The condition is called benign prostatic hyperplasia or BPH and, according to the National Institutes of Health, occurs in more than half of men in their 60s and 90 percent of men in their 70s and 80s.
Symptoms of BPH include difficulty urinating, more frequent and urgent urination, especially at night and a weak urine flow. “While the condition is not cancer and is not life-threatening, the symptoms can be very severe and substantially affect a man’s quality of life,” said James Spies, MD, principal investigator of the study and chair of Radiology at MedStar Georgetown. “Because so many men are affected by this condition, the potential impact of an effective minimally-invasive treatment could be substantial.”
Alternatives to treating BPH include drug therapy or partial removal of the prostate through the urethra in the penis, called a TURP procedure or removal of the prostate by way of an open abdominal operation,” said Dr Spies. “We hope PAE will be a less invasive, less drastic approach that will be safe and effective.”
Prostate artery embolization is a non-surgical, minimally invasive procedure that injects small beads into the arteries surrounding the prostate. The beads block the prostate’s blood supply and the prostate begins to shrivel and shrink. The patient stays in the hospital for one night and can usually return to regular activities within several days.
“We go in through the artery at the top of the leg and the procedure usually takes two hours or less,” said Dr. Spies, who also is a professor of Radiology at Georgetown University School of Medicine.
Sixty-eight year old Ron Simmons of Woodstock, Virginia is one of the first to enroll in this study and have the procedure. “My biggest problem has been trying to urinate in the morning. It’s not a life threatening problem but I’m miserable. I’m on the maximum dosage of the prescription I take for this and I’m just hoping for some relief. I’ve also researched the side effects of some of the other treatments out there and I was concerned about the potential problems.”
Studies that have been conducted in other countries suggest the procedure is effective in most men and that injuries to other structures are rare.
“This procedure does carry some potential risks,” said Dr. Spies. “This study will focus on the safety of the procedure, particularly to make sure there are no injuries to the bladder or rectum which are very close to the prostate. The study will also measure the severity of symptoms before and for five years after the procedure.”
Since 2001, Dr. Spies has pioneered fibroid embolization in women and is considered an international expert in interventional radiology. In that procedure, called Uterine Fibroid Embolization (UFE), the same kinds of tiny beads are used to block the blood supply to the fibroid which causes it to shrink and die.
This is the first PAE study authorized in the U.S. by the FDA under an Investigational Device Exemption and will allow the research team to study the safety and effectiveness of the treatment. PAE is still considered investigational in the United States.
Because this is a clinical study, there are certain criteria that are required for participation and some conditions that might exclude a patient from taking part. In general, patients must be at least 50 years of age but not older than 90, have had symptoms of BPH for at least six months, and meet certain criteria for urine flow and size of the prostate gland. They cannot have had prior surgery for BPH or have prostate cancer. Each patient will be screened for prostate cancer as a part of the protocol.
About two weeks after his PAE procedure Ron Simmons said he was feeling positive about his experience. “I feel like my symptoms have improved and I’m interested to see how much my prostate might shrink over the next year.”