic organ prolapse. In patients surgically treated for rectal
prolapse, the prevalence of coexisting urinary incontinence
59.1 Introduction was 18% and 34% for pelvic organ prolapse [4]. In the same
study, only 45% of subjects reported their coexisting symp-
The traditional view has been that of a vertical organization toms to their colorectal surgeons.
of organ systems (e.g., kidneys-ureters-bladder, colon- In a retrospective review of 55 women diagnosed with
rectum-anus) within the pelvis. Under this premise, pelvic rectal prolapse, 52 were found to have defects in pelvic floor
floor dysfunction symptoms such as bladder dysfunction, support and/or stress urinary incontinence [5]. This review
pelvic organ prolapse, and colorectal dysfunction are each also reported that surgical treatment for pelvic organ pro-
managed by a separate specialty: urology, gynecology, and lapse occurred at a median age of 16 years younger than first
colorectal surgery. Figure 59.1 shows the distribution of care surgical treatment for rectal prolapse with the mean number
for pelvic floor disorders. of 1.5 procedures for genital prolapse before the diagnosis
The notion of the pelvic floor as a single functional entity and treatment of rectal prolapse.
with horizontal rather than vertical organization is becom- Among women with symptoms of urinary incontinence
ing a more recognized valid concept [1]. Evaluation of dys- and pelvic organ prolapse (beyond the hymenal ring), the
function of the pelvic floor in one compartment frequently prevalence of coexisting fecal incontinence was 24% and
leads to discovering to some degree dysfunction of neigh- 21% [6]. Between 31% and 41% of patients presenting with
boring compartments of the pelvic floor. This is likely due to pelvic organ prolapse or urinary incontinence report coexist-
a commonality of risk factors for condition such as pelvic ing constipation based on Rome II criteria [7]. Anorectal pain
organ prolapse including vaginal birth and associated neuro- disorders coexist in 16–25% of patients with pelvic organ
muscular damage also linked to other disorders of the pelvic prolapse or urinary incontinence. In addition, the presentation
floor [1, 2]. of proctalgia fugax (functional recurrent anorectal pain) is
elevated in patients with pelvic organ prolapse compared to
urinary incontinence [7]. Various observations can be made
D. Ossin · G. W. Davila (*) based on the above literature. Due to direct pelvic floor trauma
Department of Gynecology, Section in Female Pelvic Medicine being the most frequent etiology of fecal incontinence and
Reconstructive Surgery, Cleveland Clinic Florida,
urogynecologic conditions, simultaneous coexistence of
Weston, FL, USA
symptoms is not surprising. However, rectal prolapse tends to
Dorothy Mangurian Comprehensive Women’s Center, Holy Cross
present at an older age, suggesting a requirement for a greater
Medical Group, Fort Lauderdale, FL, USA
e-mail: OSSIND@ccf.org; GWILLY.DAVILA@holy-cross.com degree or more longstanding, pelvic floor trauma.
Vaginal prolapse
Rectocele ++++ +
Fistula
Vesicovaginal ++++ O
59.3 Why the Multidisciplinary Approach new and has been successfully utilized at tertiary referral
centers such as Cleveland Clinic Florida for many years [1].
A survey of International Urogynecological Association
(IUGA) members found overall agreement in management
of dysfunction in the anterior and middle compartments 59.4 T
he Use of Quality of Life
between urologists and urogynecologists, but colorectal sur- Questionnaires
geons seem to differ in the proposed management of the pos-
terior compartment. For example, colorectal surgeons There are several validated quality of life (QoL) question-
regularly conduct functional/dynamic analysis of posterior naires which assess a broad range of pelvic floor disorders.
compartment dysfunction prior to initiating therapy [8]. They can be particularly useful to help identify and assess
Urogynecologists tend to look at the posterior compartment severity of various pelvic floor symptoms. We only mention
with a primarily anatomic focus. a few in this chapter.
To comprehensively treat pelvic floor dysfunction, clini- The Pelvic Floor Distress Inventory short form 20
cians must be specialized not only in the management of pel- (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7)
vic organ prolapse but also disorders effecting the urinary are composed of three scales which evaluate urinary dys-
system, the colorectal system, the pelvic neuromuscular sys- function, pelvic organ prolapse, and colorectal dysfunction
tem, and the patient’s sexual function. Since no one clinician [10]. The Pelvic Organ Prolapse/Urinary Incontinence
is an expert in all these areas, a team approach is required to Sexual Questionnaire (PISQ-12) is a validated self-admin-
achieve optimal outcomes. istered questionnaire to assess sexual function in the setting
Many organizations, such as the National Institute for of pelvic organ prolapse and/or urinary incontinence [11].
Health and Care Excellence (NICE) in the UK, suggest The Pelvic Floor Bother Questionnaire (BPFQ) goes on to
patients may benefit from the expertise of a team approach in assess the degree of bother of different conditions in a
the treatment of pelvic floor prolapse and associated pelvic patient [12].
floor dysfunction [9]. NICE recommends a multidisciplinary Other useful questionnaires include e-PAQ, a computer-
team which would include a urogynecologist, a urologist ized clinical tool based on the paper-based Birmingham
specializing in female urology, a specialist nurse, a pelvic Bowel and Urinary Symptoms Questionnaire (BBUS-Q), the
floor therapist, a colorectal surgeon, a specialist in elderly Sheffield Prolapse Symptoms Questionnaire (SPS-Q), and
care, and an occupational therapist [9]. This concept is not Female Sexual Function Index (FSFI), which have been
59 Management of Pelvic Organ Prolapse: A Unitary or Multidisciplinary Approach? 731
found in preliminary studies to be superior in efficiency and floor dysfunction and should be included in a multidisci-
acceptability [13]. plinary center.
These questionnaires can help link associated conditions
and in turn help direct consultation with multiple specialties.
Severity of symptoms and efficacy of surgical and medical 59.6 Models for Multidisciplinary
treatment of pelvic floor conditions can be evaluated with Approach
quality of life questionnaires before and after interventions.
One approach to multidisciplinary care of patients is a sched-
uled multidisciplinary conference where patient cases with a
59.5 Improved Treatment Rates with Pelvic set criteria are reviewed by a group of specialists [20].
Floor Rehabilitative Therapy Multidisciplinary evaluation and care can then be prioritized
and coordinated. Concomitant rather than sequential surger-
Pelvic floor muscle rehabilitative therapy has been shown to ies can be planned and the intraoperative order of procedures
reduce the prevalence of bladder, bowel, and sexual symp- determined. The feasibility of multidisciplinary conferences
toms [14, 15]. This form of therapy is a nonsurgical treat- is challenged by required conference time, cost, and surgical
ment modality for pelvic organ prolapse, urinary, and fecal wait time. One of the disadvantages of multidisciplinary con-
incontinence. Most recently in the POPPY trial, women in ferences includes the lack of personal contact with the patient
the intervention group of one-to-one pelvic floor muscle being discussed. We prefer to hold the conference once a
therapy reported greater improvement in prolapse symptoms selected patient has completed the examinations ordered by
at both 6 months and 12 months compared to the control all treating clinicians.
group [14]. After 12 months, significantly fewer women in Another approach to logistically organize a multidisci-
the intervention group received further treatment for pelvic plinary program includes a pelvic floor specialty clinic for
organ prolapse. But this is based on the trial’s relatively short women with combined urogynecological/colorectal symp-
follow-up period and cannot exclude the possibility of delay- toms [3]. In the specialty clinic, the team is led by a colorec-
ing, rather than avoiding surgical treatment. A randomized tal surgeon and a urogynecologist. After workup, a
controlled trial reported that 19% of pelvic floor muscle ther- management plan is designed for each patient. If conserva-
apy group, versus only 8% of the control group, improved by tive management is desired, a specialized mid-level provider
1 POP stage [15]. such as a colorectal nurse specialist will monitor the patient’s
A meta-analysis by Li et al., assessing pelvic floor muscle care independently. If combined surgery is indicated, the
therapy as an adjunct to surgical management of pelvic organ patient is scheduled on a predetermined session when both
prolapse, showed the analysis to be inconclusive [16]. Four surgeons are available. When patients are found to have iso-
studies were included in the meta-analysis, but validity lim- lated issues, follow-up appointments are scheduled in the
ited due to the varied methods used to measure outcomes. corresponding urogynecologic or colorectal clinic. There is a
Two of the studies showed that women undergoing surgical theoretical benefit in cost reduction with a combined clinic
treatment for pelvic organ prolapse could improve physical and surgical model that results in reduced outpatient visits,
outcomes and quality of life with pelvic floor muscle ther- operative time, and hospital stay. Advantages of the com-
apy, but the other two studies reported no improvement of bined specialty clinic approach reported through patient sat-
prolapse symptoms with pelvic floor muscle therapy in con- isfaction surveys include joint physical examination, the
junction with prolapse surgery. development of a combined management plan, and a reduced
As stated above, pelvic floor muscle therapy has been number of office visits, which are associated with patient
considered as an effective treatment for multiple pelvic floor logistical difficulties such as transportation, childcare, and
disorders. A review by Scott on pelvic floor muscle therapy time off from work. Of all the advantages mentioned, the
for the treatment of fecal incontinence reported that the greatest number of patients, 70%, listed reduced office visits
majority of studies had success rates of 50–80% [17]. A as the most advantageous. Advantages of combined surgery
Cochrane review by Dumoulin et al. found women with any include resolution of multiple problems at the same time,
type of urinary incontinence in the pelvic floor muscle ther- having to undergo anesthesia only once, a single recovery
apy group were more likely to report cure versus the control period, reduced time off from work, and reduced burden on
group and were also more satisfied with treatment [18]. A family members. Patient satisfaction with overall care
review by Bo proposes pelvic floor muscle therapy as a first- reported by patients who attend a combined specialty clinic
line treatment for stress urinary incontinence and pelvic was reported as 46% excellent, 27% good, 12% satisfactory,
organ prolapse, but proper training and close follow-up are and 6 % unsatisfactory.
required for effectiveness [19]. Therefore, pelvic floor mus- A limitation of combined specialty clinic is the require-
cle therapy can be an effective addition to treatment of pelvic ment for a screening and triage system to help with patient
732 D. Ossin and G. W. Davila
placement into the clinic when needed. All specialists have Survey (NHANES) [24]. This was the first study to assess
to be engaged in the process and be willing to refer their pelvic floor disorders of women in the USA nationwide and
patients to the clinic. found that 23% of women had one or more pelvic floor dis-
A special mention should be made of the roles of neurolo- orders based on patient symptoms.
gists and physical therapists as part of the multidisciplinary Nonsurgical specialists such as neurologists, physical
team. Not all patients benefit from neurologic assessment, so therapists, epidemiologists, and geriatricians have been
specific neurology appointments can be scheduled. Since found to be very valuable in the care of patients with pelvic
most patients will require pre- or postoperative physical ther- floor disorders and are increasingly included in their care.
apy, access should be planned, and the diagnosed dysfunc-
tions communicated clearly to the physical therapist. It is
usually not valuable for the physical therapist to be present at 59.10 Conclusion
a multidisciplinary clinic or conference.
Since the organs of the female pelvic floor have common
muscular and soft tissue support, vascularity, and innerva-
59.7 Combined Surgical Cases tion, dysfunction in one organ system is very frequently
associated with symptomatic problems in adjacent organs.
Several studies have shown that combined pelvic organ pro- As such, a multidisciplinary approach is rational and is asso-
lapse and colorectal surgery procedures improve patient sat- ciated with improved outcomes.
isfaction [3, 21, 22]. Halverson et al. reported on a prospective
study comparing outcomes and cost in patients undergoing
anal sphincteroplasty alone versus combined with proce- Take-Home Messages
dures for pelvic organ prolapse and/or urinary incontinence. • There are several multidisciplinary management
There was no significant difference in overall subjective options developed over the years, which can be
improvement or physical and/or sexual limitations postop- adapted to best meet one’s practice.
eratively, but there was a noted cost benefit [21]. Similar • Optimal outcome may not be achieved unless all of
results have been reported from other tertiary referral centers a patient’s symptomatic pelvic floor dysfunctions
where a comprehensive multidisciplinary surgical team is are addressed at the same time.
convened.
Wall and DeLancey introduced the concept that political 1. Davila G, Ghoniem G. Pelvic floor dysfunction: the importance of
a multidisciplinary approach. Clin Colon Rectal Surg. 2003;16:3–4.
compartmentalization of care by medical specialties repre- 2. Swash M, Snooks S, Herny M. Unifying concept of pelvic floor
sents a barrier to shifting to a multidisciplinary approach for disorders and incontinence. J R Soc Med. 1985;78:906–11.
pelvic floor disorders [23]. The pelvis has been divided into 3. Kapoor D, Sultan A, Thakar R, Abulafi M, Swift R, Ness
sections to fit the scope of the clinician specialization, which W. Management of complex pelvic floor disorders in a multidisci-
plinary pelvic floor clinic. Colorectal Dis. 2006;10:118–23.
has led to neglect of the critical interrelationships among pel- 4. Gonzalez-Argente F, Jain A, Nogueras J, Davila G, Weiss E, Wexner
vic organ systems. This has also created a financial incentive S. Prevalence and severity of urinary incontinece and pelvic genital
to individual care, which specialists may fight to maintain. prolapse in females with anal incontinence or rectal prolapse. Dis
Colon Rectum. 2001;44:920–6.
5. Peters W, Smith M, Drescher C. Rectal prolapse in women with
other defects of pelvic floor support. Am J Obstet Gynecol.
59.9 Future of Multidisciplinary Approach 2001;184:1488–95.
6. Meschia M, Buonaguidi A, Pifarotti P, Somigliana E, Spennacchio
The future of the multidisciplinary approach to pelvic floor M, Amicarelli F. Prevalence of anal incontinence in women with
symptoms of urinary incontinence and genital prolapse. Obstet
disorders includes an initiative for collaborative research. Gynecol. 2002;100:719–23.
The Pelvic Floor Disorder Network (PFDN) was established 7. Jelovsek J, Barber M, Paraiso M, Walters M. Functional bowel
by the NICHD (National Institute of Child Health and and anorectal disorders in patients with pelvic organ prolapse and
Human Development) in 2001 to develop a research collab- incontinence. Am J Obstet Gynecol. 2005;193:2105–11.
8. Davila G, Ghoniem G, Kapoor D, Contreras-Ortiz O. Pelvic floor
orative to improve patient care. In 2003, at the urging of the dysfunction management practice patterns: a survey of members of
PFDN questions about pelvic floor disorders were added to Teh International Urogynecological Association. Int Urogynecol J.
the 2005–2006 National Health and Nutrition Examination 2002;13:319–25.
59 Management of Pelvic Organ Prolapse: A Unitary or Multidisciplinary Approach? 733
9. National Institute for Health and Care Excellence. Urinary incon- 16. Li C, Gong Y, Wang B. The efficacy of pelvic floor muscle training
tinence in women: the management of urinary incontinence in for pelvic organ prolapse: a systematic review and meta-analysis.
women. Cg171;2013. Int Urogynecol J. 2016;27:981–92.
10. Barber M, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, 17. Scott K. Pelvic floor rehabilitation in the treatment of fecal inconti-
Nygaard I, Weidner A, Janz N, Spino C. Further validation of the nence. Clin Colon Rectal Surg. 2014;27:99–105.
short form versions of the pelvic floor distress inventory (PFDI) 18. Dumoulin C, Hay-Smith E, Mac Habée-Séguin G. Pelvic floor
and pelvic floor impact questionnaire (PFIQ). Neurourol Urodyn. muscle training versus no treatment, or inactive control treatments,
2011;30:541–6. for urinary incontinence in women (Cochrane Review ). Cochrane
11. Rogers R, Coates K, Kammerer-Doak D, Khalsa S, Qualls C. A Database Syst Rev. 2014;(14):CD005654.
short form of the pelvic prolapse/urinary incontinence sexual ques- 19. Bø K. Pelvic floor muscle training in treatment of female stress
tionnaire. Int Urogynecol J. 2002;14:164–8. urinary incontinence, pelvic organ prolapse and sexual dysfunction.
12. Peterson T, Karp D, Aquilar V, Davila G. Validation of a global World J Urol. 2012;30:437–43.
pelvic floor symptom bother questionnaire. Int Urogynecol J. 20. Gopinath D, Jha S. Multidisciplinary team meeting in urogynaecol-
2010;21:1129–35. ogy. Int Urogynecol J. 2015;26:1221–7.
13. Radley S, Jones G, Tanquy E, Stevens V, Nelson C, Mathers
21. Halverson A, Hull T, Paraiso MF, Floruta C. Outcome of sphincter-
N. Computer interviewing in urogynaecology: concept, devel- oplasty combined with surgery for urinary incontinence and pelvic
opment and psychometric testing of an electronic pelvic floor organ prolapse. Dis Colon Rectum. 2001;44:1421–6.
assessment questionnaire in primary and secondary care. BJOG. 22. Lim M, Sagar P, Gonsalves S, Thekkinkattil D, Landon C. Surgical
2006;113:231–8. management of pelvic organ prolapse in females: functional out-
14. Hagen S, Stark D, Glazerner C, et al. Individualised pelvic
come of mesh sacrocolpoexy and rectopexy as a combined proce-
floor muscle tranining in women with pelvic organ prolapse dure. Dis Colon Rectum. 2007;50:1–10.
(POPPY): a multicentre randomised controlled trial. Lancet. 23. Wall L, DeLancey J. The politics of prolapse: a revisionist approach
2014;383:796–806. to disorders of the pelvic floor in women. Perspect Biol Med.
15. Braekken I, Majida M, Engh M, Bo K. Can pelvic floor muscle 1991;34:486–96.
training reverse pelvic organ prolapse and reduce prolapse symp- 24. Nygaard I, Barber M, Burgio K, Kenton K, Meikle S, Schaffer J,
toms? An assessor-blinded, randomized, controlled trial. Am J Spino C, Whitehead W, Wu J, Brody D. Prevalence of symptomaic
Obstet Gynecol. 2010;203:170.e1–7. pelvic floor disorders in US women. JAMA. 2008;300:1311–6.
Part VII
Constipation and Obstructed Defecation
Epidemiology and Etiology
of Constipation and Obstructed 60
Defecation: An Overview
60.4.2 Primary Constipation Table 60.3 Constipation due to pelvic outlet obstruction
Mechanical causes Functional causes
Primary or intestinal causes of constipation can be broadly Rectal prolapse Anismus (dyssynergic defecation)
divided into three large groups, of either primary or coexis- Rectocele Megarectum
tent pathology: Enterocele Hirschsprung’s disease
Anal stenosis Descending perineum syndrome
Anal/rectal strictures or Neuropathy (spinal cord injury, multiple
60.4.2.1 Normal Transit Constipation masses sclerosis)
and Irritable Bowel Syndrome (IBS)
This condition represents up to 70% of cases, and these
patients demonstrate normal bowel transit time and lack of stool passage. The normal defecatory process is very com-
pelvic floor dysfunction. Patients have difficulty in evacuating plex, and it consists of coordinated movement of the abdomi-
their bowels and frequently demonstrate significant accompa- nal and colonic and rectal wall musculature, with reflexory
nied distress. Patients with constipation- predominant IBS relaxation of the puborectalis and the anal sphincter muscles,
have accompanied abdominal pain and discomfort, while typi- allowing for straightening of the anorectal angle, as well as
cally the physical examination is normal. This diagnosis is shortening and opening of the anal canal and perineal
typically made by exclusion. descent. Functional causes of outlet obstruction include vari-
ous neurologic or behavioral disorders, leading to pelvic
60.4.2.2 Slow Transit Constipation floor dysfunction, discoordination of the defecatory process,
Slow transit constipation (STC), sometimes referred to as and impaired rectal sensation. In dyssynergic defecation, for
“colonic inertia,” is a dysfunction in the colonic motility in example, this results in inadequate relaxation or even para-
which there is a severe functional delay in bowel motility, doxical contraction of the pelvic floor muscles during defe-
infrequent bowel movements (<1/week), laxative depen- cation, which hinders evacuation [11, 12].
dence, and radiologic evidence of increased colonic transit
time (typically the markers are scattered throughout the Recommendations for Practice
colon). Patients typically complain of nausea and bloating Physicians should use the Rome IV criteria for the diagnosis
that does not necessarily improve with defecation. There is a of constipation and the Cleveland Clinic Florida Constipation
reduced urge to defecate and, typically, patients do not com- Score to help differentiate the etiology of the constipation. A
plain of rectal fullness. STC is more common in women and standardized and organized evaluation for the etiology of
accounts for 15–30% of patients with constipation [8]. In constipation should also be implemented.
STC, the pelvic floor function is typically normal, and there is
evidence of neurodegeneration of myenteric plexus ganglia
and reduced number of the intestinal pacemaker cells of 60.5 Future Directions
Cajal, as well as abnormal levels of enteric neurotransmitters
such as pancreatic polypeptide, peptide YY, neuropeptide Y, More studies should be undertaken to allow a better under-
serotonin, vasoactive intestinal peptide, substance P, and cho- standing of the different mechanisms of constipation. This
lecystokinin. These patients demonstrate reduced cholinergic hopefully will allow a better treatment strategy.
response and accelerated adrenergic response, with abnormal
gastrocolic reflex and blunted response to administered cho-
linergic agents and stimulants such as bisacodyl [9, 10].
Take-Home Messages
60.4.2.3 Outlet Obstruction • Constipation is the most common GI complaint.
Outlet obstruction is characterized by persistent sensation of • Constipation has considerable healthcare, social,
rectal fullness and painful prolonged or excessive straining, and economic implications.
accompanied by a sensation of incomplete evacuation and • Diagnosis of constipation should be based on the
clustering, often, digital manipulation. Typically, symptoms Rome IV criteria and the Cleveland Clinic Florida
are refractory to laxative use. Colonic transit studies typi- Constipation Score.
cally show normal transit through most of the colon with • Constipation has a plethora of primary and second-
markers retained in the rectosigmoid. ary etiologies.
Constipation due to outlet obstruction represents approxi- • Primary constipation can be divided into normal
mately 7–15% of all causes of constipation [11]. The etiol- transit, slow transit, and outlet obstruction.
ogy for constipation due to outlet obstruction can be broadly • A standardized and organized approach is mandatory
divided into mechanical and functional causes (Table 60.3). for efficient evaluation of patients with constipation.
Mechanical causes physically interfere with and prevent
740 M. Abu Gazala and S. D. Wexner
Toshiki Mimura
colorectal surgeons and gastroenterologists, respectively. validated and are currently available with their characteris-
The ODS score is specifically used to evaluate the symptom- tics as well as the presence or absence of confirmation
atic severity of evacuation disorders. BFI is utilized to evalu- regarding reliability, validity, and responsiveness are sum-
ate the symptomatic severity of opioid-induced constipation marized in Table 61.1.
(OIC). The PAC-QOL and CRQOL are used to assess the Constipation Assessment Scale (CAS) (Table 61.2) is an
constipation-specific QOL. eight-item self-report measure that was designed for nurses to
In this chapter, the currently available PROMs for consti- assess the presence and severity of constipation during the past
pation are described, and it is proposed how to choose appro- 1 week [5]. Each symptom is rated with a 3-point scale from 0
priate PROMs for constipation in clinical practice and to 2, and the total CAS score ranges between 0 and 16. A score
research. For the information of principal methods regarding of >1 indicates constipation, but no cutoff score was provided.
the development and validation of PROMs including their The eight items were developed through the literature
reliability, validity, and responsiveness, please refer to the review. The formal item generation and reduction were not
chapter “PROMs in Fecal Incontinence.” performed, and the content validity was not examined. The
CAS was validated in 32 cancer patients receiving vinca
alkaloids or morphine and in 32 healthy controls. Although
61.1.1 Constipation Symptom Severity Scales its reliability of internal consistency (Cronbach’s
alpha = 0.70) and test–retest reliability (Pearson correlation
At least 10 scales have been reported for rating the severity coefficient = 0.98) as well as the discriminant validity were
of constipation [15, 16]. Among them, Constipation Scoring confirmed, its convergent validity and responsiveness were
System (CSS) [6] and Patient Assessment of Constipation not formally examined.
Symptom (PAC-SYM) questionnaire [7] are most widely One of the characteristics unique to CAS is the item of
used in clinical studies at present. Eight scales that have been “oozing liquid stool,” which is not included in any other
PROM for constipation. It implies passive overflow fecal Although it is sometimes referred as Cleveland Clinic
incontinence due to rectal fecal impaction. In the original Constipation Score or Wexner Constipation Score, it should
study, this item was separately analyzed and finally kept with be called CSS to avoid the confusion with Cleveland Clinic
the statement of “The item of ‘oozing liquid stool’ was cho- Florida Fecal Incontinence Score (CCFIS) that is also called
sen by only 16% of the sample. Because of this result, the Wexner score [19].
alpha coefficient was recomputed with the item deleted. The The original 12 items were generated through patient
result was a lower alpha (0.67). Further analysis of individ- interview and were reduced to the final eight items based on
ual responses revealed that subjects with the highest scores some statistical analysis although its details were not
were the ones who chose the item. Therefore, it was left in described in the original CSS paper [6]. The CSS was evalu-
the scale” [5]. ated in 68 patients with colonic inertia and 164 patients with
The CAS was subsequently modified and validated for pelvic outlet obstruction as well as in 50 nonconstipated
use in women during pregnancy, being revised to a 5-point patients. Their diagnosis was confirmed with colonic transit
rating scale (score range: 0–32) instead of an original 3-point study, anorectal physiology testing, defecography, and anal
scale [17]. At present, the CAS is rarely used, although its electromyography. Its discriminant validity was confirmed
Italian version was validated in 2012 [18]. by differentiating between constipated and nonconstipated
Constipation Scoring System (CSS) (Table 61.3) is an patients, and the physiological tests were used to establish
eight-item self-report scale designed to diagnose constipa- convergent validity. However, the internal consistency, test–
tion and evaluate its symptomatic severity. Each item is rated retest reliability, and responsiveness were not reported in the
with 5-point Likert scale from 0 to 4 except for the item of CSS paper [6].
“type of assistance,” which is rated with 3-point scale from 0 It is reported that a score of more than 15 is the definition
to 2, and the total CSS score ranges between 0 and 30 [6]. of “constipation” in the CSS study because 97% of the entire
group of constipated patients had a score greater than 15.
However, this must be interpreted with caution. This study
Table 61.2 Constipation Assessment Scale (CAS) [5]
included 68 patients with “colonic inertia,” which was
Item 0 1 2
defined as “the presence of at least 80 percent of transit
Abdominal distention or No Some Severe
bloating problem problem problem
markers scattered diffusely throughout the colon on the fifth
Change in the amount of gas No Some Severe day after ingestion,” citing the study by Hinton et al. [20]. In
passed rectally problem problem problem the study by Hinton et al. [20], however, nonconstipated sub-
Less frequent bowel No Some Severe jects “passed 80% of the markers within five days.” In other
movements problem problem problem words, constipation was defined as “the presence of more
Oozing liquid stool No Some Severe
problem problem problem
than 20 percent of transit markers on the fifth day after inges-
Rectal fullness or pressure No Some Severe tion” according to the Hinton’s study. Therefore, the 68
problem problem problem patients in the CSS study had severe slow transit constipa-
Rectal pain with bowel No Some Severe tion, namely “colonic inertia,” and a CSS score of more than
movement problem problem problem 15 is NOT the definition of “constipation” but could imply
Small volume of stool No Some Severe
“severe constipation.”
problem problem problem
Urge but inability to pass No Some Severe One of the characteristics unique to CSS is the item of
stool problem problem problem “History: duration of constipation,” which is not included in
Score range: 0–16 any other PROM for constipation except for PAC-SYM. Long
history of constipation does not necessarily mean severe con- consisting of 12 items in three domains that include “abdom-
stipation, because some patients with no symptoms of consti- inal symptoms” (four items), “rectal symptoms” (three
pation due to appropriate medical therapy can have a long items), and “stool symptoms” (five items) [7]. Each symp-
history of constipation. Another problem of including “the tom is rated with a 5-point Likert scale from 0 (=absence of
duration of constipation” is that the CSS score does not symptoms) to 4 (=very severe) with each domain and the
become zero even if the constipation is completely cured with total score being calculated as an average score raging
some appropriate therapy. For the assessment of treatment, between 0 and 4. A formal questionnaire table exactly pre-
therefore, modified CSS (mCSS) can be proposed, in which senting the 12 items of PAC-SYM is not available in the
one item of “the duration of constipation” is deleted from the original paper [7], but it can be obtained in another literature
original CSS with the mCSS score ranging between 0 and 26. by Neri et al. [21].
In spite of these problems and insufficient evidence of The original 44 items were generated through literature
reliability and validity, CSS has been popular and is still review and patient interview, and they were reduced to the
widely used at present in clinical studies, particularly among final 12 items based on the evaluation of information redun-
colorectal surgeons, probably because it is easy to adminis- dancy, floor and ceiling effects, and internal consistency.
ter, and its questions seem appropriate to evaluate symptoms Because a high correlation was observed between the fre-
of constipation. quency items and the severity items, and given the clinical
Patient Assessment of Constipation Symptom (PAC- meaningfulness of severity ratings for symptoms, the fre-
SYM) questionnaire (Table 61.4) is a self-report measure quency items were deleted. Moreover, the exploratory factor
analysis and multitrait analysis identified original five
Table 61.4 Patient Assessment of Constipation–Symptom (PAC- domains, including “abdominal symptoms,” “rectal symp-
SYM) [7] toms,” “stool symptoms,” “systemic symptoms,” and
Item 0 1 2 3 4 “urgency symptoms.” Because the two domains of “systemic
Abdominal symptom symptoms” and “urgency symptoms” were considered clini-
Discomfort in your Absent Mild Moderate Severe Very cally separate from the constipation symptom domain, they
abdomen severe
were deleted, resulting in the final three domains with 12
Pain in your abdomen Absent Mild Moderate Severe Very
severe items.
Bloating in your Absent Mild Moderate Severe Very The PAC-SYM was evaluated in 216 patients with chronic
abdomen severe idiopathic constipation. It is one of the most formally and
Stomach cramps Absent Mild Moderate Severe Very meticulously developed and validated PROMs, in which all
severe of the internal consistency (Cronbach’s alpha = 0.89), test–
Rectal symptoms
retest reliability (intraclass correlation coefficient = 0.75),
Painful bowel move- Absent Mild Moderate Severe Very
ments severe content validity, convergent validity, discriminant validity,
Rectal burning during or Absent Mild Moderate Severe Very and responsiveness were confirmed. Its convergent validity
after a bowel movement severe was demonstrated with the comparison between PAC-SYM
Rectal bleeding or Absent Mild Moderate Severe Very scores and the investigator and subject global rating of con-
tearing during or after severe
bowel movement
stipation severity on a 7-point scale (absent to very severe).
Stool symptoms Its discriminant validity was confirmed by comparing
Incomplete bowel Absent Mild Moderate Severe Very responders with nonresponders to treatment (mean total
movement like you did severe scores, 0.63 for responders vs. 1.44 for nonresponders,
not finish P = 0.0001).
Bowel movement that Absent Mild Moderate Severe Very
The reliability, validity, and responsiveness of PAC-SYM
were too hard severe
Bowel movement that Absent Mild Moderate Severe Very were also confirmed for opioid-induced constipation in 680
were too small severe patients with chronic lower back pain [22]. Furthermore, the
Straining or squeezing Absent Mild Moderate Severe Very minimal important difference of “−0.6” for clinical practice
to try to pass bowel severe and “−0.75” for clinical trials was proposed for the threshold
movements
of reduction in total PAC-SYM score to be used in defining a
Feeling like you had to Absent Mild Moderate Severe Very
pass a bowel movement, severe meaningful clinical response [23].
but you could not Modified PAC-SYM (M:PAC-SYM) was proposed,
For total score, the scores of nonmissing items were summed and claiming that only a minority of patients reported any rectal
divided by the total number of nonmissing items (total score range: tearing (38%) [21]. Deletion of such item (rectal bleeding or
0–4) tearing during or after bowel movement) led to a 11-item
For subscales, the scores of nonmissing items within the subscale were
summed and divided by the total number of nonmissing items for that version, and the remaining two items in the original “rectal”
subscale (subscale score range: 0–4) domain in PAC-SYM were merged into “stool” domain in
61 Patient-Reported Outcome Assessment in Constipation and Obstructed Defecation 745
M:PAC-SYM because they were moderately correlated with and responsiveness with the minimal important difference
“stool” domain. Consequently, the M:PAC-SYM consists of established. PAC-SYM is also appropriate to use with PAC-
only two domains including “abdominal” (four items) and QOL as the “full PAC,” while it is not suitable to use on its
“stool” (seven items). The authors concluded that “the rectal own to evaluate the symptomatic severity due to its develop-
domain may not represent a relevant cluster of symptoms for ment process.
patients with chronic constipation” and that M-PAC-SYM Knowles–Eccersley–Scott Symptom (KESS) question-
“might better represent symptom severity of most patients naire (Table 61.5) is an 11-item interviewer-led question-
seeking care in gastroenterology referral centers” [21]. naire to assist in diagnosing constipation and in
Another and more major problem of PAC-SYM is the discriminating among pathophysiologic subgroups of slow
lack of item regarding bowel movement frequency and its transit constipation and rectal evacuatory disorders [8].
reason. In the process of the item reduction, overlap between Each symptom is rated with a 4- or 5-point Likert scale
the PAC-SYM and Patient Assessment of Constipation either from 0 to 3 or from 0 to 4, and the total KESS score
Quality of Life (PAC-QOL) questionnaire [13] was exam- ranges between 0 and 39.
ined. The instruments were finalized on the basis of consid- The 11 items were developed by incorporating items from
eration of the joint results, and two items from the original CSS [6] and Rome II criteria. The formal item generation
PAC-SYM including “decreased appetite” and “less frequent and reduction were not performed, and the content validity
bowel movements than desired” were identified as more was not examined. KESS was evaluated in 71 patients with
appropriate to measure the quality of life and were included intractable constipation and 20 healthy controls. Although its
in the final version of the PAC-QOL. Therefore, it is recom- convergent validity against CSS and discriminant validity
mended to utilize “full PAC,” which means the usage of both with healthy controls were confirmed, its reliability and
PAC-SYM and PAC-QOL at the same time, for the evalua- responsiveness were not formally examined. The KESS was
tion of constipation [7, 24]. It is also recommended that able to predict which patients had pure slow transit constipa-
“when used without the PAC-QOL, a frequency item should tion or rectal evacuatory disorder for 55% (95% CI: 43–67%).
be asked in addition to the PAC-SYM,” which effectively The cutoff score for constipation was >10 with both a sensi-
means that the PAC-SYM alone is not enough to evaluate the tivity and specificity of 100%.
symptomatic severity of constipation. KESS was further validated in 105 patients with consti-
PAC-SYM has been popular and is widely used at present pation, and the overall prediction of the correct pathophysi-
in clinical studies, particularly among gastroenterologists. It ologic subgroup was reported to be 47% [25]. In clinical
is probably because it possesses good reliability, validity, studies, the KESS has been less frequently utilized than
746 T. Mimura
Table 61.6 Chinese Constipation Questionnaire (CCQ) [9] ecation” (six items), “colonic inertia” (six items) and “pain”
Item 0 1 2 3 4 (four items). Each symptom is rated with a 5-point Likert
1. Severity of false Absent Mild Moderate Severe Very scale either from 0 to 4 or from 1 to 5, and the total CSI score
alarm: feeling like severe ranges between 0 and 73.
you have to pass a The original 80 items were generated through literature
stool, but you cannot
2. Frequency of <3 Not provided review and patient interview, which were reduced to the final
defecations/week 16 items by exploratory and confirmatory analysis. The CSI
3. Severity of incom- Absent Mild Moderate Severe Very was evaluated in 191 constipated patients and 103 healthy
plete evacuation severe volunteers. Its reliability of internal consistency (Cronbach’s
4. Severity of lumpy or Absent Mild Moderate Severe Very alpha = 0.9) and test–retest reliability (intraclass correlation
hard stool severe
5. Number of laxatives Not provided
coefficient = 0.91) was demonstrated. Content validity, con-
used vergent validity against PAC-SYM, and discriminant validity
6. Severity of abdominal Absent Mild Moderate Severe Very were confirmed, while responsiveness was not examined.
bloating severe The CSI has rarely been utilized since its development
Score range: not reported, possibly 0–24 although it was formally developed and meticulously vali-
The cutoff score for the diagnosis of constipation is 5 dated. It is probably because the CSI has too many items and
its rating is rather complicated although its authors claimed,
CSS probably because it is similar to CSS with more items “The CSI is a short, easy to use, reliable, and valid instru-
than CSS. ment to assess constipation severity and identify subtypes of
Chinese Constipation Questionnaire (CCQ) (Table 61.6) constipation.”
is a six-item self-report measure designed to diagnose con- Obstructed Defecation Syndrome (ODS) score
stipation and evaluate its symptomatic severity in Chinese (Table 61.8) is an eight-item interviewer-led questionnaire
participants [9]. Although each item is rated with a 5-point specifically designed to assess obstructed defecation syn-
Likert scale from 0 (absent symptom) to 4 (very severe drome (ODS), in which the stool in the rectum cannot be
symptom), it was not provided how to rate the items of evacuated sufficiently or comfortably due to various patho-
“bowel frequency” and “number of laxatives used” in the physiologies, including pelvic floor incoordination, recto-
original paper [9]. The total CCQ score is not reported and cele, and rectal intussusception [11]. Each symptom is rated
could range between 0 and 24. with a 5-point Likert scale from 0 to 4 except for the item of
The original 30 items were generated through literature “stool consistency,” which is rated with a 4-point scale from
review and patient interview, which were reduced to the final 0 to 3, and the total ODS score ranges between 0 and 31.
six items based on a principal component analysis. The CCQ The eight items were developed by incorporating items
was evaluated in 111 patients with constipation and 110 from CSS [6] and KESS [8] with taking into account the
healthy controls. Its reliability of internal consistency definition of constipation by Rome II criteria. The formal
(Cronbach’s alpha = 0.79) and test–retest reliability (intra- item generation and reduction were not performed, and the
class correlation coefficient = 0.77) was demonstrated, while content validity was not examined. The ODS score was eval-
content validity, convergent validity against SF-36, discrimi- uated in 76 patients with ODS and 30 healthy controls. Its
nant validity, and responsiveness were all confirmed. A cut- test–retest reliability was confirmed by the Bland–Altman
off score of >5 was determined to discriminate between plot, and relatively weak internal consistency (Cronbach’s
constipated patients and controls with both a sensitivity and alpha = 0.51) was demonstrated. Discriminant validity with
specificity of 91%. healthy controls was confirmed, while convergent validity
The CCQ has rarely been utilized since its development and responsiveness were not examined.
although it is one of the most formally and rigorously vali- The ODS score is suitable and frequently used in evaluat-
dated PROMs. There are possible two reasons for this. First, ing the ODS symptomatic severity and the effect of treat-
the CCQ was validated only in Chinese and requires another ments for ODS.
validation study of its English version to be reliably used in There is another scale, called Longo’s ODS score, that is
English. Second, a formal questionnaire table exactly pre- designed to evaluate ODS. It is specifically used to evaluate
senting the six items of CCQ was not provided in the original the efficacy of a surgical procedure, called Stapled Transanal
paper. Rectal Resection (STARR), for the treatment of rectocele
Constipation Severity Instrument (CSI) (Table 61.7) is a and/or rectal intussusception [26]. This score, however, has
16-item self-report measure designed to assess constipation never been formally validated to examine its reliability and
severity and identify subtypes of constipation, including validity.
obstructed defecation and slow transit constipation [10]. The Bowel Function Index (BFI) (Table 61.9) is a three-item
CSI consists of three subscales that include “obstructed def- clinician-administered and patient-reported questionnaire,
61 Patient-Reported Outcome Assessment in Constipation and Obstructed Defecation 747
(continued)
748 T. Mimura
Table 61.7 (continued)
Item 0 1 2 3 4 5
Pain Subscale: Rectal/anal pain due to your bowel problems
CSI 6. During the last month, on average how severe was the pain in your rectum/anus?
I haven’t Mild Somewhat Severe Extremely ―
experienced severe severe
this
CSI 7. Rate the level of your rectal/anal pain at the present moment
No pain Mild Somewhat Severe Extremely ―
severe severe
CSI 8. How much suffering do you experience because of rectal/anal pain?
None Mild Somewhat Severe Extremely ―
suffering severe suffering severe
suffering
CSI 9. During the last month, due to your bowel habits, how often have you had bleeding during/after a bowel movement?
Never Rarely Occasionally Usually Always ―
Score range: 0–73
Table 61.8 Obstructed Defecation Syndrome (ODS) score [11] Table 61.9 Bowel Function Index (BFI) [12]
Item 0 1 2 3 4 Item 0 – 100
Mean time <5 min 6–10 min 11– 21–30 min >30 min 1. Ease of defection during the last 7 Easy/no – Severe
spent at the 20 min days according to patient assessment difficulty Difficulty
toilet 2. Feeling of incomplete bowel Not at all – Very strong
N attempts to 1 2 3–4 5–6 >6 evacuation during the last 7 days
defecate per according to patient assessment
day 3. Personal judgment of patient Not at all – Very strong
Anal/vaginal Never >1/month, Once a Two to Every regarding constipation during the
digitation <1/week week three per defecation last 7 days
week BFI (numerical analogue scale: 0–100) is calculated as the mean score
Use of Never >1/month, Once a Two to Every day of the three items
laxatives <1/week week three per Score range: 0–100
week The cutoff score for the diagnosis of constipation is 30
Use of Never >1/month, Once a Two to Every day For item 1, ask the subject: “During the last 7 days, how would you rate
enemas <1/week week three per your ease of defecation on a scale from 0 to 100, where 0 = easy or no
week difficulty and 100 = severe difficulty?”
Incomplete/ Never >1/month, Once a Two to Every For item 2, ask the subject: “During the last 7 days, how would you rate
fragmented <1/week week three per defecation your feeling of incomplete bowel evacuation on a scale from 0 to 100,
defecation week where 0 = no feeling of incomplete evacuation and 100 = a very strong
Straining at Never <25% of <50% <75% of Every feeling of incomplete evacuation?”
defecation the time of the the time defecation For item 3, ask the subject: “During the last 7 days, how would you rate
time your constipation you felt on a scale from 0 to 100, where 0 = not at all
Stool Soft Hard Hard Fecaloma – and 100 = very strong?”
consistency and formation
few ered in the Rome III criteria. The third item relates to the
Score range: 0–31 personal judgment of patient regarding constipation
severity.
which has been developed and validated to evaluate opioid- The three items were developed through the literature
induced constipation (OIC) in cancer and noncancer chronic review including Rome III criteria. The formal item genera-
pain patients [12, 27–29]. Each item is rated from 0 to 100 tion and reduction were not performed, and the content
using a numeric analogue scale over the last 7 days, and the validity was not examined. The BFI was evaluated using the
total BFI score is calculated as the mean of the three-item data from clinical studies of prolonged-release oxycodone/
scores (range 0–100). The two items include ease of defeca- naloxone in three multicenter, randomized controlled double-
tion and feeling of incomplete bowel evacuation that are cov- blind parallel group trials involving 202, 460, and 323
61 Patient-Reported Outcome Assessment in Constipation and Obstructed Defecation 749
patients, respectively [12]. The reliability of internal consis- 61.1.2 Constipation-Specific Quality-of-Life
tency (Cronbach’s alpha >0.7) and reproducibility was con- Questionnaire
firmed [12]. Correlations between BFI item and total scores
to stool frequency were statistically significant, demonstrat- Constipation causes annoying symptoms and impairs QOL,
ing convergent validity [12], and another study also demon- which can be evaluated by generic or symptom-specific
strated convergent validity against PAC-SYM [27]. Each BFI instruments. Increasing evidence suggests that chronic con-
item in the scale decreased with increased doses of naloxone, ditions should be assessed not only by the severity of symp-
indicating the responsiveness [12]. The clinical validity and toms but also by their impact on QOL. The
responsiveness of this scale were further validated in a mul- constipation-specific QOL PROMs provide a refined assess-
ticenter prospective observational study of 7836 patients suf- ment of the impact of constipation on QOL, and there are
fering from chronic pain and being treated with oxycodone currently only two such validated tools including Patient
PR/naloxone PR [30]. Tests using standard error of measure- Assessment of Constipation Quality of Life (PAC-QOL)
ment and standard deviation showed that a decrease in BFI questionnaire [13] and Constipation-Related Quality of Life
score of ≥12 points represents a clinically meaningful (CRQOL) [14]. These two questionnaires are summarized
change in constipation [12]. The cutoff score >30 was pro- in Table 61.10.
posed to differentiate between OIC and nonconstipated Patient Assessment of Constipation Quality of Life (PAC-
patients [28, 31]. QOL) questionnaire is a self-administered questionnaire con-
BFI has been utilized to evaluate the severity of OIC sisting of 28 items in 4 subscales that include “worries and
and efficacy of medical treatment for OIC. It is, however, concerns” (11 items), “physical discomfort” (4 items), “psy-
not frequently used among gastroenterologists and chological discomfort” (8 items), and “satisfaction” (5 items)
colorectal surgeons to evaluate symptomatic severity of [13]. Each item is rated with a 5-point Likert scale from 0 to
general constipation, probably because the number of 4, and the total score is calculated as an average score of the
three items in BFI seems too small and might not be 28 items (total score 0–4), with lower scores indicating better
enough to evaluate a constellation of symptoms in consti- health-related quality of life. If there are missing items, the
pation particularly to evaluate the efficacy of surgical scores of nonmissing items were summed and divided by the
interventions. If the three items of BFI are enough to eval- total number of nonmissing items. The subscales are also cal-
uate constipation symptomatic severity, just one item of culated as an average score of each subscale items (score
visual analogue scale might be also enough, and if that is range 0–4), and if there are missing items, the scores of non-
the case, the development and validation of PROMs might missing items within the subscale were summed and divided
not be required anymore. by the total number of nonmissing items for that subscale.
750 T. Mimura
PAC-QOL is one of the most formally and meticulously Constipation-Related Quality of Life (CRQOL) is a self-
developed and validated PROMs to evaluate constipation- administered questionnaire consisting of 18 items in 4 sub-
specific QOL in patients with chronic constipation. For the scales that include “distress” (six items), “social impairment”
development of PAC-QOL, original 35 items were generated (five items), “eating habits” (three items), and “bathroom
through literature review, clinical and outcomes research attitudes” (four items) [14]. Each item is rated with a 5-point
experts, and patient interview. They were evaluated in 260 Likert scale from 1 to 5, and the total score is calculated as a
patients in the United States or the United Kingdom and sum of the 18 items ranging between 18 and 90, with lower
were reduced to the final 28 items based on an exploratory scores indicating better quality of life. The subscale scores
principal component analysis. During this item generation are also calculated as a sum of each subscale items with their
and reduction process, three items were removed due to the score ranging from 6 to 30 in distress, from 5 to 25 in social
redundancy with the PAC-SYM [7], while two items were impairment, from 3 to 15 in eating habits, and from 4 to 20 in
added from the PAC-SYM based on the relevance of their bathroom attitudes.
content. For the development of CRQOL, original 59 items were
For the validation study, the 28-item PAC-QOL was eval- generated through literature review, patient interview, and
uated in 223 patients in the United States and was classified healthcare providers, including internists, gastroenterolo-
into 4 subscales based on a principal component analysis and gist, nurses, and colorectal surgeons. They were evaluated
a multitrait analysis. The PAC-QOL demonstrated excellent in 240 patients with constipation and 103 healthy volun-
reliability of internal consistency (Cronbach’s alpha = 0.93) teers, and they were reduced to the final 18 items based on
and test–retest reliability (intraclass correlation coeffi- an exploratory factor analysis and a confirmatory factor
cient = 0.82). Its convergent validity was confirmed against analysis.
“abdominal pain” and “patient and investigator global rat- In the validation study, the 18-item CRQOL demonstrated
ings of constipation severity,” while its discriminant validity excellent reliability of internal consistency (Cronbach’s
was demonstrated with its difference depending on the sever- alpha = 0.93) and test–retest reliability (intraclass correlation
ity of “abdominal pain” and “patient and investigator global coefficient = 0.92). Its convergent validity was also con-
ratings of constipation severity.” The responsiveness of the firmed with its significant correlation with the Medical
PAC-QOL was also demonstrated with its effect sizes being Outcomes Study Short Form-36 Mental and Physical
moderate to large in patients reporting improvements in con- Component Summary Score (SF-36) as well as with Irritable
stipation over a 6-week period. Bowel Syndrome Quality of Life Scale (IBS-QOL). The
In the original study, the PAC-QOL was translated into CRQOL well differentiated between patients with constipa-
French, Dutch, Canadian English, Canadian French, and tion and healthy controls, demonstrating the discriminant
Australian English [13]. The English French and Dutch ver- validity. However, its responsiveness was not evaluated in
sions of the PAC-QOL were evaluated in the United Kingdom the original study. Each of the CRQOL subscales and the
(n = 74), France (n = 30), the Netherlands (n = 33), Belgium CRQOL total score was well correlated with the Constipation
(n = 20), Canada (n = 55), and Australia (n = 33). The three Severity Index (CSI) subscales and the CSI total score [10],
versions continued to demonstrate internal consistency, which was developed and validated in conjunction with the
reproducibility, convergent validity, discriminant validity, CRQOL.
and responsiveness.
In the original study, 0.5-point change was proposed to be
a valid threshold for defining a clinically meaningful differ- 61.1.3 Recommendation for Practice
ence [13], while 1.0-point improvement used as target in Choosing Appropriate PROMs
response level for the main treatment effect analyses was for Constipation
validated as a relevant definition of response for treatment
group comparison in an analysis of the pooled data from the It is commonly assumed that the QOL in patients with con-
three prucalopride trials for chronic constipation [32]. stipation is well correlated with its symptomatic severity
The PAC-QOL is the best constipation-specific PROM [36]. This might be true in most patients, but it is not always
available at present and deserves to be called the gold stan- true because the impact on QOL caused by constipation
dard for the evaluation of the QOL in patients with constipa- symptoms varies depending on individuals, particularly in
tion, because it has been most frequently used in many psychological and social aspects. In clinical research set-
high-quality studies and has been translated into and vali- tings, therefore, it is essential to evaluate both symptomatic
dated in many languages [13, 33–35]. The utilization of the severity of constipation and constipation-specific QOL. On
PAC-QOL makes it easy to compare international studies on the other hand, in clinical practice, only the constipation
constipation and enables us to conduct international multi- symptom severity scale would be enough to minimize the
center studies in several languages. burden of both patients and healthcare providers.
61 Patient-Reported Outcome Assessment in Constipation and Obstructed Defecation 751
To choose appropriate PROMs for constipation, charac- PAC-QOL is recommended, although BFI alone is accept-
teristics of each PROM should be considered. To evaluate able because the simplicity and minimal burden seem par-
symptomatic severity of constipation, the CSS [6] and PAC- amount in the field OIC. A combination of CSI and
SYM [7] have been widely used by colorectal surgeons and CRQOL can be utilized in clinical researches, although
gastroenterologist, respectively. Although PAC-SYM was they have rarely been used.
more formally and rigorously developed and validated than
CSS, it is supposed to be used in conjunction with PAC-QOL
[13]. Therefore, the PAC-SYM might not be suitable to be 61.2 Future Directions
used on its own in clinical practice, particularly when the
evaluation of bowel frequency is important because it is not 1. Patient Assessment of Constipation Symptom (PAC-
included in the PAC-SYM. The PAC-SYM should be used SYM) questionnaire and Constipation Scoring System
together with PAC-QOL in clinical research settings. (CSS) will continue to be used to evaluate the symptom-
The CCQ [9] is the most formally and rigorously devel- atic severity of constipation by gastroenterologists and
oped and validated PROM. However, its major limitation is colorectal surgeons, respectively. Colorectal surgeons
that it was designed for Chinese-speaking patients and has might learn to use PAC-SYM more frequently in the
never been validated in English-speaking populations. future.
Besides, the full version of CCQ is not available. These seem 2. Obstructed Defecation Disorder (ODS) score will con-
main reasons why it is not widely used at present. tinue to be used to evaluate the symptomatic severity of
The CSI [10] was formally and rigorously developed in evacuation disorders.
conjunction with the CRQOL [14]. It is, however, too com- 3. Bowel Function Index (BFI) will continue to be used to
plicated and has too many items to be used in clinical prac- evaluate the symptomatic severity of opioid-induced con-
tice. The CSI can be used in clinical research settings together stipation (OIC). BFI might be utilized in general consti-
with the CRQOL. pation other than OIC due to its simplicity.
The ODS score [11] was specifically designed, devel- 4. Patient Assessment of Constipation Quality of Life (PAC-
oped, and validated to evaluate the symptomatic severity of QOL) questionnaire will continue to be used to evaluate
evacuation disorders. Therefore, it should be used to evaluate the constipation-specific QOL in conjunction with PAC-
symptomatic severity and treatment efficacy in patients with SYM, CSS, ODS score, or BFI. It is expected to be trans-
evacuation disorders, including functional defecation disor- lated and validated in many other languages for the
der, rectocele, and rectal intussusception. international usage.
The BFI [12] was designed, developed, and validated to
evaluate the symptomatic severity of patients with opioid-
induced constipation (OIC). Although it is a simple measure Take-Home Messages
with only three items and can be used for OIC, it has never • In clinical practice, PAC-SYM or CSS is recom-
been validated in patients with constipation cause by other mended to use for the evaluation of symptomatic
pathologies. severity of constipation.
Although the CAS [5] and KESS [8] are rarely used in • In clinical practice, ODS score is recommended
clinical studies at present, the CAS might be useful to evalu- to use for the evaluation of symptomatic severity
ate the symptomatic severity of constipation in patients of evacuation disorders, including functional def-
whose constipation is associated with rectal fecal impaction ecation disorder, rectocele, and rectal intussus-
causing overflow passive fecal incontinence because it ception.
includes an item of “oozing liquid stool.” • In clinical practice, BFI, PAC-SYM, or CSS is rec-
In clinical research settings, particularly in prospective ommended to use for the evaluation of symptomatic
controlled trials, both a constipation symptom severity severity of opioid-induced constipation.
scale and a constipation-specific quality-of-life question- • In clinical research, particularly if it is a prospective
naire should be used. The usage of both PAC-SYM and full-scale study, both a constipation symptom sever-
PAC-QOL is the most recommended combination, ity scale, such as PAC-SYM, CSS, ODS score, or
although a combination of CSS and PAC-QOL is accept- BFI, and a constipation-specific quality-of-life
able because the CSS has been widely used in the field of questionnaire, such as PAC-QOL, should be used to
colorectal surgery and is useful to compare the results with evaluate symptomatic severity and its impact on
the previous studies. For studies of evacuation disorder, a quality of life, respectively, separately in patients
combination of ODS score and PAC-QOL is recom- with constipation.
mended. For studies of OIC, a combination of BFI and
752 T. Mimura
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Anorectal Manometry, Rectal Sensory
Testing and Evacuation Tests 62
Mitul Patel, Kumaran Thiruppathy, and Anton Emmanuel
anal canal length and reflex responses of the sphincter to to by the smooth-muscle internal anal sphincter, while vol-
perianal and rectal manoeuvres can also be assessed. untary squeeze depends entirely on striated external anal
Anorectal manometry has traditionally been used to gain sphincter function. A large proportion of the data in the lit-
measurements of involuntary and voluntary anal sphincter erature utilizing anal manometry have been based on obstet-
pressures at the mid anal canal. It is performed by the place- ric injury patients.
ment of a manometry catheter in the anal canal to ascertain It is clear that in patients with symptoms of anal inconti-
resting pressure and then asking the patient to squeeze the nence following instrumental delivery, episiotomies, occult
anal muscles to ascertain squeeze pressure followed by rais- or overt sphincter injury, there is a reduction in anal sphinc-
ing intra-abdominal pressure (say, by coughing) to gain an ter function [8, 9]. Episiotomy and perineal trauma (second-
involuntary squeeze pressure. or third-degree tears) are associated with a significant
Manometry tests can be performed with a wide variety of decrease in maximum squeeze pressures as compared to
devices available. These include either open-tipped or side- intact perineum [10, 11]. Data comparing women with intact
opening water-perfused catheters, direct online solid-state perineum and those with spontaneous perineal tear or episi-
microtransducers, or air- or water-filled balloons (Fig. 62.1). otomies show statistically significant differences in mean
Normal anal sphincter pressure values vary depending on squeeze pressures of 105 ± 26 mmHg vs. 92 ± 30 mmHg [8].
testing methodology, gender (males higher than females) and When patients with incontinence are assessed, most will
age (young greater than older) [7]. The last decade has seen be found to have identifiable structural damage. However,
the advent of high-resolution anal manometry, but the place there remains a group of patients who have neither structural
of this technology is in its infancy (compared to the advances sphincter damage nor evidence of impairment of the nerves
made over a similar period in understanding the clinical role of the pelvic floor, but who have symptoms and objective
of high-resolution oesophageal manometry). evidence of dysfunction of the internal anal sphincter. Vaizey
Reduced anal sphincter pressures tended to be associated et al. identified a group of patients with reduced resting anal
with an increase symptom load of anal incontinence. It is pressures and degeneration of the IAS recognized as internal
estimated that about 80% of resting anal tone is contributed sphincter thickness of 1 mm or less on endo-anal ultrasound
[12]. This entity of internal anal sphincter degeneration
accounts for 4% of patients presenting to a tertiary care
incontinence service.
EAS atrophy is more difficult to diagnose and is now
done on MRI by demonstrating increase of fatty replacement
and thinning of the striated muscle. Atrophy of the EAS can
be associated with poor anal sphincter function [13].
Additionally, specific injuries to the anterior EAS which may
be suitable for surgical intervention can be defined on MRI
[14]. Early studies show that non-specific, decreased resting
and squeeze pressures can be found in 90% of patients with
anal sphincter injury [15].
The role of manometry in detecting abnormalities within
dyssynergic defaecation and Hirschsprung’s disease has
been shown. The recto anal inhibitory reflex is absent in
Hirschsprung’s disease and is described as being pathogno-
monic. As previously mentioned, the presence or absence of
this reflex can be elucidated using manometry to measure
anal sphincter pressure while simultaneously inflating a rec-
tal balloon—it is described in greater depth below [16, 17].
Anal manometry can be used to characterize the chief
pathophysiology of dyssynergic defaecation. To maintain
continence, the anal canal resting pressure is higher than that
of the rectum within the resting state. When a subject
attempts to defecate, there is normally a voluntary, learned
relaxation of the anal sphincter with a synchronized rise in
the rectal pressure [18]. The inability to perform this can be
Fig. 62.1 High-resolution water-perfused manometry catheter with due to impaired rectal contraction, paradoxical anal contrac-
rectal balloon attached tion, impaired anal relaxation or a combination of these
62 Anorectal Manometry, Rectal Sensory Testing and Evacuation Tests 755
180
D 100
80
60
40
20
90 270
0
Radial segment: 15 - 20 mm
Fig. 62.2 Figure showing three-dimensional reconstruction of anal sphincter pressure recording during vector manometry
mechanisms. Based on these features, at least four types of HR-ARM can be carried out by solid-state or water-
dyssynergia have been proposed. It has been suggested that perfused manometry catheter. Water-perfused manometry
these types of dyssynergia may form the basis of tailored requires more preparation, technical skills and training. The
biofeedback [19]. However, this remains to be widely dynamic performance of water-perfused systems is several
demonstrated. orders of magnitude less than that of solid-state systems,
limiting their accuracy; however, this does not seem to be a
limitation in the anorectum where rapidly changing pres-
62.3 Vector Manometry sures are not observed. It is suggested that the test allows for
reduced movement artefact, simplifies data interpretation
Vector manometry was a pioneering technique of demon- and allows for more sophisticated analysis of the anal sphinc-
strating a three-dimensional pressure assessment of the anal ters. HR-ARM is commonly used in research-based centres,
canal. It relied on a multi-channel manometry catheter being while traditional anorectal physiology is used elsewhere [20,
pulled through the anal canal at a steady speed automated 21]. High-resolution anorectal and colonic manometry pro-
puller withdrawn at 3 and 25 mm [43]. Using advanced com- vides a more comprehensive characterization of motility pat-
puter software, a three-dimensional graph/image of the pres- terns and coordinated activity, which may help to improve
sure variations of the anal canal could be created (Fig. 62.2). our understanding of the normal physiology and pathophysi-
This image will show areas of low pressure to be identified ology in these areas. To date, however, no published study
and correlated with clinical history (surgical interventions, has conclusively demonstrated a clinical, diagnostic or inter-
etc.) or symptoms. ventional advantage over conventional manometry [22].
62.4 H
igh-Resolution Anal Manometry 62.4.1 Rectal Sensory Testing
(HR-ARM)
Though it is not fully understood how humans perceive stool
The introduction of high-resolution anal manometry within the rectum, with early studies failing to show rectal
(HR-ARM) in 2007 has allowed for three-dimensional pres- sensory nerves, more recent studies have shown that disten-
sure assessments of the anal canal—resulting in high- sion is perceived within the rectum and has a role in main-
resolution topographical plots of the intraluminal pressure taining continence [4]. Specialized mechanoreceptors and
(Fig. 62.3). nerve endings within the rectal wall are thought to mediate
756 M. Patel et al.
Fig. 62.3 An eight-channel high-resolution anorectal manometry reading in a female demonstrating squeeze pressure with fatigue. EAS external
anal sphincter, IAS internal anal sphincter
this. Animal models have shown such rectal afferent nerves chronic constipation show rectal hyposensitivity, with it
and characterized for in vitro experimentation [23]. being more common in patients with dyssynergic defaeca-
The normal rectum is capable of accommodating increases tion [31]. Lowered rectal pain threshold is a hallmark of
in volume by distending with only minor alterations of pres- irritable bowel syndrome (IBS) patients. Rectal barostat test-
sure. Rectal compliance is the volume response to pressure ing can be used in the diagnosis of IBS and to discriminate
distension of the rectum and can be measured using a IBS from other causes of abdominal pain. Although IBS can
barostat, a pump that is capable of delivering air into a rectal have heterogeneous precipitating factors, visceral hypersen-
balloon at a fixed pressure or volume [24]. sitivity remains an important feature [32, 33].
