In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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.
Followup Visits and Length of Followup
Subjects are followed for 5 years following initial treatment with Macroplastique or until alternative treatment
