GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04829058
Collaborator
(none)
100
Enrollment
3
Locations
96.2
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 DiseaseIntervention/TreatmentPhase
  • 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 :
May 31, 2029
Anticipated Study Completion Date :
Nov 30, 2029

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire [Post-surgery through study completion, approximately 7yrs]

  2. Pelvic Floor Distress Inventory (PFDI-20) Questionnaire [Post-surgery through study completion, approximately 7yrs]

  3. 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:
No
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Institute for Female Pelvic MedicineNorth WalesPennsylvaniaUnited States19454
2UMPCPittsburghPennsylvaniaUnited States15213
3Universitatsklinikum TubingenTubingenGermany

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:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ethicon, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022