Synthetic Versus Autologous Sling For Stress Incontinence

Recruiting now · Not applicable

Conditions studied: Urinary Incontinence

In brief

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 facts

Study ID

NCT07276295

Run by

University of British Columbia

People needed

232

Starts

2026-01-12

Expected to finish

2032-12-01

Last updated by the study team

2026-01-16

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Paul's Hospital — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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