MUST: Mid-Urethral Sling Tensioning Trial

Sponsor
University of Calgary (Other)
Overall Status
Completed
CT.gov ID
NCT02480231
Collaborator
Boston Scientific Corporation (Industry)
318
1
2
54
5.9

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
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Rate of discharge from hospital with on-going need for catheterization [12 months]

    2. Duration of catheterization after surgery [12 months]

    3. Questionnaire scores [12 months]

      standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire)

    4. Pad test [12 month]

      Standardized 1 hour pad test values

    5. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Foothills Hospital, University of Calgary Calgary Alberta Canada T2N 4J8

    Sponsors and Collaborators

    • University of Calgary
    • Boston Scientific Corporation

    Investigators

    • Principal Investigator: Erin A Brennand, MD, University of Calgary

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erin Brennand, Dr., University of Calgary
    ClinicalTrials.gov Identifier:
    NCT02480231
    Other Study ID Numbers:
    • REB15-0455
    First Posted:
    Jun 24, 2015
    Last Update Posted:
    Apr 1, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Erin Brennand, Dr., University of Calgary
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2020