Synthetic Versus Autologous Sling For Stress Incontinence (SASSI)

University of British Columbia

Status

Enrolling

Conditions

Urinary Incontinence

Treatments

Procedure: tension-free vaginal tape

Procedure: autologous fascia sling

Study type

Interventional

Funder types

Other

Identifiers

NCT07276295

H25-02899

Details and patient eligibility

About

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.

Enrollment

232 estimated patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

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