GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

NCT04829058 | Recruiting FDA Device

• 1 other identifier: ESC_2020_02
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 3

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

Keywords

GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh; POP

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Post-surgery through study completion, approximately 7yrs

• Pelvic Floor Distress Inventory (PFDI-20) Questionnaire

  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)

  Post-surgery through study completion, approximately 7yrs

Interventions

Intervention DEVICE

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.

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female subjects ≥ 21 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (3)

Institute for Female Pelvic Medicine

North Wales, Pennsylvania, 19454, United States

RECRUITING

UMPC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Universitatsklinikum Tubingen

Tübingen, Germany

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Methods

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Martin Weisberg, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Central Study Contacts

Christine Romanowski

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 2, 2021
• Study Start: November 24, 2021
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): March 31, 2032
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); US (2)