Voiding Dysfunction

Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic)

in Adults: AUA/SUFU Guideline Amendment 2019
Deborah J. Lightner, Alexander Gomelsky, Lesley Souter and Sandip P. Vasavada
From the American Urological Association Education and Research, Inc., Linthicum, Maryland and the Society of Urodynamics, Female Pelvic Medicine & Urogenital
Reconstruction, Schaumburg, Illinois

Purpose: The purpose of this guideline is to provide a clinical framework for the
Abbreviations
diagnosis and treatment of non-neurogenic overactive bladder (OAB).
and Acronyms
Materials & Methods: The primary source of evidence for the original version
AHRQ [ Agency for Healthcare
Research and Quality
of this guideline was the systematic review and data extraction conducted as
part of the Agency for Healthcare Research and Quality (AHRQ) Evidence
AUA [ American Urological
Report/Technology Assessment Number 187 titled Treatment of Overactive
Association
Bladder in Women (2009). That report was supplemented with additional
ICS [ International Continence searches capturing literature published through December 2011. Following
Society
initial publication, this guideline underwent amendment in 2014 and 2018.
OAB [ overactive bladder The current document reflects relevant literature published through October
RCT [ randomized controlled 2018.
trial Results: When sufficient evidence existed, the body of evidence for a particular
TEAE [ treatment-emergent treatment was assigned a strength rating of A (high), B (moderate), or C (low).
adverse event Such statements are provided as Standards, Recommendations, or Options. In
UUI [ urgency urinary instances of insufficient evidence, additional guidance information is provided as
incontinence Clinical Principles and Expert Opinions.
Conclusions: The evidence-based statements are provided for diagnosis and
Accepted for publication April 22, 2019.
The complete unabridged version of the amend- overall management of OAB, as well as for the various treatments. Diagnosis and
ment is available at https://www.jurology.com. treatment methodologies can be expected to change as the evidence base grows
This document is being printed as submitted and as new treatment strategies become obtainable.
independent of editorial or peer review by the
editors of The Journal of Urology.
Key Words: urinary bladder, overactive; urinary bladder; urinary
incontinence; nocturia; guideline

OAB is a clinical diagnosis charac- have used varying combinations of

terized by the presence of bothersome these symptoms to identify patients
urinary symptoms. Most studies of for study inclusion and to define
OAB, including this guideline, exclude treatment response.
individuals with symptoms related to Urgency is defined by the ICS as
neurologic conditions. The Interna- the “complaint of a sudden, compelling
tional Continence Society (ICS) defines desire to pass urine which is difficult
OAB as the presence of “urinary ur- to defer.”1 Urgency is considered the
gency, usually accompanied by fre- hallmark symptom of OAB, but it has
quency and nocturia, with or without proven difficult to precisely define or
urgency urinary incontinence (UUI), in to characterize for research or clin-
the absence of urinary tract infection or ical purposes. Therefore, many studies
other obvious pathology.”1 OAB studies of OAB treatments have relied upon

0022-5347/19/2023-0558/0 https://doi.org/10.1097/JU.0000000000000309
THE JOURNAL OF UROLOGY® Vol. 202, 558-563, September 2019
Ó 2019 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC. Printed in U.S.A.

558 j www.auajournals.org/jurology
 OVERACTIVE BLADDER (NON-NEUROGENIC) GUIDELINE AMENDMENT 559

