GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Purpose
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
Condition
- Pelvic Organ Prolapse
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse 2. GYNEMESH PS Mesh was used as a bridging material according to the IFU. 3. Able and willing to participate in follow-up 4. Subject or authorized representative has signed the approved informed consent
Exclusion Criteria
Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 1. Subjects < 21 years of age at the time of informed consent 2. Subjects who had transvaginal approach for surgery 3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
North Wales, Pennsylvania 19454
Pittsburgh, Pennsylvania 15213
More Details
- Status
- Recruiting
- Sponsor
- Ethicon, Inc.