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| ID | Type | Description | Link |
|---|---|---|---|
| URGE-I | Other Identifier | OB/GYN | |
| URGE-I | Other Identifier | OB/GYN Köln | |
| 11-016 | Other Identifier | University of Köln |
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The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solifenacin | Active Comparator | 10 mg solifenacin per day for three months |
|
| cesa/vasa | Experimental | repair of USL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin | Drug |
|
| |
| cesa/vasa |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| stress incontinence | Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolfram H Jager, PhD | Contact | 0049221478 | 4900 | wolframjaeger@gmx.de |
| Peter S Mallmann, Phd | Contact | 0049221478 | 4940 | peter.mallmann@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Wolfram H Jager, PhD | Study Supervisor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln | Recruiting | Cologne | North Rhine-Westphalia | 50931 | Germany |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Procedure |
surgical repair of USL |
|
| 12 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |