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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01563653
First received: March 16, 2012
Last updated: January 2, 2015
Last verified: December 2014
History of Changes
  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:

U.S. FDA Resources

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: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 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: January 2, 2015
Health Authority: France: Committee for the Protection of Personnes
France: 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
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
 Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on February 27, 2015