Clinical trial NCT01563653: Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
Official title: Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Incontinence, Stress
Keywords: predicting surgical success
simple diagnostic test device
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
timeFrame: 58-60 weeks
Secondary outcomes:
measure: McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
timeFrame: 2-4 weeks
measure: McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
timeFrame: 6-8 weeks
measure: Positive Bonney maneuver
timeFrame: 2-4 weeks
measure: Positive Bonney maneuver
timeFrame: 6-8 weeks
measure: Positive TVT maneuver
timeFrame: 2-4 weeks
measure: Positive TVT maneuver
timeFrame: 6-8 weeks
measure: McNemar Score: Clip strip test versus Bonney maneuvre
timeFrame: 58-60 weeks
measure: McNemar Score: Clip strip test TVT Bonney maneuvre
timeFrame: 58-60 weeks
measure: Intra-urethral pressure during the Bonney maneuver
timeFrame: 2-4 weeks
measure: Intra-urethral pressure during the Bonney maneuver
timeFrame: 6-8 weeks
measure: Intra-urethral pressure during the TVT maneuver
timeFrame: 6-8 weeks
measure: Intra-urethral pressure during the TVT maneuver
timeFrame: 2-4 weeks
measure: Intra-urethral pressure during the clip strip test
timeFrame: 2-4 weeks
measure: Intra-urethral pressure during the clip strip test
timeFrame: 6-8 weeks
measure: UDI-6 questionnaire
timeFrame: 2-4 weeks
measure: UDI-6 questionnaire
timeFrame: 12-14 weeks
measure: UDI-6 questionnaire
timeFrame: 58-60 weeks
measure: IIQ7 questionnaire
timeFrame: 2-4 weeks
measure: IIQ7 questionnaire
timeFrame: 12-14 weeks
measure: IIQ7 questionnaire
timeFrame: 58-60 weeks
measure: PGI-I Questionnaire
timeFrame: 58-60 weeks
measure: Intra- and inter operator reproducability for 4 diagnostic tests
timeFrame: 2-4 weeks
measure: Intra- and inter operator reproducability for 4 diagnostic tests
timeFrame: 6-8 weeks
measure: Angle associated with Q-tip test
timeFrame: 2-4 weeks
measure: Angle associated with Q-tip test
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Digne-les-Bains
country: France
facility: CH de Dignes les Bains
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Renaud de Tayrac, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: