Urge Urinary Incontinence
Conditions
Keywords
surgery, solifenacin, urge urinary incontinence
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).
Interventions
DRUGsolifenacin
PROCEDUREcesa/vasa
surgical repair of USL
Sponsors
Klinikum der Universität Köln
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cure from urge urinary symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| cure from urge urinary symptoms | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| stress incontinence | 12 months | Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests. |
Countries
Germany
Contacts
Primary ContactWolfram H Jager, PhD
Backup ContactPeter S Mallmann, Phd
Outcome results
None listed