Clinical Data

Proven clinical results with Aquablation^® therapy

PROCEPT BioRobotics® is committed to delivering clinical excellence and has supported the execution of several studies evaluating Aquablation therapy. The robust body of clinical data is based on four studies from the WATER, WATER II, OPEN WATER, and JAPAN PMS for a broad range of prostate sizes, which support the safety, efficacy, and durability of Aquablation therapy as a solution for BPH.

A summary of the four major studies evaluating Aquablation therapy:

Safety

Low rates of irreversible complications across prostates of all shapes and sizes

The safety profile of Aquablation therapy is characterized by the incidence of irreversible complications, such as erectile dysfunction, ejaculatory dysfunction, and incontinence.

In clinical studies, Aquablation therapy demonstrated low rates of irreversible complications across four major studies with varying patient profiles, prostate shapes and sizes, and surgeon experience.^1-3

Aquablation therapy delivers best-in-class safety results by enabling surgeons to:

Visualize and preserve key anatomical structures associated with sexual and urinary function, such as the bladder neck, verumontanum, and external sphincter
Customize the resection contour to each patient’s anatomy to optimize tissue resection and anatomical preservation

Efficacy

Best-in-class, durable results across prostates of all shapes and sizes

Efficacy following a BPH procedure is determined by symptom reduction and quality-of-life improvement.

The efficacy of Aquablation therapy is characterized by change in BPH symptom scores, urinary flow rates, and quality-of-life scores at each follow-up point.
The WATER data revealed that Aquablation therapy has a similar symptom reduction and quality-of-life improvement to TURP at all follow-up points¹
Analysis of a patient subgroup within the WATER study of patients with prostates above 50 mL revealed that Aquablation therapy was superior in symptom reduction as compared with TURP¹

WATER II evaluated Aquablation therapy specifically in large prostates, showing best-in-class symptom reduction

The symptom reduction and quality-of-life improvement observed across the WATER, WATER II, OPEN WATER, and JAPAN PMS studies demonstrate the size- and shape-independent efficacy of Aquablation therapy.^1-3 The low retreatment rates from the four studies support the durability in efficacy results of the procedure.

Efficacy data from all four studies characterized by metrics such as IPSS, IPSS quality of life, post-void residual volume, and peak flow rate over a 5-year follow-up.

About the studies

A double-blind, prospective, randomized controlled clinical trial

The WATER Study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) set out to challenge the industry gold standard, TURP, in treating BPH. The bold study design examined the safety and efficacy of resecting prostates 30 mL to 80 mL in a double-blind, prospective, randomized, controlled clinical trial.

The landmark results of the WATER study concluded that Aquablation therapy is superior in safety and noninferior in efficacy to TURP. Aquablation therapy significantly reduced the rate of irreversible complications driven by ejaculatory dysfunction and matched improvement in symptom score, urinary flow rate, and residual urinary volume.

Analysis of a patient subgroup with prostates above 50 mL revealed that Aquablation therapy was superior in safety and symptom reduction. The results from WATER depict the size independence of Aquablation therapy and durability of outcomes out to 5 years.

A single-arm, prospective, clinical trial

The WATER II study evaluated the safety and efficacy of Aquablation therapy on prostates 80 mL to 150 mL in a single-arm, prospective, clinical trial. As the only successfully completed study to assess treatment among large prostates, the WATER II study concluded that Aquablation therapy significantly improved symptom scores and urinary flow rates.

The results from WATER II depict the size independence of Aquablation therapy and durability of outcomes out to 5 years. Conclusion of this clinical study prompted assessment in a commercial setting to validate results.

A prospective, multicenter, real-world study

OPEN WATER was conducted in a commercial setting, spanning patients with prostates between 20 mL and 150 mL. The results validated clinical study outcomes in a real-world setting and supported the size and shape independence of the therapy.

A prospective, real-world cohort

JAPAN PMS is a prospective, multicenter, real-world study conducted in a commercial setting, spanning patients with prostates between 33 mL and 242 mL. The results validated clinical study outcomes in a real-world setting and supported the size and shape independence of the therapy.

View publications

References:

Gilling PJ, et al. Can J Urol. 2022.
Data on file, PROCEPT BioRobotics.
Leong JY, et al. Curr Sex Health Rep. 2019.
Comiter CV, Speed J. UpToDate. 2024.
Sapetti J, et al. Prog Urol. 2019.
Khera M. Medscape. 2023.