Surgical options are limited when treating large (>80cc) prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH); there is a need for novel surgical approaches with shorter learning curves and effective treatment. Aquablation (AquaBeam System, PROCEPT Bio-Robotics, Inc., USA), an ultrasound-guided, robotically executed waterjet ablative procedure, could be this novel tool. This analysis compares the outcomes of Aquablation in 30cc to 80cc prostates with the outcomes in 80cc to 150cc prostates.METHODS: WATER (NCT02505919) is a prospective, doubleblind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and transurethral resection of the prostate in the treatment of LUTS/BPH in men 45 to 80 years old with a prostate between 30cc and 80cc. WATER II (NCT03123250) is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate between 80cc and 150cc. We herein report baseline parameters and 6-month outcomes in 116 WATER (W-I) and 101 WATER II (W-II) study subjects undergoing Aquablation. Students' t-test or Wilcoxon tests were used for continuous variables and Fisher's test for binary variables.RESULTS: Mean operative time was 33AE17 minutes in W-I and 37AE13 minutes in W-II. The average length of stay post-procedure was 1.4AE0.7 days (W-I) vs. 1.6AE1.1 days (W-II). Mean changes in International Prostate Symptom Score (IPSS) and IPSS quality of life were substantial, occurring soon after treatment and averaging (at 6 months) 16.9 and 3.5 points, respectively, in W-I and 17.4 and 3.2 points in W-II (p[.6046 and .2607 respectively). By 3 months, Clavien-Dindo grade 2 or higher events occurred in 19.8% of W-I subjects and 34.7% of W-II subjects (p[.4680). One W-I subject (0.9%) and 6 W-II subjects (5.9%) required postoperative blood transfusion (p[.0517).CONCLUSIONS: Aquablation clinically normalizes outcomes between patients with a 30cc to 80cc prostate and patients with an 80cc to 150cc prostate treated for LUTS/BPH with an expected increase in the risk of complication. It is effective in patients with large prostate glands (>80cc) with acceptable complications.
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