Opinion: Clinical Trial Puts Inova Alexandria at PAE Forefront

Opinion: Clinical Trial Puts Inova Alexandria at PAE Forefront

— A clinical trial at Inova Alexandria Hospital is showing positive results for men who seek a non-surgical option for relief from symptoms of an enlarged prostate. Ours is the first trial in the U.S. to test a procedure called Prostate Artery Embolization (PAE) and is attracting patients from across the country and abroad.

Since we launched the PAE trial last year, early findings among 21 enrolled men show that 94 percent experienced a “significant improvement” in their symptoms related to benign prostatic hyperplasia, or BPH. None of them reported any complications. Those findings are consistent with results in South America and Europe where PAE is already approved, according to our Primary Investigator, Sandeep Bagla, M.D., an interventional radiologist who trained with PAE experts in Portugal and Brazil and who wrote the hospital’s PAE trial protocol. We expect to enroll a total of 45 men with BPH for the trial. We will track their progress for two years post-procedure to document their results.

While PAE is still years away from potential U.S. Food and Drug Administration approval, our early results forecast great news for men who have sought an effective alternative to standard BPH treatment. Many understandably shy away from surgical intervention due to potential risks that include impotence, bleeding, urinary leakage and chronic infections. And not all men respond to medicine. Sadly, many “just deal” with their symptoms rather than risk complications.

BPH is a non-cancerous condition that occurs naturally as men age, affecting nearly 50 percent of men over age 50 and greater than 80 percent of men by age 80. It occurs as the prostate — a walnut-sized gland located just below the bladder — enlarges and squeezes the urethra, which is the tube that carries urine from the bladder out of the body. As the urethra is slowly clamped shut, it becomes increasingly difficult to urinate, and eventually the bladder weakens. Symptoms include frequent trips to the bathroom, especially at night, leakage, and an inability to completely empty the bladder. Left untreated, BPH may result in bladder or kidney damage.

Most men report that BPH has a negative impact on the quality of their lives.

“I was going [to the bathroom] four or five times a night,” said Alexandria resident C. Tony Gee. “I knew something was wrong.”

At age 72, Mr. Gee had suffered with BPH for several years. He read about our trial in a local newspaper and contacted the hospital. Last fall, he underwent the procedure and says he has been “completely satisfied” with the results. He’s even recommended PAE to several fellow church members.

PAE is a minimally invasive procedure that is conducted on an outpatient basis. During the procedure, an interventional radiologist inserts a spaghetti-sized catheter through an artery in the groin up to the two main arteries that supply the prostate. Microscopic beads are delivered through the catheter to the prostate’s arteries. These beads block some of the blood supply to the prostate, causing it to shrink, thereby alleviating associated BPH symptoms. Most patients report no pain other than mild soreness at the incision site.

We are very excited to be at the forefront of the U.S. testing for PAE and hope our work may someday give men a better option for treatment. If you suffer from BPH and have tried other treatments without improvement, you may be eligible for our clinical trial. Call 703-504-7950 or go to www.inova.org/pae to inquire. Plans are already underway for a second phase trial to further study PAE.