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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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5 year registry - ROSE

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Study Status Progress Adequate
Application Number P040050 / PAS001
Date Current Protocol Accepted 10/30/2006
Study Name 5 year registry - ROSE
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Real-Time Observation of Safety and Effectiveness (ROSE) study is a non-randomized, prospective, multi-center, registry of Macroplastique safety and effectiveness.
Study Population Description The study population consists of women at least 18 years of age diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency who are candidates for treatment with the device according to the approved labeling,. This device is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.
Sample Size 275 enrolled patients and maximum of 20 sites
Data Collection The primary endpoints are additional or alternative surgical treatment over a 5-year period and incidence of genitourinary and treatment-related adverse events. Other endpoints collected are: change in Incontinence Quality of Life questionnaire, change in Stamey grade, and change in number of incontinence episodes per day from baseline to 5 years as well as subject perception of treatment success.
Follow-up Visits and Length of Follow-up Subjects are followed for 5 years following initial treatment with Macroplastique or until alternative treatment for stress urinary incontinence.

5 year registry - ROSE Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 04/30/2007 04/26/2007 On Time
1 year registry report 10/30/2007 11/01/2007 Overdue/Received
18 month registry report 04/29/2008 04/29/2008 On Time
2 year registry report 10/29/2008 10/29/2008 On Time
3 year registry report 10/29/2009 10/29/2009 On Time
4 year registry report 10/29/2010 10/29/2010 On Time
5 year registry report 10/29/2011 10/28/2011 On Time
6 year registry report 10/28/2012 10/26/2012 On Time
7 year report 10/28/2013 10/25/2013 On Time
8 year report 10/28/2014 10/24/2014 On Time
9 year report 10/28/2015 10/15/2015 On Time
10 year report 10/28/2016 10/20/2016 On Time
11 year report 10/28/2017 10/20/2017 On Time
12 year report 10/28/2018 10/09/2018 On Time
13 year report 10/28/2019 10/23/2019 On Time
Final report 12/28/2020 12/31/2020 Overdue/Received

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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