Minnesota-based medical device company NxThera, Inc. recently announced the completion of the enrollment phase of a clinical trial to test new technology for treating benign prostatic hyperplasia (BPH). A Texas-based researcher is part of the new trial, serving as co-principal investigator.
NxThera, which specializes in developing new technologies for treating a range of urologic diseases, will now begin the testing phase of its Rezūm II IDE clinical trial. The trial will evaluate the use of the company’s novel Rezūm® System, which utilizes a convective-based system that delivers sterile steam directly into the prostate as an obstructive prostate tissue treatment method. The technology allows physicians to use a minimally invasive medical procedure that only takes a few minutes to perform.
NxThera’s trial will test the new procedure in several different investigation centers across the U.S., which will include 195 men who are age 50 or older, who will be randomized 2:1 to treatment with the Rezūm System versus a control procedure. Both co-principal investigators for the trial, Kevin McVary, MD, a Professor and Chairman of Urology at Southern Illinois University, and Claus Roehrborn, MD, Professor and Chairman of Urology at the University of Texas Southwestern, noted in a recent press release from NxThera that, “The Rezūm II clinical trial is designed to collect comprehensive information for review and evaluation by FDA and physicians,” adding that they ” . . . look forward to completing the required follow-up assessments and evaluating patients’ outcomes in conjunction with the promising data previously reported from NxThera’s single-arm Rezūm trials.”
BPH is a common health issue for men over 60. The condition leads to the constriction of normal urine flow from the bladder, which is typically the result of an enlarged prostate. As a result, BPH symptoms, such as an increased frequency of urination, sudden urges to urinate, and a weak flow of urine can diminish quality of life for patients. Considering that more than 32 million men in the United States — 70% of which who are over the age of 60 — deal with these symptoms, the Rezūm® System if proven to be effective could offer relief from BPH which, if left untreated, can progress into other conditions like incontinence, bladder stones, and even kidney or bladder damage. Thus far, the standard treatment for BPH is medicinal and typically offers only temporary relief along with side effects. The Rezūm® System promises long-lasting relief from the condition with no side effects.
“It was very rewarding and exciting to see independent clinical study teams at 14 U.S. sites complete recruitment and enrollment of the Rezūm II trial in just 44 weeks, which speaks to the number of men who are seeking alternatives to currently available BPH treatments and procedures,” said Bob Paulson, President & CEO of NxThera. “We look forward to filing our submission with FDA in 2015 to seek U.S. market clearance of the Rezūm System, and the opportunity to offer a new treatment option to urologists and the millions of their patients who suffer from BPH.”