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

Stress Urinary Incontinence

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

Inclusion Criteria10

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

Exclusion Criteria11

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

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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.