NCT01737411

Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Klinikum der Universität Köln · Academic / Other
• Sex: Female
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Urge Urinary Incontinence

Interventions

Type	Name	Description
DRUG	solifenacin
PROCEDURE	cesa/vasa	surgical repair of USL

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2012-11-29
• Last updated: 2015-04-07

Locations

1 site across 1 country: Germany