Urethral Length and TOT (Transobturator Tape) Positioning

Study Overview
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Brief Summary
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This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.

Detailed Description
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This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.

Official Title
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Prospective, Observational Study: Can Pelvic Floor Ultrasound Help to Optimize TOT (Transobturator Tape) Positioning?

Conditions
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Stress Urinary Incontinence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test. Patient is age 18 or older. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board (IRB)/Ethic commission (EC)-approved informed consent. Patient is able to fill in all questionnaires (on judgement of investigator) Exclusion Criteria: Patient has an associated or suspected neurological disease. Patient has an active lesion or present injury to perineum or urethra. Patient has a urethral obstruction. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment. Patient currently has an urinary tract infection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stress Urinary Incontinence<br>Stress Urinary Incontinence | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | The primary outcome of the TOT procedure will be assessed using a combination of objective and subjective criteria. Patients with a negative stress test, a negative 1-h pad test (less than 2 g) and the degree of subjective suffering improving to over 90% (VAS score of 0-1) at 6 months follow-up evaluation are classified as cured. All other patients are classified as treatment failure even if one aspect shows marked improvement from the preoperative condition. | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethral length | Urethral length will be measured by pelvic floor sonography. | Preoperative | 
| Linear urethral dorsocaudal movement (LUDM) | Linear urethral dorsocaudal movement (LUDM) will be assessed by pelvic floor sonography. | Preoperative | 
| Urethral tape position | The position of the TOT along the urethra will be determined by pelvic floor sonography and expressed as percentage of urethral length. | 1-3 days and 6 months postoperative | 
| Distance between tape and longitudinal smooth muscle (LSM) complex | To characterize the location of the TOT, the shortest distance between the tape and the longitudinal smooth muscle (LSM) complex of the urethra will be measured by pelvic floor sonography. | 1-3 days and 6 months postoperative | 
| Urodynamic testing | Urodynamic testing will be performed only for patients undergoing recurrent incontinence surgery. | Preoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary Incontinence, Transobturator sling, TOT