Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women (URGE-I)
|Urge Urinary Incontinence||Drug: solifenacin Procedure: cesa/vasa||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women|
- cure from urge urinary symptoms [ Time Frame: 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
- cure from urge urinary symptoms [ Time Frame: 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
- stress incontinence [ Time Frame: 12 months ]Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: solifenacin
10 mg solifenacin per day for three months
Other Name: VESICUR
repair of USL
surgical repair of USL
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737411
|Contact: Wolfram H Jager, PhD||0049221478 ext email@example.com|
|Contact: Peter S Mallmann, Phd||0049221478 ext firstname.lastname@example.org|
|Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln||Recruiting|
|Köln, NRW, Germany, 50931|
|Contact: Wolfram H Jager 0049221478 ext 4900 email@example.com|
|Principal Investigator: Wolfram H Jager, PhD|
|Study Director:||Wolfram H Jager, PhD||Study Supervisor|