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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01225-36 | Other Identifier | RCB number |
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The investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence.
The main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral TVT (tension-free vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in women. The Q-tip test (test mentioned in the French and international recommendations) is compared to test a new test (clip strip).
Secondary objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 diagnostic tests for surgical success | Procedure | Q-tip test, Bonney maneuver, TVT maneuver, clip strip test |
|
| Measure | Description | Time Frame |
|---|---|---|
| McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results | McNemar test for comparing sensitivity and specificity between two factors | 58-60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results | McNemar test for comparing sensitivity and specificity between two factors | 2-4 weeks |
| McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud de Tayrac, MD PhD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France | ||
| CH de Dignes les Bains |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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McNemar test for comparing sensitivity and specificity between two factors |
| 6-8 weeks |
| Positive Bonney maneuver | yes/no | 2-4 weeks |
| Positive Bonney maneuver | yes/no | 6-8 weeks |
| Positive TVT maneuver | yes/no | 2-4 weeks |
| Positive TVT maneuver | yes/no | 6-8 weeks |
| McNemar Score: Clip strip test versus Bonney maneuvre | Comparison of the prognostic capacities of the clip strip and Bonney maneuver tests. McNemar test for comparing sensitivity and specificity between two factors | 58-60 weeks |
| McNemar Score: Clip strip test TVT Bonney maneuvre | Comparison of the prognostic capacities of the clip strip and TVT maneuver tests. McNemar test for comparing sensitivity and specificity between two factors | 58-60 weeks |
| Intra-urethral pressure during the Bonney maneuver | mm Hg | 2-4 weeks |
| Intra-urethral pressure during the Bonney maneuver | mm Hg | 6-8 weeks |
| Intra-urethral pressure during the TVT maneuver | mm Hg | 6-8 weeks |
| Intra-urethral pressure during the TVT maneuver | mm Hg | 2-4 weeks |
| Intra-urethral pressure during the clip strip test | mm Hg | 2-4 weeks |
| Intra-urethral pressure during the clip strip test | mm Hg | 6-8 weeks |
| UDI-6 questionnaire | 2-4 weeks |
| UDI-6 questionnaire | 12-14 weeks |
| UDI-6 questionnaire | 58-60 weeks |
| IIQ7 questionnaire | 2-4 weeks |
| IIQ7 questionnaire | 12-14 weeks |
| IIQ7 questionnaire | 58-60 weeks |
| PGI-I Questionnaire | 58-60 weeks |
| Intra- and inter operator reproducability for 4 diagnostic tests | Bonney maneuver, q-tip test, tvt maneuver and clip strip test | 2-4 weeks |
| Intra- and inter operator reproducability for 4 diagnostic tests | Bonney maneuver, q-tip test, tvt maneuver and clip strip test | 6-8 weeks |
| Angle associated with Q-tip test | 2-4 weeks |
| Angle associated with Q-tip test | 6-8 weeks |
| Digne-les-Bains |
| 04000 |
| France |
| 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 |