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

NCT01563653 | Terminated DMC

• 2 other identifiers: LOCAL/2011/RdeT-012011-A01225-36
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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).

Conditions

Urinary Incontinence, Stress

Keywords

predicting surgical success; simple diagnostic test device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results

  2-4 weeks

• McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results

  6-8 weeks

• Positive Bonney maneuver

  2-4 weeks

• Positive Bonney maneuver

  6-8 weeks

• Positive TVT maneuver

  2-4 weeks

Study Arms (1)

Patients

EXPERIMENTAL

Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria.

Procedure: 4 diagnostic tests for surgical success

Interventions

4 diagnostic tests for surgical success PROCEDURE

Q-tip test, Bonney maneuver, TVT maneuver, clip strip test

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another study (except the PISQ-R 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

CH de Dignes les Bains

Digne-les-Bains, 04000, France

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Renaud de Tayrac, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 27, 2012
• Study Start: February 20, 2014
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

FR (2)