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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
318
Foothills Hospital, University of Calgary
Calgary, Alberta, Canada
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.
Time frame: 1 year post operative
Rate of discharge from hospital with on-going need for catheterization
Time frame: 12 months
Duration of catheterization after surgery
Time frame: 12 months
Questionnaire scores
standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire)
Time frame: 12 months
Pad test
Standardized 1 hour pad test values
Time frame: 12 month
Uroflow parameters
Maximum urine flow rate, post void residual
Time frame: 12 months
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