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Compares treatment options for Urinary Incontinence
Official title Synthetic Versus Autologous Sling For Stress Incontinence
ClinicalTrials.gov ID: NCT07276295
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, women only
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.