A new clinical trial at the University of Virginia Health (UVA) will examine a nonsurgical treatment for lower urinary tract symptoms (LUTS) due to an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH).
UVA is collaborating with Siemens Medical Solutions for this pilot study testing the safety and effectiveness of the non-surgical procedure known as prostatic artery embolization (PAE), first used by interventional radiologists in Europe and Latin America. Investigators hope is that PAE will become an alternative to current and invasive BPH surgical treatment.
In a PAE procedure, the doctors make a small incision in the inguinal region (groin area) to guide a microcatheter into the arteries that bring blood to the prostate. Those arteries are then injected with microparticles to block the blood flow, in order to shrink the prostate size and improve urinary function. “We’re excited to study this nonsurgical option for prostate symptoms, hopefully sparing men the risks of incontinence and sexual dysfunction, in the setting of this U.S. Food and Drug Administration-monitored clinical study,” Ziv J. Haskal, MD, FSIR, the trial’s principal investigator and a professor of Radiology at the UVA School of Medicine, said in a news release.
Data from a previous clinical trial, the largest trial to date, reports evidence of consistent improvement in symptoms for 72% of men who underwent the procedure.
BPH, which is not related to cancer, affects an estimated 210 million men worldwide, according to UVA’s Division of Interventional Radiology and Department of Urology. Nine out of 10 men by age 80 have an enlarged prostate, and at least half of these men experience BPH symptoms, like frequent or painful urination, weak urine stream, and unsatisfactory emptying of the bladder.
UVA expects to enroll 50 to 80 men, age 45 to 80, with BPH symptoms and who are either not responding to or declining to be treated with medications, or unwilling to undergo surgery. One overnight hospital stay for the PAE procedure is required of trial participants, followed by nine study visits over some two years that will include physical examinations and symptom review, and prostate imaging.