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RECRUITING Not applicable ClinicalTrials.gov

Synthetic Versus Autologous Sling For Stress Incontinence

Sponsor: University of British Columbia • ClinicalTrials.gov ID: NCT07276295

Registry updated: 2026-10-14
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Description

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.

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.

Eligibility criteria

Inclusion Criteria: * Adult females at birth (female anatomy, any gender) * Aged 18 years or older (19 years or older for BC participants) * Have stress predominant urinary incontinence (spUI) eligible for both types of surgery (tension-free vaginal tape and autologous fascia sling) * Exhausted conservative management options for UI (Kegel's exercises, physiotherapy, pessary) * Completed childbearing * Able to follow up with clinic visits for up to five years after surgery Exclusion Criteria: * Clinical Frailty Score of 6 or more, as moderate frailty is likely associated with excessive postoperative deterioration * Concurrent pelvic surgery * Neurogenic bladder * Previous UI surgery * Previous pelvic radiation * Previous mesh exposure * Presence of pelvic pain for more than three months in the last five years * Likely unable to follow up * Immunocompromised individuals receiving immunosuppressive medications for at least 3 months * Chronic systemic steroid use for at least 3 months for autoimmune diseases * Unable to stop smoking for at least 3 months prior to surgery and at high risk of restart smoking post-operatively

Conditions

Urinary Incontinence

Locations

  • Kelowna General Hospital — Kelowna, British Columbia, Canada
  • St. Paul's Hospital — Vancouver, British Columbia, Canada
  • Vancouver General Hospital; UBC Hospital — Vancouver, British Columbia, Canada
  • Victoria General Hospital — Victoria, British Columbia, Canada
  • Kingston Health Sciences Centre — Kingston, Ontario, Canada
  • The Ottawa Hospital — Ottawa, Ontario, Canada
  • St. Paul's Hospital; Saskatoon City Hospital — Saskatoon, Saskatchewan, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record