Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
Overview
- Phase
- Phase 1
- Intervention
- solifenacin
- Conditions
- Urge Urinary Incontinence
- Sponsor
- Klinikum der Universität Köln
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- cure from urge urinary symptoms
- Last Updated
- 11 years ago
Overview
Brief 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).
Investigators
Professor Dr. Wolfram Jäger
Professor
Klinikum der Universität Köln
Eligibility Criteria
Inclusion Criteria
- •urge urinary incontinence
Exclusion Criteria
- •stress urinary incontinence
- •cancer disease of the females genital tract
- •pregnancy
- •neurologic/psychological reasons for incontinence
- •body weight \>100kg
- •previous urogynecological surgery (TVT)
- •syndrome of dry overactive bladder (\>20 micturitions within 24 hours)
Arms & Interventions
solifenacin
10 mg solifenacin per day for three months
Intervention: solifenacin
cesa/vasa
repair of USL
Intervention: cesa/vasa
Outcomes
Primary Outcomes
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
Secondary Outcomes
- cure from urge urinary symptoms(12 months)