Minimally Invasive Rezum® Radiofrequency System Treats Obese Men With Lower Urinary Tract Symptoms Caused by BPH


MedicalResearch.com Interview with:
Dr. Nikhil K. Gupta
and
Kevin McVary, MD, FACS
Professor, Department of Surgery
Chair, Division of Urology
Southern Illinois University School of Medicine

MedicalResearch.com: What is the background for this study?

Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.

Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.

Response: Male lower urinary tract symptoms due to benign prostatic hyperplasia, or LUTS due to BPH, have most commonly been treated with a combination of medication, such as alpha-blockers and 5-alpha reductase inhibitors, and surgery, such as transurethral resection of prostate (TURP) and Greenlight photovaporization of prostate (PVP). These treatments, however, have potentially serious adverse and sexual side effects. Minimally invasive surgical therapies (MIST) for LUTS due to BPH have tried to thread the needle between medications and invasive surgery, giving effective relief of symptoms with minimal anesthetic need while preserving sexual function. Previously developed MISTs have been unable to provide durable relief of symptoms, causing patients to undergo multiple treatments in a short period of time, and have been limited by prostate size and conformation, e.g. the inability to treat a middle lobe or median bar. LUTS due to BPH is also very strongly and likely causally linked with obesity, and obesity seems to have an effect on the efficacy of treatment as well, as obesity affects response to medication and tends to dampen the treatment effect of TURP.

Convective Radiofrequency Water Vapor Energy ablation of the prostate, named Rezūm®, is a new MIST that uses radiofrequency to generate energy in the form of water vapor. The water vapor acts as a convective energy source and, once injected into the treatment area, distributes itself evenly within the treated tissue, causing uniform necrosis througout the treated area. This mechanism using convection is in contrast to previous technologies using conductive heat energy, which created a heat gradient with tissue closest to the heat source receiving the largest amount of energy and tissue farthest from the heat source receiving almost no energy. Thus conductive energy has a different effect on different parts of the treated area. With Rezūm, MRI studies have shown that the water vapor creates a uniform treatment effect while staying within collagen barriers, obeying natural tissue planes and affecting only the intended treatment areas.

The purpose of this study was to determine the efficacy of Rezūm in treatment of LUTS due to BPH, examine the treatment’s effect on sexual function, and to determine whether obesity affected treatment efficacy.

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Prostate Artery Embolization Is Less Invasive Choice For BPH Treatment

MedicalResearch.com Interview with:

Dr. João Martins Pisco, MD PhD Hospital St. Louis, International Prostate Medical Center Lisbon, Portugal

Dr. João Martins Pisco

Dr. João Martins Pisco, MD PhD
Hospital St. Louis, International Prostate Medical Center
Lisbon, Portugal

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Enlarged prostate, also known as benign prostatic hyperplasia (BPH), is one of the most common prostate problems occurring in men older than 50. According to the National Institutes of Health, as many as 14 million men in the U.S. had symptoms suggestive of BPH, which can affect 50 percent of men between 51 and 60 years of age and up to 90 percent of men older than 80. A few years ago, Dr. João Martins Pisco developed the minimally invasive treatment, known as prostate artery embolization, to treat BPH. The study that Dr. Pisco presented at the Society of Interventional Radiology on March 8 is the first of its kind – a study with 1,000 patients with long-term efficacy data.

Between March 2007 and March 2016, Dr. Pisco and his team performed PAE on 1,000 men who averaged 67 years of age. All patients were evaluated in the short term (one, three, and six months), 807 patients were seen through the medium term (every six months between six months and three years), and 406 patients were evaluated long term (every year after three years).

During each evaluation, the men’s symptoms were measured by the International Prostate Symptom Score (IPSS), which tests for the blockage of urine flow, and the International Index of Erectile Function (IIEF), which assesses erectile dysfunction. Researchers also measured the size of the prostate and the amount of urine left in the bladder after urination. They also evaluated the peak urinary flow rate and the prostate-specific antigen (PSA) level, a test used to screen for prostate cancer.

MedicalResearch.com:  What are the main findings?

Response:  The data from these measures revealed at the short-term mark that the treatment had an 89 percent cumulative success rate—measuring the success across all variables through the given testing period. The 807 men evaluated at the medium-term mark had an 82 percent success rate. And of the 406 patients measured at the long-term mark, 78 percent were considered cumulative successes.

