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Synthetic Versus Autologous Sling For Stress Incontinence

Synthetic Versus Autologous Sling For Stress Incontinence

Recruiting
60 years and older
Female
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Adult females at birth (female anatomy, any gender)
  • Greater than or equal to 60 years old
  • 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

Study details
    Urinary Incontinence

NCT07276295

University of British Columbia

1 February 2026

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