Mid-Urethral Sling Tensioning Trial

Study Overview
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Brief Summary
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Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.

Official Title
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Mid-Urethral Sling Tensioning Trial

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Device: Retropubic Midurethral Sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Women who have elected for surgical management of symptomatic urinary incontinence Ability to read & write in English Other prolapse surgery at time of sling placement is allowed Must consent to participation in trial Exclusion Criteria: Women with a prior incontinence procedure Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence) Declines participation in trial Women with existing urinary retention or significant overactive bladder (requiring medication)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Babcock tensioning technique<br>Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp. | Device: Retropubic Midurethral Sling<br> <br> * Other names: Tension free Vaginal Tape;|
| Active Comparator: Scissor spacer technique<br>Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer. | Device: Retropubic Midurethral Sling<br> <br> * Other names: Tension free Vaginal Tape;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal Bladder Function | Abnormal post-operative bladder function a composite outcome assessed at 12 months after surgery. It is one or more of the following: 1) significantly bothersome stress incontinence or over active bladder symptoms after surgery as measured by questions 1, 2, 3 of the Urogential Distress Inventory (UDI-6) 2) a positive cough stress test in the office, 3) re-treatment for stress urinary incontinence (repeat surgery or pessary use), 4) post-operative urinary retention (presence of self-catheterization at 6 weeks post-operatively or beyond, or therapeutic intervention for retention at any time during the 12 months after, such as pelvic floor physiotherapy, sling lysis, urethrolysis, or sacral nerve stimulation. | 1 year post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of discharge from hospital with on-going need for catheterization |  | 12 months | 
| Duration of catheterization after surgery |  | 12 months | 
| Questionnaire scores | standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire) | 12 months | 
| Pad test | Standardized 1 hour pad test values | 12 month | 
| Uroflow parameters | Maximum urine flow rate, post void residual | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tension-Free Vaginal Tape, Suburethral Slings, Midurethral Slings, Mid-urethral sling, urinary retention