Recruiting

Observational Study

Sponsor:

Ethicon, Inc.

Code:

NCT04829175

Conditions

Stress Urinary Incontinence

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Intervention

Study Details

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.

Conditions

Stress Urinary Incontinence

Pelvic Organ Prolapse

Study ID

NCT04829175

Start date

Apr 11, 2022

Status verified date

Jul, 2026

Completion date

Mar 31, 2038

Anticipated

Primary completion date

Mar 31, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change [ Time Frame: Post-surgery through registry completion, approximately 5-10 yrs ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Duke University

Recruiting

Durham, North Carolina, United States, 27707

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Ethicon, Inc.

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Stress Urinary Incontinence
  • Pelvic Organ Prolapse
  • SUI
  • POP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ethicon, Inc. on 2026-07-06.