Background and aims:
The outcomes of Aquablation in men with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) with prostate volumes between 80-150cc have not been prospectively studied. Present 6-month safety and effectiveness data from a multicenter prospective study of Aquablation.
Methods:
Between September and December 2017, 101 men with BPH due to LUTS were prospectively enrolled at 16 centers from Canada and the US.
Results:
Mean prostate volume was 107cc. The average length of stay following the procedure was 1.6 days (range same day-6 days). The primary safety endpoint (Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of less than 65% (p<0.0001). At 6 months, 22% of subjects had experienced a Clavien-Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in 8 patients prior to discharge and 6 patients post discharge. Mean IPSS improved from 23.2±6.3 at baseline to 6.7±5.1 at 3 months meeting the study's primary efficacy endpoint goal (p<.0001). Maximum urinary flow rate increased from 8.7 to 18.8 cc/sec (p<.0001) and post-void residual decreased from 131 at baseline to 47 at 6 months (p<.0001). At 6 months, PSA reduced from 7.1±5.9 ng/mL at baseline to 4.0±3.9 ng/mL, a 44% reduction.
Conclusions:
Aquablation is safe and effective in treating men with larger prostates (80-150cc) without significant increase in procedure or resection time. ClinicalTrials. gov number, NCT03123250. This article is protected by copyright. All rights reserved.
