SIR Announces Promising Data for Prostatic Artery Embolization

April 15, 2013—The Society of Interventional Radiology (SIR) announced that early findings from the first prospective trial in the United States of prostatic artery embolization (PAE) were presented at SIR's 38th Annual Scientific Meeting in New Orleans, Louisiana. The study's principal investigator is Sandeep Bagla, MD, who is an interventional radiologist in the Department of Cardiovascular and Interventional Radiology at Inova Alexandria Hospital in Alexandria, Virginia. The study, Abstract 154, is available online at www.sirmeeting.org.

SIR noted that benign prostatic hyperplasia affects more than 50% of men aged 50 years, and more than 80% of men aged 80 years. When the prostate becomes enlarged, it blocks urine flow through the urethra, leading to aggravating symptoms including nighttime urinary frequency, weak flow, and inability to completely empty the bladder. Untreated benign prostatic hyperplasia can lead to bladder stones, poor kidney function, and infections. By temporarily blocking blood flow through the prostate artery, PAE causes the prostate to shrink, providing a larger passageway for urine.

In SIR's press release, Dr. Bagla commented, “Nearly all men eventually suffer from an enlarged prostate as they age, and this treatment is almost like turning back the clock and giving them the prostate of their youth. Medications are of limited benefit and surgery—while it can correct the problem—can be risky and may cause significant side effects. PAE is a minimally invasive alternative with low risk that appears to reduce symptoms in the overwhelming majority of patients.”

Dr. Bagla added, “All patients are looking for the least-invasive treatment with lowest risk, and this United States clinical study confirms the results reported by interventional radiologists in Europe and South America.” He noted that millions of men shy away from surgical and other transurethral procedures because they do not want to risk urine leak, impotence, or other complications that may arise from invasive procedures.

As summarized in the SIR announcement, the early findings of the study showed that 13 of 14 men (92%) who had PAE noticed a significant decrease in symptoms after 1 month. None of the men experienced any major complications, such as impotence, leaking urine, or infection. Most went home the day of treatment.

Dr. Bagla advised that enrollment of 30 men for the first prospective United States study to evaluate PAE for enlarged prostates is underway and will be completed by fall 2013. The study will look at clinical success and safety and will follow patients for 2 years to assess long-term results.

“The participants in our study report a true lifestyle-changing effect after this treatment, with some men stopping medication for their prostate symptoms altogether,” said Bagla. “Patients who have not been helped by surgery or laser treatments have benefited. Since the treatment does not involve placing a catheter or device into the penis, there is no risk of narrowing of the urethra, incontinence, or bleeding.”