f Post-Approval Studies (PAS) Database
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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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Coloplast PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P000006 / PAS001
Date Original Protocol Accepted 07/14/2000
Date Current Protocol Accepted  
Study Name Coloplast PAS
Device Name TITAN INFLATABLE PENILE PROSTHESIS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The post-approval study was a multi-center cohort study whose patients were part of the premarket study.
Study Population The study population is as per device indication. The device is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Sample Size 326 subjects
Key Study Endpoints The primary safety endpoint was the assessment of the rate of revision surgeries at 18 months post-implantation. The primary assessment of efficacy of the penile prosthesis was the determination that the device supplied sufficient penile rigidity to obtain an erection adequate to permit vaginal penetration. In addition, axial penile rigidity was measured in accordance with the Penile Rigidity Measurement Protocol.
Follow-up Visits and Length of Follow-up Study subjects underwent clinical visits at 2, 3 and 5 postoperative years.
Interim or Final Data Summary
Actual Number of Patients Enrolled 172 subjects
Actual Number of Sites Enrolled Not Mentioned
Patient Follow-up Rate 73.80%
Final Safety Findings A total of 93.2% of the implanted patients had adequate rigidity for intercourse. A total of 34 patients experienced a revision during the study period. Of these 34 revision cases, 17 were device explantations, 5 were device repair surgeries, and 12 were other surgeries, such as circumcision, that did not require explantation of the device. Using a Kaplan-Meier Survival Analysis, the probability of patients being free of revision at 18 months was 88.5%. The sponsor contended that these rates of revision and explantation were consistent with those in the published literature.
Study Strengths & Weaknesses The follow-up rate is less than 80%. Losses to follow-up can introduce bais and limit the validity of study results.
Recommendations for Labeling Changes Modify label to reflect the findings of the study


Coloplast PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
5 year rigidy data Report 08/21/2007 08/21/2007 On Time


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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