Procept BioRobotics’ BPH treatment Aquablation meets primary endpoints in phase III study

Procept BioRobotics’ benign prostatic hyperplasia (BPH) treatment Aquablation therapy has met its primary safety and efficacy endpoints in the global phase III waterjet ablation therapy for endoscopic resection of prostate tissue (WATER II) study.

The study demonstrated the achievement of primary safety and efficacy endpoints for Aquablation in the treatment of BPH.

Procept’s study showed the use of Aquablation in men with prostate volumes ranging from 80 from 80 to 150 milliliters (mL) improved both symptom scores and urinary flow rates.

Delivered by the firm’s AquaBeam system, Aquablation uses a robotically controlled waterjet to remove prostate tissue without applying heat.

The company enrolled 101 male patients aged between 45 years and 80 years in the single-arm and prospective WATER II study, which was conducted at 16 sites in the US and Canada.

The trial is a follow-up to the WATRE study, which demonstrated a better safety profile for Aquablation with enhanced efficacy outcomes comparable to transurethral resection of the prostate (TURP) to treat BPH in prostates size 30 to 80 mL.

WATER II study co-principal investigator Dr Mihir Desa said: “On the heels of the WATER Study, the results of the WATER II Study confirmed Aquablation delivers predictable and reproducible results regardless of the size of the prostate.”

Desai also revealed the results of a pooled analysis of 364 men with prostates ranging from 20 to 150 mL who were treated with Aquablation under five different clinical trials across six countries.

Aquablation showed a very low rate of major bleeding events in the analysis of all 364 patients. The analysis also demonstrated the use of heat-free hemostasis techniques showed no difference in overall bleeding events compared against cautery after Aquablation.

Procept BioRobotics co-founder and CEO Nikolai Aljuri said: “PROCEPT BioRobotics is committed to sound clinical research and we are excited to have the results of our second pivotal study presented as part of the AUA late-breaking abstracts for the second year in a row.”