Urinary Incontinence Clinical Trials

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Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
St. Paul's Hospital
RECRUITING
Vancouver
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2032-12
Participants
Target number of participants: 232
Treatments
Active_comparator: tension-free vaginal tape
Active_comparator: autologous fascia sling
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov