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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00688181 |
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. Subjects that participated in the Prepubic Post Market Clinical Study had their prepubic slings placed between 30/AUG/2004 and 28/MAR/2007. No additional procedures are required beyond the physician's standard of care and those that were performed at the time of the Clinical Study participation.
Condition | Intervention |
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Stress Urinary Incontinence |
Device: The Prefyx PPS™ Pre-pubic Sling System |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | The Prefyx PPS™ System eRegistry for Prepubic Clinical Study Subjects |
Enrollment: | 60 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | November 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Cohort 1
Subjects that participated in the Prepubic Post Market Clinical Study and had their prepubic slings placed between 30/AUG/2004 and 28/MAR/2007.
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Device: The Prefyx PPS™ Pre-pubic Sling System
device designed to treat female stress urinary incontinence (SUI).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All subjects from clinical sites which participated in the Prepubic Post Market Clinical Study (U0299) with enrollment greater than eight subjects treated will be invited to participate in the Registry. These subjects were previously treated for female Urinary Stress Incontinence (SUI) under a similar clinical protocol. The clinical study patients will be included in a registry with subjects outside of the clinical study population.
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
OB/GYN Specialists of the Palm Beaches | |
West Palm Beach, Florida, United States, 33401 | |
South Florida Urology Center | |
Pembroke Pines, Florida, United States, 33028 | |
United States, Georgia | |
Urology Specialists of Atlanta, LLC /Northside Hospital | |
Atlanta, Georgia, United States, 30328 | |
United States, Michigan | |
Affiliates in Urology | |
Westland, Michigan, United States, 48186 |
Principal Investigator: | Neeraj Kohli, M.D. | Brigham and Women's Hospital |
Study Director: | Robert Walsh, M.D. | Boston Scientific Corporation |
Responsible Party: | Boston Scientific ( Kurt Douglass ) |
Study ID Numbers: | U8043 |
Study First Received: | May 28, 2008 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00688181 |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Urological Manifestations |