Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence

Study Overview
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Brief Summary
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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).

Detailed Description
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Secondary objectives include: Compare the prognostic ability of the clip strip test with the Bonney maneuver Compare the prognostic ability of the clip strip test with the TVT maneuver Compare the maximum intraurethral pressure during various tests Compare the quality of life before / after surgery Estimate patient satisfaction one year after surgery Describe the intra and inter-operator reproducibility of various prognostic tests. Estimate the optimal threshold of the Q-tip angle based on surgical results and compare with the reference threshold of 30 ° found in the literature.

Official Title
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Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Procedure: 4 diagnostic tests for surgical success


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 60 weeks of follow-up Candidate for stress urinary incontinence surgery by TVT or TOT procedures Positive cough or valsalve maneuver test Exclusion Criteria: The patient is participating in another study (except the PISQ-R study) The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding The patient has a contra-indication for stress urinary incontinence surgery via TVT or TOT procedures. The patient has an untreated vaginal or urniary infection The patient has a history of allergy to polyurethane and / or Watershed XCX11122

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria. | Procedure: 4 diagnostic tests for surgical success<br>* Q-tip test, Bonney maneuver, TVT maneuver, clip strip test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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predicting surgical success, simple diagnostic test device