MedicalResearch.com Interview with:
Kevin T. McVary, MD, FACS
Chair, Division of Urology
The Pavilion at St. John’s Hospital
Springfield, IL
Chair and Professor of Urology
SIU School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. McVary: Benign Prostatic Hyperplasia (BPH) is a localized enlargement of the prostate gland in aging adult men. It affects approximately 75% of men over the age of 65. This excess growth of tissue compresses and obstructs the urethra, reducing the flow of urine from the bladder and sometimes blocking it entirely. As the symptoms increase, they can greatly impact a man’s quality of life. Both BPH and the existing treatments for it can negatively affect an individual’s sex life.
The Rezūm II IDE pivotal study was a prospective, multicenter, randomized (2:1) controlled trial that enrolled 197 patients across 15 clinical sites in the U.S. The main finding showed that radiofrequency generated convective water vapor thermal therapy provides rapid and sustainable improvement of lower urinary tract symptoms (LUTS) secondary to BPH and urinary flow over a 12-month period without negative effects on erectile and ejaculatory function. These results support the application of convective water vapor energy (WAVE) technology as safe and effective minimally invasive therapeutic alternative for symptomatic BPH. Additionally, no treatment or device related de novo erectile dysfunction occurred after thermal therapy, ejaculatory bother score improved 31% over baseline, and 27% of subjects achieved minimal clinically important differences (MCIDs) in erectile function scores at 1 year, including those with moderate to severe ED.
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