Journal of Pediatric Urology (2008) 4, 100e106

A randomized controlled trial of the effectiveness

of osteopathy-based manual physical therapy
in treating pediatric dysfunctional voiding
Diane R. Nemett a,d,*, Barbara A. Fivush b, Ranjiv Mathews c,
Nathalie Camirand d, Marlo A. Eldridge c, Kathy Finney c, Arlene C. Gerson b,c

a
Kennedy Krieger Institute, Physical Therapy Department, 707 North Broadway, Baltimore, MD, USA
b
Johns Hopkins University School of Medicine, Department of Pediatrics, Division of Pediatric Nephrology,
Baltimore, MD, USA
c
Johns Hopkins University School of Medicine, Brady Urological Institute, Baltimore, MD, USA
d
Canadian College of Osteopathy in Toronto, Toronto, Ontario, Canada

Received 19 August 2007; accepted 2 November 2007

Available online 11 January 2008

KEYWORDS Abstract Objective: Pediatric dysfunctional voiding (DV) presents physical and emotional
Dysfunctional voiding; challenges as well as risk of progression to renal disease. Manual physical therapy and osteo-
Osteopathy; pathic treatment have been successfully used to treat DV in adult women; a pediatric trial of
Manual physical manual physical therapy based on an osteopathic approach (MPT-OA) has not been reported.
therapy; The aim of this study was to determine whether MPT-OA added to standard treatment (ST)
Vesicoureteral reflux; improves DV more effectively than ST alone.
Urinary tract Methods: Twenty-one children (aged 4e11 years) with DV were randomly assigned to receive
infections; MPT-OA plus standard treatment (treatment group) or standard treatment alone (control
Biofeedback; group). Pre-treatment and post-treatment evaluations of DV symptoms, MPT-OA evaluations
Children and inter-rater reliability of DV symptom resolution were completed.
Results: The treatment group exhibited greater improvement in DV symptoms than did the control
group (Z Z 2.63, p Z 0.008, ManneWhitney U-test). Improved or resolution of vesicoureteral
reflux and elimination of post-void urine residuals were more prominent in the treatment group.
Conclusions: Results suggest that MPT-OA treatment can improve short-term outcomes in children
with DV, beyond improvements observed with standard treatments, and is well liked by children
and parents. Based on these results, a multi-center randomized clinical trial of MPT-OA in children
with vesicoureteral reflux and/or post-void urinary retention is warranted.
ª 2007 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Abbreviations: CG, control group; DI, daytime incontinence; DV, dysfunctional voiding; DYS, dyssynergic voiding; MPT-OA, manual physical
therapy based on an osteopathic approach; PVR, post-void residuals; TG, treatment group.
* Corresponding author. Tel.: þ1 410 955 2467; fax: þ1 410 614 3680.
E-mail address: nemett@kennedykrieger.org (D.R. Nemett).

1477-5131/$30 ª 2007 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.jpurol.2007.11.006
Manual physical therapy and dysfunctional voiding
Introduction
Dysfunctional voiding (DV) encompasses a wide spectrum of
symptoms that may include urinary urgency, increased
voiding frequency (sometimes associated with bladder
instability, bladder spasms, small or hypertonic bladder),
decreased urination and urine retention (often associated
with bladder hypotonia, enlarged bladder, recurrent UTIs or
bladder hyposensitivity), daytime urine incontinence (DI),
nocturnal enuresis, and dyssynergic voiding (DYS) [1e4].
Chronic DV may lead to anatomical changes in the bladder
wall [5], renal scarring even in the absence of reflux [6,7]
and delayed spontaneous reflux resolution with poorer
long-term outcomes following surgery for VUR [1]. The inci-
dence of DV is approximately 10% in children aged 4e6
years and 5% in children aged 6e12 years, and is more com-
monly seen in girls [4,8].
The type of DV manifested by DYS is characterized as
a non-neuropathic incoordination between the bladder,
bladder outlet and pelvic floor during filling and/or empty-
ing phases of micturition, and is particularly problematic
because it creates a functional bladder outlet obstruction
which may result in increased intravesical pressures, VUR,
bladder instability, post-void residuals (PVR) and/or re-
current UTIs.
