Long-Term Registry Monitoring of Ethicon Gynecare Pelvic Mesh for Surgery Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women

What this Trial Is About

This research aims to evaluate the long-term performance of Ethicon Gynecare pelvic mesh products used in surgical treatment for stress urinary incontinence SUI and pelvic organ prolapse POP in women. The study focuses on women undergoing surgery for these conditions, using either Gynemesh PS Mesh or Artisyn Mesh with laparotomic, laparoscopic, or robotic-assisted approaches. The registry is a post-market clinical follow-up to monitor outcomes over time. Participants have surgery using the TVT family of products or vaginal vault or uterine prolapse repair with synthetic mesh. The surgical procedures follow standard care without additional interventions from the study. The registry tracks women who had planned surgery for primary SUI or uterinevaginal vault prolapse, with or without combined SUI surgery. The follow-up period extends approximately 5 to 10 years post-surgery. During the study, participants will undergo assessments such as the Cough Stress Test and Pelvic Organ Prolapse Quantification to measure changes in symptoms. Questionnaires evaluating urinary incontinence, pelvic floor distress, sexual function, pain, and patient global impressions of improvement will be collected at baseline and during follow-up. The study involves long-term monitoring to understand outcomes related to these mesh products over about 10 years.

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry