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Josh: Our next panel, I'm very excited about this group. We have Dr. Kevin McVary, a professor of urology from Loyola University of Chicago, Stritch School of Medicine. Kevin's the director of their men's health center, and Kevin's been on at least, I counted, 16 years of the AUA BPH committee. He's got over 500 publications in BPH and ED, has been involved in every major trial, every device trial probably in the last 20 years. It's a pleasure and honor to have Kevin leading this discussion. Next, we have Tim, Tim McClure. Tim is from Cornell, he's an associate professor. The interesting thing about Tim, Tim is double board-certified. He's a urologist as well as a diagnostic radiologist, and did a fellowship at UCLA in interventional radiology, so, interesting perspective. Tim gave a great presentation at the AUA plenary last year in San Antonio. Last but not least, Kevin Zorn. Kevin is from Canada, leads BPH Canada. Kevin is a big supporter of LUGPA. We appreciate you always being around. He's been involved in basically every major device trial. You see Zorn, K.C., listed as a co-author, well-published, and we really have a world-class panel of the brains behind BPH treatment in the U.S. today. I'm going to pass it off to Kevin, and thank you again, guys, for being here.

Kevin McVary: Thank you for the kind words, Josh, and gentlemen and ladies, thanks for coming today for our panel. I am going to... I know our theme is new technologies, and I'd like to put some of that into perspective. I've produced a couple of clinic scenarios and we'll try to draw some of these technologies in. Tim, I'll go with you. You've got a 62-year-old guy, he's got LUTS. What are the first kinds of things that you start thinking about when you see such patients?

Timothy McClure: When we see these patients, we do the thorough evaluation. You want to see dietary changes, you want to do an exam, you need to check labs, the full standard workup, from that perspective.

Kevin McVary: Yeah, and I encourage an assessment of LUTS, some type of questionnaire. Most of that's the IPSS/AUA Symptom Index. It's really the basis of a lot of the stuff we do. Let's start off with our 62-year-old guy. He's got bad LUTS with a score of 21. Just a big gland, post-void residual, and he's got a UA that looks like it needs a little investigation. Tim, where are you going to start?

Timothy McClure: With this, I'd also make sure he had a prostate MR prior to that negative biopsy, and make sure, because I think we get a better assessment of the actual prostate volume with that. With the UA, we need to do cystoscopy and work that up with a CT urogram as well.

Kevin McVary: Here you go, and this is our actual patient and he's got this thing, and it's pretty clear he's got this [inaudible 00:03:23] to the diverticulum. You can see it but you can't see the whole space. Where would you go next?

Timothy McClure: In my practice, he would see Rich Lee, and I'd send him our way. I'd send him to—

Kevin McVary: Okay, play the game. Yeah, so you'd scope him in some way. If you can't get in there, then maybe some other type of image. I mean, obviously the deal is, he's got a tic. He's got this big lesion in the middle of that baby right there, and we've got to figure out, which turns out to be a stone. It turns out, at the same time, at ultrasound, he had a pretty gigantic gland. In summary, we've got a 62. Where are you going to start? Where are you going to start on this guy? 62, big gland, bothersome LUTS. He's got a diverticulum, a stone, 220 grams.

Timothy McClure: Well, with this you've got to fix... I mean, I'd defer to you guys on this aspect with regard to that, but I think you've got to address the stone, the tic, and then you've got to address the—

Kevin McVary: Kev, do you want to weigh in?

Kevin Zorn: Sure, I'll back it up. He's 62. As [inaudible 00:04:34] would say, is he a good 62, or is he—

Kevin McVary: He's got a lot of tread left, man.

Kevin Zorn: That's the thing, is you've got to understand, what other comorbidities? Is he anticoagulated? What is his bladder function? How was he emptying, and then from that, to look, and has he gone through any medical therapies, or are we going right to...

Kevin McVary: I guess that's the question, so you'd start with medical therapy?

Kevin Zorn: Well, first I want to get a better understanding. His PVR, I mean, he's got a diverticulum, but is he symptomatic in terms of infections or things that are going to push me toward a surgical therapy?

Kevin McVary: No, at presentation, microscopic hematuria and lots of LUTS.

Kevin Zorn: Okay.

Kevin McVary: Now you've got to this point—

Kevin Zorn: I think, is it only BPH? Does he have some degree of overactive bladder? Does he have a hypotonic bladder?

Kevin McVary: I don't have the urodynamics to show you, but, so you would start going down that pathway?

Kevin Zorn: Well, just to make sure, before you pull out a surgery. You don't want to operate on someone right off the bat and to realize, "Wow, we didn't fix your nocturia."

Kevin McVary: The guidelines would tell us that that stone's got to come out, and the question is whether or not the diverticulum is to be done at the same time. Because that stone, it's got to be removed, so medical management would probably be okay, I mean, might be okay, but that stone's got to come out first, and with a big gland, you're going to do a drive-by prostatectomy.

Kevin Zorn: The stone, like I said—

Kevin McVary: Missed that one.

Kevin Zorn: It was a diverticulum, but I was focusing on the bladder wall thickness, which looked quite large.

Kevin McVary: Yeah, no, it is legitimate.

Kevin Zorn: If it is a stone, you have indication. That's one of your indications to move to cystolitholapaxy, and then to open...

Kevin McVary: You would stage it?

Kevin Zorn: Well, you can either stage it. I know sometimes in the States, too, you don't get paid for certain parts, and then...

Kevin McVary: How about you, Tim? Would you stage it, do a drive-by, try and do them both at the same time? Big gland?

Timothy McClure: I mean, I guess you could consider doing a robotic simple prostatectomy and remove the stone at that. You could potentially do that.

Kevin McVary: Let's mix it up. He's got hydronephrosis and a big large post-void residual. Would that change what you're doing?

Timothy McClure: Well, if he's got hydronephrosis, you need to make sure there's not... what his renal function is, and he needs... What's that?

Kevin McVary: No, I agree. With hydro, now the gloves are off, medical management's out, we've got to do something.

Timothy McClure: Yeah, you've got to treat him from a standpoint of—

Kevin McVary: Kev, you're going to take him to the OR. Let's say all your questions are answered.

Kevin Zorn: Sure, I'm satisfied?

Kevin McVary: Which might be an endless list from what I'm learning today, but your questions are answered, it's time to make a decision. Where are you going?

Kevin Zorn: I mean, if I'm skill set, across the board, if you're looking for something that's going to address the bladder, you're going to take out the stone, you want to be quick and on the table and you're savvy, you can do a robotic, a simple prostatectomy.

Kevin McVary: How about in New York, Tim? Such a patient?

Timothy McClure: I think to your point, it depends on the person's expertise who's seeing the patient. If you have a high-volume surgeon who's used to doing a lot of simple prostatectomies, then I think they'd address it all at once. Other people would probably... I mean, I can think of a similar situation probably where someone might do a HoLEP in addition to that, so it really just depends on the expertise.

Kevin Zorn: If you're in Cleveland, this will be done robotically, and that's what the guys, GI and so forth, or the descendants thereof. Then, if you're Amy Krambeck in this neck of the woods, you may have someone doing a HoLEP, cystolitholapaxy, and then you can coagulate something. People burn some of the diverticulum or the ostium to try and reduce it, to do it endoscopically.

Kevin McVary: Yeah, so there's not a right answer, really, because there are a couple ways to do that. My personal prejudice is one-stop shopping and do it all robotically, and take the tic at the same time.

Kevin Zorn: How about you? How are you—

Kevin McVary: That's what I do.

Kevin Zorn: Okay, well, that's what I was going to say.

Kevin McVary: Yeah, but I'm saying, my point is that there isn't a right answer.

Kevin Zorn: Sure, sure, but I was just curious.

Kevin McVary: Yeah, so Kevin, what do you counsel patients before surgery? What do you tell them about ED and EJD?

Kevin Zorn: Well, the first thing, I think most people sort of... It's your average patient. I've realized that you've got to break it down for them. I don't think everyone sort of understands. They're like, "Okay, well, tell me about the sexual function. Is this my ejaculation?" They think that may be the potency, so you've got to break it down. So one is getting hard, maintaining hardness, getting an understanding of what you are beforehand, and there's a time that some patients do get better. By getting them off the 5ARI. In Canada, they're on 5ARIs for a long time, so that could get better. Probably won't change. Certain types of techniques, it may get worse. Ejaculatory function, I think anyone ad nauseam understands the difference between some of the aquablation versus some of the other techniques, and that is important to discuss, and trying to take the time in your 10 or 15-minute visits, of, "Are you sexually active? Is it important, your ejaculation?" Really trying to understand what it is. Some people don't even care. They're like, "I haven't had sex in six months."

Kevin McVary: Urologists do a great job with the first three.

Kevin Zorn: Yeah, but the other ones, the SUI—

Kevin McVary: Blood loss, not as critical and not mentioned much, but then the treatment recurrence is really not explained to most patients. At least, that's what they say.

Kevin Zorn: Agreed.

Kevin McVary: That's what patients claim, and that's going to be something that may come back and bite us later. Let's move on. We've got a 48-year-old guy, he's sexually active, lots of symptoms, smoking history. He also had microscopic hematuria and really bad symptoms. We go to the guidelines, I'll move it ahead. The culture is negative, and he has a CT scan that is unremarkable. He's got a median bar, not a low bar, and cytology is negative. Tim, where would you start?

Timothy McClure: With this, I think I would start with medical management with him first.

Kevin McVary: Fair enough, and that would be what? An alpha blocker?

Timothy McClure: Start with alpha blocker. Lots of men don't like the ejaculatory dysfunction with that. You could move on to kind of daily Cialis, if needed.

Kevin McVary: Okay.

Kevin Zorn: I was going to say, my first bet on a 48-year-old, I probably would say, "Look, I can give you alfuzosin, because it has that less impact, or Cialis." We're in Canada, I think the biggest side effect is poverty, but it's something that is shown to be equivalent to Flomax, and that may be something to have a discussion with, so you don't get that odd phone call. He's going to have retrograde... You know he's going to complain about it, so plan ahead.

Timothy McClure: I'd just be worried with the IPSS score that high, that I'm not sure you're going to offer much improvement with medical therapy.

Kevin Zorn: I would like to break down the IPSS. Is it the FUN, the frequency, urgency? Is it the irritative storage issues, or is it more his obstructive? Look to see what his flow rate and PVR are.

Kevin McVary: We'll see. Anyway, on this guy, you want to think about alfuzosin, that doesn't have the ejaculatory dysfunction. Not every insurance company will cover the Cialis, which is also a very good thing, a good approach. We actually did try that, and not so good, didn't move him much. We tried anticholinergics, and had a good effect but dry mouth, so then we tried beta-three agonists and insurance wouldn't cover it, so we're stuck. That's a problem in America. Maybe it's going to change with some new studies coming out. Our guidelines would say, "Hey, it's time to start thinking about an intervention," and here's his urodynamics, since you asked about it, and he looks pretty well obstructed. Kev, what are you going to do? What are you going to offer this guy?

Kevin Zorn: What was his volume?

Kevin McVary: It was like 32. Something smallish.

Kevin Zorn: Okay, and not anticoagulated and—

Kevin McVary: None of that.

Kevin Zorn: In terms of IPP, when you say a median bar...

Kevin McVary: It's a middle lobe with no clefting. That's the definition.

Kevin Zorn: I think that's [inaudible 00:11:55] what I was thinking. It's a high neck and all these things. I mean, I think you could... In that category you have your, you know, TUIP, TURP. You can do Optilume BPH. I've done, those kinds of size prostates, iTind. Some people are UroLift.

Kevin McVary: I'm hearing a lot of MIST. You're thinking about MIST. Yeah.

Kevin Zorn: MIST option. How big is the prostate again?

Kevin McVary: 30-something.

Kevin Zorn: Is that really BPH? At 35 grams, the idea that you're small, and is it—

Kevin McVary: He's obstructed, and—

Kevin Zorn: Yeah, and then, is it kissing lobes? At that point you can think of any of the options, and it really depends on how important, at 40, is ejaculatory function. Is he looking to have children? Those kinds of questions.

Kevin McVary: Right, so problem becomes, hey, how are you going to balance a big impact on a symptomatic patient with a procedure that may or may not tip the scale that much? That's where MIST comes in. It fits that middle ground. It's pretty sweet in that regard. It's good for... Many of the MISTs are good, not so much for what they do but for what they do not do, and that's cause, in most men, change their sexual function. This is data I put together on the UroLift, and it really has virtually no impact on sexual function. Ejaculation is also, it's pretty much a sweet spot, although there's a cost to that. Anyone do a TUIP?

Kevin Zorn: I think we've all done... I mean, I think everyone's done one or two, but it's like, do you move the needle? You can't guarantee... I mean, we have things now that guarantee. UroLift does not affect ejaculatory function. This cannot be said for that. I think we're all tempted with a loop. Not everyone uses the incision. You tend to TURP the five and seven, but—

Kevin McVary: With the small gland, I would tell him about it, but again, I would be moving him towards a more standard MIST. The outcomes usually aren't as good. I'm sorry?

Timothy McClure: You had put PAE on there as well. I don't think, for such a small gland, I don't think... I wouldn't offer him PAE for that.

