Status:
COMPLETED
The Prefyx PPS™ System eRegistry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Brief Summary
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
Detailed Description
Registry to gather information about the long term use of the Prefyx PPS System which utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone) for the treatment of SU...
Eligibility Criteria
Inclusion
- Patients presenting for treatment of female Urinary Stress Incontinence (SUI)
Exclusion
- Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
- Any patients with soft tissue pathology into which the implant is to be placed.
- Patients with any pathology which would compromise implant placement.
- Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00688181
Start Date
December 1 2006
End Date
April 1 2009
Last Update
March 1 2021
Active Locations (5)
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1
South Florida Urology Center
Pembroke Pines, Florida, United States, 33028
2
OB/GYN Specialists of the Palm Beaches
West Palm Beach, Florida, United States, 33401
3
Urology Specialists of Atlanta, LLC /Northside Hospital
Atlanta, Georgia, United States, 30328
4
Affiliates in Urology
Westland, Michigan, United States, 48186