|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P080025 / PAS001 |
Date Original Protocol Accepted |
03/14/2011
|
Date Current Protocol Accepted |
03/14/2011
|
Study Name |
FI-PAS
|
Device Name |
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Prospective, non-randomized, multicenter study
|
Study Population |
Study subjects are individuals enrolled in IDE study with a history of chronic fecal incontinence who failed or were not candidates for more conservative treatments. Subjects serve as self controls.
|
Sample Size |
285 subjects, 12 sites
|
Follow-up Visits and Length of Follow-up |
5 years post implant Yearly up until at least 5 years post implant
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
120
|
Actual Number of Sites Enrolled |
13
|
Patient Follow-up Rate |
60% (72/120)(Rate included 14 subjects who were lost due to death of Principal Investigator and 5 died of causes unrelated to the device or therapy)
|
Final Safety Findings |
There were no specific study safety endpoints in this post approval study. Safety was monitored in a purely descriptive fashion. There were 21 serious device/therapy related adverse events and 351 non-serious device or therapy related adverse events, many of which required surgical intervention.
Over the course of the study that there were 10 device revisions among 10 subjects, 40 device replacements among 29 subjects and 22 device explants among 22 subjects. The overall device revision and replacement rate was 24.4%, and the overall device explantation rate was 19%. The all cause surgical intervention rate for the 120 enrolled subjects was 35.6% for the first 5 years
|
Final Effect Findings |
Primary Endpoint: Incontinent Episoides ( ¡Ý50% improvement from baseline): Proportion of Successes: 69% (95%CI- 60%-77%), based on last observation carried forward imputation method for missing subjects
|
Study Strengths & Weaknesses |
Strength: Prospective hypothesis driven study, high level of quality control, multiple effectiveness outcomes evaluated including patient centered disease specific QoL questionnaires. Weakness: High loss to follow-up, no study safety hypothesis.
|
Recommendations for Labeling Changes |
yes
|