Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07276295

Synthetic Versus Autologous Sling For Stress Incontinence

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location status: Recruiting

Location contact

Judy Fan

CONTACT

[email protected]

6048069829

Roxana Geoffrion, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous fascia sling

Procedure

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

tension-free vaginal tape

Procedure

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

Primary outcomes

  1. Objective urinary incontinence status measured by standing cough test

    Time frame: 5 years post-op

    Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no

  2. Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: SASSI

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Dec 11, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.