NCT01737918

Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa

Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence

• 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 – 85 Years
• Healthy volunteers: Not accepted

Summary

Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.

Detailed description

It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.

Conditions

• Surgical Treatment of Urge Incontinence

Interventions

Type	Name	Description
PROCEDURE	TOT
DRUG	solifenacin

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-12-01
• Completion: 2018-07-01
• First posted: 2012-11-30
• Last updated: 2015-04-07

Locations

2 sites across 1 country: Germany