To measure rectal distension sensitivity, a highly compli- Studies suggest that an important component of successful
ant balloon is placed within the rectum and progressively biofeedback training for faecal incontinence is an improved
distended with air or water until a desired perception is ability to sense rectal distention. The first rectal sensory thresh-
achieved. The thresholds often used are of first sensation of old is of value in the biofeedback training of patients with fae-
fullness, urge to defaecate and maximum tolerated volume. cal incontinence; normalization or reduction of the threshold
Investigators have either rapidly filled the balloon or used a correlates with success, and poor or absent sensation to disten-
continuous infusion to achieve the first sensation. The type sion makes a good response to treatment unlikely [34].
of inflation, phasic or continuous and speed of inflation all It has been shown that patients with significant perineal
can produce variability, and so normal threshold ranges can trauma have altered rectal sensation requiring larger volumes
differ between laboratories. A barostat can help remove these to elicit the first sensation of rectal filling. Impairment of
variations to the distension regimen. threshold for first rectal sensation to filling has been associ-
Rectal sensory testing with distension has been used to ated with a significant risk of passive seepage of faeces [35].
assess constipation with such patients having absent or high To avoid the variability that rectal balloon distension and
urge to defaecate threshold and a phenomenon known as rec- barostat testing creates, direct stimulation of the rectum has
tal hyposensitivity. Twenty-three percent of those with been used in a research setting. A barostat is a device used to
62 Anorectal Manometry, Rectal Sensory Testing and Evacuation Tests 757
maintain a constant pressure within a closed chamber. Due to Studies have shown that BET is best done in a sitting
the exceptional capacity of the gut to expand and to sponta- position rather than a left lateral decubitus position [40].
neously or by reflex contract, rapid adjustments are required Performing BET in other positions may lead to over diagno-
to maintain a constant pressure within it. A highly compliant sis as the usual anatomical and physiological changes are not
polvinyl chloride (PVC) balloon is placed within the rectum allowed for that are afforded by the sitting position.
and step-wise inflation by a pneumatic pump is performed. A The normal time for the balloon to be expelled has been
pressure transducer detects for changes as the rectum relaxes variable among studies ranging from 1 to 5 min [37].
or contracts and the volume of inflation is increased or Normative data conclude that expulsion should take less than
reduced accordingly. These changes in volume of the balloon 30 s for men younger than 40 years and less than 1 min above
can be measured giving an indirect assessment of the tonic 40 years. For women, expulsion should occur in 1 min
changes of the luminal wall. Its main use is in the research regardless of age [41].
setting and allows rectal compliance to be assessed. Findings from the BET have a high level of agreement
International consensus is being reached regarding the with those from anorectal manometry (ARM) and electro-
standardization of barostat procedures for testing smooth- myogram (EMG). The level of agreement between BET and
muscle tone and sensory thresholds in the gastrointestinal ARM for dyssynergia was 78%, and between BET and
tract to reduce variability among laboratories [25]. EMG, it was 83% [42].
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Ultrasonography in the Assessment
of Obstructive Defecation Syndrome 63
Marc Beer-Gabel, Ugo Grossi,
Christian Raymond S. Magbojos, and Giulio A. Santoro
63.2 Transperineal/Translabial/Introital
Ultrasound
a b
Fig. 63.3 End-fire transducer placement for introital ultrasound. (a) Horizontal position for midsagittal field of view; (b) vertical position for
transverse field of view
a b
Fig. 63.4 Transperineal ultrasound by 2D convex probe. (a) Transverse view of the anal canal; (b) midsagittal view of the posterior pelvic floor
compartment (EAS external anal sphincter, IAS internal anal sphincter, PRM puborectalis muscle)
left lateral decubitus can still reproduce the angle between the (Fig. 63.4). It is measured at the level of the posterior anorec-
trunk and the thighs typically obtained on defecation. tal wall by the junction of a line tangent to the posterior anus
The first part of the assessment (Phase 1) is performed with another in the mid rectum parallel to the posterior rectal
without contrast. The anal canal is initially assessed with the wall (Fig. 63.5). At rest, its normal values range from 90 to
transducer applied transversely to the PB to obtain an axial 100°. The ARA opens at strain and typically closes with
view of the anus, using the hypoechoic ring of the internal squeeze efforts. The bladder neck junction is located anteri-
anal sphincter (IAS) as a landmark (Fig. 63.4). Thereafter, orly and deeply posterior to the symphysis pubis. Its position
the probe is turned by 90° to provide a midsagittal view of is measured in relation to the symphysis pubis using orthog-
the pelvic floor. Care is taken in order to avoid any pressures onal lines passing by the symphysis and the bladder neck
on the perineum, which may distort the normal anatomy/ (Fig. 63.5). During Phase 1, the bladder is empty. The patient
function. On the midsagittal plane, the anal canal can be seen is asked to squeeze the anus and strain to simulate defeca-
from posterior to anterior, drawn by the hypoechoic IAS and tion. The gross deformation of the pelvic organs and the
its continuation in the rectum (Fig. 63.4). The EAS is seen as motion of the pelvic muscles are reported without any con-
a hyperechoic structure located at the distal end of the IAS. In trast. Variations in the posterior ARA and the descent of the
female patients, EAS typically appears asymmetric (i.e., posterior (anorectal tip) and the anterior (bladder neck junc-
thinner anteriorly than posteriorly) (Fig. 63.4). The posterior tion) pelvic floor are measured. The posterior urethro-vesical
anorectal angle (ARA, or anorectal junction) can be clearly angle is measured by the axis of the urethra and a line mark-
recognized by the bright hyperechoic elliptical PRM sling ing the bladder wall (Fig. 63.5).
764 M. Beer-Gabel et al.
2
UVJ
PUBIS
UR
Point A
ETH
D3
RECTUM Point D 90°
RA
ARJ
ANAL
1 CANAL
D2
Point C
Point B
X-axis 90°
D1
Fig. 63.5 Schematic representation of the pelvic floor at rest using sagittal dynamic transperineal ultrasound
The second phase (Phase 2) is performed with contrast, midsagittal plane at the same time. Any pelvic organ pro-
inserting 10 ml of US gel into the vagina and 50 ml in the lapse may be elicited by Valsalva maneuver. Rectal and vagi-
rectum. The anal canal, already identified in the initial US nal contrast allows functional evaluation, which is of utmost
sweep for landmarks, is examined in greater detail during importance since organ deformation at strain does not neces-
maximum straining and evacuation of the intrarectal acoustic sarily explain ODS symptoms. Thus, it is crucial to under-
gel. While giving a sense of rectal fullness similar to that per- stand both anatomical and functional changes and correlate
ceived prior to defecate, the use of contrast medium helps the dynamics of pelvic organs, perineal muscles, and sphinc-
defining the landmarks of the pelvic organs more precisely. ters to patient’s symptoms.
The volume of gel is lower than that of barium paste used for
DEF to avoid significant deformation of the rectum. Special
contrast to enhance the small bowel is no longer used as intes- 63.2.2 Dynamic Translabial Ultrasound
tinal loops can be recognized by spontaneous contractions.
Rectal contrast evacuation is the first end point of DTPUS. The The method of dynamic translabial ultrasound (DTLUS)
second end point is to evaluate the anatomical deformation at was described by Santoro et al. [15] and Dietz [24].
strain, having the rectum loaded with gel prior to simulating Differently from DTPUS, no rectal enemas/suppositories or
defecation. For patients with ODS, the intention is to try to contrast medium are needed prior and during the procedure.
correlate symptoms with impaired rectal evacuation. A convex transducer is placed between the labia majora of
During the examination, the operator may change focus, the patient lying in the lithotomy position (i.e., supine with
frequency, and angle of the transducer, concentrating on dif- hips flexed and abducted). The scanning process includes
ferent pelvic floor regions according to patient’s symptoms resting phase, maximal pelvic floor contraction (MPFC),
and assessment needs. The large field of view of the trans- and Valsalva maneuver. Conventional convex transducers
ducer allows visualization of all pelvic floor structures on the (3–6 MHz frequencies and field of view of 70°) provide 2D
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 765
a b Cranial
Uterus
Rectum
Bladder
Puborectalis
Pubic
Bone
Anal
Canal Vagina Urethra
c d
Fig. 63.6 Translabial ultrasound performed by convex transducer (type 8802, BK Medical). Schematic representation of the field of view (a, b).
Ultrasound images (c, d) (A anal canal, P pubis, PB perineal body, PR puborectalis muscle, U urethra, V vagina)
imaging of the pelvic floor. In the midsagittal plane, all pel- 63.2.3 Dynamic Endovaginal Ultrasound
vic organs between the posterior surface of the symphysis
pubis and the posterior part of the levator ani are visualized Similar to DTLUS, dynamic endovaginal ultrasound
(Fig. 63.6). Using 3D transabdominal probes developed for (DEVUS) is performed with the patient in the dorsal lithot-
obstetric imaging, 3D- and 4D-TLUS may be performed omy position with hips flexed and abducted. Either an elec-
[25] (Fig. 63.7). These transducers combine an electronic tronic biplane (linear and transverse perpendicular arrays) or
curved array of 4–8 MHz with mechanical sector technol- a radial electronic probe can be used (Fig. 63.8). After inser-
ogy, allowing fast motorized sweeps through the field of tion into the vagina up to the posterior vaginal fornix, the
view. Compared with 2D mode, this technique provides a transducer must be held in a neutral position to avoid ana-
comprehensive assessment of the PRM and its attachment to tomical distortion. The biplane electronic probe provides 2D
the pubic rami by the acquisition of tomographic or mul- sagittal (linear array) and axial (transverse array) sectional
tislice imaging (e.g., in the axial plane) (see Chap. 6). It is imaging of the posterior compartment (see Chap. 7). In the
also possible to measure the diameter and area of the levator midsagittal plane, anterior and posterior rectal walls, PB,
hiatus and determine the degree of hiatal distension on PRM, and ARA are visualized (Fig. 63.9). Scanning is
Valsalva. The 4D imaging involves real-time acquisition of acquired during rest, MPFC, and Valsalva. Color Doppler
volume US data, which can then be visualized instantly in mode can assess the vascular pattern of the pelvic floor struc-
orthogonal planes or post-processing rendered volumes. tures. The rectal electronic probe allows a computer-
Offline analysis is possible on the actual system or on a per- controlled 3D acquisition (high-resolution 3D-EVUS)
sonal computer using dedicated software. (Fig. 63.8). Compared with 2D, 3D mode provides sagittal,
766 M. Beer-Gabel et al.
a b
Fig. 63.8 Dynamic endovaginal ultrasound performed by (a) biplanar transducer (convex and longitudinal arrays), (b) linear transducer,
(c) 3D-transducer
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 767
Perineal
Cranial body
Anorectal Junction
Puborectalis
Internal anal sphincter
Longitudinal
Fibres
Fig. 63.9 Endovaginal ultrasound allows a midsagittal visualization of the posterior compartment (A anal canal, ARJ anorectal junction, IAS
internal anal sphincter, PB perineal body, PR puborectalis muscle)
riorly (6 o’clock) [29]. The recording of data should encom- also known as a paradoxical contraction of the PRM and
pass the whole anal canal length, from the upper aspect of EAS. A non-relaxing perineum is a less-obvious feature of
the PRM to the anal verge. Dynamic endoanal ultrasound or dyssynergic defecation, defined by failed opening of the pos-
EDF is discussed in detail in Chap. 64. terior ARA at strain (Fig. 63.11). PRM tension can be indi-
rectly assessed by measuring its length from the symphysis
pubis to the posterior ARA: PRM normally shortens at
63.3 Ultrasonographic Assessment squeeze and lengthens at strain; it shortens at strain in
of Obstructive Defecation Syndrome patients with anismus (Fig. 63.11). However, the presence of
pelvic organ prolapse may affect PRM length. The descended
Ultrasound plays an important role in visualizing clinically organ occupies space, thus stretching the PRM. This typi-
undetected abnormalities and/or confirming clinical findings cally occurs in case of mid- or anterior compartment pro-
that may explain symptoms of ODS [30]. The descent of the lapse (e.g., uterine prolapse, cystocele, or enterocele).
posterior pelvic floor can be easily assessed by measuring Consequently, detailed measurements should be provided by
the vertical displacement of the posterior ARA in relation to reporting the presence of any pelvic prolapse. The position
a horizontal axis passing through the inferior symphysis of the bladder neck junction is of utmost importance for con-
pubis (Fig. 63.10). Posterior dynamic perineal descent is tinence mechanisms. The length of the displacement along
defined as a pelvic floor descent of more than 2 cm on strain its vertical axis may explain stress urinary incontinence. On
compared to rest. The measurement of the motion of the the other hand, an acute posterior urethro-vesical angle may
bladder neck junction in relation to the same plane at rest, suggest a voiding disorder, with a kinking effect hampering
squeeze, or Valsalva maneuver will serve to assess the ante- the passage of urine (Fig. 63.12).
rior perineal descent. Changes of the posterior ARA from Ultrasonography allows characterization of several ana-
rest to squeeze or strain can serve as a surrogate of PRM tomical abnormalities, including rectocele, intussuscep-
mobility. A closure of this angle on Valsalva defines anismus, tion, enterocele, and cystocele (see Chap. 48). Rectocele
768 M. Beer-Gabel et al.
a c
Y-ax
is
POINT A
RECTUM
PUBIS
ARI ANAL
CANAL
DI
X-axis
90°
b POINT B
Z-axis
POINT D
POINT C
RECTUM
W-axis
90° D2 PUBIS
ARJ
90°
X-axis
ANAL
ARJ CANAL
Fig. 63.10 Schematic representation of the posterior pelvic floor dur- measurement of rectocele depth. The Z-axis passes through the pro-
ing sagittal dynamic transperineal ultrasonography (DTPUS). (a) The jected anterior aspect of the anal canal perpendicular to the X-axis. The
X-axis passes through the central portion of the symphysis pubis, and W-axis passes at right angles to the Z-axis through the most anterior
the Y-axis passes perpendicularly to the X-axis abutting the posterior point of the rectocele. The distance between points C and D represents
aspect of the anorectal junction (ARJ). The anorectal angle (ARA) is the depth of the rectocele (distance D2); (c) large rectocele visualized
clearly definable on DTP-US. The distance between points A and B as a bulging of the anterior rectal wall by transperineal ultrasound (AC
represents ARJ displacement (distance D1) between the resting position anal canal, B bladder, PR puborectalis muscle, R rectum, SP symphysis
and following maximal straining; (b) schematic representation of the pubis, U urethra)
depth, intussusception, enterocele, and cystocele grades are sured. The relation of the size of the rectocele with anismus
also defined. Rectoceles are diagnosed by an anterior bulg- should also be determined before considering surgical cor-
ing of the rectum into the posterior vaginal wall (Fig. 63.13). rection, since paradoxical PRM contraction may improve
Their depth is measured perpendicular to a line projected with physiotherapy and biofeedback [28]. Large rectoceles
along the expected contour of the anterior rectal wall are believed to be associated with difficulty or sense of
(Fig. 63.10). Rectoceles of 2–4 cm in depth are considered incomplete evacuation, rectal pain, and rectal bleeding.
medium-sized, while those deeper than 4 cm are considered Patients often report a sense of vaginal mass or heaviness
large-sized. Recent evidence suggests that only rectoceles and low rectal blockage on defecation. Rectoceles associ-
≥4 cm in depth should be considered truly pathological ated with refractory ODS are often treated with surgery in
[11, 27]. Indeed, a large overlap exists between healthy order to resolve fecal entrapment. However, the size of a
subjects and patients with ODS when considering <4 cm rectocele should not be deemed as the sole indication for
rectoceles [11]. However, medium-sized rectoceles may surgery. A recent study demonstrated that only the evacua-
become clinically significant when trapping stool tion of rectoceles correlated to their size, although with no
(Figs. 63.14 and 63.15). Their emptying at strain is mea- proved clinical significance [31].
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 769
a Rest b Strain
AC
Up
AC
ARA
ARA
R Down R
Fig. 63.11 Perineal ultrasound of a patient complaining of obstructive closure of the ARA to 91°. The contraction of the puborectalis muscle
defecation at strain. (a) At rest, the posterior anorectal angle (ARA) at strain, showed by its imprint on the posterior anorectal junction and
designed by a tangent line to the posterior border of the anal canal and by the closure of the ARA, is responsible for the obstructive defecation
the posterior rectal wall is 105°. (b) At strain, there is a paradoxical (AC anal canal, R rectum)
a b
Fig. 63.13 Rectocele is defined as a herniation of the anterior rectal wall into the vagina (posterior vaginal wall prolapse). (a) Schematic repre-
sentation; (b) clinical finding
a b
Fig. 63.14 Transperineal ultrasound showing (a) prolapse of the distal appears as an enlarged hyperechoic rectovaginal septum between these
posterior vaginal wall (VP) on Valsava. Fecal residues impinging the structures. (b) Typical appearance of a rectocele as an anterior rectal
anterior rectal wall highlighted by hypoechoic gel (R). A thin layer of bulging deforming the posterior vaginal wall in a different patient
hypoechoic gel is also seen in the vagina (V). The vaginal wall prolapse
sigmoidocele can be categorized as small if extended der beyond the introitus defines a grade 3 cystocele [32]
between 3 and 6 cm below the vaginal apex, moderate if the (Fig. 63.23) (see Chap. 48).
extension is between 6 and 9 cm, and large if it is more than
9 cm [33]. Cystocele is defined as a herniation of the bladder
into the anterior vaginal wall. It can coexist with a rectocele 63.4 U
ltrasound vs. X-ray Defecography
in the same vaginal prolapse (Fig. 63.22). The grade of the (DEF) vs. MR Defecography (MR-DEF)
cystocele is defined by the lowest position of the detrusor in in the Assessment of ODS
relation to the vaginal wall. Grade 1 cystocele reaches the
mid-vagina and is not clinically significant. Grade 2 cysto- Currently, DEF and MR-DEF are largely used as imaging
cele occurs when the bladder prolapses far enough to come modalities for the assessment of ODS, whereas pelvic floor
close to the vaginal opening. A deeper prolapse of the blad- US is yet to be implemented in clinical practice. However,
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 771
a b
Fig. 63.15 Translabial ultrasound by convex transducer showing a large rectocele with stool entrapment (a, b) (AC anal canal, B bladder, PR
puborectalis muscle, R rectum, U urethra)
a b
Fig. 63.16 Intussusception is defined as an invagination of the rectal wall into the rectal lumen. It may be classified as intra-rectal (a, b) if it
remains in the rectum or intra-anal if it extends into the anal canal (c)
772 M. Beer-Gabel et al.
a b
c d
Fig. 63.17 Dynamic transperineal ultrasonography showing (a, b) a recto-anal intussusception with gel entrapment into the rectocele (AC
rectocele at the first stage of Valsalva; at further evacuation, an anterior anal canal, B bladder, R rectocele, RAI recto-anal intussusception, RRI
rectal wall prolapse initially determining a (c) recto-rectal and then (d) recto-rectal intussusception, V vagina)
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 773
a
Grade Defaecation Proctography - Oxford Radiological Posterior Transvaginal Ultrasound -
Classification System Sonographic Interpretation of Oxford
System
Recto – Rectal
Non – Pathological
II
Recto – Rectal
Non – Pathological
Low rectal - in folding descends onto the level of In folding rectal wall stops prior to inferior
the rectocoele edge of PR (caudal half of PR)
b
Grade Defaecation Proctography - Oxford Radiological Posterior Transvaginal Ultrasound -
Classification System Sonographic Interpretation of Oxford
System
II
Recto – Anal
Pathological
III
Recto – Anal
Pathological
Low rectal - in folding descends onto the level of In folding stops between the inferior edge
the rectocoele of PR but before PB (into anal canal)
Fig. 63.18 Posterior endovaginal ultrasound. Sonographic interpreta- before the perineal body; (c, d) Grade V: infolding rectal wall protruded
tion of Oxford system (see text). (a) Grades I–II: infolding rectal wall beyond the perineal body. (B bladder, R rectum, RAI rectoanal intus-
ceased prior to the inferior edge of the puborectalis (PR); (b, c) Grade susception, RRI rectorectal intussusception, V vagina)
III–IV: infolding reached beyond the inferior edge of PR but stopped
774 M. Beer-Gabel et al.
c
Grade Defaecation Proctography - Oxford Radiological Posterior Transvaginal Ultrasound -
Classification System Sonographic Interpretation of Oxford
System
Pathological
The in folding rectal wall protrudes from the anus Limit of in folding beyond the PB.
Fig. 63.18 (continued)
a b
Fig. 63.19 Enterocele is defined as a hernia of the small bowel or sigmoid colon (sigmoidocele) into the vagina. (a) Schematic representation;
(b) at the clinical assessment, an enterocele may result in a posterior vaginal wall prolapse that needs to be differentiated from a true rectocele
nificantly lower (p = 0.015, p < 0.001, and p = 0.002), with 268) compared to MR-DEF (DOR 181), DTPUS (DOR
sensitivity of DEVUS also being significantly lower than 161), DEVUS (DOR 19), and EDF (DOR 92) [37]. For the
MR-DEF and DTPUS (p < 0.001 and p = 0.003). The non- diagnosis of intussusception, the pooled sensitivity of
significant difference in sensitivity of DAE vs. DEF was DTPUS (0.90) was lower but not significantly different
likely due to the low numbers of included studies; hence, from DEF (0.97) (p = 0.532); however, sensitivities of
no clear conclusions could be drawn. Specificities of all MR-DEF (0.63), DEVUS (0.64), and DAE (0.09) were sig-
index tests for diagnosis of enterocele were not signifi- nificantly lower (p = 0.039, p = 0.032, p < 0.001).
cantly different compared to DEF (0.96–1.00 vs. 0.96) Specificities of all index tests for diagnosis of intussuscep-
(p = 0.386–0.984). Overall diagnostic test accuracy for tion were not significantly different compared to DEF
diagnosis of enterocele was highest for DEF (pooled DOR (0.86–0.94 vs. 0.90) (p = 0.387–p = 0.791). Overall diag-
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 775
a b
Fig. 63.20 Dynamic translabial ultrasound by convex transducer showing large enteroceles (E) (a–c) (AC anal canal, B bladder, R rectum, SP
symphysis pubis, U urethra)
nostic test accuracy for diagnosis of intussusception was to MR-DEF (DOR 43), DTPUS (DOR 40), DEVUS (DOR
highest for DEF (pooled DOR 315) compared to MR-DEF 40), and EDF (DOR 56) [37]. For the diagnosis of pelvic
(DOR 24), DTPUS (DOR 104), DEVUS (DOR 18), and floor descent, the pooled sensitivity of MR-DEF (0.76) was
DAE (DOR 1) [37]. For the diagnosis of anismus, the significantly lower compared to DEF (0.97) (p = 0.009),
pooled sensitivities of MR-DEF (0.76), DTPUS (0.89), and the pooled specificity was lower but not significantly
DEVUS (0.86), and EDF (0.87) were not notably different different (0.76 vs. 0.97; p = 0.085). Given the very low
compared to DEF (0.89) (p = 0.807–0.999). Specificity of number of published studies for DTPUS, DEVUS, EDF,
MR-DEF (0.93) was not significantly different from DEF and DAE, no clear conclusions could be drawn for these
(0.98) (p = 0.062); however, specificities of DTPUS (0.83), index tests. Overall diagnostic test accuracy for diagnosis
DEVUS (0.86), and EDF (0.89) were significantly lower of pelvic floor descent was highest for DEF (pooled DOR
than DEF (p < 0.001, p = 0.001 and p = 0.015), with DTPUS 1121) compared to MR-DEF (DOR 10) [37]. The use of
and DEVUS also lower than MR-DEF (p = 0.001 and rectal contrast significantly increased the sensitivity of
p = 0.024). Overall diagnostic test accuracy for diagnosis of DTPUS for the diagnosis of enterocele and intussuscep-
anismus was highest for DEF (pooled DOR 360) compared tion, however did not change test’s accuracy for rectocele
776 M. Beer-Gabel et al.
a b
Fig. 63.21 Dynamic endovaginal ultrasound by linear transducer showing enterocele (E) and intussusception (IN) (a, b) (R rectum)
a b
Urethra
Cystocele
Rectocele
Enterocele with
vault eversion
Fig. 63.22 Multicompartmental prolapse (cystocele, enterocele, recto- translabial ultrasound by convex transducer (AC anal canal, B bladder,
cele) into the vagina. (a) Schematic representation; (b) at the clinical C cystocele, E enterocele, R rectocele)
assessment, organs prolapsed need to be differentiated; (c) dynamic
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 777
Fig. 63.22 (continued)
a b
Fig. 63.23 Dynamic translabial ultrasound by convex transducer showing a multicompartmental prolapse (cystocele and rectocele) (a, b)
778 M. Beer-Gabel et al.
a b c
Fig. 63.24 Laparoscopic ventral mesh rectopexy. (a) Schematic representation; (b) intraoperative view; (c) dynamic translabial ultrasound by
convex transducer showing the mesh (arrows) (AC anal canal, B bladder, R rectum, U urethra, V vagina)
Fig. 63.25 Dynamic
translabial ultrasound by
convex transducer showing a
hematoma after laparoscopic
ventral mesh rectopexy (AC
anal canal, R rectum, SP
symphysis pubis, U urethra,
V vagina)
age tool; sensitivity >50%, specificity >95%) and only after ventral mesh rectopexy (Fig. 63.24). In this setting, US
women tested could be sent for DEF or MR-DEF [37]. will be useful in determining functional outcome and develop-
ment of mesh complications, such as erosion, support failure,
migration, and chronic pain [39] (Fig. 63.25).
63.5 U
ltrasound Assessment After Pelvic
Floor Surgery
63.6 Conclusions
Since the late 1990s, synthetic suburethral implants have
become very popular. Ultrasound can confirm the presence and Ultrasound imaging provides a comprehensive assessment of
location of these slings, especially in the axial plane. Given patients with ODS and can define the presence and grade of
their high echogenicity, US is superior to MR-DEF in identify- posterior compartment prolapse. Combining DTPUS,
ing implants [38] and has helped clarify their way of action. For DTLUS, DEVUS, and EAUS has the potential to comple-
the posterior compartment, it is very helpful to reassess patients ment the advantages and overcome the limitation of each of
63 Ultrasonography in the Assessment of Obstructive Defecation Syndrome 779
these modalities with substantial improvements on the clini- 13. Grossi U, Di Tanna GL, Heinrich H, Taylor SA, Knowles CH, Scott
SM. Systematic review with meta-analysis: defecography should
cal management of posterior compartment disorders. The be a first-line diagnostic modality in patients with refractory consti-
greatest utility of this ultrasonographic “integrated approach” pation. Aliment Pharmacol Ther. 2018;48(11–12):1186–1201.
is the identification of both anatomical and functional pelvic 14. Kelvin FM, Hale DS, Maglinte DD, Patten BJ, Benson JT. Female
floor abnormalities in a nonionizing office procedure. pelvic organ prolapse: diagnostic contribution of dynamic cysto-
proctography and comparison with physical examination. AJR Am
J Roentgenol. 1999;173:31–7.
15. Beer-Gabel M, Teshler M, Barzilai N, et al. Dynamic transperineal
Take-Home Messages
ultrasound in the diagnosis of pelvic floor disorders: pilot study. Dis
• Clinical examination cannot accurately determine Colon Rectum. 2002;45:239–45, discussion 245–8.
the pathophysiology mechanisms of ODS (often 16. Dietz HP. Pelvic floor ultrasound: a review. Clin Obstet Gynecol.
resulting from a combination of anatomical and 2017;60:58–81.
17. Santoro GA, Wieczorek AP, Dietz HP, et al. State of the art: an inte-
functional abnormalities) and detecting multicom-
grated approach to pelvic floor ultrasonography. Ultrasound Obstet
partmental anatomical defects of the pelvic floor. Gynecol. 2011;37:381–96.
• DTPUS, DTLUS, DEVUS, and EDF represent 18. Tunn R, Petri E. Introital and transvaginal ultrasound as the main
alternative imaging modalities to DEF and MR- tool in the assessment of urogenital and pelvic floor dysfunction: an
imaging panel and practical approach. Ultrasound Obstet Gynecol.
DEF for the investigation of ODS and could be per-
2003;22:205–13.
formed as screening method in the initial assessment 19. Barthet M, Portier F, Heyries L, et al. Dynamic anal endosonog-
of evacuation disorders. Positive findings on US raphy may challenge defecography for assessing dynamic ano-
may avoid more invasive tests, whereas negative rectal disorders: results of a prospective pilot study. Endoscopy.
2000;32:300–5.
findings may require confirmation by DEF or
20. Wieczorek AP, Wozniak MM, Stankiewicz A. Imaging and
MR-DEF. Multidisciplinary Approach to Management. In: Santoro GA,
Wieczorek AP, Bartram C, editors. Pelvic Floor Disorders.
Dordrecht: Springer; 2010. ISBN: 978-88-470-1541-8.
21. Wieczorek AP, Stankiewicz A, Santoro GA, Wozniak MM,
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AJR Am J Roentgenol. 1999;172:439–44. obstructed defecation, a comparison with defecography. Surg
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Echodefecography: Technique
and Clinical Application 64
Sthela M. Murad-Regadas, Francisco Sérgio P. Regadas,
and Steven D. Wexner
a b
Fig. 64.2 Anal canal anatomy comparing female (a) with male (b) images (sagittal plane). GAP the area in the anterior quadrant without striated
muscle, measured from the proximal edge of the posterior puborectalis muscle (PR) to the proximal edge of the anterior external anal sphincter
(EAS). IAS internal anal sphincter
64 Echodefecography: Technique and Clinical Application 783
a b
Fig. 64.3 Combined external anal sphincter (EAS) and internal anal the middle anal canal. Measurements of the lengths of the residual EAS
sphincter (IAS) defects after vaginal delivery. (a) Mid anal canal—The and IAS (sagittal plane). PR puborectalis
EAS and IAS defects (axial plane). (b) The lesion compromised only
–– Scans 1, 2, and 4 use a slice width of 0.25 mm and lasts the angle size) is compared between scans 1 and 2. Normal
50 s each. relaxation is recorded if the angle increases by a minimum of
–– Scan 3 lasts 30 s with a slice width of 0.35 mm. one degree, whereas paradoxical contraction (Anismus) is
recorded if the angle decreases by a minimum of one degree
Scan 1 (at rest position without gel): The transducer is (Figs. 64.4 and 64.5). Non-relaxation is recorded if the angle
positioned at 4.0–5.0 cm from the anal margin to visualize changes less than 1°.
the anatomic integrity of the anal sphincter muscles and to Scan 3: The transducer is positioned proximally to the PR
identify any occult defect. The endovaginal approach is valu- (anorectal junction). The scan starts with the patient at rest
able in patients who underwent vaginal delivery and/or in (3.0 s), followed by maximum straining with the transducer
patients with obstructed defecation and fecal incontinence. in fixed position (the transducer does not follow the descend-
(Fig. 64.3) ing muscles of the pelvic floor). Scanning continues distally
In this scan, the anorectal angle is measured at rest. The until the PR muscle becomes visible.
angle is formed between a line traced along the internal bor- Perineal descent is quantified by measuring the distance
der of the posterior EAS-PR muscles (1.5 cm) and a line between the position of the proximal border of the PR at rest
traced perpendicular to the axis of the anal canal. and the point to which it has been displaced by maximum
All the following scans are dynamic evaluation. straining (PR descent). Straining time is directly propor-
Scan 2 (at rest—straining—at rest without gel): The tional to the distance of perineal descent.
transducer is positioned at 6.0 cm from the anal verge. The Even with patients in the lateral position, the displace-
patient is requested to keep at rest during the first 15 s, then ment of the PR muscle is easily visualized and quantified.
to maximally strain for 20 s, and then to relax again, with the Normal perineal descent during straining is defined as a dif-
transducer following the movement. The purpose of this scan ference in PR muscle position of ≤2.5 cm and perineal
is to evaluate the movement of the PR-EAS muscles during descent >2.5 cm (Fig. 64.6). The normal range values were
straining in order to identify normal relaxation, non- established by comparing EDF findings with DF [10].
relaxation, or paradoxical contraction (Anismus). The result Scan 4: Following injection of 120–180 mL ultrasound
of the posterior EAS-PR muscles’ position (represented by gel into the rectal ampulla, the transducer is positioned at
784 S. M. Murad-Regadas et al.
a b
Fig. 64.4 Patient with normal relaxation (sagittal plane). (a) Angle measured at rest position (lines), (b) Increased angle during straining (lines).
EAS external anal sphincter, IAS internal anal sphincter, PR puborectalis muscle
a b
EAS
EAS
PR
EAS
PR
EAS
Fig. 64.5 Patients with Anismus (sagittal plane). (a) Angle measured at rest position (lines). (b) Decreased angle (anismus) during straining
(lines). EAS external anal sphincter, IAS internal anal sphincter, PR puborectalis muscle
64 Echodefecography: Technique and Clinical Application 785
a b
Fig. 64.6 Perineal descent measurement (sagittal plane). (a) Puborectal descent (PD) ≤2.5 cm—normal perineal descent. (b) Puborectal descent
(PD) >2.5 cm—Perineal descent. PR puborectalis muscle
7.0 cm from the anal verge. The scanning sequence is the straining position, and the other line drawn at the point of
same as Scan 2 (at rest during 15 s, strain maximally during maximal straining. The distance between the two lines (vagi-
20 s, and then relax again, with the transducer following the nal wall positions) determines the size of the rectocele
movement). The purpose of the scan is to visualize and quan- (Fig. 64.8). Intussusception is clearly identified by observing
tify all anatomical structures and functional disorders the rectal wall layers protruding through the anorectal lumen.
(Rectocele, Intussusception, grade II or III sigmoidocele/ No classification is used to quantify Intussusception
enterocele, and cystocele). (Figs. 64.9 and 64.10). Grade II or III Sigmoidocele/
In normal patients, the posterior vaginal wall displaces Enterocele is recognized when the bowel bulges downward
the lower rectum and upper anal canal inferiorly and to the pelvis, between the posterior vagina and the anterior
posteriorly but maintains a straight horizontal position dur- lower rectal wall (on the projection of the lower rectum and
ing defecatory effort (Fig. 64.7). If rectocele is identified, it upper anal canal) (Fig. 64.11). Cystocele is identified using a
is classified as grade I (<6.0 mm), grade II (6.0–13.0 mm), or reference line drawn perpendicular to the proximal margin of
grade III (>13.0 mm) (Fig. 64.8). Measurements are calcu- the puborectal muscles and measured by a displacement of
lated by first drawing two parallel horizontal lines along the the bladder or bladder neck below the proximal margin of the
posterior vaginal wall, with one line placed in the initial PR ≥ 0.5 cm (Figs. 64.12 and 64.13).
786 S. M. Murad-Regadas et al.
a b
Fig. 64.7 Using intrarectal gel. Patients without rectocele (sagittal plane). (a) Case 1, (b) Case 2. The vagina maintains a straight horizontal posi-
tion during defecatory effort. EAS external anal sphincter, IAS internal anal sphincter, PR puborectalis muscle
In patients in whom a prosthesis has been placed (such as introduced to an extent to the bladder [11, 12]. The pur-
a urethral sling), it is possible to identify the position of the pose of this scan is to visualize the anatomic integrity of
prosthesis in relation to the organ (Fig. 64.14). the levator ani muscles and measure the levator hiatus
The main advantage of using ultrasound is the possibility area that is determined by the inner margins of the lateral
to simultaneously evaluate the morphology (anal canal and branches of the levator muscles and the pubic bone. The
pelvic floor anatomy), as well as any dynamic dysfunction. nomenclature regarding the levator ani varies. As pro-
In patients with obstructed defecation symptoms without posed by DeLancey, the term Pubovisceral muscle (PVM)
associated fecal incontinence, who underwent vaginal deliv- is used, which is synonymous with the term pubococ-
ery or anorectal surgery that resulted in sphincter division, cygeus/puborectalis since the two components cannot be
such as fistulotomy or sphincterotomy, assessment may distinguished on imaging [13].
reveal occult defects. Similar results may be obtained from The scanning identifies any defects defined as the detach-
transvaginal placement of the same 360° rotating transducer ment (discontinuity) of the pubic visceral muscles from their
probe). insertion on the pubic ramus on each side (Fig. 64.15) and
Endovaginal/Transvaginal technique—The patient measure the area of the levator hiatus (Fig. 64.16). Complete
is kept at rest and in dorsal lithotomy position. The trans- detachment of the PVM involves the entire muscle, and par-
ducer is placed in the vagina in the neutral position and tial detachment can be either unilateral or bilateral.
64 Echodefecography: Technique and Clinical Application 787
a b
Fig. 64.8 Rectocele grade (sagittal plane) is measured by one line Patient classified as grade II rectocele (arrows). (b) Patient classified as
placed in the initial straining position (1), and the other line drawn at the grade III rectocele (arrows). EAS external anal sphincter, IAS internal
point of maximal straining (2). The distance between the two lines anal sphincter, PR puborectalis muscle
(vaginal wall positions) determines the size of the rectocele (3). (a)
a b
Fig. 64.9 Using intrarectal gel. Patient with grade III rectocele (arrows eral intussusception (axial plane, arrows). (c) Grade III rectocele and
head) and intussusception (arrows). (a, b) Anterior, right, and left lat- intussusception (sagittal with coronal plane)
788 S. M. Murad-Regadas et al.
a b
Fig. 64.10 Using intrarectal gel. Patient with grade III rectocele side intussusceptions (arrows, axial plane). (b) Grade III rectocele and
(arrow head) and intussusception (arrows). (a) Anterior and right lateral intussusception (sagittal with coronal plane)
64 Echodefecography: Technique and Clinical Application 789
a b
Fig. 64.11 Patient with grade II or III sigmoidocele/enterocele—the bowel bulges downward to the pelvis. (a, b) Axial plane. (c) Sagittal plane.
PR puborectalis muscle
790 S. M. Murad-Regadas et al.
a b
Fig. 64.12 Patient with cystocele and without rectocele. (a) Axial margin of the PR (line 1). EAS external anal sphincter, IAS internal anal
plane – bladder below the puborectalis muscle (PR). (b) Cystocele mea- sphincter
sures by the displacement of the bladder below (line 2) the proximal
ultrasound, and the results demonstrated good correlation for moidocele, and intussusception in women with obstructed
diagnosis of anismus, rectocele, and cystocele. defecation syndrome.
The other option of dynamic ultrasound is to assess the
ODS using the 3D biplane transducer with combined trans-
vaginal and transrectal approaches. The technique was stan- 64.3.1 Technique
dardized comparing with echodefecography and achieved
high rates of concordance and accuracy in the diagnosis of TTUS is performed using a biplane transducer (type 8848,
anismus, rectocele, enterocele/sigmoidocele, and intussus- BK Medical, Herlev, Denmark), diameter of 22 mm, with a
ception in women with obstructed defecation syndrome, as 60-mm linear array and a frequency of 12 MHz. The trans-
mentioned below [24]. ducer has two perpendicular arrays that could be used for
either a midsagittal view (linear array) or an axial view
(transverse array with a field of view up to 180°) of the pelvic
64.3 3D Transvaginal and Transrectal floor. When the 3D is activated, a sample of volume that cov-
Ultrasonography (TTUS) ers a 180° view is acquired in 30 s.
After receiving an enema, 120–180 mL of gel is injected
Dynamic ultrasonography combining transvaginal and tran- into the rectal ampulla while the patient is in the left lateral
srectal approaches using a 3D biplane transducer has been decubitus position. Scanning is performed by two combined
used in the diagnosis of anismus, rectocele, enterocele/sig- approaches and three automatic scans, with analysis in the
64 Echodefecography: Technique and Clinical Application 791
a b
Fig. 64.14 Patients underwent an intravaginal mesh sling procedure. The scanning assesses mesh position. (a) Mesh around the urethra (axial
plane). (b) The length of the mesh (sagittal plane). IAS internal anal sphincter, PR puborectalis muscle
a b
Fig. 64.15 3D endovaginal ultrasonography. (a) Anatomic integrity of the pubovisceral muscles (PVM). (b) Render mode – The measurement of
the levator hiatus area (black draw). AC anal canal, SP symphysis pubis, U urethra, V vagina
64 Echodefecography: Technique and Clinical Application 793
a b
Fig. 64.16 3D endovaginal ultrasonography. (a) Unilateral pubovisceral muscle (PVM) defect (left side, arrow). (b) Bilateral PVM defect
(arrow). AC anal canal, SP symphysis pubis, U urethra, V vagina
a b
Fig. 64.17 3D endovaginal ultrasound. Measurements of bladder neck (BN) position. Distance from the BN to the lowest margin of the symphy-
sis pubis (SP) (line 1). (a) At rest. (b) Valsalva maneuver (sagittal plane). AC anal canal, ARJ anorectal junction, B bladder, R rectum, U urethra
64 Echodefecography: Technique and Clinical Application 795
a b
a
Fig. 64.18 3D endovaginal ultrasound. Patient with perineal descent— anal canal, ARJ anorectal junction, B bladder, R rectum, SP symphysis
displacement of the anorectal junction >1cm (compared Valsalva pubis, U urethra
maneuver with at rest, line 1). (a) At rest. (b) Valsalva maneuver. AC
796 S. M. Murad-Regadas et al.
a b
Fig. 64.19 Dynamic 3D transvaginal and transrectal ultrasonography the anal canal, and a line is drawn along the posterior border of the rectal
technique (TTUS). Using intrarectal gel. Transvaginal approach. (a) At wall (lines). (b) Increased angle during straining (lines). EAS external
rest. The angle is measured at the intersection of the longitudinal axis of anal sphincter, IAS internal anal sphincter, PR puborectalis muscle
a b
Fig. 64.20 Dynamic 3D transvaginal and transrectal ultrasonography rectal wall (lines). (b) Decreased angle (anismus) during straining
technique (TTUS). Using intrarectal gel – transvaginal approach. (a) At (lines). EAS external anal sphincter, IAS internal anal sphincter, PR
rest. The angle is measured at the intersection of the longitudinal axis of puborectalis muscle
the anal canal, and a line is drawn along the posterior border of the
64 Echodefecography: Technique and Clinical Application 797
a b
Fig. 64.21 Dynamic 3D transvaginal and transrectal ultrasonography Rectocele grade (sagittal plane) is measured by one line placed in the
technique. Using intrarectal gel—Transrectal approach—the vagina initial straining position (1), and the other line drawn at the point of
maintains a straight horizontal position during defecatory effort. (a) maximal straining (2). The distance between the two lines (vaginal wall
Patient without rectocele—the vagina maintains a straight horizontal positions) determines the grade of the rectocele (3)
position during defecatory effort. (b) Patient with grade III rectocele.
a b
Fig. 64.23 Patient with grade II or III sigmoidocele/enterocele—bulges downward to the pelvis. (a) Patient without rectocele. (b) Patient with
grade II rectocele
19. Abdool Z, Shek KL, Dietz HP. The effect of levator avulsion on sphincter and pubovisceral muscle defects using a new scoring sys-
hiatal dimension and function. Am J Obstet Gynecol. 2009;201:89. tem in women with fecal incontinence after vaginal delivery. Int J
e81–5. Colorectal Dis. 2017;32:499–507.
20. Lammers K, Futterer JJ, Inthout J, et al. Correlating signs and 23. Murad-Regadas SM, Pinheiro Regadas FS, Rodrigues LV, et al.
symptoms with pubovisceral muscle avulsions on magnetic reso- Correlation between echodefecography and 3-dimensional vaginal
nance imaging. Am J Obstet Gynecol. 2013;208:148.e141–7. ultrasonography in the detection of perineal descent in women with
21. Murad-Regadas SM, Fernandes GO, Regadas FS, et al. Assessment constipation symptoms. Dis Colon Rectum. 2016;59(12):1191–9.
of pubovisceral muscle defects and levator hiatal dimensions 24. Murad-Regadas SM, Regadas Filho FS, Regadas FS, et al. Use of
in women with faecal incontinence after vaginal delivery: is dynamic 3-dimensional transvaginal and transrectal ultrasonogra-
there a correlation with severity of symptoms? Colorectal Dis. phy to assess posterior pelvic floor dysfunction related to obstructed
2014;16:1010–8. defecation. Dis Colon Rectum. 2014;57(2):228–36.
22. Murad-Regadas SM, Fernandes GO, Regadas FS, et al. Usefulness
of anorectal and endovaginal 3D ultrasound in the evaluation of
Evacuation Proctography
65
Magdalena Maria Woźniak, Aleksandra Stankiewicz,
Alexander Clark, and Andrzej P. Wieczorek
has found an increasing role in imaging multicompartment greater in the elderly [20]. Some pelvic floor descent dur-
pelvic organ prolapse [15]. ing evacuation is considered normal, and a descent of up
to 3 cm from the rest position to anal canal opening is
acceptable [18, 21].
65.4 Image Analysis The anorectal angle (ARA) has received considerable
attention, although absolute measurements are of question-
65.4.1 Parameters able clinical use. Qualitative assessments of changes in the
ARA in individual patients are more useful than absolute
65.4.1.1 Anorectal Angle (ARA) angle measurements. The puborectalis length (PRL) can be
The anorectal angle (ARA) is measured between the longitu- estimated by measuring the distance between the ARA and
dinal axis of the anal canal and the posterior rectal line, par- symphysis pubis. However, as for the ARA, qualitative
allel to the longitudinal axis of the rectum. It can be difficult assessment of the PRL in individuals is of greater use than
to measure because the posterior wall of the rectum is often reliance on absolute measurements.
not clearly delineated and the angle becomes highly subjec-
tive [16]. At rest, the physiologic range is 65–100° without 65.4.2.2 Squeeze/Strain (Push)
noticeable differences between men and women [9, 17]. During voluntary contraction of the pelvic floor (squeeze),
ARA is an indirect indicator of the puborectalis muscle the ARA decreases to about 75°, and the ARJ migrates crani-
activity. During muscle contraction, ARA becomes more ally. The puborectal impression becomes more evident
acute while during relaxing phase it becomes obtuse. because of the contraction of levator ani [3]. While the
patient is asked to push or strain to empty, the ARA increases
65.4.1.2 Anorectal Junction (ARJ) with partial to complete loss of puborectal impression and
The second important parameter for evaluation is the shift of the pelvic floor descends. The degree of caudal migration of
the anorectal junction (ARJ) during straining. ARJ is the ARJ is considered normal when less than 3 cm relative to the
uppermost point of the anal canal. The line drawn between resting position.
the ischial tuberosities is called the bi-ischiatic line and can
be used as a fixed bony landmark. Another fixed reference 65.4.2.3 Evacuation
point is represented by the tip of the coccyx. The craniocau- The emptying phase of the proctogram gives important
dal migration of ARJ indirectly represents the elevation and information about rectal structure and function. During evac-
descent of pelvic floor. uation, wide opening of the anal canal and funneling of the
The reproducibility and reliability of these two parame- anorectum are seen with near complete loss of puborectal
ters as usually measured have been confirmed, but their clini- sling impression [2, 3]. In the normal patient, the anal canal
cal significance is still controversial [9]; hence, some should open fully within a couple of seconds, and evacuation
experienced practitioners do not routinely measure them. should then proceed promptly and to completion. It is impor-
tant to remember that in essence, only contrast below the first
65.4.1.3 Pubococcygeal Line (PCL) rectal fold is expected to be evacuated during the examina-
Pubococcygeal line (PCL) is the line between the inferior tion; retained contrast above the first fold is a normal finding
margin of pubic symphysis and the sacrococcygeal [21]. The ARA increases with the relaxation of the anal
junction. sphincter and puborectalis muscle. Typically, the ARA
should increase by around 20–30°, and the PRL should
increase by around 3–4 cm [18], although absolute measure-
65.4.2 Normal Findings ments are of limited value for individual patients [7]. At the
end of evacuation, the rectum is empty and its walls collapse.
65.4.2.1 Rest Eventually, the rectum is restored to its original resting con-
At rest, the anal canal is closed, and the rectum assumes dition. The rate and degree of contrast emptying is highly
its normal upright configuration [7]. The impression of relevant in the diagnosis of functional disorders of
the puborectal sling is visible on the posterior wall of the defecation.
lower rectum, and the ARA is about 90° [3]. The position This was described first by Mahieu et al. who divided the
of the pelvic floor is often inferred by reference to the normal proctogram into five elements: increase in the ARA,
pubococcygeal line (PCL), although the side of the com- obliteration of the puborectalis impression, wide opening of
mode or inferior margins of the ischial tuberosities are the anal canal, evacuation of rectal contents, and lack of sig-
useful approximations. Perineal descent is measured from nificant pelvic floor descent [21]. Although later refined, this
this line to the ARJ and may be up to 1.8 cm at rest [18], initial description remains a very useful baseline of
although usually less in younger patients [19] and often normality.
804 M. M. Woźniak et al.
65.4.2.4 Recovery
After evacuation is complete, the anal canal should close, the
ARA recover, and the pelvic floor return to its normal base-
line position. Post-toilet imaging may be required, particu-
larly in those suspected of retained barium within rectoceles
[7] and to visualize rectal prolapse previously obscured by
retained rectal barium.
embarrassment may both simulate the condition and should mally wide rectal wall of more than 3 mm thickness, which
be recognized by the radiologist. is presented as a funnel or ring-like configuration during
straining, represents intussusception [3]. Rectal collapse
65.4.3.3 Intussusception and Rectal Prolapse may mean normal folds mimic intussusception in the lat-
Rectal intussusception is a concentric invagination or eral view [40], and thus repeat examination in the AP pro-
infolding of the entire rectal wall into the rectal lumen dur- jection may be required [7]. Minor degrees of infolding of
ing straining or defecation. It may be classified as intrarec- less than 3 mm thickness represent mucosal prolapse and
tal, intraanal, or total (external) rectal prolapse, where the are probably not significant. Once the intussusception
rectum passes through the anal canal. The etiology of rectal enters the anal canal, diagnosis is more clear-cut. The canal
intussuscepting is not clear; however, it is more common in is seen to splay on both the lateral and AP views, as it is
multiparous women [25, 26], suggesting it may be a sign of filled by the descending intussusceptum. Perhaps a more
more global pelvic floor damage. Although originally pos- robust method has been recently described whereby the
tulated as a cause of obstructed defecation [38], intussus- ratio of the intussuscipiens diameter and intussusceptum
ceptions seems more likely a secondary phenomenon, diameter are calculated [41]. A ratio of more than 2.5 is
occurring as it does at the end of evacuation rather than highly suggestive of true intussusception. An advantage of
preceding it [7]. There is, however, a very strong associa- this technique is the relative nonambiguity of the intussus-
tion with solitary rectal ulcer syndrome (SRUS), a condi- cipiens and intussusceptum borders and the nondependence
tion related to chronic straining. Patients with SRUS present on technical factors. In complete rectal prolapse, dilatation
with rectal bleeding, mucus discharge, and symptoms of of the anal canal is evident during evacuation, and an
obstructed defecation. The proctographic diagnosis is not infolding of the rectal wall invaginates into the lumen.
clear-cut, and there is often difficulty in distinguishing Descent can be so dramatic as to pass through the anus and
from normal mucosal descent [7]. It usually begins at prolapsed externally [3]. The Oxford grading system is
6–8 cm above the anal canal as an invagination of one of widely used to describe rectal prolapse on clinical and
the valves of Houston [39]. Some degree of rectal intussus- imaging assessment. It divides prolapse into internal rectal
ception is seen in normal volunteers [17], although symp- prolapse and external.
tomatic patients tend to have more advanced findings [40]. Internal rectal prolapse is further subdivided into rectal
The categorization of intussusceptions into intrarectal and intussusception (grade I—descent to the proximal limit of
intraanal is undoubtedly very useful, as it seems likely that the rectocele; grade II—descent into the rectocele) and rec-
all intussusceptions commences in the rectum and descends toanal intussusception (grade III—descent to the top of the
toward the anal canal. Furthermore, there is no clear defini- anal canal; grade IV—descent into anal canal); while exter-
tion of purely intrarectal intussusception [21]. However, nal rectal prolapse corresponds to grade V, when rectal pro-
the presence of transverse or oblique infolding of abnor- lapse protrudes from the anus [42] (Figs. 65.3 and 65.4).
a b c
Fig. 65.3 At rest (a), and pushing/straining (b, c). Moderate rectocele (R) and internal rectal prolapse Oxford grade 2 (arrows) are demonstrated.
Note clear demarcation of vagina (dotted arrow)
806 M. M. Woźniak et al.
a b
Fig. 65.4 A 60-year-old lady with recurrent symptoms of obstructed defecation syndrome. (a) Initially, a small rectocele is seen. Note sacral nerve
stimulator (SNS). (b) In the same patient, during straining, circumferential rectal prolapse (Oxford grade 4) is also demonstrated (arrow)
a b c
Fig. 65.5 (a) During “squeeze and lift”—puborectalis contraction. (b) rectocele and a circumferential rectal mucosal prolapse (arrows)
At rest, the pelvic floor level is unremarkable. (c) On straining—pelvic descending into the rectocele, but no intussusception into the anal canal
floor descent and anorectal angle widening are noted. There is a small (Oxford grade 2)
Fig. 65.6 Large rectocele measuring 50 mm is shown. There is pre- Fig. 65.7 A 6.5-cm rectocele (R) is formed by a loop of the rectum
dominantly posterior, rectal mucosal prolapse, which intussuscepts the (including rectosigmoid) folded anterior to the anus under a large
anal canal—Oxford grade 3 (arrow). R rectocele enterocele (E). Circumferential (posterior predominant) rectal mucosal
prolapse (arrow) is demonstrated, with intra anal intussusception to the
anal verge (Oxford grade 4)
Of more relevance, however, is barium trapping at the end of
evacuation defined as retention of >10% of the area [46] and
is related to the size of the rectocele [47]. A pressure drop
within “trapping” rectoceles has been demonstrated [46],
which explains the relief obtained by patient digitation, when
pressure is applied on the perineum and posterior vagina to
complete rectal emptying [48]. Indeed, the effect of digita-
tion may be imaged during proctography after careful dis-
cussion with the patient. Proctography has an important role
in triaging patients for surgical treatment. The patients with
an underlying functional disorder of defecation tend to
respond poorly to surgery and benefit from biofeedback.
Patients with proctographic evidence of significant looking
structural abnormalities are more likely to benefit from sur-
gery. Interestingly, however, even patients who obtain symp-
tomatic relief from surgical repair of a rectocele may still
have proctographic evidence of a rectocele on postoperative
imaging [49], suggesting that factors other than the anatomi-
cal abnormality give rise to symptoms. Rarely, the rectum
may be herniated in a posterolateral direction through a
defect in the levator ani, commonly related to childbirth [7]. Fig. 65.8 Large sigmoidocele (S). A small- to moderate-sized anterior
rectocele (R) measuring 23 mm is demonstrated. There is also a rectal
prolapse, including prolapse of the rectocele roof, which intussuscepts
65.4.3.5 Enterocele and Sigmoidocele into the anus almost to the anal verge (Oxford grade 4)
An enterocele is diagnosed when small bowel loops enter the
potential space between the rectum and vagina (rectogenital
space) (Fig. 65.7). When a loop of sigmoid enters and wid- rectovaginal space. The diagnosis of an enterocele on proc-
ens the rectovaginal septum, it is a sigmoidocele (Fig. 65.8). tography is more reliable if oral contrast has been adminis-
They result from the herniation of the peritoneal sac into the tered before the examination. On proctography, descent of
808 M. M. Woźniak et al.
barium-filled ileal loops is evident during evacuation in the accuracy in diagnosing rectal intussusception [53].
space between the rectum and vagina that is widened. Moreover, controversies exist as to the interpretation and
Widening of this space, or the presence of air in this space, is clinical utility of the technique due to absent or imperfect
also an indirect sign of enterocele when opacification of ileal reference standards for comparison. The main limitation of
loops is not achieved [2, 3]. The rectogenital space widens as this technique is patient’s exposure to ionizing radiation in
evacuation occurs (and after it) when pressure from the comparison to MR defecography, but MR defecography is
adjacent full rectum is reduced, and as such, enteroceles are limited due to its high costs and still low availability.
usually diagnosed at the end of the procedure [7]. Formation However, when performed in specialized centers by well-
can be prevented by filling of the rectogenital space with any trained and experienced personnel, this technique still plays
other structure such as a cystocele or large rectocele, and for a very important role in management of patients with defe-
this reason, the bladder should be emptied prior to rectal cation dysfunctions.
evacuation when performing extended proctography [7].
Enteroceles may also only become apparent after repeated
straining, and some authors recommend post-toilet strain Take-Home Message
images to increase diagnosis [14]. Kelvin et al. found over Evacuation proctography remains the main radiologi-
40% of enteroceles were diagnosed only on the post-toilet cal examination in the assessment of posterior com-
images [50]. Prior hysterectomy is a major precipitating partment disorders in patients with constipation and
cause of enteroceles, but there is also an association with obstructed defecation, especially when rectal intussus-
multiparity, age, obesity, and connective tissue disorders. ception is suspected.
Patients typically complain of pelvic pressure or dragging,
but it is increasingly clear that, contrary to popular belief,
enteroceles are not a cause of obstructed defecation [51].
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29. Ekberg O, Nylander G, Fork FT. Defecography. Radiology.
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1985;155(1):45–8. pelvic organ prolapse: diagnostic contribution of dynamic cysto-
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functional disorders of defecation causing the solitary rectal ulcer J Roentgenol. 1999;173(1):31–7.
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The Abdominal Approach
to Rectal Prolapse 66
Sthela M. Murad-Regadas, Rodrigo A. Pinto,
and Steven D. Wexner
Learning Objectives Complete rectal prolapse has been reported since the
• Describe and discuss multiple surgical techniques Egyptian and Greek ancient civilizations [4]. The first writ-
that have been developed to treat rectal prolapse, ten report dates from 1500 BC, by Ebers Papyrus [5]. Over
each with advantages and disadvantages; the years, multiple treatments came and went. Mickulicz [6]
• Analyze many treatment options developing over popularized the perineal amputation in 1888, and Lockhart-
the years and develop an individualized plan for Mummery [7], in 1910, performed a perineal procedure for
management of each patient according to the sever- the treatment of rectal prolapse. In 1912, Moschowitz [8]
ity and frequency of symptoms, full anorectal started the abdominal repair.
examination, associated dysfunctions, and condi- The estimated incidence of rectal prolapse is 4 per 1000
tions of the patient; population, being more common in elderly females after the
• Demonstrate and discuss the result in the literature fifth decade. The female to male ratio ranges from 6:1 to
concerning multiple surgical techniques that have 10:1. Among children, males and females are equally
been developed to treat rectal prolapse. affected, usually by the age of 3 years [9, 10].
66.2 Etiology
66.1 Introduction
The anatomical basis for rectal prolapse is a deficient pelvic
Full-thickness rectal prolapse is defined as the protrusion of floor through which the rectum herniates [3, 11–13]. The
all layers of the rectal wall through the anal sphincters [1]. If exact way that the prolapse takes place is not completely
the prolapsed rectal wall does not protrude through the anus, understood, thus it is based on theories.
it is called intussusception or internal rectal prolapse [2, 3]. Rectal prolapse as an intussusception of the rectal wall
Mucosal prolapse is the protrusion of only the rectal mucosa. was first described by Hunter [14] and confirmed by Broden
and Snellman [11] with cineradiography. Complete rectal
prolapse is thought to be a process that starts within 6–8 cm
of the anal verge, continuing through the anal canal, and
S. M. Murad-Regadas (*) everting onto the perineum [11, 15, 16]. The lower rest and
Colorectal Surgery at University Hospital, School of Medicine, squeeze pressures found in the anal manometries of these
Federal University of Ceara, Fortaleza, Ceara, Brazil
patients compared to normal control subjects support this
Anorectal Physiology and Pelvic Floor Unit, Sao Carlos Hospital, theory [17]. However, defecographic studies have found that
Fortaleza, Ceara, Brazil
in patients with intussusception, the risk of developing rectal
e-mail: smregadas@hospitalsaocarlos.com.br
prolapse was small, which contradicts this theory [18, 19].
R. A. Pinto
Parks et al. postulated the theory that repeated stretching
Department of Gastroenterology, Service of Colorectal Surgery,
Hospital das Clínicas, University of São Paulo School of Medicine, of the pelvic floor muscles can injure the pudendal nerves
São Paulo, Brazil and can be a part of the cause of rectal prolapse [20]. This
e-mail: rodrigo.ambar@hc.fm.usp.br suggested mechanism is supported by some surgeons who
S. D. Wexner have detected a frequent association between neurogenic
Digestive Disease Center, Department of Colorectal Surgery, fecal incontinence and rectal prolapse [12, 13]. However, the
Cleveland Clinic Florida, Weston, FL, USA
improvement of fecal incontinence after surgery, and the
e-mail: wexners@ccf.org
electromyographic findings of normal innervation in patients ing age, and chronic constipation are some factors allied with
with rectal prolapse challenge this proposal. rectal and genital prolapse [23].
Lax lateral ligaments combined with an atonic condition Up to 75% patients with rectal prolapse experience fecal
of the muscles of the pelvic floor and the anal canal could be incontinence, and 25–50% have significant constipation [23,
the main cause of rectal prolapse [11, 12]. In addition, the 24, 26, 27]. Metcalf and Metcalf et al. [28] supposed that an
lack of normal fixation of the rectum, with a mobile meso- increased external sphincter activity seen by electromyogra-
rectum and a laxity of the lateral ligaments, may predispose phy could be a cause of outlet obstruction and constipation.
to and/or be associated with rectal prolapse [12, 21, 22]. Reducible protrusion that may be associated with mucous
Regardless of which theory is chosen, the following ana- discharge is a common sign of initial prolapse. Prolapse may
tomic findings are commonly associated with rectal pro- theoretically be due to bowel movements, straining, and
lapse: abnormally deep cul-de-sac, loss of posterior fixation increased intraabdominal pressure. After the diagnosis of
of the rectum, laxity of the anal sphincters, and redundant prolapse has been made, patients may experience loss of
sigmoid colon. All of the procedures described to date control of stool because of stretching of the sphincter mus-
attempt to correct some or all these abnormalities. cles and the pudendal nerves. In addition, bleeding may
develop if the rectum remains exposed and therefore becomes
traumatized.
