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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040047 / PAS001 |
| Date Original Protocol Accepted |
11/10/2005
|
| Date Current Protocol Accepted |
09/29/2008
|
| Study Name |
Coaptite
|
| Device Name |
COAPTITE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Interim or Final Data Summary |
| Interim Results |
10% of patients have developed urge incontinence, which may be advisable to monitor.
|
| Actual Number of Patients Enrolled |
459 Patients
|
| Actual Number of Sites Enrolled |
23 Sites
|
| Patient Follow-up Rate |
91.3% (419/459) at 6 months, 88.2% (405/459) at 12 months, 81.5% (374/459) at 18 months, 78.9% (362/459) at 24 months, 73.4% (337/459) at 30 months, and 72.5% (333/459) at 36 months.
|
| Final Safety Findings |
Primary Safety Objective
The primary safety objective of the study was to assess the long-term safety of Coaptite, specifically
tissue erosion, dissection, and material migration. At 36 months, only one patient among the 459 enrolled patients developed this event for an incidence of 0.2% (95% confidence interval: 0.01%, 1.4%). The incidence in the initial 24-month follow-up IDE trial was 1.3% in the Coaptite group and 1.5% in the control group. The 36-month incidence in this study supports the hypothesis that tissue erosion occurred at a rate of < 5% of subjects, because the upper limit of the 95% confidence interval for the incidence is lower than 5%.
One to two retreatments with the device were needed in 262 patients, two to three in 90, three to four in 26, four to five in 7, and five to six in 1 patient.
Fifty-one subjects reported a variety of alternative treatments for the incontinence during the study.
Other Adverse Events
Of a total of 459 enrolled subjects, 68% of the subjects reported AEs; 10% of study subjects experienced a severe AE. A total of 20.5% and 47.7% of study subjects experienced device-related and not device-related AEs, respectively.
The most frequent AE was UTI, observed among 29.6% (136/459) of the study subjects, followed by urge incontinence, and urinary retention. The most frequent treatment was antibiotics.
Of the 136 subjects with urinary tract infection (29.6%), 13 were documented as related to treatment and 123 were documented as unrelated.
Of the 109 subjects with urge incontinence (23.7%), 8 of them were documented as related to treatment and 101 were documented as unrelated.
Of the 66 subjects with urinary retention (14.4%), 60 subjects were documented as related to treatment and 6 were documented as unrelated.
Of the 29 subjects with micturition urgency (6.3%), 4 subjects were documented as related to treatment and 25 were documented as unrelated.
|
| Final Effect Findings |
Analysis of Stamey Grades (Primary Objective)
The primary effectiveness endpoint was the percent of subjects who maintained at least 1-point improvement from baseline, at the following times, based on observed cases in which a 4-day voiding diary was available for evaluation:
• 44.8% (171/382) of subjects with voiding diaries at 6- and 12-month follow-up
• 46.9% (129/275) of subjects with voiding diaries at 3-year follow-up
• 39.3% (42/107) of subjects who had device failure or were discontinued before 3 years
A similar trend was observed when considering the “Baseline Observation Carried Forward” (BOCF) imputation, where 37.3%, 43.3% and 26.3% of subjects maintained at least 1-point improvement from baseline among the three disposition groups.
Urge Incontinence Medication (UIM) Status
Urge Incontinence Medication (UIM) Status went up from 15.2% during pre-treatment to 41.5% at the end of the 3-year follow-up.
Incontinence Quality of Life (QoL) Scores
The overall QoL scores were much higher for all time points post-baseline: Baseline QoL score was 39.5, while it was 69.6 at 6 months, 70.3 at 12, 70.4 at 18, 71.2 at 24, 73.5 at 30, and 72.7 at 36 months.
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| Study Strengths & Weaknesses |
Strengths: Multi-center study, large sample size, long follow-up up to 3 years, while the premarket study followed subjects through 1 year.
Weaknesses: No concomitant comparator, and 27.5% losses to follow-up.
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| Recommendations for Labeling Changes |
The labeling should be updated to include results of the PAS
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