Alan Wein: Hi, I am Alan Wein, the editor for Functional Urology for UroToday. And today it's my very great pleasure to have Dean Elterman on the show. Dean is the Lang Family endowed Chair in urologic innovation at the University of Toronto. He's also on the guidelines committee for the EAU for non-neurogenic male lower urinary tract dysfunction, and he directs the Functional Urology Fellowship at the Toronto Western Hospital. And what I've asked him to do is to go through a subject that he's intimately familiar with and also very objective about, and that is what type of BPH procedure do you select for what type of patient? And he has a set of slides to begin that he'll go through, and then afterwards we'll have a short conversation about those. So, Dean, thank you so much for doing this and take it away.

Dean Elterman: Well, thank you very much. It's a pleasure to join you and thanks, Alan, for the introduction. So, I'm going to take us through some of these slides, and really it's which surgery for which patient BPH, and of course you could give an hour-long lecture on the topic. You could write a textbook on the topic. But I really want to touch upon some of the key points that we're considering when it comes to the different types of technologies. So, what is the state-of-the-art for BPH? We know that there is a growing international burden for male LUTS. Men are living longer with a greater emphasis on quality of life. And we know that in over 50% of men, they're really not going to be satisfied with the outcome or the effects of BPH medications. It won't work for them or they'll have a lot of side effects.

And now more than ever, we have more choices. If you look at the guidelines in the America or Europe, the diagram has become so complicated it's difficult to know how do we choose. So, we have conventional, traditional transurethral surgeries. We're all very familiar with these. TURP and bipolar TURP, they remain the most commonly utilized technologies around the world. The range is for prostate between 80 to 100 mL. It's widely available. Greenlight, very similar to TURP. Some less bleeding evidence showing some faster recovery, particularly shines in men who are anticoagulated. And of course, enucleation remains a size agnostic treatment. It has the best durability in class as you're really removing all of the adenoma. But we do see lower adoption relative to the other methods, particularly in the United States has done very well elsewhere around the world and at the expense of loss of ejaculatory function in the vast majority of men.

So, I want to go through some of the pros and cons of some of the newer technologies. So, what we're talking about with traditional or resective surgery, I would include aquablation. So, aquablation is image guided robotic surgery. Who is it good for? A wide range of prostate volumes. There's evidence to show it's effective for large prostates bigger than 80 grams. In fact, there's probably no size limit. It's effective for men with median lobes or intravesical protrusion of their prostate. And I think the key feature of aquablation is that it balances the durability of a resective technology whilst maintaining sexual function, including anterograde ejaculation like we see in the minimally invasive treatments in the vast majority of men. Who should we not do it in? Those who are anticoagulated and cannot stop? And for those who absolutely must keep ejaculation, because we know based on meta-analyses and literature, the rate of ejaculatory dysfunction is somewhere between five to 10%.

So, the EAU guidelines make this very interesting statement. Men are clearly wanting to value sexual function and preserved higher safety at perhaps the expense of durability. And that's really why we have all of these new minimally invasive treatments that I'm going to talk about. Patients are wanting to have a safe experience, they want it to be well tolerated. They want to have a fast recovery with improvement in function and preservation of sexual function. Those are all the checkboxes. So, we now have four FDA approved minimally invasive treatments. We have the iTINDs, the temporary implantable nitinol device. We have the UroLift prostatic urethral lift, we have Rezum water vapor thermal therapy, and the newest, Optilume drug-coated balloon for BPH. So, let's talk first about UroLift. It's good for prostates between 30 to 100 grams. That's the labeling. Particularly good for lateral lobe obstruction. It preserves ejaculatory function.

