Grant: Project Grant

Urinary incontinence (UI) is NOT a "normal part of aging". It is an extremely common and undeniable threat to healthy aging. UI ostracizes aging patients because of embarrassment, isolation and caregiver burden. Aging females in particular feel neglected, with ageism producing lower quality care. In Canada, older women will account for 24% of the female population in 2031. More than one in five females have moderate to severe UI and more than one in ten need surgery. These staggering statistics underscore the importance of refining UI treatments and empowering patients to pursue successful options regardless of age. The two main surgeries are: a synthetic mesh sling (tension free vaginal tape, TVT) and a sling from the patient's connective tissue (autologous fascia sling, AFS). Unfortunately, these two procedures have not been investigated head to head, in a long-term comparison of relevant outcomes. In the current trial, we plan to investigate TVT vs AFS by randomizing UI patients to one or the other surgery, follow-up to 5 years. Our two primary outcomes are: pain at 6 months and UI recurrence at 5 years. We aim to recruit 232 patients, receiving care from collaborating surgeons across Canada. Patients will be examined regularly up to 5 years postoperative for chronic pain, UI cure, and will fill out periodic validated questionnaires for pain, opioid use, mental health, degree of bother, subjective improvement. We will collect complications, reoperations, health utility. We are working with a patient partner for both trial design and a diverse Patient Advisory Group for knowledge dissemination to marginalized populations such as extremes of age, new immigrants, gender-diverse patients. We will partner with our national organization, dedicated to female pelvic floor health, to share findings and maintain functional ability for both physical and mental well-being in all patients. Our trial results will inform patient counselling and UI treatment standardization.