other measures (e.g., number of voids, number of in- Frequency that is the result of polydipsia and
continence episodes) to measure treatment response. resulting polyuria may mimic OAB; the two can
Urinary frequency can be reliably measured with only be distinguished with the use of frequency-
a voiding diary. Traditionally, up to seven micturi- volume charts. In polydipsia, urinary frequency oc-
tion episodes during waking hours has been curs with normal or large volume voids, and the
considered normal,2 but this number is highly var- intake is volume matched. In this case, the fre-
iable based upon hours of sleep, fluid intake, co- quency is appropriate because of the intake volume,
morbid medical conditions, and other factors. and the patient does not have OAB. Frequency due
Nocturia is defined by the ICS as the complaint of to polydipsia is physiologically self-induced OAB
interruption of sleep one or more times because of and should be managed with education, with
the need to void.1 In one study, three or more epi- consideration of fluid management.
sodes of nocturia constitutes moderate or major The clinical presentation of interstitial cystitis/
bother.3 Like daytime frequency, nocturia is a bladder pain syndrome shares the symptoms of uri-
multifactorial symptom that is often due to factors nary frequency and urgency, with or without ur-
unrelated to OAB (e.g., excessive nighttime urine gency incontinence; however, bladder and/or pelvic
production, sleep apnea). pain, including dyspareunia, is a crucial component
UUI is defined as the involuntary leakage of of its presentation in contradistinction to OAB. Other
urine, associated with a sudden compelling desire to conditions also can contribute to OAB symptoms and
void. Incontinence episodes can be measured reli- should be assessed. For example, in the menopausal
ably with a diary, and the quantity of urine leakage female patient, atrophic vaginitis can be a contrib-
can be measured with pad tests. However, in pa- uting factor to incontinence symptoms. There is some
tients with mixed urinary incontinence (both stress evidence for symptom improvement with the use of
and urgency incontinence), it can be difficult to vaginal (but not systemic) estrogen.6
distinguish between incontinence subtypes. There-
fore, it is common for OAB treatment trials to utilize
total incontinence episodes as an outcome measure.
METHODOLOGY
The AHRQ report that served as the primary source of
evidence for the initial version of this guideline searched
PATIENT PRESENTATION PubMed, MEDLINE, EMBASE and CINAHL for English-
language studies published from January 1966 to October
Symptoms 2008 relevant to OAB.7 The American Urological Associ-
When symptoms of both daytime and nighttime ation (AUA) conducted an additional literature search to
urinary frequency and urgency (with or without capture articles published between October 2008 and
urgency incontinence) are self-reported as bother- December 2011 (DOI: 10.1016/j.juro.2012.09.079).
some, the patient may be diagnosed with OAB.4 The AUA update literature review process, in which an
Additionally, a caregiver or partner may perceive additional systematic review is conducted periodically to
these symptoms as bothersome and lead the patient maintain guideline currency with newly-published rele-
vant literature, was initiated in 2014 and 2018. These
to seek care. It is common for patients to have suf-
reviews identified an additional 72 (2014) and 37 (2018)
fered with their symptoms for an extended time articles relevant to treatment. These articles were added
before seeking medical advice. to the database, and AUA’s qualitative and quantitative
analyses were updated as appropriate. The review panels
Differentiation determined that each update review warranted targeted
OAB symptoms may occur only at night, causing a updates to the document, thereby creating the 2014 and
single symptom of nocturia. The differential of noc- 2019 amendments. The subject of this current review is
turia includes nocturnal polyuria (the production of the 2019 amendment, which provides additional guidance
greater than 20 to 33% of total 24 hour urine output related to the use of combination therapy for the treat-
during the period of sleep, which is age-dependent ment of OAB.
with 20% for younger individuals and 33% for The AUA Nomenclature System used for this guideline
can be found in the supplementary unabridged guideline
elderly individuals),5 low nocturnal bladder capacity,
amendment (https://www.jurology.com). The diagnostic
or both. In nocturnal polyuria, nocturnal voids are
and treatment algorithm is provided in the figure.
frequently normal or large volume as opposed to the
small volume voids commonly observed in nocturia
associated with OAB. Sleep disturbances, vascular UPDATED GUIDELINE STATEMENT
and/or cardiac disease and other medical conditions The 2019 amendment was based on the inclusion of
are often associated with nocturnal polyuria. combination therapy for the treatment of OAB. All
OAB also must be distinguished from other con- other statements in the previous guideline iteration
ditions such as polydipsia. In OAB, urinary fre- remain unchanged. The clinician should bear in
quency is associated with many small volume voids. mind that the treatment framework does not require
560 OVERACTIVE BLADDER (NON-NEUROGENIC) GUIDELINE AMENDMENT

Figure.

