Synthetic Versus Autologous Sling For Stress Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: autologous fascia sling, tension-free vaginal tape.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial
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.
Interventions
- Procedure autologous fascia sling
Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence. - Procedure tension-free vaginal tape
Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- St. Paul's Hospital — Vancouver
Identifiers
NCT: NCT07276295 · H25-02899