66.3 A
ssessment of Patients with Rectal Full anorectal examination should include inspection of
Prolapse and Associated Symptoms the perineum including the perineal body and urogenital hia-
tus; urogynecologists will also include the pelvic organ pro-
The assessment of patients with rectal prolapse is based on a lapse quantification (POP-Q) [29]. The prolapse may be
complete history including the investigation of all pelvic easily visible on anorectal examination. Otherwise, the
floor compartment involvement, like the severity and fre- patient is asked to sit down on a commode, leaning forward,
quency of fecal incontinence and constipation/obstructed with the examiner standing behind to confirm the diagnosis.
defecation symptoms as well as urge of urinary incontinence Digital examination may reveal hypotonia or a patulous anus
and pelvic organ prolapse symptoms applying score systems and it is necessary to exclude rectal/pelvic tumor. A reduc-
and quality of life to quantify the dysfunctions before and ible protrusion that may be associated with mucous discharge
after treatment. is a common sign of initial prolapse. Prolapse may theoreti-
Other pelvic floor disorders may be present in 8–27% of cally be due to bowel movements, straining, and increased
patients with rectal prolapse [23]. Altman et al. [23] observed intraabdominal pressure. After the diagnosis of prolapse has
an incidence of 48% of genital prolapse and 31% of urinary been made, patients may experience loss of control of stool
incontinence in patients with rectal prolapse (Fig. 66.1). because of stretching of the sphincter muscles and the puden-
Gonzalez-Argente et al. [24] observed a higher incidence of dal nerves. In addition, bleeding may develop if the rectum
urinary incontinence (58%) and genital prolapse (24%) in remains exposed and therefore becomes traumatized.
patients operated for rectal prolapse. Previous pelvic surgery, A search for risk factors should also be considered as well
obstetric trauma, elevated intra-abdominal pressure, increas- as previous pelvic surgeries.
Evaluation of the colon with colonoscopy and barium
enema is recommended to exclude coexisting conditions,
such as polyps, cancer, and diverticular disease, which may
influence the choice of procedure. The colonic transit study
is important, especially in patients with associated
constipation.
Madoff [26] suggested that slow colonic transit time is the
primary factor associated with constipation in patients with
rectal prolapse. It has also been postulated that an increased
sigmoid transit is a significant factor associated with fecal
incontinence in patients with rectal prolapse [27].
Symptoms of obstructive defecation in those patients in
whom the prolapse cannot be reproduced during the physical
examination usually require the use of dynamic evaluation
including defecography, dynamic ultrasound with different
modalities (transperineal, transrectal, and ecodefecography),
and magnetic resonance image (MRI). The findings can
Fig. 66.1 Rectal and uterine prolapse reveal associated functional abnormalities such as entero-
66 The Abdominal Approach to Rectal Prolapse 813
sigmoidocele, paradoxial contraction of puborectal muscles ity rates of 15% with open techniques [34, 37, 42].
(anismus), cystocele and vaginal vault prolapse; such tests Furthermore, the laparoscopic approach, first introduced by
are useful. The advantage of dynamic images makes it pos- Berman [45] in 1992, tried to integrate the surgical stress
sible to visualize the anatomical structures of the anal canal reduction associated with the perineal approach with the
and pelvic floor. The anorectal and transvaginal ultrasound lower recurrence rates achieved with abdominal repair.
are important methods in patients with a previous history of The decision as to whether to perform sigmoid resection
vaginal delivery and anorectal and/or low colorectal surgery is based on bowel function and sphincter muscle status. If the
to identify the anal sphincter or/and levator ani muscle patient has normal bowel function, or constipation associ-
defects. Previous studies have demonstrated levator ani dam- ated with normal anal tone, a resection is preferred. Whenever
age in 15–55% after vaginal delivery with MRI and trans- diarrhea or sphincter damage is suspected, maintenance of
vaginal ultrasound as well as pelvic organ prolapse and the sigmoid colon seems to be correlated with better func-
ballooning hiatal dimensions. [30–32] tional results.
The evaluation with anorectal manometry and electromy- Choosing the optimal repair for rectal prolapse involves
ography is useful to evaluate the pelvic floor muscles, par- consideration of the patient’s health and the preexisting
ticularly in patients with preoperative fecal incontinence; bowel function as well as any history or physical findings
also, patients with urinary incontinence may benefit from consistent with either constipation or fecal incontinence.
urodynamic examination to complete the evaluation and Lastly, the individual surgeon’s experience is always an
allow for concomitant surgical intervention. important factor in the decision-making process as to which
Although it is not life-threatening, rectal prolapse is an procedure is most appropriate for the individual patient. This
extremely distressing condition that affects patients’ quality chapter addresses the abdominal approaches for rectal
of life; therefore, surgical treatment should be considered prolapse.
even in high-risk patients.
Fig. 66.3 Posterior mesh fixation of the sacral promontory in the Wells
plication rate and an overall recurrence rate of 10%. procedure. Supplied courtesy of Dr Amanda M. Dantas
Furthermore, a review by Madiba et al. [48] also showed a
high complication rate, with mortality ranging from 0 to
2.8%, and recurrence rates ranging from 0 to 13%. mesh insertion may be associated with an increased risk of
infection because of the presence of an anastomosis and a
new foreign body; thus, the placement of a mesh for recto-
66.5.2 Posterior Mesh Rectopexy pexy seems to be reasonable without resection, due to lower
mortality and infection rates [52, 53, 62].
First described by Wells [49] in 1959, this technique was pop- The placement of a drain in the presacral space is also
ular in the UK. The procedure consists of placement of a recommended while inserting a mesh to prevent infected col-
prosthetic Ivalon® (polyvinyl alcohol) sponge between the lections or hematomas [45, 47, 53]. Whenever sepsis occurs,
rectum and the promontory in either side of the rectum, after it is worthwhile to remove the mesh [50, 52, 57, 59–61].
mobilization of the posterior rectal wall (Fig. 66.3). The ante-
rior part of the rectum must stay free to prevent stenosis. The
parietal peritoneum is closed to isolate the mesh from the 66.5.3 Suture Rectopexy
peritoneal cavity. The well-built fibrous reaction promoted by
the presence of a foreign body restores the anorectal angle. First described by Cutait [63] in 1959, the operation involves
Novell et al. [50], in a prospective randomized trial com- a mobilization and upward fixation of the rectum to the sacral
paring the Ivalon sponge to sutured rectopexy, showed simi- promontory with two to three unabsorbable sutures on either
lar recurrence rates and higher wound infection in the mesh side of the rectum (Fig. 66.4). The healing process by fibro-
group. They failed to demonstrate any advantage of the sis keeps the rectum fixed in the elevated position, prevent-
Ivalon rectopexy over the simpler sutured rectopexy. ing recurrence [1].
Other nonabsorbable and even absorbable meshes have Despite the sound theory, the recurrence rates range from
been introduced, and have undergone evaluation with similar 0 to 27% [50, 63–67]; however, most reports have included
results, including mortality ranging from 0 to 1% and recur- recurrence rates ranging from 0 to 3%.
rence rates ranging from 0 to 6%, using absorbable [51–53] The effect of rectopexy on constipation may include exac-
or nonabsorbable [25, 26, 50–54] meshes. erbation of constipation and sometimes the development of a
The main concern about the presence of a foreign mate- new onset of constipation [67, 68]. Currently, the lower com-
rial is the development of infection and sepsis. Sepsis after plication rates and similar long-term outcomes associated
mesh placement has varied from 2 to 16% [11, 12, 52, 55– with the suture rectopexy compared to mesh placement have
61]. The performance of a resection associated with de novo led surgeons to prefer sutures to foreign material.
66 The Abdominal Approach to Rectal Prolapse 815
66.6 Abdominal Surgical Techniques patient is positioned in a modified supine position to facili-
tate the exposure, retracting the small bowel, the omentum,
Patients are placed in a Lloyd-Davis position with split legs, and the redundant sigmoid from the pelvis.
and the prolapse is reduced before starting the procedure. For Either the medial to lateral or lateral to medial dissection is
an open approach, an infra-umbilical midline incision is usu- acceptable, as are diathermy scissors, harmonic scalpel (Ethicon
ally preferred, although some surgeons use a Pfannestiel Endo-Surgery, Cincinnati, OH, USA), or Ligasure (Valleylab,
incision to perform the rectopexy. Tyco Healthcare Group Lp, Boulder, CO, USA). The posterior
In the case of laparoscopy, the pneumoperitoneum is dissection is undertaken anteriorly from the promontory distal
established with a Veress needle or opened under direct to the pouch of Douglas after identifying the ureters, in a plane
vision using a Hasson trocar. The surgeon and the camera- surrounding the mesorectum between the parietal and visceral
holder stay on the right side of the patient, while the assistant fascial planes of the pelvis. During the dissection, care has to be
surgeon stands between the legs, and the monitor is placed in taken to identify and preserve the pelvic splanchnic nerves
the left side of the patient. Placement of three to five trocars (superior hypogastric nerves, the autonomic branches of S2, S3,
is described by different authors. Usually one 10 mm umbili- S4, and the pelvic autonomic nerve plexus). The posterior dis-
cal port is positioned for the camera, and two 5 or 10 mm section is carried down to the levator plane. The lateral liga-
ports in the right lower quadrant (12 mm if a stapler device is ments of the rectum should preferably be preserved.
used) and in the right upper quadrant. An additional 10 mm The promontory is exposed to visualize the presacral fas-
port can be placed in the left lower quadrant to help facilitate cia. If the sigmoid is going to be excised, some surgeons pre-
the exposure, particularly in obese patients (Fig. 66.5). The fer a lateral to a medial laparoscopic dissection. The superior
hemorrhoid artery may be preserved and the rectum can be
transected at the rectosigmoid junction, followed by con-
struction of a circular stapled colorectal anastomosis.
The rectopexy can be performed with the placement of a
mesh, usually when there is no resection, or by a suture rec-
topexy. The mesh is placed in the right posterior side of the
rectum, usually fixed with sutures or with staples. A simple
suture rectopexy can be an option, and two to four stitches
are placed in the posterior side of the mesorectum or in the
lateral rectal wall, and fixed to the periosteum of the sacral
promontory, taking care to avoid injury of the middle sacral
artery with the needle. At the end of the procedure, the peri-
toneum can be closed with absorbable running sutures. The
10 or 12 mm ports, or the open incision, are then closed, and
a drain may be placed into the pelvis. The open dissection is
performed similarly in an identical manner, except that most
surgeons routinely mobilize from lateral to medial instead of
medial to lateral during laparotomy.
Some technical aspects seem to be directly related to
patients’ postoperative functional outcomes, especially exac-
erbation of constipation. Some authors consider preservation
of the lateral ligaments of the rectum for normal evacuation
after surgery to avoid the parasympathetic denervation that
may be responsible for rectosigmoid dysmotility [77–81].
Bruch et al. [78] reported that preservation of the lateral liga-
ments leads to a significant improvement in constipation
after resection rectopexy and suture rectopexy. Darzi et al.
[79] observed persistence of constipation in 18% of patients
who underwent resection rectopexy with division of the lat-
eral stalk of the rectum. A Cochrane meta-analysis of 10 ran-
domized controlled trials comprising 324 patients concluded
that division of the lateral ligaments of the colon was associ-
Fig. 66.5 Placement of ports for the laparoscopic approach. Supplied ated with less prolapse recurrence, but more postoperative
courtesy of Dr Amanda M. Dantas constipation [83].
66 The Abdominal Approach to Rectal Prolapse 817
Other features related to constipation may be functional open group. The overall and the major morbidity incidence
obstruction caused by kinking of the redundant sigmoid left also favored laparoscopy (overall 3% vs. 9% and major 0%
in place, and fibrosis related to the rectal dissection or the use vs. 4%, respectively for laparoscopic and open groups).
of a mesh, creating stenosis [38, 83]. Mckee et al. [38] sug- Likewise, Stage et al. [90] observed no difference in respira-
gest that the redundant or kinking sigmoid colon could cause tory function, and decreased pain scores and morphine
delayed colonic transit, which eventually leads to persistent requirements for laparoscopy. There was also minor stress
constipation. response represented by IL-6 and C-reactive protein, and
shorter hospital stay (5 vs. 8 days for laparoscopy and open,
respectively), favoring laparoscopy. In contrast, Milsom
66.7 Minimally Invasive Approach et al. [91] reported improvement in respiratory function with
laparoscopic rectopexy, but similar hospital stay (6 vs. 7 days
During the last 20 years, due to the advent of laparoscopy, for laparoscopy and open, respectively).
abdominal rectopexy for the management of rectal prolapse Regarding constipation after surgery, Kariv et al. [76],
has become one of the earliest procedures. The results are reviewing the experience of Cleveland Clinic Foundation,
comparable with the open approach, with the advantages noticed that laparoscopic cases were related to better
associated with a minimally invasive approach. Rectopexy improvement of constipation (74% vs. 54%, respectively in
alone can be performed as a completely laparoscopic proce- laparoscopy and open procedures) and lower worsening of
dure since there is no specimen to be retrieved. constipation (3% vs. 17%, respectively in laparoscopy and
Recent reports have compared laparoscopic to open pro- open procedures) compared to open cases. Postoperative
cedures and have shown reduced postoperative pain, earlier constipation rates also seemed better following laparoscopy
recovery, and shorter length of hospital stay for laparoscopy (35% vs. 53%, respectively in laparoscopy and open proce-
[80, 84–87], despite a longer operative time and higher direct dures). However, anterior mesh placement in open cases may
costs [84, 86–89]. However, Salkeld et al. [88] stated that contribute to higher constipation rates. Within the laparos-
laparoscopy is associated with an overall cost saving per copy data, resection and no resection outcomes were compa-
patient from faster recovery, less use of pain medications, rable in terms of constipation (70% vs. 59% improvement,
and shorter stay in the hospital. Forty-four percent of the P = 0.53; respectively in patients without and with
additional operative costs for laparoscopy were attributed to resection).
longer operative times. The latest meta-analysis comparing open to laparoscopic
Carpelan-Holmström et al. [75] addressed the abdominal abdominal rectopexy included six studies and 195 patients
approach for elderly high-risk patients, evaluating 65 patients (98 open and 97 laparoscopic cases) [92]. The length of hos-
operated by laparoscopy and 10 patients operated in an open pital stay was significantly shorter in the laparoscopic group,
fashion. Half of the patients were American Society of while the operative time was 60.38 min longer. There was no
Anesthesiologists (ASA) classification III and IV. The opera- difference in morbidity or recurrence rates in the studies
tive time was similar overall, although the laparoscopic included in the analysis. Cost was addressed by two studies
resection rectopexies were more time-consuming (150 vs. that favored the laparoscopic group. The long-term func-
80 min; P = 0.07). The hospital stay and intraoperative bleed- tional results reported with open and laparoscopic approaches
ing were significantly shorter for laparoscopic procedures. are described in Table 66.2.
Sixty-eight patients were selected for follow-up, after a mean
of 1.8 years, and the results were comparable between lapa-
roscopic and open procedures. Full-thickness rectal prolapse 66.7.1 Ventral Mesh Rectopexy
recurrence occurred in two patients. There was no difference
in constipation after the procedures, and continence was The initial description of ventral mesh rectopexy known as
fully restored in 86% of patients who underwent rectopexy Orr-Loygue procedure involved full mobilization of the
and 79% of patients who underwent resection rectopexy. The rectum with a mesh fixed to the anterolateral rectal wall and
authors concluded that laparoscopic procedures can be safely suspended to the sacrum. A modification and adaption to
performed and well tolerated by elderly patients. laparoscopy was proposed by one of our Cleveland Clinic
Solomon et al. [89] performed a randomized controlled Florida alumni Professor Andre D’Hoore in 2004 [97]. The
trial with 39 patients allocated to either open (19) or laparo- ventral mesh retopexy (LVMR) was proposed as a nerve-
scopic (20) mesh rectopexies, and analyzed some objective sparing procedure to manage rectal prolapse with less com-
parameters related to stress response to surgery. Acute-phase plications. The technique was described in detail in 2006
reactants, such as urinary catecholamines, interleukin-6 (IL- [98] and involves a distal mobilization of the anterior rec-
6), serum cortisol, and C-reactive protein favored laparos- tum from the rectovaginal septum to the pelvic floor mus-
copy. Respiratory function was comparable between the cles with fixation to the sacral promontory using a mesh
groups, whereas respiratory morbidity was greater in the (Figs. 66.6–66.8). Just anterior mobilization of the rectum
818 S. M. Murad-Regadas et al.
Table 66.2 Follow-up and functional results in open and laparoscopic abdominal approaches
Follow-up Constipation Incontinence Recurrence
Author Year N Procedure (months) improvement (%) improvement (%) (%)
McKee et al. [37] 1992 9 RR 20 50 0 0
Duthie and Bartolo 1992 29 RR 6 Yes 78 n.s.
[38]
Madoff [26] 1992 47 RR 65 50 30 FT 6; MP 8
Deen et al. [41] 1994 10 RR + PFR 17 Yes 90 FT 0; MP 10
Huber et al. [44] 1995 39 RR 54 42 65 FT 0; MP 0
Cirocco et al. [93] 1995 41 AR+FRM 72 18 48 Total 7
Benoist et al. [94]a 2001 18 LARR 20 82 100 n.s.
Kellokumpu et al. [70]a 2000 17 LARR 24 64 80 n.s.
Ashari et al. [74]a 2005 117 LARR 62 69 62 FT 2.5; MP 18
Kariv et al. [76]a 2006 136 LARR/OR 56 LR; 63 OR 74 LR; 54 OR 48 LR; 35 OR 9.3 LR; 4.7 OR
Madbouly et al. [80]a 2003 24 LARR/ 18.1 95 80 0
LWP
Lechaux et al. [69]a 2005 48 LARR 36 3 (23% worse) 31 4.2 FT; 4.2 MP
Dulucq et al. [68]a 2007 68 LWP 34 36 89 1.5
a
Laparoscopy-assisted procedures. AR anterior resection, FRM full rectal mobilization without fixation, FT full thickness, LARR laparoscopy-
assisted resection rectopexy, LWP laparoscopic Wells procedure, MP mucosal prolapse, n.s. not specified, OR open rectopexy, PFR pelvic floor
repair, RR resection rectopexy
a b
Fig. 66.6 (a, b) A superficial peritoneal window is made over the right part of the sacral promontory and extended caudally over the right outer
border of the mesorectum down to the right side of the pouch of Douglas to start the dissection of the rectovaginal septum
Fig. 66.7 Careful dissection of the rectovaginal septum was performed Fig. 66.8 The mesh is sutured as distally as possible on the anterior
down to the pelvic floor rectal wall/perineal body with three interrupted nonabsorbable sutures
in each side
66 The Abdominal Approach to Rectal Prolapse 819
helps preserve the lateral stalks, preventing from postoper- difference in recurrence nor mesh complications were found
ative constipation and improving continence. The tech- [107]. The 2008 National Institute of Clinical Excellence
nique is indicated to treat full-thickness rectal prolapse, (NICE) review of surgery for pelvic organ prolapse demon-
rectoceles, and internal rectal prolapse. It has gained popu- strated that complications are related to the type of mesh
larity due to a reduced rate of recurrence of pelvic organ used and depends on the follow-up time. The erosion rate for
prolapse at 3.4% and low postoperative morbidity of 4.8% a biological mesh (xenografts) was zero, rising to 7% for a
with no mortality. Additionally, 88% of patients reported an synthetic mesh and to 14% for a combined synthetic and bio-
overall improvement with significant decrease in fecal logical one. On the other hand, there was a higher failure rate
incontinence, obstructed defecation symptoms, and vaginal for a biologic mesh compared to the synthetic one (23% vs.
discomfort [98]. 9%) [108].
Recently, D’Hoore has updated the technique reviewing Biological implants are recommended for young
405 patients operated between 1999 and 2008 for rectal pro- patients, women of reproductive age, diabetics, smokers,
lapse (43%), internal prolapse (45.9%), and rectocele and patients with a history of pelvic radiation and inflam-
(11.1%), describing only minor postoperative complications matory bowel diseases or contaminated fields with intraop-
of 7%, low conversion rate of 2%, and median hospital stay erative violation of the rectum or vagina. [107, 108]
of 4 days. At 25 months’ follow-up the recurrence rate was Superiority of one mesh over the other has not yet been
4.6% and the main complication was mesh erosion to the demonstrated in the literature and randomized control trials
vagina in five cases (1.2%), only when associated with peri- are needed to prove the role of the different types of meshes
neotomy. Symptomatic improvement was observed in 85% for rectopexy [109].
of the patients with total rectal prolapse and in 70% of A multicenter study included 2203 patients undergoing
patients with internal rectal prolapse (p < 0.050). The differ- LVMR and compared the safety of synthetic meshes with
ence was mainly due to a lesser effect on obstructed defeca- biological grafts. This study demonstrated mesh erosion
tion symptoms [99]. rates of 2% and authors identified that the polyester mesh
A multicenter collaboration including the technique’s was associated with a significantly higher incidence of mesh
author enrolled 919 consecutive patients who underwent erosion compared to titanium-coated polypropylene.
LVMR to evaluate the long-term outcome. The estimated 10- However, there was no statistically significant difference in
year recurrence rate was 8.2%. Mesh-related complications mesh erosion rates when comparing synthetic and biological
occurred in 18 patients (4.6%), including 7 with vaginal meshes [106].
mesh erosion (1.3%). Five of these patients underwent com- Recently, Brunner et al. [110] showed their results and a
bined perineotomy. The incidence of fecal incontinence literature compilation of LVMR with a biological graft
decreased from 37.5 to 11.1% and constipation rate also between 2009 and 2017, including 454 patients. The types
decreased from 54 to 15.6% [100]. of mesh used were Pelvicol, Permacol, and Surgisis
Otherwise, major complications are related to a place- Biodesign. At the long-term follow-up, the recurrence rates
ment of a foreign body including mesh infection leading to varied from 0 to 5% and complication rates from 0 to 23%.
sepsis, vaginal/rectum, or bladder mesh erosion, and mesh There was no mesh-related complication at any study ana-
detachment [100]. Furthermore, studies have mentioned lyzed. Functional results were good with obstructed defe-
rectovaginal fistula and sacral discitis as complications cation improvement in most studies and only 3% worsening.
after the procedure. On the other hand, discitis can occur Also, for fecal incontinence, there was a significant
after any type of rectopexy, where a suture is applied to improvement.
secure the mesh at the site of the sacral promontory [101, Regarding functional outcomes which are expected to be
102]. better improved after the anterior approach, Lundby et al.
Studies have mentioned factors to have good outcomes, [111] studied the bowel function after sutured rectopexy and
such as experience to perform the technique with good qual- LVMR in a randomized controlled trial including 75 patients
ity make possible a complete ventral dissection of the recto- and found a similar reduction in obstructed defecation syn-
vaginal septum down to the pelvic floor as well as the fixation drome for both techniques. Gosselink et al. [112] selected
of the mesh without tension [100, 103–106]. patients without a response to maximum medical treatment
The type of the mesh did not interfere in the results. A (including biofeedback) who complained of fecal inconti-
systematic review of 767 patients who had a repair with a nence and grade II to IV rectal prolapse for LVMR. The
synthetic mesh and 99 with a biological implant compared results have demonstrated an improvement in fecal
both types of mesh and demonstrated that neither significant continence.
820 S. M. Murad-Regadas et al.
66.7.2 Robotic Ventral Mesh Retopexy New minimally invasive techniques are emerging, such as
robotic-assisted and single trocar laparoscopy; however, no
The use of robotic surgery has been increasing since its benefit has yet been proven; in fact, one study found a higher
development in 2006, conferring several advantages over recurrence rate after robotic compared to laparoscopic recto-
laparoscopic surgery, including improved dexterity of move- pexy [95]. Heemskerk et al. [96] recently reviewed 14
ment, obliteration of hand tremor, image magnification with robotic-assisted rectopexies and compared them to 19 lapa-
three-dimensional view, and instruments with a wide range roscopic cases. The authors found the new approach to be
of movements allowing for unrivalled precision. These fac- 39 min longer than laparoscopy and it was associated with an
tors are especially advantageous in confined spaces, such as increased charge of $745 per patient, while the postoperative
the pelvis [113]. The use of robotics in ventral mesh recto- morbidity was similar. The lack of experience, and hence
pexy (RVMR) has been shown to be safe and feasible [114]. publications, and the influence of a learning curve process
A recent meta-analysis comparing RVMR to LVMR for limit further conclusions about these new procedures.
the management of rectal prolapse [114] including five pro- Tables 66.3 and 66.4 summarizes the results in terms of
spective nonrandomized studies and 244 patients (101 improvement of symptomsrecurrence, morbidity and mortal-
robotic and 143 laparoscopic) observed a shorter operative ity of procedures for complete external rectal prolapse.
time favoring LVMR with a mean weighted difference of
27.94 min, similar conversion and recurrence rates, and a
trend toward a reduction in length of inpatient stay and early 66.7.3 Combined Rectopexy and Pelvic Organ
postoperative complications in the robotic group without sta- Prolapse Approach
tistical significance.
Recently, van Iersel et al. [113] reported a 5-year experi- Recent advances in knowledge of pelvic floor dynamic anat-
ence of 258 patients who underwent RVMR and were fol- omy and dysfunctions associated with the available diagnos-
lowed for more than 2 years. There was a low morbidity of tic modalities and multidisciplinary assessment and
7%, despite 0.4% mortality rate. Only one vaginal mesh ero- combined treatment of complex dysfunctions have worked
sion occurred. There was a significant improvement in together to find the appropriate surgical technique and avoid
obstructed defecation (78.6%) and fecal incontinence recurrence. Studies have demonstrated a substantial propor-
(63.7%) and worsening symptoms were reposted in 3.9% tion of females with multiple pelvic floor dysfunctions.
and 0.4%, respectively. Recurrence rates were 12.9% for There is a difference in the prevalence of pelvic floor dys-
external prolapse. functions due to heterogeneity in definition, population
Table 66.3 Follow-up and functional results of laparoscopic and robotic ventral mesh rectopexy with synthetic mesh
Constipation Incontinence
Laparoscopic studies Year N Median follow-up improvement (%) improvement (%) Recurrence (n/%)
D’Hoore [97] 2004 42 71 84.2/de novo 4.8 90.3 2 (4.8)
Auguste [115] 2006 54 12 70/de novo 17.6 72.4 4 (7.4)
Verdaasdonk [116] 2006 13 7 66 69 2 (15.4)
Cristaldi [117] 2007 63 18 78 90/ de novo 3.2 1 (1.7)
Boons [118] 2010 58 19 72 83/de novo 1.5 1 (1.5)
Formijne Jonkers [119] 2013 36 30 57.9 76.2 –
Randall [120] 2014 190 29 – 93 9 (4.7)
Gosselink [121] 2015 41 12 – 50 1 (2.3)
Tsunoda [122] 2015 19 12 52 62 –
Consten/van Iersel [100] 2015 242 33.9 63.3 73.2 –
Tsunoda [123] 2015 31 12 – – 3 (9.7)
Robotic vs. laparoscopic studies
De Hoog [95] 2009 20 R 23.4 – – 4 (20)
Wong [124] 2011 23 L 12 – – 1 (4.3)
15 R 1 (6.7)
Wong [125] 2011 40L 6 – – 0
23R 0
Mantoo [126] 2013 23L 16 – – 6 (8)
12R 3 (7)
Mäkelä-Kaikkonen [127] 2014 14L 3 36 89 1 (5)
13R 0
L laparoscopic, R robotic
66 The Abdominal Approach to Rectal Prolapse 821
Table 66.4 Summary of results, including morbidity, mortality, and recurrence, of abdominal open and laparoscopic procedures for complete
external rectal prolapse [128]
Approach Technique Year Morbidity (%) Mortality (%) Recurrence (%)
Conventional Laparotomy
Suture rectopexy Sudeck 1922 9–20 0–4 0–20
Encircled/anterior mesh rectopexy Ripstein 1963 4–33 0–3 0–12
Rectopexy and resection Frykman-Goldberg 1955 7–23 0–7 0–9
Lateral mesh rectopexy Orr-Loygue 1957 0–4 0–17 0–5
Posterior mesh rectopexy Wells 1959 0–28 0–4 0–10
Laparoscopic surgery
Suture rectopexy – – 9–19 0 0–7
Lateral mesh rectopexy – – 0–5 0 0–6
Posterior mesh rectopexy – – 0–14 0 0–4
Rectopexy and sigmoidectomy – – 8–21 0–1 0–11
Ventral mesh rectopexy D’Hoore 2004 10–36 0 0–15
studied, as well as methodology applied. The combined dys- 66.8 Incontinence Improvements
functions have been found from 30 to 50% in the patients and Mechanisms
with pelvic floor dysfunctions [129–131]
The combined technique as sacrocolpopexy with recto- Fecal incontinence in patients with rectal prolapse is attrib-
pexy consists of distal mobilization of the anterior rectum uted to pudendal nerve neuropathy causing sphincter dener-
from the rectovaginal septum to the pelvic floor muscles vation [89], direct sphincter trauma caused by intussuscepting
down to the levator ani. Once the rectum is fully mobi- rectum, and chronic rectoanal inhibition and abnormal ano-
lized, a 5-cm-wide piece of mesh is sutured to the vaginal rectal sensations [37, 84, 94, 133, 134]. Associated factors
cuff anteriorly and posteriorly. This mesh is then sutured that may be present are impaired internal anal sphincter, pel-
to the presacral fascia at the S3 level. The procedure treats vic floor muscle dysfunction, and abnormal somatic nerve
the posterior compartment due to rectopexy that improves stimulation [20, 36]
the position and angle of the rectosigmoid junction in the The anal sphincters usually start to regain tone approxi-
pelvis, allowing a more complete and satisfactory evacua- mately 1 month after surgery, and responsive patients are
tion. Additionally, obliterates the deep Pouch of Douglas fully continent in 2–3 months [24]. Functional improvement
that results in reduces or eliminates the potential space for after surgery is seen in 60–90% of patients, although the
an enterocele or sigmoidocele. exact mechanism is not well established [51, 52, 70, 93, 94,
A large study including 110 women reporting functional 135–137]. Some authors have suggested that the restoration
outcome, quality of life, and recurrence rate after combined of internal anal sphincter function and improved anorectal
sacrocolpopexy and rectopexy described more than 80% of sensation or rectal compliance after surgery contribute to the
complete resolution or improvement in constipation without patients regaining continence [37].
the added morbidity of a bowel resection. Furthermore, a Different abdominal procedures have shown a similar
significant improvement in constipation, incontinence, and improvement of anal continence. Benoist et al. [94] reported
quality-of-life measures was shown. A multidisciplinary no difference in incontinence improvement among different
approach to repairing of both compartments at the same laparoscopic techniques (suture, mesh, and resection) in a
operation may have a synergistic effect in prevention of 2-year follow-up period, with 75% of the patients having
recurrence and treatment success [132]. The approach to better continence after surgery.
anterior retopexy with or without sacrocolpopexy may be
laparoscopy or robotic, depending on the surgeon’s prefer-
ence and patient’s age and comorbidity. 66.9 M
anagement of Recurrent
Recently, Jallad et al. [45] demonstrated that combined Rectal Prolapse
laparoscopic pelvic organ suspension is effective but not free
of complications. From 59 patients who underwent LVMR The mean reported time period for complete rectal prolapse
with sacrocolpopexy (81.3%) or sacrohysteropexy (18.6%), recurrence is between 2 and 3 years after surgery. Early sur-
the composite success rate was 57.4% in 17 months, despite gical failures are generally attributed to technical problems
a 25.4% rate of perioperative adverse event. The use of bio- [138, 139]. The reported surgical management of prolapse
logic graft was associated with a higher adverse event rate of recurrence is limited. Steele et al. [138] reviewed the man-
40%, as compared to 10.3% of the synthetic mesh. agement of 78 recurrences in 685 patients operated for initial
822 S. M. Murad-Regadas et al.
rectal prolapse, and compared the abdominal to the perineal During the last two decades, laparoscopy has augmented
approach. The incidence of re-recurrence was 29% and was the low morbidity rates and reduced the surgical stress
significantly higher in the perineal cases (37.3% vs. 14.8%, related to perineal approaches, maintaining the long-term
P = 0.03, respectively for perineal and abdominal efficacy of abdominal procedures. Currently, laparoscopy is
approaches). The authors concluded that abdominal repair the preferred approach for the abdominal management of
has consistently lower re-recurrence rates for recurrent rectal complete rectal prolapse. Robotic surgery seems to present
prolapse, independently of the number of previous repairs, similar results to laparoscopic approach, with a low morbid-
and suggested that whenever possible the abdominal ity rate, acceptable long-term recurrence rates, and a good
approach for recurrent prolapse should be undertaken, if the functional outcome.
patient’s risk profile permits.
A systematic review of surgical techniques and outcomes
for recurrent rectal prolapse was unable to create guidelines
due to the heterogeneity of surgical techniques, the short- Take-Home Messages
term follow-up in most studies, and the low quality of evi- • Rectal prolapse is a benign disorder and causes dis-
dence [139]. comfort due to the prolapsing tissue both internally
Whenever performing surgery for recurrent prolapse, it is and externally.
important to be aware of the previous procedure. If there is • The resections techniques for the treatment of rectal
any prior resection involved, either perineal rectosigmoidec- prolapse can be divided into abdominal and peri-
tomy or resection rectopexy, and another resection is planned, neal categories. So, the condition should be com-
the surgeon must preferably excise the previous anastomosis pletely investigated to choose appropriate
to avoid devitalization of the remaining colonic segment. techniques for surgery and approach to treat ade-
quately and avoid recurrence.
• The decision-making should be with respect to
66.10 Conclusions the choice of specific techniques according to the
patient’s conditions and the experience of the
Rectal prolapse is a fairly uncommon pathology that mainly surgeon.
affects female adults after the fifth decade. The etiology is
poorly understood and most patients present with an abnor-
mally deep cul-de-sac, loss of posterior fixation of the rec-
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The Perineal Approach to Rectal
Prolapse 67
Alison Althans, Anuradha Bhama, and Scott R. Steele
Learning Objectives
• Understand the indications for perineal approach to
rectal prolapse.
• Describe the perioperative care and steps of the
Delorme procedure.
• Describe the perioperative care and steps of the peri-
neal rectosigmoidectomy (Altemeier procedure).
• Understand the historical perspective behind the
Thiersch wire (anal encirclement).
• Understand the management of recurrent rectal
prolapse and strangulated/incarcerated rectal
prolapse.
67.1 Introduction
Table 67.1 Recurrence and morbidity rates for both retrospective and
prospective studies of Delorme procedure
Number Recurrence Morbidity
Author (year) of patients % %
Tobin (1994) [8] 43 26 –
Oliver (1994) [9] 40 22 25
Senapati (1994) [10] 32 13 6
Lechaux (1995) [11] 85 14 14
Pescatori (1998) [12] 33 21 45
Watts (2000) [13] 101 27 –
Tsunoda (2003) [14] 31 13 13
Watkins (2003) [7] 52 10 4
Marchal (2005) [15] 60 23 15
Pascual (2006) [16] 21 10 5
Lieberth (2009) [17] 76 8 15
Chen (2012) [18] 25 4 32
Fazeli (2013) [19] 52 10 10
Elagil (2016) 53 16 7
Pares (2017) 11 18 18
Fig. 67.3 Delorme procedure. (Courtesy of Cleveland Clinic
Foundation, Copyright 2001)
Table 67.2 Recurrence and morbidity rates for both retrospective and The PROSPER trial is the only randomized control trial
prospective studies of Altemeier procedure comparing the different surgical approaches to rectal pro-
Number Recurrence Morbidity lapse. In this study, there were no statistically significant dif-
Author (year) of patients % %
ferences in recurrence rates or functional outcomes between
Altemeier (1971) [24] 106 3 24
these two perineal approaches [6]. However, this study may
Williams (1992) [25] 114 10 12
Kimmins (2001) [26] 63 6 10 have been underpowered and had potential bias in the ran-
Steele (2006) [27] 48 recurrent 39 17 domization. Therefore, the operation best suited for each
Glasgow (2008) [28] 103 9 9 patient should be selected on a case-by-case basis at the dis-
Kim (2009) [29] 38 3 18 cretion of both surgeon and patient.
Altomare (2009) [30] 93 18 9
Cirocco (2010) [31] 103 0 14
Ris (2011) [32] 60 14 12
Ding (2012) [21] 113 primary 18 17
67.4 Anal Encirclement (Thiersch Wire)
23 recurrent 39 17
Towliat (2013) [33] 28 27 – Anal encirclement was initially described in 1891 by Carl
Thiersch. The underlying principle of this procedure is to
create a tunnel around the distal anal canal and using a
keep the bowel oriented and to avoid the bowel from retract- wire, mesh, or suture through the tunnel to create a partial
ing back into the pelvis. Suture material should be braided obstruction of the anal opening. This procedure can be
and absorbable. After four cardinal stitches are placed, done under local anesthetic and is therefore preferred in
intervening sutures are placed to complete the anastomosis. patients who cannot tolerate any or minimal systemic anes-
Once the anastomosis has been completed, ensure that the thetic. In general, this procedure is rarely used currently
lumen of the proximal bowel and the anastomosis are and is only reserved for the rarest cases, typically in a pal-
widely patent. This can be done using a flexible or rigid liative setting.
scope or simply a Hill-Ferguson retractor. The anastomosis The procedure is performed with the patient in either
should easily accommodate a medium- sized retractor. lithotomy or prone jackknife position, whichever can be tol-
Some surgeons will choose to perform a levatorplasty prior erated physiologically and based upon surgeon preference.
to starting the anastomosis. Care must be taken not to cre- An incision is made in the skin of the posterior perineum
ate an overly tight levatorplasty as this can lead to outlet about 2–4 cm from the anal verge. A closed curved Kelly
dysfunction. A single finger should comfortably fit between clamp is used to dissect a tunnel around the anal verge in the
the colon and the pelvic floor. A levatorplasty is typically deep subcutaneous tissues. The clamp is brought all the way
performed by approximating the levator muscles anteriorly around to the anterior perineum and another incision is made.
using a monofilament absorbable suture. This is then recreated on the other side. The material of
Perineal rectosigmoidectomy, in general, carries a low choice is then passed through this tunnel circumferentially
complication rate. Complications include anastomotic leak, circling the anal opening. Several different types of materials
bleeding, stenosis, and pelvic abscess [21]. As this is a full- have been used to create the encirclement. This includes
thickness resection (in contrast to the Delorme), the leak can metal wire, nylon suture, prolene suture, Dacron graft, sili-
result in peritoneal sepsis and severe morbidity or even mor- cone band, or biological graft.
tality; however, this is rare. Several studies examining out- The utilization of anal encirclement has largely fallen
comes of the Altemeier operation have demonstrated success out of favor due to very high recurrence rates upwards
in improving patients’ constipation, fecal incontinence, and of 44% and problems with outlet constipation [34]. In
anal manometry metrics [22]. Retrospective and prospective modern-day use, this procedure has been reserved for
studies evaluating outcomes of perineal rectosigmoidectomy patients with permanent colostomies with rectal pro-
with associated recurrence and complication rates can be lapse with severe comorbidities that would not tolerate
seen in Table 67.2. Recurrence rates are generally lower than perineal proctectomy. Recently, the utilization of anal
those seen in patients undergoing Delorme procedure, and encirclement with biological mesh to augment perineal
morbidity rates are comparable. Recurrence rates with proctectomy was found to reduce rates of recurrent pro-
Altemeier procedure may even be further augmented by the lapse from 29% without encirclement to 8% with encir-
implementation of levatorplasty [23]. Some surgeons do pre- clement [35]. Given the problems with anal encirclement,
fer the Delorme procedure over the Altemeier as functional this procedure is rarely done in current times (Table
results may be improved with the Delorme. 67.3).
832 A. Althans et al.
67.5 M
anagement of Recurrent Rectal
Prolapse
34. Kuijpers H. Treatment of complete rectal prolapse: to narrow, to 36. Sainio A, Halme L, Husa A. Anal encirclement with polypropyl-
wrap, to suspend, to fix, to encircle, to plicate or to resect? World J ene mesh for rectal prolapse and incontinence. Dis Colon Rectum.
Surg. 1992;16(5):826–30. 1991;34(10):905–8.
35. Eftaiha SM, Calata JF, Sugrue JJ, Marecik SJ, Prasad LM,
37. Fengler S, Pearl R, Prasad M, Orsay C, Cintron J, Hambrick E,
Mellgren A, et al. Bio-thiersch as an adjunct to perineal proctec- et al. Management of recurrent rectal prolapse. Dis Colon Rectum.
tomy reduces rates of recurrent rectal prolapse. Dis Colon Rectum. 1997;40(7):832–4.
2017;60(2):187–93.
The Laparoscopic Approach to Rectal
Prolapse 68
Bart Van Geluwe and Andrè D’Hoore
p rolapse are nulliparous excluding birth trauma as a cause. The endopelvic fascia and pelvic floor muscles provide
Psychiatric disorders are also a risk factor [2, 10]. most of the support function in female pelvis although the
support for the pelvic viscera, vagina and rectum involves a
complex interplay between muscles, fascia, nerves, liga-
68.3 Etiology ments and anatomical orientation. The anatomical pathology
of the posterior compartment is best understood in terms of
There are two theories postulating the etiology of rectal pro- the DeLancey level of pelvic organ support [18]. Three levels
lapse. This is based on observations of abnormalities in local of vagina support are described:
anatomy associated with the prolapse.
• Level 1: The superior suspension of the vagina apex from
1. Sliding Hernia Theory the lateral pelvic sidewall by the uterosacral–cardinal
This theory was described by Moschowitz in 1912 based complex. The cardinal–uterosacral complex provides api-
on the observation that the rectal lumen is usually poste- cal support by suspending the uterus and upper one-third
riorly placed in procidentia and small bowel occasionally of the vagina to the bony sacrum. This complex can be
present anteriorly in the “hernia sac.” The concept is that described as two separate entities: the cardinal ligament
rectal prolapse is rather a sliding perineal hernia, which and the uterosacral ligament. The cardianal ligamant is a
develops as a weakness in the transversalis fascia second- fascial sheath of collagen that envelops the internal iliac
ary to increased intraabdominal pressure. Hence, the pro- vessels and then continues along the uterine artery merg-
lapse starts as a hernia in the pouch of Douglas and ing into the visceral capsule of the cervix lower uterine
because the perineal reflection is closely adherent to the complex and upper vagina. The uterosacral ligament is
rectum, and the anus is relatively fixed, the hernia pro- denser and more prominent than the cardinal ligament.
trudes as an intussusception toward the anal canal [11]. Collagen fibers of the uterosacral ligament fuse distally
with the visceral fascia over the cervix, lower uterine seg-
2. Intussusception Theory ment, and upper vagina, forming the pericervical ring.
Devadhar proposed that rectal prolapse starts as a circum- Proximally, these fibers and at the presacral fascia overlie
ferential intussusception of the rectum [12]. This has been the second, third, and fourth sacral vertebrae. This com-
confirmed by defecographic studies by several authors plex seems to be the most suppurative structure of the
[13]. Intussusception may due to congenital failure of fixa- uterus and upper one third of the vagina. Disruption of the
tion of the mesorectum to the sacrum with straightening cardinal–uterosacral complex may result in uterine
the anorectal angle or secondary to trauma, obstetric descensus or vaginal (vault-prolapse). Likewise, the most
injury, or surgical procedures. A nonrelaxing puborectal common cause of vaginal vault prolapse is previous hys-
muscle may also play a role. Whether or not this internal terectomy with failure to adequately reattach the cardi-
intussusception represents an early finding in patients who nal–uterosacral complex to the pubocervical fascia and
eventually develop full-thickness prolapse is unclear [14]. rectovaginal fascia at the vaginal cuff intraoperatively.
Numerous anatomic abnormalities are associated with A vaginal vault or uterine prolapse and retropubic fixa-
rectal prolapse syndrome and include an abnormally deep tion of the anterior wall will result in an abnormal deep
pouch of Douglas, lax and atonic muscles of the pelvic pouch of Douglas. The descent of small bowel (enterocele)
floor, weak anal sphincter muscles, nonrelaxing puborec- or abundant sigmoid (sigmoidocele) in this space between
tal muscle, and poor sacral and lateral ligament fixation of the posterior vaginal wall and the anterior rectum will
the rectum. The real cause of rectal prolapse may be a always be associated with at least some rectal descent, and
combination of disturbances in one or more of these fac- the clinical presentation of a bulge in the upper posterior
tors [13–17]. vagina, the sign of a recto- and/or entero/sigmoidocele.
the levator ani muscles. The rectovaginal septum is the nonrelaxing m. puborectalis syndrome. A flexible endoscopy
most important support system of the posterior vaginal is advisable to exclude a neoplasm, inflammatory bowel dis-
wall and helps maintain the rectum in its posterior posi- ease, or diverticular disease. Anorectal functional assess-
tion. A breech in the integrity of the rectovaginal septum ment with manometry and balloon evacuation test is useful
or a defect in its lateral attachments results in develop- to evaluate the anal sphincter and to exclude severe dyssyn-
ment of a rectocele or may lead to a failure of the fixation ergia. In patients with a long history of constipation, transit
of the anterior rectum wall, creating a leading cause for a marker studies are necessary to identify patients with total
rectal intussusception. colonic inertia.
the rectum to the sacrum. Following full mobilization of torsion or volvulus of the abundant sigmoid colon. By
the rectum, the lateral stalks are sutured to the presacral performing a resection, the mobility of the left colon
fascia using nonabsorbable suture material. Two or three almost disappear, which also helps to prevent recurrences
sutures are used on one or both sides of the rectum mak- [21–23].
ing sure not to narrow the rectum. In this technique, adhe- The procedure carries the risk of anastomotic leakage;
sions progresses due to fibrosis, keeping the rectum however, it results in low incidence of recurrence (0–5%).
anchored to the rectum. After surgery, incontinence is In most cases, both incontinence and constipation is
improved but the relief of constipation varies with the improved (Table 68.2). In patients with a major degree of
investigators [21]. Recurrence rates are reported to be low fecal incontinence, a resection should be avoided [31]. In
(0–9%) (Table 68.1) [23–29]. males, a wide pelvic dissection may induce serious sexual
dysfunction [32–39].
2. Laparoscopic Resection Rectopexy (Frykman-
Goldberg) [30]. 3. Laparoscopic Mesh Rectopexy
After a rectal resection, it has been commonly observed Based on the assumption that when a foreign body is used,
that a strong adhesion between rectal anastomosis and stronger fibrosis and adhesion than simple suture could be
sacrum enables to fix the rectum to the sacrum. For that induced, the mesh rectopexy was introduced [31].
reason, bowel resection has been applied to the treatment Initially, the procedure involved supporting the rectum
of rectal prolapse. The technique combines direct suture against the sacrum with a sling of mesh attached to the
rectopexy with sigmoid resection (laparoscopic presacral fascia. Depending on the fixation site, the
resection-rectopexy) method is classified as anterior sling rectopexy (Ripstein
The rectum is mobilized and the sigmoid colon is resected procedure) or posterior mesh rectopexy (Well’s posterior
and a tension-free anastomosis is created. Preservation of rectopexy) [40, 41]. In the Ripstein procedure, an anterior
the A. rectalis superior should be attempted. Fixation sling is positioned in front of the rectum and sutured to
sutures are placed from the lateral stalks to the endopelvic the presacral fascia. However, this approach was found to
fascia in a similar fashion to the suture rectopexy. The be associated with significant postoperative constipation
rectum must be elevated out of the pelvis as high as pos- arising from obstruction to the rectum from the sling. A
sible prior placement of the sutures. The anterior cul-de- subsequent modification of the procedure to avoid this
sac is closed. Additional theoretical advantages of this problem involved a partial wrap of the rectum by two
procedure include suspension of the rectum by straighten- sides of a piece of mesh which have been previously
ing and “shortening” the left colon and the prevention of attached to the presacral fascia. In the UK, a similar
68 The Laparoscopic Approach to Rectal Prolapse 839
Fig. 68.4 The mesh is fixed to the sacral promontory using an endo- Fig. 68.5 The lateral borders of the incised peritoneum are then closed
scopic “tacker” device. The position of the strip is slightly deviating to over the mesh, resulting in an elevation of the “neo-Douglas” (com-
the right side of the sacral promontory. No traction is exerted on the pared with the deep pouch of Douglas in Fig. 68.1)
rectum, which remains in the sacrococcygeal hollow
68.10 Role of Lateral Ligaments? feasible, and the bowel anastomosis can be avoided [8, 45,
53]. An inherent step in all other rectopexies is the full
The left colon and rectum receive retrograde innervation mobilization of the rectum. Autonomic nerve injury during
from neural efferents running through the so-called “lateral extensive posterolateral rectosigmoid mobilization may
ligaments”; thus, lateral ligament division during rectopexy lead to postoperative dysmotility and impaired evacuation
has been suggested to denervate the rectum, causing postop- (Table 68.3). Published results concerning laparoscopic
erative constipation. ventral mesh rectopexy are good, especially with regard to
A number of studies looked at the effect of the division or functional outcome even in the long term. According to
preservation of ligaments. Bachoo et al. performed a meta- several recent studies and one review, morbidity is low, the
analysis of articles reporting on surgery for rectal prolapse. recurrence rate is below 5%, preexisting constipation is
They concluded that division rather than preservation of the treated in almost 80% of the cases, and incontinence
lateral ligaments was associated with less recurrent prolapse improves in 90% [27, 52–66]. To avoid any complication
but more postoperative constipations, although these find- from the synthetic prosthesis, use of biological mesh has
ings were found in small numbers [48]. also been used with comparable success rates, although on
short-term follow-up. [67].
The advantage of laparoscopic ventral mesh-rectopexy
68.11 Choice of Operation? includes a correction of the posterior compartment on the
three DeLancey levels of pelvic organ support (Table 68.4)
There are many options to repair rectal prolapse syndromes, [68]: by performing the dissection into the rectovaginal sep-
and since there is no consensus on the best surgical treatment tum as deep as possible and introducing a mesh at the level
for these conditions, the choice of an optimal treatment is of the perineal body (level 3), a supra-anal rectocele can be
difficult. It is best tailored to the individual patient and sur- treated. Interposition of the mesh on the anterior surface of
geon. The skill and the surgeon’s familiarity with the proce- the rectum will reinforce the rectovaginal septum correcting
dure should be considered. a concomitant rectocele and will prevent recurrence of rectal
In our practice, we favor laparoscopic (nerve-sparing) intussusceptions (level 2). Moreover, the choice of a ventral
ventral mesh rectopexy because the procedure is safe and position for the mesh is based on defecographic data that
68.16 Conclusion 10. Koc O, Duran B. Role of elective cesarian section in prevention of
pelvic floor disorders. Curr Opin Obstet Gynecol. 2012;24:318–23.
11. Moschcowitz AV. The pathogenesis, anatomy, and the cure of pro-
Treatment of rectal prolapse is one of the most challenging lapse of the rectum. Surg Gynecol Obstet. 1912;15:7.
conditions to treat because of the poorly understood nature 12. Devadhar DS. A new concept of mechanism and treatment of rectal
of these disorders and the lack of adequate evidence to guide procidentia. Dis Colon Rectum. 1965;8:75.
13. Broden B, Snellman B. Procidentia of the rectum studied with cine-
the most appropriate approach for an individual patient. radiography. A contribution to the discussion of causative mecha-
There are no detectable differences between the methods nism. Dis Colon Rectum. 1968;11:330–47.
used for mobilization and fixation of the rectum. Division, 14. Wijffels NA, Collinson R, Cunningham C, Lindsey I. What is
rather than preservation of the lateral ligaments was associ- the natural history of internal rectal prolapse? Colorectal Dis.
2010;12:822–30.
ated with less recurrent prolapse but more postoperative con- 15. Hull TL. Rectal prolapse: abdominal approach. Clin Colon Rectal
stipation. Laparoscopic ventral mesh rectopexy has gained Surg. 2003;16:259–62.
wide spread global acceptance due to its results relative to 16. Madoff RD, Mellgren A. One hundred years of rectal prolapse sur-
the cure of prolapse and function. The long-term outcome gery. Dis Colon Rectum. 1999;42:441–50.
17.
O’Brien DP. Rectal prolapse. Clin Colon Rectal Surg.
data support its efficacy and beneficial functional outcome, 2007;20:125–32.
while complications are acceptable [81]. 18. DeLancey JO. Anatomical aspects of vaginal eversion after hyster-
ectomy. Am J Obstet Gynecol. 1992;166:1717–24.
19. Festen S, van Geloven AAW, D’Hoore A, Lindsey I, Gerhards
MF. Controversy in the treatment of symptomatic internal rectal
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The Role of Robotic Surgery in Rectal
Prolapse 69
Adam Studniarek, Anders Mellgren,
and Johan Nordenstam
Learning Objectives likely as men to present with RP, approximately one third of
After completing this chapter, the reader should be women are younger and nulliparous at presentation [5].
able to: Thus, obstetric history is not the only risk factor for the
development of RP. Men with RP frequently suffer from
• Describe and understand the pathophysiology disordered defecation, dysmotility, psychiatric comorbidi-
behind rectal prolapse and the two theories explain- ties, and/or developmental delays [6, 7].
ing the etiology of rectal prolapse. Various anatomic variations and pelvic floor abnormali-
• Understand the indications, different approaches, ties are associated with the development of RP, including a
and complications associated with both abdominal deep pouch of Douglas, a laxity of rectal attachments, and a
and perineal operations for rectal prolapse. redundant sigmoid colon. Patients frequently have a laxity of
• Describe the most common pitfalls and complica- the anal sphincters and evidence of pudendal nerve
tions for each procedure. neuropathy can frequently be found [8, 9]. Other contributing
• Present the most current evidence regarding robot- factors may include a mobile mesorectum and lax lateral
assisted rectopexy techniques and both advantages ligaments [9–12].
and disadvantages that come with this approach. From an anatomic and functional standpoint, RP can be
• Define the aspects of robotic surgery that will divided into external and internal prolapse [13]. An external
require further research in order to compare long- rectal prolapse (ERP) extends beyond the anus, while an
term outcomes of all available surgical approaches. internal rectal prolapse (IRP) does not. Several authors have
suggested that IRP represents the first stage of a progressive
anomaly and may eventually lead to a full-thickness external
rectal prolapse (ERP) [8–10]. The Oxford group has
69.1 Introduction suggested a radiological classification with five different
degrees of prolapse (Table 69.1, Fig. 69.1) [9]. Their data
External rectal prolapse (ERP) is defined as a full-thickness
extrusion of the rectum of the rectum beyond the anal verge.
Rectal prolapse (RP) was described already in the 1500s BC in Table 69.1 Oxford rectal prolapse grade, a radiological grading
the Ebers Papyrus and in 1900 Edmond Delorme reported the system
first successful surgical treatment of RP [1, 2]. Grade
The peak incidence of RP is found in elderly women and of rectal Radiological characteristics
prolapse of rectal prolapse
may be associated with other pelvic floor disorders, such as
Internal
vaginal prolapse (enterocele, cystocele, rectocele) and/or Recto-rectal I (high rectal) Descends not lower than
urinary incontinence. The peak incidence is in women older Intussusception proximal limit of the rectocele
than 50 years and women represent 80–90% of patients (RRI) II (low rectal) Descends into the level of the
[3, 4]. Interestingly, even though women are six times as rectocele, but not into anal canal
Recto-anal III (high anal) Descends into anal canal
Intussusception
(RAI) IV (low anal) Descends into anal canal
A. Studniarek · A. Mellgren (*) · J. Nordenstam
External
Division of Colon and Rectal Surgery,
University of Illinois at Chicago, Chicago, IL, USA External rectal V (overt rectal Protrudes outside the anus
e-mail: adamstudniarek@yahoo.com; anders.mellgren@icloud.com prolapse (ERP) prolapse)
OPG-4 OPG-5
demonstrate a relationship between age and prolapse grade, A multidisciplinary approach is recommended and an
supporting the view of IRP as a precursor to ERP in the urogynecological evaluation can be useful. A colonoscopy is
spectrum of rectal prolapse disease. usually recommended in adults to exclude coexisting condi-
Symptoms of rectal prolapse are variable, including tions. Colonoscopy frequently demonstrates proctitis in the
feeling of a bulge, mucous drainage, fecal accidents, distal rectum.
constipation, pelvic pressure, pain, and rectal bleeding.
Symptoms can often affect the daily quality of life and result
in psychosocial distress resulting in isolation and depression 69.3 S
urgical Approaches to Rectal
in the most extreme cases. Prolapse
69.4 Perineal Operations in a fixed position as adhesions formed attaching the rectum
to the presacral fascia [23]. The majority of case series report
The two most commonly performed perineal procedures are a low recurrence rate (usually between 5 and 10%), with
Delorme mucosal sleeve resection and Altemeier perineal most of the reports showing improvement in fecal continence
rectosigmoidectomy [17]. Several studies have shown the as well [24–26].
safety of a perineal approach in the elderly, high-risk patients,
but the recurrence rates are significantly higher when com-
pared with abdominal repairs [18–21]. 69.5.2 Abdominal Resection Rectopexy
This procedure, which consists of a perineal proctosigmoid- 69.5.3 Laparoscopic Ventral Mesh Rectopexy
ectomy was first described by Miles in 1933 [19], subse-
quently popularized by Altemeier in 1971 [20]. It involves Laparoscopic Ventral Mesh Rectopexy (LVMR) was first
excising the prolapsed segment of the rectum and creating a described by Andre D’Hoore et al. in 2004 [28]. The initial
low end-to-end coloanal anastomosis. idea for the laparoscopic ventral rectopexy repair was derived
from the cinegraphic data of Broden and Snellman [10], who
demonstrated that the intussusception of the rectum starts
69.5 Abdominal Operations usually in the anterior aspect. LVMR aims to correct the
descent of the rectum and middle compartment by mobiliz-
An abdominal approach for the treatment of rectal prolapse is ing the rectovaginal septum down to the pelvic floor between
suited for patients without significant comorbidities, and fit the rectum and the vagina [30]. Once the rectovaginal sep-
for an abdominal operation [21]. Historically, the abdominal tum is dissected, it is reinforced with a mesh. The mesh is
approach has been reported to have longer operative times, typically fixated to the promontory.
but lower recurrence rates, whereas perineal approach was The recurrence rate after LVMR was evaluated in a meta-
considered safer, but with higher recurrence rates. Since the analysis of 789 patients in 12 published articles, reporting
introduction of laparoscopic and robotic surgery to rectal pro- a 3.4% recurrence rate. The overall mean decrease in fecal
lapse, abdominal procedures can be performed with relatively incontinence score was 45% along with a significant
low morbidity, and less physiological burden on the patient. decrease in constipation [31]. Jonkers et al. [32] compared
LVMR with laparoscopic resection rectopexy and found
that there is a reduction in constipation and incontinence
69.5.1 Abdominal Suture Rectopexy with both approaches; however, more complications
occurred after laparoscopic resection rectopexy than with
Abdominal suture rectopexy is a common approach with the LVMR.
goal of anchoring the rectum directly to the sacrum. This LVMR achieves excellent functional results in a large
procedure can be performed with open, laparoscopic, or proportion of patients, and the technique has therefore gained
robotic techniques. Cutait et al. described this approach for widespread acceptance in Europe as the treatment of choice
the first time in 1959, and the main steps consist of thorough for rectal prolapse. The indications have expanded from
mobilization and upward fixation of the rectum to correct the treatment of patients with ERP to also include some patients
telescoping of the bowel [22]. The idea of subsequent heal- with advanced IRP. In the USA, ventral rectopexy is gaining
ing and fibrosis of sutured rectum allows the bowel to remain an increased interest as well.
850 A. Studniarek et al.
There is some debate regarding which type of mesh the deep pelvis and easier dissection and mesh placement in
should be used at LVMR. Smart et al. [33] performed a sys- the rectovaginal septum. The ability to angulate the wrist and
tematic review of 13 observational studies, reporting out- perform precise movements in the small pelvic space allows
comes in 866 patients undergoing LVMR. In 767 patients, a for adequate suturing technique and placement of the mesh.
synthetic mesh had been implanted and in 99 a biological
mesh was used. There was no difference in recurrence
(3.7 vs. 4%; P = 0.78) or mesh-related complications 69.7 Technique
(0.7 vs. 0%; P = 1.0). Major mesh-related complications
described at LVMR include erosion into the vagina, bladder Preoperative preparation for RVMR remains the same as for
or rectum, mid-rectal stricture, rectovaginal fistula, and LVMR and open procedures. Patients typically receive an
chronic pelvic pain. In most stuies, the frequency of mesh- enema or a complete bowel preparation before the surgery,
related complications seems to be low, but further long-term and a single dose of appropriate perioperative antibiotics is
follow-up is warranted. given according to the local hospital standards. A urinary
LVMR can be technically challenging and requires catheter is usually placed after induction of anesthesia and
advanced laparoscopic skills to be able to perform the com- may be removed prior to reversal before the end of the case.
plete ventral dissection and intracorporal suturing within a Port placement and patient’s positioning are important
confined space. The introduction of robotic surgery in this aspects of a successful surgery during both laparoscopic and
field and the application of robotic dexterity and angulation robotic cases. Before RVMR, the patient is placed in a modi-
may facilitate sometimes this difficult dissection. fied lithotomy position. The support column with robotic
arms is usually placed between the legs of the patient.
With the da Vinci Si® Robotic System (Intuitive Surgical,
69.6 Robotic Approach to Rectal Prolapse Sunnyvale, CA), the 12-mm port is placed just above the
umbilicus in the midline for the camera robot arm #1. An
Robotic surgery was implemented into the surgical arma- 8-mm port is placed in the right lower quadrant 8 cm below
mentarium in the late 1990s to expand the benefits of laparo- the umbilical port at the lateral edge of the rectus muscle for
scopic surgery [34]. The three-dimensional, enhanced the right robotic arm #2. Another 8-mm port is placed oppo-
visualization, tremor filtering, dexterity, and precision make site in the left lower quadrant for the left robotic arm #3. The
the use of surgical robots particularly suitable for confined #4 arm is placed through an 8-mm port in the anterior axil-
spaces such as pelvis. The new developments of robotic sur- lary line on the left at the level of umbilicus. An additional
gery have minimalized the limitations of conventional lapa- 12-mm port can be placed for assistance (Fig. 69.2). After all
roscopic surgery such as rigid instruments, lack of wrist the arms are securely placed and connected, the patient is
movement and angulation, difficult suturing, and operating placed in a steep Trendelenburg position to allow the abdom-
in the confines of a deep pelvis. inal contents to retract cranially and allow for better visual-
Robotic-assisted surgery is a rapidly developing field. In ization in the pelvis.
