Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT07276295
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Study:
NCT07276295
Study Brief:
Protocol Section:
NCT07276295