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About
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:
SUI
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
Planned surgery for primary SUI
Patient able and willing to participate in follow-up
Patient or authorized representative has signed the approved Informed consent POP
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:
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Central trial contact
Christine Romanowski
Data sourced from clinicaltrials.gov
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