What this Trial Is About

This trial studies women with symptomatic anterior and apical pelvic organ prolapse who have hiatal ballooning or levator ani injury and are candidates for vaginal surgery. It is a randomized pilot study comparing three surgical methods to repair prolapse and improve pelvic function. The research also evaluates the impact on symptoms and quality of life using validated questionnaires and ultrasound imaging. Participants will be randomly assigned to one of three groups: vaginal hysterectomy with anterior colporrhaphy; vaginal hysterectomy followed by placement of a human acellular dermal matrix (hADM) for anterior reinforcement plus sacrospinous fixation using the Anchorsure4 device; or vaginal hysterectomy with sacrospinous fixation using the Anchorsure4 device alone. These surgical procedures are tested to compare their effectiveness in prolapse repair. Women will be followed at 4 weeks, 6 months, 12 months, and then annually for up to 36 months to monitor anatomical recurrence of prolapse and any complications. Follow-up includes 3D/4D transperineal ultrasound to assess pelvic floor anatomy and function, as well as validated questionnaires to evaluate prolapse symptoms, sexual function, and quality of life. The study is single-blinded to ensure unbiased evaluation of outcomes.

Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment