Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

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.

Conditions

Stress Urinary Incontinence, Pelvic Organ Prolapse

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Study Overview

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Study Details

Study overview

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.

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 Pelvic Mesh Post Market Clinical Follow-up Registry

Condition
Stress Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Durham

Duke University, Durham, North Carolina, United States, 27707

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Pittsburgh

UPMC, Pittsburgh, Pennsylvania, United States, 15213

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ethicon, Inc.,

Martin Weisberg, MD, STUDY_DIRECTOR, Ethicon, Inc.

Study Record Dates

2036-08-30