An observational study in Pelvic Organ Prolapse, sponsored by Ethicon, Inc.. Terminated at 3 sites in 2 countries. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Ethicon, Inc. · Observational
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.
Female subjects ≥ 21 years of age:
Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
Exclusion Criteria
Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.
Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange
Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam.
Time frame: Post-surgery through study completion, approximately 7 yrs
Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire
Time frame: Post-surgery through study completion, approximately 7yrs
Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
Time frame: Post-surgery through study completion, approximately 7yrs
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Time frame: Post-surgery through study completion, approximately 7yrs
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ethicon, Inc.