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Stress Urinary IncontinenceKidney and urinaryDevice

What this study is

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.

What's being tested

  • Intervention

    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.

Study details

Official title
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.
Conditions
Stress Urinary Incontinence · Pelvic Organ Prolapse
Enrolling
1,000 people
Starts
2022-04-11
Est. completion
2038-03-31
Record
View on ClinicalTrials.gov ↗