Well-Established Procedure with 5-Year Data in USA and Asia
FDA Approved 5-Year Data*
A total of 225 subjects were enrolled for the Prolieve post-market study. The study was conducted to evaluate the long-term effectiveness of the Prolieve System. All parameters were studied in comparison of change of baseline at Week 2, Month 3, Year 1, Year 2, Year 3, Year 4 and Year 5 among all subjects. Inclusion criteria: Diagnosed with BPH, peak urine ow rate <12 mL/sec on voided volume of >125mL, AUA symptom Score value >9, prostate weigh of 20-80g, prostatic urethra length of 1.2-5.5cm.
Asia Follow-Up Data
Following the protocol of the FDA post-market study, data of Asian patients treated by Prolieve was collected to evaluate the long-term effectiveness. All parameters were studied in comparison of change of baseline at Week 2, Month 3, Year 1, Year 2, Year 3, Year 4 and Year 5. The findings in Asia is consistent with the FDA approved 5-Year data.
*Bidargaddi, V & Mon, J, ‘Post-Marketing Study Using Prolieve for the Treatment of Benign Prostatic Hyperplasia (BPH), 120-Month Post-Approval Study Annual Status Report, Unpublished Report, February 19, 2004, Columbia, United States.