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Completed

NCT Number: NCT02480231

Mid-Urethral Sling Tensioning Trial

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.

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Key information

Conditions

Urinary Stress Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Hospital, University of Calgary

Calgary, Alberta, T2N 4J8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Retropubic Midurethral Sling

Device

Other names: Tension free Vaginal Tape

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: MUST

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jun 24, 2015
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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