Synthetic Versus Autologous Sling For Stress Incontinence (SASSI)

January 14, 2026 updated by: Roxana Geoffrion, University of British Columbia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital
        • Contact:
        • Principal Investigator:
          • Roxana Geoffrion, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tension-free vaginal tape
Procedure: tension-free vaginal tape
Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.
Active Comparator: autologous fascia sling
Procedure: autologous fascia sling
Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years post-op
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
6 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Estimated)

December 11, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H25-02899

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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