The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the new Reia System (RS), which includes a Reia pessary and applicator, compared to standard pessary care among women with stage II-IV pelvic organ prolapse (POP). The study will recruit 200 women who have not used a pessary before and who choose vaginal pessary management for their POP. Participants will be randomly assigned to either the Reia System group or the standard pessary care group, with the goal of comparing satisfaction and other outcomes over six months. Participants in the Reia System group will be fitted with one of three pessary sizes and will receive an applicator matching their pessary size to assist with home use. Those in the standard pessary care group will be fitted with either a Gellhorn pessary or a ring pessary with or without support, following usual clinical procedures. The study involves a total of four visits over six months, during which pessary fitting, use, and management will be monitored. Throughout the study, participants will complete surveys to measure satisfaction with treatment at six months, quality of life, patient impressions of severity and improvement, and the number of self-management events. Researchers will also assess ease or difficulty of pessary insertion and removal, the importance of self-management ability, and any adverse events. Safety and continued pessary use will be tracked to understand the risks and benefits of each pessary type during the six-month period.

POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment