Clinical trial Recruiting at 7 sites Interventional Ages 18 and up Women only

Synthetic mesh versus own-tissue sling for stress urinary incontinence in older women

Official title: Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial

Run by University of British Columbia · NCT07276295 · Data updated 2026-11-12

This will test whether a synthetic mid-urethral mesh sling or an autologous fascia (own-tissue) sling works better for women aged 60 and older with stress-predominant urinary incontinence.

More Urinary Incontinence trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment232 (estimated)
SponsorUniversity of British Columbia
Academic / other
Drugs / interventionsradiation
Locations7 sites (Kelowna, British Columbia and 6 other locations)
StatusRecruiting
StartedJanuary 12, 2026
Main results expectedJune 2032
Study endsDecember 2032
Registry record updatedOctober 14, 2026
Trial IDNCT07276295 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 60 or older with stress-predominant urinary incontinence who have completed childbearing, tried conservative treatments, and are eligible for either tension-free vaginal tape or an autologous fascia sling are ideal candidates.

Probably not a fit

Patients with significant frailty (Clinical Frailty Score ≥6), neurogenic bladder, prior pelvic radiation or prior UI surgery, chronic pelvic pain, ongoing immunosuppression, or those unable to attend follow-up are unlikely to benefit or are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will compare two surgical options — tension-free vaginal tape (synthetic mid-urethral mesh) and autologous fascia sling (own-tissue sling) — in women aged 60 and above with stress-predominant urinary incontinence. Participants eligible for both procedures who have exhausted conservative treatments will be randomly assigned to one procedure and followed with clinic visits for up to five years. Primary outcomes include new-onset pelvic pain at six months and objective cure of incontinence at five years, with secondary outcomes addressing opioid use, mental and sexual health, and other postoperative measures. The trial is led by the University of British Columbia with enrollment at St. Paul’s Hospital and collaborating Canadian centers.

Why it matters

Potential benefit: If successful, the trial could show which sling gives better long-term continence and lower rates of new pelvic pain in older women, helping surgeons choose the safer, more effective option.

How similar studies have gone: Synthetic mid-urethral slings have shown good short-term cure rates in many prior studies and autologous slings have durable historic results, but randomized comparisons focused specifically on older patients are limited.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Kelowna General Hospital
    Kelowna, British Columbia, Canada
    Recruiting
  • St. Paul's Hospital
    Vancouver, British Columbia, Canada
    Recruiting
  • Vancouver General Hospital; UBC Hospital
    Vancouver, British Columbia, Canada
    Recruiting
  • Victoria General Hospital
    Victoria, British Columbia, Canada
    Recruiting
  • Kingston Health Sciences Centre
    Kingston, Ontario, Canada
    Recruiting
  • The Ottawa Hospital
    Ottawa, Ontario, Canada
    Recruiting
Show 1 more location
  • St. Paul's Hospital; Saskatoon City Hospital
    Saskatoon, Saskatchewan, Canada
    Recruiting

Study contacts

  • Principal investigator: Roxana Geoffrion — University of British Columbia
  • Study coordinator: Judy Fan
  • Email: judy.fan@phc.ca
  • Phone: 604-806-9829

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.