Int Urogynecol J (2010) 21:895–899
DOI 10.1007/s00192-009-1075-7
CASE REPORT
Retrospective chart review of vaginal diazepam suppository
use in high-tone pelvic floor dysfunction
Matthew J. Rogalski & Susan Kellogg-Spadt &
Amy R. Hoffmann & Jennifer Y. Fariello &
Kristene E. Whitmore
Received: 7 August 2009 / Accepted: 2 December 2009 / Published online: 12 January 2010
# The International Urogynecological Association 2010
Abstract To study intravaginal diazepam suppositories as
adjunctive treatment for high-tone pelvic floor dysfunction
(HTPFD) and sexual pain. A retrospective chart review was
conducted on 26 patients who received diazepam suppos-
itories as adjuvant therapy to pelvic physical therapy and
intramuscular trigger point injections for bladder pain,
sexual pain, and levator hypertonus. Pelvic floor muscular
tone and pain were assessed by palpation and perineometry;
sexual pain was objectively rated by Female Sexual
Function Index (FSFI) and the Visual Analog Scale for
Pain (VAS-P). Twenty-five out of 26 patients reported sub-
jective improvement with suppository use; six out of seven
sexually active patients resumed intercourse. Sexual pain as
assessed on FSFI and serial VAS-P improved with diazepam
(by 1.44 on 10-point scale, p=0.14). PFM tone improved
during resting (p<0.001), squeezing (p=0.014), and relaxa-
tion (p=0.003) phases. Vaginal diazepam suppositories gave
a clinically significant improvement in the treatment of
HTPFD compared with the usual treatment regimen alone.
Keywords Dyspareunia . High-tone pelvic floor dysfunction .
Pelvic pain . Perineometry . Diazepam . AUGS 2009
M. J. Rogalski (*)
The Division of Urogynecology, Women and Infants’ Hospital,
Warren Alpert Brown School of Medicine,
695 Eddy St., Lower Level, Suite 12,
Providence, RI 02903, USA
e-mail: mrogalski@wihri.org
S. Kellogg-Spadt : A. R. Hoffmann : J. Y. Fariello :
K. E. Whitmore
The Pelvic and Sexual Health Institute,
Philadelphia, PA, USA
Introduction
High-tone pelvic floor dysfunction is a disorder character-
ized by hypertonus of the levator ani complex, and pain
upon attempted penetration, squeeze, or palpation of the
vaginal and pelvic musculature. This condition is frequently
comorbid with hypersensitivity disorders of the bladder,
bowel, and vulva, as well as sexual dysfunction. The true
prevalence of this condition is unknown, but is estimated
at 87% in one cohort of patients with interstitial cystitis
[1].
Measurement of pelvic floor muscle tone has been
imprecise at best prior to the development of perineometry.
Although vaginal assessment of pelvic floor muscle
strength may be internally consistent, reproducibility and
reliability in its assessment between examiners has consis-
tently varied from fair to good [2]. Objective measurements
of pelvic floor muscle contractions, such as perineometry,
EMG, and perineal ultrasound, have been tested and found
to be consistent in providing evidence of contractions,
though none of them assessed true strength [3].
Currently accepted therapies include pelvic floor muscle
(Thiele) massage to elongate musculature and relieve pain
[4, 5]; warm sitz baths, which reduced measured anal canal
pressures in patients with anorectal pain complaints related
to muscle spasm [6]; biofeedback with electrical stimula-
tion to arrest the sustained contractions [7]; and acupunc-
ture [8]. Trigger point injections into chronically contracted,
painful pelvic floor musculature can be helpful as well [9].
Benzodiazepines are well known for their antispasmodic
activity in treatment of seizure and muscular hypertonus,
and have been used orally with some success in improving
pain and urgency symptoms in this cohort [10]. Their added
anxiolytic activity may also play a therapeutic role, but its
contribution is much more difficult to define.
896
The current study evaluated the intravaginal rather than
the oral administration of diazepam as adjunctive treatment
of HTPFD. Oral dosing has proven effective on repeated
testing for use in spastic muscular conditions such as
cerebral palsy [11], and we sought to examine the
effectiveness of this alternative delivery route for relief of
local high-tone pelvic floor dysfunction symptoms. Similar
modalities to the non-oral administration of diazepam in
epileptic populations for recalcitrant seizures were proven
efficacious without significantly increased rates of adverse
events or intolerability due to the therapy [12]. More recent
experience with perineometers has shown reliability equiv-
alent to or surpassing vaginal palpation rating scales, such
as the Brink scale; hence we used this modality to measure
the response of the pelvic floor musculature to diazepam
suppository treatment [13]. The precedent for this applica-
tion of diazepam lies in its previous use in chronic
