Long-Term Follow-Up of GYNEMESH PS Mesh Use in Surgery for Vaginal or Uterine Prolapse in Women

What this Trial Is About

Researchers are evaluating the long-term outcomes in women who have undergone surgery for vaginal or uterine prolapse using the GYNEMESH PS Mesh. This observational, post-market study involves both retrospective and prospective data from multiple centers to understand the effects and results of this mesh used in surgery. The purpose is to monitor patient outcomes following these surgical procedures. Participants in this study previously received laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted surgery, where the GYNEMESH PS Mesh was used as a bridging material. There is no additional intervention beyond the routine clinical care these women have already received. This study follows patients for up to approximately seven years from surgery to assess the long-term impact. During the study, participants will undergo physical examinations including Pelvic Organ Prolapse Quantification POP-Q to measure anatomical changes after surgery. They will also complete questionnaires such as Patient Global Impression of Improvement or Change, Pelvic Floor Distress Inventory, and Pelvic Organ ProlapseUrinary Incontinence Sexual Questionnaires to assess symptoms and quality of life. These assessments will be conducted from post-surgery through study completion to monitor safety and effectiveness over time.

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study