Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa
- Conditions
- Surgical Treatment of Urge Incontinence
- Interventions
- Procedure: TOT
- Registration Number
- NCT01737918
- Lead Sponsor
- Klinikum der Universität Köln
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- prior vasa or cesa operation as part of the URGE I study
- stress urinary incontinence
- mixed urinary incontinence
- previous urogynecological surgery
- avulsion of cesa or vasa tape
- pregnancy
- neurologic/psychological reasons for incontinence
- body weight >100kg
- syndrome of dry overactive bladder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description trans obturatorial tape (TOT) TOT placement of a sub-urethral tape solifenacin solifenacin 10 mg per day
- Primary Outcome Measures
Name Time Method cure of incontinence 3 months
- Secondary Outcome Measures
Name Time Method improvement of urge symptoms 3 months
Trial Locations
- Locations (1)
Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln
🇩🇪Köln, NRW, Germany