LBA16 AQUABLATION PROCEDURAL OUTCOMES FOR BPH IN LARGE PROSTATES (80-150G): RESULTS FROM THE WATERII STUDY

Abstract

You have accessJournal of UrologyPlenary: Next Frontier1 Apr 2018LBA16 AQUABLATION PROCEDURAL OUTCOMES FOR BPH IN LARGE PROSTATES (80-150G): RESULTS FROM THE WATERII STUDY Mihir Desai Mihir DesaiMihir Desai More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.03.111AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To present early safety and efficacy data from a multicenter prospective study of Aquablation in treatment of symptomatic men with BPH and prostate volumes 80-150 cc. METHODS 101 men with moderate-to-severe BPH symptoms and prostate sizes of 80-150g underwent Aquablation in a prospective multicenter international clinical trial. The primary safety endpoint was the occurrence of persistent CD Grade 1 or Grade 2 or higher operative complications at 3 months. The primary efficacy endpoint was the reduction in IPSS score at 3 months. Baseline demographics and standardized postoperative management parameters were carefully recorded in a central independently monitored database. Surgeons answered analog scale questionnaires on intraoperative technical factors and postoperative management. Adverse events through 1 month were adjudicated by an independent clinical events committee. RESULTS Mean prostate size was 107g (range 80 to 150). Mean Aquablation resection time was 8 minutes (3 to 15) and mean operative time was 37 minutes (15 to 97). Hemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (N=98, mean duration 18 hours) or direct tamponade using a balloon inflated in the prostate fossa (N=3, mean duration 15 hours). The average length of stay following the procedure was 1.6 days. The Clavien-Dindo (CD) grade 2 or higher event rate at 1 month was 28.7%. Six (5.9%) subjects required a blood transfusion during the index procedure hospitalization prior to discharge and 2 patients required fulguration postoperatively. Mean max flow rate increased from 8.7 mL/s to 21.3 mL/s, mean PVR decreased from 131 mL to 54 mL and mean IPSS scores decreased from 23.2 to 6.6, from baseline to 3-months follow-up, respectively. CONCLUSIONS This prospective multicenter trial shows that Aquablation is feasible and safe in men with symptomatic BPH and large prostate volumes (80-150g). Outcome and safety parameters will be further assessed up to the target 1 year follow up end point and seem comparable or superior to other established procedures currently used to treat large volume BPH. (ClinicalTrials.gov number, NCT03123250). © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e990 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Mihir Desai More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...