Bruce Kava: Thank you so much, Alan. Thank you. It's my great honor to be sharing this with you, and I appreciate it. So as you know, we've had Aquablation at the University of Miami now for about a year and a half, and I'm really excited about this. I think that Aquablation is really here to stay, and I think it's one of the premier options that patients have these days. So as somebody who's done this for many years, and I continue to emphasize to residents who may be watching now, really know your craft. The TURP is so important. The various steps to doing it, performing a transurethral resection of the prostate, I wouldn't underplay this in the future because I still think it has a lion's share of the prostate surgery that we have in the future, and it should always be your go to for the actual technical maneuvers that you're going to be using in the future.
Most of the surgical options that you have in endoscopic urology are offshoots of the TURP, so learn this skill very, very well. Focus on it. It's still highly effective. It's still the gold standard, regardless of who claims one procedure over another. TURP is still the gold standard of procedures. It does require a general anesthetic. It's minimally invasive. And we know that there are tremendous improvements in the IPSS, quality of life, the urinary flow rates, as well as post-void residuals, which really are everything that we compare to the TURP has to be something that's not inferior to TURP when we're first studying it.
Unfortunately, it's not perfect, and resection times can last for a while, especially when you're dealing with bigger prostates. Bigger prostate size means bigger resection times, more blood loss, and there is, despite the fact that we kind of understate it and we try to downplay this a little bit, there are some small numbers of patients that will require a transfusion associated with the TURP, particularly with larger prostates. Urethral strictures, bladder neck contractures also occur to some degree as well. And then there's the quality of life issues like erectile dysfunction. And again, most of the older literature didn't really quantitate erectile function very well. We're dealing with an operation that's a hundred years old and they didn't have self-administered questionnaires. The IIEF questionnaire wasn't around a hundred years ago.
So what we can piece together from some of the more recent literature comparing one arm to another, just particularly with TURP, is that about five to 7% of patients will complain that their erections are not as strong as they used to be after a TURP. With that being said, 30 to 40% actually say there were improvements. Ejaculatory dysfunction is up. Up to 85% of patients after TURP will lose their ejaculation. Retreatment rates pretty low compared to some of the other minimally invasive procedures, 15% at eight to 10 years. So it's a good operation, but not perfect. What we're all looking for is that perfect operation, that minimally invasive procedure, reduces the risk of bleeding, transfusion, strictures and incontinence, preserves erectile and ejaculatory function, minimizes anesthesia requirements, and improved convalescence, or eliminates hospital stays, reduces or eliminates the need for a postoperative catheter, rapid relief and return to activities, rapid significant durable improvements in the lower urinary symptoms, and a reduced cost.
And from the urology perspective, I always tell my residents, you got to get something that's easy to learn, reproducible results, and few adverse events. Obviously favorable reimbursement would be something that's important, but again, I think that most importantly is patient safety and good results. This is our current surgical armamentarium. We have procedures that are available for smaller prostates, average prostates, and then larger prostates. The average prostate, based upon the AUA guidelines, the water vapor thermotherapy, that's the resume procedure. And the RWT, which is the robotic water therapy, that's the Aquablation therapy considered for the average prostate. If you look at the AUA guidelines currently, they've extended this actually to larger prostates as well for the robotic water therapy.
So we're dealing with a lot of different options for patients. You have different sizes. It's not one size fits all anymore for the TURP anyway. And so urologists have to become familiar with a number of different procedures. Now, what I would suggest is that people can't do every procedure and do it well. And I was told this many years ago when I was doing my training, that if you want to focus on one procedure, you can get really good at it and become an expert at that particular procedure. And urologists have taken this to heart. If you look at the average... This is a great article. Lori Lerner and Company published this several years ago looking at the number of different BPH procedures that most urologists practice.
And if you look at it, the average urologist knows about three procedures. So a TURP is usually one of them. It would be good to learn one minimally invasive one for smaller prostates and one procedure that would fit for an average prostate or in a larger prostate. Those are the things that you really should focus on. You should be adept at doing different things in case you need to, but you should form alliances with some of the urologists in your community or that you work with to try to focus on one particular procedure or a few procedures without overburdening yourself with a number of them, because you can't be an expert at everything. So these are the procedures currently that we have available. And you could see that there's some changes. TURP, again, for the residents watching this out there, TURP still has the lion share of procedures for the prostate. And that's here to stay. And that can be your fallback whenever you need it, if you know how to do that well, and so that's something really to focus on during your training.
