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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P920023 / PAS001 |
| Date Original Protocol Accepted |
05/06/1996
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| Date Current Protocol Accepted |
|
| Study Name |
Urolume PAS
|
| Device Name |
UROLUME ENDOPROSTHESIS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objectives were to assess the incidence, duration and severity of positive urine cultures, incontinence and post-void dribbling, to assess changes in sexual dysfunction and global function, and to assess the number of retreatments.
|
| Study Population |
Study population is as per device indication. Urinary stent indicated for use in men with recurrent bulbal urethral stricture, prostatic obstruction secondary to benign prostatic hyperplasia (BPH), or detrusor external sphincter dyssynergia over age 60 or under age 60 who are poor surgical candidates and who have prostate glands at least 2.0cm in length.
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| Sample Size |
110
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| Key Study Endpoints |
Incidence, frequency and severity of the following: urinary tract infection (measured by culture), incontinence, and post-void dribbling. Changes in sexual function, global assessment and number of retreatments
|
| Follow-up Visits and Length of Follow-up |
At 6-weeks, 6-months, 1year and 2year post-stent placement
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
72 enrolled but 61 patients treated
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| Actual Number of Sites Enrolled |
10
|
| Patient Follow-up Rate |
78.7
|
| Final Safety Findings |
Negative urine culture at 2 years: 76.2% (95% CI 71.7% - 80.7%). Stress incontinence: 18.5% (10/54) at baseline and 72.2% (39/54) at final evaluation (either at 1- or 2-year visit). Patient bothered by stress incontinence: 31% (13/42) not bother at 2 years vs. 81.4% (48/59) at baseline (p-value<0.001). Urge incontinence: 42.6% (23/54) at baseline and 59.3% (32/54) at final evaluation. Patient bothered by urge incontinence: 48.8% (20/41) not bother at 2 years vs. 55.9% (33/59) at baseline (p-value>0.05). Overflow incontinence: 16.7% (9/54) at baseline and 46.3% (25/54) at final evaluation. Patient bothered by overflow incontinence: 64.3% (27/42) not bother at 2 years vs. 83.1% (49/59) at baseline (p-value<0.05).
Post void dribbling: 63% (34/54) at baseline and 72.2% (39/54) at final evaluation. Patient bothered by post void dribbling: 35.7% (15/42) not bother at 2 years vs. 33.9% (20/59) at baseline (p-value<0.05).
Patients’ responses indicated no negative effects because of stent placement on sexual function. Global assessment (If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?): Roughly 55.7% of patients reported new satisfaction with their urinary status.
The probability of patients remaining free from re-treatment for recurrent strictures or reobstruction within the stented area in the study was greater than 90% through the 1-year evaluation and approx. 87% at the 2-year follow-up.
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| Study Strengths & Weaknesses |
Low precision of estimate since a 72-patient study has a 81% precision and a CI that is 124% wider compared to the planned 110-patients study.
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| Recommendations for Labeling Changes |
As per PAS closing letter: Labeling should be revised to include the long term follow-up, safety information and adverse events, including information regarding the proportion of explants observed during the post-approval study, which his twice that identified in the literature
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