NCT01563653

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
PROCEDURE	4 diagnostic tests for surgical success	Q-tip test, Bonney maneuver, TVT maneuver, clip strip test

Timeline

• Start date: 2014-02-20
• Primary completion: 2017-02-23
• Completion: 2017-02-23
• First posted: 2012-03-27
• Last updated: 2017-06-19

Locations

2 sites across 1 country: France