So, if that's a high priority, this is something to consider. There's essentially minimal to no catheterization time and evidence shows a faster return to work, but who not to give it to? Those who have a very high bladder neck or a tight bladder neck. It'll actually make it worse. Those who have a very large median lobe, it may be challenging to do even with the median lobe technique. And there's some concern around MRI usage in those on active surveillance for prostate cancer. What about Rezum water vapor thermal therapy? Who is it good for? Demonstrated to be good for a wide range of volumes. The recent labeling in the United States has changed it so that you can now treat glands up to 150 milliliters or cc's. So, a wide range of treatments. It is effective for median lobes or prostatic protrusion into the bladder. You can do it for regrowth and it really does do a good job with respect to durability compared to maybe some of the other minimally invasive treatments.

Who to avoid it in? Who should you not give it to? Those with prostate that are so big you'll need more than the maximum number of 15 injections. I would never do a Rezum in a patient who's had previous radiation. Anyone who cannot tolerate a catheter, don't do it because they're going to need a catheter for at least three days, seven, even up to 10 or more days. And for those who must 100% keep ejaculation, it runs the risk. It's less than 10%, but there is a chance for them. Optilume BPH, who's it good for? The clinical trials were up to 80 grams. Now, it's based on prostatic length, not volume. So, maybe we can go bigger, especially good for lateral lobe obstruction, good for preserving ejaculation.

It has a shorter catheter time, so those men who want less catheterization and there's no permanent implant, it's okay if there's a small median lobe, maybe for sure no median lobe, but you should avoid it in prostates that are either too short, less than three centimeters, too long, more than 4.8 centimeters, and those with a big median lobe because that'll still cause obstruction even though you're opening up the prostate anteriorly. What about the iTIND, the temporary stent? This is actually really good for those who have a high or tight bladder neck, different than the other ones that we talked about. It is very good at preserving ejaculation and it's a non-permanent implant, but who should we not give it to? Median lobes would be an exclusion. Prostates bigger than about 75 grams an exclusion, and those who cannot tolerate the device being left in for those seven days. In this past year, we've introduced this concept, a new almost category called first-line interventional therapies or FITs. And this is almost a new classification somewhere between medications and the existing minimally invasive treatments or MISTs.

The idea being that these are feasible as an outpatient, they provide durability, but they're much more patient-centered in terms of the experience of getting it performed as well as preserving sexual function. So, I used to give a talk when we talked about stents 2.0, which is very different than the stents from the 1990s. And this is really FITs. This is first-line interventional therapies. You can see here there's a variety of devices, and I'll zoom in on a couple of these in a moment. And the idea is that they're performed as an outpatient in a clinic generally with a flexible scope and they're reversible in nature. So, if we zoom in here, there's a couple examples. Top left is the Rivermark FloStent. We've got the Zenflow stent on the top right. We've got a butterfly stent, we've got a protean and a proviron.

So, all of these are different shapes and sizes made out of nitinol and time will tell. All of the studies are now maturing. We're going to see FDA approval anytime now, and we're really going to have to learn how to select the right patient, the right prostate for these FITs. So, with that, I think FITs and MISTs do meet the demand of our population. It's growing. They want emphasis on quality of life. They want something that has lower risks that are avoiding complications. A lot of this can certainly be done as an outpatient. And we're really trying to take into consideration all of these factors, the anatomy, the size, the shape of the prostate, sexual function preservation, permanent, non-permanent implant, catheter duration. And that's how we're going to tailor BPH therapy in 2025 and beyond. So, Alan, let's talk about it.

Alan Wein: That was a great presentation. So, I was very much interested in that article that you wrote with Steve, and it almost seemed as though you were suggesting, and tell me if I'm incorrect about this, that if a guy comes in who has a typical history of BPH, is on medications, is on a 5-alpha reductase inhibitor, an alpha blocker, but his stream is getting where everything is getting worse, it points to BPH. The guy basically is in retention. Does it make sense to put something in like an Optilume balloon at the first visit for that guy and leave it in and see what happens?

Dean Elterman: Well, I think there's a couple things. One is with medical therapy, we're seeing more men present with retention and end stage bladders. And so the idea is if we can shift the paradigm earlier in terms of intervention and treatment, but in a less invasive way, this really may meet the demands of the patients. Now once they're in retention, it might be too late to really offer them a minimally invasive treatment. But the concept, the paradigm of offering them an Optilume, a minimally invasive treatment earlier so that they really don't get to that end bladder damage is the main consideration that we're trying to propose here.

