Urinary Incontinence
Conditions
Keywords
autologous fascia sling, stress predominant urinary incontinence, tension-free vaginal tape
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.
Interventions
PROCEDUREautologous fascia sling
Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.
PROCEDUREtension-free vaginal tape
Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.
Sponsors
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective urinary incontinence status measured by standing cough test | 5 years post-op | Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no |
| Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale | 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 |
Countries
Canada
Outcome results
None listed