NEW ORLEANS—Early findings from the first prospective U.S. trial of prostatic artery embolization (PAE) suggest this approach may be safe and effective for treating lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH), researchers reported at the Society of Interventional Radiology’s 38th Annual Scientific Meeting.

This minimally invasive treatment appears to have high success rates with no urologic complications, including impotence or incontinence, they found.

“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,” said lead study investigator Sandeep Bagla, MD, an interventional radiologist in the Department of Cardiovascular and Interventional Radiology at Inova Alexandria Hospital in Alexandria, Va. “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.”

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Virtually all men with BPH-related LUTS are looking for the least invasive treatment with the lowest risk and 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, Dr. Bagla said. The new clinical study confirms the results reported by interventional radiologists in Europe and South America, he added.

Dr. Bagla presented early findings showing technical success in 17 of 18 men (94%) who underwent PAE and clinical success in 14 (93%) of the 17 patients. The men ranged in age from 57-81 years. None suffered any major complications, such as impotence, leaking urine, or infection, none reported post-procedural pain, and none required urinary catheterization. Ninety-four percent of the patients were discharged the same day; one stayed overnight for observation.

The researchers found that 47% of the treated men reported transient increased urinary frequency for 24 hours. Three of 17 patients reported post-procedural hematospermia, and one of 17 reported transient diarrhea.

“The results have been great so far,” Dr. Bagla told Renal & Urology News.  “The quality of life is one thing we measured at baseline and after the procedure and the quality of life scores also significantly improved.”

The study population had a mean decrease in American Urological Association symptom score of 11.1 points at one month post-procedure. No non-target embolizations occurred, but more trials are warranted to show that PAE has significant benefit over other existing therapies, he said. “It is probably best that it is performed in a limited fashion now. It takes a lot of expertise.”

The short- and long-term results have been promising from centers around the world, he noted.  Dr. Bagla and his colleagues plan to enroll 30 men. The study, which is expected to be completed this fall, will follow up patients for two 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,” Dr. Bagla said. “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.”