Alan Wein: Do you think that those patients need any type of urodynamic study, let's say, other than a uroflow and a post-void residual, which are really the most minimally invasive you can do?

Dean Elterman: I think certainly when it comes to the first line interventional therapies are FITs, the idea is you put them in, flexible scope, local anesthesia, outpatient. If they do great, and usually the responder rate for these treatments is in the 70, 75% range. So, you're going to know if it's working for them. And I don't necessarily think they need urodynamics. Of course, this is a clinical decision. If someone comes in with mixed symptoms, a little bit of storage in nature, you don't know or there's something to clarify on urodynamics, then for sure do it. But most run-of-the-mill BPH, it's pretty straightforward and I think they'll do fine with one of these devices.

Alan Wein: Yeah, I mean I agree with you. I think that in that type of patient that sometimes we're overdoing the use of urodynamics, because I think the only thing that ... I'm not sure you can find anything that's going to change your treatment. I mean even if they have a few involuntary bladder contractions, it's not going to change what you do if you're really treating mostly their emptying abnormalities. For something like the procedures that actually staple the prostate to the side of the [inaudible 00:12:00], basically the UroLift. And if they have a median lobe, does it ever make much sense just to resect the median lobe because there's really no danger of ejaculatory problems and then do a UroLift on the remaining prostate?

Dean Elterman: You can, you can do it stepwise. There's really good data showing that middle lobe resection, middle lobe only resection does quite well, right? Their flow improves to an extent. Their risk of ejaculatory dysfunction is very low. And then of course, once you deal with that, you could still deal with the lateral lobes by putting in, say, a UroLift. It gets into the number of procedures and costs. But from a theoretical perspective, I totally agree, middle lobe resection and then lateral lobe management, however you want to do it. And of course with the UroLift, there is a middle lobe technique. The next generation has this tissue control wings on the end of the tip that you can actually use to really pull the middle lobe in and pin it out of the way. It takes a little bit of expertise, but either way, dealing with the median lobe and then lateral lobes in a different way is quite clever, I think.

Alan Wein: And basically, I guess because of the results, is it true that the bigger the hole, I mean excluding ejaculatory issues and excluding, let's say somewhat higher risk of urinary incontinence, is it true that the bigger the hole, the better the result?

Dean Elterman: I think it goes to an extent. And what I mean by that is some of these minimally invasive treatments and these stents that fit are really trying to just restore normal anatomy. You're not trying to widen it so much. And that's why we see big improvements in IPSS, but not massive improvements in flow. And on the other end, you have something like the WATER III study, which just came out, which compared enucleation HoLEP to aquablation, and we know for sure enucleation will take out a little bit more tissue, more tissue than an aquablation, but the flow rates are very similar. The IPSS improvements are very similar, but you get to preserve ejaculation with aquablation. So, maybe you don't need to remove all the adenoma like in the enucleation to get the benefit. And that's what aquablation does.

Alan Wein: So, for a smaller prostate, let's say 80 grams in someone who wants to preserve ejaculation, wants an outpatient procedure, doesn't mind a catheter for a couple days, I mean, what's your favorite for those types of therapy?

Dean Elterman: So, once you get up to 80, I really think some of the less invasive options tend to go down in their durability and their efficacy. So, for me, in my hands, if they want something minimally invasive, they're okay with a catheter. I think Rezum water vapor ablation or aquablation. But again, aquablation, people kind of get them confused. Aquablation is a real surgery. It happens in an operating room. Rezum is more ASC office, they're in and out. So, for an in and out 80 gram procedure with ejaculation sparing, I think Rezum is a pretty good option. It's not the only option, but it's a pretty good option.

Alan Wein: Great. Listen, that was a great discussion. Really appreciate it and I'm sure the audience is going to take advantage of that presentation a lot. So, thanks again.

Dean Elterman: Thanks for having me. Appreciate it.