GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Launched by ETHICON, INC. · Mar 31, 2021

Keywords

ClinConnect Summary

The GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study is looking at the results of surgery for pelvic organ prolapse in women who had a specific type of mesh called GYNEMESH PS used during their procedure. This study is being conducted at multiple centers and will include both women who have already had the surgery and those who are currently being treated. The main goal is to see how well the mesh performs and how it affects recovery and quality of life for these women.

To participate in this study, women must be 21 years or older and have undergone a specific type of surgical procedure for vaginal or uterine prolapse using the GYNEMESH PS Mesh. They should also be willing to take part in follow-up assessments and provide consent. Participants can expect to share their experiences and outcomes after the surgery, helping to improve understanding of this treatment option. The study is currently recruiting eligible participants, so it’s a great opportunity for those who meet the criteria to contribute to important research.

Gender

FEMALE

Eligibility criteria

• 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)