Jared J. Wallen, MD, Physician, Urologist at Florida Hospital Physician Group, talks about a minimally-invasive treatment for men with an enlarged prostate called Rezūm.
Tell us a little bit about Rezūm?
Dr. Wallen: The beauty of Rezūm is that it’s a minimally-invasive treatment for men with an enlarged prostate or benign (not cancer) prostate hypertrophy (BPH). Ultimately the nice part about it is that it can be performed in the office versus a surgical setting. Currently, most of the other procedural or surgical treatment options available for BPH at this stage in the game after you progress beyond medications are in the operating room. Remember it is a minimally invasive approach to remove enough tissue to clean the pipe (urethra) out so that urine can flow when it needs to. The other nice thing about Rezūm is that it’s a quick treatment that we can do in under thirty minutes in the office, and because it is minimally invasive it is associated with lower side effects..
What does a patient do before they try this, is this like the last resort?
Dr. Wallen: I would say Rezūm is actually probably a first line procedural treatment. Most patients will typically try medications first if they come in with certain symptoms. Depending on what they prefer, some patients can progress pretty quickly beyond medications if they don’t prefer to take a medication for the rest of their life or if they have other medical problems such as kidney failure, stones in the bladder, or urinary retention that would possibly progress them beyond the medications a little quicker. Rezūm is nice because it’s a procedural treatment to remove some prostate tissue and allow men to urinate easier but they don’t have to go to the operating room, and they don’t have to have general anesthesia. We do this procedure with oral sedatives and local anesthesia.
Can you explain a little bit more how it works and how you do the procedure?
Dr. Wallen: Yes. Ultimately what happens during the procedure is it’s very similar to any standard camera procedure into a patient’s bladder. In this case a small camera is slid into the urethra. We identify the prostate tissue that’s hypertrophic or enlarged and then essentially what we do is we use a very small needle to direct steam treatments to the prostate tissue essentially to vaporize the inner thirty percent or so of the prostate.
So you’re using water?
Dr. Wallen: Yes it’s a steam vaporization treatment so it takes water, converts it in to steam; via essentially radiofrequency energy. Then that steam is used to treat the tissue to cause the tissue to be ablated which essentially causes the tissue to die in that very small 1 cm circumferential area near the needle and then over 1-3 months the body actually reabsorbs that tissue.
What are any side effects?
Dr. Wallen: The nice part about it is that it’s probably the least invasive treatment that we have at this point for BPH or enlarged prostate. Some of the other treatments that are out there tend to cause things like retrograde ejaculation or possibly have a small risk of erectile dysfunction. But this one has been shown in three year data studies that it doesn’t cause these side effects. Some side effects are noted with the procedure however, things like urinary urgency, urinary frequency, some minor burning with urination or possibly even some minor pain associated with the procedure itself.
How often do you have to get a procedure?
Dr. Wallen: At this point in time the longest clinical trial that’s out there so far is about three years of data that shows that there are very few patients who need to be retreated within three years. Now obviously we’ll have to follow out that data longer to see kind of where they fall off but most surgical procedures for BPH or an enlarged prostate usually we quote patients that around five to seven years there’s a possibility exists that they may have to have a retreatment. I would expect that Rezūm probably would have about the same results.
Why did you decide to start doing this with your patients?
Dr. Wallen: I think anytime we approach a patient about a particular problem no matter what it is, whether it’s BPH or a prostate cancer or any disease or dysfunction we always have to balance the risks and benefits of any treatment we do. Because no matter if it’s surgical or medication there’s always risks that can come up for a patient undergoing any type of treatment. So the nice part about Rezūm is that a lot of patients have benefits that are as good as if we did a typical surgical procedure in the operating room but the side effects are much less. From that standpoint ultimately my main goal as a physician is to serve patients and try to make their quality of life better. I think Rezūm does that very nicely through a safe procedure in the office which is fantastic.
So using water seems like wow, in the medical field is that something that is wow-able that you’re using steam, is it used in other treatments?