constipation for its skeletal muscle relaxant properties,
specifically the subtype more likely attributed to pelvic
floor dyssynergia [14]. We believed that diazepam in
addition to pelvic physical therapy and intramuscular
trigger point injections, the usual treatment regimen, would
improve both HTPFD and sexual pain, and sought to
characterize the magnitude of the effect.
Materials and methods
The project was submitted for review and approved by the
internal review board of the Drexel University College of
Medicine. Seventy-two charts detailing female patients
between the ages of 18 and 79 previously diagnosed with
high-tone pelvic floor dysfunction and who were prescribed
diazepam vaginal suppositories were obtained for the
retrospective chart review. These patients were established
with the Pelvic and Sexual Health Institute in Philadelphia,
PA, which is affiliated with Drexel University College of
Medicine. Patients were initially enrolled into the practice
after referral between 1999–2008, and followed through
sequential therapeutic visits. Demographic information,
including age, race, height, weight, body mass index,
menopausal status, coital status on presentation, pelvic
floor diagnoses, pelvic floor treatments, past medical
history, current medications (as of last visit), obstetric
history, and social history was collected. Similarly, several
rating scales were administered for symptoms of interstitial
cystitis, chronic pelvic pain, global functioning, and sexual
dysfunction were collected at that time (including Female
Sexual Function Inventory (FSFI) and Visual Analog Scale
for Pain (VAS-P)), depending on their existence at date of
enrollment. Physical exam at practice enrollment con-
tained a thorough assessment of pain and tone of the
levator ani complex and obturator internus, as well as
Int Urogynecol J (2010) 21:895–899
perineometry documenting resting, squeeze, and relaxation
pressures.
For the diagnosis of high-tone pelvic floor dysfunction,
patients were initially prescribed diazepam 10 mg suppos-
itories compounded in a paraffin base by either of two
compounding pharmacies routinely used by the Pelvic and
Sexual Health Institute (Custom Prescriptions, Lancaster,
PA; and Stokes Pharmacy, Mt. Laurel, NJ) to be used
nightly for 30 days with assessment of benefit and titration
of dosing frequency at the successive visits. In addition, the
usual treatment regimen of pelvic floor physical therapy
and intramuscular injection of trigger points with Traumeel
(a homeopathic anti-inflammatory preparation, http://www.
heelusa.com/) and lidocaine was followed. Frequency of
use and dose (if patients specifically requested a lower
dose) were altered as clinically appropriate at this time, and
frequency and ease or comfort of coital events was
subjectively assessed. VAS-P and adverse effect informa-
tion was also collected at each subsequent visit, with serial
perineometry and physical examinations also having been
performed.
For inclusion, the definition of high-tone pelvic floor
dysfunction needed to be established by physical exam
documenting hypertonus of the levator ani complex by an
experienced examiner (KW, SK, AR, or JF), with the
physical assessment repeated throughout the treatment
course and documented. Perineometric assessment of
vaginal tone was then performed using the Peritron clinical
perineometer (SportsTek, Victoria, Australia), unless spe-
cifically declined by the patient, and this was repeated at a
later time in the treatment course. This was performed by
having the patient relax during insertion of the vaginal
manometric probe, followed by a voluntary sustained
contraction of the pelvic floor as if performing a Kegel
exercise, then an active relaxation of the pelvic floor, with
all values recorded by the examining clinician. The
examiners also assessed completion of the FSFI [15] and
VAS-P for quantification of treatment response based on the
intervention; again, the VAS-P was repeated during the treat-
ment course at successive visits for data on the progression
of sexual pain while on the therapy. Exclusion criteria from
this review included: male gender; failure of diagnosis
confirmation by either physical examination or perineom-
etry in the medical record; or failure to complete the FSFI
or VAS-P.
After thorough chart review, 26 patients were identified
as having complete medical records for the purpose of the
abstraction, which was completed. Using PASW Statistics
version 17.0 (SPSS Inc., Chicago, IL), we performed paired
t tests to obtain p values upon the means of tabulated data
on the FSFI scores and VAS-P scores for change in pain
rating before and after treatment. Perineometer scores
before and after treatment to determine the effect from
Int Urogynecol J (2010) 21:895–899 897

