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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 232 (estimated) |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Kelowna, British Columbia and 6 other locations) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | June 2032 |
| Study ends | December 2032 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07276295 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
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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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.