Presentation Authors: Naeem Bhojani*, Montreal, Canada
Introduction: In a large, blinded, multicenter, randomized trial (WATER) (30-80cc), Aquablation, an ultrasound-guided, robotically executed waterjet ablative procedure demonstrated better outcomes in larger glands compared to TURP. These observations identified the need to assess the safety and efficacy of performing Aquablation in men with larger prostate glands (80-150cc) (WATER II). Herein we report the 6-month outcomes.
Methods: Between September and December 2017, 101 men with moderate-to-severe benign prostatic hyperplasia symptoms and prostate volume of 80-150cc underwent Aquablation in a prospective multicenter international clinical trial. Baseline demographics and standardized postoperative management parameters were carefully recorded in a central independently monitored database. Functional and safety outcomes were assessed at 6 months postoperatively.
Results: Mean prostate volume was 107cc (range 80-150). Mean operative time was 37 minutes with a mean Aquablation resection time of 8 minutes (range 3-17 minutes) and a mean of 1.8 treatment passes. The average length of stay following the procedure was 1.6 days (range same day-6 days). Bleeding complications were recorded in 10 (9.9%) patients during the index procedure hospitalization prior to discharge and included six (5.9%) peri-operative transfusions. 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). Mean IPSS improved from 23.2 (+/-6.3) at baseline to 11.5 (+/-6.6) at 1 month and 6.7 (+/-5.1) at 3 months meeting the study's primary efficacy endpoint goal (p < 0.0001). IPSS at 6 months was 5.9 (+/-5.4), a 75% reduction. Maximum urinary flow rate increased from 8.7 to 18.8 cc/sec (an improvement of 10.4 cc/sec, p < 0.0001) and post-void residual decreased from 131 at baseline to 47 at 6 months (a 91-cc decrease). 81% of the sexually active men in this study (107cc baseline prostate size) maintained their ejaculatory function. At 6 months, PSA reduced from 7.1 (+/-5.9) ng/mL to 4.0 (3.9+/-) ng/mL, a 44% reduction.
Conclusions: With 6 months follow-up, Aquablation is safe and effective in treating men with larger prostates (80-150cc) without significant increase in procedure or resection time. The one year follow up will be completed in December 2018 and those results will be available for the 2019 AUA Congress. ClinicalTrials.gov number, NCT03123250.Presentation on behalf of the Water II investigators
Source of Funding: PROCEPT BioRobotics