Synthetic Versus Autologous Sling For Stress Incontinence

NCT07276295 | Recruiting DMC

• 1 other identifier: H25-02899
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Objective urinary incontinence status measured by standing cough test

  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

  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

Study Arms (2)

tension-free vaginal tape

ACTIVE COMPARATOR

Procedure: tension-free vaginal tape

autologous fascia sling

ACTIVE COMPARATOR

Procedure: autologous fascia sling

Interventions

autologous fascia sling PROCEDURE

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

autologous fascia sling

tension-free vaginal tape PROCEDURE

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

tension-free vaginal tape

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 11, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

CA (1)