RECRUITING

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Conditions

Stress Urinary Incontinence Pelvic Organ Prolapse SUI POP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-04-13

Study Completion:2036-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04829175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

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
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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Christine Romanowski

CONTACT

908-808-6219

cromanow@its.jnj.com

Principal Investigator

Martin Weisberg, MD

STUDY_DIRECTOR

Ethicon, Inc.

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Duke University

Durham, North Carolina, 27707

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

UPMC

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Ethicon, Inc.

Martin Weisberg, MD, STUDY_DIRECTOR, Ethicon, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-13

Study Completion Date2036-08-30

Study Record Updates

Study Start Date2022-04-13

Study Completion Date2036-08-30

Terms related to this study

Keywords Provided by Researchers

Stress Urinary Incontinence
Pelvic Organ Prolapse
SUI
POP

Additional Relevant MeSH Terms

Stress Urinary Incontinence
Pelvic Organ Prolapse