2001, Weber et al. performed the first robotic-assisted lapa- With the da Vinci Xi® Robotic System (Intuitive Surgical,
roscopic colectomy for benign disease [35]. Since that pro- Sunnyvale, CA), the port placement is usually different. The
cedure, robotic surgery has been employed in multiple other 12-mm camera port is placed just above the umbilicus in the
procedures including abdominoperineal resection, low ante- midline similarly to the da Vinci Si® System (Intuitive
rior resection, and rectopexy [36]. Surgical, Sunnyvale, CA). All four 8-mm ports are placed in
Robotic surgery is generally considered user-friendly and a suprapubic location with the camera inserted through the
can be adopted by a competent surgeon. Bokhari et al. per- port just lateral to the midline. An additional 12-mm port can
formed a retrospective analysis to look at the learning curve be placed for assistance as well (Fig. 69.3).
in robotic colorectal surgery and found that the learning RVMR is done in a similar fashion as in LVMR. In a step-
phase was achieved after 15–25 robotic cases [36]. This wise fashion, the rectosigmoid is retracted to the left, and
number is significantly lower than the learning curve associ- peritoneal incision is made to the right of the sacral promon-
ated with laparoscopic colorectal procedures [37]. tory and extended along the rectum. Lateral and posterior
Makela-Kaikkonen et al. [38] compared robotic-assisted dissection should be avoided to prevent damage to the auto-
ventral rectopexy (RVMR) and LVMR and found no signifi- nomic nerves, which may cause increased constipation, as
cant difference in operating time, blood loss, length of hospi- well as neurogenic impairment of the urinary bladder and
tal stay, and complication rate (5%) between the two groups. genital organs. Next, the rectovaginal septum (recto-prostatic
Ventral rectopexy is ideally suited for robotic surgery. septum in men) is mobilized to the pelvic floor, approxi-
The previously mentioned advantages of robotic surgery per- mately 2–3 cm above the dentate line [39–43]. The curved
fectly apply to this procedure, with improved visualization in portion of the mesh is sutured to the ventral aspect of the
69 The Role of Robotic Surgery in Rectal Prolapse 851
distal rectum. The upper part of the mesh is fixed to the sacral
promontory by an endofascial stapler or non-absorbable
A suture. The posterior vaginal fornix may be sutured to the
anterior aspect of the mesh, and the peritoneum is closed
over the mesh [44].
C
69.8 Complications
69.9 R
ecurrence Rates and Functional
Outcomes
69.10 Other Aspects and in this process, RVMR seems to be a perfect operation to
introduce robotic technique in colorectal surgery.
The debate around increased operative time and costs with
robotic is an ongoing controversy. For robotic surgery, oper-
ative time is often divided into total operative time and the Take-Home Messages
time spent behind the robotic console. In general, operative • Surgery is the only curative option for patients with
experience and familiarity with the robot decreases the over- severe rectal prolapse. The decision about the type
all operating time. Makela-Kaikkonen et al. reported a mean of surgery should be based on a patient’s functional
operative time of 159 min and total time of 231 min in OR status, anatomical differences, and surgeon’s expe-
for robotic cases. The matched-pair laparoscopic cases had a rience with each method of treatment.
mean operative time of 153 min and total time of 234 min in • LVMR and RVMR are currently attractive and pop-
the OR [38]. Some authors advocate that there is still a lon- ular methods of treatment for patients with rectal
ger operative time during robotic cases when compared with prolapse due to low recurrence rates and complica-
laparoscopic technique, but limited robotic experience often tions. However, since they were introduced to prac-
negatively influences these results. Wong et al. [34] pre- tice in the last decade, more long-term follow-up
sented their results with 40 laparoscopic ventral rectopexies studies are warranted.
vs. 23 robotic ventral rectopexies. The reported robotic oper- • Robotic platform allows for improved three-
ative time was 221 min (setup time was 17 min) compared to dimensional enhanced visualization, tremor filter-
162 min in the laparoscopic cases. Robotic surgery requires ing, and precise dissection within the confined
the team to be familiar with the instruments and the robot spaces of the pelvis, which makes RVMR a great
itself. The operative time can be improved with adequate procedure to implement in the treatment of rectal
training of the team. prolapse. Further studies on the long-term recur-
From economic standpoint, robotic surgery is a costly rence rates and complications associated with the
investment for the institution. On the other hand, length of robotic approach also need to be performed.
hospital stay after ventral rectopexy may offset some of • With the emerging technology and the state-of-the-art
these costs. The typical postoperative course with timely robotic systems, RVMR can be safely and success-
return of bowel function, adequate food intake, and pain tol- fully performed; however, the surgical team’s experi-
erance may allow patients to be safely discharged sooner ence and training are of paramount importance.
than open surgery. The length of stay difference between
laparoscopic and robotic is minimal, with some studies
favoring robotic approach while other studies favor laparo-
scopic approach. References
1. Classic articles in colonic and rectal surgery. Edmond Delorme
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69.11 Conclusions excision of the rectal mucous membranes or recto-colic. Dis Colon
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art robotic equipment, RVMR can be safely and successfully DW. Preoperative anal manometry predicts continence after
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IP. Systematic review of ventral rectopexy for rectal prolapse and ence with robotic rectopexy. Int J Med Robot Comput Assist Surg.
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Mäkelä J. Robot-assisted versus laparoscopic ventral rectopexy for Is robotic-assisted ventral mesh rectopexy superior to laparoscopic
external, internal rectal prolapse and enterocele: a randomised con- ventral mesh rectopexy in the management of obstructed defeca-
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51. De Hoog D, Heemskerk J, Nieman F, van Gemert W, Baeten G, 53. Louis-Sylvestre C, Herry M. Robotic-assisted laparoscopic sacro-
Bouvy N. Recurrence and functional results after open versus con- colpopexy for stage III pelvic organ prolapse. Int Urogynecol J.
ventional laparoscopic versus robot-assisted laparoscopic recto- 2013;24(5):731–3.
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2009;24(10):1201–6.
Sacral Neuromodulation
for Constipation 70
Klaus E. Matzel and Birgit Bittorf
70.4 Indications
Learning Objectives
• Understand the technique and patient selection. Patient selection is based on the outcome of a test stimula-
• Understand the clinical outcome of SNM for tion, during which the reduction of symptoms is measured.
constipation. It is noteworthy that there is no general agreement on a spe-
cific outcome measure; a variety have been used. Also the
selection for test stimulation is not limited to a specific
pathophysiologic or morphologic cause of constipation.
70.1 Introduction Thus, the broad criteria result in heterogeneous patient
collectives.
Since the introduction of sacral neuromodulation in the field
of coloproctology, there has been an interest in its applica-
tion in patients with constipation. This interest was encour- 70.5 Prognostic Factors of Outcome
aged by the clinical observation that patients treated with
SNM for other pelvic organ dysfunctions reported, among As a consequence of the technique’s broad use in constipa-
other changes, a tendency toward less constipation. Since tion, no prognostic factor for clinical success could be iden-
2001, the role of SNM in the treatment of constipation refrac- tified. As noted above, the selection for permanent
tory to conservative treatment has been studied [1]. Overall, therapeutic stimulation relies on the outcome of the test
the existing evidence is low, with three systematic reviews phase. However, the failure rate of test stimulation appears
having been published [1–4]. to be higher and the results are less reliable than in fecal
incontinence.
70.2 Technique and Its Evolution
70.6 Outcome
The technique is the same as that for fecal incontinence (see
Chap. 40).
Since the introduction of SNM for constipation, outcome
reports on symptoms and quality of life have accumulated
[7–23], few with long-term follow-up (see Table 70.1). A
70.3 Mechanism of Action
difference in outcome can be found between early, mainly
retrospective, studies and more recent methodologically
The mechanism of action is also described in the above-cited
improved studies, which report less favorable results. The
chapter. However, regarding the use of SNM in constipation,
latter and the limitation of quality outcome data have
an observed increase in colonic transit and anterograde con-
resulted in some countries declining coverage for this use.
tractile activity and a reduction in retrograde colonic activity
However, despite uncertain and relatively low clinical effi-
were of special interest [5, 6].
cacy, the technique continues to be used because of its lim-
ited invasiveness and reversibility and is considered an
K. E. Matzel (*) · B. Bittorf
alternative to more invasive, irreversible operative inter-
Sektion Koloproktologie, Chirurgische Klinik der Universität ventions. [24].
Erlangen-Nürnberg, Erlangen, Germany
e-mail: Klaus.matzel@uk-erlangen.de
Recently, there has been increased interest in the use of 4. Pilkington SA, Emmett C, Knowles CH, et al. Surgery for consti-
this technique in constipation owing to rectal hyposensitivity pation: systematic review and practice recommendations: results
V: Sacral Nerve Stimulation. Colorectal Dis. 2017;19(Suppl
[7] in children [25–27] and in patients with low anterior 3):92–100.
resection syndrome after rectal resection [28, 29]. For these 5. Dinning PG, Fuentealba SW, Kennedy ML, et al. Sacral nerve
indications, despite limited existing evidence, the lack of stimulation induces pan- colonic propagating pressure waves and
attractive alternatives renders the technique a possible thera- increases defecation frequency in patients with slow-transit consti-
pation. Colorectal Dis. 2007;9:123–32.
peutic option. 6. Patton V, Wiklendt L, Arkwright JW, et al. The effect of sacral nerve
stimulation on distal colonic motility in patients with faecal inconti-
nence. Br J Surg. 2013;100:959–68.
Take-Home Messages 7. Knowles CH, Thin N, Gill K, Bhan C, et al. Prospective random-
ized double-blind study of temporary sacral nerve stimulation in
SNM for treatment of constipation is less effective patients with rectal evacuatory dysfunction and rectal hyposensitiv-
than for treatment of fecal incontinence. Recently, its ity. Ann Surg. 2012;255:643–9.
therapeutic effectiveness has been challenging. Despite 8. Kenefick NJ, Nicholls RJ, Cohen RG, et al. Permanent sacral nerve
uncertain and relatively low clinical efficacy, the tech- stimulation for treatment of idiopathic constipation. Br J Surg.
2002;89:882–8.
nique is continued to be used because of its limited 9. Kenefick NJ, Vaizey CJ, Cohen CR, et al. Double-blind placebo-
invasiveness and reversibility and is considered an controlled crossover study of sacral nerve stimulation for idiopathic
alternative to more invasive, irreversible operative constipation. Br J Surg. 2002;89:1570–1.
interventions. Patient selection for permanent stimula- 10. Holzer B, Rosen HR, Novi G, et al. Sacral nerve stimulation in
patients with severe constipation. Dis Colon Rectum. 2008;51:524–
tion therapy is based on the clinical outcome of test 9; discussion 529–30.
phase. 11. Vitton V, Roman S, Damon H, et al. Sacral nerve stimula-
tion and constipation: still a long way to go. Dis Colon Rectum.
2009;52:752–3.
12. Kamm MA, Dudding TC, Melenhorst J, et al. Sacral nerve stimula-
tion for intractable constipation. Gut. 2010;59:333–40.
References 13. Maeda Y, Lundby L, Buntzen S, et al. Sacral nerve stimulation for
constipation: suboptimal outcome and adverse events. Dis Colon
1. Ganio E, Masin A, Ratto C, et al. Short-term sacral nerve stimula- Rectum. 2010;53:995–9.
tion for functional anorectal and urinary disturbances: results in 40 14. Naldini G, Martellucci J, Moraldi L, et al. Treatment of slow-
patients: evaluation of a new option for anorectal functional disor- transit constipation with sacral nerve modulation. Colorectal Dis.
ders. Dis Colon Rectum. 2001;44:1261–7. 2010;12:1149–52.
2. Mowatt G, Glazener C, Jarrett M. Sacral nerve stimulation for fae- 15. Carriero A, Martellucci J, Talento P, et al. Sacral nerve stimulation
cal incontinence and constipation in adults. Cochrane Database for constipation: do we still miss something? Role of psychological
Syst Rev. 2007;(3):CD004464. evaluation. Int J Colorectal Dis. 2010;25:1005–10.
3. Thaha MA, Abukar AA, Thin NN, et al. Sacral nerve stimulation for 16. Sharma A, Liu B, Waudby P, et al. Sacral neuromodulation for the
faecal incontinence and constipation in adults. Cochrane Database management of severe constipation: development of a constipation
Syst Rev. 2015;(8):CD004464. treatment protocol. Int J Colorectal Dis. 2011;26:1583–7.
70 Sacral Neuromodulation for Constipation 857
17. Govaert B, Maeda Y, Alberga J, et al. Medium-term outcome of 24. Thomas GP, Dudding TC, Rahbour G, et al. Sacral nerve stimula-
sacral nerve modulation for constipation. Dis Colon Rectum. tion for constipation. Br J Surg. 2013;100:174–81.
2012;55:26–31. 25. Lu PL, Koppen IJN, Orsagh-Yentis DK, et al. Sacral nerve
18. Ortiz H, de Miguel M, Rinaldi M, et al. Functional outcome of stimulation for constipation and fecal incontinence in children:
sacral nerve stimulation in patients with severe constipation. Dis long-term outcomes, patient benefit, and parent satisfaction.
Colon Rectum. 2012;55:876–80. Neurogastroenterol Motil. 2018;30(2).
19. Graf W, Sonesson AC, Lindberg B, et al. Results after sacral nerve 26. Janssen PTJ, Meyer YM, Van Kuijk SMJ, et al. Long-term out-
stimulation for chronic constipation. Neurogastroenterol Motil. come of intractable constipation treated by sacral neuromodula-
2015;27:734–9. tion: a comparison between children and adults. Colorectal Dis.
20. Ratto C, Ganio E, Naldini G, et al. Long-term results following 2018;20:134–43.
sacral nerve stimulation for chronic constipation. Colorectal Dis. 27. van der Wilt AA, van Wunnik BP, Sturkenboom R, et al. Sacral
2015;17:320–8. neuromodulation in children and adolescents with chronic consti-
21. Patton V, Stewart P, Lubowski DZ, et al. Sacral nerve stimulation pation refractory to conservative treatment. Int J Colorectal Dis.
fails to offer long-term benefit in patients with slow-transit consti- 2016;31:1459–66.
pation. Dis Colon Rectum. 2016;59:878–85. 28. Ramage L, Qiu S, Kontovounisios C, et al. A systematic review
22. Zerbib F, Siproudhis L, Lehur PA, et al. Randomized clinical trial of sacral nerve stimulation for low anterior resection syndrome.
of sacral nerve stimulation for refractory constipation. Br J Surg. Colorectal Dis. 2015;17:762–71.
2017;104:205–13. 29. D’Hondt M, Nuytens F, Kinget L, et al. Sacral neurostimulation
23. Maeda Y, Kamm MA, Vaizey CJ, et al. Long-term outcome of for low anterior resection syndrome after radical resection for
sacral neuromodulation for chronic refractory constipation. Tech rectal cancer: evaluation of treatment with the LARS score. Tech
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Part VIII
Pelvic Pain and Sexual Dysfunction
Bladder Pain Syndrome/Interstitial
Cystitis 71
Mauro Cervigni
criteria, which were developed to ensure the comparability essential part of the evaluation, by categorizing patients as to
of patients enrolled in clinical studies [14]. These include: whether either procedure was done, and if so, the results, it is
possible to follow patients with similar findings and study
• Hunner’s ulcers, each identified cohort to compare natural history, prognosis,
• any two of: and response to therapy. See Table 71.1.
–– pain on bladder filling, relieved by emptying. Sometimes a significant proportion of BPS/IC patients do
–– suprapubic, pelvic, urethral, vaginal, or perineal pain not complain of pain but relate their feelings to pressure and
for 9 months. discomfort [20]. In this situation, patients not complaining of
–– glomerulations on endoscopy or upon hydrodistension pain would remain undiagnosed for IC if only pain syn-
under spinal or general anesthesia. dromes are applicable to a diagnosis of BPS/IC; therefore, in
May 2009, the Asian Society published clinical guidelines
However, over 60% of patients with possible BPS/IC for IC, proposing a new definition of the syndrome as
appear to fail these criteria expanding the definition [15]. “Hypersensitive Bladder Syndrome” (HBS)—bladder hyper-
The International Continence Society (ICS) in 2002 sensitivity, usually associated with urinary frequency, with
defined the term painful bladder syndrome as “the complaint or without bladder pain [21].
of suprapubic pain related to bladder filling, accompanied by
other symptoms such as frequency and nocturia in the
absence of proven pathologies” [16]. 71.3 Epidemiology
In Kyoto at the ICICJ (International Consultation
Interstitial Cystitis Japan) in March 2003, it was agreed that The prevalence of BPS/IC is enormously variable according
the term “interstitial cystitis” should be expanded to “inter- to various authors and studies. The lack of an accepted defini-
stitial cystitis/chronic pelvic pain syndrome” when pelvic tion, the absence of a validated diagnostic marker, and ques-
pain is at least of 3 months duration and associated with no tions regarding etiology and pathophysiology make much of
obvious treatable condition/pathology [17]. the literature difficult to interpret. Overlapping patterns of
Most recently, the European/International Society for the bladder pain, lower urinary tract symptoms, and pelvic pain
Study of Interstitial Cystitis (ESSIC) named this disease are common and present challenges for clinicians and
Bladder Pain Syndrome [18] according to the definition by the researchers [22]. The other major difficulty in evaluating vari-
International Association for the Study of Pain (IASP) [19] ous prevalence studies is that some are based on unverified
According to ESSIC, BPS/IC is indicated by two symbols, the self-report; others by physician diagnoses or by identification
first of which corresponds to cystoscopy with hydrodistention of BPS symptoms. This confusion becomes apparent when
findings (1, 2, or 3, indicating increasing grade of severity) and one looks at the variation in prevalence reports in the United
the second to biopsy (A, B, and C, indicating increasing grade States and around the world. These range from 3.5 per
of severity of biopsy findings). Although neither cystoscopy 100,000 population in Japan [23] to 18.1/100,000 women in
with hydrodistention nor bladder biopsy was prescribed as an another epidemiologic study [24]. Subsequent studies in 2002
not done XX 1X 2X 3X
normal XA 1A 2A 3A
biopsy
inconclusive XB 1B 2B 3B
positive3 XC 1C 2C 3C
indicated it was 450 per 100,000 (0.45%), and more recently, the prevalence of BPS/IC in first-degree relatives has been
it was 680 per 100,000 (0.68%) for a probable IC and 300 per shown to be 17 times higher than in the general population
100,000 (0.3%) for a definite diagnosis of IC [25, 26]. A [36].
recent study of 981 urban females in Vienna showed an over-
all prevalence of 306 per 100,000 (0.3%), with the highest
number in the 40–59 years age group [27]. BPS/IC has also 71.4 Nonbladder Syndromes (NBS)
been reported in children and adolescents [28–30]. Another
Japanese study showed the prevalence reported from a ques- Over 75% of women with a clinical diagnosis of IC/BPS
tionnaire survey of 300 major hospitals of only 2 per 100,000 report pain outside the pelvis (pelvic pain and beyond) [37].
patients [31]. The patients were older than those in Europe Multiple observations have shown that BPS patients are
and the USA [32]. This may indicate that patients have had more likely than controls to have pain-related syndromes
symptoms for a long time before diagnosis. However, a recent manifesting symptoms beyond the bladder and even the
epidemiological investigation in Japan found that 1.0% of the pelvis. Warren et al. [38] demonstrated that significantly
general population experienced bladder pain every day [33]. more BPS cases than matched controls had 11 antecedent
Estimations of prevalence based on physicians’ diagnoses syndromes: fibromyalgia (FM), chronic fatigue syndrome
may be thought to produce more accurate estimates. Bade (CFS), inflammatory bladder disease (IBS), Sicca syn-
et al. [34] used a physician questionnaire-based survey in the drome (SS), chronic pelvic pain, migraine, allergies,
Netherlands yielding an overall prevalence of 8–16 per asthma, depression, panic disorder, and vulvodynia. Nickel
100,000 females, with diagnosis heavily dependent on pathol- et al. [39] found significantly higher prevalence of self-
ogy and presence of mast cells. The Nurses Health Study I reported FM, CFS, IBS, migraine and tension headaches,
and II showed a prevalence of IC between 52 and 67 per vulvodynia, temporomandibular disorder and low back
100,000 in the United States [35]. pain in female BPS cases than in controls, as well as sig-
In 2000, the European Parliament and the Council of the nificantly more with depression and anxiety in a study in
European Union defined rare diseases (RD) as conditions several urology practices in three continents [40]. The etio-
with a low prevalence threshold (5/10,000 inhabitants in the logical and epidemiological questions that remain unan-
EC and a high degree of complexity, differently from the swered is how are these NBS associated with BPS, do these
rates reported by United States (7.5/10,000) and Japan NBS precede or follow IC/BPS, and do multiple NBS
(4/10,000). increase the risk of BPS. Warren et al. [41] have introduced
In May 2001 in Italy, the Ministry of Health approved a a number of hypotheses; however, the studies to validate
decree to officially establish a very complex national network these have not yet been done. Relatives of BPS patients
with reference centers for various diseases with high degree of appear to have an increased risk of associated conditions
complexity including RD, and a National Registry of Rare including myalgia and fibromyalgia, as well as constipa-
Diseases (NRRD) was established. The latter had the objective tion, suggesting shared underlying genetic factors [42].
of collecting data on epidemiology (number of cases and their One other NBS that is sometime neglected or forgotten in
distribution nationwide) and risk factors. This would help these epidemiological associations is the association of
define the size of the problem, estimate the delay in the time to BPS with sexual dysfunction. Multiple studies have shown
diagnosis, and the healthcare migration pattern by patients. that women with BPS diagnoses or symptoms experience
Data were recorded in 5 centers and the prevalence ranged very high levels of sexual dysfunction [43]. This is likely
from 1,9 to 5,1/10,000. related to deep dyspareunia associated with anterior vagi-
In 2013–2014, NRRD had 1192 patients in a population nal wall pain from a hypersensitive bladder and can also be
of almost 61 million. The Italian prevalence was 1.9 out of related to vulvodynia, a common NBS seen in female IC/
100,000. These results indicate that BPS/IC is not a common BPS patients [44].
occurrence in the Italian population. It is widely agreed that
a disease registry is a valuable source of information both for
epidemiology and for public health. 71.5 Etiology and Pathogenesis
It is apparent that there has been no standardized method
of determining the prevalence of BPS, with wide variation of Several etiologic theories have been proposed in recent
estimates in the same study employing different definitions years, although they remain somewhat speculative and con-
or criteria for identifying the condition. Many factors includ- troversial, and the precise causes of BPS/IC are still unknown.
ing bias, cultural differences, methodology, geographic vari- One aspect has been emphasized: the multifactorial etiology
ations in diagnostic criteria, and/or possibly real differences of the disease. Interaction between nervous, immune, and
in different populations lead to further variations between endocrine factors creates a vicious cycle, provoking and
countries. There is some evidence of genetic predisposition; maintaining the inflammatory effect in the bladder.
864 M. Cervigni
71.5.1 Infection damaged in BPS/IC [37, 38, 56, 57]; this deficiency allows
irritants in the urine to leak through the urothelium and
To date, no infectious etiology has been identified using causes inflammation, irritation, and numerous other reac-
reverse transcriptase polymerase chain reaction (RT–PCR) tions [58].
for Chlamydia trachomatis, adenovirus, cytomegalovirus, Increased urinary levels of CS and SH have been reported
herpes simplex virus, papillomavirus, or Gardnerella vagina- in some BPS/IC patients [59, 60] with concomitant decrease
lis [45, 46]. It is well known that antibiotic treatment is inef- of mucosal glycoprotein GP1 [61].
fective for BPS/IC. Flare-up of symptoms can occasionally Zhang et al. [62] demonstrated significantly increased
be elicited by an infection, as an associated factor that initi- paracellular permeability, decreased expression of the tight
ates or exacerbates IC [47]. junction proteins ZO-1 and occludin, and increased expres-
Recently, Siddiqui et al. using 16S ribosomal DNA data sion of the adhesion protein E-cadherin from patients with
demonstrated alterations of microbiota in urine from women BPS. Shie et al. [63] further showed that in the urothelium of
with interstitial cystitis [48]. Using culture independent the BPS bladder a reduced E-cadherin expression was asso-
method to compare the microbiota of the lower urinary tract ciated with a higher level of apoptosis.
in standard culture negative (for bacteria) female patient with The etiology of the defect in the GAG layer is currently
BPS, Nickel et al. showed that among women with BPS the unknown. Antiproliferative factors (APFs), detected in the
prevalence of fungi (Candida and Saccharomyces sp.) was urine of IC patients, downregulate expression of genes that
significantly greater in those who reported a flare compared stimulate proliferation of bladder epithelial cells and upregu-
to those who did not [49]. Nevertheless, the possibility of a late genes that inhibit proliferation, leading to urothelial
microbial contribution to the etiology of BPS remains an undermaturation and dysfunction [64, 65].
open question.
be involved in central cross-organ sensitization of visceral similar to Category IIIB chronic prostatitis/chronic pelvic
nociception between the colon and urinary bladder. This pro- pain syndrome (CP/CCPS) in male population [75, 76].
vides information that not only supports a neurogenic etiol- An inflammatory or pain disorder of pelvic viscera, a
ogy but also may account for the substantial overlap of BPS trauma, or an abnormal behavior may elicit noxious stimuli
with other chronic pelvic pain disorders, especially the to sacral cord that set up a pelvic floor muscle dysfunction
inflammatory bowel disorders [67]. The brain might also play with sacral nerve hypersensitivity and a sacral cord wind-up
a role in the neurobiological component of BPS/IC. Using [77–81].
contrast-enhanced magnetic r esonance imaging, Kairys et al. The “guarding reflex” is a viscero-muscular reflex acti-
[68] showed an increased brain gray matter in the primary vated with the aim to increase the tone of the pelvic floor
somatosensory cortex associated with increased pain and during routine daytime activity [82].
mood disturbance in patients with BPS. In BPS/IC patients, there is an afferent autonomic bom-
bardment that may enhance and maintain a guarding reflex
that manifests itself as a hypertonus of the pelvic floor. On
71.5.5 Reduced Vascularization the other hand, vulvodynia, dyspareunia, scrotal, and peri-
neal pain are one of the expressions of the exaggerated mus-
A decrease in the microvascular density has been observed in cle tone activity, contributing to the maintenance of the
the suburothelium in patients with BPS/IC [69]. Bladder vas- noxious stimuli. Approximately 15% present with pain as the
cular perfusion is reduced by bladder filling in BPS/IC, while only symptom [83].
it is slightly increased in controls [70].
A recent paper showed that hyperbaric therapy seems to
relieve the symptoms of BPS/IC [71], confirming indirectly 71.5.7 Autoimmunity
that a reduced blood supply may cause a decrease in epithe-
lial function, as well as epithelial thinning and denudation Many of the clinical features of BPS/IC reflect an autoim-
[72]. It is reasonable that the impaired blood circulation in mune component of the disease process. Investigators have
the bladder is related to BPS/IC and the apoptotic activity of also reported concomitant association of BPS/IC and other
microvascular endothelial cells is increased [73]. autoimmune diseases, such as SLE, rheumatoid arthritis, and
Sjögren’s syndrome [84–86]. There are numerous reports on
autoantibodies in patients with BPS [85, 87]. The precise
71.5.6 Pelvic Floor Dysfunction identity of these autoantibodies has yet to be determined.
Some of the common clinical and histopathological charac-
Many patients with bladder painful syndrome/interstitial teristics present in BPS patients show certain similarities
cystitis (BPS/IC) have concomitant pelvic floor dysfunction with other known autoimmune disturbances. Studies on
(PFD), with muscle tenderness and spasm also known as autoantibodies in BPS have shown that these mainly consist
hypertonic pelvic floor dysfunction (HPFD). Previous stud- of antinuclear antibodies, and these findings are in turn simi-
ies found that myofascial pain and HPFD are present in as lar to the autoantibody profiles in some systemic diseases
many as 85% of patients with BPS/IC and/or chronic pelvic [87, 88]. Table 71.2 summarizes the integrated pathophysiol-
pain (CPP) syndrome [74]. Probably, it is the same or very ogy of the syndrome in a schematic way.
Visceral hyperalgesia/allodynia
From [18]
71 Bladder Pain Syndrome/Interstitial Cystitis 867
7b. Does your pain bother you? Never Occasionally Usually Always
8b. Does your urgency bother you? Never Occasionally Usually Always
Interstitial Cystitis Symptoms Index during the past month: How much has each of the following been a problem for you.
How often have you felt the strong need to urinate with little or no warning: Frequent urination during the day?
0. — Not at all 0. — No problem
1. — Less than 1 time in 5 1. — Very small problem
2. — Less than half the time 2. — Small problem
3. — About half the time 3. — Medium problem
4. — More than half the time 4. — Big problem
5. — Almost always
How you had to urinate less than 2 hours after you finished urinating? Getting up at night to urinate?
0. — Not at all 0. — No problem
1. — Less than 1 time in 5 1. — Very small problem
2. — Less than half the time 2. — Small problem
3. — About half the time 3. — Medium problem
4. — More than half the time 4. — Big problem
5. — Almost always
How often did you most typically get up at night to urinate? Need to urinate with little warning?
0. — Not at all 0. — No problem
1. — Once per night 1. — Very small problem
2. — 2 times per night 2. — Small problem
3. — 3 times per night 3. — Medium problem
4. — 4 times per night 4. — Big problem
5. — 5 or more times per night
Have you experienced pain or burning in your bladder? Burning, pain, discomfort, or pressure in your bladder?
0. — Not at all 0. — No problem
1. — A few times 1. — Very small problem
2. — Fairly often 2. — Small problem
3. — Usually 3. — Medium problem
4. — Almost always 4. — Big problem
Add the numerical values of the checked entries:
Total score
868 M. Cervigni
Biopsy with histopathology may be necessary to exclude neo- most commonly dysmenorrhea, cyclic pelvic pain, or
plasm and eosinophilic or tuberculosis cystitis. A count of trypt- deep dyspareunia. In women who undergo a laparoscopy
ase-positive bladder mast cells is recommended by the European to evaluate CPP, the prevalence of endometriosis is
Society, with >28 mast cells/mm constituting detrusor mastocy- 30–90% [122]. There is a high prevalence and association
tosis, which is considered diagnostic for BPS/IC [99, 107, 110]. of IC and endometriosis. A study by Chung et al. of 178
An increased number of mast cells were also recently proposed women with CPP found that 65% of CPP patients suffered
as a diagnostic criterion for vulvodynia syndrome [111]. from both active endometriosis and IC [5]. A recent sys-
There are no specific blood or urine markers available for tematic review estimated the prevalence of BPS/ IC, and
diagnosis. A major factor affecting the controversy over the coexistence of BPS/IC and endometriosis in women
accepted clinical diagnostic criteria is that the current criteria with CPP. Nine studies including 1016 patients with CPP
are predominantly symptom specific. An objective biomarker showed the mean prevalence of BPS was 61%, of endo-
would advance the establishment of reproducible diagnostic metriosis 70%, and coexisting BPS and endometriosis
criteria for BPS and also aid in monitoring effects of treat- 48%. These data suggest the importance of considering
ment. A biomarker for any disease needs to demonstrate high the bladder as the source of pain even where endometrio-
sensitivity and high specificity. An antiproliferative factor sis is confirmed, and in the case of unresolved endome-
(APF), recently identified as a frizzled-8 surface sialoglyco- triosis and persistent pelvic pain, patients must be
peptide [112], was increased in BPS/IC urine as determined evaluated to rule out the presence of BPS/IC [123].
by its ability to decrease in vitro proliferation of bladder epi- (c) Vulvodynia: also known as vulvar vestibulitis or vulvar
thelial cells and could distinguish BPS/IC from other uro- dysesthesia syndrome, it literally means pain, or an
logic disorders [113]. Urine APF levels also apparently unpleasant altered sensation, in the vulva. Pain can be
distinguished BPS/IC from CPPS in men [114]. However, unprovoked, varying from constant to intermittent or
APF still needs to be validated and independently repro- occurring only on provocation, such as in sexual inter-
duced. Classic BPS/IC might be differentiated from nonulcer course. Peters et al. reported that vestibulodynia affects
disease by elevated urine nitric oxide (NO) [115]. GP-51 is a 25% of women with BPS/IC [124]. The etiology of vul-
glycoprotein present in both the transitional epithelium and vodynia is presumed to involve many factors: infections
urine of humans and other mammals. Moskowitz et al. have and altered vaginal acid–base balance and the upregula-
shown that bladder biopsies of BPS patients had decreased tion of pro-inflammatory immune responses.
staining for GP-51 [116]. The same laboratory also demon- Furthermore, a large community-based study found that
strated that although GP-51 demonstrates a high specificity vulvodynia was strongly associated with childhood
for BPS, it is not as sensitive as APF [117]. physical or sexual abuse [125].
(d) Pudendal Neuropathy: is a common feature of syndromes
such as dysfunctional voiding, nonobstructive urinary
71.6.1 Gynecological Associated/Confusable retention, chronic pelvic pain syndromes, and urinary
Disease and fecal incontinence. It could be ruled out as a confus-
able disease in BPS/IC patients. Pudendal neuralgia is a
In female population affected by BPS/IC, the gynecological functional entrapment of the pudendal nerve, and pain
pathologies may be present in about 20% of patients, and occurs during compression or stretch maneuvers, such as
there is also an overlapping of musculoskeletal pathologies repetitive microtrauma, fracture, straining with constipa-
in 12% of cases [118]. tion and childbirth, falls onto the buttocks, and suture
entrapment during pelvic surgery. The main symptom is
The associated pathologies are: pain aggravated by sitting/driving/exercise, reduced by
(a) Pelvic Floor Dysfunction: it affects the anterior, apical, recumbence or standing, and relieved by sitting on a toi-
or posterior vaginal compartment with muscle tender- let. The quality of neuropathic pain varies and can be
ness, spasms, and voiding dysfunction, both manifesta- induced by voiding, defecating, vaginal penetration, or
tions of pelvic floor hypertonicity [74]. It has been orgasm. It can occur in the perineum and urethra and
estimated that the prevalence of HPFD in patients with extends to suprapubic, inguinal regions and to the upper
BPS/IC ranges from 50 to 87% [119]. Pelvic floor dys- medial thighs. Urinary symptoms and rectal dysfunction
function exacerbates BPS/IC symptoms and has been might occur. Sexual dysfunction could be present [126].
reported to appear in response to events such as bladder In women affected by BPS/IC is mandatory to observe
inflammation, gait disturbance, and trauma [120]. not only the bladder but also the other components
(b) Endometriosis is the presence of endometrial glands or responsible for the pain disorder. Patients with bladder
stroma outside of the endometrial cavity and affects 1–7% tenderness alone responded better than patients with mul-
of the general population [121]. Up to 70% of women tiple tender trigger points, possibly because in these
with endometriosis have some type of pain symptoms, patients, the bladder is the only target organ and the
870 M. Cervigni
patients are less severely affected than patients with mul- Therefore, the therapeutic strategy is to reduce or elimi-
tiple trigger points. Multimodal therapy remains the gold nate the symptoms of BPS/IC, thereby interfering with the
standard in the management of female BPS/IC patients. potential disease mechanism and improving quality of life.
Because IC is a chronic disease, patients should be coun-
seled regarding realistic expectation of treatment. Remission
71.7 Treatment may be attained but should not be expected, and even when it is
attainable, months of medical treatment may be required [131].
There is no curative therapy for BPS/IC [127–130]. This is Exacerbations during periods of remission are common,
consistent with the fact that the causes of BPS/IC are yet not and patients need to be encouraged that therapy is not failing.
understood, and the pathophysiology remains uncertain. See Algorithm in Table 71.5.
Urinary
History infection
Frequency/volume chart
“Complicated BPS”
Focused physical examination
BASIC Incontinence
Urinalysis, culture
ASSESSMENT Urinary infection
Hematuria
“Uncomplicated BPS” Gynecologic signs/symptoms
Conservative therapy
Stress reduction normal
Patient education Consider:
Dietary manipulation Urine cytology
Nonprescription analgesics Further imaging
1’ST LINE RX Endoscopy
Pelvic floor relaxation
Pelvic floor physical therapy Urodynamics
Consult if associated disease abnormal Laparoscopy
Treat as indicated
considered far superior to sodium pentosan polysulfate in Table 71.6 Oral medications for treatment of bladder painful syn-
all clinical outcome parameters measured at 6 months. drome/interstitial cystitis (BPS/IC)
Patients who responded to cyclosporine A had a signifi- Drug RCT GoE: LR
cant reduction of urinary levels of epidermal growth fac- Amitriptyline; tricyclic antidepressant Yes B: 2
tor (EGF), [145] Forrest et al. [146] retrospectively Cimetidine Yes C: 3
Hydrocortisone No Ineffective
summarized results from cyclosporine off-label use in 44
Cyclosporine No C: 3
BPS patients. In 34 patients presenting with Hunners Hydroxyzine Yes D: 1
lesion upon cystoscopy, the success rate was higher com- l-Arginine Yes A: 1
pared to those patients without lesions (68% vs. 30%). PPS Yes D: 1
However, side effects were common and demand a close Quercetin No D: 4
monitoring of patients including blood pressure and renal Sodium pentosane polysulfate Yes D: 1
failure. Suplatast tosilate No D: 3
• Suplatast Tosilate: Suplatast Tosilate (IPD-1151 T) is an GoE grade of evidence, LR level of recommendation, RCT randomized
controlled trials (Adapted from Hanno P, et al.—ICI 2013)
immune-regulator that selectively suppresses IgE pro-
duction and eosinophilia via suppression of helper T
cells that produce IL-4 and 5. Ueda et al. reported a small were mild to moderate and transient. The mode of action
study in 14 women with interstitial cystitis [147]. of sildenafil in BPS remains unclear. Further, larger stud-
Treatment for 1 year resulted in a significantly increased ies are necessary to confirm the results of this innovative
bladder capacity and decreased urinary urgency, fre- study. More detailed results of the use of oral drugs in
quency, and lower abdominal pain in 10 women. Larger, BPS/IC patients are reported in Table 71.6.
multicenter international RCTs have been completed,
and results did not justify further development for this
indication. 71.7.3 Intravesical Instillation
• Corticosteroids: reports on outcome with corticosteroid
therapy have been both promising and discouraging Intravesical and subcutaneous heparin has been used for
[148]. The side effects of steroids can be very serious, the treatment of IC since early 1960. It is either instilled
making it difficult to justify their use [149, 150]. or administered subcutaneously. When instilled, heparin
does not have systemic anticoagulant effects. In one study,
Other Oral Medications 48 patients with IC are self-administered intravesical hep-
• l-Arginine is a natural substrate of nitric oxide synthase arin (10,000 IU in 10 mL sterile water three times weekly
(NOS) (grade of recommendation D). It may re-activate for 3 months). Fifty-six percent of the patients attained
NOS activity, which is suppressed in IC, and relieve clinical remission after 3 months. Subcutaneous heparin
symptoms [151]. No significant effect was observed in has been demonstrated to produce rapid relief of symp-
double-blind studies [152, 153]. toms in eight patients who reported long-term benefit over
• Quercetin is a bioflavenoid that has an anti-inflammatory 1 year [156].
effect and is found in fruits, vegetables, and some spices.
In a small study of 22 BPS patients followed for 4 weeks, • Intravesical dimethylsulfoxide (DMSO) remains the basis
all but one patient had some improvement in the O’Leary– of intravesical therapy for IC (grade of recommendation
Sant symptom and problem scores, as well as in a global B, level of evidence 2). It has been shown to reduce symp-
assessment score. Further studies are necessary to deter- toms for up to 3 months. Its multiple effects include an
mine efficacy [154]. anti-inflammatory and analgesic effect, muscle relax-
• Sildenafil: the contraction of smooth muscle caused by ation, mast cell inhibition, and collagen dissolution [157].
elevating potassium or adrenergic activity can be relaxed Patients treated with DMSO have experienced a 50–70%
by phosphodiesterase type 5 inhibitors (a class of drugs reduction of symptoms, although the relapse rate is
approved to treat erectile dysfunction). Forty-eight 35–40%. Administration in combination with various
women with a clinical diagnosis of BPS were randomly other agents including hydrocortisone, heparin, and
assigned to treatment or placebo for 3 months [155]. The sodium bicarbonate has been recommended to improve
O’Leary–Sant IC symptom and problem indices, VAS, the response to DMSO.
and a micturition diary were recorded before treatment, • Intravesical hyaluronic acid (grade of recommendation
and after the treatment until 3 months. The IC symptom C, level of evidence 1) has been used with a long-lasting
and problem indices scores and urodynamic index were moderate efficacy with no side effects, but an RCT per-
significantly improved in sildenafil treatment group com- formed by Bioniche Company reported no significant
pared with placebo group and baselines (p < 0.05). The efficacy of their preparation (40 mg or 200 mg per cc,
efficiency of treatment reached 62.5%. The adverse events respectively) and neither showed significant efficacy of
71 Bladder Pain Syndrome/Interstitial Cystitis 873
sodium hyaluronate compared to placebo in large phase 3 Table 71.7 Intravesical medications for treatment of bladder pain-
trials. These negative studies have not been published in ful syndrome/interstitial cystitis
peer-reviewed literature (http://www.medicalnewstoday. Intravesical therapy RCT GoE/LR
com/articles/112053.php). Neither preparation has been DMSO Yes B: 2
approved for use for BPS in the United States. BTX (intramural) Yes A: 1
BCG Yes −A: 1 ineffective
• Chondroitin Sulfate (grade of recommendation C, level of
Hyaluronic acid Yes D: 1
evidence 1): Steinhoff et al. treated 18 patients with
Chondroitin Sulfate No D: 4
40 mL intravesical chondroitin: 46.2% showed a good Hyaluronic + chondroitin Yes C: 2
response, 38.5% had a partial or no response [158]. In PPS Yes D: 4
2013, a larger and long-term study was made on 213 GoE grade of evidence, LR level of recommendation, RCT randomized
patients. At the end of the treatment, GRA rates were controlled trials (Adapted from Hanno P, et al.—ICI 2013)
43.2% in the chondroitin group and 27.4% in the control
group, and the chance of becoming a responder with NIDDK research criteria, showed that there was no statis-
chondroitin sulfate was 55% significantly higher than tical difference at 34 weeks [166].
with placebo. The small decrease in total score and urine
frequency between the two groups was less impressive
and not statistically significant. 71.7.4 Pain Modulators
• Combined Instillation of Hyaluronic Acid and Chondroitin
Sulfate (grade of recommendation: C, level of evidence: 2). The long-term, appropriate use of pain medications is one of
Recently, Cervigni et al. [159] published a randomized, the main step in the treatment of BPS/IC. Many nonopioid
open-label, multicenter study involving 110 women ran- analgesics and the nonsteroidal anti-inflammatory drugs
domized to receive 13 weekly instillations of HA (1.6%— (NSAIDs) and even antispasmodic agents have a place in pain
800 mg) and CS (2.0%—1 g) (Ialuril®; IBSA) or 50% therapy.
DMSO solution (RIMSO®; Bioniche), with a 2:1 alloca-
tion ratio. This study showed that treatment with HA/CS 71.7.4.1 Analgesics
appears to be as effective as DMSO with a potentially
more favorable safety profile. Both treatments increased (Grade of Recommendation: C—Level of Evidence: 4)
health-related quality of life, while HA/CS showed a • Gabapentin, introduced as an anticonvulsant, has found
more acceptable cost-effectiveness profile. efficacy in neuropathic pain disorders, and it demon-
• Botulinum toxin (grade of recommendation A, level of evi- strates synergism with morphine in neuropathic pain
dence 1) inhibits the release of calcitonin gene-related pep- [167]. Sasaki et al. reported that 10 of 21 male and female
tide and substance P from afferent nerves, and weakens patients with refractory genitourinary pain had subjective
pain [160, 161]. Several studies of intravesical Botox into improvement of their pain following treatment with gaba-
the bladder wall indicated symptom relief in IC patients, pentin [168].
without significant adverse events. In a pilot study, repeated • Pregabalin has similar structure as gabapentin and might
injections for a total of 13 patients were followed up for be worthwhile to try for bladder pain syndrome, particu-
2 years, 10 patients reported a subjective improvement. larly for those with concurrent fibromyalgia, though stud-
Mean VAS scores and mean daytime and nighttime urinary ies are lacking [169]. Opioids are seldom the first choice
frequency decreased significantly. At 1 and 2 years follow- of analgesics in chronic pain states, if less powerful anal-
up, the beneficial effects persisted in all patients [162]. gesics have failed [170]. Chronic opioid therapy can be
These results are in contrast with those in another study considered a last resort in selected patients who have dis-
from Kuo et al. [163] of Botox-A in 10 patients with abling pain and often receive inadequate doses of short-
BPS. None of the patients became symptom- free; two acting pain medications. The major impediment to the
showed only limited improvement in bladder capacity and proper use of opioids when they are prescribed for long-
pain score. Trigonal-only injection seems effective and term nonmalignant pain is the fear of addiction. In addi-
long lasting since 87% of patients reported improvement tion to narcotics, concurrent usage of nonsteroidal
after a 3-month follow-up period in a study by Pinto et al. anti-inflammatory drugs, cyclooxygenase inhibitors, acet-
[164]. Further studies will be needed to obtain conclusive aminophen, and tricyclic antidepressants may provide
evidence for its efficacy, duration of effect, and side effect. better pain control [171]. The common side effects of opi-
Table 71.7 shows the results of drugs administered intra- oids include sedation, nausea, and mild confusion.
vesically for the treatment of BPS/IC. Constipation is common, and a mild laxative is generally
• Intravesical Bacillus Calmette–Guérin (BCG) (not rec- necessary.
ommended) was initially reported to have some benefit in • Tricyclic Antidepressants (TCAs)
BPS/IC [165]; however, a subsequent, randomized Amitriptyline is known to have pain-reducing effects
placebo-controlled trial of BPS/IC patients, who met the (grade of recommendation B, level of evidence 2). One
874 M. Cervigni
recent RCT of amitriptyline evaluated 50 patients with Laser resection, augmentation cystoplasty, cystolysis,
IC. Improvement in overall symptom scores was signifi- cystectomy, and urinary diversion may be the ultimate option
cantly greater in the treatment group, as well reduction in for refractory BPS/IC patients [131]. Continent diversion
pain and urgency (P < 0.001). van Ophoven et al. per- may have better cosmetic and lifestyle outcome, but recur-
formed the first prospective, double-blind, placebo- rence is a real possibility.
controlled study of amitriptyline. Fifty patients were Posterior tibial nerve stimulation somewhat improved
randomized to placebo. About 42% of patients had greater less than half of patients [166].
than 30% decrease in O’Leary/Sant symptom and prob- Sacral nerve neuromodulation as a treatment for BPS/IC
lem scores at 4 months compared to 13% of patients in the in initial studies seems to relieve the symptoms of IC. Further
placebo group [290]. They subsequently reported a long- studies are needed [177].
term follow-up of amitriptyline for patients who can tol-
erate the side effects and continued the medication. With
a mean follow-up of 19 months, 64% of 94 patients had 71.8 Conclusions
response [172]. Foster and Hanno [173] reported a second
multicenter, RCT, double-blind, placebo-controlled study Bladder pain syndrome/interstitial cystitis is a chronic, multi-
of amitriptyline in subjects with BPS/IC. Only of the sub- factorial disorder with symptoms of urinary frequency,
group of 207 subjects who achieved a drug dose of at least urgency, and pelvic pain, often associated with other painful
50 mg, a significantly higher response rate was observed diseases, which profoundly affects patients’ quality of life
in the amitriptyline group (66%) compared to placebo due to its disabling aspects. Pelvic pain in BPS/IC is a vis-
(47%) (p = 0.01). ceral pain syndrome with multiple pain generators, which can
Doxepin, Desipramine, and Duloxetine are other tricy- make the diagnosis difficult. The knowledge of a pathology
clic antidepressants that have been used for bladder pain so difficult to understand and to treat is fundamental. Patients
syndrome are doxepin and desipramine. Wammack et al. with a history of recurrent UTIs that are culture negative,
used the combination of doxepin and piroxicam, a cox-2 those with endometriosis and significant bladder symptoms,
inhibitor. Twenty-six of 32 patients (81%) experienced those with overactive bladder syndrome who have responded
remission of symptoms [174]. One study reported satis- poorly to therapy, or those with vulvodynia or chronic pelvic
factory outcome with desipramine [175]. Duloxetine, a pain are all likely to have untreated BPS/IC.
serotonin-norepinephrine reuptake inhibitor, has also An underlying principle is that, where possible, decisions
been tried but without therapeutic effects [176]. on the treatment of bladder pain syndrome should be evi-
dence based. Unfortunately, high-level evidence of efficacy
is lacking for many common treatments, either because such
71.7.5 Multimodal Medical Therapy studies have not been done or were done and failed to dem-
onstrate efficacy. Another principle is that we should be
To manage the multiple pathological features of IC, a multi- guided by patient perceived and driven outcomes for BPS/IC
modal approach, combining agents from different classes, is after exclusion of confusable diseases. Many patients prefer
suggested to improve the therapeutic response by attacking noninvasive therapies (diet, behavioral modification, stress
the disease at several points. One common multimodal reduction, physical therapy) associated with oral therapy.
approach is The use of surgical therapies should be approached with
some caution in a very selected group of refractory patients.
1 . to restore epithelial function with heparinoid,
2. to treat neural activation and pain with TCA,
3. to control allergies with an antihistamine. Take-Home Messages
• Pelvic pain in BPS/IC is a visceral pain syndrome
In advanced form, intravesical treatment may be required. with multiple pain generators, which can make the
Combination intravesical therapy is also indicated for diagnosis difficult.
patients who experience significant flare of symptoms after • Patients with a history of recurrent UTIs that are
remission. culture negative, those with endometriosis and sig-
nificant bladder symptoms, those with overactive
bladder syndrome, who have responded poorly to
71.7.5.1 Procedural Intervention therapy, or those with vulvodynia or chronic pelvic
BPS/IC is a chronic and debilitating disease with an impair- pain are all likely to have untreated BPS/IC.
ment of quality of life due to disabling symptoms. Surgical • The earlier the diagnosis is made and therapy
options should be considered only when all conservative begun, the sooner patients with BPS/IC will experi-
treatment has failed. ence improvement of their symptoms.
71 Bladder Pain Syndrome/Interstitial Cystitis 875
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Pelvic Pain Associated
with a Gynecologic Etiology 72
Megan B. Shannon and Elizabeth R. Mueller
No PAIN Yes
ACUTE CHRONIC
Duration ≥ 6 months
Adenomyosis
Leiomyomas
Tubal Pregnancy
Fig. 72.1 Evaluation of pelvic pain of gynecologic etiology and common causes of pain by site
location of the muscle, its tendons, and site of insertion. It is portion of the pelvis can cause pain to radiate into the back;
just as important that the patient identifies the site of tender- for instance, a posterior uterine fibroid can present with a
ness on the vulva or perineum as with the abdominal exam. dull backache. Pain which radiates into the lower extremities
A diffuse pattern of CPP on the perineum suggests either a may be originating from a musculoskeletal or neurologic dis-
chronic irritant such as dermatoses or a neuropathic cause. ease process.
Chronic recurrent painful ulcerative lesions can be found Description of exacerbating events is an important
with Behçet’s syndrome, herpes, or from the “itch-scratch” piece of the clinical puzzle. Movement can elicit pain for
syndrome of a nonspecific irritation. many patients. A common exacerbating event for pelvic
The patient’s description of the location of radiation of pain is intercourse, a complaint known as “dyspareunia”.
her pain can also be helpful. Pelvic structures in the posterior The pain can occur during sex or afterward. Introital
72 Pelvic Pain Associated with a Gynecologic Etiology 881
pain with initial penetration is suggestive of a vulvar, fascial pelvic pain (MFPP). When an examiner can
vaginal, or muscular source. Pain with deep penetration reproduce the pain with a digital vaginal exam, this
suggests a condition that is aggravated with contact, information aids in diagnosis and subsequent clinical
such as cervicitis, endometriosis, adenomyosis, or myo- decision-making.
882 M. B. Shannon and E. R. Mueller
Alleviating factors are an important component of the his- anterior abdominal wall, and is initiated by asking the patient
tory and may be helpful in creating a differential diagnosis. to engage her abdominal wall muscles by lifting her head or
The use of analgesics, narcotics, rest, and heat can be non- legs off the exam table, then palpating the abdomen. Pain
specific therapies which help with many types of pain. It is with this maneuver would be documented as a “positive
imperative to document any pain medications the patient has Carnett sign” and suggests an abdominal wall etiology and
used in the past, as well as current medications with dosing less likely a visceral cause of the pain [5]. Trigger points in
schedule and strength. the rectus muscles, abdominal wall endometriomas, or
The patient’s qualitative description of the pain can also entrapped nerves near incisions may be identified with such
be helpful. It is thought that the neurophysiological mecha- palpation. The Valsalva maneuver will also elicit a bulge if
nism of pain caused by injury to an anatomic structure can there is a hernia or diastasis recti present. Deep palpation
determine the type of pain experienced by the patient. For should begin at the point furthest away from the site of pain.
instance, pain originating from somatic structures such as The examiner should look for an abdominal or pelvic mass,
musculoskeletal injury is described as dull or aching due to evidence for distention caused by constipated stool in the
transmission along sensory fibers. Visceral organs transmit colon, ascites, and a full bladder as he or she is isolating the
pain sensation via sympathetic fibers of the autonomic ner- location of the tenderness.
vous system, which is perceived as diffuse and crampy. The postvoid residual urine volume should be measured
Patients many times use the descriptive term “burning” or to rule out urinary retention which can be a cause of diffuse
“tingling” to describe pain caused by a neuropathy [1]. suprapubic pain. This can be done by straight catheterization
History taking should include a question addressing or bladder ultrasound within a few minutes after voiding. If
physical or sexual abuse, as pelvic pain can be a complex the patient complains of dysuria, urinary incontinence, or
syndrome affected by psychological and behavioral factors. urinary urgency–frequency, a urine specimen should be
There is a high incidence of pelvic pain among those who obtained for urinalysis and reflex culture.
have been victimized by such abuse [2–4]. Questions about Inspection of the female genitourinary structures is per-
bladder and bowel habits (e.g., dysuria, urinary urgency, formed in the dorsal lithotomy position with the physician
constipation, diarrhea, bloating) as well as prior musculo- seated. The external genitalia, specifically the vulva and the
skeletal diagnoses (e.g., orthopedic surgeries of the pelvis perineum, should be inspected for any lesions or skin break-
or back, arthritis, prior accidents) can aid in proper down. If the pain is localized, the patient may be asked to
diagnosis. point out the site of symptoms. Any suspicious skin lesion
should be biopsied or referred for consultation to rule out
malignancy. A Q-tip test is used to faintly stroke the vulva
72.2.2 Physical Exam and hymenal opening in order to note any dysesthesia found
with vulvodynia. Visual examination of the urethra may
The clinician should initiate the physical exam of a CPP demonstrate a small rim of urethral mucosa posteriorly,
patient after establishing rapport during the interview p rocess. which is called a urethral caruncle. If the mucosa appears
The exam may elicit significant pain for the patient, so effec- circumferentially around the urethra, it is referred to as ure-
tive communication and trust need to be developed. It is also thral prolapse. Both of these findings are benign, do not
important to note that patients will respond to a painful exami- cause pain, and rarely require treatment. However, patients
nation with guarding, which may render the remainder of the may attribute their symptoms to this finding, especially if
exam difficult to interpret. We prefer a systematic, gentle they have been performing self-examination.
approach with maneuvers that are likely to cause pain per- The neurologic exam should include assessment of sensa-
formed last. Physical examination of the patient is critical to tion of the genitalia and inner thighs. The bulbocavernosus
directing further evaluation and formulating a treatment plan, reflex is elicited by stroking the clitoris or looking for con-
and thus is a crucial part of the patient evaluation. traction of the bulbocavernosus muscles and anal sphincter
The exam typically starts with the patient seated on the (known as the anal wink) [6]. While the presence of this
exam table. The back is carefully inspected for sacral defects, reflex assures that the reflex arc is intact, it may be absent in
tenderness over the spine or sacroiliac joint, and normal spi- patients who are neurologically intact.
nal alignment. An exam of the lower extremities can then be A double-bladed speculum exam is indicated for women
performed and is indicated in patients who present with a who present for evaluation of pelvic pain. Visualization of
potential neurologic cause to their symptoms. the vaginal walls will allow you to see erosion or extrusion
The abdominal exam is performed with the patient in a of synthetic materials used during prolapse or incontinence
supine position. The examination of the abdomen begins procedures. The vagina and cervix can be visualized in
with visual inspection: note abdominal scars and any super- order to take samples for microscopy, cultures, or
ficial masses or skin retraction. The next step isolates the cytology.
72 Pelvic Pain Associated with a Gynecologic Etiology 883
After removal of the speculum, place two fingers beneath tonic muscles that seem to be in a constant state of contrac-
the cervix and elevate the vaginal apex. By gently placing the tion and cannot relax. Such women require treatment with
other hand suprapubically, one can elicit uterine tenderness internal myofascial manipulation with a trained pelvic floor
and evaluate uterine size. By sweeping these digits anterolat- physical therapist.
erally, one can evaluate for tenderness or mass in the adnexal
region, again using the abdominal hand gently to guide these
structures for palpation. In women with obesity, guarding, or 72.3 E
tiologies and Treatments of Pelvic
postmenopausal status, it may not be feasible to palpate ova- Pain by Site
ries; the transvaginal ultrasound will allow effective and
diagnostic visualization and many clinicians make this part 72.3.1 Perineum and Vulva
of their protocol for women presenting with CPP. A simple
palpation and movement of the cervix can evaluate for pelvic When the targeted evaluation of a patient suggests a vulvar
inflammatory disease (PID); nodularity and tenderness in the issue, care should be taken to obtain a good vulvar hygiene
cul-de-sac can raise suspicion for endometriosis. Palpation history. For example, many women wear pads that can irritate
of a circumferential mass in the anterior vaginal wall may the skin, especially if constantly damp from urinary inconti-
indicate a vaginal wall cyst, urethral diverticulum, periure- nence. Similarly, women have often tried many over the coun-
thral leiomyoma, or urethral carcinoma [7]. ter creams before presenting for care, which can exacerbate
Following the speculum and bimanual exams, the physi- symptoms. Many vulvar conditions are poorly understood by
cian should perform a systematic examination of the pelvic clinicians, given their complexity. This section is not compre-
floor with a single digit inserted into the vagina. apply digital hensive, but is of high yield for physicians treating PP. More
pressure on the pelvic floor muscles through her vagina to information can be obtained from the International Society for
check for tenderness. Demonstrate the amount of pressure the Study of Vulvovaginal Disease’s (ISVVD) website.
you will use by firmly pushing her thigh muscles. Ask her to Infectious causes of vulvitis that will be discussed here
rate her tenderness on a scale of 0–10, where 0 is no pain and are candidiasis and herpes. Vulvar candidiasis is an infec-
10 is the worst pain imaginable. Use a single digit to firmly tion by the Candida organisms. Symptoms typically consist
palpate the muscles of the posterior, lateral, and anterior pel- of pruritus, burning, irritation, and dyspareunia may be
vic walls, looking for trigger points or myofascial tender- accompanied by vaginal discharge. Microscopy in the
ness. Next, with 1–2 digits in the vault, ask the patient to absence of a vaginal discharge is less reliable, but a culture
contract her pelvic floor muscles (commonly referred to as a can be taken if the diagnosis is unsure or in a patient with
Kegel). Normally functioning muscles will move ventrally complicated candidiasis who has been refractory to prior
and cranially with this contraction [8]. Next, ask her to relax treatment protocols [9]. Topical or oral agents can be pre-
the muscles. Well- functioning muscles can contract and scribed (Table 72.1). Vulvovaginal candidiasis is more com-
relax, whereas oftentimes patients with MFPP have hyper- monly diagnosed in women with immunocompromising
conditions, such as diabetes, HIV, or chronic corticosteroid management of vulvodynia are best done in a multidisci-
use; it may also be seen after recent antibiotic use that dis- plinary clinic with physical therapists, gynecologists who
rupts the vaginal microbiome. Herpes simplex virus (HSV) specialize in pain, and psychologists. These women
is a sexually transmitted infection that presents with oftentimes suffer from other pain disorders such as fibro-
extremely painful vesicles and ulcerations on the vulva. myalgia. Treatments may include topical lidocaine jelly,
HSV-1 and HSV-2 subtypes are both capable of causing pelvic floor physical therapy, psychosocial therapy, and
genital herpes. The first infection may be accompanied by medications such as amitriptyline, gabapentin, or prega-
fever, myalgias, and enlarged inguinal lymph nodes. balin [13, 14].
