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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT04552457
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-85 years
* Urodynamic-proven stress incontinence or stress leakage on physical exam
* Desires surgical management for stress incontinence with a midurethral sling
Exclusion Criteria:
* Prior midurethral sling or urethropexy
* Prior pelvic reconstruction
* Prior pelvic radiation
* Connective tissue disorder
* Severe physical limitation at baseline
* Currently pregnant or desires future childbearing potential
* Concomitant surgeries (except for anterior colporrhaphy for anterior wall prolapse less than 0 on POPQ or other minor procedures).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04552457
Study Brief:
Protocol Section:
NCT04552457