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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P900030 / PAS001 |
| Date Original Protocol Accepted |
09/30/1993
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| Date Current Protocol Accepted |
|
| Study Name |
Long term Cohort C
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| Device Name |
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study design is open-label and multi-center. Cohort C included patients aged 30 and younger who are to be followed for 10 years post implant. Although there are no study hypotheses, the primary objectives of the study are: 1. To determine the duration of improvement 2. To measure various serologic values over time following exposure to bovine collagen 3. To evaluate rheumatologic history 4. To monitor adverse events
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| Study Population |
The study population is male and female patients who were 30 years or younger at enrollment and had urinary incontinence due to intrinsic sphincter deficiency and have been incontinent for at least 12 months. The device is indicated to treat urinary incontinence.
|
| Sample Size |
100 male, 100 female
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| Key Study Endpoints |
Data collection included: Effectiveness was measured by incontinence grading, described as follows: Grade 0 Continent dry, Grade 1 Patient loses urine with sudden increases in abdominal pressure but never in bed at night, Grade 2 Patient s incontinence worsens with lesser degrees of stress such as walking standing erect from a sitting position or sitting up in bed
Grade 3 Patient has total incontinence without any relation
Safety: 1. Serological hypersensitivity reaction through measurement of enzyme-linked immunosorbent assay (ELISA). 2. Local hypersensitivity 3. Urinary retention
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| Follow-up Visits and Length of Follow-up |
visits every 6 months up to 10 years
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| Interim or Final Data Summary |
| Interim Results |
Study is completed. See Final Results
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| Actual Number of Patients Enrolled |
62
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| Actual Number of Sites Enrolled |
Not mentioned
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| Patient Follow-up Rate |
21%
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| Final Safety Findings |
During the study, 66.1% (N=41) of the 62 patients experienced a total of 161 adverse events.71.4% of the females and 61.8% of the malesexperienced adverse events. There was no significant difference in the AE rate of both genders. 66.7% of the dry patients and 82.4% of the improved incontinence patients and 70.6% of the not improved incontincence patients experienced adverse events. THe differences are not statistically significant.
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| Study Strengths & Weaknesses |
Low follow-up rate
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| Recommendations for Labeling Changes |
labeling should be updated to include the long-term findings, specifically that there may be a higher incidence of autoimmune responses in females.
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