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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Urinary Incontinence, Stress

Treatments: Procedure: 4 diagnostic tests for surgical success

Study type: Interventional

Funder types: Other

Identifiers

NCT01563653

LOCAL/2011/RdeT-01

2011-A01225-36 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Patients

Experimental group

Description:

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

Treatment:

Procedure: 4 diagnostic tests for surgical success