In an additional analysis, researchers found that among 112 patients who also suffered acute urinary retention (AUR) before undergoing PAE, 106 or 94.6 percent had their catheter removed between two days and three months after treatment. At medium-term and long-term follow up, 95 of the 112 (84.8 percent) and 89 of the 112 (78.5 percent) did not experience any recurrence of their AUR.

The team also performed PAE in 210 patients who had limited treatment options due to extreme enlargement of the prostate (larger than 100 cm³). Of these men, 84 percent experienced cumulative success at short-term evaluation and 76.2 percent at medium- and long-term. The normal size of a prostate is 15 cm3 to 30 cm3.

MedicalResearch.com: What should readers take away from your report?

Response:  Prostate artery embolization gives men with BPH a treatment option that is less invasive than other therapies and allows them to return to their normal lives sooner. Time and time again, Dr. Pisco has seen patients who are relieved to find out about PAE because they are not able to tolerate medications for BPH due to their side effects. These men also don’t want traditional surgery because it involves greater risks, has possible sexual side effects, and has a recovery time that is relatively long compared to PAE, which is generally performed under local anesthesia and on an outpatient basis.

Prostate artery embolization should also be presented to patients who are exploring options to resolve their BPH.

That said, PAE may not be appropriate for all patients, such as those with advanced arterial atherosclerosis that may be due to smoking or diabetes. Patients should speak with an interventional radiologist or other members of their care team to discuss treatment options.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: As a next step, Dr. Pisco and his team are now conducting a study comparing the effectiveness of PAE to a sham – or placebo—treatment to address any possible placebo effect that may have occurred during Pisco’s research with these 1,000 patients.

MedicalResearch.com: Is there anything else you would like to add?

Response: Prostate artery embolization is a safe and effective treatment and these data demonstrate the efficacy of the therapy in the long term. It’s important that patients know about this therapy as they explore how to resolve their BPH. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Society of Interventional Radiology abstract discussing:

Prostate artery embolization for BPH

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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WAVE Therapy For Benign Prostatic Hyperplasia

MedicalResearch.com Interview with:

Kevin T. McVary, MD, FACS Chair, Division of Urology The Pavilion at St. John’s Hospital Springfield, IL

Dr. Kevin T. McVary

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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Elevated PSA Linked To Increase Risk of Urinary Symptoms in Men

MedicalResearch.com Interview with:

Stephen J. Freedland, MD Associate Director, Faculty Development Samuel Oschin Comprehensive Cancer Institute Co-Director, Cancer Genetics and Prevention Program Director, Center for Integrated Research in Cancer and Lifestyle Professor, Surgery Warschaw Robertson Law Families Chair in Prostate Cancer Cedars-Sinai, Los Angeles

Dr. Stephen Freedland

Stephen J. Freedland, MD
Associate Director, Faculty Development Samuel Oschin Comprehensive Cancer Institute
Co-Director, Cancer Genetics and Prevention Program
Director, Center for Integrated Research in Cancer and Lifestyle
Professor, Surgery
Warschaw Robertson Law Families Chair in Prostate Cancer
Cedars-Sinai, Los Angeles 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Freedland:   PSA is a marker of prostate pathology.  While often used to screen for prostate cancer, it is not prostate specific and can be elevated due to inflammation or enlarged prostate or other reasons.  Whether it predicts the development of urinary symptoms is not clear.  Among men with minimal to no urinary symptoms, we found that the higher the PSA, the greater the risk of future development of urinary symptoms.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Freedland: The readers should know that if a man has an elevated PSA and a negative prostate biopsy, the higher the PSA, the greater the risk of future urinary symptoms.  These are men who may need closer follow-up. Continue reading

Men Have Small Risk of Falls and Fractures When Starting Prostate Alpha Blockers

Blayne Welk MD Assistant Professor in the Division of Urology The University of Western Ontario

Dr. Welk

MedicalResearch.com Interview with:
Blayne Welk MD
Assistant Professor in the Division of Urology
Department of Surgery, Western University Institute for Clinical Evaluative Sciences
Department of Epidemiology and Biostatistics
Western University, London, Ontario 

Medical Research: What is the background for this study? What are the main findings?

Dr. Welk: Alpha blocker medications are used to treat urinary symptoms in men. They are very commonly prescribed, especially among the elderly. One of the potential side effects of these medications is low blood pressure and fainting. Newer medications are designed to be more specific to the prostate, in order to try and reduce these risks. Previous studies have had conflicting results regard the risk of low blood pressure, and whether this risk translates into clinically relevant complications like serious falls, fractures or head injury.

This study demonstrated that there is a small, but significant increase in the risk of falls, fractures and head injury associated with the initiation of prostate specific alpha blockers. Most men, however have a very low risk of these events to begin with, so the absolute change in their risk is very small. The mechanism of these outcomes is likely mediated through hypotension, which was also diagnosed in the majority of men with a fall or fracture.

Medical Research: What should clinicians and patients take away from your report?

Dr. Welk: Men starting alpha blocker medication for urinary symptoms should be counselled about the potential risk of low blood pressure and fainting. While not dangerous most of the time, these medications can lead to fractures and head injuries, which have serious consequences in the elderly. Avoiding dangerous activities when first starting these medications, and taking the mediation at night time may help avoid these risks.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Welk: Further research could examine the the role of 5 alpha reductase inhibitors (also used for male urinary symptoms) in modulating the risk of falls and fractures in men being treated with alpha blockers.

Citation:

Welk Blayne, McArthur Eric, Fraser Lisa-Ann,Hayward Jade, Dixon Stephanie, Hwang Y Joseph et al. The risk of fall and fracture with the initiation of a prostate-selective α antagonist: a population based cohort study 2015; 351 :h5398

Blayne Welk MD (2015). Men Have Small Risk of Falls and Fractures When Starting Prostate Alpha Blockers

BPH Symptoms May Be Reduced By Exercise

Kate Wolin, ScD, FACSM Associate Professor Departments of Surgery & Public Health Sciences Loyola University Chicago, Stritch School of MedicineMedicalResearch.com Interview with:
Kate Wolin, ScD, FACSM
Associate Professor
Departments of Surgery & Public Health Sciences
Loyola University Chicago, Stritch School of Medicine

Medical Research: What are the main findings of the study?

Answer: Men who are physically active are less likely to experience nocturia. Continue reading

PSA Screening and Prostate Cancer Mortality

Professor Fritz H Schröder Department of Urology, Erasmus University Medical Center Rotterdam, NetherlandsMedicalResearch.com Interview with:
Professor Fritz H Schröder
Department of Urology, Erasmus University Medical Center
Rotterdam, Netherlands

Medical Research: What are the main findings of the study?

Professor Schröder: I consider as the main finding that we could report a continuing effect of PSA driven screening on prostate cancer mortality for men aged 55 – 69 years in the screen arm of our study after 13 years of follow-up. The absolute reduction in the risk of death from prostate cancer amounts to 1.28 per 1000 men randomized to the screening arm. This translated into numbers to be invited to screening and numbers needed to be diagnosed to save one prostate cancer death of 781 and 27. These figures show an increasing effect with increasing time of follow-up. The relative risk reduction related to the control arm has remained unchanged with respect to the 11 year follow-up period. For men who actually participated and were screened the relative risk reduction amounted to 27%, the figure most applicable to men who consider to be tested.
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Prostate Biopsy: Psychological Impact

Dr Julia Wade PhD Research Associate University of Bristol, Clifton, BristolMedicalResearch.com Interview with:
Dr Julia Wade PhD
Research Associate
University of Bristol, Clifton, Bristol
MedicalResearch.com: What are the main findings of the study?

Dr. Wade: We hope that our study provides men with more information about diagnosing prostate cancer.  A diagnosis of prostate cancer can only be confirmed through prostate biopsies after the finding of a raised PSA.  This biopsy process requires 10 or so samples to be taken rectally, with a local anaesthetic, and this has some side effects.  Most men describe prostate biopsies as uncomfortable, but around 40% report pain and many experience bleeding; a small number, 1%, are admitted to hospital and 10% need to see a doctor because of post-biopsy symptoms.   We found that the men who experienced post-biopsy symptoms as ‘problematic’ at 7 days post biopsy also experienced raised anxiety compared to men who experienced symptoms as non-problematic

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