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Clinical Trial Summary

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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01737411
Study type Interventional
Source Klinikum der Universität Köln
Contact Wolfram H Jager, PhD
Phone 0049221478
Email wolframjaeger@gmx.de
Status Recruiting
Phase Phase 1/Phase 2
Start date January 2013
Completion date June 2018

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