Synthetic mesh versus own-tissue sling for stress urinary incontinence in older women
Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial
NA · University of British Columbia · NCT07276295
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | University of British Columbia (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT07276295 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vancouver, British Columbia
- St. Paul's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Incontinence, autologous fascia sling, stress predominant urinary incontinence, tension-free vaginal tape