And then there are other things that have come about. The UroLift, actually. We've seen over the last 10, 15 years that the UroLift has gone up in prevalence, but then there's a slow decline here. I think some of the problems with the UroLift are that the retreatment rates are a little bit high. So we could see that there has been a downtick in the number of UroLifts being done. HOLEP has gone up consistently over time. HOLEP is a great procedure, but very few urologists have learned to do it. Now, the problem with the HOLEP is the learning curve is supposedly very high. But what I would say is if you're interested in doing a procedure like that, what are you going to do? You're going to spend the time learning it. And there's nothing wrong with having a good learning curve because that'll make you an exceptional urologist to be able to offer something like that.
Aquablation, as we could see here, has gone up over the last couple of years. We started just around the pandemic, and then we could see now that the number of Aquablations, and I would expect 2024, 2025, is going to exponential growth in this particular area. The nice thing about Aquablation is that the learning curve is pretty low if you know how to do a TURP.
So we've got the robotic water-jet therapy here at the University of Miami about a year and a half ago. I've done over 300 cases here. It's a really neat setup that we have. It's done with image guidance, real-time ultrasonography. That, I think, is the biggest thing for me because when I was doing a TURP, I had two dimensions that I was looking at. I was looking endoscopically into the prostate. All I could see were the insides of the prostate. I didn't know how deep I could go. I had attendings, when I was doing my training, they would have this special finger probe that they could put into the rectum and they could feel the prostate while they were doing it to see how deep they were going. But using ultrasound guidance really adds a new dimension to this. You could really help... Because when you have the water going in and going out, really distends the prostate capsule so you can't tell how deep you are. You think that you've gone all the way down and then you let the water out, then you see how much more tissue is there.
So with the continuous flow, it's done a great job at removing the risks of absorption. But the problem is though that you can't really judge more than two dimensions. The ultrasound is great, and that's one of the advantages of this. The sweep angle you can control, the depth of treatment, number of passes through the prostate can be varied. We generally do more than one pass through the prostate with the robotic water-jet therapy or the Aquablation. And the learning curve is just amazing, amazingly quick if you know how to do a TURP. We have this hydro system now that really puts a lot of the responsibility on you, which is great. You can control a lot more. It used to be, with the other system, the Aquabeam system, most of the controls were on the outside, and you were scrubbed into surgery, you had to rely on other people to do it. Now with this Aquabeam, with the hydro system, you have everything on your screen and it's all based upon your touch to the screen.
So surgeon operated, you have AI powered planning. I'm not so thrilled with that yet, but eventually that'll be good. That'll be better as we get more and more cases done. Superior real-time imaging, digital cystoscopy. This really adds a tremendous aspect to the hydro system as well. And the 3D mapping is pretty interesting too.
So what do we have with Water? Well, the data speak for themselves. This was the Water-I trial, double-blind, randomized clinical trial, two-to-one randomization, robotic water jet versus TURP. And these are traditional patients that we would operate on. The Aquablation had 117 patients, TURP 67. They were randomized. And we could see that it was non-inferior to the TURP. In fact, the Aquablation was very much exactly the same results as far as the change in IPSS, quality of life, as well as a Qmax. Safety was a little bit better for the Aquablation, I will tell you that. And there was a little bit less bleeding, fewer transfusions, and the safety profile was pretty similar between the two with a slight improvement with the Aquablation. These were for larger prostates. We could see actually for larger prostates, the Aquablation did a little bit better. These are 50 to 80 gram prostates. Aquablation resulted in better improvement in IPSS and fewer complications. So that's where I think that the nice thing is.
It does it so quick. I mean, the Aquablation, the passes through the prostate are anywhere between two and a half to seven minutes, and it goes so quickly. When you get back in there and you could see what's in there and you can control of the bleeding, it's a lot faster than doing a resection, which for a larger prostate, can take a long time to do. You're not bleeding during this period of time. It's so quick. So I think that's one of the main advantages of the Aquablation, plus the fact that they can spare the ejaculatory ducts. And this is what we could see with the sexual function. There's really no change in erectile function. Intercourse satisfaction is exactly the same as it was preoperatively. And compared to the TURP, the changes in the MSHQ, which, it's a guide for your ejaculatory function, you could see that with the TURP, which is in the red, there was a decline in the ejaculatory function versus an improvement in the ejaculatory function in the Aquablation arm.
Five-year outcomes? It's durable. You have 6% of people going for additional treatment with the Aquablation versus 12.3%, which is more than we would expect with TURP. So I think that we're doing pretty well. It's a durable response. This looks a lot different than a lot of the minimally invasive procedures that we have out there. We have 20, 25% retreatment rates. Water-II used larger prostates. This is another look. This is a single arm study. It was a good study. It was a good idea to look at this. These were patients with larger prostates. On average, the prostate volumes were between 80 and 150 grams, and the patients did pretty well. I mean, as far as their outcome parameters go, their IPSS changed significantly, 17 point improvement, 3.3 point improvement for quality of life, and the Qmax improved by 12 milliliters per second. And ejaculatory function was not changed again.
