Back to resultsDevelopment and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence (IEUF)
Primary Purpose
Urinary Incontinence, Stress
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
4 diagnostic tests for surgical success
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Incontinence, Stress focused on measuring predicting surgical success, simple diagnostic test device
Eligibility 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
Sites / Locations
- CHU de Nîmes - Hôpital Universitaire Carémeau
- CH de Dignes les Bains
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Positive Bonney maneuver
yes/no
Positive Bonney maneuver
yes/no
Positive TVT maneuver
yes/no
Positive TVT maneuver
yes/no
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
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
Intra-urethral pressure during the Bonney maneuver
mm Hg
Intra-urethral pressure during the Bonney maneuver
mm Hg
Intra-urethral pressure during the TVT maneuver
mm Hg
Intra-urethral pressure during the TVT maneuver
mm Hg
Intra-urethral pressure during the clip strip test
mm Hg
Intra-urethral pressure during the clip strip test
mm Hg
UDI-6 questionnaire
UDI-6 questionnaire
UDI-6 questionnaire
IIQ7 questionnaire
IIQ7 questionnaire
IIQ7 questionnaire
PGI-I Questionnaire
Intra- and inter operator reproducability for 4 diagnostic tests
Bonney maneuver, q-tip test, tvt maneuver and clip strip test
Intra- and inter operator reproducability for 4 diagnostic tests
Bonney maneuver, q-tip test, tvt maneuver and clip strip test
Angle associated with Q-tip test
Angle associated with Q-tip test
Full Information
NCT ID
NCT01563653
First Posted
March 16, 2012
Last Updated
June 16, 2017
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01563653
Brief Title
Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
Acronym
IEUF
Official Title
Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Not enough inclusions.
Study Start Date
February 20, 2014 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
predicting surgical success, simple diagnostic test device
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Women with stress urinary incontinence schelduled for TVT or TOT procedures. See inclusion/exclusion criteria.
Intervention Type
Procedure
Intervention Name(s)
4 diagnostic tests for surgical success
Intervention Description
Q-tip test, Bonney maneuver, TVT maneuver, clip strip test
Primary Outcome Measure Information:
Title
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
Description
McNemar test for comparing sensitivity and specificity between two factors
Time Frame
58-60 weeks
Secondary Outcome Measure Information:
Title
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
Description
McNemar test for comparing sensitivity and specificity between two factors
Time Frame
2-4 weeks
Title
McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results
Description
McNemar test for comparing sensitivity and specificity between two factors
Time Frame
6-8 weeks
Title
Positive Bonney maneuver
Description
yes/no
Time Frame
2-4 weeks
Title
Positive Bonney maneuver
Description
yes/no
Time Frame
6-8 weeks
Title
Positive TVT maneuver
Description
yes/no
Time Frame
2-4 weeks
Title
Positive TVT maneuver
Description
yes/no
Time Frame
6-8 weeks
Title
McNemar Score: Clip strip test versus Bonney maneuvre
Description
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
Title
McNemar Score: Clip strip test TVT Bonney maneuvre
Description
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
Title
Intra-urethral pressure during the Bonney maneuver
Description
mm Hg
Time Frame
2-4 weeks
Title
Intra-urethral pressure during the Bonney maneuver
Description
mm Hg
Time Frame
6-8 weeks
Title
Intra-urethral pressure during the TVT maneuver
Description
mm Hg
Time Frame
6-8 weeks
Title
Intra-urethral pressure during the TVT maneuver
Description
mm Hg
Time Frame
2-4 weeks
Title
Intra-urethral pressure during the clip strip test
Description
mm Hg
Time Frame
2-4 weeks
Title
Intra-urethral pressure during the clip strip test
Description
mm Hg
Time Frame
6-8 weeks
Title
UDI-6 questionnaire
Time Frame
2-4 weeks
Title
UDI-6 questionnaire
Time Frame
12-14 weeks
Title
UDI-6 questionnaire
Time Frame
58-60 weeks
Title
IIQ7 questionnaire
Time Frame
2-4 weeks
Title
IIQ7 questionnaire
Time Frame
12-14 weeks
Title
IIQ7 questionnaire
Time Frame
58-60 weeks
Title
PGI-I Questionnaire
Time Frame
58-60 weeks
Title
Intra- and inter operator reproducability for 4 diagnostic tests
Description
Bonney maneuver, q-tip test, tvt maneuver and clip strip test
Time Frame
2-4 weeks
Title
Intra- and inter operator reproducability for 4 diagnostic tests
Description
Bonney maneuver, q-tip test, tvt maneuver and clip strip test
Time Frame
6-8 weeks
Title
Angle associated with Q-tip test
Time Frame
2-4 weeks
Title
Angle associated with Q-tip test
Time Frame
6-8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud de Tayrac, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
CH de Dignes les Bains
City
Digne-les-Bains
ZIP/Postal Code
04000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence
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