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Recruiting Observational

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

NCT04829175 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-04-11
Last updated
2026-07-06

Condition(s) studied

Stress Urinary IncontinencePelvic Organ Prolapse

Investigational drug(s) / intervention(s)

Intervention

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
21 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (10)

FacilityCityRegionStatus
Yale University New Haven Connecticut Recruiting
Duke University Durham North Carolina Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
UPMC Pittsburgh Pennsylvania Recruiting
Krankenhaus der barmherzigen Schwestern Linz Austria Recruiting
Herlev Hospital Hillerød Denmark Not Yet Recruiting
Hopital Jeanne de Flandres Lille France Not Yet Recruiting
Universitatsklinikum Tubingen Tübingen Germany Active Not Recruiting
Bio-Medical University Rome Rome Italy Recruiting
Karolinska Institute Stockholm Sweden Recruiting

More Ethicon, Inc. trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04829175 on ClinicalTrials.gov ↗ ← All trials in Italy