Pelvic Organ ProlapseNCT04829058
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
An observational study of Pelvic Organ Prolapse, run by Ethicon, Inc. at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Nov 2021to 24 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female subjects ≥ 21 years of age: * with a baseline diagnosis of apical vaginal or uterine prolapse; * who had laparotomic or laparoscopic sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse within 7 years of enrolment; * where GYNEMESH PS Mesh was used as a bridging material, and; * who are willing and able to participate in prospective follow-up.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, 19454
UMPC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Intervention
- Keywords
- GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh, POP
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-surgery through study completion, approximately 7 yrs
Secondary outcomes (3)
Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire
Measured: Post-surgery through study completion, approximately 7yrs
Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
Measured: 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)
Measured: Post-surgery through study completion, approximately 7yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start24 Nov 2021
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Why it stopped: Change in business strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Weisberg, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829058
- Sponsor's protocol ID
- ESC_2020_02
- Status last verified
- Sep 2026
- First submitted
- 19 Mar 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
- ClinicalTrials.gov ID
- NCT04829058
- Acronym / sponsor ID
- ESC_2020_02
- Conditions
- Pelvic Organ Prolapse
- Keywords
- GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh, POP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in business strategy
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects ≥ 21 years of age: * with a baseline diagnosis of apical vaginal or uterine prolapse; * who had laparotomic or laparoscopic sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse within 7 years of enrolment; * where GYNEMESH PS Mesh was used as a bridging material, and; * who are willing and able to participate in prospective follow-up.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThere 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. | Device | – |
Primary outcome
Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange
Time frame: Post-surgery through study completion, approximately 7 yrs
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.
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Change in business strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Pelvic Organ Prolapse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Weisberg, MD study director
Ethicon, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Ethicon, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in business strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange (time frame: Post-surgery through study completion, approximately 7 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.