This first-in-man study was designed to demonstrate the safety and feasibility of Aquablation. This is a novel minimally invasive water ablation therapy combining image guidance and robotics (AquaBeam(®) ) for the targeted and heat-free removal of prostatic tissue in men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
A prospective, non-randomized, single-center trial in men between the ages of 50 - 80 years of age with moderate-to-severe LUTS was conducted. Under real-time image-based ultrasonic guidance, AquaBeam technology enables surgical planning and mapping, and leads to a controlled heat-free resection of the prostate using a high-velocity saline stream. Patients were evaluated at one, three, and six months.
Fifteen patients were treated with Aquablation under general anaesthesia. The mean age was 73 years (range of 59 to 86 years) and a mean prostate size of 54 ml (range of 27 to 85 ml). A significant median lobe was present in 6 of the 15 subjects. The mean International Prostate Symptom Score (IPSS) was 23 and peak urinary flow rate (Qmax) was 8. 4 ml/s at baseline. The mean procedural time was 48 minutes with a mean Aquablation treatment time of 8 minutes. All procedures were technically successful with no serious or unexpected adverse events. All but one patient had removal of catheter on day one, and the majority of patients were discharged on the first postoperative day. No patient required a blood transfusion, and post-operative sodium changes were negligible. No serious 30 day adverse events occurred. One patient underwent a second Aquablation treatment within ninety days of the first procedure. The mean IPSS score statistically improved from 23. 1 at baseline to 8. 6 at 6 months (P
These preliminary results from this initial study demonstrate Aquablation of the prostate is technically feasible with a safety profile comparable to other BPH technologies. The combination of surgical mapping by the operating surgeon and the high-velocity saline provides a promising technique delivering a conformal, quantifiable, and standardized heat-free ablation of the prostate. Advantages of this technique include reduction in resection time compared to other endoscopic modalities as well as the potential to preserve sexual function. This article is protected by copyright. All rights reserved.
BJU international. 2015 Oct 19 [Epub ahead of print]
Peter Gilling, Rana Reuther, Arman Kahokehr, Mark Fraundorfer
Department of Urology, Tauranga Hospital, Bay of Plenty District Health Board, Cameron Road, Private Bag 12024, Tauranga, 3143, New Zealand. , Department of Urology, Tauranga Hospital, Bay of Plenty District Health Board, Cameron Road, Private Bag 12024, Tauranga, 3143, New Zealand. , Department of Urology, Tauranga Hospital, Bay of Plenty District Health Board, Cameron Road, Private Bag 12024, Tauranga, 3143, New Zealand. , Department of Urology, Tauranga Hospital, Bay of Plenty District Health Board, Cameron Road, Private Bag 12024, Tauranga, 3143, New Zealand.