Your description... "experimental" procedure, by definition simply means a procedure that iis both not widely accepted by the medical community and insurance companies and therefore needs further study both in the form of peer review studies. Is not something that I fully agree with and my only concern is you are stating something that would actually scare off a man from pursuing this treatment if he is as you say a "new" participant to this site.
Insurance companies are not paying because they will and do resist paying as many treatments as possible until enough pressure can and is brought against them by the associations and lobbyist. that does not mean that clinic trails is not a valuable tool to use by these groups but Interventional Radiology does not have that interest level in the prostate realm of the treatments. We (men in general) are very lucky that we at least have a few IR doctors would will pursue PAE and FLA treatments as Urology cannot do this procedures. Insurance companies do acknowledge and accept that both FLA and PAE are completely FDA approved as prostate treatments and it does not have to do with BPH.
I know this because Medicare paid two check on my FLA for a partial total of $4,700. It was not an issue of FDA approval or clinical trials. They usually do not even pay for PCa on this treatment but FDA approval is complete and has nothing to do with it. The medical community you speak of is the Urological community and they are not in favor of anyone mess up their play ground. Realize that the blind 12 needle biopsy is a 10 minute procedure in office and it is a $1.3 billion dollar product for the Urologist industry. It is horribly inefficient and yet the Urologist will frown on any mention of a MRI follow by an focal single needle biopsy which is extremely efficient. These are just the facts. Your clinical trail theory should be reapplied to the TRUP that is their gold standard. My fear of you over stating this is that you will scare men who need to understand that another cash offered product is fine for their consideration and if you continue to say it is not FDA approved when in fact it is, this will cause them to do what the Urologist are trying to sell them rather than consider the alternatives.
The 20 to maybe 25 men that Dr. K has done in the last year are only a percentage of what was done and I believe that more have come from other sites than this one. Below is an email I received today for one of those men who does the majority of communication on those other sites. No it is not 100 percent as you have point out several times and that is good that you have. But it is much more predictable and very controlled and the success rate percentage is climbing. The clinical trial must be kept very stringent and pure in its selection. Men who have tried other treatments are never included. This is one such person. Also he is even more evidence to me that the success is due in large part to who you chose to do the treatment. I am not complaining to you I just don't want to scare men off from researching FLA.
Received today:
" Focal Laser Ablation for BPH"....Yes! That was the headline on a Google website that more or less has changed my life. I will admit, it is still a little early to completely define my experience but for the benefit of others who suffer from this condition with or without cancerous lesions, I thought my journey would be interesting.
My prostate size was never really large. Just 50 grams, but it wasn't about size. It was about location. A very large median lobe had engulfed about 2/3 of my prostate interfering with my urination and literally as I was told, forming a plug around my bladder neck. Of course, getting up at night to pee multiple times interfered with my sleep and my energy levels. I had tried multiple holistic solutions including saw palmetto, nettle root, hormone balancing, green juicing etc etc. all to no avail. I even traveled to Israel, spent $17,000 for the Gat Goren procedure which embolized my internal spermatic veins (ISV's) but to my consternation I later learned this promising procedure did not work for those with a large median lobe nor did PAE.
And after 6 years of suffering, that Google website caught my attention. I learned a large group of individuals who all had the same BPH affliction were members of a club called the K Club. What did K stand for? It stood for Karamanian, a doctor who had treated each individual, with success, compassion and a deep knowlege of the affliction at hand.
On January 7th, I traveled from South Florida to Houston, Texas and underwent a 3 hour focal laser treatment at Houston Medical Imaging under the care of Dr. Ara Karamanian. Why undergo the expense of traveling to Houston and incurring hotel and airline costs in addition to the $21,000 for the surgery? The answer was simple! Dr. K not only had a medical degree but also was a graduate of Duke University with an engineering degree. When he examined the MRI of my prostate, unlike my urologist and those in South Florida who do FLA, he found two other areas that needed ablation aside from the median lobe. It was both his engineering and medical experience that convinced me (despite my initial objection) that to do the job right, as much as 50% of the prostate tissue needed to be removed. The facility was Houston Medical Imaging. In all of Houston, I learned that there were only two Siemens Skyra 3T MRI Magnetom imaging machines. Just about the latest technology with each machine costing $3 million dollars. Obviously, if surgery were to be done on my prostate, I wanted a machine with the latest web technology that was MRI compatible, unlike the older GE machines that some doctors use at more that half the price.
Approximately 30% of my prostate was removed. Intravenous IV conscious sedation presented a higher level of care. At no time during the 3.5 hours of surgery did I feel any pain or discomfort. I have heard of patients that have had oral valium sedation with nerve block. This I learned is less costly but can involve some pain for the patient.
It is now 18 days since I have had the operation. For a 75 year old man, having a catheter in his bladder for 8 days was no fun. I was warned of spasms and though I took uribel (?) to ease the discomfort, the spasms which occurred several times a day initially, can make a grown man scream like a baby. Throughout this period I began to understand why a fan club grew around Dr. K. When it was an unusually cold day, below 15 degrees in Houston, Dr. K came to my hotel not once but twice to check on how I was doing. I did not expect that level of care as most doctors do not provide home visits anymore. Not even 30 minutes in an office before you are rushed out for another patient. Today it is hard to fine optimized clinical care, much less a doctor who is willing to speak to you for multiple hours and even be on call at any time of the night. Dr K was the exception and I am very thankful.
Results so far have been beyond my expectations for such a short period of time. Of most concern to me was that my pipes were all working well. No damage to the neuromuscular bundle or the ejaculatory ducts etc. Yes, this 75 year old previously had a perfect score on a sexual health questionnaire and I didn't want that changed. After 10 days, ejaculation was better than I expected....A climax that a 30 year old would relish!!! Imagine that! Ejaculatory fluid actually increased. Hard to expect that when 30% of your prostate is removed. No retrograde! Those poor naive TURP sufferers. They forgot what they are missing. I currently release close to 200 ml upon urination, double the increase before the surgery. I have been told the best results come after 30 days for which continual improvement will happen for 6 months. Yes, their is still some blood in the urine which I was told can be expected for a while as the prostate inflammation goes down and healing progresses.
I hope I haven't bored anyone with my journey. Good luck and success to all of you!