Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorEthicon, Inc.
About this trial
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 criteria
Qualifiers
Stress urinary incontinence symptoms
Urodynamic stress incontinence confirmed with urodynamic testing
Female patient ≥ 21 years of age
Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
Disqualifiers
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
Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
Pregnancy or plans for future pregnancy
Trial design
Treatments tested in this trial
- Intervention
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov