Comparing Vaginal Patch Plastron and Anterior Colporraphy for Pelvic Organ Prolapse Repair in Women Over 50

What this Trial Is About

Researchers are evaluating treatments for pelvic organ prolapse, a condition affecting many women over 50, causing loss of pelvic support and impacting quality of life. The study compares two surgical approaches for repairing cystocele, a common type of prolapse, focusing on combined anatomic and functional success one year after surgery. This comparison addresses concerns about complications related to mesh and aims to identify effective native tissue repair methods. The study compares anterior colporraphy, which involves retensioning the bladders median support with colpectomy, to the vaginal patch plastron, which uses a vaginal strip attached to the bladder and suspended to the pelvic fascia. Surgeries will be standardized among surgeons. Patients will be randomly assigned to one of these procedures and will not know which surgery they received. Follow-up includes a visit 45 days after surgery for complication assessment, phone calls at 4 and 8 months, and a 1-year visit by an independent assessor. Participants will have evaluations including anatomic and functional success of the surgery, monitored complications, and sexual function assessments. Follow-up visits and phone calls will track recovery and outcomes up to three years. The main measure is the rate of prolapse surgery success at one year. Safety and complications will also be reviewed shortly after surgery, ensuring comprehensive monitoring throughout the study period.

Vaginal Native Tissues Repair for Pelvic Organ Prolapse