MUST: Mid-Urethral Sling Tensioning Trial

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT02480231

Collaborator

Boston Scientific Corporation (Industry)

318

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Stress Incontinence	Device: Retropubic Midurethral Sling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

318 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Mid-Urethral Sling Tensioning Trial

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Babcock tensioning technique

Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp.

Device: Retropubic Midurethral Sling

Other Names:

Tension free Vaginal Tape

Active Comparator: Scissor spacer technique

Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer.

Device: Retropubic Midurethral Sling

Other Names:

Tension free Vaginal Tape

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts 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)