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

Not Applicable

Terminated

• Conditions: Urinary Incontinence, Stress
• Interventions: Procedure: 4 diagnostic tests for surgical success

• Registration Number: NCT01563653
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Start: 2014-02-20
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	4 diagnostic tests for surgical success	Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria.

Primary Outcome Measures

Name	Time	Method
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results	58-60 weeks	McNemar test for comparing sensitivity and specificity between two factors

Secondary Outcome Measures

Name	Time	Method
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results	6-8 weeks	McNemar test for comparing sensitivity and specificity between two factors
Positive Bonney maneuver	6-8 weeks	yes/no
Positive TVT maneuver	6-8 weeks	yes/no
McNemar Score: Clip strip test versus Bonney maneuvre	58-60 weeks	Comparison of the prognostic capacities of the clip strip and Bonney maneuver tests. McNemar test for comparing sensitivity and specificity between two factors
McNemar Score: Clip strip test TVT Bonney maneuvre	58-60 weeks	Comparison of the prognostic capacities of the clip strip and TVT maneuver tests. McNemar test for comparing sensitivity and specificity between two factors
Intra-urethral pressure during the Bonney maneuver	6-8 weeks	mm Hg
Intra-urethral pressure during the TVT maneuver	2-4 weeks	mm Hg
Intra-urethral pressure during the clip strip test	6-8 weeks	mm Hg
UDI-6 questionnaire	58-60 weeks
IIQ7 questionnaire	58-60 weeks
PGI-I Questionnaire	58-60 weeks
Intra- and inter operator reproducability for 4 diagnostic tests	6-8 weeks	Bonney maneuver, q-tip test, tvt maneuver and clip strip test
Angle associated with Q-tip test	6-8 weeks

Trial Locations

Locations (2)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France

CH de Dignes les Bains; 🇫🇷 Digne-les-Bains, France