that every patient go through each line of treatment anti-muscarinics and b3-adrenoceptor agonists. While
in order. There are many factors to consider when these therapies have different mechanisms of action,
identifying the best treatment for a particular pa- co-administration appears to have no noticeable ef-
tient, including information regarding allergies, fects on pharmacokinetics.8 Further, studies have
sensitivity to various adverse drug events, patient demonstrated improved efficacy with combination
ability and motivation to comply, and availability of therapy without any significant effect on the safety
and access to specific treatments. profile when compared to monotherapy. While the
strongest evidence for combination therapy comes
Second-Line Treatments: Pharmacologic from the SYNERGY I/II9,10 and BESIDE11 trials,
Management which utilized solifenacin (5 mg) and mirabegron
Clinicians may consider combination therapy with (25 or 50 mg), additional combinations utilizing
an anti-muscarinic and b3-adrenoceptor agonist for various other drug classes and dosing schedules
patients refractory to monotherapy with either anti- have been tested and are discussed below. At this
muscarinics or b3-adrenoceptor agonists. Option time, the Panel feels that such data are less robust;
(Evidence Strength Grade B). as such, more data will be required before such
The 2019 update literature review uncovered a additional combinations can be recommended.
number of studies looking at combination therapy In the 18-week SYNERGY trial, Herschorn et al.
for the treatment of OAB. Typical pharmacotherapy (2017)9 randomized 3,398 wet OAB patients (77%
options for the management of OAB include both women) to solifenacin (5 mg) plus mirabegron (25 mg),
 OVERACTIVE BLADDER (NON-NEUROGENIC) GUIDELINE AMENDMENT 561

solifenacin (5 mg) plus mirabegron (50 mg), placebo, Drake et al. (2016)11 in the BESIDE trial evalu-
mirabegron (25 mg) monotherapy, mirabegron (50 mg) ated the efficacy, safety, and tolerability of combi-
monotherapy, or solifenacin (5 mg) monotherapy in nation therapy (solifenacin 5 mg plus mirabegron
a 2:2:1:1:1:1 ratio. While the solifenacin/mirabegron 50 mg) versus monotherapy (solifenacin 5 or 10 mg)
50 mg group was superior to solifenacin monotherapy in a 1:1:1 randomized trial for OAB patients remain-
for mean adjusted difference in urinary incontinence ing incontinent after 4 weeks of solifenacin 5 mg. A
episodes per 24 hours (-0.20, 95% CI -0.44 to 0.04, total of 2,174 patients were randomized (83% women).
P[ 0.033), statistical superiority was not seen versus At end of treatment, combination therapy was found
mirabegron 50 mg monotherapy (-0.23, 95% CI -0.47 to be superior to solifenacin 5 mg, with significant
to 0.01, P[ 0.052). improvements in daily incontinence (p [ 0.001), daily
In secondary analyses, all active treatment groups micturitions (p < 0.001), and incontinence noted in
showed greater improvements in urinary inconti- a 3-day diary (p [ 0.014). Combination was non-
nence episodes per 24 hours versus placebo (nominal inferior to solifenacin 10 mg for key secondary
P values all <0.05). Effect sizes for the combined end points, including a change from baseline to end
therapy groups (solifenacin/mirabegron 25 mg: -0.70; of treatment in the mean number of micturitions
solifenacin/mirabegron 50 mg: -0.65) were higher per 24 hours and number of incontinence episodes
than those obtained with monotherapy (range -0.37 noted in a 3-day diary at end of treatment. Combina-
for mirabegron 25 mg to -0.45 for solifenacin 5 mg). tion was superior to solifenacin 10 mg for improving
All active treatment groups had greater improve- daily micturitions.
ments in the mean numbers of micturitions per 24 One randomized controlled trial (RCT) by Kosilov
hours versus placebo, with effect sizes for the com- et al. (2018)12 and one prospective cohort study by
bined therapy groups (solifenacin/mirabegron 25 mg: Kosilov et al. (2013)13 evaluated combination sol-
0.85; solifenacin/mirabegron 50 mg: 0.95) higher ifenacin and trospium in women with OAB. The
than with mirabegron monotherapy (25 mg: 0.36; Panel notes that the doses of solifenacin and
50 mg: 0.39) and solifenacin 5 mg (0.56). trospium utilized in the Kosilov et al. studies are
Researchers noted that the combined solifenacin/ higher than the standard recommended doses. The
mirabegron 50 mg group was statistically signifi- RCT randomized 312 women (60-83 years of age) to
cantly superior to both monotherapies at end of high dose solifenacin (20 mg/day) plus high dose
treatment for UUI episodes, urgency episodes and trospium (60 mg/day), or a lower dose of solifenacin
nocturia, with effect sizes that appeared to be ad- (10 mg/day) plus a lower dose trospium (30 mg/day),
ditive. Adverse events including dry mouth, con- or placebo.12 Following treatment, quality of life
stipation, and dyspepsia, were slightly increased in parameters in terms of the functional state of the
the combination therapy groups compared to mon- lower urinary tract were improved compared with
otherapies. Additionally, events indicative of uri- placebo, but with no differences between the higher
nary retention were reported more frequently in the dose and lower dose combination groups (p<0.05).
combination groups compared to monotherapy and The prospective cohort study was designed in two
placebo. phases and included 229 women (65-77 years of
In the follow up SYNERGY II trial, Gratzke et al. age).13 In the first phase all women received 60 mg
(2018)10 evaluated the safety and efficacy of combi- trospium and 40 mg solifenacin daily, while in the
nation therapy over 12 months. The trial randomized second phase, defined as the maintenance phase,
1,829 wet OAB patients (80% women) to combination women were allocated to additional trospium plus
5 mg solifenacin plus 50 mg mirabegron, solifenacin solifenacin treatment, electrical stimulation of
monotherapy, mirabegron monotherapy, or placebo. detrusor muscle, laser puncture using a helium-neon
The primary objective was safety as measured by laser applied to acupuncture points, or placebo for
treatment-emergent adverse events (TEAEs); addi- one month. The study reported that maintenance
tionally, efficacy was measured as the change from with the combination therapy resulted in effective
baseline to the end of treatment in the mean num- maintenance of clinical and urodynamic results for at
ber of incontinence episodes and micturitions per least seven months, while electrical stimulation was
24 hours. TEAEs were reported more frequently in less effective, and laser puncture was inefficient.
the combination group (49%) than in the mirabegron Another RCT by Ellington et al. (2016) evaluated
group (41%) or solifenacin group (44%), with dry combination tolterodine and intravaginal estradiol
mouth being the most commonly reported TEAE. cream in 58 menopausal women.14 Women were
Combination therapy was statistically superior to randomized to either oral tolterodine or estradiol
mirabegron and solifenacin monotherapy for cream for 12 weeks and then offered addition of the
decreasing number of incontinence episodes (mir- alternative therapy with follow-up at week 24 and
abegron, p<0.001; solifenacin, p[0.002) and mictu- week 52. Both monotherapies resulted in decreased
ritions (mirabegron, p<0.001; solifenacin, p[0.004). symptom bother scores at 12 weeks when compared
562 OVERACTIVE BLADDER (NON-NEUROGENIC) GUIDELINE AMENDMENT

