Waterjet Ablation Therapy for Treating Benign Prostatic Obstruction in Patients with Small- to Medium-size Glands: 12-month Results of the First French Aquablation Clinical Registry

Abstract

Background: Aquablation has emerged as a novel ablative therapy combining image guidance and robotics for targeted waterjet adenoma resection.

Objective: To describe a standardised technique of aquablation in the treatment of benign prostatic obstruction (BPO), and to report the perioperative and 1-yr functional outcomes obtained by multiple surgeons with no previous experience of the technique.

Design, setting, and participants: Between September 2017 and January 2018, patients referred to three different urological centres for BPO surgical management were prospectively enrolled to undergo an aquablation procedure.

Surgical procedure: Aquablation was performed using the Aquabeam system (Procept BioRobotics, Redwood Shores, CA, USA) that combines transrectal prostatic image guidance and robotics bespoke tissue resection with a high-pressure saline jet. The surgeon defines the area of treatment, and the resection is executed automatically.

Measurements: The primary endpoint was the change in total International Prostate Symptom Score (IPSS) score at 6 and 12mo. Functional outcomes were assessed at 1, 3, 6, and 12mo with IPSS, International Index of Erectile Function (IIEF)-15, Sexual Health Inventory for Men, and Male Sexual Health Questionnaire questionnaires and uroflowmetry.

Results and limitations: Thirty patients were enrolled in the study. The median operative time and resection time were 30.5 (24-35) and 4 (3.1-4.9)min, respectively. The median catheterisation time was 43 (23-49)h. The median hospitalisation stay was 2 (2-4)d. The IPSS score improved to 3 (1-6) at the 6mo, with a mean change of 15.6 points (95% confidence interval 13-18.2). IPSS improvements persisted at month 12. The maximum urinary flow rate improved to 20.4 (17-26)ml/s at 12mo. The 6-mo rates of Clavien-Dindo grade 2 and 3 events were 13.3%. There were no reports of incontinence or de novo erectile dysfunction. Postoperative de novo ejaculatory dysfunction was observed in 26.7% of patients.

Conclusions: This clinical registry confirmed that aquablation was feasible, safe, and effective, and provided immediate good functional results and similar outcomes to those of prior studies despite the lack of surgeons' previous experience with the technique.

Patient summary: Aquablation is feasible, safe, and reproducible with promising outcomes for treating benign prostatic enlargement.

Keywords: Aquabeam; Aquablation; Benign prostatic hyperplasia; Prostate; Waterjet.