MEDICAL BREAKTHROUGHS RESEARCH SUMMARY

Transcription

1 MEDICAL BREAKTHROUGHS RESEARCH SUMMARY TOPIC: Urolift: Helping Men Go With the Flow REPORT: MB #4190 BACKGROUND: Benign prostatic hyperplasia (BPH) is an enlarged prostate gland. The prostate gland surrounds the urethra, the tube that carries urine from the bladder out of the body. As the prostate gets bigger, it may squeeze or partly block the urethra. About half of all men older than 75 have some symptoms. It is a normal part of the aging process in men, caused by changes in hormone balance and in cell growth. BPH causes urinary problems such as trouble getting a urine stream started and completely stopped (dribbling), often feeling the need to urinate and this feeling may even wake the person up at night. In a small number of cases, BPH may cause the bladder to be blocked, making it impossible or extremely hard to urinate. This problem may cause backed-up urine (urinary retention), leading to bladder infections or stones or kidney damage. (Source: TREATMENTS: Medication is the most common treatment for mild to moderate symptoms of prostate enlargement. Options can include Alpha blockers which relax the bladder neck muscles and muscle fibers in the prostate, making urination easier. These usually work quickly in men with relatively small prostates. Five-alpha reductase inhibitors shrink the prostate by preventing hormonal changes that cause growth. Both can take up to six months to be effective and both have side effects. Combination drug therapy may be necessary if either medication alone isn t effective. In some cases taking Tadalafil, which is often used to treat erectile dysfunction can also treat prostate enlargement; however it s usually not routine for BPH and generally prescribed only to men who also experience erectile dysfunction. There are also several types of minimally invasive or surgical therapy options if these medications don t show results. (Source: NEW TECHNOLOGY: Urolift is a procedure that can be done in an outpatient setting with a mild sedative and takes less than thirty minutes to complete. A lens with a special instrument enters the bladder and through it two (or four or six) small implants are placed on each side of the prostate gland. These implants are very small, around the size of a staple. The implants lift the prostate off the bladder, similar to curtain rods drawing up curtains. It creates a vision or channel that then the patient can experience the symptom relief they were seeking. Typically surgery would shave or laser the tissue; these procedures can cause bleeding and impair natural anatomy. This procedure doesn t change the anatomy other than to lift the prostate from the area where it s causing the problem. (Source: Dr. Frank Costa) FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT: Doug Braunsdorf Doug.braunsdorf@highmarkhealth.org

2 If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at

3 Frank J. Costa, M.D., a urologic surgeon at Allegheny Health Network in Pittsburgh, Pennsylvania, talks about a new procedure to relieve the symptoms of a common agerelated condition for men. Interview conducted by Ivanhoe Broadcast News in October I want to ask you starting with BPH, what does it stand for? Dr. Costa: BPH stands for benign prostatic hyperplasia. Now that s actually a pathologic diagnosis. The symptoms associated with BPH are usually called LUTS, lower urinary track symptoms. Now I consider BPH a disease of aging. Why is that? Because most men as they get older develop the signs and symptoms of BPH. That is things like frequency of urination, urgency, nocturia which is getting up two, three, four times in the night. Hesitancy, dribbling, all the things you see that gentlemen have when they get to the football game and stand at the urinal and these long lines develop even more than the women s rooms. It is a disease of age. As men approach the age of fifty upward in the United States 30 million men are afflicted with this so it s huge. Compared to prostate cancer where there s about 28,000 men a year that are diagnosed. You talk in the millions. It s significantly more prevalent. The other thing that we should know is that BPH is a benign non-cancer enlargement of the prostate gland which is a reproductive organ in men. Usually the size of a walnut but as men age and we think it s due to hormonal changes that occur the prostate gland enlarges and because it sits in front of the bladder it constricts the bladder neck which is the tube that allows urine to pass and it goes through the penis. As this constricts the tube it brings on some of the symptoms that impede the flow of urine and this is what brings men to the doctor. Before surgery what are some of the things that men can do to alleviate some of the symptoms? Dr. Costa: Well first of all it s incumbent upon the physician to insure that, that is the cause of what their symptoms are. We want to rule out other causes. You would want to rule out prostate cancer, bladder cancer, infection, stricture disease, neurologic illnesses, a multitude of different things that can mimic the signs of an enlarged prostate. Once we have ruled that out and the most common cause is benign prostatic enlargement then we have a discussion with the patient and depending on what their symptoms are and how much they bother the patient there s a couple important considerations. First of all the size of the prostate is not always consistent with what their symptoms are. There are patients with large prostates that don t have symptoms and there are patients with smaller prostates that have a lot of symptoms. It s really important to engage the patient and see how much those symptoms bother them. Now once we ve established that the symptoms bother them and we have ways of doing this objectively with certain questionnaires. Then the physician has a discussion with the patient to see what the options are and the options can consist of anything from medical management to surgery and there s an entire spectrum. It s also important to understand the BPH is also a spectrum of manifestations the way it presents clinically. What does that mean? It can be something that just bothers one s lifestyle but in