Standard non-surgical treatment approaches for DV
frequently include: medications, e.g. antibiotic prophy-
laxis, anticholinergics, alpha-blockers and muscle relaxants
[9]; the establishment of timed voiding and evacuation
schedules [10]; treatment of constipation [4,11]; and pelvic
floor muscle retraining [11,12]. A multi-modal and multidis-
ciplinary approach is now considered necessary for effec-
tive treatment of DV [4,10].
Existing medical and psychological treatments have
demonstrated variable rates of improvement in children
with DV using non-surgical treatment approaches ranging
from 33% to 100% [4,13,14]. Given the potentially serious
long-term consequences of ineffective treatment, there is
growing interest in finding interventions that can consis-
tently and efficiently improve outcomes for the greatest
number of children. Whereas standard treatments rely
heavily on child and family compliance with therapeutic
routines between clinic visits, certain interventions such
as manual physical therapy, osteopathic manipulative tech-
niques and acupuncture approaches are not dependent on
compliance for impact [15].
Previous studies of manual treatment (osteopathy,
manual physical therapy) have demonstrated some success
in treating adult women with DV and/or tension myalgia of
the pelvic floor [16e18]. In addition, there are theoretical,
animal and clinical studies supporting the rationale of oste-
opathy-based treatment and manual physical therapy for
upper and lower urinary tract dysfunction [19e25]. Manual
physical therapy based on an osteopathic approach (MPT-
OA) involves the palpation and responsive manipulation of
body tissues to alleviate restrictions (also referred to as
‘lesions’) that interfere with optimum mobility and health.
Specifically, manual physical therapy techniques were em-
ployed to mobilize and balance muscular, skeletal and fas-
cial (including cranial, dural, visceral, vascular and
lymphatic) structures that are hypothesized to influence
101
elimination processes [16,17,19,20,24,26,27]. Unfortu-
nately, no pediatric studies evaluating the efficacy of
MPT-OA in children with dysfunctional voiding have been
performed.
The objective of this randomized controlled trial was to
evaluate whether manual physical therapy based on an
osteopathic approach (MPT-OA) added to standard treat-
ment improves dysfunctional voiding in children with PVR,
DI, recurrent UTIs, DYS and VUR more effectively than
standard treatment alone.
Patients and methods
Patient population
Children aged 4e11 years who were consecutive new refer-
rals to an interdisciplinary pediatric urology clinic, special-
izing in the treatment of children with recalcitrant voiding
dysfunction, between 1999 and 2003 were considered for
enrollment in the study. Each of the children enrolled in
this study had been treated by a pediatric urologist for at
least 6 months prior to study entry. The pediatric urologists
had recommended timed voiding, adequate hydration and
in some cases medications (e.g. anticholinergic medica-
tions, prophylactic antibiotics) to resolve the presenting
voiding dysfunction symptoms without significantly im-
proved outcomes. All of the subjects in this study reported
voiding dysfunction symptoms of stable severity for at least
6 months prior to study entry. Inclusion required a diagnosis
of DV with symptoms of DI and/or VUR. Children with neu-
rological, spinal or urogenital structural anomalies, a known
history of child abuse, and/or girls who had progressed to
Tanner Stage IV pubertal development were excluded
from enrollment. Thirty-two children were enrolled and
21 children completed the study.
Study design and interventions
Approval for this study was obtained from the Johns Hopkins
University School of Medicine Institutional Review Board and
the Canadian College of Osteopathy in Toronto. After
informed consent was obtained from a parent (or legal
guardian) and assent was obtained from the child, study
subjects were sequentially and randomly assigned to either
the treatment group (TG) who received MPT-OA and
standard clinic treatment or to the control group (CG) who
received standard clinic treatment but not MPT-OA.
Children were followed in the study for at least a 3-month
period. Beyond the end of the study period, data on
outcomes were not systematically or consistently collected.
