GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Recruiting now

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT04829058

Run by

Ethicon, Inc.

People needed

100

Starts

2021-11-24

Expected to finish

2032-03-31

Last updated by the study team

2026-07-06

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
• Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
• GYNEMESH PS Mesh was used as a bridging material according to the IFU.
• Able and willing to participate in follow-up
• Subject or authorized representative has signed the approved informed consent

You may not qualify if…

• Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
• Subjects < 21 years of age at the time of informed consent
• Subjects who had transvaginal approach for surgery
• Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Where it is running

• Institute for Female Pelvic Medicine — North Wales, Pennsylvania, United States (enrolling)
• UMPC — Pittsburgh, Pennsylvania, United States (enrolling)
• Universitatsklinikum Tubingen — Tübingen, Germany (enrolling)

Full record on ClinicalTrials.gov

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