NxThera, a therapeutic device company responsible for the development of the Convective Water Vapor Energy (WAVE) technology platform, presented the sexual function preservation data from a trial evaluating the Rezūm system for the treatment of benign prostatic hyperplasia (BPH) at the 2016 American Urological Association annual meeting in San Diego earlier this month.
The presentation, “Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia with Convective Water Vapor Energy Ablation: Preserved Erectile and Ejaculatory Function,” affirms the system as an effective non-pharmaceutical treatment option for men with BPH secondary to lower urinary tract syndrome (LUTS).
The Rezūm II IDE pivotal study enrolled 197 men from 15 centers across the U.S. The men were age 50 or older and had International Prostate Symptom Scores (IPSS) of 13 or higher. The patients were randomized to either a group where they would receive the Rezūm treatment, which works by radiofrequency energy, creating sterile water vapor that convectively delivers thermal energy treatment, or to a control group, receiving rigid cystoscopy with simulated active treatment sounds.
The researchers reported symptom reduction and preserved sexual function among the patients, with the study establishing the safety and effectiveness of the system. Results on erectile and ejaculatory function of patients enrolled in the study had previously been published in the Journal of Sexual Medicine, in a research paper titled “Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study.”
“The progressive and increasingly bothersome symptoms of BPH afflict more than 75 percent of men in this country over the age of 65, and LUTS is strongly correlated with compromised sexual function,” said Kevin T. McVary, M.D., professor and chair, Division of Urology at Southern Illinois University School of Medicine, in a news release.
“As urologists, we need BPH treatment options for our patients who decline, are resistant to, or are dissatisfied with medical management therapies, or who are unwilling or unable to undergo a surgical procedure. This data demonstrates the Rezūm system not only provides an effective first-line treatment option for men suffering from BPH, but does so while preserving sexual function and improving their quality of life,” McVary said.