Recurrent outbreaks of HSV are usually less severe and are Pudendal neuralgia is a vulvar pain disorder character-
characterized by similar lesions. Oral treatment can be pre- ized by neuropathic pain in the pudendal nerve distribu-
scribed with suppression offered to those with recurrent out- tion. Nantes criteria states the diagnosis must include pain
breaks or nonconcordant partners [10]. Topical lidocaine along the anatomic distribution of the pudendal nerve, pain
jelly is an analgesic option for patients to use locally during aggravated by sitting, pain that does not awaken the patient
a painful outbreak. at night, lack of objective sensory loss on clinical exam,
Contact dermatitis of the vulva can occur after exposure and pain that is improved by an anesthetic pudendal nerve
to external irritants or allergens, resulting in inflammation of block [15]. Proposed etiologies include mechanical (child-
the vulvar skin. Symptoms of pruritus, irritation, burning, or birth, surgery, and trauma), infectious, or immunologic.
discharge may be present. Skin will appear raw, erythema- Treatments include pelvic floor physical therapy, muscles
tous, or even lichenified in more chronic disease [9]. relaxants, neuropathic pain medications, and nerve blocks
Treatment includes topical corticosteroids, removal of the [16].
offending agent, and counseling about irritants and vulvar Hidradenitis suppurtiva, syphilis, vulvar squamous cell
hygiene. carcinoma, Bechet’s disease, and Paget’s disease are less
The inflammatory dermatoses—lichen sclerosus and common causes of vulvar pain that will not be elaborated
lichen planus—will be discussed here. Vulvar lichen sclero- upon in this chapter.
sus typically affects the labia menora with loss of a rchitecture
and white papules or plaques that create a thin cigarette
paper appearance, oftentimes in an hourglass pattern (around
the vaginal opening and anus). The clitoral hood and labia A. Vulvar pain caused by a specific disorder*
menora may even fuse. Symptoms are pruritus, irritation, Infectious (eg, recurrent candidiasis, herpes)
Inflammatory (eg, lichen sclerosus, lichen planus,
pain, and sexual and voiding dysfunction [9, 11]. In contrast immunobullous disorders)
to lichen planus, lichen sclerosus only affects the vulvar skin. Neoplastic (eg, Paget disease, squamous cell
It is treated with long-term low-dose topical steroids. carcinoma)
Diagnosis can be confirmed with a punch biopsy, and should Neurologic (eg, postherpetic neuralgia, nerve
be performed if the diagnosis is uncertain or a patient is not compression or injury, neuroma)
Trauma (eg, female genital cutting, obstetrical)
responding to initial treatment. Lichen planus has similar
Iatrogenic (eg, postoperative, chemotherapy, radiation)
symptoms and physical exam findings, except that it can also Hormonal deficiencies (eg, genitourinary syndrome
include red friable appearing lesions affecting the vulva and of menopause [vulvovaginal atrophy], lactational
vagina, sometimes resulting in complete obliteration of the amenorrhea)
vaginal canal. Oral lesions may be present too. Topical and B. Vulvodynia—vulvar pain of at least 3 months’ duration,
intravaginal steroids are the mainstay of treatment for lichen without clear identifiable cause, which may have
potential associated factors.
planus [9]. The following are the descriptors:
Vulvodynia is defined as vulvar pain present for at Localized (eg, vestibulodynia, clitorodynia) or
least 3 months without a clear identifiable cause, which generalized or mixed (localized and generalized)
may have potential associated factors [12]. See Fig. 72.3. Provoked (eg, insertional, contact) or spontaneous or
This syndrome has been described in women of all ages mixed (provoked and spontaneous)
Onset (primary or secondary)
and is not well understood. A wide range of heteroge-
Temporal pattern (intermittent, persistent, constant,
neous pain descriptions may be present in women with immediate, delayed)
this disorder. Proposed etiologies include combinations
* Women may have both a specific disorder (eg, lichen sclerosus)
of MFPP, neuropathic pain, psychological factors, and
and vulvodynia.
genetic predisposition. The Q-tip test is commonly used
in diagnosis of this disorder, with pain to light touch of Fig. 72.3 2015 Consensus terminology and classification of persistent
the vulva being reported by the patient. Diagnosis and vulvar pain and vulvodynia
72 Pelvic Pain Associated with a Gynecologic Etiology 885
72.3.2 Vagina nal pain; the abscess may even spontaneously rupture with
copious, odorous, and purulent fluid. Culture of this abscess
A common cause of vaginal discomfort is vaginitis, which is often polymicrobial. Treatment with a Word catheter or
the American College of Obstetricians and Gynecologists incision and drainage can be performed in this setting [20,
(ACOG) refer to as a spectrum of conditions that cause vul- 21]. Oral antibiotics should be considered if surrounding cel-
vovaginal symptoms of itching, burning, irritation, and lulitis is present.
abnormal discharge. It can affect any age group. The most A Skene’s (“peri-urethral”) gland cyst or abscess,
common causes are bacterial vaginosis (22–50% of symp- Gartner’s duct cyst, or urethral diverticulum are other less
tomatic women), vulvovaginal candidiasis (17–39%), and common cystic findings in the vagina that should be consid-
trichomoniasis (4–35%) [17]. See Table 72.1 for treatment ered as a source of pain.
considerations for each condition.
Bacterial vaginosis is a polymicrobial infection that can
occur when there is a lack of peroxide-producing lactoba- 72.3.3 Cervix
cilli, thus leading to overgrowth of facultative anaerobic
organisms. Patients often complain of a “fishy” smelling Cervicitis can be an acute or chronic condition; it is often-
vaginal discharge. On exam, a thin homogenous gray dis- times asymptomatic and caused by the sexually transmitted
charge may be seen. The pH of this discharge is often greater diseases, Neisseria gonorrhoeae or Chlamydia trachomatis.
than 4.5, and has a positive amine odor when a drop of KOH These will be mentioned again in the “Adnexal” section of
is added (“whiff test”). On saline microscopy, clue cells this chapter. Patients may complain of an odorless vaginal
comprising over 20% of all squamous cells are seen. discharge, spotting, postcoital bleeding, or dyspareunia.
Candidiasis, already mentioned in the vulvar section, can Pelvic exam findings include a friable, inflamed cervix with
present with additional symptoms when vaginal involvement purulent discharge. A swab of the endocervix or vagina can
is present. In addition to pruritus, a patient may complain of confirm diagnosis with a NAAT; urine can also be tested. See
an odorless white, thick, cottage cheese-like vaginal dis- Table 72.1 for treatment [22]. Check guidelines for treatment
charge, swelling, excoriations, or dyspareunia. Upon taking on the CDC’s website for optimal therapy due to many resis-
a swab of the discharge, 10% KOH wet preparation show tant drug strains (www.cdc.gov).
blastopores or pseudohyphae. A fungal culture may also be
obtained to confirm diagnosis. Trichomoniasis is a sexually
transmitted disease in which women complain of a frothy, 72.3.4 Uterus
green, foul-smelling discharge. Vaginal or cervical erythema
with or without petechiae may be present on speculum exam. Endometriosis is the presence of endometrial tissue
Diagnosis relies on visualization of motile trichomonads on implanted outside of the uterine cavity. It can be found in the
saline microscopy or a positive nucleic acid amplification myometrium (referred to as “adenomyosis”), peritoneum,
test (NAAT) or culture. Atrophic vaginitis is a condition seen ovaries, rectovaginal septum, and has even been found in the
in postmenopausal women and characterized by dryness, brain and lungs. It is associated with chronic pelvic pain and
dyspareunia, irritation, and yellow or green discharge. subfertility. Endometriosis is most commonly diagnosed in
Vaginal pH is often > 4.7 and saline microscopy shows reproductive-aged women [23]. Although it is commonly
increased parabasal cells and decreased mixed flora. This can cited that as many as 70–80% of women with chronic pelvic
be managed with vaginal estrogen and counseling on ade- pain have the disease, these numbers come from old studies;
quate lubrication use during intercourse [18, 19]. many other etiologies of pelvic pain have been better eluci-
The Bartholin’s glands are pea-sized glands whose ducts dated in recent years and clinicians are finding that not all
open at the 4 and 8 o’clock positions at the vaginal vestibule. pelvic pain is caused by endometriosis. In a 2016 review of
They are involved in mucus secretion. If this gland is blocked almost 4000 women who underwent laparoscopic or abdom-
at the level of the duct with mucus secretion, the gland may inal hysterectomy for the indication of chronic pelvic pain,
enlarge. Patients with a symptomatic Bartholin’s gland cyst only 21.4% had endometriosis at time of surgery [24].
complain of tenderness, particularly with sexual intercourse. Endometriosis can be asymptomatic. However, patients
Treatment with a Word catheter (which will allow epitheliza- with this disease who present for care may present with pain-
tion of a new drainage tract) or marsupialization can be per- ful periods, dyspareunia, dyschezia, or dysuria. The gold
formed. Anyone who is postmenopausal is more prone to a standard for diagnosis of endometriosis is surgical assess-
malignancy of the gland or duct, thus biopsy of this gland ment with laparoscopy and biopsy. The American Society for
should be performed in any woman over age 40 with afore- Reproductive Medicine has a classification system for
mentioned symptoms. If a Bartholin’s gland cyst becomes describing endometriosis by anatomic location and severity
infected, the Bartholin’s gland abscess may cause acute vagi- [25]. Management of endometriosis requires a multidisci-
886 M. B. Shannon and E. R. Mueller
plinary approach with consideration of surgical debulking of orrhea. However, a history of tubal sterilization did not lead
disease, hormonal management to suppress and delay recur- to increased risk of hysterectomy in this group [29].
rence and progression, and pain management. Recurrence of
disease is not uncommon [26]. The reason for pain in endo-
metriosis is not well understood. Increased macrophages and 72.3.5 Adnexa
inflammatory cytokines in peritoneal fluid of patients with
the disease have been demonstrated. Nerve growth factor is Adnexal torsion is a surgical emergency and occurs when the
more highly expressed in the lesions, and an increased den- ovary and fallopian tube twist on the axis created between the
sity of nerve fibers, especially in deep infiltrating disease, infundibulopelvic ligament and the utero-ovarian ligament.
has also been described [27]. It’s possible for the ovary or fallopian tube alone to be involved.
Adenomyosis is the presence of heterotopic endometrial Patients complain of acute onset abdominal pain, which is
tissue in the myometrium. Symptoms are similar to those of usually unilateral. Pain is due to the occlusion of the vascular
endometriosis. On exam, a practitioner may note a bulky or pedicle, thus may be constant or intermittent as the ovary
globular uterus. Magnetic resonance imaging (MRI) or twists and untwists with changes in position. Nausea, vomit-
transvaginal ultrasound can suggest adenomyosis, but there ing, and fever are also common symptoms. Torsion generally
are no standard diagnostic criteria for radiologists to follow. occurs in women with moderately enlarged ovaries in associa-
Treatment is preferentially medical with nonsteroidal antiin- tion with an ovarian cyst. If the ovary is very large, it is actu-
flammatory medications (NSAIDs) and hormonal suppres- ally less likely to twist due to its weight. Common cysts
sion because true myometrial assessment can only occur associated with torsion are follicular cysts, corpus luteui,
after removal of the uterus and histologic examination. benign teratomas, and cystadenomas. Pelvic exam may show
Uterine fibroids are benign tumors of the uterine smooth an enlarged tender adnexa and abdominal exam may reveal
muscle and are the most common tumors of the female pel- signs of peritonitis. A urine pregnancy test should be per-
vis. Growth of these tumors is estrogen- and progesterone- formed. Laboratory analysis may be normal or show a leuko-
dependent. Fibroids increase in prevalence during cytosis. Transvaginal ultrasound is used to aid in diagnosis.
reproductive years and their size decreases after menopause. Common findings include an ovarian mass with or without
Symptoms depend on fibroid size and location. Many cyst and free fluid in the pelvis. Lack of Doppler venous flow
patients are asymptomatic and fibroids are found inciden- to the ovary would support the diagnosis, but if flow is present,
tally on imaging. For those who are symptomatic, abnormal the diagnosis cannot be ruled out [30]. Preservation of ovarian
uterine bleeding, pelvic pressure, bowel dysfunction, and function should be a priority, with surgical reduction of torsion
urinary frequency, urgency, or retention may be present [28]. and ovarian cystectomy. In most cases, ovarian function will
Although fibroids can undergo a degeneration process which be preserved after reperfusion [31].
can cause acute pain and fever, this is usually a self-limited Pelvic inflammatory disease (PID) is a polymicrobial
process, and it is atypical for a patient with a fibroid to have infection of the internal pelvic organs. It is diagnosed if a
CPP as the presenting symptom. A patient presenting with woman has uterine, adnexal, or cervical motion tenderness;
CPP and uterine fibroids should undergo a thorough evalua- diagnosis is supported by presence of fever, mucopurulent
tion to rule out other causes of pain. Management algorithms cervical discharge, or cervical friability, white blood cells on
depend on symptoms, but symptomatic fibroids are generally saline microscopy of a cervical swab, or presence of gonor-
treated with NSAIDs, hormonal treatments, interventional rhea or chlamydia. Symptoms include abdominopelvic pain,
radiology-guided fibroid embolization, radiofrequency abla- nausea, yellow vaginal discharge, dyspareunia, or dysuria.
tion, myomectomy, or hysterectomy. Inflammation of the liver capsule, called Fitz-High-Curtis
Postablation syndrome has been described as pain from syndrome, can accompany PID and may lead to right upper
hematometra and/or hematosalpinx after an endometrial quadrant pain. Patients with early PID can be treated in an
ablation. This occurs because the cervical os is oftentimes outpatient setting if they appear stable, have normal vital
scarred after an endometrial ablation, thus leaving no path signs, and can tolerate oral antibiotics. Otherwise, these
for blood to drain into the vagina. Postablation tubal steril- patients should be admitted for intravenous antibiotics. If no
ization syndrome describes a patient who has had a tubal improvement is noted within 72 h of treatment, imaging
ligation previously and remnant endometrium at the cornua should be performed to look for a tubo-ovarian abscess.
causes hematometra and/or partial hematosalpinx. The defin- Interventional radiology-guided drainage should be consid-
itive treatment for this diagnosis is a hysterectomy. In a large ered in these patients. Complicated, refractory cases may
retrospective cohort study of almost 300 patients who under- require surgical exploration with abscess drainage and
went endometrial ablation, pain developed in 23% of all removal of necrotic tissue; such cases are uncommon. Given
patients. Risk factors for postablation pain included non- changing antibiotic resistances, the CDC guidelines should
white race, history of tubal ligation, and history of dysmen- be consulted for treatment of PID [32–34].
72 Pelvic Pain Associated with a Gynecologic Etiology 887
pain in these surgical situations. As stated before, the rela- minology and classification of persistent vulvar pain and vulvo-
dynia. Obstet Gynecol. 2016 Apr;127(4):745–51.
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• Chronic pelvic pain is a common complaint, yet 17.
ACOG Committee on Practice Bulletins—Gynecology.
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• A detailed history is essential to making the proper
18. Bornstein J. Chapter 39. Benign disorders of the vulva & vagina.
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therapy. J Reprod Med. 2013;58(11-12):504–10. treatment of interstitial cystitis/bladder pain syndrome. J Urol.
38. Tu FF, As-Sanie S, Steege JF. Prevalence of pelvic musculoskel- 2011;185(6):2162–70.
etal disorders in a female chronic pelvic pain clinic. J Reprod Med.
2006;51(3):185–9.
Chronic Idiopathic Anorectal
Pain Disorders 73
Bruno Roche and Cosimo Riccardo Scarpa
73.3 T
opographic Sensitive Innervation 73.4 H
istory and Physical Examination
of the Perineum of the Perineum
The pudendal nerve innervates the skin covering the anus 73.4.1 History
and the central fibrous bundle of the perineum. Innervation
of the external genital organs is more complicated, as there is History taking in the case of pelvi-perineal pain should be
some overlap (Fig. 73.1): accurate and detailed and should be focused on tracing the
history of the pain. The mode of onset is most often insidi-
–– The pudendal nerve innervates the clitoris, the labia ous, or at times acute. All triggering factors should be noted
minora, and the labia majora. in chronological order. In some cases, pain may develop sud-
–– The iliohypogastric nerve innervates the mons pubis and denly and permanently, without remission; in other cases,
the prepubic area. pain evolves in periods. At the initial consultation, the patient
–– The ilioinguinal nerve innervates the labia majora, often reports one or more periods of pain, lasting a few
together with the genitofemoral nerve. months and then regressing spontaneously, before pain even-
–– The inferior cluneal nerve, a branch of the posterior cuta- tually becomes regular and daily.
neous nerve of the thigh, innervates the skin of the peri- The type of pain is a key point in history taking.
anal gluteal region, lateral to the territory of the pudendal Currently, there are no agreed-upon diagnostic criteria that
nerve. make it possible to relate pain to a definite injury. The use of
–– In 8–15% of cases, the perforating cutaneous nerve easily applicable neuropathic pain criteria, validated by an
described by Schwalbe, a branch of the pudendal plexus expert panel under the name Neuropathic Pain Symptom
or nerve, supplies the perianal region, together with the Inventory (NPSI) developed first in French as “douleurs
inferior cluneal nerve. neuropathiques 4 questions (DN4)” [10], allows to differen-
Fig. 73.1 Topographic
sensitive innervation of the
perineum
73 Chronic Idiopathic Anorectal Pain Disorders 893
tiate between pain arising from nerve damage and other the presence of pain during the day, at night, or both, all
kinds of pain. The NPSI classification combines a question- provide valuable information. Whether pain is triggered
naire and a number of clinical examination items and has by urination, bowel movement, or sexual intercourse is
been validated in French (a translation is provided in investigated, as these are all major elements of the diag-
Table 73.1). One point is given to each affirmative answer. nostic workup.
The final score, greater than or equal to 4, allows for the
proper identification of 86% of patients suffering from neu-
ropathic pain, with a sensitivity of 82.9% and a specificity 73.4.2 Associated Signs
of 89.9%. This questionnaire must be an integral part when
obtaining the history of perineal pain. The topography of The condition is often associated with cutaneous, mucosal,
pain must be as accurate as possible; patients should be subcutaneous, muscular, or visceral hypersensitivity. The
asked to point out their tender points, or to draw them on a existence of sexual dysfunctions is hard to interpret in the
simple anatomical diagram. The same goes for pain radiat- context of chronic perineal pain syndromes. Constipation is
ing to the back, the buttocks, or the sciatic nerve. a banal symptom, but is often present as anorectal dyschezia.
The circumstances of pain onset, i.e., posture as a A causal relationship can be suggested if the onset of pain is
trigger or contributing factor, the moment of onset, and concomitant with constipation.
Burning
Cold, painful
Electric shocks
- Question 2: Is the pain associated with one of more of the following symptoms in the same
area?
Tingling
Numbness
Itching
Patient examination
- Question 3: Is the pain located in an area where the physical examination may reveal one or
more of the following characteristics?
Hypoesthesia to touch
Hypoesthesia to prick
73.4.3 Physical Examination and internal obturator muscles). The physical examination
should also be extended to the thoracolumbar and lumbosa-
The examination must be accurate and systematic. In our cral spine and should also include searching for fibromyalgia
usual practice, patients are placed in the lithotomy position, tender points [11].
relaxed. They may follow the examination live, by means of The assessment is then completed by radiographic, com-
a camera and a monitor placed on their right. puted tomography (CT) and magnetic resonance (MR) imag-
At first, patients are tested for sensory disorders at the ing of the spine and of the origin of the lower extremities.
perineum, anal reflexes, and vasomotor disturbances of the
external genitalia or buttocks.
Afterward, the specific bone tenderness of the pelvic gir- 73.5 Psychologic Aspects
dle is assessed: and Somatization of Pain
–– Tail end of the coccyx The close interconnection between somatic and visceral
–– Ischia innervation is the specific feature of the anorectal-perineal
–– Pubic symphysis region. In healthy individuals, the sympathetic nervous sys-
–– Sacroiliac joints tem (SNS) plays a key role in protecting against pain, through
medullary inhibition of nociceptive transmission.
The pelvic examination aims at assessing specific trigger Experimental studies suggest that this system may be
points, following a predetermined diagram (Figs. 73.2 and involved in regulating peripheral inflammation and nocicep-
73.3). The exam is performed using the right index finger for tion. However, the context and duration of activation of the
the right pelvis and the left index finger for the left pelvis. SNS determine the suppressive or magnifying effect of pain
The physical examination is then completed by searching control by the system itself. A very interesting study has
for myofascial trigger points in the gluteal region (piriformis shown that, whenever fear or immediate threats to the body’s
integrity are sensed, pain perception is reduced, and pain- Psychological assessment and support psychotherapy are
related behavior is suppressed. Similarly, in a context of paramount in these cases [15].
chronic anxiety, pain perception can be amplified and per-
ceived as a potential threat for the future [12]. This means
that either cortical activation in response to the perceived 73.6 Proctalgia Fugax
life-threatening situation or different effects pertaining to the
circumstances that elicit the activation of the SNS, and the 73.6.1 Definition
duration, will affect pain suppression or amplification. The
patient’s perception will make them unsure about their bodily Proctalgia fugax is marked by deep, intense pain in the rec-
response, and in turn, uncertainty will generate anxiety, tum area, which lasts from a few seconds to minutes (rarely
which will result in disrupting pain regulation and pain- over 30 min), and then resolves spontaneously and com-
related behavior [13]. Unfortunately, little is known about pletely [16, 17].
the molecular mechanisms involved in the interaction The condition can be associated with tenesmus, urgency
between the sympathetic system and pain. These mecha- to defecate, or neurovegetative disorders.
nisms are too specific to human beings, which limits the Pain most often occurs at night, waking the patient from
development of animal study models. Knowledge of these sleep. It evolves into a recurrent event and may reappear
molecular mechanisms is paramount to develop specific unpredictably and at irregular intervals. Patients may experi-
treatments targeting sympathetic activity, which causes ence one single episode or, conversely, repeated bouts that
chronic pain [14]. might last for weeks or even months. On average, up to five
Recent studies have shown the close relationship between episodes a year are reported in 51% of patients [18]. Pain is
pain, pain regulation, and the subject’s mental state at the felt like a cramp, a knife stab, a bite, or muscle soreness. Pain
time the nociceptive event occurs. Such patients should ranges from unpleasant to unbearable in intensity [17], and it
always be investigated for signs of stress, abuse, or coercion. causes half of the patients to interrupt their activities [19].
896 B. Roche and C. R. Scarpa
• Rectal angina with transient mesenteric ischemia –– Chronic or recurrent rectal pain.
• Muscle spasms of the anorectal junction –– Episodes last 30 min or longer.
• Neurovegetative painful manifestation –– Tightness and tenderness with traction of the puborectalis
muscle.
At present, the spontaneous and abnormal contraction of –– Other causes of rectal pain have been excluded.
the smooth muscle is believed to be the most likely cause of
this condition. A relationship between hereditary proctalgia These criteria must have lasted for at least 6 months
fugax and internal anal sphincter hypertrophy in the context before diagnosis was made, and persist 3 months afterward,
of associated constipation has been described in two trials in a context of chronic proctalgia.
[21, 22].
Another study has shown a personality-related predisposi-
tion in anxious, perfectionistic, and/or hypochondriac patients 73.7.2 Epidemiology
[23]. Similarly, it is observed that episods of proctalgia fugax
occur chiefly in a situation of stress and anxiety [24]. These symptoms affect 6.6–11.6% of the general population
and mostly women [1]. Over half of the patients are aged
between 30 and 60, with a peak at the age of 45 [1].
73.6.4 Physical Examination
very clear, but is most likely related to the prevalence of will examine myofascial and coccygeal pain syndromes,
right-handed physicians performing the examination. This is postoperative anorectal neuralgias, nerve compression neu-
why we emphasize the importance of conducting the physi- ralgias, and pain of central origin.
cal examination using both the right and left index fingers
(Sect. 73.4.3).
73.8.1 Myofascial and Coccygeal Pain
Syndromes
73.7.5 Treatment
Coccygodynia can manifest in two main forms: sacrococ-
Treatment is made difficult by patient heterogeneity, as cygeal and/or anorectal pain of coccygeal origin. In either
well as by the associated psychological aspects. Treatment case, patients report pain that is triggered by pressure to,
should be focused on relieving pelvic floor muscle stiffness or manipulation of, the coccyx. Pain can be exacerbated
and tenderness. It often includes a combination of Thiele by bowel movements or prolonged seated immobility.
massage [30], baths or sitz baths, and muscle relaxants Coccygodynia occurs much more frequently in women
such as methocarbamol, diazepam, and cyclobenzaprine. than in men [34], in a ratio of 5:1, with no preferred age
These are mostly anecdotal treatments that were not dis- [35]. The difference in the anatomical location of the
cussed in controlled studies; only two randomized con- sacrum and coccyx between men and women explains the
trolled trials have been published to date. In the first one, female preponderance of the disease. Body weight is a
157 patients diagnosed with levator syndrome have been contributing factor to coccygodynia starting from a body
randomized into 3 groups: electrogalvanic stimulation, mass index (BMI) greater than 27.4 in female subjects and
levator ani muscle massage plus tempered sitz baths, and greater than 29.4 in males [36].
biofeedback plus psychologic counseling [3]. The results
have shown that 87% of the patients who had muscle ten- 73.8.1.1 History
derness upon palpation reported symptom relief following Sacrococcygeal trauma (such as a fall onto the tailbone, con-
biofeedback, compared to only 45% who reported an tusions, or fractures) is a frequent finding [36, 37]. Subjects
improvement following electrical stimulation and 22% in should also be investigated for repeated microtrauma related
the massage group. Symptom relief was maintained at to their profession (secretary, driver) or sporting activities
1-year follow-up. The other trial compared injections of (horse-riding, motorcycling). Dystocic or forceps-assisted
botulinum toxin A to placebo in 12 randomized patients. delivery may be responsible for long-term coccygeal pain in
The injection was repeated after 90 days, showing no dif- women [38].
ference between the two kinds of injection and no signifi-
cant pain improvement [31]. 73.8.1.2 Physical Examination
Surgery has no place in treating this disease: it involves The rectal examination checks for tender areas at the coccyx
the lateral division of the puborectalis muscle and can and surrounding structures. Digitally the palpation look for
result in major functional disorders, especially inconti- pain at the tip of the coccyx and pain at mobilisation of the
nence [32, 33]. sacrococcygeal joint. Systematically the finger palpate the
middle line of the coccyx, the lateral borders of the coccyx
location of the ischiococcygeal ligaments insertion. Then
73.8 Unspecified Anorectal Pain levator ani and puborectalis muscle tendeness are evaluated.
Contraction of these muscle may be associated with tene-
This third group of anorectal pain syndromes recognized by mus. This direct examination is considered an essential part
the Rome criteria is by far the most interesting, the hardest to of diagnosis [39].
treat, and, definitely, the most debated and the most question- The radiological assessment using lateral radiographs,
able one. It encompasses all the clinical manifestations that both standing and sitting in the painful position (Fig. 73.4a,
do not meet the criteria for proctalgia fugax or levator ani b), may show a luxation or pseudo-luxation of the coccyx. In
syndrome. The term “unspecified” reflects the current lack of most cases, a coccyx mobility over 20–25° in the anteropos-
knowledge of anorectal and, by extension, pelvi-perineal terior plane is identified as pathological [37].
pain disorders. MRI examinations are essential to rule out possible
The structure of this chapter reflects our clinical experi- organic causes, infections, benign tumors, and malignan-
ence, with inputs from supporting literature. Specifically, we cies [40].
898 B. Roche and C. R. Scarpa
Fig. 73.4 (a) Lateral standing position. (b) Lateral sitting position with posterior luxation of the coccyx
a b
Fig. 73.5 (a) Bad position (sitting on the coccyx). (b) Good position (sitting on the ischium. Coccyx is free)
cerophoby, and who underwent multiple surgeries of the who underwent anopexy complain of spontaneous pain or
lesser pelvis. In these cases, pain involves the entire pain during defecation, compared to 0% in the conventional
perineum [46]. surgery group [52]. The treatment of postdefecation pain
The development of stapling techniques for the treat- involves conservative treatment using nifedipine [50].
ment of hemorrhoidal disease and defecation disorders has Hard-to-treat chronic pain is the most frequent cause for
generated new causes of postoperative anorectal pain. reintervention (44%), including the removal of retained
These new techniques may offer the advantage of reducing staples and the surgical reconstruction of the anastomosis
postoperative pain, when compared to traditional tech- [48, 51] (Fig. 73.6a, b).
niques. However, despite these encouraging results, chronic A more conservative approach consisting of local ste-
postoperative anorectal pain still affects 1.6 to 31% of roid and/or anesthetic infiltrations, along with endoanal
patients [47]. These severe and chronic proctalgias may or electrical stimulation, must be attempted before surgery
may not be related to defecation [48] and may be associated is proposed [48] (Fig. 73.7). In three patients suffering
with defecation urgency [49]. Symptoms may occur right from uncontrolled pain after S surgery, we succeeded in
after surgery or in the 3–5 following weeks [50]. This liberating the inferior rectal nerve branch by transgluteal
chronic pain, mainly affecting male subjects, is described access.
as rectal spasms or a burning sensation located at the rec-
tum, irradiating to the lower back, the buttocks, and, some-
times, the posterior surface of the lower extremities. Areas 73.8.3 Nerve Compression Anorectal
of hypoesthesia or anesthesia can be found on the internal Neuralgias
surface of the thigh, indicating damage of the obturator
internus nerve. Chronic pain can be due to smooth muscle The skin that covers the anus and the central fibrous bundle
injury during the stapling technique, to sphincter spasm, to of the perineum is innervated by the pudendal nerve. The
suture dehiscence, to sepsis, or to the presence of staples inferior cluneal nerve, a branch of the posterior cutaneous
[48, 51]. A comparative study of conventional surgery and nerve of the thigh, innervates the skin of the perianal gluteal
stapled hemorrhoidectomy has shown that 8% of patients region, lateral to the territory of the pudendal nerve. In
900 B. Roche and C. R. Scarpa
Fig. 73.6 (a) Resection of scar tissue and staplers. (b) Hand-sewn redo anastomosis
Fig. 73.7 Decision-making
Inflammation Staples’ Stenosis Scar
tree for chronic postoperative
retention
pain
First
line treatment Topical Nifedipine
Third
line treatment Agraffectomy Redo suture line
8–15% of cases, the perforating cutaneous nerve described –– At the falciform process of the sacrotuberous ligament
by Schwalbe, a branch of the pudendal plexus or nerve, sup- and at the Alcock canal
plies the perianal region, together with the inferior cluneal
nerve (Fig. 73.1). However, considering the anatomical variability of the
Our discussion will not include the innervation of external path of the nerve, the localization of perineal pain can only
genitalia, which is more complicated and made of be a clue to localize the compression site.
intertwining innervations, as described above, and is unlikely
to cause anorectal symptoms. Symptoms of Pudendal Neuralgia
There is a resemblance between neuralgia by pudendal nerve
73.8.3.1 Pudendal Neuralgia compression and canal syndromes. Compression affects
The pudendal nerve (nervus pudendus) is mainly a somatic women more often than men, in a 2:1 ratio. Symptoms are
nerve, arising from the anterior branches of the S2–S4 spi- caused by perineal pain, which is localized systematically
nal nerves. Four conflict zones are described [53] and permanently. Pain falls into the neuropathic category; is
(Fig. 73.8a–c): characterized by paresthesia and, rarely, by electric shocks;
and is exacerbated by sitting or resting on the ischia (as in
–– Inferior to the piriformis muscle cycling) [54]. Patients report a burning sensation associated
–– At the ischial spine with pain, which is relieved by standing and/or while walk-
–– At the clamp formed by the sacrospinous and sacrotuber- ing. Pain has been seldom reported while lying; however, it
ous ligaments does not usually disrupt sleep and does not occur at night.
73 Chronic Idiopathic Anorectal Pain Disorders 901
a b
Superior
Superior
Right
Dorsal
Superior
Medial
Fig. 73.8 (1) Pudendal nerve, (2) lower gluteal vessels, (3) lumbosa- to expose the nerve, which becomes visible in the place where it circles
cral trunk, (4) post. cutaneous femoral nerve, (5) obturator int. muscle the ischiatic spines behind the sacrospinal ligament. (b) Medial pelvic
et gemelli muscle, (6) piriformis muscle, (7) sacrotuberal ligament, (8) view. Origin of the pudendal nerve sacral roots S2, S3, S4. The levator
sacrospinal ligament, (9) obturator int.fascia, (10) inf. rectal nerve, (11) ani muscle (13) is partially separated. One sees the sacrotuberal liga-
perineal nerve, (12) dorsalis penis/clitoridis nerve, (13) open levator ani ment (7) and the pudendal nerve (1), which enters the pelvis along this
muscle, (14) ischiatic spine, (15) fossa ischioanalis, (16) ischiatic tuber- ligament under the sacrospinal ligament (8) fenestrated: compression
cle, (S1, 2, 3, 4) sacral nerves. (a) Posterior view of the right gluteal C. (c) Posterior medial view into the ischioanal fossa. Opening of the
region after opening gluteus max. muscle. Path of the pudendal nerve Alcock canal. The edges are held by clamps. The nerve runs in the canal
through the major ischiatic foramen under the piriformis muscle. The together with the blood vessels and delivers its branches, which lead
sacrotuberal ligament is separated and supported with clamps, in order into the ischioanal fossa
Pain can be localized to the anal sphincter or rectum, with a may recall the patient-reported pain, in all respects. The find-
feeling of an endorectal foreign body. All these symptoms ings from the physical examination and the medical history
occur mostly unilaterally. This damage might be the mirror become particularly relevant when they are localized unilater-
of a specific damage of a single branch of the nerve. ally, or along the side showing the most symptoms.
Additional etiology of neurological lesions include damage
Physical Examination to the radicular plexus caused by shingles, perineal herpes or
Often, the physical examination does not indicate any sensory radiation therapy, neoplastic invasion of the plexus, spinal injury,
impairment. However, the alteration of sensitivity to prick benign or malignant tumors, neurinomas, and ependymomas.
and touch is pathognomonic of nerve injury in 92% of cases
[55]. Subjects are investigated for trigger points by palpation Diagnostic Workup
of the ischial spine during the anorectal examination. The As pudendal neuralgia is now recognized and accepted as a
compression of this region elicits an exquisite pain, which disease entity, the condition is increasingly over- or underdi-
902 B. Roche and C. R. Scarpa
agnosed in the absence of any organ pathology. The diagno- Table 73.2 Diagnostic criteria for pudendal neuralgia by pudendal
sis is based on the medical history and physical findings that nerve entrapment (Nantes criteria)
we have already discussed and is supported by complemen- Essential criteria for the diagnosis of pudendal neuralgia
tary electrophysiology or imaging studies and by selective Pain in the territory of the pudendal nerve (from the anus to the penis
or clitoris)
infiltrations of the pudendal nerve.
Pain predominantly experienced while sitting
The pain does not wake the patient at night
Electrophysiological Diagnosis No objective sensory impairment
In electromyography (EMG), needle electrodes are used to Positive pudendal nerve block (subject to an irreproachable
look for signs of denervation in the striated muscles that technique)
are under control of a somatic nerve. The interpretation of Complementary criteria for the diagnosis of pudendal
neuralgia
perineal electrophysiology studies is often delicate and
Burning, electric shock-like pain, tightness, and numbness
difficult. In some pathological conditions, including previ- Rectal or vaginal foreign body sensation (sympathalgia)
ous pelvic surgery or dystocic delivery, latency is found to Worsening of pain during the day
be increased, although not pathognomonic of pudendal Predominantly unilateral pain
nerve compression syndrome [56, 57]. Hence, the investi- Pain triggered by defecation
gation of pudendal nerve distal latency time is difficult to Presence of exquisite tenderness on palpation of the ischial spine
interpret. As of today, this test is virtually no longer used Clinical neurophysiology findings in men or nulliparous women
in our division for the diagnosis of pelvic floor neurologi- Exclusion criteria
Exclusively coccygeal, gluteal, pubic, or hypogastric pain
cal disorders.
Pruritus
These exams should be carried out solely by specialist Exclusively paroxysmal pain
physicians with extensive experience in their interpretation. Imaging abnormalities able to account for the pain
Associated signs not excluding the diagnosis
Pelvic Radiography Buttock or sciatic pain, especially on sitting
Pelvic radiographs, in front and lateral view, allow the exclu- Suprapubic pain
sion of neoplasia localized at the sacrum or at the ischial Urinary frequency and/or pain on a full bladder
Pain occurring after ejaculation
spine, compressing the sacral roots or the pudendal nerve
Dyspareunia and/or pain after sexual intercourse
roots. These lesions are extremely rare. A few cases of exos- Erectile dysfunction
tosis of the ischial tuberosity compressing the pudendal Normal clinical neurophysiology
nerve have been described [58]. Pelvic radiography is cur-
rently integrated by MRI.
Magnetic Resonance Imaging of the Pelvis –– Essential criteria for the diagnosis of pudendal
Pelvic MRI can substantiate pelvic static disorders or neuralgia
presacral tumors compressing the plexus [59]. Plexus –– Complementary criteria for the diagnosis of pudendal
injuries and nerve compression are often difficult to see neuralgia
in MRI. –– Exclusion criteria for the diagnosis of pudendal neuralgia
and associated signs
Magnetic Resonance Imaging of the Medullary Cone –– Associated signs not excluding the diagnosis of pudendal
This is a fundamental examination in the diagnostic workup neuralgia
of pelvic pain and may substantiate focal abnormalities such
as benign or malignant tumors (neurinomas, ependymomas) Treatment
that might cause perineal pain. Pudendal Canal Injections
In the absence of pathognomonic imaging, biological The areas of compression of the pudendal nerve are acces-
and electrophysiological parameter, the diagnosis of puden- sible for infiltration with corticosteroids and long-acting
dal neuralgia remains essentially probabilistic and clinical. local anesthetics. These injections can be performed under
It is based on a set of criteria discussed and validated by a radioscopic, computed tomography [61], ultrasonography
multidisciplinary expert group and known as the Nantes [62], or magnetic resonance [63] guidance. Symptom
criteria [60]. Four diagnostic domains have been defined relief or reduction is achieved in 40–85% of patients after
(Table 73.2): the first infiltration, and a further set of injections (up to 3)
73 Chronic Idiopathic Anorectal Pain Disorders 903
may have a therapeutic effect lasting several months [55, Multidisciplinary postoperative patient management pro-
56, 61]. motes a gradual decline in pain intensity. In our experience,
Pudendal nerve perineural injections are a key element which reflects that discussed in literature, 65% of patients
of the diagnostic workup. The reduction (or temporary have improved 1 year postsurgery and can discontinue their
disappearance) of symptoms allows for the selection of pain-relieving medicines, and 35% see no benefit or just a
eligible patients for pudendal nerve decompression short-term benefit. There is no evidence of symptom worsen-
surgery. ing [65, 71].
Questions
–
DN4
+
No neuropathic
Neuropathic pain
pain
History of
anorectal surgery
Rectal pain Coccygeal or
spasm perinal muscle
pain
Nocturnal
Postoperative Constant
Nerve entrapment short-term
neuralgia pain
pain
Local infiltration
Decision- Pyriformis Proctalgia Chronic Coccygodynia
anesthesia MRI
making tree a pain fugax proctalgia myofascial pain
test +
Pain of
Pyriformis See Section
Pudendral nerve Cluneal nerve central Biofeedback
syndrome 73.8.1
origin
Decompression
surgery
at the ischium may be considered after a positive anesthetic 73.8.4 Pain of Central Origin
block if the patient still experiences discomfort. This type of
surgery consists of decompressing the nerve posteriorly, This term indicates nonspecific pelvi-perineal pain types, such
along the ischium and all the way to the pyriformis, in order as paresthesia and/or dysesthesia, which can be associated
to liberate the nerve throughout its course [72]. with objective sensory disorders and may also affect the lower
This treatment approach yields variable results. Neither extremities. Any accompanying proprioceptive and urinary
infiltration techniques nor surgical approaches were assessed disorder may be indicative of multiple sclerosis. In these cases,
in randomized comparative studies. Reported post-infiltration the diagnostic workup should include central and peripheral
or surgical risk is minimal. MR imaging, as described in Sect. 73.8.3 (Fig. 73.9).
73 Chronic Idiopathic Anorectal Pain Disorders 905
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Female Sexual Dysfunction
74
Dorothy Kammerer-Doak and Rebecca Rogers
PLATEAU
RE
SO
LUT
EXCITEMENT
ION
DesireArousal
Time
Sexual Neutrality
Emotional
Intimacy
Emotional and
Physical Satisfaction
Spontaneous Sexual
Sexual Drive Stimuli
Arousal and
Sexual Desire
Sexual Biologic
Arousal
Psychological
woman may then become sexually aroused and experience of the initial sexual drive if reactive sexual arousal and desire
reactive or secondary sexual desire. For many women, sex- are maintained and sexual satisfaction can be achieved with-
ual desire is strongly linked to intimacy, and therefore satis- out orgasm in every encounter. Women often have a skewed
faction can be both emotional, such as enhancing the bond concept of normal female sexual function based on media
with a partner, and physical responses, such as an orgasm portrayals, and the circular female sexual response concept
(Fig. 74.2). These concepts are imperative to understand, reassures that decreased spontaneous desire and lack of
since it is completely normal for women to have a lessening climax with every sexual encounter does not mean loss of
74 Female Sexual Dysfunction 911
sexuality or that a sexual partner is no longer desirable. 78, with the most common reason for sexual inactivity lack
Sexual neutrality, or being receptive to rather than initiating of a partner [15]. In those with and without partners, 39.3%
a sexual encounter, and sexual satisfaction encompassing of women between 60 and 69 years of age and 23.6% over
both the physical and emotional are considered normal the age of 70 years were sexually active [12]. A sample of
female sexual function. 749 women from the United States between the ages of 40
Knowledge of average sexual practices is important for and 80 years noted 69.3% sexually active over the past
understanding abnormal sexual function, although norms of 12 months, with 27.8% more than once/week [14]. A survey
sexual activity are not well studied. While frequency of sex- of middle-aged and older women reported that about 75%
ual activity may vary, the average frequency of sexual were sexually active [16]. Sexual behavior in a global evalu-
encounters is about 4–6/month, with 37% less than or equal ation from 29 countries and 27,500 men and women between
to monthly, 33% weekly, and less than 1% daily [5, 6]. the ages of 40 and 80 years found 65% of women to be sexu-
Vaginal intercourse is the most common sexual activity, but ally active within the past year, with 38% more than once/
with climax infrequent solely with this route. Only 20% of week, and significant differences based on region [17].
women routinely experience orgasm during vaginal inter- Sexual activity declined from 88% in women aged
course, and 80% require direct clitoral stimulation either 40–49 years to 21% of those 70–80 years of age [17]. Only
before or after vaginal intercourse. The ability to achieve 23% of these women felt that “older people no longer want
vaginal orgasm appears to have a strong genetic component sex,” and 76% believed that “satisfactory sex is essential to
[7]. While most women are able to experience orgasm maintain a relationship” [17].
through masturbation, orgasm during partnered sexual activ-
ity is less frequent [8]. Use of a vibrator during partnered sex
is relatively common, and its use and the use of erotica are 74.2 Female Sexual Dysfunction
associated with increased sexual function scores in women
[9]. The National Health and Social Life Survey noted that Sexual dysfunction is recognized as a widespread problem,
30% of women almost always or always achieve orgasm but incidence and prevalence vary depending on population
with sexual relations compared to 75% of men [10, 11]. studied as well as definition. An early and widely quoted
Several recent studies addressing prevalence and inci- study, the National Health and Social Life Survey, a national
dence data for rates of sexual activity indicate that women probability sample of 1749 women and 1410 men aged
are sexually active throughout their lifetimes [6, 12–14]. In 18–59 years, reported on adult sexual behavior in the United
the United States, a national probability sample published in States in 1992 [18]. Low libido was the most common com-
2010 of 2929 women between the ages of 14 and 94 years plaint noted in 51%, followed by problems with arousal in
noted that 12.4% of teenagers 14–15 years of age had ever 33% and issues with pain in 16%. Weaknesses of this evalu-
experienced vaginal intercourse, 31.6% of those 16–17 years, ation include no assessment in individuals more than 59 years
64% of those 18–19 years, and 90.7% by 25 years of age and the lack of evaluation as to the bother or distress of the
[13]. In a sample of 8869 women ages 16–74 years from sexual problem(s). A recent consensus conference that
Great Britain, 17.4% reported heterosexual intercourse reviewed and summarized the literature reported on preva-
before 16 years of age [6]. Overall, the mean number of sex- lence of female sexual dysfunction [19]. The consensus com-
ual encounters, vaginal, oral, or anal, was 4 per month [6]. mented that female sexual dysfunction has been poorly
Over the past year, 58.4% had engaged in vaginal inter- studied as compared to male sexual dysfunction with varying
course, 59.9% had given or received oral sex, and 10.5% methodologies, including definition and severity, the ages
were recipients of anal intercourse [6]. Over the past 4 weeks, studied, and timeframe of the sexual dysfunction, ranging
32.9% had engaged in masturbation [6]. Only 6.1% reported from lifelong problems to the past 3–12 months. Despite
sexual encounter that included genital contact with another these variations, the prevalence of female sexual dysfunction
women. A very recent study of 1046 women ages 18–91 years in most studies was 40–50%. Low desire was the most com-
from the United States noted 70% were sexually active over mon (17–55%), and some studies showed increased prob-
the past year; 11.7% were in a partnered, monogamous, but lems in women over the age of 60 years (40–50%) as
sexless relationship; 92.2% reported they were heterosexual, compared to younger women (15–33%) [19]. Arousal dys-
3.6% bisexual, 1.5% gay, 1.3% asexual, and 0.9% other; function, manifested by decreased lubrication, ranged from
82.5% had ever given their partner and 84.6% had ever 12 to 28%, with highest rates noted in Iran (34%). The preva-
received oral sex; and 37.3% had ever received anal sex [12]. lence of orgasmic dysfunction ranged from 11 to 25% in
Although the frequency of sexual activity declines with western countries and again was highest in Iran (37%). While
age, population-based studies indicate continued sexual up to 80% of women have problems with orgasm, in only
activity in about 50% of married women between the ages about 8–15% are the difficulties with orgasm severe.
of 66 and 71 years and about 1/3 of women over the age of Dyspareunia and vaginismus are the least prevalent sexual
912 D. Kammerer-Doak and R. Rogers
dysfunction, noted in most studies to be less than 10%, but objective arousal, which results in an erection. In females,
with a few reporting up to 27% [19]. there is very poor correlation between subjective and objective
While most women at some point have sexual problems, arousal in that women can experience subjective arousal with-
the definition of female sexual dysfunction requires that the out increased genital blood flow and vice versa. Women expe-
sexual problem be distressful or bothersome to the affected riencing forced sexual activity can have increased genital
woman. A woman may have no desire for sexual activity, and blood flow and lubrication without any subjective arousal indi-
even if that is bothersome to her partner, this is not classified cating a physiological response. Additionally, decreased or
as her sexual dysfunction if the lack of sexual activity is not loss of sexual desire and arousal were only FSD if there was
distressful to her. Sexual dysfunction is more common in failure to respond to appropriate stimuli, whereas reactive
younger women as sexual problems tend to cause more dis- arousal and desire were normal. Orgasmic FSD was defined as
tress in this age group. While sexual issues such as lack of failure to achieve an orgasm, or a marked delay in orgasm,
desire and lubrication increase with aging, there is less despite subjective high levels of arousal, taking into account
distress, and overall, decreased female sexual dysfunction that sexual satisfaction can be both emotional and physical
with advancing years (Fig. 74.3). (Table 74.1).
Female sexual dysfunction (FSD) is separated into four Controversy exists in the exact definitions and categories
categories: problems with desire, arousal, orgasm, and pain of female sexual dysfunction as FSD has also been classified
that cause individualized personal distress. Problems in by two other systems, the International Classification of
more than one area are common, as women with desire dif-
ficulties usually experience issues with arousal and orgasm.
FSD can also be characterized as lifelong/primary versus 70
% LOW DESIRE DISTRESS
acquired/secondary, generalized versus situational, and
60
with etiology as organic/physical, psychosocial, mixed, or
unknown.
50
In 2000, an international consensus conference defined
four categories of FSD: female sexual arousal disorder 40
(FSAD), female orgasmic disorder (FOD), female hypoactive
sexual desire disorder (FHSDD), and sexual pain disorder, 30
which was subdivided into dyspareunia, vaginismus, and non-
coital sexual pain disorder (Table 74.1) [20]. In 2004, the 20
American Foundation for Urologic Disease Consensus group
published its own set of female sexual dysfunction definitions 10
and recommendations, taking into account the Female Sexual
Response Cycle as proposed by Basson, which led to an 0
20-29 30-39 40-49 50-59 60-70
update by the international consensus group [3, 21].
N = 3589
Importantly, sexual arousal is different in females as compared
to males with both a subjective and objective component.
Fig. 74.3 Women’s International Study of Health and Sexuality.
Objective arousal results in increases in genital blood flow. In Menopause. 2006;13:46–56 {Y axis, % with sexual problem; X axis,
males, there is a direct correlation between subjective and ages in years}
Diseases, 10th Edition (ICD-10), and the Diagnostic and rated many of the recommendations of the American
Statistical Manual of Mental Disorder 5th Edition (DSM-V). Foundation for Urologic Disease Consensus group, as well
In addition, the International Consultation on Sexual as duration, frequency, and severity of sexual problems [21,
Medicine (ICSM) updated their definitions in 2015, and the 22]. For the diagnosis of sexual dysfunction, the problem(s)
International Society for the Study of Women’s Sexual must be present for at least 6 months, occur at least 75% of
Health in 2016 [22, 23]. The ICD-11 was approved by the the time, cause personal distress, not be secondary to non-
World Health Organization and adopted in 1992, with the sexual psychiatric disorder, not be due to severe life or rela-
11th edition revisions planned for release in 2018. The ICD- tionship stressors, and not be caused by illness or medication.
10 focuses on the definition of medical conditions and cate- The DSM-V lists six FSD diagnoses: female orgasmic disor-
gorizes FSD into organic, which includes vaginismus and der, genito-pelvic pain-penetration disorder, female sexual
dyspareunia of medical etiology, and also has ten nonorganic interest-arousal disorder, substance- or medication-induced
FSD codes (Table 74.2) [22]. disorder, and specified FSD and non-specified FSD [22]. In
The DSM-V defines psychiatric conditions and was pub- the DSM-V, problems with arousal and desire are combined
lished by the American Psychiatric Association in 2015 [22]. into one diagnosis, female sexual interest arousal disorder,
New to the DSM-V from the 4th edition is that sexual dys- and problems with dyspareunia and vaginismus are com-
function definitions no longer relied on the sexual response bined into the diagnosis of genito-pelvic pain-penetration
cycle proposed by Masters and Johnson, but instead incorpo- disorder (Table 74.3).
Table 74.2 International classification of diseases 11th edition (ICD-11). Classification of female sexual dysfunction
ICD-11 Organic (physical cause) Nonorganic
Dyspareunia Lack or loss of sexual desire that is not secondary to another sexual problem such as pain
Vaginismus Sexual aversion where sexual activity is avoided as consideration of sexual interaction causes
negative feelings and anxiety
Lack of sexual enjoyment in which normal sexual responses occur including orgasm, but without
appropriate pleasure
Failure of sexual response/lack of lubrication not organic in etiology
Orgasmic dysfunction, with orgasm either markedly delayed or absent
Vaginismus, or tightening of pelvic floor muscles inhibiting vaginal penile penetration not due to
physical cause
Dyspareunia, or pain with intercourse not due to physical cause such as infection or atrophy
Excessive sexual drive additional code is used if secondary to other medical conditions such as
dementia or affective disorder such as hypermania
Two nonspecific sexual dysfunction codes
Table 74.3 Diagnostic and statistical manual of mental disorder 5th edition (DSM-V). Female sexual dysfunction categories
Category Definition(s)
DSM-V Female sexual interest-arousal disorder At least three: absent or decreased
– Combines arousal and desire disorders – Interest in sexual activity
– Sexual thoughts/fantasies
– Initiation of or unreceptive to partner for sex
– Sexual excitement or pleasure with sex
– Sexual interest or arousal in response to any sexual stimuli (written,
verbal, visual)
– Genital or non-genital sensations with sex
Genito-pelvic pain-penetration disorder Persistent or recurrent:
– Combines dyspareunia and vaginismus – Pain and/or difficulty with vaginal penetration or
– Marked fear/anxiety of pain with vaginal penetration or
– Marked tensing/tightening of pelvic floor muscles with attempted vaginal
intercourse
Orgasmic disorder Orgasm: markedly delayed or markedly infrequent or absent or markedly
decreased intensity
Female substance or medication-induced
disorder
Other specified and non-specified female sexual
dysfunction
ALL also classified as: Lifelong vs. acquired
Generalized vs. situational
Level of distress:
Mild, moderate, or severe
914 D. Kammerer-Doak and R. Rogers
The fourth International Consultation on Sexual Medicine Table 74.4 Medications and medical conditions affecting female sex-
(ICSM) evaluated all available literature in their recom- ual function
mended definitions, giving levels of evidence [22]. FSD was Medications Psychological Antidepressants
defined as sexual problems which cause individualized dis- Antipsychotics
Barbiturates
tress, persist for at least 3 months, and occur at least 75% of
Benzodiazepines
the time. Female hypoactive sexual desire disorder and Hypnotics
female sexual arousal disorder were retained as separate dys- Hormonal Oral contraceptives
function categories, but pain disorders were combined into a Gonadotropin-
single definition, female genital-pelvic pain dysfunction releasing agonists
(Table 74.1). New categories of FSD proposed with level of and analogues
Anti-androgens
evidence expert opinion included persistent genital arousal
Anti-estrogens
disorder (unwanted spontaneous and intrusive genital arousal Other medications β-Blockers
without sexual interest unrelieved by at least one orgasm, Spironolactone
with possible persistence for hours or days), post-coital syn- Chemotherapeutics
drome (negative feelings and/or physical symptoms after Opiates/narcotics
sexual activity), hypohedonic orgasm (lifelong or acquired Substances of abuse Controlled Opiates/narcotics
decreased or low levels of sexual pleasure), and painful Legal Alcohol
Tobacco
orgasm (pain during or shortly after orgasm) [22].
Marijuana
Illegal Heroin, cocaine, etc.
Medical illnesses Depression
74.3 Assessment Diabetes
Urinary incontinence
Assessment of FSD begins with identification of the woman (OAB)a
with FSD, determination of the primary sexual dysfunction as Neurologic disease,
spinal cord injury
there is often an overlap in categories, the amount of personal Cancer
distress experienced from the sexual problem(s), and how long Cardiovascular
the symptoms have been experienced. Evaluation and treat- disease
ment can then be tailored to the individual woman based on a Adapted from Parish SJ, Goldstein AT, Goldstein SW, Goldstein I,
medical history and physical examination focused on identifi- Pfaus, J, et al. Toward a more evidence-based nosology and nomencla-
cation of treatable causes. Screening for FSD can be accom- ture for female sexual dysfunctions—Part II. J Sex Med.
2016;13:1888–901
plished with three simple questions easily obtained from an a
OAB overactive bladder
intake questionnaire which are as effective as a lengthy inter-
view: Are you sexually active, Are there any problems, and Do
you have pain with sexual activity [24, 25]? In-depth evalua- 74.4 Sexual Function Questionnaires
tion of FSD can also be accomplished using validated sexual
function questionnaires, covered in a separate section. Objective measures of sexual health including physical
No routine laboratory screening is recommended includ- exam, laboratory analyses, and physiologic testing are poorly
ing sex steroid levels unless endocrinopathy is suspected. correlated with sexual health. Therefore, assessment is reli-
Further evaluation includes an assessment of the motivation ant on patient-reported outcomes, including diaries and
for seeking treatment, a careful history of current life and questionnaires. Sexual diaries have been proposed as one
relationship stressors or changes, illicit drug or alcohol way to assess function. In a diary, the patient may record
abuse, prescription medications and medical illnesses which sexual thoughts, desires, and events. The Food and Drug
may effect sexual function by interference with mood/affect, Administration of the United States has in the past proposed
decrease in genital blood flow and lubrication, decrease in “sexually satisfying events” as an important outcome to
sex hormone-binding globulin and therefore free testoster- measure the efficacy of treatments for sexual health, even
one, or interference with the sexual neurological response though these diaries have not always correlated well with
(Table 74.4). Vaginal atrophy, difficult vaginal deliveries, other validated measures of sexual function.
and vaginal surgery have potential for denervation or dyspa- Other measures of sexual function include validated ques-
reunia. An assessment for possible referral for psychother- tionnaires. A variety of these measures have been used in the
apy is made based on the woman’s current life stressors/ research setting and range from self-administered question-
social situation/relationships, accompanying psychiatric ill- naires to those that are administered in an interview. Nearly
ness, and history of sexual abuse as well as type of sexual all of these measures were validated in young heterosexual
dysfunction(s). women, as these are women more likely to report sexual
74 Female Sexual Dysfunction 915
activity. Questionnaires can be further dichotomized into and impact of vaginal symptoms, mainly prolapse, and sex-
those which measure sexual function among women with ual matters, and the International Consultation on Continence
pelvic floor disorders and those which are more generalized Questionnaire-Female Lower Urinary Tract Symptoms Sex
and measure sexual function without reference to pelvic (ICIQ-FLUTSsex) which measures the impact of urinary
floor dysfunction. In general condition-specific measures are incontinence on sexual function [30, 31]. Questionnaires that
more responsive to change than questionnaires that are not are not condition specific have also been used to evaluate
condition specific. sexual function in women with pelvic floor dysfunction. A
The most commonly used sexual condition-specific sexual number of these have been evaluated by the International
function measure in women with pelvic floor dysfunction is Consultation on Incontinence and rated (Table 74.5).
the Pelvic Organ Prolapse/Urinary Incontinence Sexual Recommendations vary on what specific aspects of sexual
Questionnaire (PISQ) [26]. A short-form version of the ques- function should be evaluated in women undergoing treat-
tionnaire has also been published, the PISQ-12 [27]. More ment for pelvic floor dysfunction. At a minimum, women
recently, the PISQ was revised by an international panel. This should be asked if they are sexually active and if they are,
new measure, the PISQ-IUGA-revised, includes the impact how their pelvic floor dysfunction affects their sexual life. In
of pelvic floor dysfunction on the decision to not be sexually addition, for those who are not sexually active, questions as
active, as well as measurement of the impact of pelvic floor to whether or not their pelvic floor dysfunction influences
disorders on sexual activity [28]. This measure has undergone their decision to not be sexually active is important. Finally,
validation in a number of languages, and a summary score for evaluation of a patient’s return to sexual activity following
the questionnaire has recently been developed [29]. treatment should also be assessed, and if new sexual prob-
Other condition-specific measure includes the lems arise, promptly addressed. Many pelvic floor specialists
International Consultation of Incontinence Questionnaire– do incorporate a sexual function questionnaire into their
Vaginal Symptoms (ICIQ-VS) which assesses the severity assessment of patients with incontinence or prolapse.
916 D. Kammerer-Doak and R. Rogers
inhibition of ST-mediated decreased sexual effect and pro- Table 74.6 Treatment and evidence levels for female hypoactive sex-
ual desire disorder, female sexual arousal disorder, and female orgasmic
motion of DA- and NE-mediated sexual excitement [33].
disorder
Although flibanserin received FDA approval in 2015 for the
Type of intervention Level of evidence
treatment of FHSDD, a recent review of RCTs reported a
Psychological interventions for FHSDD
mean improvement of only 0.50 (95% CI, 0.32–0.67) in sex- Sensate focus 2
ually satisfying events per month and a 0.27 (95% CI 0.17– Cognitive behavioral therapy (CBT) 2
.03.8) point increase in the Female Sexual Function Index Mindfulness plus CBT 2
(FSFI) questionnaire desire subscale [41]. Bupropion is an Pharmacologic interventions for FHSDD
antidepressant that has no ST effects, but rather inhibits both Testosterone therapy 1
DA and NE reuptake, and therefore can be used in women Flibanserin 1
Bremelanotide 1
with antidepressant medication-induced FSD [42]. In small
Bupropion 2
RCTs, bupropion has also resulted in small-moderate Buspirone 2
improvements in sexual function versus placebo in women Testosterone plus buspirone or PDE5i 2
with FHSDD [33]. Trazadone, a ST receptor antagonist; bus- Psychological interventions for FSAD
pirone, a partial ST agonist; apomorphine, a DA receptor Mindfulness plus CBT 2
agonist; oxytocin; and bremelanotide, a synthetic melano- Pharmacologic interventions for FSADa
cortin modulating sexual behavior at the level of the Tibolone 2
Bupropion 2
hypothalamus, are all under investigation for use in FSD
Testosterone therapy 1
involving low desire and arousal (Table 74.6).
