FLA

I agree with what you are saying Doc and I think it's good advice/ On the other hand if one can afford it it's the only procedure besides Urolift that as far as I know has almost no chance of Retro and apparently not everyone is a good fit for Urolift. Also it can be done for 14k if one has not had prior surgeries and be part of a study, admittendly still a fortune. Rezum sounds promising but evidence from my Uro's office appears to show 10% chance of Retro. I DID speak to my Urologist before having it done, he does button turp, a colleague in his office does Rezum and at that time I was not aware, and my Uro did not say, "why don't you try Rezum with my colleague Dr Cowan rather than fork out 20k ?" I probably would have met with Dr Cowan first had that happened.

There is no data for this procedure for its use for BPH.

There are only 2 physicians (I believe) offering this for BPH, and there are exactly 0 published results from any physician.

Insurances "considering it" means nothing, unfortunately; it takes years before they actually add it to their LCD coverage (and they generally only do so after Phase 3 trials, of which there are none in the pipeline for this. It was my understanding that anyone in the trial still had to pay a lot of money for it.

It would be against my medical training to not tell perspective patients the facts.

Hello;

It is experimental because there are no studies; beyond around (20?) anonymous folks on a forum, there's no documented patients who have had this performed for BPH; there is no objective data on this whatsoever.

I refer plenty of folks to interventional radiologists (and other doctors) for established procedures. In fact, I refer patients pretty much daily out of my practice; I'm definitely not selling anything. In 2017, I cannot recommend this procedure.

 

Pretty much every procedure has a non-zero risk of retrograde ejaculation- obviously some more than others!

Urolift, I believe, will be proven to have the lowest, as no tissue is ablated.

You listed no facts. I'm completely honest- there is no data for this experimental procedure for BPH.

I was told of two doctors doing this for BPH; a Dr. "K" and a Dr. "S", and multiple people said "stay away from Dr. S".

It is NOT FDA approved for BPH, as there is no data, and no Phase III studies.

Any MD who has heard of this procedure (regardless of his or her field) would recommend to stay away from this until there is legitimate data.

Hey guys go easy on the Jersey doc he is doing everyone a service by giving free knowledge and answers about stuff in general - I don't see anything wrong with it nor do I feel he's pushing people to come on down to New Jersey to get Rezum. Ie didn't say FLA is not FDA approved that I saw, just that it is considered to be "experimental".

Urologists won't go broke if FLA takes off, there are so many things they do, OK maybe some will lose if they make a lot off Rezum, Urolift or whatever.

It is an FDA approved procedure with insurance codes. If anybody wants the insurance codes for MRI guided FLA, I have them, I'll gladly procide them.

I personally know of 2 men who have been reimbursed either fully or partially. I am not in touch with everyone who has ever had this done and so there may well ne many more. 

My Urologist in Manhattan gave FLA his blessing as he knew that Rezum, trurp etc wouldn't help me and other procedures that are urological standards would have left me sexually disabled. One urologist I saw in May recommended a prostatectomy. Thank goodness there are some decent urologists out there with open minds and good hearts.

 

Ross;

unfortunately, as there is literally no data for this experimental procedure, (and virtually nothing beyond this anonymous forum), "heresay" is all we have.

As mentioned, I have a great relationship with multiple interventionalists, and refer patients to them all the time for established procedures.

J12080 how much of your FLA is insurance covering?

Jerseyuro I don't know of any actual published data either. I do know there is quite a bit of anecdotal evidence of prostate cancer patients that had BPH symptoms relieved after having MRI/FLA for their cancer.

Ross what percentage is being covered of the FLA for these men?

One i know had half and the other I am not certain but believe it was most of it!

Hi Mike,

Well said.  Also, "experimental" is not a dirty word as some are taking it, but rather medical terminology describing a medical procedure that has not had sufficient data based on peer reviewed studies. And that is what FLA is.

That doesn't mean one should necessarily avoid FLA for BPH, but it does mean that the risks and reward still not been well documented, and peer reviewd, like the more established procedures.

Remember TUNA and Microwave? A lot of initial excitement but they ended up not panning out. And in this case, there is a considerable investment (I'm pretty sure Medicare won't pay anything) as a more difficult recovery period, say as compared to less invasive procedures like Urolift, Rezum and PAE. 