Kevin McVary: Okay. Well, thanks for offering that. Yeah, that's a good point. That'll come up a little bit later, I think. We've got a 59-year-old, he had a bipolar TURP at another institution. It might've been in Montreal, but I'm not sure. Initially had really good symptom improvement, and now he comes back, "Hey, I'm bad. I'm worse again." Tim, how are you going to tackle him?

Timothy McClure: Well, you need to see the recurrence. You'd want to do a cystoscopy, evaluate.

Kevin McVary: Yeah, so there's other things to consider, but these types of things, and obviously those are distractors. The very first thing guidelines would tell us is you get in there and take a look, because of the possibility of something like this, a stricture. That's what this guy had. A couple of ways to fix that. Do you have a set approach, Kevin, on post-TURP stricture?

Kevin Zorn: Is it urethral? Bladder neck?

Kevin McVary: It's bladder neck.

Kevin Zorn: Yeah, so that's always the tough one to get, because it's typically diabetics or hypotonic bladders. You can do a DVIU incision. I don't think dilation does that much. There's some people who've done... I've had a few cases where I've done Optilume BPH on the failed, redo fails, or you can cut out laterally, you can make it more oval, so if it does contract, it won't be annular. They're a tough one to deal with, and I tend to be, that you're going to do a cysto. You know that he's symptomatic and you're right there in front of him, and you're tempted to either put a guidewire and dilate it to get some acute improvement, or an incision. I've done a couple under local. It's really not kind of—

Kevin McVary: It's kind of a wild west. One of our guys at Loyola is doing—

Kevin Zorn: Yeah, you're cutting through a scar and it really—

Kevin McVary: Using the Optilume off-label on this exact type of patient, so it's kind of a wild west.

Kevin Zorn: We have, again, I'm not sure if some people in the office have nitrous oxide, but we have, it's the green whistle.

Kevin McVary: We have a green light laser.

Kevin Zorn: No, but not a green light laser, but it's the inhaled... It's methoxyflurane. Patients can—

Kevin McVary: Yes, okay. You mean local in the office?

Kevin Zorn: Yes, so we can do that and do an incision right there, so you [inaudible 00:15:50] for two days.

Kevin McVary: Yeah. I bet you a lot of the people in the audience have that opportunity. We actually can't do that at Loyola, too bad. The slide here just says essentially that a monopolar cut is better than a bipolar, that the re-stricture rate, so I suppose that's one thing to take home. Okay, we've got a 52-year-old. He's got what I call the small pesky gland. Medicine is not really doing it. He's complaining. Again, small gland. How do you approach a small gland, Tim? Where would you start?

Timothy McClure: I mean, I think you have to do... I would make sure he has formal urodynamics to figure out if this is more of a bladder issue, more of a prostate issue, and then base my decision planning or recommendations off of that.

Kevin McVary: Okay, so let's say he's obstructed.

Timothy McClure: Well, then you have to figure out, kind of put his priority for his health with regards to sexual function after treatment, and there's different approaches. I don't do those aspects, so I don't know. I'm not as in tune to the risk-benefits of doing Rezum or UroLift or something like that, but I think each of those has its own set of risks and benefits with regards to—

Kevin McVary: How about you, Kevin? How would you approach the small pesky guys?

Kevin Zorn: Again, primary, as I'm reading your slide here, not salvage. We're talking primary, small gland. This is not the bladder neck contracture patient.

Kevin McVary: Not a bladder neck contracture.

Kevin Zorn: Okay, because I'm reading your slide. I just want to make sure—

Kevin McVary: This is another guy.

Kevin Zorn: Okay, good. Yeah, I mean, internally you've got a—

Kevin McVary: Would you do a green light on a small gland like this?

Kevin Zorn: I have.

Kevin McVary: You're a big green light guy. At least one time, you were.

Kevin Zorn: I was, and again, I think it's something that has its role at that point. There's other options now, and it tends to be, smaller prostates tend to be younger guys, and I think... We've even seen in older guys, the impact of ejaculation is important. We underestimate. We kind of look at guys, "He's 70, we shouldn't even bring it up." I tend to look at ones and bring that up, and they are looking for something like that, unless they're anticoagulated and they've got a small gland, that's where I relegate most of my green lights. Otherwise now, I think the MIST have a great opportunity, and I kind of offer them all. I just want to make sure, "Are you looking for a short catheter time? No catheter? Are you looking for Amazon Now, or do you mind, with a Rezum, toughing it out for a couple of weeks of inflammation?" I think that's the key, is trying to decipher, understand their personality and what their goals are.

Kevin McVary: How about an iTind, Kev?

Kevin Zorn: Yeah, if they meet the requirements and it's a tight neck, especially that, I call it the Maverick. We've all done that. With flexible, you don't realize how much of a bladder neck there is, but then you go with a Rezum and you feel like you're splitting their scrotum in half, you're doing that 9G... We all know what I'm talking about, when they do Top Gun, where he goes up that mountain. That kind of angle that you're doing with your scope, that's the kind of procedure where we need to straighten out the urethra. These are the kind of techniques I think have a role. We don't estimate that until we're in the OR. That's our...

Kevin McVary: I'd say probably a lot of people would be thinking about the MIST category on these types. I mean, that's kind of a cherry spot for them, and doesn't look like you're really losing anything. Although, recovery, time to recovery, time to maximum symptom improvement, is slower on the smaller ones. It's the exact opposite of what we might expect, where you think the big ones would take longer. The data shows actually smaller, probably because of associated overactivity. Here's a kind of traditional BPH, I call it. He's 70, big gland, 110, fails. Would you use any of these techniques? MIST? What would be your approach? Kev?

Kevin Zorn: Yeah. I mean, I just got a text message three minutes ago. I had a 94-year-old guy, huge prostate, no one wanted to touch him. Retention for six months, and we did a Rezum because it's really the only MIST that actually shrinks prostate. We've studied it, 30, 34%, from first demand to the ultimate. We looked at our series, we had about a 34% reduction. You actually create an opening, and you get guys like that out of retention. If you're going to pull the trigger on something that size, that 110 grams, I don't think UroLift is or iTind or those will address that length and size of prostate. If you are looking for a MIST procedure, Rezum fits that category.

Kevin McVary: Yeah, that's our experience as well. Again, larger gland, less sexual side effect, faster return to sexual activity, and a better IPSS outcome. The exact opposite of what I would've expected.

Kevin Zorn: Again, I'm not sure if... In the Canadian environment, you have one gun, you have 15 nine-second treatments. Like that gentleman I did, we can do more in terms of doing eight-second treatments. It doesn't count for one treatment.

Kevin McVary: Tim, is this your cherry spot for a PAE?

Timothy McClure: It's a good spot for prostate artery embolization. It's a good size. I think it's important to understand where the patient is on their IPSS score, how severe it is, and how fast they want a symptom improvement. Prostate artery embolization, when you do it, it's not immediate.

Timothy McClure: You'll see some patients who don't care about the risks that are associated with standard TURP and are okay waiting a couple of weeks to see the gradual improvement with urinary symptoms, but that's a good size for prostate artery embolization. You need to look at cardiac history as well. Is he on blood thinners? Things like that, because those are other things that we can do with embolization without an issue, from that perspective.

Kevin McVary: Okay, and then, what do you tell them about sexual side effects and risk of retention?

Timothy McClure: Risk of retention?

Kevin McVary: A bigger one like this.

Timothy McClure: A bigger one like this, we probably see it about one in 50.

Kevin McVary: Pretty low.

Timothy McClure: Pretty low. If you look at Gao's data, which was the initial kind of randomized controlled trial, about 20% of their patients went into retention, so it varies. Part of it is just their history too, so if I see a patient like this, you always want to ask them, have they had retention? If they had a hernia repair or orthopedic surgery, from that perspective, I think that increases their risk of going into retention. That PVR of, what was it? 170? I don't know what it was.

Kevin Zorn: It was 177.

Timothy McClure: I'm not too worried about it, from that perspective. If he had a high PVR, that's when I need to make sure that he sees my colleagues who can do formal urodynamics, make sure he doesn't have a hypotonic bladder, things like that.

Kevin McVary: I'm not participating in it, but the aquablation, also, this is kind of a nice cherry spot for it too. I'm sure many in the audience are using that, as well as HoLEP, so it's a pretty nice spot. Let's just, almost the same guy, but now our gland's 150 and it's a problem. Dutasteride used to work, now it's not, so when they start getting bigger and bigger, what are you thinking? Tim, are you still sticking with the PAE?

Timothy McClure: The bigger they are, the easier they are, from that perspective. It is a good option for patients, I think, with large glands like this. Again, it's about setting patients' expectations, though, because it's not going to be immediate, for relief. Last week, I saw someone who had horrible LUTS; he wants something done now, and he's not a good PAE candidate from that perspective. The other thing with those older patients, you want to make sure that they have good function. You don't want to do a procedure, or a history of recurrent urinary tract infections; I don't think those are ideal candidates either, for PAE.

Kevin McVary: How about you, Kev?