Dependent variables
PVR were assessed using portable bladder ultrasound (Di-
agnostic Ultrasound) or during a VCUG procedure. A study
patient with a urine volume exceeding 30 cm3 subsequent
to voiding was considered to have PVR.
UTI was diagnosed using standardized laboratory culture
and sensitivity procedures. A study patient whose urine
contained 100,000 colonies/ml or more of bacteria was
considered to have a UTI.
102
DI was assessed through parent and child reporting of
symptoms.
DYS was assessed using a uroflow machine (Brown
Urobreeze) that measured flow rate and electromyography
activity during voluntary micturition and produced a print-
out of the outcomes. A study patient whose uroflow print-
out evidenced interrupted or staccato flow-void pattern
and/or sustained EMG activity of the sphincter/pelvic floor
during voiding was considered to have DYS.
VUR was assessed using a VCUG. A study patient whose
VCUG evidenced urine backflow into the ureters was
considered to have VUR.
MPT-OA assessment
MPT-OA assessments, used as a basis for MPT-OA treatment
for children in the TG, included a detailed history of birth,
illness, accident or injury, and daily patterns; analysis of
posture (while standing, sitting and supine); and a detailed
evaluation of the alignment and mobility of the cranium,
spine, pelvis, lower extremities and related viscera/organs.
Post-treatment MPT-OA assessments were made of children
in both groups.
Treatment methodology
Participants in the CG received standard-care treatments
provided in the urology clinic, as appropriate to their
needs. The urology clinic provided a range of coordinated
treatments which included: medications, establishment of
timed voiding and evacuation schedules, dietary modifica-
tions, behavior modification, pelvic floor muscle retraining,
biofeedback training, and treatment of constipation. Clinic
appointments, lasting approximately 1 h, were scheduled
at 2-week intervals to assess for improvement in voiding
dysfunction symptoms and to continue implementing treat-
ment procedures aimed at resolving DV symptoms.
In addition to the standard-care treatments received by
the CG, participants in the TG received four 1-h MPT-OA
treatment sessions. MPT-OA treatments were customized
for each child based on results from the initial MPT-OA
evaluation, and included gentle mobilization of body
tissues to relieve movement restrictions, and thereby
achieve balanced alignment and mobility and postural
symmetry, with particular attention to the thoracolumbar
spine, thoracic and pelvic diaphragms, pelvis, pelvic or-
gans, and lower extremities. MPT-OA treatments were
scheduled to coincide with urology clinic appointments,
occurring either before or after a child’s regularly sched-
uled urology clinic visit. Approximately 2 weeks after the
last MPT-OA treatment in the TG and following four urology
clinic appointments in the CG, children in both groups re-
ceived an evaluation to assess DV symptoms (PVR, UTI,
DI, DYS) and remaining lesions (i.e. movement/postural
restrictions).
Statistical analysis
Pretreatment group differences were assessed using chi-
square analyses, t-tests or non-parametric ManneWhitney
U-tests. The effectiveness of MPT-OA (relative to standard
care) was examined by comparing the proportion of DV out-
come variables for which clinically significant improvement
was observed using ManneWhitney U-tests. In addition,
D.R. Nemett et al.
individual lesions (i.e. movement/postural restrictions)
noted in the assessments were grouped for analysis into
16 composite anatomical structures/regions considered
relevant to DV, and evaluated using Kendall’s Taueb corre-
lation coefficients to examine the associations between
changes in lesion severity and improvement in DV
symptoms.
Results
Study sample
Twenty-one children completed the study. In almost all
cases (n Z 8) attrition was due to patient’s failure to at-
tend the voiding clinic follow-up visits, and therefore study
visits were also unachievable. In one case, neurological ex-
clusion criteria were discovered subsequent to enrollment.
In another case, surgical re-implantation of the ureters was
scheduled prior to study completion. The 11th patient, in
retrospect, should not have been enrolled in the study as
she did not have either VUR or DI, although she did have
many other symptoms of voiding dysfunction (i.e. recurrent
UTIs, enlarged bladder, DYS, PVR).
