Mid-Urethral Sling Tensioning Trial

Not Applicable

Completed

• Conditions: Urinary Stress Incontinence
• Interventions: Device: Retropubic Midurethral Sling

• Registration Number: NCT02480231
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Study Start: 2015-09
• Primary Completion: 2019-04
• Status Verified: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 318

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Babcock tensioning technique	Retropubic Midurethral Sling	Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp.
Scissor spacer technique	Retropubic Midurethral Sling	Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration of catheterization after surgery	12 months
Rate of discharge from hospital with on-going need for catheterization	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

Trial Locations

Locations (1)

Foothills Hospital, University of Calgary; 🇨🇦 Calgary, Alberta, Canada