Table 1 FSFI and VAS-P data

Raw score Mean score Mean score, adjusted VAS-P
(±SD) (adjusted, out out of 10 post-treatment
of 6, n=26)

Desire (max 10) 4.04 (2.25) 2.47

Arousal (max 20) 6.85 (5.87) 2.05
Lubrication (max 20) 5.96 (5.79) 1.81
Orgasm (max 15) 4.42 (4.6) 1.77
Satisfaction (max 15) 6.5 (4.01) 2.6
Pain (max 15) 8.42 (6.34) 3.37 5.44 4
Total 14 (7.56) P value (95% CI) for FSFI 0.14 (−0.51, 3.38)
(baseline) vs. VAS-P

diazepam suppository administration was also submitted to
t tests.
Results
Abstraction of the demographic data showed 23 Caucasian
subjects and three Asian-American subjects within the
population. Mean age of the subjects was 33.9 years; BMI
was 23.4; 21 were premenopasual; five were menopausal;
18 patients were nulliparous. The incidence within this
population of comorbid pelvic conditions was as follows:
dyspareunia, 22 of 26 patients (84.6%); provoked vestibu-
lodynia (formerly vulvar vestibulitis), 21 of 26 patients
(80.7%); chronic pelvic pain, 16 of 26 patients (61.5%);
interstitial cystitis, 12 of 26 patients (46.1%); hypoactive
sexual desire disorder and lichen sclerosus et atrophicus,
two of 26 patients (7.7%); and overactive bladder, vaginal
fibrosis, urethritis, trigonitis, fissures, and vulvovaginal
atrophy, one of 26 patients each (3.8%).
Concomitant psychiatric conditions included anxiety (7/
26, or 26.9%); depression (4/26, or 15.4%); and other
psychiatric diagnoses (8/26, includes anorexia, bulimia,
generalized affective disorder, insomnia, narcolepsy, and
attention-deficit hyperactivity disorder). Medical issues in
our patient population included irritable bowel syndrome
(IBS; 5/26 or 19.2%); gastroesophageal reflux disorder or
peptic ulcer disease (GERD/PUD, 3/26 or 11.5%); asthma
(3/26, 11.5%); seasonal allergies (2/26, 7.7%); migraines
(2/26); recurrent UTI (2/26); hypercholesterolemia (2/26);
and several other medical conditions in one patient each
(stress urinary incontinence, endometriosis, eczema, mitral
valve prolapse, HPV infection with cervical dysplasia, left
breast lump, uterine polyp, coronary artery disease, athero-
sclerosis, arthritis, diverticulitis, nephrolithiasis, peritoneal
adhesions, vocal cord polyps, herniated nucleus pulposis,
and cervical cancer(3.8%)).
The FSFI data for the study population are as shown in
Table 1. The mean score was 14/36 (±7.56), with mean
adjusted scores by domain being desire, 2.47; arousal, 2.05;
lubrication, 1.81; orgasm, 1.77; satisfaction, 2.6; and pain,
3.37. For reference, the mean scores by domain and total
from the control group from validation of the FSFI is
included. This pain domain score was then converted to a
scale out of 10 and compared with the most recent
measurement on VAS-P, with a difference between the
means of 1.44 but p=0.14 for the relationship. It should be
noted, however, that subjective recording of improvement
of sexual function (as either resumption of coitus or
improved comfort and/or frequency of events) occurred in
25/26 patients abstracted, with range of first reporting of
benefit from 3–16 weeks from treatment prescription (mean
6.9 weeks). No adverse effects of the treatment were
reported by the subjects. Further, of the seven of 26
patients who entered the practice abstinent from inter-
course, six of these resumed intercourse as soon as they
were partnered after having initiated suppository treatment.
Perineometry data can be found in Table 2. Mean pre-
treatment pelvic floor muscular tone as measured in cm
H2O were 47.5 (±10.3 SD) for resting; 75.3 (±21.1) for

