GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Sponsor

Ethicon, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04829058

Collaborator

(none)

100

Enrollment

Locations

112.2

Anticipated Duration (Months)

33.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Device: Intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

Actual Study Start Date :

Nov 24, 2021

Anticipated Primary Completion Date :

Dec 30, 2030

Anticipated Study Completion Date :

Mar 31, 2031

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Female Pelvic Medicine	North Wales	Pennsylvania	United States	19454
2	UMPC	Pittsburgh	Pennsylvania	United States	15213
3	Universitatsklinikum Tubingen	Tubingen		Germany

Sponsors and Collaborators

Ethicon, Inc.

Investigators

Study Director: Giovanni A Tommaselli, MD, Ethicon, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ethicon, Inc.

ClinicalTrials.gov Identifier:

NCT04829058

Other Study ID Numbers:

ESC_2020_02

First Posted:

Apr 2, 2021

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ethicon, Inc.

GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

POP

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Aug 9, 2022