A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.

What this Trial Is About

Researchers are comparing two surgical methods for treating apical compartment pelvic organ prolapse (POP) in women: vaginal mesh surgery and robotic-assisted abdominal mesh surgery. The study aims to determine if vaginal mesh surgery is not less effective than the abdominal approach and to evaluate the safety of vaginal mesh use. This is a prospective, randomized non-inferiority study focusing on women diagnosed with stage II or higher apical prolapse who need surgery. Participants will be randomly assigned to one of two surgical treatments. One group will receive vaginal prolapse repair using the Splentisae mesh, which involves anterior colporrhaphy and mesh anchoring to the sacrospinous ligaments. The other group will undergo robot-assisted laparoscopic abdominal repair using the Upsylonae mesh, which fixes the mesh to the vaginal walls and sacral promontory. The study plans include 43 participants per group, considering possible loss to follow-up. During the study, patients will be evaluated at one month after surgery and then every six months up to two years. Researchers will assess objective cure rates based on prolapse stage and monitor surgical complications. They will also evaluate clinical factors such as mesh erosion, pain, and quality of life using a validated questionnaire adapted for Portuguese speakers. The total follow-up period aims to provide comprehensive data on outcomes and safety.

Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study