Table 2 Perineometry data

Rest Squeeze Relax

Mean pre-treatment (±SD) 47.5 (10.3) 75.3 (21.1) 45 (10.5)

Mean post-treatment (±SD) 35.1 (11.6) 62.5 (17.3) 35.2 (12)
Change (±SD) over mean treatment 12.4 (16) 12.7 (25) 10.9 (17)
duration 6.21 months
P values (95% CI) <0.001 (6, 18.7) 0.014 (2.9, 22.6) 0.003 (4.2, 17.6)
898 Int Urogynecol J (2010) 21:895–899

Table 3 Pelvic floor muscular

exam data (scale 0-4) Pre-treatment (±SD) Post-treatment (±SD) Change (±SD) P value (95% CI)

Right PC 1.69 (1.69) 1.59 (1.15) 0.10 (1.63) 0.74 (−0.52, 0.73)
Left PC 2.07 (1.73) 1.34 (1.08) 0.72 (1.53) 0.017 (0.14, 1.31)
Right IC 1.52 (1.6) 0.72 (1.0) 0.80 (1.84) 0.028 (0.093, 1.50)
Left IC 1.97 (1.74) 0.69 (1.0) 1.28 (1.85) 0.001 (0.57, 1.98)
Right Cocc 0.83 (1.44) 0.24 (0.51) 0.59 (1.48) 0.041 (0.025, 1.15)
Left Cocc 0.97 (1.55) 0.28 (0.59) 0.69 (1.51) 0.021 (0.11, 1.27)
Legend: PC pubococcygeus, IC Right OI 1.1 (1.59) 0.59 (1.09) 0.52 (1.98) 0.17 (−0.23, 1.27)
iliococcygeus, Cocc coccygeus, Left OI 1.21 (1.68) 0.48 (0.99) 0.72 (1.91) 0.050 (−0.001, 1.45)
OI obturator internus