with baseline values. Following addition of the urgency, incontinence episode frequency, and
alternate therapy at the 12 week time-point, within reporting of the variance for each of these measures.
group OAB symptom severity and health-related Further research is needed focused on combina-
quality of life scores remained improved signifi- tion therapy utilizing other drug classes and dosing
cantly at 24 and 52 weeks from baseline, though it regimens looking at both efficacy and adverse ef-
should be noted that only addition of tolterodine at 12 fects. Additionally, the use of vaginal estrogen
weeks to the estradiol group resulted in further sig- should be studied as a monotherapy for OAB as well
nificant improvement in the OAB-q symptom bother as in combination with other therapies.
score and the health-related quality of life scores The effect of treatment of OAB on the elderly, the
above the single therapy effect noted at 12 weeks. very frail, and those with pre-existing cognitive
Finally, an RCT by Rovner et al. (2018)15 compared deficiencies needs further research. These include
a 3 month combination of oral desmopressin 25 mg measures of cognitive side effects from anti-
plus 4 mg tolterodine with 4 mg tolterodine mono- muscarinic treatments.
therapy in 106 women. When evaluating the overall Diagnosis and treatment protocols for OAB can be
population, combination therapy resulted in a non- expected to change as the evidence base continues to
significant reduction in nocturnal voids over mono- grow. As such, this document will undergo regular
therapy (P[0.112). In a subgroup of patients with review to ensure currency of recommendations.
nocturnal polyuria, combination therapy resulted in
improved nocturnal void volume (P[0.034) and time
to first nocturnal void (P[0.045). DISCLAIMER
This document was written by the Overactive Bladder
Amendment Panel of the American Urological Asso-
RESEARCH NEEDS AND FUTURE ciation Education and Research, Inc., which was
DIRECTIONS created in 2018. The Practice Guidelines Committee
(PGC) of the AUA selected the committee chair. Panel
Better Stratification of OAB
members were selected by the chair. Membership of
OAB is primarily a diagnosis of exclusion. Treat-
the panel included specialists with specific expertise
ments are aimed at relieving symptoms and not
on this disorder. The mission of the panel was to re-
necessarily at reversing pathophysiologic abnor-
view existing statements for currency and provide
malities. Understanding the pathophysiology and
new statements that are analysis-based or consensus-
the risk factors for development of OAB is needed
based, depending on panel processes and available
both to treat the syndrome as well as to prevent it.
data, for optimal clinical practices in the diagnosis
Future research will need to address the entire
and treatment of overactive bladder.
spectrum of research endeavors including epidemi-
Funding of the panel was provided by the AUA.
ology, quality of life measurements, treatment mo-
Panel members received no remuneration for their
dalities, and basic bladder physiology including
work. Each member of the panel provides an
sensory and motor signaling. Within the field of
ongoing conflict of interest disclosure to the AUA.
OAB, research is sometimes dichotomized between
While these guidelines do not necessarily estab-
OAB/lower urinary tract symptoms (e.g., OAB-dry)
lish the standard of care, AUA seeks to recommend
versus OAB/urgency incontinence (OAB-wet).
and to encourage compliance by practitioners with
However, this type of compartmentalization high-
current best practices related to the condition being
lights our lack of understanding of OAB. In addi-
treated. As medical knowledge expands and tech-
tion, particularly in females, stress urinary
nology advances, the guidelines will change. Today
incontinence symptoms may exist concomitantly
these evidence-based guidelines statements repre-
with OAB symptoms. Further, isolated nocturia is a
sent not absolute mandates but provisional pro-
separate symptom entity, requiring different eval-
posals for treatment under the specific conditions
uation and management strategies.
described in each document. For all these reasons,
the guidelines do not pre-empt physician judgment
Clinical Research in individual cases.
Several validated OAB symptom and OAB symptom Treating physicians must take into account varia-
bother tools have been developed. However, objec- tions in resources, and patient tolerances, needs, and
tive measures of the “cornerstone” OAB symptom of preferences. Conformance with any clinical guideline
urgency16 remains poorly assessed. Investigators does not guarantee a successful outcome. The guide-
have tested urgency questionnaires to assess for line text may include information or recommenda-
validity and reliability;17e19 however, no single tions about certain drug uses (‘off label’) that are not
measure is used consistently across trials. Objective approved by the Food and Drug Administration
outcomes should include frequency, nocturia, (FDA), or about medications or substances not subject
 OVERACTIVE BLADDER (NON-NEUROGENIC) GUIDELINE AMENDMENT 563

