Benign Prostatic Hyperplasia—or BPH for short—affects about half of men over age 60. It happens when the prostate becomes enlarged and often results in a host of unpleasant symptoms. Until now, drugs and invasive surgeries were the only solutions.
Ron Simmons spends most of his free time on the back of his Harley.
But a few months ago, long rides were too painful for this 68-year-old.
“It was uncomfortable. It wasn’t enjoyable,” Simmons told Ivanhoe.
Simmons has BPH… an enlarged prostate.
“Most of my problems were going to the bathroom. You know, trying to urinate, that was difficult,” Simmons said.
Medications stopped working and the only other option was an invasive surgery to cut or ablate the prostate. It could cause side effects like sexual dysfunction or urinary incontinence.
Georgetown Dr. James Spies, Radiologist, Medstar Georgetown University Hospital,
offered Simmons something new… a non-surgical procedure called prostatic artery embolization.
“We put a catheter, a very thin tube into the artery that feeds the prostate gland,” Dr. Spies explains.
Then, doctors inject tiny beads—called microspheres—in the arteries surrounding the prostate to block its blood supply.
“It decreases the size of the prostate and more importantly relieves the obstruction of urinary flow,” Dr. Spies said.
Simmons was just the second patient at Georgetown to have the procedure. The relief was immediate… and he’s even planning a 10-thousand- mile ride this summer!
“There’s so many more things I can do today because of that prostate,” Simmons said.
For the clinical trial, patients have to have a prostate between 50 and 100 grams and be between ages 50 and 90 years old. Dr. Spies also stresses that this is not a treatment for prostate cancer—only an enlarged prostate.
BACKGROUND: An enlarged prostate or benign prostatic hyperplasia (BPH) affects about half of men over 60 years old, and 90 percent of men in their 70's and 80's, according to the National Institutes of Health. It is not a life-threatening condition but it can negatively affect your lifestyle. The symptoms include difficulty urinating, more frequent and urgent urination especially at night and a weak urine flow.
TREATMENTS: Treatment for BPH can include drug therapy or partial removal or the prostate through the urethat in the penis. This is called the TURP procedure or removal of the prostate through an open abdominal operation. According to a University of Maryland study, doctors aren't sure exactly what causes benign prostatic hyperplasia. But, they think the changes that occur with male sex hormones as part of the aging process could play a role in the prostate gland enlargement. (Source: http://umm.edu/health/medical/reports/articles/benign-prostatic-hyperplasia#ixzz31Vu0xsLV)
NEW TECHNOLOGY: Prostate artery embolization is a minimally invasive procedure that injects small beads into the arteries surrounding the prostate. The beads then block the prostate's blood supply. Then, the prostate begins to shrivel and shrink. The patient typically stays in the hospital for one night and can go back to regular activities within several days. According to doctors at Georgetown University, studies from other countries show that the procedure is effective in most men and injuries to other structures are rare. Dr. Spies says, “Ron Simmons is the second person to have the procedure at Georgetown. There are others treated in other centers, but this is very new and there are very few patients treated in the United States.” The procedure does have risks. A clinical study is looking at the safety to make sure there are no injuries to the bladder or rectum since they are close to the prostate. The study is also researching the severity of symptoms before and for five years after the procedure.
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Medstar Georgetown University Hospital
Jams Spies, MD, Interventional Radiologist at Medstar Georgetown University Medical Center talks about a new way doctors are shrinking prostates.
What is BPH?
Dr. Spies: BPH is benign prostatic hyperplasia that means the prostate gland, which every man has, becomes enlarged. It becomes enlarged in almost every man as they grow older and particularly in the 70s and 80s, but in many men, even over the age of 50 that enlargement will begin to make urinary flow difficult.
And is that a precursor to prostate cancer?
Dr. Spies: No, it really is not related to prostate cancer. Older men do need to have surveillance for prostate cancer because that’s also very common condition, but the two are really unrelated.
What are the symptoms of BPH?
Dr. Spies: It’s difficult to start urination; it’s a weak stream of urination and it takes a long time to empty the bladder. There is often a sense of incomplete emptying. In fact, if one measures this with medical tests, there often is incomplete emptying of the bladder. This results in the recurrent sensation that one has to urinate, called urinary frequency and this often leads to urinary problems at night, as men have to get up from sleep in order to urinate.
If you live long enough chances are that you’re going to get it?
Dr. Spies: Once you got enough gray hair, you’re very likely to have these symptoms. Prostate enlargement happens in nearly all men and most will eventually have at least some symptoms.
But do a lot of men shy away from the traditional treatment because it’s pretty invasive and there are a lot of risks to it?
Dr. Spies: Well, there are two ways to approach it. First, you need to be evaluated to be sure that’s what the condition is and that’s usually done by an urologist. Once that’s done, there are medications that are approved for this and they can help many men. But many medical treatments, medications can cause side effects or they may not provide sufficient relief. So once a reasonable trial of medical treatments, of medicines have failed, then urologists usually begin to think about invasive procedures. And these are mostly procedures that are done to reduce the size of the prostate usually by ablating or, or killing a portion of the gland or removing it and those are usually procedures that are done through the urethra in the operating room. They’re regular operations. The most common one is called transurethral resection of the prostate and that is a fairly significant procedure. There is no external scar; it’s done in the operating room. A man has to have a catheter in the bladder for several days to even a week or more after that procedure and there are some significant side effects on occasion.
Is there a chance of sexual dysfunction?
