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
This is a prospective cohort study of 450 women with stress urinary incontinence to study
the long term safety of Coaptite.
Study Population Description
The study population is as per device indication. This device is indicated for soft tissue
augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult females.
Sample Size
450 women at 20 sites
Data Collection
Primary objective is to evaluate the long term safety of Coaptite. This will be accomplished
by performing 4-day voiding diaries at baseline and all follow up visits, recording time to additional coaptite treatment, recording of all Coaptite injections received, and correlating the number of re-treatments with adverse event rates
Followup Visits and Length of Followup
There will be approximately 8 visits over a 3 years period (7 visits if there
is only one treatment). The length of follow up is 3 years.
