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

Ethicon, Inc.4 sites in 2 countries100 target enrollmentNovember 24, 2021

ConditionsPelvic Organ Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Ethicon, Inc.
Enrollment: 100
Locations: 4
Primary Endpoint: Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange
Status: Recruiting
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 24, 2021

End Date

March 31, 2032

Last Updated

19 days ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Ethicon, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange

Time Frame: 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 Outcomes

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)