NCT04829175

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Ethicon, Inc. · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Intervention	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.

Timeline

• Start date: 2022-04-11
• Primary completion: 2033-03-31
• Completion: 2038-03-31
• First posted: 2021-04-02
• Last updated: 2026-04-13

Locations

10 sites across 7 countries: United States, Austria, Denmark, France, Germany, Italy, Sweden

Regulatory

• FDA-regulated device study