squeezing; and 45 (±10.5) for relaxation. These values
changed to 35.1 (±11.6); 62.5 (±17.3); and 35.2 (±12) after
a mean of 6.21 months treatment by diazepam vaginal
suppositories. The mean changes in values were: 12.4
(±16); 12.7 (±25); and 10.9 (±17), with all of the changes
having p values achieving statistical significance (<0.001,
0.014, and 0.003, respectively).
Physical examination pain, rated on a scale of 0–4, was
rated pre- and post-treatment for each muscle considered
within the levator ani complex. The right pubococcygeus
had a change of rating from 1.69 to 1.59 (change 0.10
(±1.63), p=0.74). The left pubococcygeus had a significant
difference in rating after treatment (from 2.07 to 1.34,
change 0.72 (±1.53), p=0.017). The iliococcygeus and
coccygeus had significantly different pain scores after
treatment (right IC 1.52 to 0.72, change 0.8 (±1.84), p=
0.028; left IC 1.97 to 0.69, change 1.28 (±1.85), p=0.001;
right coccygeus 0.83 to 0.24, change 0.59 (±1.48), p=
0.041; left coccygeus 0.97 to 0.28, change 0.69 (±1.51), p=
0.021), while the obturator internus failed to achieve
statistical significance with its change in score after
treatment (right OI 1.1 to 0.59, change 0.52 (±1.98), p=
0.17; left OI 1.21 to 0.48, change 0.72 (±1.91), p=0.05).
These data are summarized in Table 3.
Discussion
High-tone pelvic floor dysfunction is an important diagno-
sis to make for a patient. Levator ani muscle spasms are
associated with increased tone and can be inextricably
linked to complaints of pelvic pain, sexual pain, and
functional bowel and bladder disorders. The fact that 25
of 26 patients described symptomatic improvement while
using adjuvant suppositories connotes that this is likely to
be a useful treatment regimen for pelvic floor muscle
dysfunction (in addition to the traditional modalities of
pelvic physical therapy and trigger point injections with or
without biofeedback.) The lack of statistical significance
despite the clinical significance that was derived from
baseline pain on FSFI to VAS-P after treatment is likely due
to either the small sample size or the difficulty in isolating
HTPFD as the pathologic culprit. The lack of adverse
effects due to the suppositories may have been due to its
administration at night, when sedation would have been
less apparent; or due to incomplete records from abstrac-
tion. A larger sample size would be helpful to explore this
aspect of the treatment more fully.
Statistically significant changes in perineometry readings
confirmed the marked improvement in pelvic floor func-
tion, and correlated with comfort with intercourse. This
finding was the exact intent of the local delivery system and
validated our approach. In the present study, each muscle
within the pelvic floor was improved on digital PFM exam
by the adjuvant suppository treatment, but statistical sig-
nificance was not uniformly achieved. In fact, a unilateral
treatment difference was seen in the pubococcygeus group;
we are not aware of a biologic reason for this finding, and
expect that the side difference would resolve with a larger
number of subjects. Digital pelvic floor muscle assessment
has been proven to have good intrarater and interrater reli-
ability as a test in the past [13], but its interrater reliability is
the weaker of the two correlations. If any effect was seen,
though, it would likely have influenced the results toward the
null hypothesis, causing us to be unable to determine a sig-
nificant change which actually existed in those muscle groups.
The frequent observation of dyspareunia, provoked
vestibulodynia (formerly vulvar vestibulitis,) chronic pelvic
pain, and interstitial cystitis in patients with HTPFD under-
scores some of the theories behind its etiology. Muscles that
contract frequently and forcefully will generate a pain
sensation in addition to localized edema; inflammation with
release of cytokines can lead to local edema. Muscular
edema can produce a sensation of localized pain, as can the
compensation in movement and maintenance of posture and
static position by the body’s core musculature. Due to the
extensive innervation of the pelvic viscera and musculature
by multiple segments of the nervous system, pain sensation
frequently occurs as vague and generalized within the
pelvis, though provoked vestibulodynia (and other vulvar
pain syndromes) may have a more easily localized
distribution.
Int Urogynecol J (2010) 21:895–899
Several confounding factors do potentially persist.
Introduction of VAS-P for quantitatively following pain
symptoms occurred in approximately April 2008, after
which each patient completed this scale at every visit.
Diazepam vaginal suppository use began around March
2007; assessment of pain improvement was subjective
during this time, and as such several time points (and some
patients) were necessarily excluded that may have intro-
duced some selection bias. In addition, since initial values
for sexual pain were obtained with FSFI but subsequent
values were obtained with VAS-P, a numeric scale
conversion (to a score out of 10) was made to facilitate
statistical analysis and comparison. The scales were not
initially designed to be used after each other, but it was
thought to be reasonable to compare the more generic value
from VAS-P during follow-up to that obtained from the
corresponding baseline FSFI pain domain.
Other limitations of this study include its retrospective
design, which may introduce selection or recall bias. Also
making analysis difficult is the constellation of comorbid
pelvic conditions which can also act as primary pain
generators. Given the incidence in this study of vulvar
vestibulitis, interstitial cystitis, and chronic pelvic pain, it is
somewhat difficult to ascribe new or worsening symptoms
solely to high-tone pelvic floor dysfunction exclusive of
comorbidities. Conversely, it is difficult to say that
improvement was only due to diazepam suppository
adjunct treatment due to the number of concurrent therapies
being used, though diazepam use was the only changing
treatment parameter as regarded the HTPFD. Since many of
the subjects were being maintained and treated for their
comorbid pelvic floor disorders, though, we believe that the
observed difference is due to the diazepam. Perineometry is
well defined for the measurement of vaginal muscular tone,
and though diazepam use clearly demonstrated an improve-
ment in levator muscular tone, it is not yet validated as a
diagnostic tool for this condition. This study is currently
being designed by our office.
Nevertheless, we feel that diazepam vaginal supposito-
ries are a useful adjunct for the treatment of high-tone
pelvic floor dysfunction, as shown by the clinical signifi-
cance of the benefit described by each patient. To further
precise the exact treatment effect of the diazepam, we
intend to initiate a randomized crossover study from
placebo to diazepam vaginal suppository in a cohort of
patients newly diagnosed with HTPFD. We expect that
these quantitative measures will show an independent
benefit to this novel HTPFD treatment: intravaginal diaze-
pam suppositories.
899
Acknowledgements We would like to acknowledge Sandy Mosiniak,
CRC, for her extraordinary insight and invaluable assistance with the
preparation and execution of this project.
Conflicts of interest None.
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