GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
ConditionPelvic Organ Prolapse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorEthicon, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Intervention
Treatment groups
No treatment groups listed
Locations
3Germany
Universitatsklinikum Tubingen Tübingen Germany
United States
Institute for Female Pelvic Medicine19454, North WalesPennsylvania, United States
UMPC15213, PittsburghPennsylvania, United States
Sponsors and collaborators
Ethicon, Inc.
Lead sponsor
Source ClinicalTrials.gov