Actively Recruiting
Synthetic Versus Autologous Sling For Stress Incontinence
Led by University of British Columbia · Updated on 2026-01-16
232
Participants Needed
1
Research Sites
359 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Synthetic Versus Autologous Sling For Stress Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult females at birth (female anatomy, any gender)
- 60 years old or older
- Have stress predominant urinary incontinence eligible for both tension-free vaginal tape and autologous fascia sling surgery
- Exhausted conservative management options for urinary incontinence such as Kegel's exercises, physiotherapy, or pessary
- Completed childbearing
- Able to attend follow-up clinic visits for up to five years after surgery
You will not qualify if you...
- Clinical Frailty Score of 6 or more
- Undergoing concurrent pelvic surgery
- Neurogenic bladder
- Previous urinary incontinence surgery
- Previous pelvic radiation
- Previous mesh exposure
- Pelvic pain lasting more than three months in the last five years
- Unlikely to be able to follow up
- Immunocompromised and 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 restarting smoking after surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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