NxThera today released three-year results from a trial of its Rezūm convective water vapor wave energy system, touting effective and durable relief from lower urinary tract symptoms for patients with benign prostatic hyperplasia.
The trial was co-authored by co-principal investigators Dr. Kevin McVary of Southern Illinois University School of Medicine and Dr. Claus Roehrborn of the University of Texas Southwestern Medical Center, and results were published in the January 2018 issue of the journal Urology.
“Rezūm warrants consideration as a first-line treatment for BPH due to the durability of LUTS relief out to three years, along with its exceptional safety profile and no reported occurrences of erectile dysfunction. Additionally, Rezūm is a highly cost-effective solution for the healthcare system due to its low medical or surgical retreatment rate, including the ability to treat men with median lobe and hyperplastic central zone tissue. Symptomatic men who wish to move beyond watchful waiting or who have become dissatisfied with medical management should consider Rezūm as a low-risk treatment that is positioned between classical medical management and more invasive surgical approaches. The one-time procedure provides rapid, significant and durable relief of LUTS/BPH in contrast to a lifetime commitment of pharmaceutical agents in which there are undesirable side effects and an inferior symptom improvement,” Dr. McVary said in a prepared statement.
The Rezūm system uses steam to treat enlarged prostate tissue that causes BPH symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Results from the 197-patient trial indicated clinically significant and durable improvement in symptomatic relief as reflected in International Prostate Symptom Scores and urinary flow rate outcomes through to three years. Relief of symptoms was also noted through seven IPSS domains, including urgency and nocturia through to three years.
No latent adverse events were reported and no de novo erectile disfunction was reported, and sexual function was preserved in patients treated with the system as measured by the international index of erectile function and the male sexual health questionnaire through 3 years.
A total of 30 patients who received treatment to the median lobe showed significant improvements in symptoms and urinary flow rates as well as decreased post-voiding residual urine from two to three years.
The rate of surgical retreatment was 4.4% over three years, the company said.
“This positive three-year data clearly demonstrates compelling sustained clinical outcomes that provide urologists with an effective minimally invasive treatment option for their patients who may have been watchfully waiting, or treating their LUTS with medications. Rezūm is transforming the BPH treatment experience for urologists and their patients by providing a versatile, in-office or outpatient treatment option that allows men suffering from BPH to resume their quality of life and preserve sexual function,” prez & CEO Bob Paulson said in a press release.
Last July, NxThera said it added another $6 million to its coffers in an ongoing round of debt financing.