Objectives: This prospective comparative cohort study aims to evaluate the safety and efficacy of transvaginal mesh compared to native tissue repair (NTR) in the surgical correction of anterior and apical compartment pelvic organ prolapse (POP) over a 36-month follow-up period.
Methods: Prospective comparative cohort study to prove superiority for efficacy and non-inferiority for serious adverse events (SAEs). The setting was 49 sites across the United States, Canada, Europe, and Australia.