Introduction: To report 4-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume prostates.
Methods: 101 men with moderate-to-severe BPH symptoms and prostate volumes between 80-150cc underwent robotically executed Aquablation in a prospective multicenter international clinical trial with scheduled follow-up at 5 years. Herein we report the 4 year data.
Results: Mean prostate volume was 107cc (range 80-150). Mean operative time, TRUS in to catheter in, was 55 minutes and mean Aquablation resection time was 8 minutes. IPSS scores improved from 23.2 at baseline to 5.6 at 4 years (change of -16.6 points, p<.0001). Qmax improved from 8.7 cc/sec at baseline to 18.2 cc/sec at 4 years. Improvements in both IPSS, IPSS Quality of Life, Qmax, and PVR were immediate and sustained throughout follow-up (Figure 1). At 4 years the retreatment rate was less than 1% per year.
Conclusions: At 4-year prospective follow-up, the Aquablation procedure was shown to be safe and effective in men with large prostates (80-150cc). ClinicalTrials.gov number, NCT03123250.
*Submitted on behave of the Water II investigators
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