Urinary Incontinence, Stress
Conditions
Keywords
predicting surgical success, simple diagnostic test device
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.
Interventions
PROCEDURE4 diagnostic tests for surgical success
Q-tip test, Bonney maneuver, TVT maneuver, clip strip test
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results | 58-60 weeks | McNemar test for comparing sensitivity and specificity between two factors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Bonney maneuver | 2-4 weeks | yes/no |
| Positive TVT maneuver | 2-4 weeks | yes/no |
| McNemar Score: Clip strip test versus Bonney maneuvre | 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 |
| McNemar Score: Clip strip test TVT Bonney maneuvre | 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 |
| Intra-urethral pressure during the Bonney maneuver | 2-4 weeks | mm Hg |
| Intra-urethral pressure during the TVT maneuver | 6-8 weeks | mm Hg |
| McNemar Score: Comparison of Q-tip test and clip strip test results with surgical results | 2-4 weeks | McNemar test for comparing sensitivity and specificity between two factors |
| UDI-6 questionnaire | 2-4 weeks | — |
| IIQ7 questionnaire | 2-4 weeks | — |
| PGI-I Questionnaire | 58-60 weeks | — |
| Intra- and inter operator reproducability for 4 diagnostic tests | 2-4 weeks | Bonney maneuver, q-tip test, tvt maneuver and clip strip test |
| Angle associated with Q-tip test | 2-4 weeks | — |
| Intra-urethral pressure during the clip strip test | 2-4 weeks | mm Hg |
Countries
France
Outcome results
None listed