Of the 21 children who completed the study, 67% were
females and 33% were males, with a mean age of 6.8 years
(range 4.5e10.0 years). Table 1 provides additional demo-
graphic details of the children in the study sample.
At study entry, 41% had VUR, 64% had DI, and 9% had
both VUR and DI. At study entry, 59% had recurrent UTIs and
77% had DYS.
Comparability of CG and TG
Attrition rate in the TG was not significantly different from
that observed in the CG. There were no clinically significant
differences between the TG and CG with regard to severity
of MPT-OA restrictions, age, gender, number of clinic
sessions or duration of treatment.
Comparability of study completers
and study drop-outs
Non-completers did not differ from completers with
regard to demographic variables that could confound
Table 1 Demographics of treatment group, control group,
completers and non-completers
TG CG Completers Non-
(n Z 10) (n Z 11) (n Z 21) completers
(n Z 11)
Mean age in 6.5 (1.7) 7.1 (2.4) 6.8 (2.2) 6.5 (2.2)
years (SD)
Age range 4.5e10.0 4.5e11.1 4.5e10.0 4.5e11.1
Female (%, n) 60 (6) 73 (8) 67 (14) 91 (10)
Male (%, n) 40 (4) 27 (3) 33 (7) 9 (1)
TG, treatment group in receipt of MPT-OA; CG, control group in
receipt of standard treatment; TG þ CG, completers; non-
completers, enrolled subjects who consented to MPT-OA study
but dropped out.
Manual physical therapy and dysfunctional voiding 103

interpretation of study results, such as age and gender (see
Table 1), or in the severity of presenting problems.
Impact of MPT-OA on DV symptoms
The TG exhibited improvement in a significantly greater
proportion of outcome measures relative to the CG
(Z Z 2.63, p Z 0.008; non-parametric ManneWhitney
U-test) (Table 2). A subgroup analysis limited to individuals
with a primary diagnosis of daytime enuresis yielded a trend
toward statistical significance (Z Z 1.99, p Z 0.065).
A similar subgroup analysis of individuals with a primary di-
agnosis of VUR also resulted in a near significant difference
between CG and TG (Z Z 1.87, p Z 0.114). Improvement
or resolution of VUR and elimination of PVR were more
prominent in the MPT-OA group.
Effect of MPT-OA on lesion severity
Comparison of initial and final MPT-OA assessments in the
TG showed a statistically significant reduction in lesions/
restrictions in 15 of the 16 anatomical structures/regions
considered relevant to DV (see Fig. 1). Improvements in pel-
vic container asymmetry and lower extremity lesions were
statistically associated with improvement in DV symptoms
(Taueb Z 0.89, p < 0.002 and Taueb Z 0.64, p < 0.03).
Discussion
To our knowledge, this study is the first randomized
controlled trial to investigate the effectiveness of MPT-OA
for children with DV. The results presented here suggest
that MPT-OA can improve outcomes beyond those expected
from the current standard-care treatment. This finding is
particularly striking given the high proportion of study
subjects in the CG who benefited from the standard
treatment, and that the children in the TG only received
four treatment sessions of MPT-OA. Further, the children in
this study represent the more severe end of the spectrum of
DV as all were attending an interdisciplinary clinic that
specialized in treating children with recalcitrant voiding
dysfunction [2,4,5].
Standard existing treatments for DV do not account for
the impact of musculo-fascio-skeletal restrictions on vis-
ceral dysfunction or the interrelationship of these compo-
nents at a neural level. Biomechanical, myofascial and
articular restrictions may contribute to DV by altering
alignment, distorting the pelvic container (comprised of
the innominates, sacrum, coccyx and their articulations),
limiting mobility and thereby affecting pressures within the
abdominal and pelvic cavities [19,20]. Altered pressure
relationships can have an impact on neural, vascular, lym-
phatic and hormonal functions of the renaleurinary system
[5,6,12,19,20,22,23,28].