PDE5i in specific medical conditions that 2
In contrast to men, female arousal is not just objective with interfere with genital neurovascular system
increases in genital blood flow, but also subjective, modulated Psychological interventions for FOD
by a variety of psychosocial and cultural factors including Directed masturbation 2
views on sexuality, attractiveness of partner, life and relation- Medications: not specifically studied for FOD, but in general,
medications which improve desire and arousal will improve orgasm
ship stressors, and distraction as well as attentiveness during
as well
sexual activity. Therefore, phosphodiesterase inhibitor medi-
FHSDD female hypoactive sexual desire disorder, FSAD female sexual
cations (PDE5i) which work well for male arousal dysfunc- arousal disorder, FOD female orgasmic disorder, PDE5i phosphodies-
tion have not been uniformly efficacious in the treatment of terase type 5 inhibitor
FSD in RCTs due to poor correlation between increased geni- Adapted from: Kingsberg, SA, Althof S, Simon JA, Bradford A, Bitzer,
tal blood flow and subjective arousal (Table 74.6) [33]. In J, et al. Female sexual dysfunction—medical and psychological treat-
ments, Committee 14. J Sex Med. 2017;14:1463–91
women with medical problems that cause a decreased neuro- a
Unable to confer levels of evidence because of small cohorts, inconsis-
vascular genital response, such as diabetes, SSRI use, spinal tent and weak evidence for bibliotherapy/self-help books alone, l-
cord injuries, multiple sclerosis, and following radiation, arginine plus yohimbine, alprostadil, phentolamine, apomorphine,
PDE5i use may play a role in the treatment of FSD. Combined Zestra, and the coital alignment technique
drug therapies, using testosterone and buspirone or testoster-
one and PDE5i, are under investigation [33]. These combined increases genital blood flow through prostaglandin and direct
drug therapies are hypothesized to stimulate desire with tes- endothelial effects [43]. Prostaglandin E1 causes smooth
tosterone, and to decrease central brain sexual inhibition with muscle relaxation resulting in vasodilation and increased
buspirone, or to increase brain sensitivity to sexual genital genital blood flow and may improve genital sensation
arousal with PDE5i. through sensory afferent nerves, but its use for FSD has not
Tibolone is a synthetic derivative of 19-nortestosterone yielded consistent results [44]. Phentolamine is an alpha
that has estrogenic, progesterogenic, and androgenic proper- receptor antagonist that can be administered orally or vagi-
ties and is available outside of the United States for treatment nally to improve genital blood flow through relaxation of the
of menopausal symptoms as well as FSD. Tibolone increases arterial smooth muscle and is under investigation for treat-
genital blood flow and vaginal lubrication as well as sexual ment of arousal FSD. L-Arginine is the precursor for nitrous
function scores for arousal and desire in RCTs compared to oxide and is one of the ingredients of the oral supplement
placebo and demonstrates greater improvement in sexual ArginMax (Daily Wellness Co, Honolulu, HI, USA), along
function than combination hormone replacement therapy with ginseng, ginkgo, damiana, and some vitamins and min-
[33]. While there are other medications available for the erals. Two RCTs by the same author published more than
treatment of FSD, they have not been well studied 10 years ago noted improved desire, orgasm, genital sensa-
(Table 74.6). Zestra (Innovus Pharmaceuticals, San Diego, tion, and sexual frequency as well as improved FSFI scores
CA, USA) is an over-the-counter massage oil applied to the compared to placebo [45, 46].
genitals containing botanicals including borage and evening Information regarding the prevalence, etiology, and treat-
primrose oil, Coleus extract, and osthole which possibly ment of persistent genital arousal disorder is lacking. This
918 D. Kammerer-Doak and R. Rogers
category of FSD has been associated with anatomical abnor- been shown to significantly improve sexual function in
malities such as peri-clitoral mass as well as with discontinu- women following radiation for cervical cancer [48]. FIERA
ation of SSRI medications, overactive bladder, and restless is a suction device that attaches to the clitoris and also uses
leg syndrome. Improvement of symptoms has been reported low-level vibrations prior to sexual activity for 5–20 min to
anecdotally with CBT and medications including pregabalin, achieve desire and arousal through increased genital blood
duloxetine, and varenicline [33]. flow and clitoral stimulation, but not lead to orgasm. While
Sex therapy is recommended depending on the patient’s there are no published studies demonstrating improved sex-
response to conservative and/or medical treatment, on the ual function, FIERA use led to increased external genitalia
stage of FSD, and the woman affected including psychiatric temperature, a marker of engorgement, as measured by ther-
issues, her relationship with her partner, as well as life stress- mography, and all of the small cohort also experienced reac-
ors. Women with primary FOD and with history of sexual tive desire [49].
abuse almost always require counseling. FHSDD has the Vaginal laser and vulvovaginal radiofrequency may also
best response to psychosocial counseling. Depression and improve sexual function. Both vaginal laser and radiofre-
anxiety have a strong association with FSD as well as poor quency cause neovascularization, neoelastogenesis, and neo-
prognosis for sex therapy, and treatment of primary psychiat- collagenesis without fibrosis, with radiofrequency also
ric issue(s) in addition to FSD is imperative to achieve best causing retraction of existing collagen. In two RCTs involv-
results. ing both pre and postmenopausal women, vulvovaginal
Several different strategies are employed in sex therapy radiofrequency demonstrated significant improvement in
(Table 74.6). Sensate focus helps to address psychological sexual function using the FSFI as well as genital appearance
rather than physical factors contributing to FSD through and vaginal laxity compared to sham treatment [50, 51].
counseling and education regarding what is pleasurable and Fractional microablative CO2 vaginal laser improved sexual
ways to achieve this pleasure for the woman alone as well as function as assessed by the FSFI in all domains as well as
with her partner. The focus is not on arousal or orgasm with total score in a small, non-blinded cohort of postmenopausal
this technique, but rather on current sensations of pleasure women with atrophy [52]. A recent comprehensive review
and enjoyment with three steps in level of intimacy begin- and meta-analysis of vaginal CO2 and Er:YAG laser noted
ning with non-genital touching, followed by breast and geni- that while these therapies seem to relieve symptoms and
tal touching, and ultimately mutual touching with sexual improve quality of life including sexual function, the quality
intercourse when the woman and her partner are more com- of evidence is low overall [53]. More studies are needed,
fortable touching, being touched, and experiencing pleasure. including long-term risks and results with both of these
Another technique of sex therapy is cognitive behavioral techniques.
therapy (CBT) which involves identification and alteration of
behaviors contributing to FSD. This includes education
about how erotic stimuli, psychological influences, and 74.6 P
elvic Floor Disorders and Sexual
physical stimulation can contribute to female arousal and Function
desire and, ultimately, orgasm. Mindfulness, the acceptance
of and being present without judgment, is often combined Like other medical conditions, pelvic floor disorders (PFD)
with CBT to improve the ability to focus on bodily sensa- and their treatment can affect sexual health [54–56]. Women
tions and decrease problems with distraction and loss of with urinary incontinence (UI) frequently experience coital
attention during sexual activity and ultimately improve sex- incontinence, with or without vaginal penetration. A recent
ual arousal. survey of 2312 women found that 47.7% of women with UI
In addition to vibrator use to increase clitoral stimulation report coital incontinence. In this study, both stress and
directly during sexual encounters, there are two devices urgency incontinence were correlated with penetration as
available both designed for use prior to sexual activity to well as orgasm [57]. Loss of urine during sexual activity can
increase arousal and orgasm by increasing genital blood cause embarrassment and diminish sexual satisfaction [55,
flow. EROS clitoral therapy device was approved by the FDA 57, 58]. Treatment of UI results in improvement of sexual
in 2000 and is a battery-powered, handheld suction device function on condition-specific measures of sexual health,
applied to the clitoris for 5–15 min at least three times/week although there is little change in desire, arousal, or orgasmic
that can be used separately from sexual activity or as part of function [59].
fore-play. In small, non-masked, non-placebo-controlled tri- Prolapse can likewise negatively affect sexual function as
als, EROS has been shown to increase clitoral and vaginal well as body image, with feelings of self-consciousness and
blood flow as well as to improve arousal, orgasm, and satis- embarrassment about partners’ perception of prolapse during
faction in women with FSAD [47]. Additionally, EROS has sexual activity [55, 60, 61]. As body image correlates with
74 Female Sexual Dysfunction 919
50. Krychman M, Rowan CG, Allan BB, DeRogatis L, Durbin S, et al. 61. Lowenstein L, Gamble T, Sanses TV, van Raalte H, Carberry C,
Effect of single-treatment, surface-cooled radiofrequency therapy et al. Sexual function is related to body image perception in women
on vaginal laxity and female sexual function: the VIVEVE I ran- wih pelvic organ prolapse. J Sex Med. 2010;7(2 Pt 2):1023–8.
domized controlled trial. J Sex Med. 2017;14:215–25. 62. Thompson JC, Rogers RG. Surgical management for pelvic
51. Lordelo P, Leal MR, Brasil CA, Santos JM, Lima MC, et al. organ prolapse and its impact on sexual function. Sex Med Rev.
Radiofrequency in female external genital cosmetics and sex- 2016;4(3):213–20.
ual function: a randomized clinical trial. Int Urogynecol J. 63. Pauls RN, Rogers RG, Parekh M, Pitkin J, Kammerer-Doak D,
2016;11:168–1687. et al. Sexual function in women with anal incontinence using a new
52. Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, et al. instrument: the PISQ-IR. Int Urogynecol J. 2015;26:657–63.
Sexual function after fractional microablative CO2 laser in women 64. Cichowski SB, Komesu YM, Dunivan G, Rogers RG. The asso-
with vulvovaginal atrophy. Climacteric. 2015;18:219–25. ciation between fecal incontinence and sexual activity and func-
53. Pitisouni E, Grigoriadis T, Ralagas ME, Salvatore S, Athanasiou tion in women attending a tertiary referral center. Int Urogynecol J.
S. Laser therapy for the genitourinary syndrome of menopause. A 2013;24(9):1489–94.
systematic review and meta-analysis. Maturitas. 2017;103:78–88. 65. Imhoff LR, Brown JS, Creasman JM, Subak LL, Van De Eeden SK,
54. Rogers RG, Pauls RN, Thakar R, Morin M, Kuhn A, et al. An et al. Fecal incontinence decreases sexual quality of life, but does
international Urogynecological Association (IUGA)/International not prevent sexual activity in women running head: anal inconti-
Continence Society (ICS) joint report on the terminology for the nence and sexual function. Dis Colon Rectum. 2012;55:1059–65.
assessment of sexual health of women with pelvic floor dysfunc- 66. Meyer I, Richter HE. Impact of fecal incontinence and its treat-
tion. Int Urogynecol J. 2018;29(5):647–66. ment on quality of life in women. Womens Health (Lond Engl).
55. Rogers RG, Villarreal A, Kammerer-Doak D, Qualls C. Sexual 2015;11:225–38.
function in women with and without urinary incontinence and/or 67. Markland AD, Dunivan GC, Vaughan CP, Rogers RG. Anal
pelvic organ prolapse. Int Urogynecol J. 2001;12:361–5. intercourse and fecal incontinence: evidence from the 2009-
56. Rogers RG, Kammerer-Doak D, Darrow A, Murray K, Qualls C, 2010 National health and nutrition survey. Am J Gastroenterol.
et al. Does sexual function change after surgery for stress urinary 2016;111:269–74.
incontinence and/or pelvic organ prolapse? A multicenter prospec- 68. Lamers BHC, Broekman BMW, Milani A. Pessary treatment for
tive study. Am J Obstet Gynecol. 2006;195:e1–4. pelvic organ prolapse and health-related quality of life: a review. Int
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incontinence by electronic questionnaire: prevalence, associations 69. Lowenstein L, Gamble T, Deniseiko Sanses TV, Raalte HV,
and outcomes in women attending a urogynecology clinic. Int Carberry C, et al. Changes in sexual function after treatment for
Urogynecol J. 2018;29(7):969–78. prolapse are related to the improvement in body image perception.
58. Coyne KS, Margolis MK, Brewster-Jordan J, Sutherland SE,
J Sex Med. 2010;7:1023–8.
Bavendam T, Rogers RG. Evaluating the impact of overactive 70. Bo K, Talseth T, Vinsnes A. Randomized controlled trial on the
bladder on sexual health in women: what is relevant? J Sex Med. effect of pelvic floor muscle training on quality of life and sex-
2007;4:124–36. ual problems in genuine stress incontinent women. Acta Obstet
59. Jha S, Ammenbal M, Metwally M. Impact of incontinence surgery Gynecol Scand. 2000;79:598–603.
on sexual function: a systematic review and meta-analysis. J Sex 71. Meriwether KV, Komesu YM, Craig E, Qualls C, Davis H,
Med. 2012;9(1):34–43. Rogers RG. Sexual function and pessary management among
60. Roos AM, Thakar R, Sultan AH, Burger CW, Paulus AT. Pelvic women using a pessary for pelvic floor disorders. J Sex Med.
floor dysfunction: women’s sexual concerns unraveled. J Sex Med. 2015;12(12):2339–49.
2014;11:743–52.
A Myofascial Perspective on Chronic
Urogenital Pain in Women 75
Marek Jantos
an important role in the pathogenesis of these syndromes. cystectomies [18]. Some of the ineffective treatments identi-
This discussion will integrate pain mapping research and fied in a study of 53 cases included antibiotics (55%), ure-
electromyography (EMG) studies and explore how pelvic thral dilation (50%), anticholinergics (30%), diazepam
muscle dysfunction impacts the integrity of the fascial sys- (22%), tricyclics antidepressants (15%), α-blockers (12.5%),
tem and results in pain and organ symptoms. The concluding phenazopyridine hydrochloride (10%), acupuncture (10%)
remarks will consider the merits of conservative interven- and surgery in a small number of cases (5%) where it was
tions based on a myofascial model of CUP. tried [19]. The same paper identified myofascial causes of
urge and frequency stating that “pelvic floor myofascial trig-
ger points are not only a source of pain and voiding symp-
75.2 B
ladder Pain Syndrome toms, but also a trigger for neurogenic bladder inflammation
and Vulvodynia via antidromic reflexes” [19]. Muscle relaxation and release
of myofascial trigger points were associated with a signifi-
According to the American Urological Association (AUA) cant reduction in symptoms. The study concluded that myo-
Guidelines, bladder pain syndrome (BPS) is defined as “an fascial trigger points underlie the pathophysiology of bladder
unpleasant sensation (pain, pressure, discomfort) perceived pain and urinary symptoms.
to be related to the urinary bladder, associated with lower Since the early 1990s, evidence has accrued confirming
urinary tract symptoms of more than six weeks duration, in an association between bladder pain and pelvic floor muscle
the absence of infection or other identifiable causes” [8]. The (PFM) dysfunctions [20, 21]. Pelvic floor spasm and myo-
incidence of BPS is higher in women than in men at a ratio fascial pain were confirmed in as many as 87% of patients
of 5:1, and the reported prevalence ranges from 5 to 16% diagnosed with BPS [22]. The report concluded that “the pel-
[9–12]. Prevalence is always difficult to establish due to vic floor may be a significant source of pain in women with
ongoing disparity in definitions and inconsistences in diag- IC [interstitial cystitis—a form of BPS], making therapy
nostic criteria. directed only at the bladder less effective” [22]. Physical
Anatomically, the bladder is a hollow muscular and dis- examination identified PFM tenderness, especially in the
tensible organ that stores urine. It is made up of smooth mus- levator ani muscles, referred pain to the suprapubic, bladder,
cle (the detrusor) and connective tissue (transitional urethra, vulvar and rectal areas. These reports confirmed that
epithelium). It is enclosed by fascia, which covers the pelvic palpation of specific points in the pelvic area reproduced
walls and floor, and is held in place in the anterior part of the symptoms of BPS, including pain and urge [23]. In one study
pelvic cavity by fascial ligaments and muscles of the pelvic the present author and his collaborators reported that palpa-
floor [13]. The kidneys filter waste from the blood and pro- tion of pelvic muscles and of the paraurethral area repro-
duce urine, which enters the bladder through two tubes, duced bladder pain and urge in 100% of BPS cases [24].
called ureters. The urine leaves the bladder through another In general, BPS cases show lack of muscle control and
tube, the urethra. In women, the urethra is a short tube about poor ability to relax the PFM [20]. Consistent with these
4.0 cm long that opens just in front of the vagina. The blad- observations, a urology report suggested that “pain and sore-
der neck and proximal and distal urethra are complex and ness, even inflammation, will develop if the muscle system is
vascularised structures [14], potentially very susceptible to functionally abused” and this will result in changes within
changes in myofascial tension [15]. the bladder [19, 23]. It recommended that stimulation or
Women diagnosed with BPS commonly report symptoms biofeedback-assisted retraining “can produce immediate
of urethral sensitivity; urinary urge and frequency; nighttime relief in muscle soreness” and that “urologists should be
voiding (nocturia); suprapubic pressure; abdominal, groin encouraged to deal with pain on as conservative a level as
and lower back pain; and painful intercourse (dyspareunia) possible”, noting that “if pelvic muscle dysfunction is not
[10]. Bladder pain was found to have a negative impact on corrected, then the chances are against therapy being suc-
quality of life with 90% of women reporting impairment in cessful even with the help of medication” [23]. With myofas-
daily activities, 88% suffering sleep disturbances, 79% expe- cial therapy an 83% improvement was noted in terms of urge
riencing work impairment and 70% confirming problems in and frequency [19].
relationships and sexual function [16]. Medical therapies frequently overlook conservative thera-
Many hypotheses regarding the pathophysiology of BPS pies and ignore the myofascial pain component, remaining
have been put forward: proteoglycan layer disruption, reliant on medications, hydrodistention, neuromodulation
immune system up-regulation, neurological sensitisation and and occasionally surgery. These were found to be suboptimal
pelvic floor dysfunction [17]. Current medical treatments in alleviating symptoms [21]. Hydrodistention was shown to
include analgesics, antidepressants, antibiotics, intravesical significantly reduce symptoms of pain but the benefits
treatments, bladder distention, neuromodulation, behav- appeared to be short lived. Medication helped only half of
ioural bladder retraining, diet, acupuncture, hypnosis and the patients, and heat application and relaxation strategies
75 A Myofascial Perspective on Chronic Urogenital Pain in Women 925
provided temporary relief in 34.6% and 25.6% of cases, cases where prevalence peaked at age 24, and the average
respectively. Surgery was reserved as an absolutely last age of symptom onset was 22.8 years (range 5.5 to 45.2 years
measure. of age) [28]. In both studies chronic vulvar pain was not
These studies influenced the formulation of the current related to parity, or commencement of sexual activity, as
management guidelines proposed by the American over 30% of cases reported the onset of symptoms prior to
Urological Association (AUA). In its guidelines, myofascial commencement of sexual activity [28].
therapy and biofeedback are recommended as a second line Current treatments for Vd include topical medications,
of treatment, preceded only by patient education [25]. such as lidocaine, corticosteroids, amitriptyline (topical and
Vulvodynia (Vd) is a descriptive term for unexplained oral), other antidepressants, gabapentin, botulinum toxin
pain in the vulvar area. The International Society for the injections, psychological treatments, dietary regulation and
Study of Vulvovaginal Diseases (ISSVD) defines Vd as “vul- surgical treatments in the form of vestibulectomy and peri-
var pain of at least 3 months duration, without clear identifi- neoplasty [2, 35, 36]. Management guidelines also recom-
able cause, which may have potential associated factors” mend the use of physical therapies and biofeedback, though
[26]. Anatomically, the vulva includes the external portion of these are not widely used [35, 36]. Considering that 90% of
the female reproductive organs: the vestibule, hymen, ure- women who reported pain with intercourse demonstrated
thral opening, ducts of the minor and major vestibular glands, pelvic floor muscle dysfunction, it would seem critical that
labia minora and majora, clitoris, mons pubis and perineum myofascial pathology be considered, assessed and managed
[27]. Women report generalised pain or provoked discomfort [37], especially in light of the fact that an online patient
when pressure is applied to the vulva. The most common assessment of 120 interventions by 2000 women showed that
descriptors of pain include burning, rawness, itching and myofascial therapies, Botox (botulinum toxin) and absti-
stabbing [28]. nence from sexual and physical activities, were some of the
The most widely accepted diagnostic procedure is the most effective in reducing symptoms [38]. It is not uncom-
Kaufman Q-tip test [29]. This test was used by Friedrich and mon for women to present with lists of inconclusive investi-
relied on for his proposed diagnostic criteria [30]. The criteria gations and a history of unsuccessful treatments [2, 39–41].
included pain on vestibular touch or attempted entry, tender- In summary, the current medical management guidelines
ness on Q-tip palpation of the vestibule and physical findings for both CUP disorders follow generic algorithms [2, 35, 36].
confined to vestibular erythema. The third criterion proved to In the absence of pathology, the most common explanations
be the least reliable but the first two are still relevant and focus on somewhat nebulous notions of central sensitisation
accepted [31]. Though the classification of Vd has changed that further enshroud the understanding of CUP. Though
over time, the diagnostic criteria have not been revised since advocating multidisciplinary therapies, the literature pro-
they were first proposed 30 years ago. In the late 1990s, the vides little practical guidance and direction. This protracts
present author and his collaborators identified pelvic muscle suffering, disability and diminished quality of life [41].
dysfunction as a feature and proposed SEMG criteria for the General assessment of CUP syndromes includes a detailed
confirmation of Vd [32]. SEMG assessment successfully dif- health history, medical screening and a psychosexual assess-
ferentiated between Vd cases and controls on the basis of rest- ment. What is notably lacking is a standardised protocol for
ing pelvic muscle tone, contractile potential, muscle stability localising and identifying the generators of pain. The author
and spectral frequency of muscle fibre types [32]. and his collaborators have developed the first validated pain
The aetiology of Vd is not understood, and the disorder is mapping protocol [41–44]. The practical benefits of such a
thought to be symptomatic of several disease states, poten- protocol include the ability to obtain an individualised pain
tially mediated by hormonal fluctuations, immune system profile and develop a customised case management plan.
dysregulation, hypertonic pelvic muscle dysfunction and neu-
roproliferative changes [2]. Common triggers that exacerbate
pain include sitting, tight clothing, tampons, physical exami- 75.3 Pain Mapping
nations, penetrative sexual activities, stress and anxiety [33].
The lifetime prevalence of Vd is estimated to be in the The term “pain mapping” refers to the process of localising
order of 4–16% [11, 34] and affects women of all ages but is pain and establishing an objective relationship between the
most common among younger women [28, 33]. A recent ret- pain source and symptoms experienced by each individual
rospective population study of 1143 women (age range of [41, 42, 45, 46]. The author and his collaborators systemati-
18–70 years), diagnosed with Vd, found prevalence to peak cally examined points that were suspected or known to
at age 25, with 76% of the cohort being under 35 years of age reproduce pain, assessing the quantitative and qualitative
[33]. By age 36, prevalence decreased noticeably and pla- characteristics. Each point was assessed in terms of pain
teaued from age 37 onwards. These findings were very simi- severity, temporal characteristics and spatial distribution [42,
lar to an earlier study by the present author, profiling 744 Vd 43]. Because pain is subjective, the clinician can only achieve
926 M. Jantos
this goal with the cooperation of the client. Pain mapping able as some of the other points assessed. In the gynaecology
becomes an empowering experience for clients because it group, though none were diagnosed with a CUP disorder,
authenticates their pain and their symptoms [47]. some points on Map A were rated as severe pain, and points
For research purposes three pain maps were developed to in the pelvic and paraurethral area rated in the high range. It
assess the external and internal pelvic points relevant to CUP would appear that a range of conditions and inflammatory
[41–45]. Map A, the external urogenital pain map, consists states trigger sensitivity in the vestibule and urethral areas.
of 27 palpation points and focuses on the vulvar area, tradi- On Maps B and C, both groups (BPS and Vd) rated all of
tionally thought to be the cause of vulvodynia (see Fig. 75.1). the points high in terms of pain severity (the only exception
Map B, the pelvic muscle pain map, consists of 15 palpa- was the piriformis muscle on Map B). On Map C, paraure-
tion points and focuses on the assessment of internal pelvic thral points consistently provided the highest pain ratings,
muscles, thought to be associated with a range of disorders making this anatomical region the most painful, even though
attributable to the levator ani muscle (see Fig. 75.2). pain from this area was imperceptible unless palpated. Mean
Map C, a new and original map, consists of 12 palpation pain scores in the paraurethral area increased consistently
points and is utilised in the assessment of pain of paraure- from the distal to proximal region of the urethra, and pain
thral and bladder origin, previously attributed to the bladder, scores on the left side of the urethra were consistently higher
but generally unrecognised and not previously mapped (see than on the right side.
Fig. 75.3). The data analysis showed that there was no relationship
A total of 54 points were assessed in the 3 anatomical between CUP and birthing and a negative correlation
regions. Each point was rated for severity of pain using the between age and pain. It was also noted that the pain profiles
numerical rating scale of 0–10, where 0 represents no pain of women with Vd and BPS were very similar in terms of the
and 10, the maximum pain ever experienced. location and severity of pain.
A study of 320 volunteers generated a total of 960 pain Logistic regression analysis of all pain scores showed that
maps and over 17,000 pain scores [43, 44]. Of the 320 volun- the most reliable points for the diagnosis of Vd and BPS came
teers, 53 were non-pain cases (mean age 34.0 ± 11.1), and from two points on Map A (vestibule, V6, and urethra, U9), two
267 CUP cases (mean age 34.7 ± 12.2). Medical specialists points from Map B (left ischial spine, ISL, and right puborec-
screened all of the non-pain and CUP cases. On the basis of talis, RPR) and two points from Map C (left paraurethral CL2
exclusion, CUP cases were diagnosed with either Vd or BPS and CL5). With 94% sensitivity (true positive diagnosis) and
or both Vd and BPS. The 53 non-pain cases consisted of 32 87.5% specificity (correct rejection), a diagnosis of CUP can
totally asymptomatic individuals attending a gynaecology be made reliably, on the basis of these six points. Diagnostically,
clinic for routine PAP tests and 21 cases presenting with gyn- of all of the points tested, the paraurethral points most reliably
aecological problems other than pain (i.e. PAP smear abnor- differentiated between the CUP syndromes, the gynaecology
malities, lichen sclerosis, polycystic ovarian syndrome). In group and asymptomatic controls [48].
the CUP group, there were 119 cases (44.57%) with the While palpating paraurethral points, pain was most com-
diagnosis of Vd, 119 cases (44.57%) with Vd and BPS and monly described as burning, sharp, stabbing and itching.
29 cases (10.86%) with a diagnosis of BPS only. Pain from this area reproduced urethral and bladder pain,
A summary of all the pain scores from Maps A, B and C suprapubic pressure, referred pain to the umbilicus, pubic
is provided in Graph A, Fig. 75.4. These show mean scores area, inguinal quadrants, lower lumbar region, gluteal area,
and severity of pain ratings for each point. Graph B, Fig. 75.5, groin and in some cases the soles of the feet (Fig. 75.6) [42].
shows the comparative mean pain ratings for each of the five This highlights the fact that pain arising from a very well-
groups. defined paraurethral region, unless palpated and symptoms
The palpation of urogenital, pelvic and paraurethral points reproduced, can be confused with, and attributed to, a range
showed that pain is limited to very specific points that can of other causes, including diseased organs, irritable bowel
reliably differentiate between asymptomatic and symptom- and endometriosis. Pain from the paraurethral area was
atic women. The pain points identified define CUP syndrome found to refer to distant locations well beyond the pelvic
disorders. Palpating these points not only reproduced the region.
pain but also the symptoms frequently reported and con- For women experiencing urinary urge (a sudden and irre-
firmed that pain is not a feature of asymptomatic women. sistible desire to void—a defining symptom of overactive or
On Map A, both the BPS and Vd cases reported high pain neurogenic bladder), this can be consistently reproduced
scores in the vestibular and urethral points. However, it was through manual palpation of specific points [49]. Palpation of
noted that even among the asymptomatic control group, the paraurethral area reproduced urge and desire to void in
some women reported discomfort and pain in the vestibule, both Vd and BPS cases. Most reported the urge to void as
which indicated that the vestibule is a very sensitive area for more distressing than pain associated with palpation. Women
all women and therefore may not be diagnostically as reli- with a diagnosis of Vd or BPS rarely speak of pain originating
75 A Myofascial Perspective on Chronic Urogenital Pain in Women 927
Fig. 75.1 Map A—urogenital pain map, identifying external assessment points
928 M. Jantos
Fig. 75.2 Map B—pelvic muscle pain map, identifying internal assessment points
from the paraurethral area, yet palpation of this area repro- In the symptomatic group, a subgroup of women reported
duced not only their pain but also symptoms of suprapubic clitoral pain (a localised form of Vd). Others reported symp-
pressure, burning, sharp stabbing pain as well as urge. The toms of persistent genital arousal, a form of unintended sex-
paraurethral area appears to be the primary generator of CUP ual arousal [50, 51]. Both of these symptoms were reproduced
symptoms yet is rarely tested during diagnostic assessments. by palpation of the paraurethral points. Even among
75 A Myofascial Perspective on Chronic Urogenital Pain in Women 929
s ymptomatic women who did not specifically report clitoral the paraurethral area. In none of the clitorodynia cases was
pain, palpation of these points produced pain radiating into clitoral pain ever reproduced by Q-tip testing of clitoral tissue
clitoral tissue. It appears that localised Vd, in the form of cli- or any other mapping points. On the basis of pain mapping,
torodynia, is a form of referred pain arising from soft tissue in clitoral pain and persistent genital arousal form part of the
Fig. 75.3 Map C—bladder pain map, identifying paraurethral assessment points
Fig. 75.4 CUP chronic urogenital pain. Mean scores and the severity of pain ratings for each point on Maps A, B and C
930 M. Jantos
Fig. 75.5 Pain mapping score comparisons for vulvodynia (VD), VD and bladder pain syndrome (BPS), BPS only, gynaecology group (Gyn) and
controls
CUP continuum originating from the paraurethral area. It is also interesting to note that the pain profiles of BPS and
Clitoral pain and persistent genital arousal both exemplify the Vd cases are almost identical [56, 57]. This suggests that BPS and
fact that symptoms affecting a given organ do not necessarily Vd may be one and the same disorder, varying only in terms of
originate from the organ but from soft tissue in a related ana- the topography of pain. Current diagnostic labels may reflect
tomical region and constitute a form of referred pain. more the medical specialties consulted, than the origins and
Unfortunately, the classification terminology used in rela- causes of CUP. As with most chronic pain conditions that have a
tion to clitorodynia, vestibulodynia, bladder pain syndrome myofascial basis, the source of pain can be elusive and difficult to
or urethral syndrome clearly implicates the organ as the localise as the source of pain is rarely found at the site of pain.
source and cause of pain. Cliterodectomies further confirmed Once the pain is localised, it ceases to be an illusive mystery [47].
that these symptoms were unrelated to the organ [52]. A pain mapping protocol fills a void in the clinical and
Likewise, reports of total removal of reproductive organs in research arena and sets a new benchmark for the study of the
a group of young women (16–30 years of age) did not elimi- origins of urogenital pain. The findings give significant cre-
nate or reduce their urogenital pain, highlighting the fact that dence to peripheral mechanisms of pain, in which pain of
organs are not the source of pain [53]. To identify the true soft tissue origin is palpable and, as such, potentially respon-
origin of CUP, all mapping points need to be examined, as sive to myofascial therapies [41, 42]. Pain mapping is cost-
patients are not able to identify the source of their pain and effective and bypasses a range of costly and invasive tests in
symptoms. the form of laparoscopies, ultrasounds and expensive imag-
Medical assessments generally do not include an exami- ing investigations that are not always sensitive to fascial dys-
nation of the musculoskeletal system and of the paraurethral function. By incorporating pain mapping into initial
area [42, 54]. In the case of Vd, they follow the traditional assessments, CUP no longer presents as a mystery and the
assessment criteria proposed by Friedrich and focus only on dreaded black box of medicine [47].
the vestibule [29, 30, 35]. Yet, as shown in the mapping stud-
ies, the vestibule should not be the sole source of diagnostic
information for differentiating asymptomatic women from 75.4 Exploring Mechanisms of Pain
other gynaecological cases. In the case of BPS, very few
studies have focused on the paraurethral area as being of Management of chronic pain is most effective when the
diagnostic significance, yet it is an important source of pain, pathogenesis and mechanisms are understood. To identify
and of diagnostic significance, and should not be overlooked potential mechanisms of pain, two methods of investigation
in CUP assessments [55]. can be used; one looks at the anatomical and functional
75 A Myofascial Perspective on Chronic Urogenital Pain in Women 931
Clitoris
3
Rectum
Vulva/Vagina 7 0
1 2
47 78 1 3
19 5
272 2
6
14 44
0
17
25 11 19
82 150
30 34 72
0 0
2 22
7
Perineum Bladder
75.5 Structure and Function of Fascia smooth muscle-like cells known as myofibroblasts that play a
key role in the regulation and recalibration of muscle and fas-
The fascial system invests organs, nerves, blood vessels and cial tonus. It is estimated that deep fascia contains ten times as
muscles and creates the immediate environment that either many sensory nerve receptors as muscle tissue itself and, on
ensures their optimal performance or mediates pain and dys- this account, plays a significant role in nociception [73].
function [63, 64]. As a fibrous communication system, it Based on functional imaging studies, an estimated 90%
conveys mechanical information to every cell within the of the slow-conducting, unmyelinated nerve fibres (C-fibre
body [65–68]. The body-wide fascial network houses the neurons) follow different pathways to the brain than those
microscopic ganglia that regulate the functioning of muscles, involved in proprioception. These are labelled as interocep-
organs and biological systems. For optimal performance a tors, which terminate not in the sensory motor cortex but
tensional balance must be maintained as any imbalance the insular cortex [71] which provides an emotional and
within its structure results in compensatory mechanisms that motivational context to the sensory information it receives.
involve the musculoskeletal system, the internal fascia, and Pain stimuli associated with injury or inflammation evoke a
progressively impacts the normal mobility and motility of sense of ill health and motivate relief-seeking behaviour.
organs [49, 69, 70]. When the body exhausts all possible Positive and pleasurable stimulation, such as sensual touch,
means of compensating, fascia loses its elasticity, and the mediates emotional, hormonal and affiliative responses. In
onset of pain can be sudden and unbearable [69]. Fascial this way the sense of wellbeing, or illness, is directly linked
restrictions lead to loss of muscle coordination and affect to the role of interoceptors originating within the fascial
organ peristalsis, and with densification there is greater pres- system [71].
sure on nerve endings and mechanoreceptors involved in Visceral (or internal) fascia is formed by the pleura and
proprioception, nociception and interoception [49, 71]. the peritoneum that extends from the cranium to the lower
These changes impact each of the biological systems; the torso. The normal tonus of visceral fascia is reliant on its
most sensitive of these is the enteric system [49]. anchorage in the bony tissue of the shoulder and pelvic gir-
The fascia forms four specialised layers that are identified dles [49]. This layer of fascia gives form to the four major
as superficial, deep, visceral and meningeal (the fourth layer internal cavities within the body (cervical, thoracic, abdomi-
will not be the focus of this discussion) [64]. These layers nal and pelvic). It holds each organ in its place and forms the
may blend and overlap with each other but differ in their conduit for the major neurovascular and lymph pathways.
structure and function. They remain linked together by reti- Visceral fascia wraps around each individual organ in a
nacula that transfer tensional forces between the layers [64]. double layer of membranous connective tissue consisting of
Superficial fascia acts as a sensory interface between the insertional fascia and investing fascia [49, 63]. The outer
external environment and the internal body. Deep fascia acts layer (insertional fascia) holds the individual organs in place,
as an interface between muscles, joints and organs, and attaching the organ to the wall of the cavity, and the inner
visceral fascia between organs, glands and the other fascial layer (investing fascia) encapsulates the organ and penetrates
layers. The visceral layer is directly implicated in organ dys- its internal structure [49]. Insertional fascia is much thicker
function via somato-visceral reflexes. This forms the basis of and more closely related to the mesenteries and ligaments
fascial manipulation therapies for internal dysfunction [49, that insert into the trunk wall. Embedded within its fibres are
69]. Therapy focuses on external muscles and fascia, which the extramural autonomic ganglia [49, 69]. Investing fascia
then impacts on visceral fascia. In the reverse order, organ is thinner and enters deep into the organ forming part of its
distress is communicated to muscles and skin via viscero- collagenic skeleton as it blends with the smooth muscles of
somatic reflexes that link organs with the deep and superfi- the organ. Within its structure rest the intramural autonomic
cial layers of fascia [49, 69]. ganglia that regulate the peristalsis of the organ. By this
Superficial fascia forms the subcutaneous soft tissue that means myofascial tension held in postural muscles can be
is highly malleable due to its lower density of collagenous relayed internally (via the somato-visceral connections), to
fibres and high adipose content [64, 72]. It provides form, the organ, impacting the organs’ peristalsis and normal func-
stores energy and hosts elements of the body’s endocrine and tion [49]. In the case of organ dysfunction, the reverse hap-
immune system as well as the estimated 80% of peripheral pens, with the visceral fascia communicating the organ’s
autonomic innervation which regulates the flow of blood and distress to the fascia of the trunk (via the viscero-somatic
lymph to the skin’s surface [64, 69]. Pain associated with the connections), changing the tensile characteristics of the
superficial fascia is only localised and does not refer to dis- abdominal wall and the lumbopelvic region, making it more
tant locations. restricted, rigid and irregular [49]. This close relationship
Deep fascia encapsulates individual muscle fibres and between muscle tissue and organs creates a two-way com-
invests into muscle tissue, providing stronger support, given munication system, which can lead to a muscle-organ- or a
its higher collagen content [58, 64]. Embedded within this net- muscle-systems-related dysfunction or, in the other direc-
work are various mechanoreceptors, interstitial receptors and tion, an organ-muscle dysfunction [49].
75 A Myofascial Perspective on Chronic Urogenital Pain in Women 933
75.6 Continuity of Pelvic Fascia compensatory mechanism that leads to pain. In a recent case,
a client suffered severe periumbilical and lower quadrant
The pelvis is a well-defined anatomical and functional pain with vomiting, caused by closed-loop small bowel
region, but not isolated from the rest of the body. From a obstruction and ischemia, associated with scar adhesions,
myofascial perspective, the musculoskeletal system and the following spinal surgery (spinal fusion on account of T11–
multiple layers of fascia provide continuity between the pel- T12 vertebral fracture). Lumbar micro-injuries and chronic
vic floor, the abdomen and the lower back, connecting the lower back pain have been shown to lead to pelvic pain and
pelvic region and its organs with the rest of the body. Muscle urinary symptoms of urge and frequency [77]. These can be
layers may generate tension enabling movement of limbs resolved by the release of restrictions and adhesions, as was
and maintenance of posture, but it is the fascia that forms the successfully achieved in the case of the patient with bowel
primary mechanism by which this mechanical tension is obstruction.
communicated with adjoining body regions, cavities, organs
and the body as a whole [64, 65].
The anatomical structure of the pelvic floor consists of 75.7 R
ole of Fascia in Chronic
four principal layers: the endopelvic fascia, the muscular Urogenital Pain
pelvic diaphragm (the levator plate), the perineal membrane
(urogenital diaphragm) and the superficial transverse perinei The mechanisms of chronic pain are closely related to the
[74]. These four layers of the pelvic floor are further delin- tensile properties of fascia, namely, its malleability and plas-
eated by three layers of fascia [75, 76]. Each of these three ticity [78]. These characteristics are influenced by tempera-
layers forms a continuum that extends from the lower ture, hydration, metabolic fluctuations, injury, surgical
abdominal area; incorporates the pelvic muscles, its anatom- trauma, infections, inflammatory states, muscle overactiva-
ical structures and organs; and traverses up to the lumber tion, emotional stress, sex hormones, physical inactivity, pH
area [75, 76], as seen in Fig. 75.8. and other variables [67, 79–85]. Of this long list, the two that
The fascial continuity between the pelvic floor and the form the focus of this discussion are soft tissue inflammation
abdominal and lumbar region highlights the anatomical con- and muscle overactivation.
nections and potential direction in which tension is commu- Skeletal muscles, and to a lesser degree smooth-like mus-
nicated. Back, groin and limb pain are often linked to pelvic cle tissue embedded in the fascia, generate most of the ten-
pain [77]. Compensation patterns may arise anywhere in this sion in the fascial system. In the case of endopelvic fascia, it
continuous sequence, in response to an initial trauma, scar is closely integrated with the pelvic diaphragm, consisting of
tissue, irritation or inflammation. Abdominal, pelvic or lum- the levator ani and coccygeus muscles [72, 86]. Tension gen-
bar surgery can disrupt fascial continuity and can lead to a erated by pelvic muscles sets the basal tone for the whole
934 M. Jantos
pelvic region, including its tendons and ligaments, organs lumbar and pelvic region form the immediate environment
and systems. The endopelvic fascia serves as both a conduit of organs and impact organ peristalsis [49, 69, 90].
over which the major organs and systems receive their blood The peristalsis of organs is a local phenomenon, mediated
supply and innervation and as a tensional network. The for- exclusively by the microscopic ganglia in the insertional fas-
mer affects perfusion, nerve conductance and lymph drain- cia [69]. The extramural and intramural ganglia of the auto-
age, and the latter impacts the autonomic ganglia that nomic nervous system act as a peripheral brain, regulating
regulate organ peristalsis. Ischemia and inflammation are the organ and gland function. The insertional fascia is highly
most common precursors to chronic pain [79]. These changes reactive to changes in tension [69, 74–76]. The dysregulation
arise in response to a prolonged state of muscle contractility, of bladder pacemaker action is a sign noted in 70% of BPS
hypoxia and the release of sensitising substances [87]. patients [88]. Micro-motions in the bladder serve as an inter-
Tension in the endopelvic fascia can be generated by both esting example of a potential relationship between non-
physical and psychological triggers. It is very susceptible to relaxing pelvic muscles, increased tension in fascia and
inflammation, with persistent or reoccurring inflammation peristalsis of the organ [91]. The bladder wall engages in
causing long-term fascial restrictions [79]. Prolonged sympa- periodic slow movements, similar to those of gastrointestinal
thetic activation stimulates the immune system to release pro- peristalsis. These movements are modulated by intramural
inflammatory cytokines. The expression of the cytokine myenteric plexuses, which regulate contracting segments,
TGF-β1 stimulates myofibroblast production that is linked to consisting of bundles of smooth muscles working as inter-
fascial contractility. Under laboratory conditions, even very linked functional units. An increase in micro-motions results
low concentrations of this cytokine elicit tissue contraction in exaggerated sensations from the bladder, even in the
[79]. Myofibroblasts develop out of regular fibroblasts but absence of any detected changes in bladder pressure, giving
contain α-smooth muscle actin (ASMA) stress fibre bundles. rise to pathological sensory urge. In the absence of micro-
These are a special phenotype of fibroblasts, identified as pho- motions, on the other hand, there may be a decrease in sensa-
tomyofibroblasts, which consist of highly contractile cells that tion and increased post–void residual urine [91]. When
are four times stronger than regular fibroblasts. comparing asymptomatic women with those experiencing
Photomyofibroblasts produce crimping-like contractures increased bladder sensations (overactive bladder) and pain,
within the fascia, which impact the mechanosensory regula- patients showed significantly higher prevalence of micro-
tion and motor-neuronal reflexes. Though slower and weaker motions, which were associated with increased urge. Given
than skeletal muscle contractions, they lead to collagen remod- that intravesicular pressure changes were not the main deter-
elling and long-lasting tissue contracture [79]. When biopsied minant, it is likely that altered myogenic properties within
tissue taken from chronic pain sites was tested, it showed two the smooth muscle cells influenced their excitability [91].
types of cells: smooth muscle cells, which are involved in the This highlights a potential relationship between the immedi-
formation of blood vessels, and myofibroblasts, which are ate environment and detrusor muscle function. Factors exter-
commonly found in wound healing and pathological tissue nal to the bladder can impact on the myenteric plexuses and
contractures [79]. These findings are consistent with CUP in the pacemaker cells regulating the initiation and coordina-
which inflammatory markers, mast cells, neuropeptides and tion of bladder function. With evidence of non-relaxing mus-
nerve growth factor levels, consistently differentiate between cles in an overactive bladder [21, 62], it seems likely that
BPS and Vd cases and controls [4, 57, 88]. increased fascial tension may be a contributor to bladder
Other stimulants that may increase myofibroblast con- dysfunction. Case studies of an overactive bladder, where
tractility include lower pH of interstitial fluids, sexual hor- lack of detrusor adaptability was shown to be linked to
mone activity, consumption of acid-producing foods, altered fascial tension, responded positively to fascial manip-
dehydration and disordered breathing (commonly associated ulation, with symptoms of overactivity and bladder pain
with emotional distress); all of these can exacerbate pain resolved at the conclusion of a short period of treatment [77].
[82]. With the half-life of collagen estimated at 300–500 days Undoubtedly, a range of other factors in the regulation of the
[58], long-term change requires intensive therapy focused on bladder can also have impact [92, 93].
softening of fascia, followed by education and lifestyle
changes [89].
75.9 Role of Non-relaxing Muscles
75.8 Fascial Tonicity and Organ Function It is estimated that 50–80% of patients with any form of pel-
vic pain present with non-relaxing pelvic floor dysfunction
The myofascial perspective on organ dysfunction shifts the and myofascial pain [94]. At times, symptoms are attributed
focus from the organ to its immediate environment [63]. The to specific muscles (e.g. levator ani syndrome, piriformis
non-relaxing muscles and investing fascia of the abdomen, syndrome or obturator internus syndrome); however, overac-
75 A Myofascial Perspective on Chronic Urogenital Pain in Women 935
tivation of pelvic muscles goes beyond an individual muscle. The overactivation of muscles has other important impli-
Muscles work in synergistic patterns and form continuities, cations for pain mechanisms. Non-relaxing muscles create
in the same manner as fascia and the resulting generalised an energy crisis within local soft tissue. As muscles shorten
tension-holding patterns are best described by the term “non- and bulk up, they create an ischemic state, which results in a
relaxing” muscles [94, 95]. sensation of burning and stabbing-like pain. A muscle con-
The resting tone of pelvic muscles determines the basal tracting at 30–50% of its maximum contraction closes off
tone of the overlying fascia [49]. The primary structural dif- arterial supply and venous blood outflow [100]. This
ference between muscle and fascia is their collagen con- contraction-ischemia cycle progressively escalates and alters
tent—muscles have less collagen but stronger contractile the physiology of local tissue with a functional shortening of
mechanisms. When muscles contract, the fascial tissue in the muscles and formation of muscle contractures [41, 101].
proximity of the contracting muscle bulks up with the mus- These morphological changes are gradual and present with a
cle and increases in thickness by 26% [96]. As the fascia chronology of symptoms that may date back to early child-
overlaying the muscles shortens, the adjoining fascia under- hood, and occur in the absence of pain but are evident in
goes a selective spatial stretching, transmitting the tension in urinary voiding and defecatory disorders. Pain may not be an
multiple directions both longitudinally and laterally [90]. initial feature but becomes evident in time or is triggered by
Approximately 70% of muscle-related tension transmission a noxious event.
is directed through tendons, and the remaining 30% of mus- Triggers can include obstetric trauma and pelvic surgery
cle force is transmitted to the connective tissue in the imme- [94, 102]. Where women present with already overactive
diate surrounding of muscles [97]. In this manner muscles, surgery can further exacerbate this problem. Most
non-relaxing pelvic muscles generate tension not only in pelvic surgeons are aware that “… if a patient has a history
parallel but also laterally, and this changes the anatomical or findings compatible with pelvic floor tension myalgia and/
dynamics in a nonspecific, generalised way, across the whole or hypertonic dysfunction we must avoid doing surgery that
pelvic region. involves attaching or anchoring the support of prolapsed
When non-relaxing muscles augment tension in the pel- organs to these muscles” [102]. Pelvic repair mesh or place-
vic region, it impacts organs and systems, especially those in ment of permanent sutures in fascia or muscle tissue creates
close proximity. Pelvic organs do not function in isolation, a formidable risk of pain. Other common triggers include
and simply rest on PFM, but form an integral part of the pel- stress-related bracing, poor posture and occasionally inap-
vic floor: propriate physical therapy, where the focus is on muscle
… the pelvic organs are often thought of as being supported by strengthening rather than relaxation.
the pelvic floor, but are actually a part of it. The pelvic viscera
play an important role in forming the pelvic floor through their
connection with structures such as the cardinal and uterosacral 75.10 S
urface Electromyography in Studies
ligaments. [98]
of Pelvic Floor Muscles
When considering this at the microscopic level, the fascia
that interacts with muscle spindles within muscle tissue also SEMG is a noninvasive, objective technique used for a func-
interacts with the neuronal network of the organs, creating an tional assessment of PFM [103]. It is also a common modal-
interactive kinetic chain in the pelvic region, similar to that ity used for pelvic muscle rehabilitation and reeducation.
of every other body cavity [49, 69]. The SEMG signal reflects the summation of all action poten-
A pathology common to non-relaxing muscles is increased tials that are propagated along the various muscle fibre types
stiffness and rigidity of fascial tissue. Increased uptake of col- in muscle tissue. If the focus is on single or multiple motor
lagen along tensional lines and the densification of loose con- units, the action potentials are best recorded by means of fine
nective tissue between fascial layers sets in motion a gradual needle EMG recordings [104]. If larger muscles are assessed,
and insidious process, evident with the onset of pain. As non- the preferred means is surface electrodes. SEMG tracings
relaxing muscles lose their contractility and extensibility, the show the resting tone, recruitment and fine coordination of
fascia loses its plasticity. When all possible means of com- various muscle fibres. No other technique makes possible an
pensating for localised tension have been exhausted and soft accurate and objective functional assessment of pelvic
tissue has become rigid, the onset of pain can be sharp and muscles.
sudden. Densification of tissue places pressure on the mecha- In the case of BPS and Vd, intravaginal SEMG probes are
noreceptors and free nerve endings embedded in myofascial used for signal acquisition, as illustrated in Fig. 75.9. The
tissue, and this gives rise to further irritation and muscle over- vaginal probe has a vertical electrode configuration that
activation as well as a lowering of pain thresholds and comes in contact with fibres of the puborectalis-
increased sensitivity to any external pressure application pubococcygeus muscle. The shape of the probe features a
(allodynia) as is the case with CUP disorders [49, 78, 99]. small t-bar at the base, to ensure repeatability of measure-
936 M. Jantos
PELVIC DIAPHRAGM - SEMG PROBE VIEW vation, coordination of muscle fibre type during muscle acti-
vation, amplitude during phasic (fast-twitch mediated) and
tonic (slow-twitch mediated) contractions, neuromuscular
stability as measured by variability of signal and muscle
endurance and fatigue as reflected in median and mean
spectral frequencies [32]. Each of these variables provides
insight into the nature of muscle dysfunction, in particular
muscle insufficiency (hypotonicity) as in the case of incon-
tinence, or muscle overactivation as seen in non-relaxing
muscles (hypertonicity), in chronic pain disorders. Patterns
of muscle substitution, co-contraction, spasms, tremors and
psychophysiological tonus (emotional arousal), these can be
appraised with the assistance of SEMG. It is important to
emphasise that SEMG signal is not a direct measure of
weakness, muscle strength or pain, but different features of
the derived signal correlate strongly with various symptoms
[99, 103, 105].
a
26
24
22
20
18
16
14
12 Low level of contraction Fatigue
Elevated rested baseline
10
(non-relaxing muscle)
8
6
4
2
Poor recovery & instability
0
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:2
:2
:3
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b Good recruitment & recovery Increased contraction amplitude
26
24
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20
Decrease in
18
resting baseline &
16 signal variability
14
12
10
8
6
4
2
0
32
35
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41
44
47
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53
56
59
02
05
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29
0:
0:
0:
0:
0:
0:
0:
0:
0:
0:
1:
1:
1:
1:
1:
1:
1:
1:
1:
1:
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Fig. 75.10 (a) Surface electromyography (SEMG) tracing, female 0–26 μV). (b) SEMG tracing of posttreatment assessment of the same
nulliparous, age 24 years, primary Vd, with an early onset of symptoms client, following biofeedback-assisted muscle retraining, showing nor-
(prior to commencement of sexual activity). The pretreatment SEMG malisation of muscle function, with good resting baseline, excellent
assessment shows two phasic and two tonic contractions, illustrating an recruitment and recovery, increased contraction amplitude and experi-
elevated resting baseline (approximately 50% of maximum voluntary encing a pain-free state (scale range 0–26 μV)
contraction), variability (irritability) and muscle fatigue (scale range
Chronic overactivation of pelvic muscles progressively or totally resolved symptoms of Vd, in 80–90% of patients
leads to painful decompensating and peripheral sensitisation, [101]. The normalisation of pelvic muscle function is illus-
most often described as burning pain [106]. trated in Fig. 75.10a, b showing the pretreatment and post-
In studies of SEMG-assisted retraining, patients reported treatment SEMG tracings.
an 83% reduction in symptoms [107]. In a study conducted When SEMG findings were compared with manual assess-
by the author involving 529 Vd patients, SEMG-assisted ments carried out by trained physical therapists, women with
retraining, in conjunction with myofascial therapy, alleviated Vd symptoms presented with superficial and deeper pelvic
938 M. Jantos
26
24
22
20
Low level of contraction
18
16 Fatigue
14
12
10
8
6
4
Elevated resting baseline
2 (non-relaxing muscle) Poor recovery & instability
0
6
3
:4
:4
:5
:5
:5
:0
:0
:0
:1
:1
:1
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Fig. 75.11 Female, nulliparous, 22 years of age, adolescent onset of bladder pain syndrome symptoms. Pretreatment surface electromyography
assessment of two phasic contractions and two tonic contractions (scale range 0–26 μV)
floor muscle hypertonicity, reduced muscle strength, inability toms was associated with progressive relaxation of pelvic
to relax and restrictions in the degree of vaginal stretch [108]. muscles, with a 65% reduction in SEMG resting tone (from
The study found that 90% of the women experiencing pain 9.73 to 3.61 μv) [19]. Both BPS and Vd cases share similar
with intercourse demonstrated pelvic floor pathology and SEMG profiles, confirming that the disorders constitute the
associated comorbidities that included irritable bowel, evacu- same regional pain syndrome.
ation difficulties and anal fissures. Advanced SEMG intravaginal probes and customised soft-
There are very few SEMG studies profiling patients with ware systems can add further sophistication enabling multi-
bladder pain. The studies that used SEMG assessments and channel assessments of PFM. Measures of muscle asymmetry,
physical exams found the same dysfunctional muscle pat- and dynamic studies evaluating the impact of movement and
terns including overactivation, inadequate voluntary control, posture on pelvic muscle function provide more insight. In
muscle shortening and trigger point referred pain [19, 103]. postpartum women, asymmetries at multiple muscle sites are
These features were not only seen as associated with bladder associated with birth-related muscle dysfunction as illustrated
pain syndrome but were seen as causing symptoms of blad- in Fig. 75.12. These tracings were obtained from a 60-year-
der pain [19]. These findings were confirmed by a study of old, following two pregnancies and two births in her mid- to
BPS, where a physical examination was carried out by late 20s. The most evident pattern is a 50–70% asymmetry in
trained nurse practitioners, who identified non-relaxing mus- muscle tone, reflecting weakness in the right pelvic muscles
cles, and myofascial trigger point pain which reproduced the (the right pubococcygeus and right iliococcygeus).
patients’ symptoms. The study noted that levator muscle ten- Four-channel SEMG assessments of the pelvis comple-
derness and palpable taut muscle bands elicited pain in the ment assessments carried out with ultrasound or scanning
bladder, vagina, vulva and perineum [62]. The pain mecha- technologies.
nisms were similar to those reported in Vd studies.
Figure 75.11 illustrates the level of PFM overactivation as
seen in a SEMG assessment of a female patient with a history 75.12 Conclusion
of bladder pain symptoms, with urge and frequency. The
22-year-old patient had undergone two hydrodistentions, both CUP is a prevalent problem that affects a disproportionately
reported as very painful, but provided no symptom relief. high number of women. Traditionally, care providers have
Non-relaxing pelvic muscles as seen in this BPS case are looked for tissue trauma or pathology to explain the symp-
characterised by a continuous state of mild contraction. The toms. With the development of a pain mapping protocol, a
level of overactivation is approximately 50–70% of that of a more pragmatic, mechanisms-focused approach to assess-
maximal voluntary contraction. A reduction of BPS symp- ment is possible. Pain mapping, as a tool, can assist in local-
75 A Myofascial Perspective on Chronic Urogenital Pain in Women 939
30
20
10
0
00:00:00 00:00:05 00:00:10 00:00:15 00:00:20 00:00:25 00:00:30 00:00:35 00:00:40 00:00:45 00:00:50 00:00:55 00:00:60
30
20
10
0
00:00:00 00:00:05 00:00:10 00:00:15 00:00:20 00:00:25 00:00:30 00:00:35 00:00:40 00:00:45 00:00:50 00:00:55 00:00:60
Fig. 75.12 Four-channel surface electromyography tracing exemplifying asymmetries: (a) right pubococcygeus; (b) left coccygeus; (c) right
iliococcygeus; and (d) left iliococcygeus. EMG RMS electromyography rigth muscles
ising the source of pain and linking symptoms to peripheral Traditionally, the presence of comorbidities and the over-
soft tissue anomalies. Historically, the association of dys- lap of CUP symptoms were explained on the basis of central
functional pelvic muscles and CUP has been well estab- sensitisation and nerve-mediated cross-talk. Though not dis-
lished. Whether by means of manual assessment, scanning or counting a central component in chronic pain, the fascial ten-
SEMG technologies, studies consistently confirm the pres- sional system, conceptually and clinically, provides a more
ence of non-relaxing muscles in CUP disorders. However, logical mechanism in terms of organ pathophysiology,
the question of how non-relaxing muscles relate to organ comorbidities and concurrent symptoms in the urinary,
dysfunction and symptoms of pain has not been addressed reproductive, digestive and musculoskeletal systems.
and requires a closer examination of the body-wide fascial Histology findings identifying the presence of ischemic
system. and inflammatory markers at chronic pain sites establish a
Fascia has been the most overlooked anatomical structure link between fascial, the limbic and immune systems.
in relation to chronic pain. Its various layers (superficial, Triggers, whether iatrogenic, mechanical, infectious, chem-
deep and visceral) are densely innervated with interstitial ical or emotional, set in process morphological changes that
and mechanoreceptors. The free nerve endings communicate lead to peripheral sensitisation and central nervous system
nociceptive information to the sensory motor cortex, but, involvement. The pathophysiological progression of chronic
more importantly, target the insular cortex, shaping proac- pain requires that intervention be directed first and foremost
tive, health-related behaviour and influencing the individu- to peripheral mechanisms. Any frontline intervention which
al’s sense of illness or wellbeing. bypasses the peripheral mechanisms and focuses only on
940 M. Jantos
GENERAL TRIGGERS
latrogenic
Mechanical/Chemical/Metabolic
Infectious/Hormonal/Emotional
(Sensory Interface – Fascia System)
NON-RELAXING MUSCLES
Generate Tension
Energy Crisis
Neuromuscular Instability/Fatigue SOM
IC ATO
MAT Muscular Contracture
-SO
-SO MA
ERO (Sensory Interface – Deep Fascia)
TIC
SC
VI
ORGAN DISTRESS FASCIAL PLASTICITY
Restriction in Visceral Mobility CHRONIC Restrictions /Densification/Remodelling
Dysregulation of Peristalsis Compression of Mechanoreceptors
Referred Pain /Autonomic Reactions UROGENITAL Motor-neuronal Excitation
(Sensory interface - Visceral Fascia) PAIN Autonomic Dysregulation
Organ/Gland Distension (Sensory Interface – Fascial System)
VI
SC PATHOPHYSIOLOGY L
ER RA
O- Pro-inflammatory Mediators E
VIS SC
CE Neuroproliferative Changes -VI
RAL ATO
Hypervascularity SOM
Peripheral & Central Sensitization
Pain
THERAPY
Myofascial Assessment
Pain Mapping & SEMG
Normalize Muscle Function
Myofascial Mobilization
Education and Stress Management
Fig. 75.13 Myofascial model of chronic urogenital pain. SEMG surface electromyography
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researchers and colleagues. Special thanks and appreciation to Drs chronic pelvic pain: EAU guidelines. Arnhem, The Netherlands:
Sherie Johns and Ewa Baszak-Radomańska for their research contribu- EAU Guidelines Office; 2014.
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Pharmacological Treatment of Chronic
Pelvic Pain 76
Ashish Shetty, Oscar Morice, and Sohier Elneil
Nonsteroidal anti-inflammatory drugs (NSAIDs), revers- endometriotic tissue and the suppression of ovarian func-
ible inhibitors of COX-1 and 2 enzymes, also relieve pain tions; COCPs come as pills, transdermal patches or vaginal
around menses, as well as menstrual flow, and moderate rings [21]. A large cohort study following an approximate
chronic pelvic pain [9, 11, 12]. Interestingly, despite the 17,000 women for over 20 years estimates the risk reduction
diversity of molecular derivatives that constitute NSAIDs, noof endometriosis with women taking the pill at 60%, demon-
specific subtype is more effective at reducing primary dys- strating the effectiveness of this treatment in suppressing
menorrhoea than others [9]. Chronic use is however associ- endometriosis and the pain associated with it [22]. Oral con-
ated with substantial cardiovascular, gastrointestinal, renaltraceptive pills are also effective in relieving noncyclic
and hepatic side effects [13]. Traditional NSAIDs inhibit chronic pelvic pain, dyspareunia and dysmenorrhoea follow-
both classes of cyclooxygenases and are therefore deemed ing surgical excision of endometriomas, with their continuous
nonselective; the inhibition of COX-2 enzymes is thought to use superior at relieving pain associated with menses [23].
mediate the anti-inflammatory effects, whereas the gastroin- Progestogens and synthetic progestogens (progestins)
testinal side effects appear to be related to the inhibition of
may be used for those who fail to tolerate combined hor-
COX-1 enzymes. Selective COX-2 inhibitors have therefore monal contraceptives. Preparations are available orally, par-
been developed, reducing significantly the risk of peptic enterally, as an implant or as an intrauterine delivery system,
ulceration. One such agent, celecoxib, improves pain scores with a wide variety of chemically related compounds avail-
in men diagnosed with chronic pain pelvic syndrome, though able. These agents inhibit the transcription of angiogenic
symptomatic relief is limited to the duration of treatment factors, suppress matrix metalloproteinases-mediated endo-
[14]. There is growing evidence that this class of NSAIDs metrial growth and induce intrauterine and extrauterine atro-
increases cardiovascular risks in the management of chronic phy of endometrial tissue [24, 25]. Norethindrone acetate, a
pain in the elderly, further limiting their use [15]. 10-nortestosterone progestin, relieves pain associated with
Paracetamol, whose mechanism of action remains largely rectovaginal endometriosis, whilst subcutaneous depot
unknown, does not provide effective relief when used on its medroxyprogesterone acetate effectively controls
own; evidence suggests that this compound may have a endometriosis-associated pain [26, 27]; the levonorgestrel
cumulative effect when used with caffeine or a NSAID, pro- intrauterine system on the other hand provides a route to
viding moderate relief of menstrual pelvic pain [16, 17]. deliver progestogen directly into the uterine cavity at a steady
Chronic use of this compound is however associated with rate for a 5-year period and has proved effective in treating
substantial hepatic and gastrointestinal complications [18]. menorrhagia, adenomyosis and pelvic and rectovaginal
Opioids are increasingly discouraged in chronic non- endometriosis, with a low side effect profile due to reduced
malignant pain as the risks likely outweigh the benefits, as a
systemic levels [28, 29].
result of significant adverse effects including sedation, con- Gonadotropin-releasing hormone agonists work by con-
stipation, urinary retention, falls and reinforcement disorders
tinuously stimulating the anterior pituitary, initially trigger-
[19]. These compounds act on three types of G-protein- ing a burst of luteinising (LH) and follicular stimulating
coupled receptors (μ, κ, δ), expressed pre- and postsynapti- hormones (FSH), to inhibit their production; this induces a
cally in the brain and spinal cord, thus affecting nociceptive
hypogonadotropic hypogonadal state akin to menopause,
transmission along the pain neuroaxis. There is currently no resulting in amenorrhoea and endometrial atrophy [30]. This
evidence to support the use of this class of compounds in class may be given intramuscularly, intranasally or subcuta-
chronic pelvic pain [20]. neously. GnRH agonists relieve 50–90% of endometriosis-
related pain, with an efficacy comparable to surgical
treatment in alleviating dysmenorrhoea and dyspareunia
76.3 Hormonal Treatment associated with endometriosis [31, 32]. GnRH agonists are
however associated with significant vasomotor symptoms,
A range of hormonal treatments are available to treat condi- sleep disturbances and accelerated bone loss related to the
tions associated with chronic pelvic pain, including combi- hypoestrogenic state; combined oestrogen and progestin hor-
nation formulas of oestrogens and progestogens, in the form mone add-back regimens reduce these adverse effects with-
of the combined oral contraceptive pill (COCP), the out compromising efficacy [33, 34].
progesterone-only pill, slow-releasing levonorgestrel- Androgens, deemed as effective as GnRH agonists at
containing intrauterine systems (IUS), gonadotrophin- relieving pain associated with menses and pelvic pain, sup-
releasing hormone (GnRH) agonists and androgens. These press the release of pituitary gonadotrophins, steroid ovarian
agents are generally deemed safe, affordable, reversible and production and the growth of endometriotic implants [30,
convenient, with a relatively low side effect profile. 35]. Their systemic use induces a hyperandrogenic state,
The commonly used combined oral contraceptive pill associated with acne, hirsutism, deepening of the voice, cli-
relieves pain by inducing the decidualisation and atrophy of macteric hot flushes, oedema and weight gain [36]. To reduce
76 Pharmacological Treatment of Chronic Pelvic Pain 947
systemic effects, topical preparations of danazol, a 17-ethinyl very limited. The selective serotonin-noradrenaline reuptake
testosterone derivative, have been developed: vaginal or inhibitor (SNRI) duloxetine increases centrally available
intrauterine applications effectively reduce menorrhagia and noradrenaline and serotonin in descending modulatory pain
the size of the lesions in recurrent deeply infiltrating endo- pathways and has proved effective in urological pain disor-
metriosis, with a lower side effect profile [37]. ders in men and women [52]. On the other hand, sertraline, a
selective serotonin reuptake inhibitor (SSRI), fails to improve
pain scores in women with chronic pelvic pain in a small
76.4 Local Anaesthetics crossover trial [53].
pelvic floor pain and dyspareunia when used as an adjunct of Urology. The 2013 EAU guidelines on chronic pelvic pain: is
management of chronic pelvic pain a habit, a philosophy, or a sci-
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76.8 Conclusion 8. Marjoribanks J, Proctor ML, Farquhar C. Nonsteroidal anti-
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expert opinion algorithms are essentially derived from mary dysmenorrhoea: a systematic review. Br J Obstet Gynaecol.
empirical knowledge due to the scarcity of the literature, 1998;105:780–9.
