Abstract

INTRODUCTION AND OBJECTIVE: To report 2 year safety and effectiveness outcomes of the Aquablation procedure for the treatment of men with symptomatic BPH and large-volume prostates. METHODS: 101 men with moderate-to-severe BPH symptoms and prostate volumes of 80-150cc underwent a robotic-assisted Aquablation procedure in a prospective multicenter international clinical trial. Functional and safety outcomes were assessed at 2 years postoperatively. RESULTS: Mean prostate volume was 107cc (range 80-150). Mean operative time was 37 minutes and mean Aquablation resection time was 8 minutes. The average length of hospital stay following the procedure was 1.6 days. IPSS scores improved from 23.2 at baseline to 5.1 at 2 years (change score of 18.1 points). At baseline, Qmax was 8.7 cc/sec and improving to 16.6 cc/sec at 24 months. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. The average annual retreatment occurrence was 0%. CONCLUSIONS: The Aquablation procedure is demonstrated to be safe and effective in treating men with large prostates (80-150cc) after 2 year of follow-up, with an acceptable complication rate and without a significant increase in procedure or resection time compared to smaller sized glands. Two-year results held consistent with one year outcomes. ClinicalTrials.gov number, NCT03123250. Source of Funding: ClinicalTrials.gov number, NCT03123250

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