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.
Between September and December 2017, 101 men with BPH due to LUTS were prospectively enrolled at 16 centers from Canada and the US.
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.
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.