11. Daniels J, Gray R, Hills RK, Latthe P, Buckley L, Gupta J, Selman
warranting the need to conduct larger randomised clinical T, Adey E, Xiong T, Champaneria R, et al. Laparoscopic uterosac-
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mal in management of chronic pain conditions. For now, a 12. Jarrell JF, Vilos GA, Allaire C, Burgess S, Fortin C, Gerwin R,
Lapensée L, Lea RH, Leyland NA, Martyn P, et al. Consensus
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physical therapy, psychotherapy, lifestyle changes and neu- Gynaecol Can. 2005;27:781–826.
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14. Zhao WP, Zhang ZG, Li XD, Yu D, Rui XF, Li GH, Ding
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Idiopathic Chronic Pelvic Pain:
A Different Perspective 77
Peter Petros and Yuki Sekiguchi
dollars p.a.; the reported time lost from paid work was 15%
Learning Objectives with 45% reduced work productivity [3].
• “Idiopathic” chronic pelvic pain (CPP) co-occurs The pathogenesis of “idiopathic” chronic pelvic pain
with bladder and bowel symptoms and is mainly (ICPP) is still not well understood. One theory is that ICPP
caused by inability of lax uterosacral ligaments is thought to be associated with changes in the central ner-
(USLs) to support the Frankenhauser and sacral vous system which may maintain the perception of pain in
plexuses. the absence of acute injury. Such changes may magnify per-
• Gentle insertion of the lower blade of a bivalve ception: nonpainful stimuli are perceived as painful (allo-
speculum into the posterior fornix will partially dynia); painful stimuli are perceived as more painful than
relieve the pain in approximately 70% of women, expected (hyperalgesia) [4]. It is hypothesized that there is
demonstrating USL causation. both peripheral and central hypersensitization [4]. Peripheral
• A high cure rate for CPP in younger women can be hypersensitization describes augmented sensory pain input
expected by USL plication. Older women are less from the peripheral nervous system. Central hypersensitiza-
likely to be cured by USL plication and may require tion describes a predisposition to dysfunctional central regu-
a posterior sling. lation of the sensory input [5]. In parallel, there are
accompanying symptoms, for example, urinary symptoms
or, frequently, psychosocial symptoms.
According to the Cochrane database, the main treatments
77.1 Introduction at present available include counseling, psychotherapy,
physical therapy, medications, psychosomatic therapy, lapa-
The International Continence Society defines chronic pelvic roscopic uterine nerve ablation, presacral neurectomy, and
pain syndrome as “Genitourinary pain syndromes are all hysterectomy, with or without removal of the ovaries [6]. Not
chronic in their nature. Pain is a major complaint but con- mentioned is the role of lax uterosacral ligaments (USLs) in
comitant complaints are of lower urinary tract, bowel, sexual the causation of ICPP. This has been known since 1996 [7] in
or gynecological in nature where there was no infection or the English literature and since 1938 in the German literature
other obvious pathology” [1]. Chronic pelvic pain occurs in [8]. In 1938 Heinrich Martius stated that “in about 30% of
19% of adult Europeans [2]. The health costs of chronic pain cases, backaches are provoked by damaged suspending or
to the community are significant: hundreds of millions of supporting ligaments of the pelvic organs” [8].
Idiopathic chronic pelvic pain is part of a specific symp-
P. Petros (*) tom complex known as the “posterior fornix syndrome” [9].
University of NSW Professorial Department of Surgery, It is caused by lax apical support. This syndrome, reported
St Vincent’s Hospital, Sydney, NSW, Australia for the first time in 1993, (variously) encompasses chronic
School of Mechanical and Chemical Engineering, pelvic pain, bladder symptoms of urgency, abnormal empty-
University of Western Australia, Perth, WA, Australia ing, and nocturia [9]. Such patients rarely present with single
e-mail: pp@kvinno.com; http://www.integraltheory.org
symptoms. These symptoms occur in predictable groupings
Y. Sekiguchi (Fig. 77.1). A detailed description of lower abdominal pain
Women’s Clinic LUNA, Yokohama, Japan
was reported in 1996 by ANZJOG [7]: “In its acute state of
Yokohama City University Graduate School of Medicine, manifestation, the pain was invariably severe, frequently
Yokohama, Japan
one-sided, situated low in the right or left iliac fossa, usually
e-mail: dumbo-ys@d9.dion.ne.jp
relieved on lying down, frequently relieved by insertion of a was too small, it fell out, or no effect was noted: if too large,
ring pessary, and reproducible on palpating the cervix and the symptoms frequently worsened.” Significant cure of
displacing it posteriorly with the patient in the supine posi- these symptoms was achieved by plication of the uterosacral
tion. Although the pain was chronic in nature, it varied con- ligaments (Fig. 77.2) [7]. Initial cure rate for these different
siderably from time to time as concerns intensity. Six patients pain manifestations by USL “native tissue” repair performed
(two of whom were nulliparas) entered the study through the under local anesthesia/sedation was 85% but subsequently
Emergency Department. The pain had become sufficiently fell rapidly. This was attributed to collagen defect in the
acute as to seek emergency care. Almost all patients com- ligaments.
plained of tiredness and irritability by the end of the day. A
ring pessary considerably relieved the symptoms in approxi-
mately half of the patients, but on occasions, if the pessary 77.2 T
he Present Scope of ICPP: Presence
of Other Symptoms
127
Fr
e
Theory Symptom
yi
nc
pt
Questionnaire (ITSQ).
ne
Em
e
nc
nti
ine
co
d
nt
ad
N
l In
es
oc
co
Bl
non-hysterectomy patients.
SU
i
ca
68
du
t
O
In
ur
D
I
al
Fe
ia
63 66 56
Ur
rin
incontinence 44
954 P. Petros and Y. Sekiguchi
Ganglion
Frankenhäuser
Sacral
pathway
Ganglion
Frankenhäuser
77.4 USL Laxity as a Cause of CPP language as a vehicle of science. Many important historical
writings became unavailable to the now dominant Anglophone
The etiology of USL laxity is generally attributed to age- or scientific community. Amongst the lost and forgotten works
birth-related collagen damage or hormone-induced depoly- were the pre-war German language writings of Heinrich
merization during pregnancy; the weakened ligament is then Martius on the role of loose uterosacral ligaments in the cau-
stretched during childbirth; if there is failure of the ligament sation of chronic pelvic pain. It is an accident of fate that
to return to normal length and strength in the post-op period, these writings were recently brought to the surface by
it may result in the prolapses and symptoms depicted in Professor Klaus Goeschen [21]. Goeschen was trained in
Fig. 77.1. gynecological surgery by Gerhard Martius, son of Heinrich.
The concept that ICPP originates in the sacral (S2-4) and He had the knowledge and access to the literature needed to
Frankenhauser nerve plexuses is not new. The anatomical recover these ‘lost’ writings. In 2015 Goeschen wrote: “Since
basis for this pain was described in the 1930s by Professor some decades, Heinrich Martius published in the German lit-
Heinrich Martius from Gottingen, Germany [8] (Fig. 77.4). erature that in about 30% of cases, backaches are provoked
Competent USLs support the nerve plexuses. They also pro- by damaged suspending or supporting ligaments of the pelvic
vide a firm contraction point for the posterior pelvic muscle organs. The paired “Ligamenta recto-uterina”, which are
vectors. These stretch the ligaments, further enabling USL connected via paraproctium to the bony sacrum und therefore
support of the nerve plexuses. How USL causation of CPP in general are termed “plica or ligamenta sacro-uterina” or
was “rediscovered” is described in the September 2017 “USL”, are placed in the centre of numerous pathophysiolog-
Editorial in Pelviperineology Journal [17]: WWII was cata- ical considerations. Unfortunately, Martius’s concepts have
strophic for German science and especially for the German remained largely unknown in the English literature. In 1993,
77 Idiopathic Chronic Pelvic Pain: A Different Perspective 955
Petros and Ulmsten independently described ICPP as being holding forceps with a gauze or a large menstrual tampon
caused by lax uterosacral ligaments as part of the “Posterior and observing the change in pain symptoms. The key prin-
Fornix Syndrome”, along with other pelvic symptoms, noctu- ciple is to gently support the USLs as they enter the cervical
ria, urgency, abnormal emptying. They reported a significant ring, not to stretch them. Any pushing usually worsens the
cure rate of ICPP and other posterior fornix symptoms fol- symptoms, which is, of course, another type of proof that the
lowing repair of the uterosacral ligaments. Petros wrote a pain originates in the anatomical position of the nerve
classic description of this pain in 1996. Heinrich Martius plexuses.
wrote detailed d escriptions of the role of uterosacral ligament Wu et al. [15] reported relief of pelvic pain and subure-
laxity, Frankenhauser and Sacral ganglia in the causation of thral tenderness by insertion of the lower part of a bivalve
ICPP”. speculum to support the posterior fornix. Bornstein relieved
vulvodynia pain by local anesthetic injection into the cervi-
cal part of the ULSs [14] as did Petros in three patients with
77.5 P
retreatment Diagnosis That USL interstitial cystitis, abdominal pain, and suburethral tender-
Laxity Is the Cause of ICPP ness [16]. Gunnemann reversed anterior rectal wall intussus-
ception with a cylindrical vaginal pessary, inserted under
Use of the diagnostic pictorial algorithm (Fig. 77.1) is the ultrasound control [18], and also pain and nocturia overnight
first step in any diagnosis. Other posterior pelvic symptoms, in 70% of women with the pessary (Gunnemann personal
bladder, bowel, are almost invariably present. In 1993, idio- communication).
pathic CPP was described as being part of the “posterior for-
nix syndrome” [9]. ICPP was almost invariably associated
with nocturia, urgency, and abnormal bladder emptying, all a 77.5.3 Confirmation of USL Origin of Pain by
consequence (for different reasons) of laxity in the uterosac- the Bornstein Test
ral ligaments (Fig. 77.1). Later a further association was
found with obstructive defecation and fecal incontinence The “Bornstein test” is a definitive test for determining
(Fig. 77.1). Two office tests help to confirm USL as a cause whether ICPP may be caused by lax USLs. The question of
of ICPP and help predict results of surgery. Later Goeschen loose USL as an etiological factor was tested in ten patients
and Gold [10] extended associated symptoms with their with chronic extreme vulvodynia in 2005 [14]. Two mL of
“Pescatori Iceberg” adaptation (Fig. 77.3). 2% lidocaine (5–10 mL of weaker solution can also be used)
was injected transvaginally at the junction of USL to the cer-
vix. On retesting after 5 min, eight patients reported com-
77.5.1 Confirmation of USL Origin of Pain by plete disappearance of introital sensitivity, and this was
Vaginal Examination confirmed by two separate examiners. In the other two
patients, direct testing confirmed that the allodynia (exagger-
A gentle vaginal examination where the cervix is gently ated sensitivity) had disappeared on one side, but remained
touched generally reproduces the particular pelvic pain. It on the other. Retesting the patients at 30 min confirmed that
can only do this once, as the pain provoked even with gentle the blocking effect on the pain had disappeared. The
examination can be severe. Some degree of USL laxity is Bornstein test was applied to three patients with ICPP and
present, even in nulliparas. USL laxity may seem absent dur- symptoms of bladder pain syndrome. The abdominal, ure-
ing vaginal examination. One technique to reveal it is to gen- thral, introital, and cervical tenderness which were demon-
tly elevate the anterior vaginal wall with the lower blade of a strated objectively pretest in all three patients disappeared
bivalve speculum and ask the patient to strain. Generally an entirely, or were substantially improved, within 5 min of the
enterocele becomes obvious. In the OR, a uterine or apical LA injection [16].
prolapse, often only to the halfway mark, is revealed on pull-
ing the cervix downward in the OR. Attempting this in the
clinic is not advised as it can provoke considerable pain. 77.6 I mprovement of CPP by Squatting-
Based PFR
77.5.2 Confirmation of USL Origin of Pain In 2004, Patricia Skilling [19] introduced the first new
with “Simulated Operations” method for pelvic floor rehabilitation (PFR) since Kegel in
1948. The Skilling PFR method is a squatting-based method;
These consist of mechanically supporting the USL by gently it works by strengthening the three directional muscles
inserting the lower blade of a bivalve speculum into the pos- which control urethral closure, its evacuation; the same three
terior fornix of the vagina, or a roll gauze, or a sponge- muscle forces stretch the vagina in opposite directions to
956 P. Petros and Y. Sekiguchi
Table 77.1 Fate of individual symptoms (n = 60) reduced from mean 202 to mean 71 mL (p < 0.005). This
Condition >50% improvement method extends indications for nonsurgical therapy beyond
Stress incontinence (n = 42) 78% stress incontinence, and the results appear to encourage this
Urge incontinence (n = 39) 61% approach. Approximately 3% of patients reported worsening
Frequency only (n = 53) 62%
of their stress incontinence and these were referred for sur-
Nocturia (n = 24) 75%
gery. Unlike the Kegel exercises, the patients do not need to
Pelvic pain (n = 20) 65%
Leakage (n = 50) 68% “squeeze upward” prior to a cough or sneeze. Urethral clo-
Bowel problems (n = 28) 78% sure occurs spontaneously and reflexly, because the three
reflexly acting closure muscles are strengthened (m.pubo-
coccygeus, levator ani, conjoint longitudinal ani muscle), not
Table 77.2 Fate of individual symptoms (n = 78)
the puborectalis “Kegel” muscle.
Condition >50% improvement
Stress incontinence (n = 69) 57 (82%)
Urge incontinence (n = 44) 33 (68%)
Frequency only (n = 12) 10 (83%)
77.6.2 The Simplified Skilling PFR Method
Nocturia (n = 32) 29 (90%)
Pelvic pain (n = 17) 13 (76%) Both PFR trials [19, 20] had a dropout rate of 50% within
3 months. Subsequent to these trials, Skilling began a simpli-
fied PFR method consisting only of 10–20 squats morning
support the bladder base stretch receptors, thereby prevent- and night. The trial was not completed, but the preliminary
ing urine loss by premature activation of the micturition clinical data indicated a virtually zero dropout rate and very
reflex (urge incontinence). Both the initial data (Table 77.1) promising improvement rates for all symptoms, especially in
[20] and the later data (Table 77.2) [19] indicate that all these younger women.
functions can be improved with this method, not just the USI
which the Kegel method addresses.
77.7 Surgical Repair Option
77.6.1 How the Skilling Squatting-Based PFR Initially, an 85% cure rate was reported at 3 months follow-
Method Evolved ing approximation of the uterosacral ligaments (USLs) [7]
(Fig. 77.2). These operations were all performed under local
By 1995 it was evident from the surgical data that a substan- anesthesia/sedation. However, the cure rate deteriorated to
tial percentage of chronic pelvic pain and bladder and bowel 70% at 12 months and further in the next 2 years. On this
dysfunctions in the female could be cured by surgical repair basis, a posterior sling was introduced to reinforce the USLs,
of the pelvic suspensory ligaments. It was hypothesized that much in the way of the midurethral sling [21–24].
a squatting-based regime would strengthen the three direc-
tional muscle forces and the ligaments against which they
contract; this would improve urethral closure (incontinence) 77.7.1 USL Native Tissue Repair Technique
evacuation (bladder emptying) and support of the bladder
base stretch receptors (urge incontinence) and enable the The posterior vaginal wall is grasped by two Littlewood’s
now strengthened USLs to better support the Frankenhauser forceps 4 cm below the cervix. Under tension, a full-thickness
and sacral nerve plexuses, thereby alleviating ICPP. The 5 cm transverse incision is made. Using a strong needle with
standard regime comprised four visits in 3 months. HRT was No1 Vicryl suture, the tissues just below the vagina are pen-
administered to all patients, electrotherapy 20 min per day etrated to a depth of 2 cm laterally, approximated, and tied
for 4 weeks with a 50 Hz probe placed into the posterior for- and the incision closed. Two such sutures are usually suffi-
nix of the vagina, squeezing 3 × 12 per day, reverse push- cient (Fig. 77.2).
downs 3 × 12 per day, and squatting or equivalent up to
20 min per day as part of daily routine (such as household
tasks). Of 147 patients (mean age 52.5 years), 53% com- 77.7.2 Posterior Sling Repair of USL
pleted the program. Median QOL improvement reported was
66%, mean cough stress test urine loss reduced from 2.2 This operation (Fig. 77.6), known as the “infracocygeal
(range 0–20.3) to 0.2 (range 0–1.4), p < 0.005, and 24-h pad sacropexy” or “posterior IVS” (PIVS), was first performed
loss from a mean of 3.7 (range 0–21.8) to a mean of 0.76 in 1992 at Royal Perth Hospital, Western Australia, under
(range 0–9.3), p < 0.005. Frequency, nocturia, and pelvic LA/sedation on a patient with major pain and incontinence
pain were significantly improved (p < 0.005). Residual urine symptoms. Twenty-month data was published in 1997 [21].
77 Idiopathic Chronic Pelvic Pain: A Different Perspective 957
Fig. 77.6 Infracoccygeal
sacropexy or “posterior IVS.”
The apex is suspended to the
sacrospinous ligaments with a
polypropylene tape. IS ischial
spine, LP m.levator plate, PB
perineal body, PC
m.pubococcygeus, PS pubic
symphysis, R rectum, S
sacrum, V vagina
A transverse incision is made in the posterior vaginal wall on where the tape has been placed. A rectal examination is
1 cm below the hysterectomy scar line. A channel is made in made to ensure there has been no perforation.
the direction of the ischial spine sufficient to insert the index
finger. The ischial spine is located and the point of entry of the
instrument marked by the index finger. Bilateral skin inci- 77.7.3 USL Tensioned TFS Sling
sions 0.5 cm long are made in the perianal skin at the 4 and 8
o’clock positions halfway between the coccyx and external A less invasive posterior sling, posterior TFS (tissue fixation
anal sphincter (EAS) in a line 2 cm lateral to the external bor- system) sling, was first reported in prototype form in 2005
der of EAS. The tunneler is pushed 3 to 4 cm into the ischio- [24] and with associated symptom cure in 2010, Tables 77.3
rectal fossa (IRF) keeping the plastic tip parallel to the floor. and 77.4 [25]. ICPP co-occurred with bladder and bowel
The index finger guides the tip of the tunneler which is then symptoms. The odds ratio for pain and other symptoms rela-
brought to the point of penetration 1 cm medial to the ischial tive to lax USLs is shown in Table 77.3. Along with ICPP,
spine (Fig. 77.6). At this point, the tunneler is safely sited well other symptoms were simultaneously cured or improved
away from the rectum and peritoneum. The tapes are inserted with a posterior sling as per Table 77.3. In Table 77.4, there
from the vagina end and pulled downward. This corrects the are similar results in 28 patients who had only minimal first-
uterine/apical prolapse, mechanically supports the USLs, and degree uterine prolapse. This validated the integral theory’s
creates a neo-cervical ring anteriorly or posteriorly depending statement that major symptoms may be caused by only
958 P. Petros and Y. Sekiguchi
77.9 Conclusions
symptoms with age, especially after the menopause. It is 10. Goeschen K, Gold DM. Surgical cure of chronic pelvic pain,
associated bladder and bowel symptoms by posterior sling in 198
futile therefore to proceed with “native tissue repair” in older
patients validates the Pescatori iceberg principle of pelvic symptom
women, especially when tapes precisely placed along the co-occurrence. Pelviperineology. 2017;36:84–8.
cardinal/uterosacral ligaments can give proven long-term 11. Pescatori M, Spyrou M, Pulvirenti d’Urso A. A prospective evalua-
5-year surgical results in 70-year-old women [28] and with tion of occult disorders in obstructed defecation using the ‘iceberg
diagram’. Colorectal Dis. 2007;9:452–6.
very minimal tape erosions. Using third-generation light-
12. Wagenlehner FM, Fröhlich O, Bschleipfer T, Weidner W, Perletti
weight individually knitted tapes, tensioned slings have been G. The Integral Theory System Questionnaire: an anatomically
inserted for both USI and prolapse with no erosions reported directed questionnaire to determine pelvic floor dysfunctions in
at 12 months [29, 30] or even at 3 years [31]. women. World J Urol. 2014;32:769–81.
13. Sekiguchi Y, Inoue H, Liedl B, et al. Is chronic pelvic pain in the
female surgically curable by uterosacral/cardinal ligament repair?
Pelviperineology. 2017;36:74–8.
Take-Home Messages 14. Zarfati D, Petros PE. The Bornstein test—a local anaesthetic tech-
• Idiopathic pelvic pain is not idiopathic. It usually nique for testing uterosacral nerve plexus origins of chronic pelvic
pain. Pelviperineology. 2017;36:89–91.
co-occurs with bladder and bowel symptoms which 15. Wu Q, Luo L, Petros PE. Case report: mechanical support of the
need to be located by specific questioning. posterior fornix relieved urgency and suburethral tenderness.
• All these symptoms can potentially be improved by Pelviperineology. 2013;32:55–6.
the Skilling PFR method or cured by surgically 16. Petros PE. Interstitial cystitis (painful bladder syndrome) may,
in some cases, be a referred pain from the uterosacral ligaments.
shortening and reinforcing the uterosacral
Pelviperineology. 2010;29:56–9.
ligaments. 17. Weintraub A, Petros PE. Editorial dedicated to Professor Heinrich
• A positive speculum test indicates surgical inter- Martius, pioneer in the ligamentous origin of chronic pelvic pain in
vention may be successful. the female. Pelviperineology. 2017;36:66.
18. Gunnemann A, Petros PE. The role of vaginal apical support in
the genesis of anterior rectal wall prolapse. Tech Coloproctol.
2014;18:517–8.
19. Skilling PM, Petros PE. Synergistic non-surgical manage-
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2004;15:106–10.
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Sub-committee of the International Continence Society. Neurourol Obstet Gynecol. 2001;94:264–9.
Urodyn. 2002;21:167–78. 21. Petros PE. New ambulatory surgical methods using an anatomi-
2. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey cal classification of urinary dysfunction improve stress, urge and
of chronic pain in Europe: prevalence, impact on daily life, and abnormal emptying. Int Urogynecol J Pelvic Floor Dysfunct.
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4. Fall M, Baranowski AP, Elneil S, et al. EAU guidelines on chronic Floor Dysfunct. 2002;13:4–8.
pelvic pain. Eur Urol. 2010;57:35–48. 23. Sivaslioglu AA, Gelisen O, Dolen I, et al. Posterior sling (infracoc-
5. Kairys AE, Schmidt-Wilcke T, Puiu T, et al. Increased brain gray cygeal sacropexy): an alternative procedure for vaginal vault pro-
matter in the primary somatosensory cortex is associated with lapse. Aust N Z J Obstet Gynaecol. 2005;45:159–60.
increased pain and mood disturbance in interstitial cystitis/painful 24. Petros PE, Richardson PA. Tissue Fixation System posterior sling
bladder syndrome patients. J Urol. 2015;193:131–7. for repair of uterine/vault prolapse—a preliminary report. Aust N Z
6. Stones RW, Mountfield J. Interventions for treating chronic J Obstet Gynaecol. 2005;45:376–9.
pelvic pain in women. Cochrane Database Syst Rev. 2000;4: 25. Petros PE, Richardson PA. TFS posterior sling improves overac-
CD000387. tive bladder, pelvic pain and abnormal emptying, even with minor
7. Petros PE. Severe chronic pelvic pain in women may be caused by prolapse—a prospective urodynamic study. Pelviperineology.
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8. Martius H. Über einen häufigen gynäkologischen, cal prolapse repair using two different sling techniques improves
Symptomkomplex. Arch Gynecol Obstet. 1938;166:332–5. chronic pelvic pain, urgency and nocturia—a multicentre study of
9. Petros PE, Ulmsten U. The posterior fornix syndrome: a multiple 1420 patients. Pelviperineology. 2016;35:99–104.
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77 Idiopathic Chronic Pelvic Pain: A Different Perspective 961
28. Inoue H, Kohata Y, Fukuda T, et al. Repair of damaged ligaments 30. Shkarupa D, Kubin N, Pisarev A, Zaytseva A, Shapovalova E. The
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Part IX
Fistulae
Urogenital Fistulae
78
Andrew Browning
Sometimes if the fistula is very small or if the fistula is from Table 78.1 Waaldijk classification system of genitourinary fistula
the bladder to the cervix or bladder to uterus after a caesar- Type 1
ean, the urine can take a long time to track through the fis- Not involving the
tula. If there is doubt, insert the swabs and dye, remove the closing mechanism
Type 2 A. Without (sub) total B. With (sub) total
catheter and have the patients walk about for 30 min to an
Involving the urethral involvement urethral involvement
hour and remove the swabs. You’ll be surprised at how many closing mechanism
patients test positive in this way. This can also reveal a ure- a. Without b. With circumferential
teric fistula—if the apical vaginal swab is wet with clear circumferential defect defect
urine and not dye, then the urine is clearly coming from the
ureter, and not the bladder and a ureteric implantation is Table 78.2 Goh Classification of genitourinary fistula
needed. In most fistula units in the world, imaging is not
Site
available, nor is it needed. The bladder can be explored Type 1 Distal edge of fistula >3.5 cm from the external urinary
abdominally, the ureter visualized or probed and the one that meatus
is not draining and/or cannot be probed is the offending side Type 2 Distal edge of fistula 2.5–3.5 cm from the external urinary
and should be re-implanted. The affected ureter is invariably meatus
dilated as compared to the normal side. Type 3 Distal edge of fistula 1.5 to <2.5 cm from the external
urinary meatus
In more resourced areas, imaging such as CT urogram can Type 4 Distal edge of fistula <1.5 cm from the external urinary
give this information prior to the operation. meatus
Size
a Size <1.5 cm in the largest diameter
78.5 Classification b Size 1.5–3 cm in the largest diameter
c Size >3 cm in the largest diameter
Scarring
There is as yet no standardized urogenital fistula classification.
i None or only mild fibrosis (around fistula and/or vagina)
There has been numerous studies confirming attributes of the and/or vaginal length >6 cm, normal capacity
fistula that will lead to a poor outcome [11, 46]. The main ii Moderate or severe fibrosis (around fistula and/or vagina)
outcomes of treatment are to close the fistula and maintain and/or reduced vaginal length and/or normal capacity
continence. Unfortunately, just closing the fistula does not iii Special consideration, e.g. post-radiation, ureteric
involvement, circumferential fistula, previous repair
mean that the patient will be continent, she might have ongo-
ing incontinence through the urethra. The risks for ongoing
urethral incontinence after fistula repair are the following: The Goh system looks at the site, size and scarring of the
fistula, and the circumferential defect is a subset of scarring
• The urethra has been affected by the ishaemic process. In (Table 78.2). There has only been one study comparing the
the worst cases the whole of the urethra has sloughed away. systems, and the Goh system was found to be more predic-
• The larger the fistula the higher the risk. tive [47].
• There is significant vaginal scarring (e.g. if the operation
has to begin with making relaxing incisions through hard
bands of scar on the posterior and sometimes anterior 78.6 Treatment
vagina, just to be able to insert a speculum and expose the
fistula). Treatment is primarily surgical; however, if a fistula is seen
• The remaining bladder volume is small. It is not uncom- early, within 2–4 weeks of the injury, prolonged catheteriza-
mon to find that most of the bladder has been destroyed, tion with free drainage may cure up to 40% of small vesico-
and after closing the defect the remaining bladder volume vaginal fistula [48, 49].
can be as little as 20 mL. There has been some debate over the timing of the opera-
tion. Traditionally it was said to wait for 3 months after the
Classifcation systems should try and incorporate prog- obstructed labour for the ischaemic tissue to slough away
nostic indicators. The two most commonly used systems are and the oedema in the surrounding tissues to resolve before
the Waaldijk and the Goh. attempting an operation. Some more experienced surgeons
Both systems pay attention to urethral involvement. This do operate earlier and with good success [48], but the tissues
is the strongest predictor of a poor outcome. are more difficult to handle and sutures can tear through, so
Waaldijk also includes if the fistula is circumferential or waiting 3 months is prudent for the less-experienced urogen-
not, that is, the whole circumference of the bladder and ure- ital fistula surgeon.
thra has sloughed away, leaving a small urethral remnant If a urological injury occurs during a pelvic operation, it
detached from the bladder (Table 78.1). would be best to repair it at the time, but if it is revealed only
78 Urogenital Fistulae 969
• Adequate exposure
• Protecting the ureters
• Adequate mobilization
• Tension-free closure
• Checking the closure with a dye test.
Fig. 78.7 A small distal fistula has been repaired and the dye test Fig. 78.8 Suburethral pubococcygeal sling made for a small urethral
revealed a second intracervical fistula. Note dye coming through the fistula. Note the urethral fistula repaired longitudinally (Dr Andrew
cervix (Dr Andrew Browning, used with permission) Browning, used with permission)
• Tension-free closure. If there is tension on the repair, it is or a secondary continence operation, and if that fails, a
at risk of breaking down. Sutures should be about 4 mm sling of rectus sheath can be used.
apart, interrupted in one layer to the bladder. • Ensure a tension-free closure of the vagina. Fistula sur-
• Check the closure with a dye test to see if there are any gery is evolving and the results are by no means perfect.
leaks on the suture line and also to exclude a second fis- One step forward is the recent realization that recon-
tula (Fig. 78.7). structing the vagina correctly seems to be just as impor-
• In all fistulae involving the urethra, maintain the length and tant as reconstructing the bladder and urethra. The
width of the urethra. This can be as simple as closing a ure- ischaemic process obviously affects the vagina, so there
thral defect vertically or in cases of partial or complete cir- is vaginal tissue loss as well. If at the end of the operation
cumferential loss of the urethra, it may mean the you just pull the vagina together, it will just lead to scar-
reconstruction of the urethra. This is done by mobilizing the ring, tension on the anterior vaginal wall which in turn
bladder anteriorly off from scarred attachments to the pubic just pulls the urethra open making it incompetent
bone and into the cave of Retzius. This can be done by the (Figs. 78.9 and 78.10). There are several ways to recon-
vaginal route and then the anterior bladder is advanced down struct and repair a vagina if there has been signficant
to where the urethral meatus should be, sutured to the back vaginal tissue loss. Either with series of 52 patients by
of the pubic bone and the anterior bladder is tuburalized into the author. In the most severe cases of fistula (4ciii Goh
a urethra. It is difficult to get the correct urethral length and and with multiple previous operations), the cure rate
width and a secondary procedure may be needed after the improved from a dismal 19% of being dry to 66% [52,
anterior bladder flap has healed in its new position. 53]. The Singapore flap is a vascular cutaneous flap with
• Reconstructing the pubourethral ligament. All fistulas its pedicle based medial to the ischial tuberosity. A flap
involving the urethra (Goh type 2–4 and Waaldijk II) have of 15 by 6 cm can be used and tunneled into the vagina
a high chance of ongoing incontinence despite an anatomi- just superficial to the inferior pubic ramus. It can be hair
cal closure. This is because the continence mechanisms bearing and any remaining follicles can be diathermied at
have been destroyed as well and the urethra that has been a later date (Figs. 78.11 and 78.12).
recreated has no physiological function. To improve out-
comes, autologous slings can be used at the time of repair,
either a sling of pubococcygeal/ levator muscle (Fig. 78.8),
or if there is no muscle remaining, simply use scar tissue 78.7 Post-operative Management
from the pelvic wall. Alternatively, use fascia, namely rec- and Results
tus sheath or fascia lata. An earlier study from 2004 showed
that the application of the pubococcygeal halved the ongo- The vagina is packed at the end of the operation and the pack
ing incontinence rates [50] in these patients and a recent, as is removed the next day. The patient is encouraged to drink
yet unpublished, trial comparing the muscle to a sling of to ensure good bladder irrigation and the catheter left on free
rectus sheath placed around the urethra and tied to the drainage.
abdominal wall showed that the use of the rectus sheath led There is no uniform agreement on how long to leave the
to more breakdowns of the fistula but was equivalent in indwelling catheter in place and surgeons vary in their prac-
cure, although a longer follow-up it might be slightly ben- tice, from 5 to 21 days, even longer in some cases. It has been
eficial. (Wilkinson, Pope unpublished data, 2018) It is the traditionally taught to leave the catheter for 14 days. Two
author’s practice to use a muscle sling at the primary repair papers recommend leaving the catheter for 10 days for all but
78 Urogenital Fistulae 971
Sling
{
Gap
Pulled inside/open
Tension on anterior
vagina Cervix pulled toward Introitus
972 A. Browning
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Rectovaginal Fistulae
79
A. Muti Abulafi and Abdul H. Sultan
Learning Objectives
79.2 Etiology
• Rectovaginal fistula can be classified according to
Rectovaginal fistulae are rare and account for less than 5% of
etiology and location of the fistula.
all anorectal fistulae [1, 2]. The causes of recto- and anovagi-
• Obstetric trauma and Crohn’s disease account for
nal fistulae are listed in Table 79.1 [1].
over two-thirds of all fistulae.
The most common cause of RVF is obstetric trauma,
• Multidisciplinary management is essential for a
which represents between 50% and 90% of RVF presenting
successful outcome.
clinically, and occurs in 0.1% of all vaginal deliveries [2].
• Surgery is the mainstay treatment.
However, the incidence of RVF in women who sustain a
• Choice of surgery depends on location and etiology
fourth-degree tear is higher and ranges between 0.4% and
of fistula as well as status of sphincters and sur-
3% [3]. In the developing world, it is most frequently related
rounding tissues.
to prolonged obstructive labor due to feto-maternal dispro-
portion and failure of timely intervention. Consequently, tis-
sue ischemia and necrosis lead to the development of a
fistula. In a case series of patients presenting with vesico-
79.1 Definition vaginal fistulae, between 6 and 24% had concurrent RVF [3,
4]. Other obstetric causes relate to an unidentified fourth-
Rectovaginal fistulae (RVF) are abnormal communications degree obstetric tear at delivery, inadvertent insertion of a
between the rectum and vagina (Fig. 79.1). They must be rectovaginal suture during repair of perineal trauma, and
distinguished from anovaginal fistulae, which are more distal severe perineal infection, particularly following a repair of a
communications between the anal canal and vagina and are third- or fourth-degree perineal tear. The problem may mani-
considered as a rare type of anorectal fistulae. Fistulae can be fest immediately after delivery due to failed recognition of a
either congenital or acquired. This chapter focuses on the fourth-degree tear or inappropriate repair, or more com-
management options and also outlines the etiology, presenta- monly after 7–14 days due to secondary infection of the
tion, diagnosis, and classification of acquired recto- and ano- wound. A more recent US study has shown that surgical
vaginal fistulae. repair as a surrogate marker of RVF has declined in recent
years due to improved obstetric management [5].
The second commonest cause of RVF is Crohn’s disease,
occurring in up to 23% of patients [6], a figure that varies
depending on the referral pattern of the institution. The prob-
lem seems to occur more frequently with large bowel
A. M. Abulafi (*) involvement, especially the rectum [7]. Ulcerative colitis is a
Department of Colorectal Surgery, Croydon University Hospital, mucosal disease that rarely causes fistulation unless as a
Croydon, Surrey, UK complication of surgery rather than the disease itself, or if it
e-mail: muti.abulafi@nhs.net
is complicated by tumor. Recurrent RVF following surgery
A. H. Sultan should raise the possibility of underlying occult Crohn’s dis-
Urogynaecology and Pelvic Floor Reconstruction Unit,
Croydon University Hospital, St George’s University of London,
ease, which must be excluded in this situation.
London, UK Trauma to the rectum, perineum, or vagina may cause
e-mail: asultan29@gmail.com RVF. The commonest form of trauma is during or following
Table 79.2 Classification of rectovaginal fistulae, modified from [35] lae when the above symptoms occur only during or shortly
Simple rectovaginal fistula Complex rectovaginal fistula after defecation. In addition, patients may complain of dis-
Low- or mid-vagina (check High vagina comfort in the pelvis/perineum and during sexual inter-
rectum) course. Other modes of presentation include recurrent attacks
≤2.5 cm >2.5 cm
of urinary tract infection, thrush, perineal and vulval irrita-
Traumatic or infectious cause Inflammatory bowel disease,
irradiation, neoplastic causes
tion, and difficulty keeping the area clean. In addition,
Prolonged obstructed labor patients may also present with other symptoms relating to
Failed prior repair the underlying etiology of the fistula. For instance, patients
with Crohn’s disease may present with abdominal pain, diar-
rhea, and rectal bleeding. Patients with anorectal cancers
may present with rectal bleeding and change in bowel habit.
RVF classified according to location is as follows: Radiation proctitis patients may present with rectal bleeding,
• Anovaginal—the anal opening of the fistula is situated at diarrhea, and pelvic pain.
or below the dentate line and the fistula tract opens at the
posterior fourchette or lower third of the vagina.
• Rectovaginal—this is further divided into two types, a 79.5 Assessment and Investigations
low and a high fistula. A low RVF is located between the
lower third of the rectum and the lower half of the vagina. The aim of assessment is to determine the location and etiol-
A high fistula is located between the middle or upper third ogy of RVF, classify them into simple or complex, and hence
of the rectum and the posterior vaginal fornix. determine the mode of surgical intervention. In our opinion
this should be undertaken jointly by both a colorectal and
RVF classified according to their cause is as follows: gynecological specialist, as is the case in our practice [36].
• Type I—RVF with or without anal sphincter disruption. Clinical assessment starts by taking a careful history, noting
• Type II—RVF due to inflammatory bowel disease. the severity of symptoms, previous operations on the anorec-
• Type III—RVF due to radiation injury. tum and vagina, mode of vaginal delivery, and whether the
• Type IV—RVF due to postoperative injury. patient has had pelvic irradiation or is known to have had
inflammatory bowel disease. Assessment should also take
Obstetric trauma is the most common cause for RVF type note of the degree of continence to both urine [37] and stools
I, with an incidence of up to 74% [33]. The incidence of RVF [38], and take account of any associated comorbidities that
type 4 following previous surgical procedures is reported at could influence management. The degree of symptom inter-
7% of all fistulae [33]. ference with daily life is best determined by quality-of-life
Both classifications are of relevance when planning treat- questionnaires [39]. For instance, patients may have signifi-
ment, and some authors argue for the use of one over the cant comorbidities but minor symptoms that are not interfer-
other [34]. We would advise that both etiology and location ing with their lifestyle, as is the case with some anovaginal
are used when planning treatment; the etiology takes into fistulae, and therefore the consequences of surgical interven-
account the status of the local and adjoining tissues, while tion need to be weighed against potential risks. It is also
the type of surgical approach will depend on the location of important to include assessment of prior sexual function,
the fistula. A convenient classification that takes account of especially dyspareunia, and remember to counsel women
both was proposed by Rothenberger and Goldberg [35] who are considering surgery about risks of de novo
(Table 79.2). They grouped RVF into two categories: simple dyspareunia.
and complex. Simple fistulae include those that are in a low- Clinical examination includes careful inspection of the
or mid-zone location, are of traumatic or infective nature, perineum and perianal area for skin rash/excoriation due to
and are of <2.5 cm in diameter. Complex fistulae are high constant soiling of liquid stools. Scars from previous anorectal
fistulae due to Crohn’s disease, pelvic irradiation, or tumors, surgery, episiotomy, or perineal tears should be noted. Perianal
and are >2.5 cm in diameter. dimpling and/or a “dovetail sign,” which consists of perianal
folds posterior to the anal opening with smooth mucosa ante-
riorly, may indicate a disrupted anal sphincter as well as the
79.4 Presentation presence of a fistula [3]. An external opening of the fistula may
be seen at the vaginal introitus/fourchette. The anus should be
Typically, the presenting symptoms of RVF are those of con- examined to determine the status of anal sphincter function by
stant passage of liquid stool, foul-smelling brown discharge, checking the resting and squeeze pressures. When an anovagi-
or flatus per vagina. This is in contrast with anovaginal fistu- nal fistula is present, a defect within the anal canal may be felt
978 A. M. Abulafi and A. H. Sultan
at this point, whereas in low RVF a defect or thinning may be 79.6 Treatment
felt in the lower rectum. Bimanual palpation of the perineum
and anal sphincter anteriorly may indicate disruption to the In a few situations, where symptoms are mild and not inter-
anal sphincter and/or perineal body. In addition, any indura- fering with lifestyle (as is the case in small anovaginal fistu-
tion, stenosis, or strictures within the anal canal, rectum, or lae), conservative treatment should be considered,
vagina should be noted. These are usually confirmed on rigid particularly if there are significant associated comorbidities
proctosigmoidoscopy or flexible sigmoidoscopy and vaginal [44, 45]. In fistulae associated with active Crohn’s disease,
speculum examination. Often, examination in the clinic is initial management involves medical treatment aimed at sta-
uncomfortable, making adequate assessment impossible, and bilizing the inflammation [46]. The vast majority of patients
in these situations an examination under anesthetic is extremely with RVF have significant and disabling symptoms, and
useful. On rare occasions, the fistula is very fine (pinhole), and therefore surgical repair is the mainstay treatment. The suc-
therefore may not be easily detected even during examination cess of surgical treatment depends on adhering to the known
under anesthetic. Various techniques have been devised to and accepted principles of good surgery, namely accurate
delineate it, including instillation of diluted hydrogen perox- diagnosis, choice of appropriate operation, and meticulous
ide or mildly soapy water into the rectum and observing bub- surgical technique. The later includes excision of diseased
bles on the vaginal side. and fibrous tissue, avoiding tension on the suture line, achiev-
The methylene blue pad test involves injecting dye into ing good hemostasis, and ensuring adequate blood supply, if
the rectum via a Foley catheter and inserting a tampon in the necessary by interposing vascularized tissues.
vagina, which is usually stained within 30 min if a fistula is
present.
Complex RVF invariably require further investigations, 79.6.1 Surgical Techniques
not only to confirm the diagnosis but also to help deter-
mine the underlying pathology. Contrast studies of either There are a large number of operations described, reflecting
the rectum or vagina [40] are useful in high RVF: com- the many combinations of RVF presentations, which depend
puted tomography (CT) with rectal contrast, endoanal on the location and diameter of the fistula and the underlying
ultrasound scan with or without contrast enhancement disease process. The operations can be grouped into three
with hydrogen peroxide [41, 42], or MRI scan with or main categories, depending on the surgical approach, as
without endocoil [43]. shown in Table 79.3.
We would strongly advocate the routine use of endoanal The patient must be counseled about the benefits, poten-
ultrasound scan in these patients not only to delineate the tial risks, and success rates of the proposed surgery.
fistula if possible but also, more importantly, to identify any Functional outcomes including sexual function should also
associated anal sphincter defects that would influence man- be discussed. In abdominal operations, the potential need for
agement. If the diagnosis remains unclear, or if there is dis- a stoma needs to be discussed and agreed.
crepancy between imaging and clinical findings, an In general, there has been a recent move away from using
endoanal/endovaginal/perineal scan can be performed dur- mechanical bowel preparation prior to bowel surgery, except
ing the examination under anesthesia. Ultrasonographic where an ultra-low colorectal anastomosis is contemplated.
imaging techniques have already been described in Parts II Instead, the rectum is prepared with suppositories or enemas
and VI. a few hours prior to the surgery, to help exposure and ensure
Flap Mucosa
Internal
Rectal
Sphincter
Mucosa
Elevated
Attenuated
Perineal Body
Internal
Sphincter
Mobilized
Probe in Recto
Vaginal Fistula
Internal
Sphincter
Approximated
Fig. 79.2 Endorectal advancement flap. Reproduced from [48], with permission
980 A. M. Abulafi and A. H. Sultan
including the site of fistula. The vaginal mucosa is left open for fistulae without Crohn’s disease, which fell to 60% for
for drainage. fistulae with Crohn’s disease. Moreover, Gagliardi and
The reports in the literature (Table 79.4) [49–66] show Pescatori [51] reported that in their hands the incorporation
mixed results, with healing rates of 41–100%. It is difficult of a sphincteroplasty in the repair routinely resulted in 100%
to know conclusively why such variation in results exists but success rates compared to 73% for repairs without sphinc-
it is possible that it is related to inclusion of complex, teroplasty. However, other authors do not recommend the
Crohn’s, and recurrent fistulae. MacRae et al. [49] reported routine use of sphincteroplasty in the repair unless there is
success rates of 85% after first repair, which fell to 55% after evidence of sphincter disruption, so as not to compromise
a third failed repair. Jones [50] reported healing rates of 77% continence [49, 52].
a b c
d e
Fig. 79.3 Transvaginal repair of a small rectovaginal fistula. (a) A cir- string suture is placed around the fistula orifice and tied. (d) The mus-
cular incision is made through the vaginal mucosa around the fistula cularis tissues are approximated with sutures. (e) The vaginal mucosa is
orifice. (b) The vaginal mucosa is dissected free circumferentially for closed with a continuous suture. Reproduced from [72], with
approximately 2 cm from the margin of the fistula orifice. (c) A purse permission
a b c
Fig. 79.4 Excision of fistula with layered closure. (a) A transverse elliptical incision is made around the fistula, and the tract with a button of vagi-
nal mucosa is excised. (b) The resulting defect is closed with Vicryl in two layers after freeing the lateral edges of the mucosa. (c) The rectal
mucosal flap is now advanced over the septal repair and sutured with Vicryl sutures. Reproduced from [74]
79.6.1.5 Episio/Perineoproctotomy
This technique is ideally suited for fistulae with associated
sphincter disruption, absent perineal body (cloacal defects),
or recurrent or failed local (transanal or transvaginal) repair.
The principle of the operation consists of identifying the fis-
tula and laying it fully open, followed by layered closure of
the divided tissues. The patient is positioned in the lithot-
omy position, which offers good exposure of both the anus
and vagina. The fistula is identified by inserting a fistula
probe via the anal canal opening and into the vagina. The
Fig. 79.5 Local excision of the fistula tract tissues superficial to this are then divided fully, thus, in
effect, creating a wound similar to that encountered by
line, after infiltrating the area with an adrenalin solution of obstetricians in a fourth-degree perineal tear (Fig. 79.7).
1:300,000. A full-thickness sleeve flap made of the mucosa The edges of the primary tract are excised and any associ-
and submucosa is then raised to expose the underlying inter- ated secondary tracts, if present, are identified and excised.
nal sphincter (Fig. 79.6). Invariably, a few fibers of the inter- The rectal and vaginal mucosa are then freed from the
nal sphincter are included in the raised flap due to associated underlying tissues. The edges of the internal and external
inflammation from the fistula and Crohn’s disease. The sub- anal sphincter as well as the perineal muscles are all identi-
mucosal plane is entered and then developed in a cephalad fied and mobilized laterally.
direction circumferentially, passing the anorectal ring and The operation is concluded by approximating the rectal
levator ani muscle. Further dissection in this plane at the mucosa with Vicryl sutures, followed by approximating the
79 Rectovaginal Fistulae 983
a b
Fig. 79.6 Rectal sleeve advancement flap. (a) Dissection begins at the absorbable suture, and the vaginal mucosa is left open; (b) The diseased
dentate line with a 90–100% circumferential mucosectomy of ulcerated distal margin of the tissue is trimmed, and the cuff of rectum is advanced
mucosa and submucosa of the anal canal and is carried cephalad until the down and sutured to the ridge of anoderm using absorbable sutures.
supralevator space is breeched. After sufficient rectal mobilization has Reprinted with permission, Cleveland Clinic Center for Medical Art and
been accomplished, the fistula tract is cored out and then closed with Photography © 1999–2014. All Rights Reserved. Courtesy of [78]
internal sphincter to create a high-pressure zone within the then closed with Vicryl sutures. The chosen tissue is then
anal canal. The external sphincter is then repaired using the interposed between the sutured vaginal and rectal defects.
overlap technique. Next, the perineum is reconstituted by The skin is then closed. The most common tissue interposed
approximating the perineal muscles and the vaginal mucosa. is an overlapping sphincteroplasty [33, 51, 52, 55, 63, 66],
The final step is to close the perineal skin from the vagina similar to that described above and in Chap. 37. This tech-
down to the anus. nique is utilized particularly when there is associated
Reported success rates are good, ranging from 68 to 100% sphincter disruption. In the presence of an intact anal
[49, 58, 78, 79]. Exposure is generally excellent with this sphincter, this technique of dividing and then performing an
approach, and it should be considered the first-line approach overlapping sphincteroplasty should be avoided due to the
for those fistulae with associated sphincter/cloacal defects. It effect on continence. Other tissues that have been interposed
should also be considered in patients who have undergone include the gracilis [69, 80, 81], sartorius [82], and rectus
previous failed repairs where exposure via the transanal abdominis [83] muscles, and labial pad of fat (Martius graft)
route may be limited. [84–88]. If Martius graft is used, the patient is positioned in
the modified lithotomy position (Fig. 79.8) [89].
79.6.1.6 Tissue Interposition Approaching the fistula via the abdomen (see also below),
The principle of this repair is to excise the fistula and inter- the healthy colon is interposed by undertaking an anterior
pose healthy vascularized tissue in the space between the resection with removal of the diseased rectum beyond the
rectum and vagina. The surgical approach is performed fistula. The vaginal opening is closed and the healthy colon
either through the perineum or the abdomen. is brought down and anastomosed with the healthy lower
Approaching the fistula via the perineum, the patient is rectum directly (an end-to-end or end-to-side colorectal
usually in the jack-knife prone position and the perineum is anastomosis or via construction of a colonic J pouch), or
infiltrated with 1:300,000 adrenalin solution. A transverse with the anal canal if the whole rectum is removed (coloanal
incision is made on the perineum close to the fourchette. anastomosis or via a colonic J pouch or via the Parks’ colo-
The incision is deepened, and dissection is carried out in the anal anastomosis [49, 90, 91]. The omentum is another struc-
plane between the rectum and vagina, taking particular care ture usually interposed in the space between the rectum and
to avoid making a button hole in either structure. The fistula vagina. Bricker reported a technique where the sigmoid
is gently separated, and dissection is carried out in this plane colon and rectum are mobilized fully with the division of the
cephalad. The rectal and vaginal openings of the fistula are fistula. The sigmoid is then transected at the midpoint and
984 A. M. Abulafi and A. H. Sultan
Fistulous Tract
Vaginal Mucosa
Anal Canal
Internal
Sphincter
Approximated
Vaginal Mucosa,
Perineal Body,
External Sphincter
Approximated
Rectal in Layers
Mucosa
Approximated
Fig. 79.7 Perineoproctotomy (see text). Reproduced from [48], with permission
the distal end folded on itself, and anastomosed to the repair using PDS 2–0 (muscle layer) and Vicryl 3–0 (rectal
debrided rectal opening of the fistula. mucosa and submucosa) sutures. After completion of the
The proximal end of the transected sigmoid is brought out transrectal advancement flap repair, the rectovaginal space is
as a colostomy. Once healing is confirmed by a contrast irrigated with antiseptic solution and then a 2 × 2 cm
study, the colostomy end is attached to the folded sigmoid Surgisis™ mesh is placed in the rectovaginal space and fixed
loop as an end-to-side anastomosis [92, 93]. with Vicryl 3–0 at each corner. Finally, the posterior vaginal
mucosa is closed over the mesh with interrupted Vicryl 3–0
79.6.1.7 Use of Biomaterials sutures. In the study by Schwandner and colleagues [95], 19
out 21 patients with RVF, most of whom had recurrent fistu-
Surgisis™ Mesh Repair lae, remained healed at a median period of 12 months; four
This is a novel technique reported initially by Pye and col- of those patients healed after a second operation. In another
leagues in 2004 [94] and more recently modified by study by Ellis [67], 22 out of 27 patients, half of whom had
Schwandner et al. [95]. The technique involves exploring the recurrent fistulae, remained healed at a median period of
fistula via a combined transvaginal and transrectal approach. 12 months (range 6–26 months).
With the patient in lithotomy position, the posterior vaginal
wall is opened and the fistula tract identified with a fistula Surgisis™ Fistula Plug
probe. The vagina is then dissected off the rectum within the Ellis [67] analyzed seven patients treated with this technique,
rectovaginal space, approximately 1 cm proximal and distal with a median follow-up of 6 months (range 3–12 months).
to the fistula tract. The fistula tract is then completely excised Six out of seven healed (86%). Goncalves et al. treated 12
via a combined transvaginal and transrectal approach includ- patients and reported 58% success rate [96]. However, lon-
ing a complete “coring-out” of the fistula tissue. The rectal ger term follow-up of 20 patients showed that only 20% of
component of the operation consists of an advancement flap fistulae remain closed at 2 years [97]. In any case, a large
79 Rectovaginal Fistulae 985
Fig. 79.8 Martius graft. The Martius graft begins with standard peri- nel is made, and the flap is pulled through the tunnel after the anterior
neal dissection followed by longitudinal incision over the labia majora. end is divided and then sutured to the posterior vaginal wall. Reprinted
Skin flaps are raised medially and laterally until the entire fat pad with with permission, Cleveland Clinic Center for Medical Art and
bulbocavernosus muscle is mobilized. A subcutaneous, subvaginal tun- Photography © 1999–2014. All Rights Reserved. Courtesy of [78]
clinical trial with longer follow-up is required before this closed primarily with interrupted Vicryl sutures. The repair
procedure can be recommended as a standard approach. is supported by interposing omentum in the intervening
space, thus separating the suture lines.
79.6.1.8 Abdominal Operations In this operation, the rectum is healthy and is not excised.
These operations are indicated for high fistulae and in the Van der Hagen et al. reported a prospective series of 40
case of post-irradiation fistulae, even if the fistula is of the patients treated by the above technique laparoscopically with
low type, since healthy tissues should be employed to achieve 95% success rate at a median follow-up of 28 months [98].
a successful repair. In this era of minimally invasive surgery,
most abdominal operations are undertaken laparoscopically Rectal Excision (Anterior Resection) with Colorectal/
where appropriate. Coloanal Anastomosis
This operation is performed in complex high fistulae where
Direct Closure with Interposed Omental Graft the rectal tissue is involved by a pathological process such as
This operation is undertaken in the case of a simple high cancer, Crohn’s disease, or radiation-induced fibrosis. When
fistula due to benign and traumatic causes, particularly those performing the anterior resection, the dissection is carried
occurring following surgery. The operation involves full out beyond the pathology and fistula until healthy tissues are
mobilization of the rectum posteriorly and anteriorly. In the exposed. This may require removal of only the upper and
anterior plane, the rectovaginal plane is entered and the middle third of the rectum, but may also require removal of
vagina separated from the rectum. At this point, the fistula is the whole of the rectum (low anterior resection).
encountered, entered, and then divided. The fistula edges are Reconstruction is achieved by performing an anastomosis,
refreshed and then both the rectal and vaginal defects are either stapled or sutured between the descending colon,
986 A. M. Abulafi and A. H. Sultan
which is mobilized and brought down into the pelvis without transanal endoscopic microsurgery (TEM) technique was
tension and with good blood supply, and the lower rectum or used in 13 patients with a reported closure rate of 92.3% at
the anus. The defect in the vagina is closed and omentum is 25 months [104].
interposed in the space between the vagina and rectum. Laparoscopic mobilization and interposition of the omen-
The Parks’ coloanal sleeve anastomosis [91] is another tum was combined with a perineal approach to the fistula in
technique that, in addition to excision of the rectum, involves two small studies of 6 and 7 patients with a reported closure
performing a mucosectomy via the transanal route, then the rate of 100% at 22 and 15 months, respectively [105–108].
healthy colon is pulled down the muscular tube of the rectum Once again, these are case reports or small series, which, if
past the fistula, and a handsewn anastomosis with the anus at anything, proves that these treatments are technically feasi-
the level of the dentate line is performed. ble but long-term outcomes are lacking. As such, they are
worth considering as a last resort but are not recommended
Proctectomy for routine use except in the context of a clinical trial.
This involves the removal of both the rectum and anus and
has been recommended by Goligher [99] as the gold stan-
dard to treat inflammatory rectovaginal fistula. However, 79.6.2 Choice of Surgery
with advances in surgical techniques, this operation has been
used with decreasing frequency, but is mentioned here as a There are no comparative studies or randomized trials com-
last-resort option when all else has failed, particularly if paring different operations, and therefore the choice of treat-
symptoms are troublesome and debilitating and patients’ ment depends largely on the experience of the surgeon and,
quality of life is poor. The technique involves excising the as alluded to above, the etiology and location of the fistula,
rectum, as described above, via the abdominal route. The and status of the anal sphincter and anorectum.
anus is excised via the perineal route using the intersphinc-
teric approach [100], which involves dissection of the inter- 79.6.2.1 Peripartum Rectovaginal Fistula
sphincteric plane and removal of the anus with the internal Rectovaginal fistulas secondary to obstructed labor develops
sphincter while leaving the external sphincter behind. Next, after “sloughing” of vaginal tissue that has become necrotic
the vaginal defect is excised and closed with interrupted from pressure of the fetal head. Typically, the sloughing fol-
Vicryl sutures. The perineal wound is then closed in layers lows a week after the delivery of the fetus, after a prolonged
by approximating the levator ani and external anal sphincter labor lasting more than 2 days. A fistula “field injury” includ-
muscle. In the presence of sepsis, all tracks should be opened ing rectovaginal and/or vesicovaginal fistula, global pelvic
and the perineum left open, to close by secondary intention floor dysfunction, and foot drop has been described and is
or by tissue grafting. indicative of widespread pelvic tissue and neurological dam-
age [3]. A fistula also results following inappropriate/ incom-
Diversion Ileostomy/Colostomy plete repair of perineal tears/episiotomy.
This is an option that was employed in the past as a primary As described earlier, it is essential to assess the anatomy
treatment of a fistula but is now recognized as an option to and function of the anal sphincter with appropriately directed
cover surgical repair whether undertaken via the perineal or questions, anal manometry, and endoanal ultrasound scan.
abdominal routes. It should be considered in complex and/ Debridement of the infected wound, removal of residual
or repeat repairs. Corte et al. reporting on 79 patients with suture material, and antibiotic therapy should be commenced
RVFs undergoing 289 procedures found that employing a prior to attempting repair of these fistulae. There is some evi-
diverting stoma early was an independent variable for suc- dence to suggest that small anovaginal and rectovaginal fis-
cess and improved the per-procedure healing rates from 6% tulae may close spontaneously. Rahman et al. [109] reported
following procedures without a diverting stoma to 32% with that in their series of 42 women with RVF, 11% healed spon-
a stoma [101]. taneously but all these women had an RVF of less than 5 mm.
Although the traditional practice of waiting at least
79.6.1.9 Other Techniques 3–6 months before attempting repair was widely followed,
There are several interesting techniques that have been there has been recent evidence to the contrary. Waaldijk
reported in the literature as a small case series or case [110] reported on 1716 Nigerian women with a vesicovagi-
reports, and the common theme is the use of minimally inva- nal fistula or genital fistula, of whom 211 had a concomitant
sive techniques to repair the fistula. The use of fibrin sealant RVF, presenting between 3 and 75 days after delivery.
was reported, but the results are conflicting [102, 103]. The Successful primary closure was achieved in at least 90%.