The concept that the pelvic floor musculature impacts
bladder functioning is not new. In fact, the relationship
serves as the basis for effective biofeedback and bladder
retraining programs [2,11,13,14,17,28,29]. We speculate
that the manual treatment provided in the MPT-OA treat-
ment sessions helped restore the structural base toward
more normal alignment and mobility. More specifically, im-
proving the symmetry of alignment and mobility of the pel-
vic container, and thereby the attachments and resultant

Table 2 Outcome by diagnostic group and treatment group

VUR Days wet PVR UTI DYS Proportion outcomes
improved
VUR diagnosis TG Improved Improved Improved Same 0.75
(no incontinence) Improved Same Improved Same 0.50
Improved Improved Improved Same 0.75
Same Improved Improved Same 0.50
CG Worse Same Improved Same 0.25
Improved Same Improved Worse 0.50
Worse Same Improved Same 0.25
Daytime incontinence TG Improved Improved Improved Improved 1.00
diagnosis (no VUR) Improved Same Improved Same 0.5
Improved Improved Same Same 0.5
Improved Same Same Same 0.25
Improved Improved Improved Same 0.75
Improved Improved Same Same 0.5
CG Improved Same Same 0.33
Improved Same Same Same 0.25
Improved Same Same Same 0.25
Improved Same Worse Improved 0.5
Worse Improved Same 0.33
Improved Same Same Same 0.25
Both VUR and daytime CG Same Same Same Same 0.00
incontinence Improved Same Improved Same 0.50
Criteria for ‘Improved’: VUR, decreased grade of reflux in one or both kidneys on VCUG; Days wet, decreased number of daytime urinary
accidents/damps; PVR, improvement from PVR > 30 ml to 30 ml; UTI, no breakthrough infections during treatment period and/or no
current UTI; DYS, uroflow improved from abnormal to normal (if uroflow improved but is still abnormal, ‘Same’).
104
Lesion Severity (mean)
12
Initial MPT-OA evaluation
10
8
6
4
2
0
Lesion Severity (mean) 0 1 2 3 4 5 6 7
12
Final MPT-OA evaluation
10
8
6
4
2
0
0 1 2 3 4 5 6 7
Anatomical Region
1. Pelvic Container Asymmetry
2. Thoraco-lumbar
3. L5/S1
4. Interosseous Sacral Lesions
5. Cervical
6. Lower Extremity
7. Thoracic Diaphragm
8. Pelvic Diaphragm
9. AnteriorVesical Fascias
Figure 1 Effect of MPT-OA on lesion severity: change in lesion severity from initial to final evaluation in treatment group.
Improvement in lesion severity was significant for all primary anatomical regions of interest except the liver.
length-tension relationships of the pelvic floor muscles, can
help the abdominal and pelvic floor muscles to function
more efficiently. The actual tension of the pelvic floor mus-
cles can not only be tested by external manual palpation,
but manual treatment can directly impact the flexibility
of the pelvic floor and its coordination with the thoracic
diaphragm and lower extremities [16,17,26,27,29]. The re-
sultant, more normal, articular, myofascial and pressure re-
lationships of the pelvic container and pelvic floor achieved
by the MPT-OA may have, in fact, potentiated the positive
impact of biofeedback-assisted muscle retraining used
during the urology clinic treatment sessions [27].
In addition to these biomechanical relationships, soma-
tovisceral relationships are another potential mechanism
through which MPT-OA might impact DV symptoms. The
visceral system (viscera, organs) and the somatic system
(muscles, fascia, bones, joints, ligaments) are intimately
connected neurologically. Consequently, dysfunction of one
system can create or exacerbate dysfunction of the other
by creating a hyperfacilitation of the cord segments
common to both [25,30]. Once segments become hyperfaci-
litated they become hypersensitive not only to visceral and
somatic inputs but to cortical inputs (e.g. stress) as well
[21,23,30,31]. Chronic hyperfacilitation can lead to actual
morphological changes in the nervous system which can
create trophic changes in the visceral and somatic tissues
that are innervated by those neurons [16,22,23]. These re-
lationships have been supported by clinical studies and ba-
sic scientific research with animal models [22,24,25,31].
