Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
NCT ID: NCT01563653
Last Updated: 2017-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2014-02-20
2017-02-23
Brief Summary
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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).
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients
Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria.
4 diagnostic tests for surgical success
Q-tip test, Bonney maneuver, TVT maneuver, clip strip test
Interventions
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4 diagnostic tests for surgical success
Q-tip test, Bonney maneuver, TVT maneuver, clip strip test
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Renaud de Tayrac, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, France
CH de Dignes les Bains
Digne-les-Bains, , France
Countries
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Other Identifiers
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2011-A01225-36
Identifier Type: OTHER
Identifier Source: secondary_id
LOCAL/2011/RdeT-01
Identifier Type: -
Identifier Source: org_study_id
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