Synthetic Versus Autologous Sling For Stress Incontinence (NCT07276295) | Clinical Trial Compass
RecruitingNot Applicable
Synthetic Versus Autologous Sling For Stress Incontinence
Canada232 participantsStarted 2026-01-12
Plain-language 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.
Who can participate
Age range
60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective urinary incontinence status measured by standing cough test
Timeframe: 5 years post-op
2
Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale