Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

Phase 1

• Conditions: Urge Urinary Incontinence
• Interventions: Procedure: cesa/vasa; Drug: solifenacin

• Registration Number: NCT01737411
• Lead Sponsor: Klinikum der Universität Köln

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Study Start: 2013-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cesa/vasa	cesa/vasa	repair of USL
solifenacin	solifenacin	10 mg solifenacin per day for three months

Primary Outcome Measures

Name	Time	Method
cure from urge urinary symptoms	12 months	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

Secondary Outcome Measures

Name	Time	Method
cure from urge urinary symptoms	12 months	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

Trial Locations

Locations (1)

Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln; 🇩🇪 Köln, NRW, Germany