Kevin Zorn: I'd reach into my drawer and pick up one of four, depending on—

Kevin McVary: Okay, what are the four?

Kevin Zorn: Depending on, again, health status and so forth, if they're anticoagulated. If they're anticoagulated, he's 81, green light, I think that's an easy one. If they're healthy and they're fit, they're running—

Kevin McVary: 150, you'll green light.

Kevin Zorn: Yes, it takes a little bit longer.

Kevin McVary: You have a lot of time... You have a lot of time off up there.

Kevin Zorn: Not time. I know, I plan. It's a green light, 150, and everyone in the room knows it's not a 30-minute spinal. It's a two-hour procedure and you can do it, but it takes longer, and if you do some of the techniques like the VIT incision and cut out small pieces of this, as well—

Kevin McVary: Would you MIST him?

Kevin Zorn: If I didn't MIST, it would be a Rezūm because it's the only one that shrinks the prostate. We don't have a randomized study, but we have the... your and my data, where we pushed over... COVID helped us with that. That shows they do just as well. Aquablation, if they're a fit healthy person, I think it's time ergonomic into the patient. Potentially ejaculatory sparing, and at 81, you have to think, we don't do a good job of their membranous urethral length. If we do a robotic process on an 80-year-old, they're going to leak, so you take a guy who's, sure, gravity urinating, Qmax of four, right, but his PVR was 33. You take a guy like him, to say, "Great, look at your flow," and he's pulling up his diaper. What did you do for the guy? You lowered his IPSS, but you turned him incontinent.

That, to me, which is the fourth option, in some people. "I want a HoLEP." I'm like, "We can do a HoLEP," but the SUI, the stress incontinence is undervalued, and, "Oh yeah, it's just small, it's transient." Well, three to six months is not transient for most people, and it's potentially permanent, and it gets under-discussed. I've yet to see, again, everything's possible, but I haven't seen any of my partners doing artificial sphincters in an aquablation. For HoLEP, yeah, he's got a handful of those as well, and I think that's under-discussed, but those would be the four treatments.

Kevin McVary: Yeah, I agree with you, absolutely, the stress incontinence.

Kevin Zorn: It's kind of never really been... "Oh, it gets better with time." Well, if you see them at four months, yeah, they tend to do well, but for four months they're miserable.

Kevin McVary: I wanted to spend a little time, because Tim's here, we have an expert, looking at the PAE, and previously in the guidelines it was considered an experimental, investigational type technique. That was based in part on studies, including these meta-analyses, which showed it really wasn't quite up to snuff, or at least the design trials were such that you couldn't discern a good impact. Then, along came this particular study, the Pisco study, which was randomized and set up pretty nicely, the study, at least as reported, and found some pretty significant improvements. It was really, I think, this paper that tilted the balance with the change in the AUA's stance on PAE from investigational to a conditional thing. There's actually more to this story, and that's what I wanted to mention today is that Pisco... Pisco was actually busted for a triplicate publication.

I was the arresting officer, and so he got... It was a problem, let's just put it that way. Then, if you'll notice, he was banned from producing literature, and that's why there's such a gap in his publications. It was a little bit of a problem for them, and then when he came back to the game, he comes out with this particular study, and in my own view and the view of [inaudible 00:27:07], who says, "The sham response here is unprecedented," the tight curves are quite suspect. I'm left wondering... This is certainly not an investigator—I understand he's passed—not an investigator who is particularly trustworthy. He's proven that, and then when he's back in the game, he produces something which is unprecedented in the urologic literature. I'm telling you that only in the sense of, as you go forward looking at PAE, that we need to have a jaundiced eye towards it.

Timothy McClure: I think when you look at that as... If you go back to that systematic review, you just had a recent one that looked at a more updated series, and you do see a benefit with prostate artery embolization. Not as good as TURP, but you do see a benefit, and on average probably about 10 or 12 points in IPSS improvement. The other aspect is, if you're looking at complications, the UK had a study that looked at about, I think it was 200 patients who had PAE, and about 80 patients who had TURP, and the complication rate was quite different as well. Fewer complications with the PAE. TURP outperforms PAE, as you would expect, but there is a notable improvement in the IPSS score from those patients, so there is a benefit to prostate artery embolization. I think this trial is actually important.

Kevin McVary: If it's believable.

Timothy McClure: Well, it's in a paper and I trust the data that's being published. It was published in 2020. That data there shows that it isn't a placebo effect, and so I think that the role for PAE is there. I think the studies that we see comparing TURP to PAE are slightly advantaged to TURP, because you want comparative arms that can go to surgery safely, and most of those prostate volumes for the GAUSS study, the [inaudible 00:29:11] study, the Carnevale study, all those studies were smaller glands, about 60 cc's, and they had improvements with it, so I think you can trust the data.

