Mid-Urethral Sling Tensioning Trial (MUST)

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 Overview

• Status: Completed
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: Device: Retropubic Midurethral Sling

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4J8
      • Foothills Hospital, University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Erin A Brennand, MD, University of Calgary

Publications and helpful links

General Publications

• Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: urinary retention; Tension-Free Vaginal Tape; Midurethral Slings; Suburethral Slings; Mid-urethral sling
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: REB15-0455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO