San Francisco, CA (UroToday.com) -- Results of a five-year clinical trial confirming the long-term durability of Rezūm™ Water Vapor Therapy for the treatment of benign prostatic hyperplasia (BPH) was published in the Journal of Urology. The supplement, available online now, includes standard and late-breaking abstracts for the American Urological Association (AUA) Annual Meeting.
The abstract notes that the study found the Rezūm System provided significant, sustained improvement of lower urinary tract symptoms (LUTS) and quality of life for patients suffering from BPH out to five years post-procedure. More detailed results will be released later this year.
"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."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 85.1 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.2 And some minimally invasive procedures may only treat BPH symptoms, not the underlying condition.
At the end of the five-year trial, the medication and surgical retreatment rates were:
- 4.4 percent of the Rezūm System patients required surgical retreatment through 5 years
- 11.1 percent of the Rezūm System patients required medications through five years
"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.”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.
About Rezūm™ Water Vapor Therapy
While benign, BPH can cause severe symptoms ranging from partial to complete blockage of the bladder, the latter of which typically requires emergency treatment to prevent infection or organ damage.3
The 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.
References:
- Publishing, Harvard. 2020. "The Growing Problem Of An Enlarged Prostate Gland - Harvard Health". Harvard Health.
- Roger K and Gilling P. Fast Facts: Benign Prostatic Hyperplasia, 7th edition. Health Press. 2011.
- "Benign Prostatic Hyperplasia (BPH): Symptoms, Diagnosis & Treatment - Urology Care Foundation". 2020. Urologyhealth.Org.