Kevin McVary: There's another study that's out that looks at medical therapy against PAE. I think you're probably aware of this. Many in the crowd may not be. I wasn't until more recently, that really did a much better job in terms of symptom improvement. The PARTEM study is going to start showing up on our radars as reasons why we should consider PAE instead of medical therapy. This is already happening in many places, and it really wasn't much of a horse race. It really kind of blew it out of the water. It was in Lancet, for those... I think 2023, I can't remember. Do you know? It doesn't matter, but anyway, so it was an open-label study. That's fair, and then I think importantly, it was a nine-month IPSS change, that was the primary outcome. Of course, the patients who were enrolled and randomized were already alpha-blocker failures. They're alpha-blocker failures randomized to PAE versus combination therapy, no dutasteride, in the same, and they on the surface did things right in terms of looking at sexual function. The issue, my issue with it, I'd love to hear your comments, Tim, is a nine-month outcome when you're looking at medication therapy.

In the MTOPS study, at nine months, it was proven that finasteride is really no better than placebo, at one year. It's only after the first year that you begin to see the impact of a 5ARI. It's a little bit of a, I'd say, under-designed trial, I'd say is probably the right thing. The other advantage in the PARTEM study is in sexual function, but the problem there is they're not looking at sexually active men. They're looking at the entire cohort, and when you look at the entire cohort, about 62% of those men are going to have ED by virtue of their BPH diagnosis. That's a very... 62 to 72% is pretty consistent across trials, so this is a group at high risk of erectile dysfunction, and when you measure the IIEF and include everybody, not just the guys who are sexually active, include the whole group, you dampen the impact of your therapy on sexual function. It looks like it's less impactful, so it's really inadequate.

The way to do it is to ask who's sexually active and not, and importantly, kind of state-of-the-art, is actually querying men, "Have you ever had a single ED episode or a single ejaculatory dysfunction episode?" If they've even had one, they track completely differently, and that's how the curves... This is from the Rezūm trial. We published this and just publishing our Optimum, where we see the exact same structure. Their history matters, and then lastly, re-treatment rate. In the PARTEM study, re-treatment rate was someplace around 38% in two years. What do you tell patients about re-treatment, Tim?

Timothy McClure: I think this paper is a good paper that shows that PAE is... I mean, you may view it as under-treatment, but I think from a patient's perspective, if they've been on a medicine for nine months and it's not improving, most men that at least I've run into don't want to be on those medications anymore, so you have a valid point. If you kept patients up to two years, they might have been better, but at that point there wasn't PAE as an option. I think a nine-point clinical endpoint is reasonable, and the fact that PAE improved the—

Kevin McVary: Tim, it's not.

Timothy McClure: What's that?

Kevin McVary: It's not. It's not adequate. You know that if you have a 5ARI arm, it's got to be at least a year. It's a marriage, not dating.

Timothy McClure: I understand, but I think patients don't want to necessarily be in that marriage, because there is divorce. The second thing is—

Kevin McVary: That's good.

Timothy McClure: With the patients that ... You're saying there are 42 patients, so in those, they did report the patients that went on to second ... It's what, 36? About a third of patients failed PAE and ended up needing either surgery or additional medical therapy.

Kevin McVary: 16 of 42.

Timothy McClure: In that same cohort of patients, if you reported the men who were on the medical therapy, two-thirds of those patients went on to surgery, so in that situation, PAE outperformed the medicine there. I think in that paper, from my perspective, for men who don't tolerate or don't want to tolerate a two-year relationship with medical therapy, PAE is a good option.

Kevin Zorn: If I may, just a point, it's hard because just like an RARP, two different surgeons have two different outcomes. It's all over the map. The reproducibility of PAE, your hands and your attention are very different.

Timothy McClure: That's tricky.

Kevin McVary: I think generalizability is an issue, maybe.

Kevin Zorn: If I could say a thing, we don't look at the reproducibility. Everyone in the room here does a TURP. If my dad was here, he would have 100 different TURP outcomes, 100 different TURP tissues, whereas if someone did an Optilume, I joke around, you need one eye, three fingers. You know the balloon will do the work. There's an inherent nature, or an iTind, there's an inherent ... There's no skill set. You have to be agnostic. Aquablation, it balances out. It can be on your first day of the job or your last day before retirement. You're going to get the same outcome, but in the PAE, what does that mean? I think that's the thing, you're not doing the renal artery. You hit the renal artery, the whole kidney goes dead. You know that, but a PAE—

Timothy McClure: Yeah, PAE, it's a fun, complex case.

