AQUABEAM robotic system use-results survey: Aquablation for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia in the Japanese Population.

Abstract

Objectives: To evaluate the safety, efficacy, and patient-reported outcomes of Aquablation therapy using the AQUABEAM Robotic System for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in a Japanese population.

Methods: This post-market use-results survey included 103 Japanese men with BPH who underwent Aquablation across five centers with previously Aquablation naïve physicians. Data were collected at baseline, during the procedure, at discharge, and at 3 and 6 months post-procedure. Key outcomes included International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, and adverse events.

Results: The mean age of patients was 71.1 years, and the average prostate size was 82.3 mL. At 6 months, the mean IPSS significantly improved from 18.1 ± 9.0 to 6.1 ± 5.0 (p < 0.0001), and QoL scores improved from 4.9 ± 1.3 to 1.8 ± 1.3 (p < 0.0001). Uroflowmetry showed a significant increase in Qmax from 8.3 ± 4.4 to 15.5 ± 7.8 mL/s (p < 0.0001) and a decrease in post-void residual volume (PVR) from 85.6 ± 107.2 to 43.3 ± 60.0 mL (p = 0.0006). At the 30-day primary safety endpoint, there were no reported adverse events of pad-use incontinence, erectile dysfunction, or ejaculatory dysfunction reported, and no device-related serious adverse events were reported. One subject (0.97%) experienced a Clavien-Dindo grade 3 adverse event.

Conclusions: Aquablation therapy using the AQUABEAM Robotic System is a reproducible, safe, and effective treatment for Japanese men with BPH, providing significant improvements in LUTS and QoL with a favorable safety profile.