GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829058
• Other study ID #: ESC_2020_02
• Status: Recruiting
• Start date: November 24, 2021
• Est. completion date: March 31, 2032

Study information

• Verified date: June 2024
• Source: Ethicon, Inc.
• Contact: Christine Romanowski
• Phone: 908-808-6219
• Email: cromanow[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2032
• Est. primary completion date: September 30, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Intervention
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.

Locations

Country	Name	City	State
Germany	Universitatsklinikum Tubingen	Tubingen
United States	Institute for Female Pelvic Medicine	North Wales	Pennsylvania
United States	UMPC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire		Post-surgery through study completion, approximately 7yrs
Secondary	Pelvic Floor Distress Inventory (PFDI-20) Questionnaire		Post-surgery through study completion, approximately 7yrs
Secondary	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