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. (part of Johnson & Johnson) · 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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's enrollment of 64 is below the median of 134 across 171 observational studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female subjects ≥ 21 years of age:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Data sharing details ↗ · yoda.yale.edu
No publications or documents are linked to this record.
Ran from Nov 2021 to primary completion in Jun 2026, 55 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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