4 extreme circumstances it can present with symptoms that can actually cause kidney failure. It s something that should be taken seriously. Now when we deal with treatment options for patients we can offer them medications. Medications exist in two forms, one is a type of medication called an alpha blocker. An alpha blocker is a medication that doesn t really effect the progression of the disease but they really relieve the symptoms. It basically takes the pressure off the tube so that it relaxes it and so the flow of the urine can be improved. A second class of medication is something that s called a 5-alpha-reductase inhibiter. This is something that actually alters the hormones that affect the prostate. It can actually cause a reduction in the size of the prostate gland. The problem with these medications is they don t work in all individuals. You might get about a 50 percent response rate in some cases and you have to take the medication for the rest of your life. With some patients it becomes a compliance issue, a cost issue and so we have to seek alternatives especially if they don t work. These alternatives are surgical alternatives. Now with the advent of minimally invasive surgery there are things that have been developed to treat the prostate like heat therapy, laser therapy, incision of the prostate gland near the bladder and historically we did something called a TURP transurethral resection of the prostate. That s been the gold standard because it gives you really good results, but there are some significant side effects that can be associated with that. For instance bleeding, loss of sexual function, incontinence. Even medications can cause a loss or impairment of sexual function and side effects, which makes it an important consideration to seek alternative therapies. The Urolift is a relatively new procedure that has been approved in the United States for about two or three years and preceded them in Europe is interesting because it provides an alternative therapy. It gives most patients immediate relief and it doesn t have any sexual side effects. No reported side effects ever have occurred with this which is really incredible. In the time that I ve been in practice this is really in my opinion very important and novel therapy that many men that are afflicted with this disease can benefit from it. And I ve been very excited about the results that I ve had with my patients. Talk to me a little bit about how the procedure is done. Dr. Costa: First of all it s important to identify the right patient for the procedure as with any particular surgery, operation or using medication. It s always important to identify which patients would benefit the most. Once that has been established and that should be done by a specialist, a urologist, or a urologic surgeon like myself. Then we offer the different alternatives to the patients, and then try to determine the best treatment for that particular patient based on their lifestyle, the quality of life they seek to obtain, what their cost considerations are, what their medical condition is like, what their life expectancy is. Then we take all these considerations and factors, and then we develop a plan of action for that particular patient. We want to individualize care for them. The Urolift in my opinion is a very, very appropriate procedure for patients that either want to replace medication because they can t afford to take them for the rest of their lives or because they have side effects or just because they don t like the idea of having to take a medicine every day. They may forget it they go on vacation and all of a sudden they re stuck without it. The Urolift also does not have the side effects of the medications and also many of the surgical procedures that we have. As I mentioned, with the transurethral resection there s risks of bleeding, of incontinence, you have to require in most cases a short hospital stay, there s sexual dysfunction. These don t occur with the Urolift. The Urolift is a procedure that s done in an outpatient setting with a mild sedative and it really takes less than thirty minutes to do. Once you make the proper determination that the patient is a suitable candidate it really works very, very well to alleviate a lot of their symptoms. Who is a suitable candidate and who would not be a good candidate for this procedure? Dr. Costa: That s a very good question. A good candidate is a person, a man, because women get the symptoms but it s not due to an enlarged prostate. A suitable candidate is a person who is on medication and can be either controlled on medication because I don t want to take them for some of the reasons that

