Urge Urinary Incontinence Clinical Trial
— URGE-IOfficial title:
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 80 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln | Köln | NRW |
Lead Sponsor | Collaborator |
---|---|
Klinikum der Universität Köln |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | stress incontinence | Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests. | 12 months | No |
Primary | cure from urge urinary symptoms | 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 | 12 months | No |
Secondary | cure from urge urinary symptoms | 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 | 12 months | No |
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