We sought to establish the safety and effectiveness of aquablation, a novel, image guided, robotic assisted, water jet tissue ablation technology, for the treatment of benign prostatic hyperplasia.Materials and Methods:
We performed a prospective, single arm, multicenter trial at a total of 3 centers in Australia and New Zealand with 1-year followup. Participants were men 50 to 80 years old with moderate to severe lower urinary tract symptoms as determined by urodynamics. All patients underwent aquablation under image guidance. Primary end points included procedural and perioperative safety. The main clinical end point was the change from baseline in I-PSS (International Prostate Symptom Score). Other secondary end points included uroflow measures, prostate volume on transrectal ultrasound and detrusor pressure. Detrusor pressure at maximum flow was only measured at 6 months.Results:
A total of 21 men underwent aquablation at a mean age of 69.7 years (range 62 to 78). Prostate volume was 57.2 ml (range 30 to 102). Procedural duration averaged 38 minutes with a mean aquablation treatment time of 5 minutes. All but 1 subject were catheterized for 1 day only and 19 of 21 were discharged home the day after the procedure. Detrusor pressure at maximum flow decreased from 65 cm H2O at baseline to 39 cm H2O at 6 months (p <0.0027). Prostate volume decreased from 57 ml at baseline to 35 ml (p <0.0001). Mean I-PSS score improved from 23.0 at baseline to 6.8 at 12 months (p <0.0001) and maximum urinary flow increased from 8.7 to 18.3 ml per second (p <0.0001). There were no important perioperative adverse events. No urinary incontinence developed and sexual function was preserved postoperatively.Conclusions:
This phase II study provides early evidence to support the safety and effectiveness of aquablation for symptomatic benign prostatic hyperplasia.