5 I elucidated, or in a patient who doesn t want to take medication. I ve had many patients like that. They want a fix, they don t want to commit to taking medication for a lifetime. That s a very good patient. You have to be able to determine how big the prostate gland is. If the prostate gland is too large it may not be the best procedure for that patient and so it s incumbent upon the surgeon, the physician to determine in which patient that those considerations must be met. If a patient for instance is desirous of having a procedure that doesn t require a general anesthetic or doesn t want to undergo the risk of having sexual side effects and many of these men are younger because prostate conditions usually start around the age of fifty. If those men are a little reluctant to undergo a procedure that may affect their potency or the ability to perform sexually then certainly the Urolift is a very, very good alternative because as I mentioned there have been no reported sexual side effects with this and so it s a great procedure for these men. You said it s about a thirty minute procedure under general anesthesia. Dr. Costa: No, I said it s a thirty minute procedure done with mild sedation. Mild sedation. Dr. Costa: And local anesthetic. Sometimes we can even do it with a local anesthetic but I prefer to do it with mild sedation. Can you describe for me the procedure? Dr. Costa: Well the patient obviously is seen in the office first, we have a discussion and a consultation with the patient. We determine what the symptoms are, what the alternative methods for therapy and ruling out other causes of their symptoms. Once we have that discussion we then, assuming that the patient is considered an appropriate candidate for the Urolift, they present to the outpatient ambulatory center like the one we have here at the Allegheny Health Network and the patient is very accommodated by our excellent staff and they re made to feel at home, comfortable. Because we always have to take in to consideration the angst that a patient has when they get any type of health facility. I think that you know having that sensitivity is really essential in being able to deliver the quality of care that every patient deserves. Once we ve established that then the patient comes to the operating room like we are in here now, they re given a mild sedative, seen by our very well trained anesthesiologist and our nursing staff and personnel, and operative personnel do whatever is necessary to make that patient feel comfortable. Once they get the appropriate sedative then I, as the surgeon do the procedure. Now the procedure involves doing what s called a cystoscopy where we have a lens with a special instrument that enters the bladder and through this we re able to deliver two small implants on each side of the prostate gland. And sometimes we use two sometimes we use four sometimes we use six it depends on the size of the prostate. These are very, very small they re probably less than the size of a staple. The way they are delivered they basically engage the prostate and they lift the prostate off the bladder. It s similar to having curtain rods, you have curtains that you know hang on the window and then the curtain rods lift the curtains off the window so that you can see through it. It creates a vision. Similarly in the prostate gland we place these implants they lift the prostate off the bladder neck so that you have a nice channel that is open and then the patient can experience the symptom relief that they were seeking. When you talk about that lift does that essentially take the pressure off? Dr. Costa: Yes, it essentially removes the obstructive tissue from the channel where it is restricting the prostate. Basically you re able to open the channel without surgery. Typically we d go in and shave the tissue or we d laser the tissue, use different forms of energy or surgical methods that cause bleeding and sometimes can impair the natural integrity of the anatomy. This doesn t really in any way change the anatomy other than to lift the prostate from the area where it is causing the problem.

