A Commitment to Clinical Excellence
Recognizing the importance of robust clinical data, PROCEPT BioRobotics has invested in two global pivotal clinical studies to support Aquablation therapy with the AquaBeam Robotic System.
The first study is the WATER Study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) directly comparing the safety and effectiveness of Aquablation therapy to the surgical gold standard transurethral resection of the prostate (TURP) in prostates 30 to 80 milliliters (mL) in size. The study is a double-blind, prospective, randomized clinical trial conducted under U.S. investigational device exemption (IDE) and completed enrollment in December 2016.
As a follow-up to the WATER study, the WATER II Study is a single-arm, prospective clinical study evaluating the safety and efficacy of Aquablation therapy in large prostates 80 to 150 mL in size. The study completed enrollment in December 2017.
- Primary Safety 3 Months
- Primary Efficacy 6 Months
- Pre-specified Subgroup Analysis – Larger Prostates
- Symptom Score Comparison - 1 Year
The WATER Study enrolled 181 patients, ages 45 to 80 years, with urinary symptoms due to BPH, at 17 sites in the United States, UK, Australia and New Zealand. Randomized to the surgical gold-standard TURP, Aquablation therapy with the AquaBeam System met its primary clinical endpoints demonstrating superior primary safety (3 months) and non-inferior primary efficacy (6 months) results.
The primary endpoint results were presented at the 2017 American Urological Association (AUA) Annual Meeting in Boston (view the presentation), with the one year results presented at the 2018 AUA Annual Meeting in San Francisco.
The WATER II Study enrolled 101 male patients, ages 45 to 80 years, with urinary symptoms due to BPH, at 16 sites in the United States and Canada. Primary endpoint results of the WATER II Study were presented at the 2018 AUA Annual Meeting in San Francisco. Aquablation therapy with the AquaBeam System met its primary clinical endpoints for both safety (3 months) and efficacy (3 months) results compared to the pre-defined measures. The data demonstrated that use of Aquablation therapy in men with large prostates (80 to 150 mL) resulted in a significant improvement in both symptom scores and urinary flow rates..
Primary Safety – 3 Months
The 3-month primary safety endpoint rate was lower in the Aquablation group compared to TURP (26% vs. 42%, p=.0149) demonstrating superiority.
The rate of persistent grade 1 events at month 3 was lower (7% vs. 25%, p=.0004) after Aquablation and the rate of grade 2 and above events was similar across groups (20% for Aquablation vs. 23% for TURP, p=.3038). The safety results held consistent at 6 months.
* Occurrence of complications graded using the Clavien-Dindo (CD) system rated as grade 2 or higher or persistent grade 1 ** CD1P incontinence, erectile dysfunction, and ejaculatory dysfunction. CD2+ events requiring pharmacological treatment, blood transfusions, endoscopic, surgical or radiological interventions, or potentially life-threatening conditions
Primary Efficacy – 6 Months
Aquablation therapy showed comparable efficacy outcomes (non-inferior) to the gold standard TURP.
Pre-specified Subgroup Analysis – Larger Prostates
Superior symptom improvements in men with larger prostates. Aquablation therapy resulted in statistically superior symptom improvements compared to TURP in a pre-specified subgroup analysis of men with larger prostate volumes (between 50 and 80 mL).
Symptom Score Comparison – 1 year
Aquablation therapy shows comparable symptom scores to the gold standard TURP.
Aquablation therapy showed a superior safety profile with very strong efficacy outcomes comparable to TURP
- 100% of Aquablation patients improved IPSS at six months compared to baseline
- 90% of Aquablation patients improved IPSS by 50% or more at six months
- Superiority in IPSS improvement with Aquablation therapy in men with prostate volume greater than 50 mL as compared to TURP (p<0.01) through six months
- A significantly lower rate of ejaculatory dysfunction among sexually active men (1 to 4 ratio, p=0.001) as compared to TURP at six months. In sexually active men with prostate volume greater than 50 mL, ejaculatory dysfunction was significantly less common after Aquablation (2%) vs. TURP (41%), p=0.0001
- Improved incontinence severity scores (ISI) at six months
- Superiority in overall sexual satisfaction as compared to TURP at six months