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

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ClinicalTrials.gov Identifier: NCT01563653
Recruitment Status : Terminated (Not enough inclusions.)
First Posted : March 27, 2012
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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).


Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Procedure: 4 diagnostic tests for surgical success Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Actual Study Start Date : February 20, 2014
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. Positive Bonney maneuver [ Time Frame: 2-4 weeks ]
    yes/no

  4. Positive Bonney maneuver [ Time Frame: 6-8 weeks ]
    yes/no

  5. Positive TVT maneuver [ Time Frame: 2-4 weeks ]
    yes/no

  6. Positive TVT maneuver [ Time Frame: 6-8 weeks ]
    yes/no

  7. 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

  8. 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

  9. Intra-urethral pressure during the Bonney maneuver [ Time Frame: 2-4 weeks ]
    mm Hg

  10. Intra-urethral pressure during the Bonney maneuver [ Time Frame: 6-8 weeks ]
    mm Hg

  11. Intra-urethral pressure during the TVT maneuver [ Time Frame: 6-8 weeks ]
    mm Hg

  12. Intra-urethral pressure during the TVT maneuver [ Time Frame: 2-4 weeks ]
    mm Hg

  13. Intra-urethral pressure during the clip strip test [ Time Frame: 2-4 weeks ]
    mm Hg

  14. Intra-urethral pressure during the clip strip test [ Time Frame: 6-8 weeks ]
    mm Hg

  15. UDI-6 questionnaire [ Time Frame: 2-4 weeks ]
  16. UDI-6 questionnaire [ Time Frame: 12-14 weeks ]
  17. UDI-6 questionnaire [ Time Frame: 58-60 weeks ]
  18. IIQ7 questionnaire [ Time Frame: 2-4 weeks ]
  19. IIQ7 questionnaire [ Time Frame: 12-14 weeks ]
  20. IIQ7 questionnaire [ Time Frame: 58-60 weeks ]
  21. PGI-I Questionnaire [ Time Frame: 58-60 weeks ]
  22. 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

  23. 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

  24. Angle associated with Q-tip test [ Time Frame: 2-4 weeks ]
  25. Angle associated with Q-tip test [ Time Frame: 6-8 weeks ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 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