Urethral Length Measurement in Women Undergoing Suburethral Sling Operative Procedure

Study Overview
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Brief Summary
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This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure.

Detailed Description
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This is a prospective, non-randomized, observational, multicenter study in which urethral length is measured in women with surgically-correctable stress urinary incontinence who undergo a suburethral sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. The urethral length will be measured intraoperatively using scaled catheters. Outcome data, including the development of postoperative complications, will be collected at several time intervals.

Official Title
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Prospective, Non-randomized, Observational Study of the Surgical Management of Suburethral Slings in Women With Stress Urinary Incontinence

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/Ethics Committee-approved informed consent form. Patient is able to fill in all questionnaires (based on judgment 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 has current 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 | Patients are classified as 'cured' if the postoperative cough test is negative, the 1-hour pad test is negative (less than 2 g) and the degree of subjective suffering improves to over 90% (VAS score of 0 or 1). All other patients are classified as therapeutic 'failures', even though they may experience marked improvement in one of the parameters compared with their preoperative status. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor sonography |  | Pre-operation, day 1 and 3 months | 
| Residual urine |  | Pre-operation, day 1 and 3 months | 
| Pad test |  | Pre-operation and 3 months | 
| Urethral length measurement | Urethral length will be measured using scaled catheters. | Intra-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary incontinence, Suburethral sling