@JerseyUro: Any MD who has heard of this procedure (regardless of his or her field) would recommend to stay away from this until there is legitimate data.

---------------------------------------------------

Are you talking about FLA specfically or "experimental" procedures in general? I ask because doctors all the time enroll their patients in trials for "experimental" procedures, Aquablation which you brought up, is one such experimental procedure. 

Jim

 

jim: Any MD would ask patients to be wary of anything that is not well established (or FDA approved.)

Aquablation, for example, is experimental; the difference (vs. FLA, for instance) is, there are multiple trials and scholarly papers on this as a treatment for BPH, with Phase III's well on the way. 

Regardless, I want to SEE all the Phase III data before I tell my patients it's as great as some purport it to be.

Very true

JerseyUro,

I wasn't comparing Aqablation (Phase III trials) and FLA (no published trial data). Just making the point that many physicians enroll their patients in trials for experimental procedures and drugs all the time. Also, remember, Aquablation was Phase I just a few years ago, and some doctor (actually Grilling) persuaded those first 15 patients that the procedure had enough merit to be in the trial.

That said, I agree that we can’t equate anecdotal accounts with trial data, and hopefully anyone considering any experimental procedure, regardless of who is doing it, understands that difference and does their due diligence beforehand. It’s also important to note that even the anecdotal reports on FLA seem mixed and are only 5 months out.

For all these reasons, FLA would not be my choice today, but I can see the allure, and undersand the choice, because of the precision of the treatment, and lack and unlikelyhood of sexual side effects. 

Time and hopefully upcoming trial data will tell more. 

Jim

 

 

But "experimental" is a very negative term disingenuously used by JUG to denigrate what is a very very promising procedure. FLA was approved 10 years ago specifically for the ablation of prostate tissue. 1000's of men have now been treated for both prostate cancer and BPH using this FDA approved technique. The fact is that FLA for BPH is an "off-label" use of FLA and is by no means a leap of faith. 

What is "experimental" about tissue ablation of the transitional zones using an FDA aproved ablation technique for the prostate? Isn't that what most ablative BPH procedures do? Now we have transitional zone ablation with a great deal more accuracy and visibility for the practitioner by way of 3T MRI guidance, keeping the treatment well away from areas of extreme sensitivity and importance to the patient, than any urological procedure out there.

Calling an FDA approved procedure for the ablation of prostate tissue "experimental" serves no other purpose than to cast aspersions on a first class option for sufferers of BPH.

 

The anecdotal reports on FLA are not mixed at all! No one has reported retro and everyone has reported improvements. (except for those who only just had the procedure)

There have been no studies for using this for BPH.

There is no data.

This is not FDA approved for treatment of BPH.

There are no Phase III studies for this.

This will likely cost you tens of thousands of dollars.

"3T MRI" has no place in the treatment of benign prostate disease.

Any medical doctor will point out these red flags for someone considering this procedure.

Buyer beware.

Ross,

That's why I brought it up. I can't speak for the doctor's intent, but "experimental" is common medical terminology that is used all the time to describe procedures, drugs, etc. Even procedures in current trials. That's why I used the Aquablation analogy, which is in Stage III trials, will probably have FDA approval soon, but it still termed "experimental" by the author's of its own studies. So here, the use certainly not being used in a derogatory fashion, it's just putting it in a category of procedures that haven't yet had adequate peer reviewed studies.

I'm not that familiar with FLA for PCa, but the "experimental" label I believe is applied per the specific use (FLA for BPH) and not for other uses. 

That said, I think some of your points are excellent as to accuracy and visibility with ablation in general, and I would definitely take that into account in a positive way in making a decision for BPH.

But that doesn't mean it's not "experimental", nor should that be seen as disparging. It is what it is.

Jim 

 

I'm basing "mixed" on nine reports I've read here. After three months, one of the nine is still on Flomax and does CIC at night. Another recently mentioned that he didn't think the FLA would hold, and he's considering more agressive procedures. Another, then at 4 weeks, said he hasn't seen any difference yet. I do realize that its still very early in the game at only 5 months out, and these cases could improve (or regress) in the future. 

