NxThera, Inc., a therapeutic device company responsible for the development of the Convective Water Vapor Energy (WAVE) technology platform for the treatment of Benign Prostatic Hyperplasia (BPH), has published the results from its Rezūm II study. The data from the first year of this multicenter study, revealing the results of transurethral prostate convective water vapor thermal energy treatment of lower urinary tract symptoms (LUTS) secondary to BPH, was published online in The Journal of Urology.
The study, titled “Minimally Invasive Prostate Convective Water Vapor Energy (WAVE) Ablation: A Multicenter, Randomized, Controlled Study for Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia,” enrolled 197 men from 15 centers across the U.S, with 50 years old or over and International Prostate Symptom Scores (IPSS) 13 or higher. The patients were randomized to either a group receiving the Rezūm treatment (which is based on radiofrequency energy that creates sterile water vapor to convectively deliver thermal energy treatment), or to a control group receiving rigid cystoscopy with simulated active treatment sounds. The researchers documented symptom reduction and preserved sexual function among patients and set the study’s primary endpoint to IPSS reduction at 3 months.
The first year results revealed the Rezūm treatment met all the primary and secondary clinical study endpoints, namely significant improvement of symptom scores and urinary flow rates, with erectile and ejaculatory function was preserved. Moreover, IPSS significantly decreased at 2 weeks by 50% or higher at 3, 6 and 12 months, peak urinary flow rates improved 6.3 ml/sec at 3 months with continuous improvement throughout 12 months. Importantly, mild to moderate adverse effects were resolved within weeks.
These impressive results led NxThera to recently launch, in the U.S, a limited release of Rezūm System with more than thirty-five patients receiving Rezūm treatment from urologists at five leading U.S. urology clinics in the first 8 days after its release.
Bob Paulson, President & CEO of NxThera, sated in a press release, “We are honored to have the opportunity to offer urologists and their patients a transformative new BPH treatment option which not only improves urological health, but also addresses the clinical and lifestyle objectives of urologists and their patients. The compelling clinical results from our Rezūm II pivotal study demonstrate a minimally invasive treatment option that can be performed in a variety of clinical settings, including as an in-office procedure. We are committed to provide urologists with world-class clinical training and patient education to support them in their efforts to improve the lives of men suffering from BPH.”