NCT07276295 Synthetic Versus Autologous Sling For Stress Incontinence
| NCT ID | NCT07276295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2032-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 232 participants in total. It began in 2026-01-12 with a primary completion date of 2032-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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
Frequently Asked Questions
Who can join the NCT07276295 clinical trial?
This trial is open to female participants only, aged 60 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07276295 currently recruiting?
Yes, NCT07276295 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of British Columbia to inquire about joining.
Where is the NCT07276295 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT07276295 clinical trial?
NCT07276295 is sponsored by University of British Columbia. The trial plans to enroll 232 participants.