Jim

Maybe there is some misunderstanding - Dr K told me that the laser tip he used for the ablation was FDA approved - maybe the procedure itself, FLA is not approved yet? We have all suffered a lot with BPH for many years so it's hard not to get emotional in these discussions - I really think the Doc is just trying to help and giving his perspective from the other side as a Urologist and I think it's interesting.

Hello, I am interested in the list of doctors, who do FLA.

​If you also have any names from other countries.

Hello, I am interested in a list of doctors  performing FLA (in any country)

I only know of about 5 doctors, all in US.

Bruno,

I only know of two in the U.S. who perform FLA for BPH. Dr. Karamanian (Houston) and Dr. Sperling (Florida and New York) . Who are the other three?

Jim

Jim

How do you figure that?

A very long procedure that costs over $20,000 and has only a few anonymous people stating they had good results? It sounds like approximately one third of the people who had this done are not happy with their results ( but, again, there are only a few people who have actually had this done. )

As with any procedure,, if I can find something effective to offer my patients, I will gladly refer them to the correct provider ( which I do frequently. )

There is nothing in the literature to support using MRI for management of benign prostatic disease. That is purely marketing

I would like to ask you Dr, how many of your patients are on this forum? And how many have you treated that are not on this forum?

To assume that everyone who has had an FLA procedure is on this forum is silly, just as it would be silly to assume that all of your patients are on this forum. The point is there are probably many more people that have been treated, and if they were unhappy we would be more likely to see them here.

 

I am probably one of the three that Jimjames is referring to as having mixed results, which is misleading. What I said is I expected to need another procedure some day, which would be my same expectation with Urolift, Rezum, TURP, etc. The question is how soon. I am happy with my results so far. Mike588 is probably the other, and he has also said he is happy with his results. 

I find it silly that you are either wanting to argue on this forum, or allow yourself to be baited into it, if that is how you feel. You can offer a lot of valuable insight without bashing other procedures, but that seems to be where it always ends up. I am willing to listen, but not take everything you say as gospel. I am sure everyone else is in the same boat. We are here because we want to know for ourselves. 

They use the MRI to help do the procedure, not "management" correct me if I'm wrong - just like they do for PAE, though PAE uses a different kind of MRI I believe. As far as I am aware I am the only one of those anonymous guys who can't say it was 100% successful, though I would still say I am very happy I did it given the alternative was at least a 10% chance of Retro. I haven't been following all the discussions carefully, so maybe I missed a negative report re FLA - well as you say very few people have had it done for BPH alone.

Dr. John F. Feller

Dr. Sangeet Ghai

Dr. Jonathan A. Coleman

Dr. Scott Eggener

​I think, some are doing it only as trials.

​There is also another doctor in Huston (not doctor K)

There is now a trial for FLA at Mayo clinic

I don't think I've bashed this procedure.

I am a data driven scientist/physician. I just want people to realize what they are getting themselves into.

I believe in the informed consent process.

Bruno,

Are you sure they do FLA for BPH or just FLA for prostate cancer? We're only talking here about FLA for BPH. The other doctor in Houston is Walser (sp?) but I don't think he's actively doing them now. 

Jim

yeh I was surprised to hear there are so many, there's actually a Urology practise in Sydney Australia doing FLA but again only for Cancer, for BPH they do Green Light or at least did so last time I checked.

Trustme,

There has been a lot of criticism (a lot of it constructive) on this site for TURP, GL, Rezum, Urolift, PAE, you name it. Why is FLA for BPH so sacred? All points of view should be heard. As I understand it, all the doc is doing is saying it's an experimental procedure that comes with the risks of any procedure that hasn't had peer reviewed trials. He's not saying not to do it, just to be careful with your decision. What's wrong with that?

Jim

I think the list Bruno gave is for FLA for cancer, like the urologist in Sydney.

Jim

@Motoman "I am probably one of the three that Jimjames is referring to as having mixed results, which is misleading."

--------

Guilty as charged, but I was not trying to be misleading. 

Eleven days ago you said, "I had the FLA procedure done 5 months ago. I had decent results, but I don't think in my case it will be a permanent solution." and then later in the post you said "So if my BPH/LUTS symptoms come back, I would be leaning towards a more permanent solution that makes peeing easier". The latter statement, which suggested at least to me, that you felt that FLA might not be as permanent a solution, as say GL or another more agressive procedure that might cause retro, which you asked about. 

