Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

NCT04829175 | Recruiting FDA Device

• 1 other identifier: ESC_2020_03
• Study Type: observational
• Target: 1,000
• Locations: 7 countries
• Sites: 10

Brief Summary

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.

Conditions

Stress Urinary Incontinence; Pelvic Organ Prolapse

Keywords

Stress Urinary Incontinence; Pelvic Organ Prolapse; SUI; POP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

  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

Interventions

Intervention DEVICE

There is no intervention, beyond necessary clinical care, in this registry. The surgical procedures being performed within the registry are identical to the surgical procedures patients would receive as part of SOC.

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female patients ≥ 21 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:
• SUI
• Stress urinary incontinence symptoms
• Urodynamic stress incontinence confirmed with urodynamic testing
• Female patient ≥ 21 years of age
• Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
• Planned surgery for primary SUI
• Patient able and willing to participate in follow-up
• Patient or authorized representative has signed the approved Informed consent POP
• \. 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

You may not qualify if:

• Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry:
• 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
• Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
• History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
• Pregnancy or plans for future pregnancy
• History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice
• Current genitourinary fistula or urethral diverticulum
• Reversible cause of incontinence (i.e. drug effect) for SUI only
• Severe vaginal atrophy
• History of pelvic irradiation therapy
• Contraindication to surgery

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (10)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

Duke University

Durham, North Carolina, 27707, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Krankenhaus der barmherzigen Schwestern

Linz, Austria

RECRUITING

Herlev Hospital

Hillerød, Denmark

NOT YET RECRUITING

Hopital Jeanne de Flandres

Lille, France

NOT YET RECRUITING

Universitatsklinikum Tubingen

Tübingen, Germany

RECRUITING

Bio-Medical University Rome

Rome, Italy

RECRUITING

Karolinska Institute

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Organ Prolapse

Interventions

Methods

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Martin Weisberg, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Central Study Contacts

Christine Romanowski

CONTACT

908-808-6219; cromanow@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 2, 2021
• Study Start: April 11, 2022
• Primary Completion (Estimated): March 31, 2033
• Study Completion (Estimated): March 31, 2038
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4); FR (1); DK (1); DE (1); SE (1); IT (1); AU (1)