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Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence (IEUF)
This study has been terminated.
(Not enough inclusions.)
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01563653
First received: March 16, 2012
Last updated: June 16, 2017
Last verified: June 2017
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Purpose
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).
| Condition | Intervention |
|---|---|
| Urinary Incontinence, Stress | Procedure: 4 diagnostic tests for surgical success |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results [ Time Frame: 58-60 weeks ]McNemar test for comparing sensitivity and specificity between two factors
Secondary Outcome Measures:
- McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results [ Time Frame: 2-4 weeks ]McNemar test for comparing sensitivity and specificity between two factors
- McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results [ Time Frame: 6-8 weeks ]McNemar test for comparing sensitivity and specificity between two factors
- Positive Bonney maneuver [ Time Frame: 2-4 weeks ]yes/no
- Positive Bonney maneuver [ Time Frame: 6-8 weeks ]yes/no
- Positive TVT maneuver [ Time Frame: 2-4 weeks ]yes/no
- Positive TVT maneuver [ Time Frame: 6-8 weeks ]yes/no
- McNemar Score: Clip strip test versus Bonney maneuvre [ Time Frame: 58-60 weeks ]Comparison of the prognostic capacities of the clip strip and Bonney maneuver tests. McNemar test for comparing sensitivity and specificity between two factors
- McNemar Score: Clip strip test TVT Bonney maneuvre [ Time Frame: 58-60 weeks ]Comparison of the prognostic capacities of the clip strip and TVT maneuver tests. McNemar test for comparing sensitivity and specificity between two factors
- Intra-urethral pressure during the Bonney maneuver [ Time Frame: 2-4 weeks ]mm Hg
- Intra-urethral pressure during the Bonney maneuver [ Time Frame: 6-8 weeks ]mm Hg
- Intra-urethral pressure during the TVT maneuver [ Time Frame: 6-8 weeks ]mm Hg
- Intra-urethral pressure during the TVT maneuver [ Time Frame: 2-4 weeks ]mm Hg
- Intra-urethral pressure during the clip strip test [ Time Frame: 2-4 weeks ]mm Hg
- Intra-urethral pressure during the clip strip test [ Time Frame: 6-8 weeks ]mm Hg
- UDI-6 questionnaire [ Time Frame: 2-4 weeks ]
- UDI-6 questionnaire [ Time Frame: 12-14 weeks ]
- UDI-6 questionnaire [ Time Frame: 58-60 weeks ]
- IIQ7 questionnaire [ Time Frame: 2-4 weeks ]
- IIQ7 questionnaire [ Time Frame: 12-14 weeks ]
- IIQ7 questionnaire [ Time Frame: 58-60 weeks ]
- PGI-I Questionnaire [ Time Frame: 58-60 weeks ]
- Intra- and inter operator reproducability for 4 diagnostic tests [ Time Frame: 2-4 weeks ]Bonney maneuver, q-tip test, tvt maneuver and clip strip test
- Intra- and inter operator reproducability for 4 diagnostic tests [ Time Frame: 6-8 weeks ]Bonney maneuver, q-tip test, tvt maneuver and clip strip test
- Angle associated with Q-tip test [ Time Frame: 2-4 weeks ]
- Angle associated with Q-tip test [ Time Frame: 6-8 weeks ]
| Enrollment: | 7 |
| Actual Study Start Date: | February 20, 2014 |
| Study Completion Date: | February 23, 2017 |
| Primary Completion Date: | February 23, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563653
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563653
Locations
| France | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | |
| Nîmes Cedex 09, Gard, France, 30029 | |
| CH de Dignes les Bains | |
| Digne-les-Bains, France, 04000 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Renaud de Tayrac, MD PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01563653 History of Changes |
| Other Study ID Numbers: |
LOCAL/2011/RdeT-01 2011-A01225-36 ( Other Identifier: RCB number ) |
| Study First Received: | March 16, 2012 |
| Last Updated: | June 16, 2017 |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
predicting surgical success simple diagnostic test device |
Additional relevant MeSH terms:
|
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms |
Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 21, 2017