RecruitingNCT04829175

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


Sponsor

Ethicon, Inc.

Enrollment

1,000 participants

Start Date

Apr 11, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term registry for women who have had pelvic floor surgery using Ethicon synthetic mesh products to treat either stress urinary incontinence (leaking urine when you cough, sneeze, or exercise) or pelvic organ prolapse (when pelvic organs slip out of their normal position). The registry collects ongoing safety and effectiveness data to fulfill post-market surveillance requirements. This is not a study testing a new treatment — it simply tracks outcomes in women who have already received these devices as part of their standard care. It includes data on symptoms, quality of life, and any complications that may arise over time. You may be eligible if: - You are female and at least 21 years old - You are scheduled for surgery using an Ethicon synthetic mesh for stress urinary incontinence (SUI) or pelvic organ prolapse (POP) - You are willing to attend follow-up appointments You may NOT be eligible if: - You have had a previous synthetic, biologic, or fascial sling or pelvic mesh procedure - You are pregnant or planning a future pregnancy - You have a history of pelvic radiation therapy - You have a current genitourinary fistula or urethral diverticulum - You have severe vaginal atrophy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntervention

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.


Locations(10)

Yale University

New Haven, Connecticut, United States

Duke University

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Krankenhaus der barmherzigen Schwestern

Linz, Austria

Herlev Hospital

Hillerød, Denmark

Hopital Jeanne de Flandres

Lille, France

Universitatsklinikum Tubingen

Tübingen, Germany

Bio-Medical University Rome

Rome, Italy

Karolinska Institute

Stockholm, Sweden

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NCT04829175


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