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Mid-Urethral Sling Tensioning Trial (MUST)

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ClinicalTrials.gov Identifier: NCT02480231
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Erin Brennand, 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.

Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Device: Retropubic Midurethral Sling Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : April 2019
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Tension free Vaginal Tape




Primary Outcome Measures :
  1. Abnormal Bladder Function [ Time Frame: 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 [ Time Frame: 12 months ]
  2. Duration of catheterization after surgery [ Time Frame: 12 months ]
  3. Questionnaire scores [ Time Frame: 12 months ]
    standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire)

  4. Pad test [ Time Frame: 12 month ]
    Standardized 1 hour pad test values

  5. Uroflow parameters [ Time Frame: 12 months ]
    Maximum urine flow rate, post void residual



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480231


Locations
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Canada, Alberta
Foothills Hospital, University of Calgary
Calgary, Alberta, Canada, T2N 4J8
Sponsors and Collaborators
University of Calgary
Boston Scientific Corporation
Investigators
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Principal Investigator: Erin A Brennand, MD University of Calgary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erin Brennand, Dr., University of Calgary
ClinicalTrials.gov Identifier: NCT02480231    
Other Study ID Numbers: REB15-0455
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Erin Brennand, University of Calgary:
Tension-Free Vaginal Tape
Suburethral Slings
Midurethral Slings
Mid-urethral sling
urinary retention
Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations