CClinicalTrials.gg
Sign In
TerminatedNCT01563653IEUFUpdated Jun 19, 2017

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

An interventional study of 4 diagnostic tests for surgical success in Urinary Incontinence, Stress, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-19.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Not enough inclusions.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

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).

Read the 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.
02

Conditions studied

  • Urinary Incontinence, Stress

Keywords

  • predicting surgical success
  • simple diagnostic test device
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 7 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Patients

    Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria.

    Procedure: 4 diagnostic tests for surgical success

Interventions

  • Procedure4 diagnostic tests for surgical success

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

06

What researchers measure

Primary outcomes

  1. McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results

    McNemar test for comparing sensitivity and specificity between two factors

    Time frame: 58-60 weeks

Secondary outcomes

  1. McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results

    McNemar test for comparing sensitivity and specificity between two factors

    Time frame: 2-4 weeks

  2. McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results

    McNemar test for comparing sensitivity and specificity between two factors

    Time frame: 6-8 weeks

  3. Positive Bonney maneuver

    yes/no

    Time frame: 2-4 weeks

  4. Positive Bonney maneuver

    yes/no

    Time frame: 6-8 weeks

  5. Positive TVT maneuver

    yes/no

    Time frame: 2-4 weeks

  6. Positive TVT maneuver

    yes/no

    Time frame: 6-8 weeks

  7. McNemar Score: Clip strip test versus Bonney maneuvre

    Comparison of the prognostic capacities of the clip strip and Bonney maneuver tests. McNemar test for comparing sensitivity and specificity between two factors

    Time frame: 58-60 weeks

  8. McNemar Score: Clip strip test TVT Bonney maneuvre

    Comparison of the prognostic capacities of the clip strip and TVT maneuver tests. McNemar test for comparing sensitivity and specificity between two factors

    Time frame: 58-60 weeks

  9. Intra-urethral pressure during the Bonney maneuver

    mm Hg

    Time frame: 2-4 weeks

  10. Intra-urethral pressure during the Bonney maneuver

    mm Hg

    Time frame: 6-8 weeks

  11. Intra-urethral pressure during the TVT maneuver

    mm Hg

    Time frame: 6-8 weeks

  12. Intra-urethral pressure during the TVT maneuver

    mm Hg

    Time frame: 2-4 weeks

  13. Intra-urethral pressure during the clip strip test

    mm Hg

    Time frame: 2-4 weeks

  14. Intra-urethral pressure during the clip strip test

    mm Hg

    Time frame: 6-8 weeks

  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

    Bonney maneuver, q-tip test, tvt maneuver and clip strip test

    Time frame: 2-4 weeks

  23. Intra- and inter operator reproducability for 4 diagnostic tests

    Bonney maneuver, q-tip test, tvt maneuver and clip strip test

    Time frame: 6-8 weeks

  24. Angle associated with Q-tip test

    Time frame: 2-4 weeks

  25. Angle associated with Q-tip test

    Time frame: 6-8 weeks

07

Study locations

2 sites
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes Cedex 09, Gard 30029, France
  • CH de Dignes les Bains
    Digne-les-Bains, 04000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01563653
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Mar 27, 2012
Start date
Feb 20, 2014
Primary completion
Feb 23, 2017
Completion
Feb 23, 2017
Last update
Jun 19, 2017

Study contacts

Renaud de Tayrac, MD PhD
principal investigator · Centre Hospitalier Universitaire de Nîmes

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Incontinence→

Other studies from this sponsor

Centre Hospitalier Universitaire de Nīmes

Start the discussion