Urinary Stress Incontinence
Conditions
Keywords
Tension-Free Vaginal Tape, Suburethral Slings, Midurethral Slings, Mid-urethral sling, urinary retention
Brief summary
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.
Interventions
Sponsors
Boston Scientific Corporation
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal Bladder Function | 1 year post operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of discharge from hospital with on-going need for catheterization | 12 months | — |
| Duration of catheterization after surgery | 12 months | — |
| Questionnaire scores | 12 months | standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire) |
| Pad test | 12 month | Standardized 1 hour pad test values |
| Uroflow parameters | 12 months | Maximum urine flow rate, post void residual |
Countries
Canada
Outcome results
None listed