to the FDA approval process. AUA urges strict For this reason, the AUA does not regard tech-
compliance with all government regulations and nologies or management which are too new to be
protocols for prescription and use of these substances. addressed by this guideline as necessarily experi-
The physician is encouraged to carefully follow all mental or investigational.
available prescribing information about indications,
contraindications, precautions and warnings. These CONFLICT OF INTEREST DISCLOSURES
guidelines and best practice statements are not in- All panel members completed COI disclosures.
tended to provide legal advice about use and misuse Disclosures listed include both topice and non-
of these substances. topic-related relationships. All unlisted authors
Although guidelines are intended to encourage have nothing to disclose. Consultant/Advisor: San-
best practices and potentially encompass available dip P. Vasavada, Allergan, Axonics, Amphora,
technologies with sufficient data as of close of the BlueWind. Meeting Participant or Lecturer: Sandip
literature review, they are necessarily time-limited. P. Vasavada, Allergan, Medtronic. Scientific Study
Guidelines cannot include evaluation of all data on or Trial: Sandip P. Vasavada, Allergan. Investment
emerging technologies or management, including Interest: Sandip P. Vasavada, NDI Medical LLC.
those that are FDA-approved, which may immedi- Health Publishing: Deborah J. Lightner, AUA,
ately come to represent accepted clinical practices. Urology/Elsevier.

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