Synthetic Versus Autologous Sling For Stress Incontinence

University of British Columbia232 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

232

Conditions

Urinary Incontinence

Interventions

autologous fascia slingPROCEDURE

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

tension-free vaginal tapePROCEDURE

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

Eligibility

Sex: FEMALEMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

RECRUITING

Outcomes

Primary Outcomes

Objective urinary incontinence status measured by standing cough test

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

Time frame: 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

Time frame: 6 months post-op

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.