Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence
• Intervention / Treatment: Device: Intervention

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Christine Romanowski; Phone Number: 908-808-6219; Email: cromanow@its.jnj.com

Study Locations

• Austria
  • Linz, Austria
    • Recruiting
    • Krankenhaus der barmherzigen Schwestern
• Denmark
  • Hillerød, Denmark
    • Not yet recruiting
    • Herlev Hospital
• France
  • Lille, France
    • Not yet recruiting
    • Hopital Jeanne de Flandres
• Germany
  • Tübingen, Germany
    • Active, not recruiting
    • Universitatsklinikum Tubingen
• Italy
  • Rome, Italy
    • Recruiting
    • Bio-Medical University Rome
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Institute
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Recruiting
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female patients ≥ 21 years of age with:

• A diagnosis of SUI, resulting from urethral hypermobility and/or intrinsic sphincter deficiency AND/OR
• A diagnosis of vaginal vault or uterine prolapses where surgical treatment (sacrocolposuspension or sacrocolpopexy, laparotomic or laparoscopic approach including robotic assisted) is warranted AND
• Are scheduled to have surgical treatment using an Ethicon Gynecare Pelvic Mesh Product

Description

Inclusion Criteria:

Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:

SUI

1. Stress urinary incontinence symptoms
2. Urodynamic stress incontinence confirmed with urodynamic testing
3. Female patient ≥ 21 years of age
4. Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
5. Planned surgery for primary SUI
6. Patient able and willing to participate in follow-up
7. Patient or authorized representative has signed the approved Informed consent POP

1. Uterine or vaginal vault prolapse symptoms 2. Urodynamic testing (optional) 3. Female patient ≥ 21 years of age 4. Desired surgical correction of POP using synthetic mesh 5. Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent

Exclusion Criteria

Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry:

1. Physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
3. History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
4. Pregnancy or plans for future pregnancy
5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice
6. Current genitourinary fistula or urethral diverticulum
7. Reversible cause of incontinence (i.e. drug effect) for SUI only
8. Severe vaginal atrophy
9. History of pelvic irradiation therapy
10. Contraindication to surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change	Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST)	Post-surgery through registry completion, approximately 5-10 yrs
Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change	Objective cure (success) approximately 5-10 years after surgery, defined as the absence of prolapse beyond the hymen as determined by a physical examination with POP-Q	Post-surgery through registry completion, approximately 5-10 yrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)		Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)		Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Patient Global Impression of Improvement questionnaire (PGI-I)		Post-surgery through registry completion, approximately 10 yrs
SUI: Wong-Baker FACES Pain Rating Scale	To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure	Post-surgery through registry completion, approximately 10 yrs
POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire		Baseline and post-surgery through registry completion, approximately 10 yrs
POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)		Baseline and post-surgery through registry completion, approximately 10 yrs
POP: Patient Global Impression of Improvement questionnaire (PGI-I)		Post-surgery through registry completion, approximately 10 yrs
POP: Wong-Baker FACES Pain Rating Scale	To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure (if applicable)	Post-surgery through registry completion, approximately 10 yrs

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Study Director: Martin Weisberg, MD, Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Estimated): March 31, 2033
• Study Completion (Estimated): March 31, 2038

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; Stress Urinary Incontinence; POP; SUI
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Prolapse; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress; Pelvic Organ Prolapse; Investigative Techniques; Methods
• Other Study ID Numbers: ESC_2020_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

• 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