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, Inc.
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
- Age range
- 21+ years
- Sex
- Female
- 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. Urodynam…
Interventions
- DeviceIntervention
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 (10)
- Yale UniversityNew Haven, Connecticut
- Duke UniversityDurham, North Carolina
- University of PennsylvaniaPhiladelphia, Pennsylvania
- UPMCPittsburgh, Pennsylvania
- Krankenhaus der barmherzigen SchwesternLinz
- Herlev HospitalHillerød