GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Last updated: May 22, 2025
Sponsor: Ethicon, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Prolapse

Treatment

Intervention

Clinical Study ID

NCT04829058
ESC_2020_02
  • Ages > 21
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Intervention
Phase:
Study Start date:
November 24, 2021
Estimated Completion Date:
March 31, 2032

Connect with a study center

  • Universitatsklinikum Tubingen

    Tubingen,
    Germany

    Active - Recruiting

  • Institute for Female Pelvic Medicine

    North Wales, Pennsylvania 19454
    United States

    Active - Recruiting

  • UMPC

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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