Recruiting

TVT & AFS

Sponsor:

University of British Columbia

Code:

NCT07276295

Conditions

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Not accepted

Interventions

autologous fascia sling

tension-free vaginal tape

Study Details

Brief 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.

Conditions

Urinary Incontinence

Study ID

NCT07276295

Start date

Jan 12, 2026

Status verified date

Dec, 2025

Completion date

Dec, 2032

Anticipated

Primary completion date

Jun, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

232 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: tension-free vaginal tape

active comparator: autologous fascia sling

Interventions

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.

Primary outcome measure

  • Objective urinary incontinence status measured by standing cough test [ Time Frame: 5 years post-op ]
  • Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale [ Time Frame: 6 months post-op ]

Central Contacts and Locations

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Judy Fan

6048069829judy.fan@phc.ca

Principal Investigator:

Roxana Geoffrion, MD

More Information

Sponsor

University of British Columbia

Last update posted

Jan 16, 2026

Last verified

Dec, 2025

Keywords

  • autologous fascia sling
  • stress predominant urinary incontinence
  • tension-free vaginal tape

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-01-16.