Dr. Spies: There are a couple of things that can happen; one is actually urinary incontinence which is not that common but it does happen in a small minority of men and that’s where you actually lose urine and you can’t hold your urine anymore. The second thing is that there is some degree of sexual dysfunction and one of the side effects is actually when a man ejaculates during sexual activity, the ejaculate doesn’t actually come out, it sort of goes backwards and so it’s called retrograde ejaculation and it’s not a very pleasant sensation for men and it can affect fertility. It is quite surprising to me how many older men, we’re talking men in their 60s, 70s, and even 80s that are very concerned about that side effect.
What is the less invasive procedure that you are testing?
Dr. Spies: We do image-guided interventions. We use x-rays or CAT scans or other things to guide that allow us to get the equivalent outcomes without doing surgery. This particular procedure we’re talking about is called prostate artery embolization. This is something that began in Europe and is being tested in a number of centers around the world. It appears to be quite effective based on those early results. It has not been evaluated broadly in the United States and that’s really the phase we’re at right now. We have research protocols that we’re involved in, in order to try to better test whether this is a safe and effective treatment. In essence, what occurs is we put a catheter, a very thin tube, into the artery that feeds the prostate gland. This is done by going into the artery at the top of the leg. It’s advanced using x-ray guidance into the branches that go to the prostate gland. Once we’re in position, we put in small beads; these are biocompatible little plastic plugs that go in and block the arteries and as a result the blood supply to the prostate gland is diminished. That results in the shriveling of that tissue, so it kind of shrivels back and it decreases the size of the prostate and more importantly, it relieves the obstruction of urinary flow. It appears to be highly effective and it‘s quite safe, at least in the initial clinical studies that have been done. This all requires a lot more evaluation, but we’re quite excited about the possibilities.
What happens do the beads? Do they just stay there forever?
Dr. Spies: They’re permanent plugs for the vessels and they get scarred in place. They are biocompatible, and have been used for other procedures for many, many years. They don’t float around your body. They do not usually cause any other harm. They just block the arteries in which they are injected.
What are the risks?
Dr. Spies: It appears that major complications from this are quite rare, but this is a part of what we’re investigating here at Georgetown. We’re trying to evaluate the safety of this in a very detailed way. So our particular protocol involves a urologist inspecting the lining of the bladder and this is done both before the procedure and at intervals afterwards in an office procedure, and we’re looking very closely to be sure there is no injury to the bladder and also the rectum. These are the two structures that are right next to where the prostate gland is and we would have the greatest concern about. So far, injuries to those structures have been quite rare. There are a few very infrequent reports of problems. The real question is what is the extent of that risk? So what we’re trying to do is assess that in a more systematic way than has been done previously.
Is there someone that this would not be good for?
Dr. Spies: Well there are a number of inclusion critieria, meaning factors that may qualify a man for our study, and then there are things that would exclude a potential candidate. The key things for exclusion are factors that might mean a man would not benefit from this. This is not a treatment for prostate cancer and those with prostate cancer are excluded. Prostate cancer has a completely different treatment algorithm, so we don’t want there to be any confusion about that. There also are limitations in terms of prostate size; initially because the study is being governed by the FDA, there are limitations on how large the prostate gland itself can be. It could be mildly enlarged to moderately enlarged, but super enlarged prostates at least initially are not being treated. There are also some age limitations. This particular study you have to be at least 50 years of age and less than 90. And there have to be no other major urinary problems or other major medical conditions. We do a screening process for patients who make inquiries and we’re actually able to go through a questionnaire and determine if a man has factors that would exclude them from the study.
Of the men who are going to get BPH, what is the percentage that would be good for this ?
Dr. Spies: We don’t know for certain. I believe it is likely that the large majority of men would be good for it once we’ve demonstrated the safety of this over time. Currently men with symptoms and a moderately enlarged prostate would be the primary candidates, but in the future, the upper range of size for prostate glands suitable for this procedure may increase. That’s a very important thing because once the gland is over a certain size, the minimally invasive surgical options are not possible and then the only option is a regular open operation to remove the prostate gland and that has a very significant risk of sexual dysfunction and urinary incontinence is actually quite common after that procedure, so many men are very fearful of that kind of a major procedure to solve this problem. So we’re hoping to be able to solve this problem for a broad range of men and it would be, we hope in the future, one of the options that will be available.
Do you think it will be the option, the gold standard, to help almost all of these men in the future?
Dr. Spies: It certainly could, although it’s very premature to say that. I think that it’s important for us to be systematic about this new treatment as affects millions of men. There are also some very well established procedures and medical treatments out there. The urology community has spent decades developing treatments and so there is a fairly high standard for us to demonstrate acceptable outcomes and so more studies are needed. There are several studies that are ongoing. We’re excited about the possibilities. The patients we’ve treated to date have done very well. We’ve not had any major problems with it and symptoms have been relieved in most and so we’re excited about that. But like most things, we need to be sure that this is well studied because it has very large public health implications.
Was Mr. Simmons one of the first?
Dr. Spies: He was one of the first. I think he was our second patient and he has done quite well and it seems like he is sort of typical of the patients that we’ve treated and that have really had a great outcome.
How large was his prostate, do you remember?
Dr. Spies: I think it was about 90 or 95 grams which is on the upper end of the size range. Our limit in this particular study is 100 grams.
Has he been good as far you know?
Dr. Spies: He’s been good. In several weeks he'll come back for a three month follow up. In talking with him, he is very happy with the outcome.