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

NCT01563653 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-06-19

No results posted yet for this study

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

Interventions

PROCEDURE

4 diagnostic tests for surgical success

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Renaud de Tayrac, MD PhD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-20
Primary Completion
2017-02-23
Completion
2017-02-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563653 on ClinicalTrials.gov