search
Back to results

Mid-Urethral Sling Tensioning Trial (MUST)

Primary Purpose

Urinary Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Retropubic Midurethral Sling
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Tension-Free Vaginal Tape, Suburethral Slings, Midurethral Slings, Mid-urethral sling, urinary retention

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Foothills Hospital, University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Babcock tensioning technique

Scissor spacer technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of discharge from hospital with on-going need for catheterization
Duration of catheterization after surgery
Questionnaire scores
standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire)
Pad test
Standardized 1 hour pad test values
Uroflow parameters
Maximum urine flow rate, post void residual

Full Information

First Posted
June 17, 2015
Last Updated
March 30, 2020
Sponsor
University of Calgary
Collaborators
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02480231
Brief Title
Mid-Urethral Sling Tensioning Trial
Acronym
MUST
Official Title
Mid-Urethral Sling Tensioning Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
Tension-Free Vaginal Tape, Suburethral Slings, Midurethral Slings, Mid-urethral sling, urinary retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Babcock tensioning technique
Arm Type
Active Comparator
Arm Description
Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp.
Arm Title
Scissor spacer technique
Arm Type
Active Comparator
Arm Description
Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer.
Intervention Type
Device
Intervention Name(s)
Retropubic Midurethral Sling
Other Intervention Name(s)
Tension free Vaginal Tape
Primary Outcome Measure Information:
Title
Abnormal Bladder Function
Description
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
Secondary Outcome Measure Information:
Title
Rate of discharge from hospital with on-going need for catheterization
Time Frame
12 months
Title
Duration of catheterization after surgery
Time Frame
12 months
Title
Questionnaire scores
Description
standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire)
Time Frame
12 months
Title
Pad test
Description
Standardized 1 hour pad test values
Time Frame
12 month
Title
Uroflow parameters
Description
Maximum urine flow rate, post void residual
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin A Brennand, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4J8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32769657
Citation
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.
Results Reference
derived

Learn more about this trial

Mid-Urethral Sling Tensioning Trial

We'll reach out to this number within 24 hrs