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

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).

Study Overview

• Status: Terminated
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Procedure: 4 diagnostic tests for surgical success

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Digne-les-Bains, France, 04000
    • CH de Dignes les Bains
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2014
• Primary Completion (Actual): February 23, 2017
• Study Completion (Actual): February 23, 2017

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 27, 2012

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: predicting surgical success; simple diagnostic test device
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: LOCAL/2011/RdeT-01; 2011-A01225-36 (Other Identifier: RCB number)