As to Mike588 and the other fellow, I never said they weren't happy, just reported what they said. Mike is still on Flomax and still caths in the evening. The other fellow said he noticed no change at 4 weeks. 

So, at this point in time, I considered it "mixed results" with these three cases out of nine, but you may disagree.

Hopefully, we can agree that by this time next year we will have more data and knowledge on what I consider a very promising, but still very new procedure.

Jim

 

The Doc stated we were not happy with the results. That is not what Mike and I said. I don't know about the other guy.

I got my money's worth, I can afford it, I wish insurance would pay for it for others. I also don't think it is permanent, which is also the case with almost every procedure I have seen. 

The jury is still out on long term results, short term it seems very effective in the small numbers reported on this site. Don't lose sight of the fact that this site is a tiny sample of the amount of patients that are probably being treated for this. Dr K and Dr Sperling would long ago been out of business if there weren't enough patients. And if they were having bad experiences they would show up.

There is no data or scholarly papers to suggest that "3T MRI" has a role in the treatment or management of BPH.

If studies are performed demonstrating its utility, I will be able to change my comment. 

@Motoman "I also don't think it is permanent, which is also the case with almost every procedure I have seen. 

---------------------------

It does seem that way with the less invasive procedures but at 20-30K a pop, a real consideration for many. FWIW I also think all the procedures to date have "mixed results", and durability issues, not just FLA. But with the other procedures, there is a longer data line. Where FLA shines for me, is no cases of retro so far. As to Dr. S., it would be nice if he released his data, assuming that he even keeps it

Jim

 

Bruno, sorry I am late getting back. I played 27 holes today.  The list I have is for the Interventional Radiologist's that preform Focal Ablation on the Prostate Gland". Period. But,  like jimjames points out, this is primarily for the ablation of Cancer that has been done in the past. The doctors that preform prostate ablation are all capably trained already for BPH tissue removal as they do it for PCa and yes, it is the same procedure.  So, now more doctors are doing it for BPH and even more are planning to start. 

The list is at my office and Monday I will find the file and then I will (PM) presonal message you the list hopefully on Monday. You can certainly call the ones that are meaningful and geographically attractive to your area. 

Clarifing a answer to a previous question, Walser is now doing FLA for BPH. There are more IR doctors doing this as they find that the procedure, when done for PCa provides an end to the BPH symptoms for a lot of the PCa patient. Sperling claims he has done well over 100 patients for BPH. And over 1100 for PCa. 

I know, I know, insurance does not appove the FLA treatment for payment in the prostate Gland. So, it has to be bad. At least that has been the pitch that has been used as presented as to why one should be leary of FLA.  The FDA HAS appoved the use of the Laser in prostate for tissue removal and PCa was the first procedure put into wide spread use over 10 years ago. Now BPH is the next treatment it is going to used for widely because the IR doctors who specialize in this treatment. These IR doctors are now well trained on the exact procedure because of PCa treatments, doing the work in the exact same gland area. They are doing this exact same procedure of the same tissue using the same abalation process that has been done thousands of times. It was noted that one of the (side) effects during these procedures was the removal of the BPH symptoms that happened after PCa tissue removal. 

This treatment of the prostate gland is apporved for use by the FDA NOW. It is a very short reach to call BPH symptom relief  "off label". Everyone understands this in the prostate medical industry including those of the all knowing and caring Inusance Companies. That is why some insurance payment approval in both PCa and BPH treatments are also changing slowly resulting in the payment by the insurance.But, I am not going to argue. I am very pleased at the moment and feel I got a steal especially since I am getting part back from Medicare.

NO I am not sure it will last. I understand the logic behind why it could last. Motoman is correct, noone that is treated by ANY one with ANY of these treatments is getting a cure of BPH. All of us need to understand none of these treatmetns stop the gland from growing. You can only put your choice behind logic of why one procedure would last longer than another.  And then do what the Motoman is talking about. Research and be ready for the next round in your fight with BPH. That is absolutly my feeling and intent to do the same as he is doing. Get Ready. We can only hope and enjoy what we got while it last. But PAE, UROLIFT, REZUM are also that same way. 

 i got what wanted. I should be happy and go away to enjoy my happyness and hope it last. It is time for me to start butting out, as they say.  I am sure that the good people of urology will not let anyone they speak with stray to  the procedures that the Urologist are not able to provide and certainly not the ones that are not approved by Insurance. And, that help provided will be out of their concern for us (the market with BPH). 

