Trial record 2 of 44 for:
Open Studies | "Urinary Incontinence, Stress"
Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
This study is not yet open for participant recruitment.
Verified April 2013 by Centre Hospitalier Universitaire de Nīmes
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: April 10, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]McNemar test for comparing sensitivity and specificity between two factors
- Positive Bonney maneuver [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]yes/no
- Positive Bonney maneuver [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]yes/no
- Positive TVT maneuver [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]yes/no
- Positive TVT maneuver [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]yes/no
- McNemar Score: Clip strip test versus Bonney maneuvre [ Time Frame: 58-60 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]mm Hg
- Intra-urethral pressure during the Bonney maneuver [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]mm Hg
- Intra-urethral pressure during the TVT maneuver [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]mm Hg
- Intra-urethral pressure during the TVT maneuver [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]mm Hg
- Intra-urethral pressure during the clip strip test [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]mm Hg
- Intra-urethral pressure during the clip strip test [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]mm Hg
- UDI-6 questionnaire [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
- UDI-6 questionnaire [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]
- UDI-6 questionnaire [ Time Frame: 58-60 weeks ] [ Designated as safety issue: No ]
- IIQ7 questionnaire [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
- IIQ7 questionnaire [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]
- IIQ7 questionnaire [ Time Frame: 58-60 weeks ] [ Designated as safety issue: No ]
- PGI-I Questionnaire [ Time Frame: 58-60 weeks ] [ Designated as safety issue: No ]
- Intra- and inter operator reproducability for 4 diagnostic tests [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Bonney maneuver, q-tip test, tvt maneuver and clip strip test
- Angle associated with Q-tip test [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
- Angle associated with Q-tip test [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (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 |
| Genders 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
- 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 infection
- The patient has a history of allergy to polyurethane and / or Watershed XCX11122
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563653
Contacts
| Contact: Renaud de Tayrac, MD PhD | +33.(0)4.66.68.32.32 | renaud.detayrac@chu-nimes.fr |
| Contact: Carey M Suehs, PhD | +33.(0)4.66.68.67.88 | carey.suehs@chu-nimes.fr |
Locations
| France | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Not yet recruiting |
| Nîmes Cedex 09, Gard, France, 30029 | |
| Principal Investigator: Renaud de Tayrac, MD PhD | |
| Sub-Investigator: Pierre Costa, MD PhD | |
| Sub-Investigator: Brigitte Fatton, MD | |
| Sub-Investigator: Laurent Wagner, MD | |
| Sub-Investigator: Vincent Letouzey, MD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Renaud de Tayrac, MD PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| 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 |
| Study First Received: | March 16, 2012 |
| Last Updated: | April 10, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: L’Agence nationale de sécurité du médicament et des produits de santé |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
predicting surgical success simple diagnostic test device |
Additional relevant MeSH terms:
|
Urinary Incontinence, Stress Urinary Incontinence Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013