Synthetic Versus Autologous Sling For Stress Incontinence

Sponsor
University of British Columbia
Study ID
NCT07276295
Status
Recruiting
Apply to this trial

Conditions

  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • autologous fascia sling — PROCEDURE
    Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.
  • tension-free vaginal tape — PROCEDURE
    Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.

Study Details

This is a multi-centre randomized controlled trial comparing mid-urethral synthetic mesh sling or tension-free vaginal tape (TVT) and autologous fascia sling (AFS) in elderly patients with stress predominant urinary incontinence. The investigators aim to investigate new onset pelvic pain 6 months post-op and objective urinary incontinence cure rate 5 years post-op. Secondary objectives include investigation of opioid use, mental health, sexual health, and other post-op outcomes.

Key Dates

First listed
Dec 11, 2025
Start date
Jan 12, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2032
Completion
Dec 31, 2032

Study Design

Enrollment
232 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: tension-free vaginal tape
  • Active Comparator: autologous fascia sling

Primary Outcome Measure

Objective urinary incontinence status measured by standing cough test [ Time Frame: 5 years post-op ]

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