Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL): 6‐month results from the WATER II trial

Abstract

Objective To present 6‐month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. Methods Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. Results The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 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 < 65% (P < 0.001). At 6 months, 22% of the patients 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 eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score 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 < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post‐void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate‐specific antigen concentration 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 (80–150 mL), without significant increase in procedure or resection time.

The role of novel minimally invasive treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia

“…Urodynamics demonstrated that before the operation 79% in the aquablation group and 95% of patients in the TURP group were obstructed vs 22% in both groups after the operation at 6 months [7]. The Water II study recruited 101 patients with a mean (range) prostate volume of 107 (80–150) mL; 12‐months follow‐up data are currently available [5]. The ablation time was 8 min, total operation time 35 min, and mean hospitalisation time 1.6 days.…”

“…Water II (prostate volume 80–150 mL, mean volume 107 mL) has opened a potential clinical scenario, i.e. in treating large prostates [5]. Alternatives for these patients are open/minimally invasive (laparoscopic or robot‐assisted) adenomectomy or transurethral enucleation.…”

“…Efficacy The two pivotal trials for aquablation are the 'Water I' and 'Water II' studies [4,5]. In Water I, a double-blind, multicentre, prospective RCT, 181 patients underwent TURP or aquablation [4].…”

Die chirurgische Therapie der benignen Prostataobstruktion (BPO) beim antikoagulierten Patienten: eine Übersichtsarbeit über die Blutungsrisiken etablierter Techniken

“…Die Datenlage zeigt gute funktionelle Ergebnisse vergleichbar der TURP. Im Rahmen des RCT WATER II zeigte sich jedoch ein erhöhtes Blutungsrisiko: 13,9 % der Patienten erlitten Nachblutungen, 7,9 % erhielten eine BT, 3 % mussten transurethral operativ revidiert werden, und 2 % benötigten sowohl operative Revision als auch BT [9]. Die Aquaablation scheint sich anhand der aktuellen Datenlage nicht für Patienten unter AC/TAH anzubieten, die EAU-Leitlinie stuft die Aquaablation als Alternative zur TURP mit jedoch erhöhtem Blutungsrisiko ein [13].…”

Aquablation for benign prostatic obstruction: Single center technique evolution and experience

“…Multi-center prospective studies demonstrated the efficacy and safety of this procedure [6,7]. In the Waterjet Ablation Therapy for Endoscopic Resection (WATER I) of prostate tissue trial, the authors showed that aquablation has comparable functional outcomes to TURP, but has a superior ability in preserving ejaculation by sparing the verumontanum [6].…”