Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial

What this Trial Is About

This research aims to compare the effectiveness of three different surgical procedures in treating women with symptomatic anterior and apical pelvic organ prolapse who are candidates for vaginal surgery. The study focuses on patients with hiatal ballooning or levator ani injury and evaluates outcomes over a 36-month period. It is a randomized, phase 2 trial with a single-blinded design where the evaluating physician is unaware of the surgery assigned to the patient. Participants are randomly assigned to one of three groups: one undergoes classic vaginal hysterectomy with anterior colporrhaphy; another receives vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors for anterior reinforcement and sacrospinous fixation with the Anchorsure® device; the third group receives vaginal hysterectomy followed by sacrospinous fixation with the Anchorsure® device alone. Follow-up visits are scheduled at 4 weeks, 6 months, 12 months, and annually up to 36 months. During the study, patients undergo anatomical assessments using the Pelvic Organ Prolapse Quantification System and 3D/4D transperineal ultrasound to measure prolapse severity. Validated questionnaires assess symptoms, sexual function, and quality of life before surgery and at follow-up visits. Researchers monitor relapse rates, complications, hospital stay, operative time, and reintervention rates, with blinded evaluation of anatomical and functional outcomes throughout the 36-month follow-up period.

Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment