Actively Recruiting

Phase Not Applicable
Age: 60Years +
FEMALE
NCT07276295

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

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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

Age: 60Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

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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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