GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Recruiting

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT04829058
• Lead Sponsor: Ethicon, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-11-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2031-09-30
• Study Completion: 2032-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange	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.

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (3)

UMPC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Universitatsklinikum Tubingen; 🇩🇪 Tubingen, Germany

Institute for Female Pelvic Medicine; 🇺🇸 North Wales, Pennsylvania, United States