MAPLE GROVE, Minn., May 16, 2017 /PRNewswire/ -- NxThera, Inc., a medical device company pioneering the application of its convective radiofrequency thermotherapy to treat endourological conditions, announced the presentation of data demonstrating the effectiveness of its minimally invasive Rezūm® System to treat obese men suffering from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) at the 2017 American Urological Association (AUA) Annual Meeting in Boston. The AUA also named this presentation as a Best Abstract out of nearly 3,000 abstracts presented during the conference.
The abstract, entitled, "Convective Radiofrequency Water Vapor Energy Ablation (Rezūm) Effectively Treats Lower Urinary Tract Symptoms Due to Benign Prostatic Enlargement Regardless of Obesity While Preserving Erectile and Ejaculatory Function," was presented by Dr. Nikhil Gupta, urologist at Southern Illinois University School of Medicine, and a fellow of Dr. Kevin McVary. The data presented by Dr. Gupta demonstrated that obese men, defined as having a body mass index (BMI) of 30 or more, enrolled in the study experienced similar improvements in International Prostate Symptom Score (IPSS), including both urinary storage and voiding domains, after a BPH procedure with the Rezūm System as compared to nonobese subjects. Obese subjects were more likely to have severe erectile dysfunction, but experienced a similar rate of minimal clinically important difference (MCID) and improvement in ejaculatory bother scores as those experienced by the non-obese subjects.
"Obesity is one of the strongest risk factors for the development of BPH and male LUTS. Additionally, in nearly all known treatments of male LUTS, whether traditional surgery or medical therapy, obesity is strongly associated with a reduced response to therapy and less improvement in urinary symptoms," Dr. Gupta said. "The results of this trial indicate that Rezūm is a promising, minimally invasive therapy for LUTS due to BPH, with the potential for long-term benefit, and the treatment effect of Rezūm is not dampened by obesity."
The Rezūm System uses radiofrequency current to create thermal energy that is convectively delivered to obstructive prostate tissue through targeted, precise treatments. The thermal energy ablates the tissue that causes BPH, which is resorbed by the body's immune system to alleviate the symptoms of BPH and improve patients' quality of life and ability to urinate.
In the Rezūm clinical study, 66 out of 196 (34 percent) patients were clinically obese. The controlled trial was conducted across 15 centers in the United States and the data demonstrated that obese patients who underwent treatment with the Rezūm System had similar improvements in IPSS and retained sexual function as reported via International Index of Erectile Dysfunction (IIEF-15) and Male Sexual Health Questionnaire for Ejaculatory Function (MSHQ-EjF) as compared to non-obese patients.
"As obesity continues to be a prominent factor in the prevalence of BPH, we're thrilled to provide urologists and their patients with a first-line BPH treatment option that is minimally invasive and equally effective in treating both obese and non-obese men, while preserving sexual function in both patient populations," said Bob Paulson, president and CEO of NxThera. "The results of this study continue to underscore the versatility of the Rezūm System, with capability to effectively treat the obstructive prostate tissue that causes BPH, including hyperplasia of the central zone."
For more information about the Rezūm System, visit www.Rezūm.com.
NxThera pioneered its convective radiofrequency thermotherapy platform technology to treat a variety of endourological conditions, beginning with BPH. The company is furthering the application of its technology platform through advanced research and development, and clinical studies, targeting the treatment of prostate cancer and kidney cancer. NxThera's FDA-cleared Rezūm System to treat BPH is a next-generation transurethral needle ablation system that uses radiofrequency to create thermal energy that is convectively delivered to obstructive prostate tissue in targeted, precise treatments, with minimal discomfort. Treatments with the Rezūm System improve the bothersome symptoms of BPH, including urine flow and quality of life. Founded in 2008, NxThera is located in Maple Grove, Minn. For more information, visit www.Rezūm.com.
SOURCE NxThera, Inc.