Synthetic Versus Autologous Sling For Stress Incontinence

Condition(s) studied

Investigational drug(s) / intervention(s)

autologous fascia sling: Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.

tension-free vaginal tape: Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.

Study 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

Primary outcome measure(s)

• Objective urinary incontinence status measured by standing cough test — 5 years post-op
  Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no
• Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale — 6 months post-op
  Proportion of participants who report new abdominopelvic pain with an average intensity greater than 3 on a 0-10 Likert pain intensity scale over the past 6 months

Trial sites (1)

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