6 Because you re using the small scope, is it correct to call this a noninvasive procedure? Dr. Costa: Yeah, I would call it minimally invasive but less invasive than many of the other quote minimally-invasive procedures. If I had to have a scale of invasiveness I would place the Urolift on the part of the scale where it is the most minimal in term of invasive. How quickly are patients up and about, and how quickly do they feel the difference? Dr. Costa: Interestingly patients are up and about immediately. We get them into the recovery room, sometimes they have a catheter overnight and sometimes they don t it depends on the prostate glands size and upon what my opinion is as to what would best suit them. Also their condition if there s an older patient that s at home by himself and doesn t have any family to be able to take care of him then I like to leave a catheter in overnight and then I have a nurse go to the house and remove it for him and insure that the patient is doing well. It imparts and extended type of care to that patient. Similarly we would do that with the other procedures also. The thing that I like about the Urolift is patients are up and around the next day. They can go back to work the next day. They don t have to deal with any of the side effects that typically they are afflicted with some of the other procedures like the transurethral resection or even the laser prostatectomy. This has been something that for me has been a very positive, enthusiastic way to react to how my patients respond. Side effects? Dr. Costa: As I mentioned the beauty of this is that there have been no reported sexual side effects. There are always or anytime you bring a patient to the operating room you can have anesthesia side effects, if you have an enlarged and gorged prostate with a lot of blood vessels you may have a little bit of bleeding when you do the insertion of the scope. But this is not necessarily related to the Urolift as opposed just to the procedure itself. But compare it to the other procedures that exist for this condition the side effects are remotely less than you would see with some of the other procedures that we have historically used for the treatment of this disorder. Is there anything that I didn t ask you that you want to make sure that people know? Dr. Costa: Well I just want to emphasize the fact that prostate disease is very common disease in men. It afflicts almost 30 million men in the United States and it significantly impairs their quality of life. Having to run to the bathroom all the time, it affects you in the workplace, it affects you at home, and it affects your sleep at night so that you don t function well the next day. This is something that many men don t seek treatment for this because men don t like to go to the doctors typically. I would encourage the wives, girlfriends or aunts, uncles or daughters to get their husbands, their boyfriends, their fathers, their cousins or their uncles to the urologist just to get checked. First of all to rule out prostate cancer, secondly to rule out other disease processes and thirdly for those patients that are afflicted with this disease, which is thirty million men in the United States and as they get older they will have a higher risk of having this disease affect them. Fifty percent of men age fifty, eighty percent of men age eighty. It s a linear situation where we see this. Going to the proper physician, having a discussion to see what the options are to treat this and then picking out a solution that suits your particular needs based on your age, your lifestyle, your life expectancy, what you can afford, what you are trying to obtain. Having that discussion with the patient, engaging the patient in the decision making process is essential in order to find the proper treatment for that patient. Is this covered by most insurance?

7 Dr. Costa: Yes. The nice thing about this and why it wasn t initially in the United States about three years ago was because it was not covered by insurance. Now Medicare has actually seen that this is a procedure that works and it is now approved by Medicare and by most insurances. And that s a huge cue because many patients can t afford to have this or any procedure done because of the cost of the procedure. It is covered and this has been really a blow for freedom. BPH is not something you have to live with? Dr. Costa: No, absolutely not. Many men do live with it and unfortunately getting the word out just like you re doing and I want to congratulate you and thank you for allowing us to have this discussion because it gets the message out to patients that are suffering with this condition it encourages them to seek therapy, to seek a diagnosis and to seek treatment that exists for them. Are there any lifestyle changes that someone can make before they start? Dr. Costa: That would be the beautiful part about this is all you have to do is go to your doctor, let him know what your problem is, have the discussion, insure that it s the right procedure for you after you go through all the alternatives and the specific issues that you as a patient that are important to you. Then you show up you let our great staff take care of you we do the procedure and hopefully you ll have the same results that most of our patients have had. It s really a very fulfilling and satisfying thing for me as a surgeon to see patients that the next day they re up and around and they call you up and say, doc I can t believe this I m having a great flow I m not getting up at night. I m sleeping through. That s really why I m here is to have this discussion with you to get the message out. To encourage other physicians to learn this technique because unfortunately I m the only one in western Pennsylvania doing it at the present time but I can t take care of everybody. We want our other physicians to be able to listen to the patients and if it s not for that particular patient at least you ve offered it as an alternative based on what all the other alternatives are for this particular condition. 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:

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