A large and potentially definitive Phase 3 clinical trial to test a new, minimally invasive method of treating lesser urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) is now enrolling patients. The WATER study trial will certainly compare the safety and efficacy of a procedure known as Aquablation along with TURP, the latest standard for treatment.
In LUTS, an abnormally enlarged prostate gland severely irritates or obstructs the uretha, making the correct and finish emptying of the bladder difficult so that urine is retained in the body. The 2 Aquablation and TURP — the transurethral resection of the prostate using an electric current — handle this by removing the excess tissue causing the blockage. However TURP, while a successful surgical method, carries risks related to surgery also as risks such as incontinence (urine leakage), retrograde ejaculation (ejaculation in to the bladder) and, though infrequent, erectile dysfunction.
Created by Redwood Shores, California-based PROCEPT BioRobotics, the AquaBeam System that delivers Aquablation is created to increase LUTS treatment by being The 2 targeted and heat-free. The system combines image recommendations and robotics to deliver Aquablation, a high-velocity waterjet therapy, to remove prostatic tissue, and aims to be the brand-new treatment standard.
“Interventional therapy is an option to alleviate symptoms for men that fall short medical management of benign prostatic hyperplasia, However current selections are a trade-off between improvement of patient symptoms and a risk of complications. There is a requirement for a minimally invasive solution that offers a sustainable and substantial improvement to quality of life and a low risk of side effects, including sexual adverse effects,” said Nikolai Aljuri, Ph.D., founder and CEO of PROCEPT BioRobotics.
“Our outcomes represent a step in the right direction as they suggest the potential for Aquablation to revolutionize the prostate treatment paradigm. We anticipate the initiation of the WATER study, our global Phase 3 clinical study evaluating the safety and effectiveness of AquaBeam as compared to the latest standard of care.”
A total of >200 men, ages 45 to 80, will certainly be enrolled in the randomized and single-blinded WATER study at 10 sites across the U.S., section of a collection of ongoing and worldwide Phase 3 clinical trails comparing the safety and effectiveness of the 2 procedures to handle LUTS. Those primary endpoints will certainly be evaluated at six months for safety and 6 months for efficacy after the procedure, along with effectiveness measured using the worldwide Prostate Symptom Score (IPSS) in The 2 Aquablation and manage groups. Participants will certainly be followed for up to three years to permit for lasting analysis. The study expects to complete compiling endpoint data by December 2017, and be completed by September 2019.
The Aquabeam System was revealed to have actually a 100 percent technical triumph rate, and IPSS scores that improved from 23.1 at baseline to 8.6 at 6 months in an earlier clinical trial in brand-new Zealand, one of several Phase 1 and Phase 2 studies in to its use. Mean prostate size at 6 months additionally low by 31 percent from baseline, according to study results. side events were described as minimal and transient, and there were no reports of incontinence, or loss of erectile function. The mean procedural time was 48 minutes, along with an Ablation treatment time of eight minutes; in a larger trial in Australia and brand-new Zealand, it was reported to be 38 and 5 minutes, respectively. TURP, in contrast, usually takes between 60 and 90 minutes.
“Aquablation is a minimally invasive technique that outcomes in efficient and precise resection of prostate tissue and could lessen the risks and discomfort associated along with prostate surgical procedures,” said Dr. Peter Gilling, the trial’s principal co-investigator. “The technology created by PROCEPT BioRobotics has actually the potential to standardize benign prostatic hyperplasia surgery, reduce the degree of complexity needed to deliver safe and efficient therapy and ultimately increase the quality of life for men suffering from benign prostatic hyperplasia.”
Preclinical studies, including in a dog model, additionally showed that the Aquabeam system selectively and successfully ablated prostate tissue devoid of injury to nearby structures adore blood vessels, researchers reported.
Throughout the entire procedure, the extent and depth of the ablation is predetermined by endoscopic and transrectal ultrasonography guidance, essentially tailoring each procedure to the personal requires of a patient. Removed tissue is collected for further analysis.
“The early clinical experience along with Aquablation has actually demonstrated considerably promise and has actually evolved in to a treatment scalable to hospitals worldwide,” Aljuri said. “The initiation of the WATER study is an essential step to achieve our target of providing men suffering from BPH a minimally invasive solution that offers The 2 a sustainable and substantial improvement to quality of life and a low risk of sexual adverse effects.”
Other countries conducting Phase 3 investigations in to Aquablation versus TURP as section of the WATER study are Germany, Switzerland, and the United Kingdom in Europe, and Australia and brand-new Zealand. WATER stands for Waterjet Ablation Therapy for Endoscopic Resection of the prostate tissue.
PROCEPT BioRobotics is a medical device business focused on the improvement of minimally invasive technology to surgically handle prostate disease.
Anyone considering a lot more short article on the WATER study, including enrollment short article and the location of the 10 U.S. sites conducting the trial, can use this link or access the formal study on clinicaltrials.gov (NCT02505919).