|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P000006 / PAS001 |
Date Original Protocol Accepted |
07/14/2000
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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.
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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.
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Recommendations for Labeling Changes |
Modify label to reflect the findings of the study
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