One-year results from the OPEN WATER trial published in the Journal of Clinical Medicine
REDWOOD CITY, Calif.–(BUSINESS WIRE)–#Aquablation—PROCEPT BioRobotics Corporation, a surgical robotics company developing intelligent solutions to transform the field of urology, has announced that the safety and efficacy outcomes from a multi-center study of Aquablation therapy replicated those achieved in its pivotal clinical trials. Aquablation therapy is a procedure for the treatment of benign prostatic hyperplasia (BPH), and is performed by the AquaBeam® Robotic System, the first FDA cleared, automated surgical robot for the treatment of this common condition.
“This study provided a very important validation of Aquablation therapy, as this is the first multi-center publication of outcomes in a commercial setting,” said Reza Zadno, president and CEO of PROCEPT BioRobotics. “These findings not only confirm the outcomes we saw in our landmark clinical trials but will also help encourage acceptance and adoption of Aquablation therapy as a new BPH treatment of choice for all prostates, in markets worldwide.”
OPEN WATER was a prospective, multicenter, single-arm, open-label clinical trial of the Aquablation procedure. One hundred and seventy-eight men with prostates sized between 20 and 150 cc were enrolled between September 2017 and December 2018 across five geographies, including Hamburg, Germany; Tauranga, New Zealand; Beirut, Lebanon; Melbourne, Australia; and Frimley, England.
The study data, which were published in the Journal of Clinical Medicine, demonstrated large improvements at 12 months in symptom relief and peak urinary flow rates while preserving sexual function and urinary continence. Similar levels of symptom relief were seen independent of surgical experience. Moreover, the authors reported that no patient underwent a secondary procedure for recurrent BPH symptoms.
“As noted in our paper, the OPEN WATER study results indicate that the Aquablation procedure provides high levels of symptom relief, consistent with most resective techniques, but with an approximately eight times lower impact on sexual function,” said lead author Prof. Thorsten Bach, Asklepios Westklinikum Hamburg-Rissen. “The magnitude of symptom relief combined with such low rates of sexual dysfunction should give confidence to every urologist considering the adoption of Aquablation therapy in his or her practice.”
About PROCEPT BioRobotics Corporation
PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the AquaBeam Robotic System delivering Aquablation therapy is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms due to BPH. Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience. For more information visit https://www.procept-biorobotics.com.
Important Safety Information
All surgical treatments have inherent and associated side effects. The most common side effects are mild and transient, and may include mild pain or difficulty when urinating, discomfort in the pelvis, blood in the urine, inability to empty the bladder or a frequent and/or urgent need to urinate, and bladder or urinary tract infection. Other risks include ejaculatory dysfunction and a low risk of injury to the urethra or rectum where the devices gain access to the body for treatment. For more information about potential side effects and risks associated with Aquablation therapy, speak with your urologist or surgeon. No claim is made that the AquaBeam Robotic System will cure any medical condition, or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may sometimes be required.
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