The Prefyx PPS™ System eRegistry
This trial is active, not recruiting.
|Condition||stress urinary incontinence|
|Treatment||the prefyx pps™ pre-pubic sling system|
|Sponsor||Boston Scientific Corporation|
|Start date||December 2006|
|End date||November 2008|
|Trial size||44 participants|
|Trial identifier||NCT00688181, U8043|
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 SUI. No additional procedures are required beyond the physician's standard of care.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Pembroke Pines, FL||South Florida Urology Center||no longer recruiting|
|West Palm Beach, FL||OB/GYN Specialists of the Palm Beaches||no longer recruiting|
|Atlanta, GA||Urology Specialists of Atlanta, LLC /Northside Hospital||no longer recruiting|
|Westland, MI||Affiliates in Urology||no longer recruiting|
|Tulsa, OK||HillCrest Medical Center||no longer recruiting|
The percentage of subjects who report substantial improvement and consider the surgery successful, as measured by the Patient's Global Impression
time frame: 12, 24 and 36 months post operatively
Evaluation of reported Adverse Events
time frame: 12 months post operatively
The percentage of subjects who remain continent or improved following treatment at timed intervals
time frame: 3 and 12 months post-operative
Female participants at least 18 years old.
Inclusion Criteria: - Patients presenting for treatment of female Urinary Stress Incontinence (SUI) Exclusion Criteria: - 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.
|Official title||The Prefyx PPS™ System eRegistry|
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