New clinical study results say the Rezūm System provided significant, sustained improvement of lower urinary tract symptoms (LUTS) and quality of life for patients suffering from Benign Prostatic Hyperplasia (BPH) out to five years post-procedure.
Background
BPH is a common condition that affects roughly half of all men by the age of 60, and up to 90 percent of men by the age of 85. BPH can cause symptoms like frequent or urgent urination, a weak or interrupted urine stream, and the need to get up several times a night to urinate. Medications to treat BPH may not work for many or may have undesirable side effects. And some minimally invasive procedures may only treat BPH symptoms, not the underlying condition.
Boston Scientific’s Rezūm System addresses BPH symptoms directly by reducing adenoma tissue with water vapor through a minimally invasive procedure, allowing cell remnants to be absorbed directly by the body. The procedure is typically performed during a single visit to the physician’s office and does not require general anesthesia or surgical implants. The Rezūm System is included in The American Urological Association’s BPH treatment guidelines, with a positive safety profile through five years supporting its continued use for the reduction of the prostate.
Results of a five-year clinical trial confirming the long-term durability of Rezūm™ Water Vapor Therapy for treatment of benign prostatic hyperplasia (BPH) has been published in the Journal of Urology.
At the end of the five-year trial, the medication and surgical retreatment rates showed 4.4 percent of the Rezūm System patients required surgical retreatment through 5 years, with 11.1 percent of the Rezūm System patients requiring medications through five years
The study also solidified the therapy’s International Prostate Symptom Score (IPSS), Qmax (peak urinary flow rate) and quality of life improvements at 48 percent, 49 percent and 49 percent respectively, all significantly improved from baseline.
Investigator comments
“These new five-year results expand upon the growing clinical evidence supporting the long-term durability of the Rezūm System as the leading minimally invasive option for men facing moderate-to-severe BPH-related symptoms,” said Kevin McVary, MD, FACS, principal investigator of the clinical trial.
“This first-of-its-kind technology can provide significant and long-term quality of life improvements for my patients suffering from the complications of BPH, all while preserving sexual function.”
Company comments
“The results from this latest clinical trial underscore our commitment to physicians and their patients with urologic conditions,” said Meghan Scanlon, senior vice president and president, Urology and Pelvic Health, Boston Scientific.
“We continue to lead innovation in urology and these results further solidify the Rezūm System as the advanced option for patients seeking lasting, long-term relief from BPH symptoms in a simple, minimally invasive procedure.”
Source: Boston Scientific