With regard to the claim that you should watch out for anything that the insurance companies will not pay for, I understand this is now changing too for BPH treatment with FLA. This is good, this makes me almost feel clean again!     At least it will help someone who is hurt by the current costs. 

Good luck, there are some good, smart, caring consumers on this thread we all get to pick our poision, or in this case our medicine. I will get back to you Monday by Personal Message.

Sorry Bruno, I didn't realize you were looking for FLA for prostate cancer. I just assumed it was FLA for BPH since that was the topic of this thread. 

Jim

Jim, I think we are good here, he is wanting to find more doctors in the field that do the process and that is changing. He needs and want to know the list of FLA Prostate IR's. He said he knew of five and wanted more. They come out of this list.  

Also, I said with regard to this list, 

There are over 25 Interventional Radiologist around the country preforming FLA on prostates. IF this list is needed of these Doctors, I can provide the shopping list but it cannot be on this thread. Everyone should consult all doctors avaliable to them.

 

I have to apologize, I am on a wrong site. There is prostate cancer forum, 

?and it has 10x less traffic. I had BPH, and chose HoLEP. There are over 20 methods for treating BPH (I have published the list). I didn't choose FLA for BPH, because I couldn't pee, and have tried CIC, and have failed. I chose Holep, because it removes more of the prostate, than any other none radical method, has a fast result, and has easiest recovery. It also provides a sample for testing. The only down side is the retro. I have been reading comments from people who had radical prostatectomy. Having retrograde ejaculation is nothing compared to what they have to deal with.

After the Holep, I feel great, everything works, and all the suffering is gone. But a test of the removed tissue came back positive for cancer.

Before the procedure, I had PSA test, came back low. DRE showed BPH and no cancer, I had MRI, also no cancer.

I was seen by a family doctor, and urologist, both agreed that I don’t have cancer. If I chose any of the several BPH methods, that don’t remove the sample for testing, I would be convinced that I don’t have cancer. Even TRUS biopsies

can miss cancer. Even 3T MRI can miss cancer, but appears to be gaining popularity over TRUS biopsy.

Now I am looking for a focal method, mainly FLA. I am scheduled next week for 3T MRI.

Many prostate sufferers are forced to be resourceful, and educate themselves.

I have made a list of available methods for BPH, and once I chose Holep, I collected a list

of doctors who do the procedure. I have spent days working on it. My doctor doesn’t know what is

FLA, or Holep. They only know TURP. If I would rely on my doctor, I would now have a catheter, be on antibiotic, and be miserable. What got me motivated was a visit to ER when I couldn’t pee. There was another patient, incontinent, and couldn’t pee. They had to wipe the chair he was sitting on, after he got up.

He had TURP done, it didn’t last, had a catheter one year, and was looking for another TURP. He was in rough shape.

Turp is all they do here. When I requested the TURP, the examination would be in one month, the TURP would be still further off. I have found a doctor in Mexico, flew there, first day examination, second day they did HoLEP.

When I got back, the receptionist at my doctor was upset with me, because I didn’t follow procedures.

Interestingly, friend of mine, lives in another town, had BPH, went to their ER, they put in a catheter, in couple of days had TURP, and has a good result with it.

I'm curious Bruno, do you have private insurance? Why are so few options available to you?

I am in Canada. We have free, government provided healthcare, and there is not enough money to provide health care for everyone, so many people 'fall through the cracks'. It is not a bad thing though, because we don't have to worry about what an insurance would cover. We don't have an insurance. Some 50,000 Canadians travel abroad every year to access healthcare. I am going to Buffalo NY for 3T MRI, and hope to go to Dr. K

?for FLA. This is only available for people who have some money saved up.

