US-based medical device firm Procept BioRobotics has started treating patients in its global Phase III clinical trial (WATER study) of the AquaBeam system to treat lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH).
The trial is designed to evaluate the safety and effectiveness of the AquaBeam system compared to the current standard of care, transurethral resection of the prostate (TURP).
The first patient in the trial was treated at Urology Bay of Plenty in Tauranga, New Zealand. The system combines image guidance and robotics to deliver Aquablation, a waterjet ablation therapy that allows targeted, controlled and heat-free removal of tissue to treat lower urinary tract symptoms.
BPH is a common prostate problem that affects more than 50% of men over the age of 50.
Waterjet Ablation Therapy for Endoscopic Resection (WATER) of prostate tissue is a prospective randomised US investigational device exemption (IDE) clinical trial for male patients between the age of 45 and 80 who have urinary symptoms due to BPH.
Tauranga Hospital surgery associate professor Peter Gilling said: "Despite the advances with laser technology, TURP is still the most common procedure worldwide for the treatment of lower urinary tract symptoms.
"While it has demonstrated durable results, it does come with certain risks affecting sexual function, ejaculation and incontinence problems.
"The AquaBeam system utilises a heat-free approach and along with the combination of image guidance and robotics has the potential to standardise BPH surgery, reduce the level of complexity required to deliver safe and effective therapy and ultimately improve the quality of life for men suffering from BPH.
"This trial has been designed to evaluate these measures."
Approximately 200 patients in up to 20 global sites, including 12 sites in the US will be enrolled in the trial.
Procept Biorobotics co-founder Nikolai Aljuri said: "The early clinical experience with Aquablation has demonstrated much promise and has evolved into a treatment scalable to hospitals worldwide.
"The initiation of the WATER study is an important step to achieve our goal of providing men suffering from BPH a minimally invasive solution that offers both a sustainable and significant improvement to quality of life and a reduced risk of sexual side effects."
Procept BioRobotics develops new minimally invasive technology to surgically treat prostate disease. The first product developed is the AquaBeam system that allows surgical planning and mapping.