Dr: Wallen: This is really the first application of steam in the treatment of BPH. We do use radiofrequency (RFA) sometimes to treat small kidney tumors or even other mostly historical forms of BPH treatments. Ultimately the majority of previous treatments for BPH were either an electrocautery loop, which you use electric energy, or things like a laser to essentially vaporize the tissue. So the fact that we can use water and have efficacious results and do minimally-invasive procedures such as this is fantastic, it’s awesome. If you think about it this follows the Primum non Nocere (first do no harm), do an inside cleaning of the pipe and do just enough to clean it out without causing harm.
Is there anything similar on the market with a different name using water vapor or is this fairly new?
Dr. Wallen: There are no other water vapor products on the market to my knowledge, however there are some previous procedures out there that use this kind of RFA technology, TUNA, but this is a mainly historical treatment for BPH. The TUNA that used to be out there, did not create steam, it was a one size fits all treatment not physician directed. It was just a treatment where a probe would be placed in the urethra and it would essentially have similar effects to the Rezūm type treatments. However, it was NOT a patient centered treatment where I could identify areas in the patient’s prostate that seemed to be more problematic and treat those specific areas. So I think the combination of water and a minimally-invasive procedure that is directed by somebody who is both skillful and knowledgeable about the anatomic and functional considerations of the prostate as the urine passes through is very valuable to many patients.
So it can be repeated if needed?
Dr. Wallen: Absolutely. It can be repeated if needed, at this point you know there’s a good amount of data out there that shows that at least three years is included in your original treatment and it may be even longer based on following patients beyond three years in the research. To some extent, the fact that the literature is only 3 years old just shows you how new this treatment is.
So it really could be used to treat prostate cancer, or could it?
Dr. Wallen: Well so that’s a good question, ultimately it’s currently not approved for that. However, they are trying to do work to figure out if they can use this technology to treat prostate cancer in a more minimally-invasive setting. Again prostate cancer is an etiology or an entity where a lot of times there’s pretty big side effects to the treatments whether you’re getting radiation or surgery for prostate cancer. There’s a significant risk of side effects with those types of treatments that specifically impact a lot of patient’s quality of life. Men end up leaking urine or have erectile dysfunction that medications don’t work for or these types of things. So if we could adapt this technology and prove that it’s efficacious and effective for treating cancer that would be awesome. But at this time it’s not approved for that.
And so the best candidate for this right now would be?
Dr. Wallen: So the nice part about this is that the fact that it’s done in the office, the fact that we don’t have to put patients to sleep, the fact that there are physicians out there who are doing this procedure even if patients are on anticoagulation medications like Warfarin or Coumadin or aspirin. This increases the applicability to any patient that walks in the door to a large degree. Obviously each patient is different and we approach them differently. If they have a huge prostate, up to ten times normal size, then sometimes we consider some other types of treatments. But the nice part about the Rezūm is that for the most part any patient who has BPH or enlarged prostate and has symptoms can undergo the treatment.
You said it’s a thirty minute treatment?
Dr. Wallen: Yeah roughly actually it all depends on how big the prostate is. We give treatments to approximately each centimeter of the prostate after we’ve kind of come backwards from the bladder neck a little bit. Each treatment takes about nine seconds. So it really just depends on how many treatments we have to deliver to the prostate. But by in large the procedure time for a visit in the office should be about 30-45 minutes when we add in the ultrasound of the prostate for size and local anesthetic block time.
I think that’s it, anything else? Do you consider this a medical breakthrough?
Dr. Wallen: That’s a tough question. I think time will tell. I think it’s certainly a change in the paradigm shift of treatment because ultimately there are at least four or five other procedural type treatments that are out there; whether it’s surgery, a prostate artery embolization with interventional radiology or what have you. But all of these treatments are done in the hospital setting which obviously increases cost and this type of thing. So the fact that we can shift treatments from patients going to sleep with the risk of anesthesia which include things like heart attack, stroke, death anytime we put somebody to sleep. If we can avoid that and effectively treat these patients just as effective as a surgical procedure with them asleep that’s huge. As far as a medical breakthrough, time will certainly tell. In the meantime, we have had some very symptomatic patients have great responses with this surgery or the procedure so far so that’s awesome. You like to believe every doctor you meet became a doctor to help their patients, so any time we can do so it makes it fun for us too.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Jared J Wallen
Richelle Hoenes
941-544-0961
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