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โ† Trials
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Synthetic Versus Autologous Sling For Stress Incontinence

RecruitingNAAges 18 Years - anyFemaleUniversity of British Columbia
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult females at birth (female anatomy, any gender) * Aged 18 years or older (19 years or older for BC participants) * 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
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What it tests

  • autologous fascia sling
  • tension-free vaginal tape
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Where

7 sites
Kelowna General Hospital
Kelowna, Canada
St. Paul's Hospital
Vancouver, Canada
Vancouver General Hospital; UBC Hospital
Vancouver, Canada
Victoria General Hospital
Victoria, Canada
Kingston Health Sciences Centre
Kingston, Canada
The Ottawa Hospital
Ottawa, Canada
St. Paul's Hospital; Saskatoon City Hospital
Saskatoon, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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