Recruiting

GYNEMESH PS Mesh

Sponsor:

Ethicon, Inc.

Code:

NCT04829058

Conditions

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Intervention

Study Details

Brief 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.

Conditions

Pelvic Organ Prolapse

Study ID

NCT04829058

Start date

Nov 24, 2021

Status verified date

Jul, 2026

Completion date

Mar 31, 2032

Anticipated

Primary completion date

Sep 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:

1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.
3. Able and willing to participate in follow-up
4. Subject or authorized representative has signed the approved informed consent

Exclusion Criteria

Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:

1. Subjects < 21 years of age at the time of informed consent
2. Subjects who had transvaginal approach for surgery
3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Intervention

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.

Primary outcome measure

  • Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange [ Time Frame: Post-surgery through study completion, approximately 7 yrs ]

Central Contacts and Locations

Central contacts

Christine Romanowski

908-808-6219cromanow@its.jnj.com

Locations

Institute for Female Pelvic Medicine

Recruiting

North Wales, Pennsylvania, United States, 19454

UMPC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Ethicon, Inc.

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
  • POP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ethicon, Inc. on 2026-07-06.