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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Urgency Frequency (UF 1635)


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General
Study Status Revised/Replaced Study
Application Number P970004 S022/ PAS001
Date Current Protocol Accepted 10/23/2007
Study Name OSB Lead-Urgency Frequency (UF 1635)
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description There are two phases in this stiudy. Phase 1 is a randomized clinical trial, where one arm receives the device and the other arm receives medical therapy. Phase 2 is a prospective cohort study in which only patients with the device are followed. Due to enrollment problems, FDA agreed to allow the sponsor redesign the study. The patients enrolled were rolled over the new study (PAS003).
Study Population Description Study population: Patients 18 years or older with urinary urge incontinent symptoms of overactive bladder who have failed or are not a candidate for more conservative treatment or have failed or could not tolerate anticholinergic or antimuscarinic medication. Indication: The treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments. The device indication applies to all post-approval studies.
Sample Size 325 patients, 30 sites
Data Collection Effectiveness: the therapeutic success rate at 6 months for the urgency frequency population is greater for the InterStim therapy group than for the standard medical therapy group. Safety: the cumulative 5-year rate of adverse events related to the tined lead that require surgery is less than 33% with 95% confidence. Data collection by office visits.
Follow-up Visits and Length of Follow-up Phase 1: 6 months, phase 2: 5 years; visits: 3, 6, 12, 24, 36, 48, 60 months


OSB Lead-Urgency Frequency (UF 1635) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/18/2008 04/23/2008 Overdue/Received
1 year report 10/20/2008 10/23/2008 Overdue/Received
18 month report 04/23/2009 04/23/2009 On Time
2 year report 10/23/2009 10/23/2009 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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