Kevin Zorn: Again, things I don't know, but maybe this is where, as a urology community, I think we need to answer. If I can ask—

Kevin McVary: In view of time, I'm just going to push along a little bit, but thank you for that. The authors concluded that there was significant improvement, but I think the alternate conclusion might be better, and that's, after inadequate medical therapy in men who have already failed medical therapy, that perhaps PAE is better.

Timothy McClure: I mean—

Kevin McVary: It's not really a horse race.

Timothy McClure: I just want to comment on his question about the expertise, because PAE is a technically challenging procedure. The key thing is to ... There are interventional radiologists who are skilled and want to partner with urologists, and the key thing is, you need to identify those interventional radiologists and you need to partner with them and make him or her the go-to person for it. At my institution, it's me. As my practice grew up, we selected different people to bring that expertise to our patients, and so if you're incorporating prostate artery embolization in your practice, you want to have someone who is the key person in that practice who's doing it, who knows the anatomy, who understands the different collaterals, understands how to do complex microcatheter work, and has the resources and the equipment to do it safely. If you have those three things, you will likely have some good outcome.

Kevin McVary: That sounds like good advice. How many in the crowd are in practices, urology practices in some form or another where PAE is being offered? Okay. Yeah. I heard, okay, interesting. Okay, we'll wrap it up here pretty fast. We've got a 72-year-old guy, and this is the guy you've been waiting for, Kevin. He's on Coumadin and he needs something done. Let's say he's completely worked up to your satisfaction, and now what are you going to do?

Timothy McClure: Sorry, I missed that. I was a bad student. Did you hear that?

Kevin Zorn: Let's do that over.

Kevin McVary: He's on anticoagulation and you can't pull him off.

Kevin Zorn: Yeah, I mean, I think—

Kevin McVary: They exist.

Kevin Zorn: GreenLight.

Timothy McClure: GreenLight or a TURP, maybe.

Kevin Zorn: HoLEP. I mean, there's tons of data on that.

Kevin McVary: Yeah. How about MIST? Have you done MIST on such patients?

Kevin Zorn: Yeah, and again, I think the anticoagulants you have to break into aspirin, which I don't think you should care too much about. DOAC—

Kevin McVary: Aspirin, we don't even wink at.

Kevin Zorn: Is probably the non-fun end. The Coumadin is, no, those are the ones that are ... With regards to treatments, the MISTs, I think you can do the non-vascular, the iTind. I've done Rezum, and those patients, I think, do well, and then GreenLights or HoLEP if you need to really de-block them and they have a very hypotonic bladder or are looking for longer-term outcomes, if they're a young person.

Kevin McVary: Yeah. The guidelines tell us a PVP or HoLEP is kind of the way to go, a laser. That's what the guidelines say. I have done MIST on these kinds of patients, and for several reasons, mostly anesthetic reasons, and I won't say I lived to regret it, but there's more visits to the ER, there's more catheters. I've just got to, when I have these kinds of patients, which frankly, I don't want them, but when they come, they're so risky. I tell them, "You're going to know where the ER is." It's a higher chance, and you can get them through it, but if you have to do it, better off sticking with the guidelines. That's my own personal—

Kevin Zorn: That's a great point. I think partly, if you do GreenLight or aquablation or whatever, or HoLEP on an anticoagulated patient, during surgery, it looks great. It's the two weeks after or three weeks after where they feel great, and they slough their ...

Kevin McVary: Boom.

Kevin Zorn: They don't see that they have no epithelium. That's where they're healing, they slough, and that's where they get that re-bleed. That has to be the counseling that you're going to have, and yeah.

Kevin McVary: You've got to warn them, basically.

Kevin Zorn: Until the day we can—

Kevin McVary: It's a tiger, it's tiger country.

Kevin Zorn: Until we can spray some urothelium and re-coat that area that heals up, right? We all want that. That surface area, if we had some skin graft, that would solve it, but until then, we have to deal with that time-dependent healing.

Kevin McVary: At the Center for Male Health in Loyola University, we end on time and on budget. I think this is probably a good analogy to where we are in BPH. It seems relatively straightforward, but it's kind of like sexual response in males. It's really not that straightforward. It's really more complex, like the sexual response in our partners. At any rate, thank you for your time and attention, and panelists, thanks a lot.