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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030006 / PAS001 |
| Date Original Protocol Accepted |
02/19/2004
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| Date Current Protocol Accepted |
03/11/2005
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| Study Name |
Prolieve PAS
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| Device Name |
PROLIEVE THERMODILATATION SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is an open label non-randomized prospective study . The primary objective of the study is to provide descriptive data on the long-term safety and effectiveness of Prolieve for Benign Prostate Hyperplasia . A secondary objective is to assess safety and effectiveness of re-treatment and to assess the proportion of patients electing re-treatment with Prolieve compared to alternative therapy (other localized therapy, surgery or drug therapy).
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| Study Population |
Study population is as per device indication. Adult men men with prostate volume of 20 to 80 grams and in whom drug therapy (Proscar) is typically indicated.
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| Sample Size |
The protocol proposes to enroll 250 new subjects in up to 30 study sites in the United States. The protocol states this will ensure at least 100 subjects will be followed for 5 years. In addition to newly enrolled subjects, the sponsor planned to encourage Pivotal Study participants and Continued Access Study participants to transfer to the postmarket study for the completion of 5 years of follow-up
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| Key Study Endpoints |
Efficacy is evaluated using the following: Time to re-treatment, American Urological Association (AUA) Symptom Index, (Classifies the severity of subject symptoms related to urinary difficulties based on seven questions that form a total score. The score can range from 0-35). Pain/Discomfort, Sexual Function, Impact of Lower Urinary Tract Symptoms (LUTS) on quality of life (QOL), (Six questions related to urinary problems and how they interfere with daily living. The score ranges from 5-24), Quality of Life Questionnaire, (Six questions related to the subjects feelings about his urinary condition, perception of urinary difficulties, sexual function, activities of daily living, general well-being and social activities. The seven-point scale ranges from delighted to terrible and scores can range from 6-42), Brief Symptom Inventory (BSI), (Seven questions related to the interference of the subject s urinary problems with common activities, scores range from 7-35), BPH Impact Index (BII), (Four questions related to concern about urinary problems and the amount of physical discomfort experienced. Scores can range from 4-17. Safety is measured by: Use of pain medication pre-treatment and during treatment, Pain associated with treatment, Local and systemic symptoms during Prolieve treatment
Catheterizations associated with treatment, PSA levels, Adverse events, Anticipated adverse events (associated with treatment or BPH), Hospitalizations , and MDR reportable events.
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| Follow-up Visits and Length of Follow-up |
Study participants are to be evaluated at two weeks, three months and annually thereafter for a period of 5 years after treatment with Prolieve.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
225 subjects were enrolled.
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| Actual Number of Sites Enrolled |
24 siteswere enrolled.
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| Patient Follow-up Rate |
102/219 (46.6%) at five year follow-up.
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| Final Safety Findings |
There were nine serious device/treatment-relatedadverse events
that required hospitalization. The most common device/treatment-related AEswere micturition urgency (13.3 events per 100 person-years), dysuria (10.5), haematuria (7.8), urinary retention (7.2), bladder
spasm (6.1), pollakiuria (5.7), urethral hemorrhage (5.2), and urine flow decrease (3.1).
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| Final Effect Findings |
The retreatment rate was 51.1% (95% CI: 43.2, 59.0) at five years. Subjects showed a general improvement in symptoms; AUA (American Urological Association Symptom Index) total scores, peak flow rate, and quality of life scores all improved from baseline to five years. A smaller percentage of patients reported pain or discomfort in urethra at five years (10/98, 10.2%) than at baseline (55/220, 25.0%).
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| Study Strengths & Weaknesses |
Strengths: Prospective design with five-year follow-up.
Weaknesses: The follow-up rate was moderately low (46.6%). However, the study met the assumptions of the protocol to obtain five year follow-up data for at least 100 subjects. Additional sensitivity analyses did not show significant differences between subjects who completed follow-up and those who did not.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the results of the five year follow-up post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study design, results, and study strengths and limitations.
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