Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Sponsor

Ethicon, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04829175

Collaborator

(none)

1,000

Enrollment

Locations

142.5

Anticipated Duration (Months)

90.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Pelvic Organ Prolapse	Device: Intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 13, 2022

Anticipated Primary Completion Date :

Aug 29, 2033

Anticipated Study Completion Date :

Feb 27, 2034

Outcome Measures

Primary Outcome Measures

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

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]
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure
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: Patient Global Impression of Improvement questionnaire (PGI-I) [Post-surgery through registry completion, approximately 10 yrs]
POP: Wong-Baker FACES Pain Rating Scale [Post-surgery through registry completion, approximately 10 yrs]
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure (if applicable)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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 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
Contraindication to surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06510
2	Duke University	Durham	North Carolina	United States	27707
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
4	UPMC	Pittsburgh	Pennsylvania	United States	15213
5	General University Hospital	Prague		Czechia
6	Herlev Hospital	Hillerod		Denmark
7	CHU de Clermont-Ferrand	Clermont-Ferrand		France
8	Hopital Jeanne de Flandres	Lille		France
9	Universitatsklinikum Tubingen	Tubingen		Germany
10	Żelazna Medical Center	Warsaw		Poland
11	Karolinska Institute	Stockholm		Sweden