?Somebody without money could be in trouble.

unckle,

Looks like Medicare has agreed to pay about $4,700 back to me. There are a couple of private insuance companies that I was told are now stating they will pay the out of network rate for FLA on BPH which is about half the costs. This has so far been stated in a pre approvment mode and we will see if BCBS does what the said. I have also been told by the insurnance companies directly that they are more ready to pay on BPH than on PCa with regard to FLA treatments. Why? I dont have the full answer yet and I was shocked to hear this but it has to do with the fact that Greenlite and other laser treatments for BPH are also covered now so they are putting FLA in the same BPH laser treatment bucket. I anticipate it will be changing faster now that some presure is being applied. Won't it be wonderful to finally be legitimate? 

John,

That's good news. Do you have traditional Medicare with a Plan F Supplemental, or do you have it with a private carrier, HMO version?

FLA for PCa was considered experimental until just recent FDA approval, and there is still some controversy when and how it should be used, so I'm guessing insurers will take it on a case to case basis.

Jim

I sent you a private message for some resources on prostate cancer. To read it, scroll all the way up to the top of the thread, and click "my messages" under your name on the right.

Jim

Hi John, I am on tricare for retired military with medicare as another carrier, but I am under contract with a contract provider, US Family Health plan so cannot use medicare. Dr. Bagla's office called me this week to inform me that 50% of the cost of PAE would be covered leaving an $8000. balance.

I plan to call on Monday and see what they say about covering FLA.

Still undecided......

Richard, are you quite sure of the info you reported from Dr B's office? It is quite different from what I was told 4 montsh ago.

Yep, just checked my notes, I would be charged $8000 out of pocket.

Hey John good luck - I just applied to United Health Care my insurance, hoping they will reimburse something - a friend told me I can claim all my expenses on my tax return - and I've had plenty besides FLA the scans on my kidneys and all those visits to the Urologist are a few thousand $$$

I'll let everyone know if I had success - this is not Medicare

You have to be careful with insurance companies, I was told once by an agent, it says "We say we cover it, but that is not a guarantee we will pay the claim".

Do you have the median lobe problem? If so PAE is less effective, I have seen a letter from someone who had PAE in Denver, and stated that Dr Bagla reported to Dr Nutting in Denver that this is an issue for men who have a median lobe bulge intrusion into the bladder, PAE might still work as it did help this guy, but might be less effective. My PAE surgeon told me it should not make a difference, it didn't work for me after two attempts. I spoke to someone who had the median lobe and it worked for him, maybe it was not bulging into bladder, who knows?

For a reference I have basic Medicare.  Last September Dr. Baglas office charged me $2200.

Wow $8K 

Get in writing (along with a reference number) that the insurance will cover.

I've seen way too many horror stories of "promises" to patients that end in tears.

>>Yep, just checked my notes, I would be charged $8000 out of pocket.

And your inusrance would cover another $ 8000?

I am in Canada. We have free, government provided healthcare, and there is not enough money to provide health care for everyone,

Seems  like thats the way it goes with free health care. Can't wait for America to go down this road 

 

We can all hope that this (or other minimally invasive) procedures actually show efficacy; it's always nice to offer our patients new procedures, particularly if they end up being covered!

The nice thing about urologists is that we stay up on technology and generally "play well with others." We are always pushing treatment options to their limits!

If this procedure ends up being cost effective, covered by insurance, and is proven to be efficacious, we will very likely work with or hire radiologists to help us perform this procedure. (Just like many urologists did with radiation therapy, ultrasonography, etc...)

The future of BPH certainly is bright!

Hi Jim...  You mentioned above, "It’s also important to note that even the anecdotal reports on FLA seem mixed and are only 5 months out."

What I have been reading in the anecdotal reports on FLA for BPH in this forum, is that almost all of the participants have had acceptable to great results, except for one, and he is, at least from what I understand, reconditioning his bladder to help in his recovery? Have I missed some other negative reports on the FLA somewhere? Thanks

 

Hi Jim- You mentioned, "The other fellow said he noticed no change at 4 weeks." Just wondering what the other fellow's "screen name" is ?

Hi Jay,

I didn't use "mixed" in a derogatory way. I also consider the results from PAE, Urolift, and Rezum mixed as well. But one big difference is that those procedures have peer reviewed trial data and that data is more than 5 months out. Yes, one of the men is reconditioning his bladder, but the fact is that men with compromised bladders make up a significant portion of those seeking surgical help for BPH. The fellow who reported no change at 4 weeks is Jim81578. I believe I quoted previously what Motoman wrote, and I'll leave it at that. 

Jim