Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

Study Overview
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Brief Summary
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The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

Detailed Description
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Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin. We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients. In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group. Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).

Official Title
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Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

Conditions
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Urge Urinary Incontinence

Intervention / Treatment
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* Drug: solifenacin
* Procedure: cesa/vasa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: urge urinary incontinence Exclusion Criteria: stress urinary incontinence cancer disease of the females genital tract pregnancy neurologic/psychological reasons for incontinence body weight >100kg previous urogynecological surgery (TVT) syndrome of dry overactive bladder (>20 micturitions within 24 hours)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: solifenacin<br>10 mg solifenacin per day for three months | Drug: solifenacin<br> <br> * Other names: VESICUR;|
| Experimental: cesa/vasa<br>repair of USL | Procedure: cesa/vasa<br>* surgical repair of USL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure from urge urinary symptoms | At the start of the study urge symptoms are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure from urge urinary symptoms | When the assigned first line treatment did not cure patients receive the treatment of the other arm (cross-over). Before cross-over urge symptoms of each patient are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, solifenacin, urge urinary incontinence