Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829175
• Other study ID #: ESC_2020_03
• Status: Recruiting
• Start date: April 13, 2022
• Est. completion date: August 30, 2036

Study information

• Verified date: June 2024
• Source: Ethicon, Inc.
• Contact: Christine Romanowski
• Phone: 908-808-6219
• Email: cromanow[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 30, 2036
• Est. primary completion date: March 30, 2036
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:

SUI

1. Stress urinary incontinence symptoms

2. Urodynamic stress incontinence confirmed with urodynamic testing

3. Female patient = 21 years of age

4. Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling

5. Planned surgery for primary SUI

6. Patient able and willing to participate in follow-up

7. Patient or authorized representative has signed the approved Informed consent POP

1. 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:

1. 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

2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products

3. History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)

4. Pregnancy or plans for future pregnancy

5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice

6. Current genitourinary fistula or urethral diverticulum

7. Reversible cause of incontinence (i.e. drug effect) for SUI only

8. Severe vaginal atrophy

9. History of pelvic irradiation therapy

10. Contraindication to surgery

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Austria	Krankenhaus der barmherzigen Schwestern	Linz
Denmark	Herlev Hospital	Hillerod
France	Hopital Jeanne de Flandres	Lille
Germany	Universitatsklinikum Tubingen	Tubingen
Italy	Bio-Medical University Rome	Rome
Poland	Zelazna Medical Center	Warsaw
Sweden	Karolinska Institute	Stockholm
United States	Duke University	Durham	North Carolina
United States	Yale University	New Haven	Connecticut
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Denmark,  France,  Germany,  Italy,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change	Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST)	Post-surgery through registry completion, approximately 5-10 yrs
Primary	Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change	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	Post-surgery through registry completion, approximately 5-10 yrs
Secondary	SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)		Baseline and post-surgery through registry completion, approximately 10 yrs
Secondary	SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)		Baseline and post-surgery through registry completion, approximately 10 yrs
Secondary	SUI: Patient Global Impression of Improvement questionnaire (PGI-I)		Post-surgery through registry completion, approximately 10 yrs
Secondary	SUI: Wong-Baker FACES Pain Rating Scale	To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure	Post-surgery through registry completion, approximately 10 yrs
Secondary	POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire		Baseline and post-surgery through registry completion, approximately 10 yrs
Secondary	POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)		Baseline and post-surgery through registry completion, approximately 10 yrs
Secondary	POP: Patient Global Impression of Improvement questionnaire (PGI-I)		Post-surgery through registry completion, approximately 10 yrs
Secondary	POP: Wong-Baker FACES Pain Rating Scale	To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure (if applicable)	Post-surgery through registry completion, approximately 10 yrs