MedicalResearch.com Interview with:
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Dr. Kevin T. McVary[/caption]
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.
Dr. Kevin T. McVary[/caption]
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.
Dr. Jed Kaminetsky[/caption]
Dr. Jed Kaminetsky MD
Clinical Assistant Professor
Department of Urology
NYU Langone Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Kaminetsky: Nocturia is a voiding disorder not well treated by available drugs for overactive bladder and benign prostatic hypertrophy. Desmopressin stimulates the kidneys to concentrate the urine which results in a greatly reduced volume of urine formation for a period of time. Serenity Pharmaceuticals has spent many years developing a low dose nasal spray version of desmopressin called Noctiva specifically for nocturia. The study reported now is a large, placebo controlled phase 3 trial to confirm the statistical efficacy and clinical benefit of this treatment for nocturia.
Dr. Hiten Patel[/caption]
Hiten D. Patel, MD, MPH
Resident, Urological Surgery
James Buchanan Brady Urological Institute
The Johns Hopkins Medical Institutions
Baltimore, Maryland 21287
MedicalResearch.com: What is the background for this study?
Dr. Patel: The study reports results of a systematic review contracted by the Agency for Healthcare Research and Quality based on input from stakeholders. Part of the motivation was due to the American Urological Association's desire to use the results as a basis to update relevant clinical guidelines.
There are four major management options for clinically localized small renal masses diagnosed on imaging including active surveillance, thermal ablation, partial nephrectomy, and radical nephrectomy. The body of research evaluating these management options is broad, but many of the studies performing comparative analyses have limitations. Therefore, the systematic review aimed to evaluate a number of outcomes (e.g. overall survival, cancer specific survival, local recurrence, metastasis, renal function, complications, and perioperative outcomes) based on available comparative studies in the literature.