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Furthering the external validity of Aquablation and implications for real-world patients

  • David-Dan Nguyen
  • Naeem Bhojani
  • Kevin C. ZornEmail author
Letter to Editor

Dear Editor,

Despite international variance, the approval process for novel surgical devices employs various means to evaluate two key aspects of new technology: safety and efficacy. To do so, prior to full clearance, devices are assessed in a controlled experimental setting; ideally, randomized trials would be the default option in this stage [1]. Aquablation, a robotically executed, surgeon-guided, high-pressure water jet technology integrating real-time ultrasonography for the treatment of benign prostatic hyperplasia (BPH), underwent such an evaluation leading to FDA approval in December of 2017 following the WATER clinical trial (NCT02505919) that demonstrated that Aquablation was safe and efficacious in men with prostates between 30 and 80 cc [2].

However, clinical trials are limited by their own design; notably, a well-designed randomized control trial requires stringent inclusion and exclusion criteria limiting its external validity [3]. To palliate to these external validity...

Notes

Author contributions

DDN: manuscript writing/editing. NB: manuscript writing/editing and review. KCZ: manuscript writing/editing and review.

Compliance with ethical standards

Conflict of interest

NB and KCZ participated in WATER II. WATER II study data were entered into an electronic data capture system by site coordinators, were monitored, and source verified by monitors hired by the study sponsor (PROCEPT BioRobotics). No author of this letter has a conflict of interest with PROCEPT BioRobotics.

Research involving human participants and/or animals

None for this letter to the editor.

Informed consent

Not applicable for the letter to the editor.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • David-Dan Nguyen
    • 1
  • Naeem Bhojani
    • 2
  • Kevin C. Zorn
    • 2
    Email author
  1. 1.Faculty of MedicineMcGill UniversityMontrealCanada
  2. 2.Division of UrologyUniversité de Montréal Health CentreMontrealCanada

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