D.R. Nemett et al.
8 9 10 11 12 13 14 15 16
8 9 10 11 12 13 14 15 16
10. Pelvic Muscles
11. Cranial
12. Liver
13. Kidney
14. Colon
15. Bladder
16. Mesentery
For example, in 1992 DeGroat [22] demonstrated a 70%
functional enhancement in spinal reflex pathways relative
to the supraspinal micturition reflex pathways in urethrally
obstructed but neurologically intact animals [22]. The vis-
ceral dysfunction created a change in the neural control
mechanisms. Such changes resulting from chronic hyperfa-
cilitation of cord segments may be an underlying mechanism
in the ‘non-neurogenic neurogenic bladder’ in which there
is apparent neurologic dysfunction without documentable
structural neurologic pathology [32]. Also, recent clinical
applications of transcutaneous electrical nerve stimula-
tion for bladder instability are based on the concept of
rebalancing the sympathetic and parasympathetic stimula-
tion of the urinary system and provide support for the
importance of aforementioned somatovisceral relationships
[29,33].
The finding that the TG showed a statistically significant
reduction in lesion severity in 15 of 16 primary anatomical
regions of interest, suggests that MPT-OA did successfully
ameliorate the initial restrictions evaluated. These data
provide support for the supposition that the significantly
greater improvement in DV outcomes observed in the TG
was the result of the MPT-OA administered (instead of non-
specific factors that may be associated with assignment to
the TG).
We do not believe that our sample size is large enough to
speculate about which children would be the best candi-
dates for MPT-OA, but our preliminary data do not suggest
that the efficacy of this treatment is age or gender
Manual physical therapy and dysfunctional voiding
dependent. The administration of MPT-OA did not have any
detrimental effects, and in all cases it improved postural
alignment and flexibility. Furthermore, within the popula-
tion of children included in this study, there was no
indication of a poorer response to the standard clinical
treatment as a result of the experimental intervention. A
similar study with a much larger sample of children would
be needed to differentiate a subgroup less likely/more
likely to benefit from the use of MPT-OA.
The study has some limitations. (1) Although the assess-
ments of outcomes relative to the hypothesis were blinded,
the initial and final MPT-OA evaluations were not, due to
practical constraints. However, as the MPT-OA evaluation
results were not primary outcomes, this did not compro-
mise the validity of our investigation. (2) An initial MPT-OA
assessment was not performed on CG participants because
there is a possibility, especially with children, that manip-
ulations inherent to the evaluation process are capable of
eliciting some degree of treatment effect. A larger sample
would have permitted the CG to be divided in half, with one
subgroup receiving initial and final MPT-OA assessments and
the other subgroup handled as in this study.
Conclusions
Results from the present investigation suggest that MPT-OA,
in conjunction with standard-care treatments, provides
significant improvements in the short-term outcomes of
children with DV, beyond the improvements observed with
conventional medical and behavioral treatments alone. The
results of this single-center randomized controlled trial
provide support for a multi-center randomized controlled
trial of MPT-OA in children with DV. Furthermore, this study
demonstrates that traditional research methodology can be
successfully used to rigorously evaluate the effectiveness of
non-mainstream treatment approaches, resulting in evi-
dence for new clinical paradigms.
Acknowledgements
This study was supported in part by grants from the National
Kidney Foundation of Maryland (DN). Parts of this study were
presented at the 2004 Pediatric Academic Societies Confer-
ence, San Francisco, California; the 9th European Sympo-
sium of Traditional Osteopathy in Germany, 2005; and at the
22nd International Osteopathic Symposium in Montreal,
Canada, 2005. Our appreciation to Philippe Druelle, DO,
Reuben Bell, DO, and Michael M. Patterson, PhD, for their
osteopathic expertise and assistance; Chris Bassel, PhD. and
Scott McNary, PhD for assistance with statistical analysis; to
Allison Plowman for assistance in grant production and, Ngoc
Pham, BA for assistance with data collection and analysis.
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