79 Rectovaginal Fistulae 987
Table 79.5 Published articles specific to or including the treatment of Crohn’s-related rectovaginal fistula (RVF), adapted from [46]
Author Study period Total n Crohn’s na RVF na Study type
Surgical treatment
Morrison et al. [112] 1973–1986 12 12 12 Retrospective
O’Leary et al. [113] 1991–1996 10 10 10 Retrospective
Penninckx et al. [114] 1993–1999 32 32 32 Retrospective
Marchesa et al. [76] 1991–1995 13 13 11 Retrospective
Joo et al. [62] 1991–1995 26 26 20 Retrospective
Garcia-Olmo et al. [115] 2003 1 1 1 Case report
Scott et al. [7] 1971–1991 67 67 29 Prospective database review
Simmang et al. [77] 1997 2 2 2 Case report
Loungnarath et al. [116]b 1999–2002 39 13 3 Retrospective
Zmora et al. [117]b 1997–2000 37 7 4 Retrospective
Ellis [67]b 2003–2006 78 7 78 Retrospective review of
prospective cohort
Medical treatment
Sands et al. [118] 2000–2001 25 25 27c Post hoc analysis of randomized,
double-blind, placebo-controlled
trial
Korelitz et al. [119] 2 yearsd 34 34 6 Retrospective review of cohort
from randomized, double-blind
study
O’Brien et al. [120] 1980–1989 35 35 6 Retrospective
Parsi et al. [121] 1998–2001 60 60 22 Retrospective
Rusche et al. [122] d 6 6 6 Retrospective
a
Numbers reflect those of all subjects and not only those with both Crohn’s disease and RVF
b
Fibrin glue or plug therapy
c
Number of fistulae treated
d
Dates not stated
988 A. M. Abulafi and A. H. Sultan
Table 79.6 Results of medical treatment of rectovaginal fistula caused by Crohn’s disease, adapted from [123]
Study Agent Number of patients Closure Improvement Recurrence
Korelitz et al. (1985) [119] 6-Mercaptopurine 6 2 1
Hanauer and Smith (1993) [124] Ciclosporin 5 4 1 2
Present and Lichtiger (1994) [125] Ciclosporin 2 1
Ricart et al. (2001) [126] Infliximab 15 5 1
van Bodegraven et al. (2002) [127] Infliximab 4 0 1
Ochsenkuhn et al. (2002) [128] Infliximab 1
Bell et al. (2003) [129] Infliximab 2 1
Topstad et al. (2003) [130] Infliximab 8 1 5 2
Rasul et al. (2004) [131] Infliximab 8 6
Parsi et al. (2004) [121] Infliximab 14 2 9
Ardizzone et al. (2004) [132] Infliximab 7 2
Specific medical therapy for Crohn’s disease includes healing in 44.2% [133]. The authors concluded that it was
treatment with steroids and immunomodulators (Table 79.6) difficult to draw any conclusions and larger high-quality
[123–132]. This will not only result in controlling the sys- clinical trials are required to determine the role of medical
temic disease but may also result in complete healing of the and surgical treatment in Crohn’s RVF. However, the above
fistula, or at least may optimize and decrease inflammation principles and stepwise approach are recommended for suc-
in perineal tissues in preparation for surgery. Once sepsis is cessful management.
under control and the active disease is in remission, the type
of surgery will depend on the location of the fistula and the 79.6.2.3 RVF Due to Radiation
presence or absence of sphincter defects, as well as the pres- Radiation-induced fistulae are a challenging entity to man-
ence and extent of active disease in the anorectum. In the age. The fistula usually develops several years after radio-
absence of any sphincter defect and active disease, a fistula therapy, and often patients are middle-aged or elderly with
in the lower rectum should be closed primarily using the considerable comorbidity. Consequently, they may not be
endorectal advancement flap. If a sphincter defect is present suitable for a major operation and therefore require careful
but no active disease, an overlapping sphincteroplasty or preoperative assessment. In addition, since radiation would
perineoproctotomy should be considered. have been delivered to treat cancer, it is essential to rule out
There are no direct comparative studies of these two oper- recurrent disease by taking a biopsy of the fistula and sur-
ations, and therefore the choice of operation depends on the rounding tissue. Once the diagnosis is made, initial treatment
surgeon’s own preference and expertise. If mild active dis- starts by raising a defunctioning colostomy, which not only
ease exists in the rectum, then an advancement sleeve opera- will help the patient cope with the debilitating symptom of
tion should be considered. In a high fistula with or without fecal incontinence but also help resolve any inflammatory
active disease, an anterior resection with a defunctioning process associated with the fistula and surrounding tissues.
stoma should be considered. If the anorectum is severely dis- Often, a colostomy is all that is needed and hence it is impor-
eased with active disease/strictures, or in recurrent fistulae, tant to manage patients’ expectations from the beginning. In
consideration should be given to either an abdominoperineal younger and fitter patients who wish to have definitive treat-
excision of the anus and rectum, proctectomy with preserva- ment, the surgical options, as in Crohn’s disease, depend on
tion of the anus if it is not involved with a view to restoring the location of the fistula and extent of the radiation damage
intestinal continuity later on, or even a diverting colostomy/ in the rectum. More importantly, any repair should involve
ileostomy. interposing well-vascularized tissue, as the blood supply to
Although there is no strong evidence to support the use of the surrounding tissues is usually compromised by the radio-
anal fistula plugs in the treatment of Crohn’s RVF, Hannaway therapy. Low fistulae with no or mild radiation damage in the
and Hull suggested that this could be considered in a simple rectum are usually approached via the perineum, with inter-
low fistula with minimal active disease [46]. A systematic position of the anal sphincter muscle (if a defect exists) or a
review by Kaimakliotis et al. of 16 studies reporting on the labial fat pad (Martius graft) or the gracilis/sartorius muscle.
medical treatment of 137 RVFs showed a complete healing In a high fistula with no or mild damage, repair is approached
in 38.3%. Three studies reporting on a combination of medi- via the abdomen with interposition of omentum or colon
cal and surgical treatment of 43 RVFs, showed complete (Bricker’s graft). Bricker reported that 19 out of 26 patients
79 Rectovaginal Fistulae 989
with radiation-induced fistula were healed [92]. If the rectum a defunctioning stoma if one is not already raised to help
is severely damaged by radiotherapy (for example the pres- control the sepsis. Rarely, small fistulae may close spontane-
ence of stricture and fibrosis), then an anterior resection/ ously, but if the fistula persists, a low one is treated by an
proctectomy should be performed with or without restora- endorectal or transvaginal advancement flap and a high one
tion of intestinal continuity, and with interposition of the by a repeat anterior resection and anastomosis with interpo-
omentum. sition of omentum. In a low fistula with sphincter disruption,
an overlapping sphincteroplasty is used to separate the two
79.6.2.4 RVF Due to Malignancy suture lines, but interposition of other tissues may be required
Management of RVF associated with malignancy is directed particularly in recurrent/failed repairs. In the rare situations
at treating the cancer, which is otherwise a progressive con- where the injury/fistula is recognized at the time of surgery,
dition. The cancers that may cause RVF are locally advanced as may happen during STARR surgery or stapled hemor-
tumors arising from the rectum, anus, or cervix. They may be rhoidectomy, the repair of the fistula should be attempted
associated with metastases, and therefore patients must be immediately by undertaking layered closure with repair of
fully staged with magnetic resonance imaging (MRI) of the the vaginal fascia.
pelvis and CT scan of the chest, abdomen, and pelvis, and a
management plan discussed and agreed in a multidisci- 79.6.2.6 Recurrent RVF
plinary setting involving surgeons, oncologists, radiologists, The principles of management are similar to those
and histopathologists. The initial treatment would involve a employed in the management of complex fistulae as dis-
defunctioning ileostomy or colostomy with benefits as cussed earlier. However, the initial choice of treatment
alluded to above. This is followed by neoadjuvant downstag- should take into account the type of previous failed repair
ing chemoradiotherapy along the accepted regimens of the and the surgeon’s experience, in addition to other factors
tumor being treated. If the tumor is in the upper or mid- such as the location and etiology of the fistula. The two
rectum, an anterior resection is undertaken using the tech- reports in the literature dedicated to this subject employ a
niques described earlier. If the tumor is in the lower rectum, variety of techniques via both the local and abdominal
an abdominoperineal excision of the rectum and anus is the routes, with success rates of up to 72% in simple fistulae
treatment of choice. If the tumor is a squamous cell cancer of and 40% in complex ones [49, 103]. It is suggested that
the anus and it resolves fully on treatment but the fistula is repair of fistulae should not be attempted soon after the
still present, then a consideration is made for a local repair recurrence develops, but delayed for a few months to allow
along the lines discussed for radiotherapy-induced fistula any inflammatory process to resolve, infection to be
earlier. Ultimately, it may be necessary to undertake a sal- treated, and the current status of the fistula to be evaluated.
vage abdomino-perineal excision of the anus and rectum Advancement flaps should not be considered if a previous
with the use of muscle graft by plastic surgeons to fill the flap repair has failed and in complex fistulae, because of
defect in the perineum. In the case of cervical cancer, an low success rates of approximately 40%. However, some
anterior resection with en-bloc radical hysterectomy would suggest that this can be considered if only one, or perhaps
be required. two, flap repairs have failed.
The success rate of 85% after first failed repair fell to 55%
79.6.2.5 Postoperative (Iatrogenic) RVF after the third failed repair [33]. Perineoproctotomy, rectal
The commonest causes of postoperative RVF are incorporat- sleeve advancement, and tissue interposition operations
ing the posterior vaginal wall with either sutures or a stapling should be considered as the initial choice in low fistulae, and
device during hemorrhoidectomy [18], treatment of rectal resection with or without reconstruction and with and
obstructed defecation by STARR [18], and reconstruction of without tissue interposition in high fistulae.
the intestinal continuity following low anterior resection or
an ileo-anal pouch construction [12, 13]. A leaking anasto-
mosis may result in pelvic sepsis and, rarely, this can lead to 79.6.3 Suggested Algorithm
fistula formation especially in the irradiated pelvis. Fistulae
can also occur following vaginal hysterectomy. In the vast Figure 79.9 shows a suggested algorithm to the management
majority of patients, the problem becomes apparent a week of rectovaginal fistula. Although rather complex, it provides
or two after initial injury, by which time local sepsis would a quick but concise overview of diagnosis and treatment of
have set in. In these situations, the treatment starts by raising the condition.
990 A. M. Abulafi and A. H. Sultan
Rectovaginal Fistula
Endorectal or Law High Law High Law High High Law High Law
Endorectal or transvaginal
transvaginal advancement flap
advancement flap + sphincteroplasty
Anterior
Treat as Rectal sleeve resection
Perineoproctotomy Proctectomy with or
low advancement without anastomosis
obstetric
Sphincter
Sphincter intact
Anterior
resection disruption
Healed Not healed
Treat as
Local repair + low
vascularised tissue obstetric
interposition
36. Kapoor D, Sultan AH, Thakar R, et al. Management of complex 58. Mazier WP, Senagore AJ, Schiesel EC. Operative repair of ano-
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Emerging Concepts in Classification
of Anal Fistulae 80
Arun Rojanasakul and Charles B. Tsang
80.2 Anatomy
80.1 Introduction
In reflection of the importance of anatomy in anal fistula,
Classification of anal fistula is the grouping of anal fistula Parks once said, “It is impossible to perform operation with-
patterns. It is an essential tool in the development of anal out accurate anatomical knowledge, and this is particularly
fistula management. However, the available anal fistula clas- true in the case of fistula-in-ano where intemperate surgery
sifications have many limitations and are becoming less can lead to such disaster results” [1].
applicable. To understand the whole spectrum of anal fistula, it is
An ideal classification should have the following vital to understand the entire anatomy of anogenital area, not
characteristics: only anatomy around the anus. The essential anatomy of the
anogenital area includes the anatomy of muscles, fasciae and
1. Correct description of anal fistula patterns based on the spaces.
integrated knowledge of anogenital anatomy, imaging
studies and operative findings.
2. Simple, clear and easily adopted by multidisciplinary
80.2.1 The Anogenital Muscles
users, including surgeons, radiologists and other health
practitioners. The internal anal sphincter muscle is the inferior continua-
3. Should cover variants of anal fistula but should not
tion of the circular muscle of the rectum. It increases in
include extremely rare cases. thickness when it descends below the anorectal ring.
4. Guide treatment options. The longitudinal muscle is the downward continuation of
5. Reflect and predict treatment outcomes. the longitudinal layer of the upper rectum. It is a thin muscle
that adheres to the internal anal sphincter.
The anogenital striated muscles can be simplified into
A. Rojanasakul (*) three levels (Fig. 80.1).
King Chulalongkorn Memorial Hospital, Bangkok, Thailand
e-mail: todrarun@gmail.com 1. The upper level: is the levator ani, which is a single,
C. B. Tsang broad and thin muscle. It attaches to the lower part of
Department of Surgery, Yong Loo Lin School of Medicine, pubic bone near pubic symphysis anteriorly, arcus tendi-
National University of Singapore, Singapore, Singapore
nous laterally, coccyx and distal sacrum posteriorly. The
e-mail: drcharlestsang@colorectalclinic.com
Anal sepsis spreads between anogenital muscles to spaces 1. The intersphincteric fascia
around the anogenital organs. Some spaces are large, such as The concept of intersphincteric fascia is controversial
perianal space, superficial perineum space, ischioanal space [3]. In our cadaveric studies, this is the fascia of levator
80 Emerging Concepts in Classification of Anal Fistulae 997
2.Ischioanal fascia
1.Intersphincteric fascia
3.Transversalis fascia
ani and superficial external sphincter muscle. This fascia Table 80.1 Acute anal abscess (personal data from Bumrungrad
does not fuse with the longitudinal muscle. It descends International hospital 2010–2016)
down and separates the subcutaneous external sphincter Number of
muscle into small bundles. Type of abscess cases Percent
1. Low intersphincteric 4 3.8
2. The transversalis fascia
2. Low transphincteric (perianal abscess) 28 26.9
The transversalis fascia separates perianal space from 3. Anterior high transphincteric (perineal 29 27.9
ischioanal space. abscess)
3 . The ischioanal fossa fascia 4. Posterior high transphincteric (deep post 33 31.7
The ischioanal fossa fascia separates the ischioanal anal and ischioanal abscess)
space into low ischioanal and high infralevator 5. High intersphincteric (supralevator 10 9.6
abscess)
space [4]. 104 100
80.3 Pathogenesis teric plane and 1% of anal glands extend outside the exter-
nal anal sphincter.
According to the cryptoglandular theory, it is generally The anorectal sepsis spreads between the anogenital mus-
accepted that the cause of anal sepsis is infection of the anal cles instead of penetrating them to reach anorectal spaces.
gland. However, the origin of anal abscess is still debatable. Since the anatomy of the muscles and spaces are constant,
Parks [5] and Eisenhammer [6] popularised the concept the natural patterns of anal fistula which relate to these mus-
that anal abscess originates in the intersphincteric space cles and spaces should also follow a constant pattern.
and then spreads to other spaces. On the contrary, Goligher
[7] reported that among 28 acute perianal/ischioanal
abscess operations, only 8 (28%) had an intersphincteric 80.3.1 Natural Anal Abscess Patterns
component. Recently, we have used the LIFT procedure for (Table 80.1 and Fig. 80.4)
acute anal abscess and found that intersphincteric abscess
was detected in only one-fifth of all acute anal abscess The internal opening is the entrance of sepsis and it extends
cases. We concluded that the majority of anal glands pass- to the anogenital spaces, leading to different types of abscess:
ing from the internal opening to intersphincteric space,
which then pass outside external anal sphincters to form 1. Low intersphincteric pattern: This abscess originates in
primary abscess. Another evidence that supports this find- the intersphincteric plane below the dentate line and
ing is the study of anal glands by Seow Choen [8], which extends between internal anal sphincter and subcutaneous
reported that only 2% of anal glands reach the intersphinc- external sphincter to reach perianal space.
998 A. Rojanasakul and C. B. Tsang
PRAA
Superficial external
High intersphincteric
sphincter
abscess
Ischioanal abscess
1. Low intersphincteric pattern: The fistula tract passes Table 80.2 Anal fistula classification
between internal anal and subcutaneous external anal Anal fistula classification
sphincters. This pattern can occur in all directions around 1. Low intersphincteric type
the anus. 2. Low transphincteric type
2. Low transphincteric pattern: The fistula tract passes 3. Anterior high transphincteric type
4. Posterior high transphincteric type
between the bundles of subcutaneous external anal
5. High intersphincteric type
sphincter. The highest tract passes between subcutaneous
and superficial external anal sphincter. This type of fistula
can occur in all directions around the anus but occurs
more commonly in the posterior and anterior directions. 80.4 A
Proposed Anal Fistula Classification
3. Anterior high transphincteric pattern: The internal (Table 80.2)
opening of this type is located anteriorly at 11, 12 or 1
o’clock position. The fistula tract from internal opening We have previously reported our outcomes of the LIFT pro-
passes above superficial external anal sphincter to cedure according to natural fistula patterns [9, 10]. We have
perineum space to external opening. In certain cases, the recently expanded the indication of LIFT procedure for acute
anterior high transphincteric fistula extends laterally to anal abscess. With this practice, we have a better understand-
ischioanal space at 1 and 11 o’clock position. ing of the patterns of the anal abscess and anal fistula. The
4. Posterior high transphincteric pattern: The internal following is the anal fistula classification that we currently
opening is at posterior midline (6 o’clock). The fistula use for both acute anal abscess and anal fistula.
tract passes between superficial external anal sphincter
and levator ani to deep post-anal and ischioanal space.
This pattern does not have intersphincteric abscess or 80.4.1 Characteristics and Benefits of the New
intersphincteric granulation tissue. Classification
5. Posterior high intersphincteric pattern: At the core of
this pattern is the intersphincteric infection. There are 1 . Focuses only fistula of cryptoglandular origin.
three possible pathways. In the first pathway, the inter- 2. Applies to both anal fistula and acute anal abscess.
sphincteric abscess spreads upwards to form a supraleva- 3. Includes only basic natural anal fistula patterns and forms
tor abscess and may become a chronic abscess without the foundation to understanding more complex fistula.
external opening. In the second pathway, the intersphinc- 4. Conversion to other classifications is possible but not vice
teric abscess spreads laterally above superficial external versa.
sphincter at 5 and 7 o’clock direction to the ischioanal 5. Guides surgical options and decision-making.
space to external opening. In the third pathway, the inter- 6. Can reflect different outcomes between types of fistula,
sphincteric abscess spreads posteriorly to deep post-anal techniques and surgeons.
space and ischioanal fossa to external opening. These 7. Parks’ supra and extrasphincteric types are not included
three patterns can occur in combination and result in in this classification but can be recorded as type 4 and
complex fistula. These patterns almost always have inter- type 5.
nal opening at 6 o’clock.
For example: Type 4 posterior high transphincteric with
Note: extrasphincteric tract and type 5 high intersphincteric with
1. The high transphincteric fistula is generally accepted as a suprasphincteric tract.
fistula involving more than one-third of the external
sphincter complex, but in reality the high transphincteric
fistula is the fistula that passes above the superficial exter- 80.5 Anal Fistula Map
nal anal sphincter.
2. Parks’ supra- and extrasphincteric are iatrogenic sequelae Anal fistula map is a recording and reporting template for
of type 4 and 5 patterns and should be classified as fol- anal sepsis.
lows: (1) posterior high transphincteric pattern with A major problem of any new fistula classification is the
extrasphincteric tract and (2) high intersphincteric pattern difficulty in gaining widespread acceptance amongst users.
with suprasphincteric tract. The other problem is the lack of common language between
1000 A. Rojanasakul and C. B. Tsang
IO (internal opening): clock face 1-12 (b) Blind end (BE): recorded by location using clock
face, where anterior midline of the anus is 12 o’clock.
Intersphincteric space: abscess(a), cavity(c), tract(t)
This blind end can either be abscess (a), cavity (c) or
tract (t).
(c) Secondary internal opening (2IO).
Level at anal sphincters: IT (intersphincteric),
LT (low transphicnteric), HT (high transphincteric) 3. Distance: The distance is the shortest measurement
between IO and End, in centimetres.
Anogenital spaces: (a,c,t) 4. Stage of sepsis process (a, c, t):
a = abscess,
c = cavity,
End point: clock face 1-12
EO (external opening), BE (blind end), 2IO (secondary IO) t = tract.
5. Level which the primary fistula tract crosses the external
sphincter:
Distance: IO to End point - cms
IT = Intersphincteric.
LT = Low transphincteric.
Diagram 80.1 Algorithm of Anal Fistula Map
HT = High transphincteric.
6. Spaces:
surgeons and radiologists. One way to solve these is the ITS = Intersphincteric space.
introduction of “The Anal Fistula Map”. It is a standardised PRA = Perianal space.
recording and reporting template using standardised nomen- PRN = Perineum space.
clature and sequence. It allows a clear description of the DPA = Deep post-anal space.
route of any fistula, and takes into account any associated ISA = Ischioanal space.
abscess/cavity/tract in each location. This recording system IFL = Infralevator space.
is an adjunct to the classification system and does not seek to SPL = Supralevator space.
replace it. (Diagram 80.1).
The benefits of the “Anal Fistula Map” are the following:
80.5.1.2 Recording Pathway
1. Any anal fistula classification can be extracted from the The recording starts from the internal opening (IO) to inter-
“Anal Fistula Map”. sphincteric space (ITS), crosses external sphincters at differ-
2. It acts like a map to guide surgeons for surgical
ent levels; low transphincteric level (LT) or high
decision-makings. transphincteric level (HT) or intersphincteric (IT); enters
3. It facilitates communication between surgeons perform- anal spaces (PRA, PRN, DPA, ISA, IFL, SPL) and ends at
ing clinical examination, recording intra-operative find- external opening (EO), second internal opening (2IO) or
ings, and radiologists documenting MRI and endoanal blindly in any space.
ultrasound findings. Note: If there are more than one pathways, each can be
recorded separately as second or third set, as in the
example.
80.5.1 Abbreviations, Pathway and Recording This example has two pathways. The first pathway is a
Format Used in Anal Fistula Map tract that passes from IO to intersphincteric space, above
superficial external anal sphincter into deep post-anal space.
80.5.1.1 Abbreviations Then it extends to the cavity in the ischioanal space and ends
at EO at 9 o’clock position. Distance between IO and EO is
1. Internal opening (IO): Internal opening is the starting 5 cm. The second pathway starts from IO to intersphincteric
point of anal fistula, recorded by location using clock space then into deep post-anal space. From this, it passes into
face, where anterior midline of the anus is 12 o’clock. cavity in the infralevator space and breaks through the leva-
Other internal openings (if any), can be recorded by num- tor ani muscle to 2IO at 9 o’clock position. Distance between
ber in front of the IO (e.g. 2IO, 3IO and so on). IO to 2IO is 4 cm (Fig. 80.7).
2. End point (End): There are three end points. The recording of “Anal Fistula Map” for this example is:
(a) External opening (EO): recorded by location using
clock face, where anterior midline of the anus is 12 1 . IO6 – ITSt – HT – DPAt – ISAc – EO9, 5 cm.
o’clock. Other external openings (if any) can be 2. IO6 – ITSt – HT – DPAt – IFLc – translevator – SPLt –
recorded by number in front of the EO (e.g. 2EO, 2IO9, 4 cm.
3EO and so on).
80 Emerging Concepts in Classification of Anal Fistulae 1001
Table 80.3 Comparison of St. James University Hospital MRI classi- References
fication and Parks’ classification
St. James University Hospital MRI 1. Parks AG, Stitz RW. The treatment of high fistula-in-ano. Dis Colon
classification Parks’ classification Rectum. 1976;19(6):487–99.
Grade 0 Normal appearance N/A 2. Courtney H. The posterior subsphincteric space; its relation to pos-
Grade 1 Simple linear intersphincteric fistula Type 1 terior horseshoe fistula. Surg Gynecol Obstet. 1949;89(2):222–6.
Grade 2 Intersphincteric fistula with Intersphincteric 3. Lunniss PJ, Phillips RK. Anatomy and function of the anal longitu-
intersphincteric abscess or secondary fistulous High dinal muscle. Br J Surg. 1992;79(9):882–4.
track intersphincteric 4. Kurihara H, Kanai T, Ishikawa T, Ozawa K, Kanatake Y, Kanai
Grade 3 Transphincteric fistula Type 2 S, et al. A new concept for the surgical anatomy of posterior deep
Transphincteric complex fistulas: the posterior deep space and the septum of the
Grade 4 Transphincteric fistula with abscess or
ischiorectal fossa. Dis Colon Rectum. 2006;49(10 Suppl):S37–44.
secondary track within the ischioanal fossa
5. Parks AG. Pathogenesis and treatment of fistuila-in-ano. Br Med J.
Grade 5 Supralevator and translevator Type 3 1961;1(5224):463–9.
Suprasphincteric 6. Eisenhammer S. The internal anal sphincter and the anorectal
Type 4 abscess. Surg Gynecol Obstet. 1956;103(4):501–6.
Extrasphincteric 7. Goligher JC, Ellis M, Pissidis AG. A critique of anal glandular
infection in the aetiology and treatment of idiopathic anorectal
abscesses and fistulas. Br J Surg. 1967;54(12):977–83.
8. Seow-Choen F, Ho JM. Histoanatomy of anal glands. Dis Colon
4. Parks’ classification includes all fistulae of different etiol- Rectum. 1994;37(12):1215–8.
ogy, e.g. inflammatory bowel diseases, trauma and intra- 9. Rojanasakul A, Pattanaarun J, Sahakitrungruang C, Tantiphlachiva
abdominal infection. K. Total anal sphincter saving technique for fistula-in-ano;
the ligation of intersphincteric fistula tract. J Med Assoc Thai.
5. Parks’ classification may not be applicable in some cir- 2007;90(3):581–6.
cumstances. Garcia-Aguilar reported that the number of 10. Malakorn S, Sammour T, Khomvilai S, Chowchankit I, Gunarasa
unclassified fistulae was as high as 20% [19]. S, Kanjanasilp P, et al. Ligation of intersphincteric fistula tract for
Another classification that needs mentioning is the St. fistula in Ano: lessons learned from a decade of experience. Dis
Colon Rectum. 2017;60(10):1065–70.
James University Hospital MRI classification [20]. This 11. Eisenhammer S. The final evaluation and classification of the surgi-
classification is widely used by radiologists, but not sur- cal treatment of the primary anorectal cryptoglandular intermus-
geons. This MRI classification is the radiological extrapo- cular (intersphincteric) fistulous abscess and fistula. Dis Colon
lation of Parks’ classification (Table 80.3) and hence Rectum. 1978;21(4):237–54.
12. Shafik A. A new concept of the anatomy of the anal sphincter mech-
should have similar limitations. anism and the physiology of defecation. The external anal sphinc-
ter: a triple-loop system. Invest Urol. 1975;12(5):412–9.
13. Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-
80.7 Conclusion ano. Br J Surg. 1976;63(1):1–12.
14. Garg P. Comparing existing classifications of fistula-in-ano in 440
operated patients: Is it time for a new classification? A Retrospective
A new concept of anal fistula classification is emerging, with Cohort Study. Int J Surg. 2017;42:34–40.
more and more experts in the fistula field realising that the 15. Yamana T. Japanese practice guidelines for anal disorders II. Anal
current classifications have many limitations and are a bar- fistula. J Anus Rectum Colon. 2018;2(3):103–9.
16. Fucini C. One stage treatment of anal abscesses and fistulas. A
rier to the development of fistula management. A change in clinical appraisal on the basis of two different classifications. Int J
fistula classification is imperative, but individual attempts Colorectal Dis. 1991;6(1):12–6.
will be futile unless international consensus is achieved. We 17. McElwain JW, Alexander RM, MacLean MD. Primary fistulec-
also propose a new “Anal Fistula Map” as a better communi- tomy for anorectal abscess: clinical study of 500 cases. Dis Colon
Rectum. 1966;9(3):181–5.
cation tool, and we expect it to be accepted and used in the 18. Hill JR. Fistulas and fistulous abscesses in the anorectal region:
near future. personal experience in management. Dis Colon Rectum.
1967;10(6):421–34.
19. Garcia-Aguilar J, Belmonte C, Wong WD, Goldberg SM, Madoff
RD. Anal fistula surgery. Factors associated with recurrence and
Take-Home Messages incontinence. Dis Colon Rectum. 1996;39(7):723–9.
• New anal fistula classification has been proposed. 20. Morris J, Spencer JA, Ambrose NS. MR imaging classification
This classification is based on natural anal sepsis of perianal fistulas and its implications for patient management.
Radiographics. 2000;20(3):623–35; discussion 35-7.
patterns.
• A new “Anal Fistula Map” has been introduced to
be a better communication language between per-
sonnel who involve in the anal abscess/fistula
management.
• This classification is awaiting international consen-
sus to be achieved.
Ultrasonographic Assessment
of Anorectal Fistulae 81
Giulio Aniello Santoro, Christian Raymond S. Magbojos,
Giovanni Maconi, and Iwona Sudoł-Szopińska
Learning Objectives
• To understand the technical aspects and imaging
interpretations of ultrasonography in the evaluation
of anorectal abscesses and fistulae.
• To understand the role of endoanal ultrasound in the
D
treatment algorithm for anorectal fistulae.
C
81.1 Introduction
E
The pathogenesis of anorectal abscesses and fistulae is gener- B
ally attributed to an infection of the anal glands, usually located
in the subepithelial position, the intersphincteric space, or the A
external sphincter, which ducts enter at the base of the anal
crypts of Morgagni at the dentate line level [1]. Infection of the Fig. 81.1 Types of anorectal abscesses: (a) perianal; (b) ischioanal; (c)
glands can result in an abscess that can spread in a number of submucosal/intramural; (d) supralevator; (e) intersphincteric.
directions, usually along the path of least resistance, and can Reproduced with permission from: Santoro GA, Wieczorek AP, Bartram
lead to the subsequent development of anal fistula. Five presen- CI, editors. Pelvic floor disorders. Springer Verlag Italia 2010
tations of anorectal abscess have been described (Fig. 81.1) [1]:
fluctuance, and anoscopic examination can demonstrate
(a) Perianal abscess is the most common type of anorectal pus exuding at the base of a crypt (Fig. 81.2).
abscess, occurring in 40–45% of cases. It is identified as (b) Submucosal abscess, arises from an infected crypt in
a superficial, tender mass outside the anal verge. Physical the anal canal and is located under the mucosa. Rectal
examination reveals an area of erythema, induration, or examination may reveal a tender submucosal mass,
which may not be readily apparent by anoscopy.
(c) Intersphincteric abscess, represents between 2% and
5% of anorectal abscesses. In this condition, the infec-
G. A. Santoro (*) · C. R. S. Magbojos tion dissects in the intersphincteric plane and can spread
Tertiary Referral Pelvic Floor and Incontinence Center,
IV°Division of General Surgery, Regional Hospital, Treviso, cephalad (high type) or caudal (low type).
University of Padua, Padua, Italy (d) Ischioanal abscess, is seen in 20–25% of patients and
e-mail: giulioasantoro@yahoo.com may present a large, erythematous, indurated, tender mass
G. Maconi of the buttock or may be virtually inapparent, the patient
Diagnostic and Gastroenterologic Pathophysiology Unit,”Luigi complaining only of severe pain or fever (Fig. 81.3).
Sacco” Hospital, Milan, Italy (e) Supralevator or pelvirectal abscesses, are relatively
I. Sudoł-Szopińska rare, comprising less than 2.5% of anorectal abscesses.
Department of Radiology, National Institute of Geriatrics, They usually lack local classic symptomas, instead gen-
Rheumatology and Rehabilitation, Warsaw and Imaging Diagnostic
Department, Warsaw Medical University, Warsaw, Poland eral conditions are present: fever, weakness, or symp-
e-mail: sudolszopinska@gmail.com toms related to another disease (Crohn’s disease). They
D D
C C
B B
A A
Fig. 81.2 Perianal abscess appears as an area of erythema, induration,
or fluctuance
a b c
Fig. 81.5 Perianal fistulas with one external orifice at 2 o’clock position (a), two external orifices at 9 and 11 o’clock positions (b), and multiple
external openings (c) (clock-wise, 12 o’clock is anterior, 3 o’clock is left lateral, 6 o’clock is posterior, 9 o’clock is right lateral)
Submucosal fistulae are those in which the tract is sub- 81.2.1 Physical Examination
sphincteric and does not involve or pass the sphincter com-
plex. Anovaginal fistulae have an extension toward the Useful information can be obtained by clinical assessment
vaginal introitus and most develop along with obstetric including digital examination [4]. Physical examination
sphincter tears. Ano-perineal fistulae are sometimes may reveal the fistulous tract proceeding into the anal canal,
described, however they represent transsphincteric fistulas and anoscopic examination may demonstrate purulent
with external orifice in the skin of perineum. Some may material exuding from the base of the crypt. Intersphincteric
develop a fistula secondary to Bartholin cysts inflammation. tracts usually open externally very close to the anal verge,
Secondary tracks may develop in any part of the anal canal and transsphincteric and other more complicated tracts
or may extend circumferentially in the intersphincteric, open far away, as they will have to traverse the external anal
ischioanal, or supralevator spaces (horseshoe extensions). sphincter first. According to Goodsall’s rule [5], when the
The term “complex” describes fistulae which treatment external opening lies anterior to the transverse plane, the
poses a higher risk for recurrence and impairment of conti- internal opening tends to be located radially and in the
nence. According to the American Society of Colon and same position as the external opening. Conversely, when
Rectal Surgeons (ASCRS) classification [4], an anal fistula the external opening lies posterior to this plane, the internal
may be termed “complex” when one or more of the follow- opening is usually located in the posterior midline, irre-
ing findings are present: the tract crosses more than 30% of spective of the site of the external opening (Fig. 81.7). An
the external anal sphincter (high transsphincteric, supra- exception to the rule are anterior fistulae lying more than
sphincteric, and extrasphincteric), horseshoe configuration, 3 cm from the anus, which may open in the posterior mid-
anterior location in a female, multiple tracts, recurrent fistu- line of the anal canal (Fig. 81.7).
las, Crohn’s disease, rectovaginal fistula, prior radiotherapy, The use of Goodsall’s rule alone in decision making
or baseline incontinence. before surgical intervention is, however, not recom-
mended because the positive predictive value is 59% for
primary fistulae (anterior fistulae: 72%, posterior fistulae:
81.2 Assessment of Anorectal Fistulae 41%) and 41% for recurrent fistulae (anterior fistulae:
67%, posterior fistulae: 12.5%) [6]. Passage of a probe
The configuration of perianal sepsis and the relationship from both the external and the internal openings may con-
of abscesses or fistulae with internal and external sphinc- firm the course of the tract; however, a stenotic or sharply
ters are the most important factors influencing the results angulated tract may preclude complete passage from
of surgical management [4]. Preoperative identification of either end. Furthermore, this method is potentially dan-
all loculate purulent areas and definition of the anatomy gerous, because a false tract can be made. Methylene blue
of the primary fistulous tract, secondary extensions, and or hydrogen peroxide injection (Fig. 81.8) through the
internal opening play an important role in adequately external opening may confirm the patency of the tract and
planning the operative approach in order to ensure com- its communication with an internal opening. The problem
plete drainage of abscesses, to prevent early recurrence with methylene blue is that the material stains the entire
after surgical treatment, and to minimize iatrogenic dam- mucosa. Staining of the tissue does not occur with hydro-
age of sphincters and the risk of minor or major degrees of gen peroxide, and bubbles may be seen through the inter-
incontinence. nal opening [4].
1006 G. A. Santoro et al.
a b
c d
Fig. 81.6 Schematic drawings of different types of anorectal fistulae tula. Reproduced with permission from: Santoro GA, Wieczorek AP,
according to Parks’ classification. (a) Intersphincteric fistula, (b) trans- Bartram CI, editors. Pelvic floor disorders. Springer Verlag Italia 2010
sphincteric fistula, (c) suprasphincteric fistula, (d) extrasphincteric fis-
Physical examination reaches a very good accuracy in iden- pilonidal cyst with anal sphincters. Deen et al. [7] were able to
tifying superficial (100%) and transsphincteric (100%) tracts, identify only 50% of the internal openings and 27.3% of the
but it appears inadequate for both suprasphincteric (63.6%) and horseshoe tracts by physical examination, and Poen et al. [8]
intersphincteric (33.3%) tracts. In addition, physical examina- reported a correct diagnosis of primary tracts in 38% of patients,
tion may not differentiate external fistula opening from hidrad- with 62% of patients unclassified. Ratto et al. [9] also con-
enitis suppurativa or in some cases assess the relation of a firmed a low overall accuracy (65.4%) of physical examination
81 Ultrasonographic Assessment of Anorectal Fistulae 1007
a b
Fig. 81.9 Three-dimensional endoanal ultrasound with rotating probe (a) Axial plane. (b) Coronal plane. Reproduced with permission from:
at 13 MHz frequency (type 2052 BK Medical). Acute abscess in the left Santoro GA, Wieczorek AP, Bartram CI, editors. Pelvic floor disorders.
anterior perianal space presenting as an area of low reflectivity. Springer Verlag Italia 2010
a b
Fig. 81.10 Three-dimensional endoanal ultrasound with rotating teric space, deep to the hyperechoic ring of the external anal sphincter
probe at 13 MHz frequency (type 2052 BK Medical). (a) Acute abscess (EAS) (IAS internal anal sphincter). (b) Longitudinal plane
(A) presenting as an area of low reflectivity in the posterior intersphinc-
external sphincters, according to the fistula type, and through widening and distortion of an otherwise narrow inter-
the perianal spaces. With regard to the anal sphincters, sphincteric plane (Figs. 81.15, 81.16 and 81.17). The
according to Parks’ classification [1], the fistulous primary tract goes through the intersphincteric space without tra-
tract can be classified into four types: versing the external sphincter fibers. Intersphincteric fis-
tulae are divided into high and low, corresponding to the
(a) Intersphincteric tract, which appears as a band of poor ultrasound levels of the anal canal [16]. Low inter-
reflectivity within the longitudinal muscle layer, causing sphincteric tract occupies up to 1/3 of the anal canal
81 Ultrasonographic Assessment of Anorectal Fistulae 1009
a b c
Fig. 81.11 Three-dimensional endoanal ultrasound with rotating in the axial plane. The abscess (A) presents as an area of low reflectivity
probe at 13 MHz frequency (type 2052 BK Medical). (a) Acute, left in the left ischioanal space. (c) Reconstruction in the coronal plane.
lateral, ischioanal abscess at physical examination. (b) Reconstruction EAS external anal sphincter, IAS internal anal sphincter
a b c
Fig. 81.12 Three-dimensional endoanal ultrasound with rotating axial plane. (b and c) Multiplanar reconstruction. The supralevator
probe at 13 MHz frequency (type 2052 BK Medical). (a) Acute, right abscess (Asp) is traversing the puborectalis muscle and becomes ischio-
lateral, ischioanal-supralevator abscess (A) presents as an area of low anal abscess (Aia)
reflectivity above the puborectalis muscle (PR). Reconstruction in the
a b c
Fig. 81.14 Three-dimensional endoanal ultrasound with rotating sonographic reconstruction in the axial plane; (c) Ultrasonographic
probe at 13 MHz frequency (type 2052 BK Medical). Posterior horse- multiplanar reconstruction
shoe suppurative collection. (a) Schematic representation; (b) Ultra
a b
Fig. 81.15 Three-dimensional endoanal ultrasound with rotating through the intersphincteric space without traversing the external anal
probe at 13 MHz frequency (type 2052 BK Medical). (a) In the axial sphincter (EAS). IAS internal anal sphincter. Reproduced with permis-
plane, a hypoechoic tract is visualized in the left intersphincteric space sion from: Santoro GA, Wieczorek AP, Bartram CI, editors. Pelvic floor
(3 o’clock). (b) In the coronal plane, the intersphincteric high fistula disorders. Springer Verlag Italia 2010
appears as a band of poor reflectivity (arrows). The tract extends
length, whereas high exceeds that height (Figs. the higher part of the anal canal, in the space below
81.15–81.20). the puborectalis (Fig. 81.21) [16];
(b) Transsphincteric tract, appearing as a poorly reflec- (c) Suprasphincteric tract goes through the puborectalis
tive tract running out through the external sphincter level (Fig. 81.23). It can be sometimes difficult to
and disrupting its normal architecture. The point at determine a suprasphincteric fistula because EAUS is
which the main tract of the fistula traverses the sphinc- not able to visualize the precise position of the levator
ters defines the fistula level. Transsphincteric fistulae plate that lies in the same plane as the ultrasound
are divided into high, and low, corresponding to the beam;
ultrasound level of the anal canal [16]. Low trans- (d) Extrasphincteric tract may be seen close to but more
sphincteric tract traverses the lower one third of the laterally placed around the external sphincter. The visu-
external sphincter. High transsphincteric tract tra- alization of these fistulae may however be difficult if
verses both sphincters in the middle (Fig. 81.20) or in they run far away from the anal canal, sometimes beyond
81 Ultrasonographic Assessment of Anorectal Fistulae 1011
a b
Fig. 81.16 Three-dimensional endoanal ultrasound with rotating space (6 o’clock). (b) In the longitudinal plane, the intersphincteric
probe at 13 MHz frequency (type 2052 BK Medical). (a) In the axial high fistula (FIS) appears as a band of poor reflectivity
plane, a hypoechoic tract is visualized in the posterior intersphincteric
a b
Fig. 81.17 Three-dimensional endoanal ultrasound with rotating teric space (12 o’clock). (b) In the longitudinal plane, the intersphinc-
probe at 13 MHz frequency (type 2052 BK Medical). (a) In the axial teric high fistula (FIS) appears as a band of poor reflectivity
plane, a hypoechoic tract is visualized in the anterior-right intersphinc-
the field of view of the ultrasound probe. To identify the to the main one and are classified as intersphincteric, trans-
internal opening into the rectum, it may be necessary to sphincteric, suprasphincteric, or extrasphincteric (Fig. 81.24).
use a water-filled balloon for transrectal ultrasound. Similarly, horseshoe tracts are categorized as intersphincteric,
ischioanal, suprasphincteric, or extrasphincteric (Fig. 81.25).
Differentiation between granulated tracts and scars is some- The exact location (radial site and anal canal level) of the
times difficult because of a similar echogenicity. Straight tracts internal opening can be difficult to be defined, as the dentate
are easily identified, but smaller and oblique tracts are more line cannot be identified as a discrete anatomical entity on
difficult to image. Secondary tracts, when present, are related EAUS. It is assumed to lie at approximately mid-anal canal
1012 G. A. Santoro et al.
a b
Fig. 81.18 Three-dimensional endoanal ultrasound with rotating taneous external sphincter. (b) Coronal plane. The length of the fistula
probe at 13 MHz frequency (type 2052 BK Medical). (a) Axial plane. (2) is lesser than one third of the length of the anal canal (4)
Low right lateral high intersphincteric fistula traversing only the subcu-
a b
Fig. 81.19 Three-dimensional endoanal ultrasound with rotating external sphincter. (b) Longitudinal plane. The length of the fistula (4)
probe at 13 MHz frequency (type 2052 BK Medical). (a) Axial plane. (arrows) is half the length of the anal canal (2)
Posterior high intersphincteric fistula traversing the middle part of the
level, which is midway between the superior border of the be identified as hypoechoic when acute inflammation is
puborectalis muscle and the most caudal extent of the subcu- present.
taneous external sphincter. According to this, the site of the EAUS showed better accuracy than digital examination in
internal opening is categorized as being above, at, or below anal fistula assessment (95.1% vs. 55.6%, P < 0.01) [17]. Law
the dentate line, or in the rectal ampulla. In addition, the site et al. [11] reported good accuracy of EAUS for the selective
can also be characterized by the clock position, being classi- identification of fistula (91.7%) and abscess (75%) configura-
fied from 1 o’clock to 12 o’clock. The internal opening can tions. However, a significant number of the internal openings
81 Ultrasonographic Assessment of Anorectal Fistulae 1013
a b
Fig. 81.20 Three-dimensional endoanal ultrasound with rotating nal sphincter. (b) Coronal plane. The length of the fistula is half the
probe at 13 MHz frequency (type 2052 BK Medical). (a) Axial plane. length of the anal canal (2)
Left lateral high transsphincteric fistula traversing the superficial exter-
a b
Fig. 81.21 Three-dimensional endoanal ultrasound with rotating puborectalis muscle level. (b) Longitudinal plane. The length of the
probe at 13 MHz frequency (type 2052 BK Medical). (a) Axial plane. fistula (4) is more than two-thirds of the anal canal length (2)
High posterior intersphincteric fistula, blindly ended just below the
(33.3%) were not detected. Worse results in the identification used. Seow-Choen et al. [6] described the ultrasonographic
of the internal opening were reported by Poen et al. [8] (5.3% criteria for identifying an internal opening, which included
accuracy), and Deen et al. [7] (11% accuracy). The most one or more of the following features: a hypoechoic breach of
probable reason for the poor results in the identification of the subepithelial layer of the anorectum, a defect in the circu-
internal openings by EAUS are the ultrasonographic criteria lar muscles of the internal anal sphincter, and a hypoechoic
1014 G. A. Santoro et al.
a b
Fig. 81.22 Three-dimensional endoanal ultrasound with rotating probe at 13 MHz frequency (type 2052 BK Medical). (a) Axial plane. High right
lateral transsphincteric fistula. (b) Coronal plane. The length of the fistula (2) is more than two-thirds of the anal canal length
a b
Fig. 81.23 Three-dimensional endoanal ultrasound with rotating Reproduced with permission from: Santoro GA, Wieczorek AP,
probe at 13 MHz frequency (type 2052 BK Medical). Suprasphincteric Bartram CI, editors. Pelvic floor disorders. Springer Verlag Italia
tract (arrows) extending through the puborectalis muscle (PR). (a) 2010
Axial plane. (b) Coronal plane. EAS: external anal sphincter.
81 Ultrasonographic Assessment of Anorectal Fistulae 1015
a b
Fig. 81.24 Three-dimensional endoanal ultrasound with rotating ischioanal space. (b) Multiplanar reconstruction. Reproduced with per-
probe at 13 MHz frequency (type 2052 BK Medical). (a) Axial plane. mission from: Santoro GA, Wieczorek AP, Bartram CI, editors. Pelvic
Posterior transsphincteric fistula (PT, primary tract) with two secondary floor disorders. Springer Verlag Italia 2010
transsphincteric tracts (ST, secondary tracts) extending through the
lesion of the normally hyperechoic longitudinal muscle abut- the fistulae, especially those with a narrow lumen, which is
ting on the normally hypoechoic circular smooth muscle. In practically identical to the fat tissue in the ischioanal fossa,
spite of the improvement in accuracy (73%) in identifying the and to the short focal length of the transducer, which pre-
internal openings, they found no significant difference vents imaging of fistulae that are located at a large distance
between EAUS and digital examination. Cho [15] proposed from the anal canal. For this reason, performing ultrasonog-
the following endosonographic criteria to define the site of raphy after injecting 1.0–2.0 mL of 3% hydrogen peroxide
the internal opening (Fig. 81.26): Criterion 1. an appearance (HPUS) through the external opening of the fistula appears
of a root-like budding formed by the intersphincteric tract, to be particularly useful. This technique allows identifica-
which contacts the internal sphincter; Criterion 2. an appear- tion of tracts whose presence has not been definitively
ance of a root-like budding with an internal sphincter defect; established, or distinction of an active fistulous tract from
Criterion 3. a subepithelial breach connected to the inter- postsurgical or posttrauma scar tissue [9]. Gas is a strong
sphincteric tract through an internal sphincter defect. Using a ultrasound reflector, and after injection, fistula tracts become
combination of these three criteria, Cho reported 94% sensi- hyperechoic and the internal opening is identified as an
tivity, 87% specificity, and 81% and 96% positive and nega- echogenic breach at the submucosa (Fig. 81.27). Because
tive predictive values. the injected HP often results in bubbling into the anal canal,
The majority of problems while investigating anal fistulae which then acts as a barrier to the ultrasound wave, injection
with EAUS occur because of limited tissue differentiation. If should be performed in two phases: an initial injection of a
the primary or secondary tracts are not dilated and filled with small amount of HP, and a further injection at a greater pres-
fluid or echogenic content, they present the same echo- sure [12]. A disadvantage inherent to HP injection is the
genicity of the surrounding tissues and may be misdiag- very strong reflection that occurs at a gas/tissue interface,
nosed. It is also difficult to differentiate a chronic recurrent which blanks out any detail deep to this interface. The bub-
fistula from a scar. Emile et al. [14] showed that although the bles produced by HP induce acoustic shadowing deep to the
accuracy and sensitivity of EAUS in assessing recurrent fis- tract, so all information deep to the inner surface of the tract
tula were lower, the difference between primary and recur- are lost. The reported diagnostic accuracy of HPUS ranges
rent fistulas was not statistically significant, denoting the from 71% to 95% for primary tracts and from 63% to 96.1%
ultimate utility of EAUS even in the presence of fibrosis and for secondary tracts, while that of standard EAUS ranges
scarring. Karanikas et al. [18] reported that acute inflamma- from 50% to 91.7% for the primary tract and from 60% to
tory processes do not affect the accuracy of EAUS. 68% for secondary tracts [8, 9, 19, 20]. The highest concor-
The disappointing results of EAUS in diagnosing the dance is usually reported for primary transsphincteric fistu-
extrasphincteric fistulae could be due to the echogenicity of lae, while the major diagnostic difficulty is still the adequate
1016 G. A. Santoro et al.
a b
c d
Fig. 81.25 Three-dimensional endoanal ultrasound with rotating probe at 13 MHz frequency (type 2052 BK Medical). (a) Axial plane. Anterior
horseshoe transsphincteric fistula. (b, c, d) Multiplanar reconstructions
identification of primary supra- and extrasphincteric fistu- lous tract along all the desired planes (axial, coronal, sagittal,
lae. Injection can also contribute to a more accurate identifi- oblique). It enables the operator to identify with certainty all
cation of the internal opening (HPUS accuracy ranging from the components of the fistula, such as position and type of
48% to 96.6% vs. EAUS accuracy ranging from 5.3% to primary and secondary tract(s), internal opening(s), as well
93.5%) [19–21]. as extent of operative sphincter division and association with
The availability of a three-dimensional (3D) imaging sys- healing rates and functional compromise [22]. In addition,
tem has further improved the accuracy of EAUS. With this volume render mode can facilitate depiction of a tortuous
technique, the operator can follow the pathway of the fistu- fistula tract after hydrogen peroxide injection, due to the
81 Ultrasonographic Assessment of Anorectal Fistulae 1017
a b
c d
e f
Fig. 81.26 Cho criteria for the identification of the internal opening. tration; (d) Endoanal ultrasound with linear probe at 13 MHz frequency
Criterion 1: an appearance of a root-like budding formed by the inter- (type 8838 BK Medical). Criterion 3: a subepithelial breach connected
sphincteric tract, which contacts the internal sphincter. (a) Schematic to the intersphincteric tract through an internal sphincter defect. (e)
illustration; (b) Endoanal ultrasound with rotating probe at 13 MHz Schematic illustration; (f) Endoanal ultrasound with rotating probe at
frequency (type 2052 BK Medical). Criterion 2: an appearance of a 13 MHz frequency (type 2052 BK Medical)
root-like budding with an internal sphincter defect. (c) Schematic illus-
1018 G. A. Santoro et al.
a b
Fig. 81.27 Three-dimensional endoanal ultrasound with rotating teric fistula becomes evident as a hyperechoic tract (arrows) extending
probe at 13 MHz frequency (type 2052 BK Medical). After hydrogen through the external sphincter (a) Axial plane. (b) Longitudinal plane.
peroxide injection through an external orifice, an anterior transsphinc- (c) Multiplanar reconstruction
transparency and depth information (Fig. 81.28) [23, 24]. 89.4%, 83.3%, and 87.9%, respectively, when the 2D system
Sudol-Szopinska et al. [24] reported that in the classification was used. Our experience [21, 23] on 57 patients with peri-
of the primary tract, the agreement between surgery and anal fistulae confirmed that 3D reconstructions improved the
3D-EAUS with volume render mode was much higher than accuracy of EAUS in the identification of internal opening
that with conventional 3D-EAUS (marginal homogeneity compared to 2D-EAUS (89.5% vs. 66.7%; P = 0.0033).
test P > 0.1, κ = 0.96, and marginal homogeneity test Primary tracts, secondary tracts, and abscesses were simi-
P = 0.0048, κ = 0.28, respectively) (Fig. 81.29). Buchanan larly evaluated by both procedures. According to Xue et al.
et al. [25] reported a good accuracy of 3D-EAUS in detecting [26], both 2D-EAUS and 3D-EAUS showed good concor-
primary tracts (81%), secondary tracts (68%), and internal dance with intraoperative findings for the internal opening
openings (90%) in 19 patients with recurrent or complex fis- (k: 0.776 vs. 0.636). 3D-EAUS had better concordance with
tulae. The addition of hydrogen peroxide (3D-HPUS) did not intraoperative findings in the diagnosis of intersphincteric,
improve these features (accuracies of 71%, 63% and 86%, high transsphincteric and suprasphincteric fistulas as com-
respectively). Using 3D imaging, Ratto et al. [20] reported pared to 2D-EAUS (k: 0.810 vs. 0.592, k: 0.863 vs. 0.548, k:
an accuracy of 98.5% for primary tracts, 98.5% for second- 1.000 vs. 0.672). 3D-EAUS showed better concordance with
ary tracts, and 96.4% for internal openings, compared with intraoperative findings for secondary tract compared to
81 Ultrasonographic Assessment of Anorectal Fistulae 1019
a b
Fig. 81.28 Three-dimensional endoanal ultrasound with rotating tion through the external orifice. (b, c) Rendering of the images facili-
probe at 13 MHz frequency (type 2052 BK Medical). (a) B-mode. tates the visualization of a intersphincteric tortuous fistula due to
Strong reflectivity of the fistulous tract after hydrogen peroxide injec- transparency and depth information
2D-EAUS (k: 0.659 vs. 0.535). Both 2D-EAUS and recurrence rate tended to be lower (8.8% vs. 13.8%) when
3D-EAUS had good concordance with intraoperative find- compared to those examined only under anesthesia.
ings for complicated abscesses (k: 0.881 vs. 0.816). Recurrence rates were lower as well for complex fistulas
Identification of secondary tracts by preoperative 3D-EAUS (12.8% vs. 22.5%). The 3D-EAUS group had shorter opera-
examination is the strongest independent risk factor for tive time that can be attributed to the facilitated identification
recurrence (hazard ratio 2.4 (95% CI 1.2–51), P = 0.016) [2]. of the internal opening, primary and secondary tracts. Anal
This stresses the importance of preoperative 3D-EAUS in sphincter injuries were minimal as evidenced by postopera-
mapping the pathological anatomy of the fistula and a thor- tive anal manometry showing both maximum resting pres-
ough search for secondary tract formation during surgery sure and maximum squeeze pressure being significantly
[2]. Overall sensitivity and specificity of 3D-EAUS in the higher in the 3D-EAUS group [28].
diagnosis of sepsis with anorectal source were reported as 3D-EAUS is more accurate than 2D-EAUS in defining
98.3% and 91.3%, respectively [27]. The outcome of surgical fistula configuration due to higher panoramicity and the
treatment of anal fistula between patients with and those ability to view coronal and sagittal planes with multiplanar
without 3D-EAUS were compared by Ding et al. [28]. Global reconstruction [16, 23]. It provides precise measurements of
1020 G. A. Santoro et al.
a b
Fig. 81.29 Three-dimensional endoanal ultrasound with rotating facilitates the visualization of the internal opening (IO) as a hyper-
probe at 16 MHz frequency (type 2052 BK Medical). (a) Recurrent echoic spot due to transparency and depth information (b. Axial plane.
anterior fistula not clearly visible in B-mode. Rendering of the image c. Longitudinal plane)
81 Ultrasonographic Assessment of Anorectal Fistulae 1021
the length of IAS or EAS involved (Figs. 81.19, 81.20, in cryptoglandular fistulas. Fourth, a wider fistula tract
81.21, and 81.22) and quantifies how much sphincter can be (≥4 mm) has been correlated with PACD [33, 37]. The pres-
safely divided or transected [16, 22, 29], reducing the inci- ence of two ultrasonographic features increases the probabil-
dence of postoperative fecal incontinence in patients with ity of having perianal CD by >80% [22]. In a retrospective
high fistulas [16, 22, 30]. Kolodziejczak et al. [16] found study of 21 cases with PACD and anal fistula (with or without
91% overall accuracy of 3D-EAUS for definition of fistula abscesses), where patients were treated strictly based on
type and 92% overall accuracy for definition of fistula 3D-EAUS data, (e.g. drainage with or without probe inser-
height, with good inter-observer agreement. Gárces-Albir tion), none developed new abscesses during follow-up with
et al. [31] reported good correlation between 3D-EAUS and more than half showing improvement in fistula activity [34].
surgical findings for transsphincteric fistulas, whereas Lahat et al. [38] reported that EAUS influenced patient man-
2D-EAUS overestimated the amount of anal sphincter agement in 86% of patients with CD perianal fistulas.
involved. EAUS can be used to evaluate the efficacy of infliximab
3D-EAUS has been used [22] in the postoperative follow- treatment in fistulizing Crohn’s disease [39]. Schwartz et al.
up to confirm healing and delayed healing without recur- [40] found that the use of EAUS to guide therapy for PACD
rence or to identify recurrences needing further surgical was associated with a high short- and long-term fistula
procedure. In a study by Murad-Regadas et al. [22], 25 response rate. EAUS identified a subset of patients who could
patients with high fistulas underwent ligation of intersphinc- discontinue infliximab without recurrence of fistula drainage.
teric fistula tract (LIFT) procedure. 3D-EAUS confirmed Similar results were reported by Spradlin et al. [41] in a ran-
complete healing in 20/25 (80%) cases demonstrating the domized controlled trial. Guidi et al. [42] treated complex
presence of fibrosis in the area previously occupied by the perianal fistulas in CD with infliximab and setons, which
fistula tract and external opening. Two of them, with a small were removed after ultrasonographic evidence of healing of
persistent cavity without evidence of recurrence, were treated fistulous tracts. However, van Bodegraven et al. [43] found
conservatively. 3D-EAUS identified five failures in patients endosonographic evidence of persistence of CD fistulas after
treated with another surgical procedure. infliximab, irrespective of clinical response. Ardizzone et al.
[44] reported that patients with fistula closure after inflix-
81.2.3.1 E ndoanal Ultrasonography in Crohn’s imab, but with endosonographic persistence of fistula tract,
Disease were at higher risk of recurrence. MRI seems to predict deep
Thirty percent of patients with perianal Crohn’s disease remission in patients with fistulizing CD on long-term main-
(PACD) may develop a perianal fistula [32], and in 10–20% of tenance anti-tumor necrosis factor (TNF)-α [45].
cases, a fistula of apparent cryptogenic origin (no history or
suspicion of inflammatory bowel disease) can be the first man- 81.2.3.2 EAUS Vs. MRI
ifestation of CD [33]. A prompt diagnosis of CD can direct In recent years, magnetic resonance imaging (MRI) has
appropriate specific treatment, and avoid surgical misadven- emerged as a highly accurate technique in diagnosing peri-
tures. In another clinical setting, a patient with an established anal fistulae (see Chap. 82) [19, 46]. Differences in detecting
diagnosis of CD may present with new-onset perianal fistulas the fistulous tract have been described in relation to the tech-
that might be cryptoglandular. In both situations, 3D-EAUS nique used [47, 48]. The best spatial resolution is achieved
becomes an invaluable imaging tool to differentiate crypto- by using dedicated endoluminal anal coils. Limitations of
glandular from CD fistula [33]. There are several 3D acoustic endoanal coils are higher cost than phased-array, relatively
characteristics described as pathognomonic of CD fistula or restricted availability, and limited field of view (2–3 cm from
abscess. First, it is the so-called Crohn’s Ultrasound Fistula the coil) [48], so fistulous extensions beyond this range can
Signs (CUFS) consisting of a hypoechoic rim around an be missed. When extensive sepsis or supralevator sepsis is
abscess collection or fistula and a hyperechoic margin along- suspected, a pelvic phased array coil is more accurate.
side, indicative of a chronic inflammatory process (Figs. 81.30 The most valuable use of MRI is in the assessment of recur-
and 81.31) [34, 35]. The biological and histological bases of rent sepsis not visualized on EAUS where differentiation
this sign are not fully understood, probably being related to the between a scar and an active tract requires i.v. contrast injec-
fact that CD fistulas are more likely to create a deep and cavi- tions [46–48]. A variety of investigators have directly com-
tating inflammatory process, with some debris inside [33]. pared EAUS with MRI, both with and without an endoanal
Zbar et al. [36] reported that CUFS were only moderately sen- coil, and these comparisons have found EAUS variously supe-
sitive but highly specific for the diagnosis of PACD. Second, rior [49], equivalent [50], or inferior [25]. West et al. [19]
the presence of debris (hyperechoic secretions) in the fistulous reported that 3D-HPUS and endoanal MRI were equally ade-
tract or abscess is a sign peculiar to perianal CD [33, 37]. quate for the evaluation of perianal fistulae. The methods
Third, the presence of a fistulous tract bifurcation or a double agreed in 88% of cases for the primary fistula tract, in 90% for
tract was found to be a specific sign for PACD, being very rare the location of the internal opening, in 78% for secondary
1022 G. A. Santoro et al.
a b
Fig. 81.30 Three-dimensional endoanal ultrasound with a linear endoprobe at 16 MHz frequency (type 8838 BK Medical). Bilateral ischioanal
abscess in Crohn’s disease (a. Axial plane. b. Coronal plane. c. Multiplanar reconstruction)
tracts, and in 88% for fluid collections. In most studies compar- and 90% for MRI. While MRI was superior in every compari-
ing EAUS and MRI, surgical findings have been used as the son made by the authors, EAUS was particularly helpful at cor-
gold standard. This, however, may be discussed and ques- rectly predicting the site of the internal opening, achieving this
tioned, especially for those patients who did not heal after sur- in 91% compared to 97% for MRI. Barker et al. [51] showed
gery. The difficulty of defining a true reference standard for that 9% of all fistulae do not heal, because fistulous tracts that
fistula-in-ano is related to the following potential source of were identified by endoanal MRI were not recognized during
bias: the operators who perform the assessments can have dif- surgery. Therefore, using clinical outcome as the final arbiter
fering levels of experience with EAUS or with MRI, and, simi- can minimize potential biases. Because it is well established
larly, the surgeons who perform the operations have different that the most common cause of fistula recurrence is infection
levels of experience. Buchanan et al. [25] classified 108 pri- that has been missed at surgical examination, patients should
mary tracts using clinical examination, EAUS, and MRI, and be followed-up to determine clinical outcome and to identify
compared the findings to a reference standard that was based patients who require further unplanned surgery because of a
on ultimate clinical outcome. Digital evaluation correctly clas- failure to heal or further recurrence. Fistula healing is, other-
sified 61% of primary tracts in comparison to 81% for EAUS wise, the only definitive assurance that all infections have been
81 Ultrasonographic Assessment of Anorectal Fistulae 1023
a b
Fig. 81.31 Three-dimensional endoanal ultrasound with rotating probe at 13 MHz frequency (type 2052 BK Medical). Bilateral intersphincteric
fistula in Crohn’s disease (arrows) (a. Axial plane. b. Coronal plane)
identified and treated. Thus, if there is disagreement between and well tolerated by patients, it is an office or an intraopera-
findings at EAUS, MRI, and surgical examination, the findings tive procedure, and it visualizes the internal sphincter better
ass