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

Ethicon, Inc.17 sites in 8 countries1,000 target enrollmentApril 11, 2022

ConditionsStress Urinary Incontinence Pelvic Organ Prolapse

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stress Urinary Incontinence
Sponsor: Ethicon, Inc.
Enrollment: 1000
Locations: 17
Primary Endpoint: Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change
Status: Recruiting
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 11, 2022

End Date

March 31, 2038

Last Updated

19 days ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Ethicon, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:
•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
•1\. Uterine or vaginal vault prolapse symptoms
•Urodynamic testing (optional)

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change

Time Frame: Post-surgery through registry completion, approximately 5-10 yrs

Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST)

Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change

Time Frame: Post-surgery through registry completion, approximately 5-10 yrs

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

Secondary Outcomes

POP: Patient Global Impression of Improvement questionnaire (PGI-I)(Post-surgery through registry completion, approximately 10 yrs)
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)
POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)(Baseline and post-surgery through registry completion, approximately 10 yrs)
POP: Wong-Baker FACES Pain Rating Scale(Post-surgery through registry completion, approximately 10 yrs)