The problem with the Water-II outcome is that they looked at the transfusion risk. What they were doing at that time with larger prostates is they would put in a large balloon catheter and put it on tension. They put it on tension up to 18 hours after the surgery, and so there was no cautery used at all. They were being completely pure with Aquablation. But unfortunately, they wound up having a 9% transfusion risk associated with the Water-II study. So with that, that's not something that any of us want, and that's something that we have to be really careful. And they went back, though, and they figured out what the problem was here. And actually, Dean Elterman actually did this study looking at just sparing coagulation at the bladder neck area. And these are the graphs that came out using robust traction, normal traction devices. And the transfusion risk went down significantly when they did sparing, and just a little bit of cautery around the bladder neck where the bleeders are occurring.
So I think that this is a good study. This is how we make progress. This is how they figured out that there was something wrong with just traction for these surgeries. And now, most of us at this point have switched over. And with the 300 cases that I've done, I haven't transfused a single patient yet. This is the Water-III study, which is in print right now. Again, Water-III is the HOLEP versus Aquablation. So we have Water-I, Water-II. Water three is moving on, moving the curve to see whether Aquablation is as good as HOLEP is. HOLEP, as you know, does a very complete resection of the prostate. And actually, the data suggests that the IPSS scores are pretty comparable between HOLEP and Aquablation patients at one month and at three months. Qmax is slightly in favor of the HOLEP. Again, you're removing more tissue. And the prostate volumes after the HOLEP are probably a little bit less as well.
But this is an ongoing issue right now. What patients are best served with the Aquablation? Which are best with HOLEP? HOLEP unfortunately has some ejaculatory dysfunction associated with it. And there is a transient and significant risk of urinary incontinence with HOLEP, which you don't get with the Aquablation. So with all that being said, what I would say is that if you look... Overall, if I was stranded on a desert island, what would I look for if I needed only one to three operations that I knew really well? With the Aquablation, is it a go to? I think so. Reduction in bleeding, preserving ejaculatory and erectile function, improving convalescence, reduce the rapid relief and return to activities, durable, improvement in your lower urinary tract symptoms, and it's easy to learn.
Favorable reimbursement, because, again, there were some special codes with the robotics and stuff. Our hospitals do better with it. So if I was stranded on a desert island, I think that I would probably pick, of all the different options available, Aquablation would be one that I would probably want to have available to me. Thank you.
Alan Wein: Thanks very much. That was a terrific and very complete summary about Aquablation. So let me ask you, at the end of the Aquablation procedure, you look in afterwards and you cauterize only the area around the bladder neck. There's not much bleeding from the fossa itself?
Bruce Kava: Basically, when I look in afterwards, it takes some getting used to. Again, that's where the learning curve comes in. So what I'll do is usually I'll put in my resectoscope, I'll remove my robotic handpiece and I'll look in there. I'll evacuate some of the clots. Now, there is a question, is it better to do a more thorough resection? Because Aquablation does leave some tissue behind. It leaves some very fibrinous material on the posterior portion of the prostate, which you can scrape out if you want. And it does leave some tissue, in some cases, behind as well. Do you want to do a more thorough resection or not? And I'm looking at this right now to ask the company if they would sponsor a trial looking at a more complete resection afterwards versus a resection that's minimal, a minimal resection, just where we get coagulation.
Most of the bleeding comes from the bladder neck area. As soon as I go in after I evacuate the clots, I usually can see bleeding coming from the five and seven o'clock position. Sometimes you'll see it from the roof where usually they haven't done much of a resection. And there's a lot of tissue overhanging, so I usually take down some of that anterior tissue as well, and that will help for... I think that helps a lot. It's funny because Alan, you trained at a time where my attendings used to tell me, "Don't worry about the anterior tissue. It's not particularly helpful to resect a lot of it."
Alan Wein: Until it falls down. Yeah.
Bruce Kava: Yeah. But what happens with this is that the floor is so well resected, that the roof comes down and it kind of obstructs things. So I usually take some of that anterior lateral tissue down as well.
Alan Wein: Yeah. So what about a big middle lobe? Will the Aquablation treat that as well?
Bruce Kava: It does address the middle lobe. In all honesty, it's not the best for the middle lobe. It does resect some of it, but at the end, the middle lobe tends to flop around a little bit as the beam hits it, depending on the mobility of it. And so it does resect some of it and you have to usually go in and resect that at the end.
Alan Wein: Good.
Bruce Kava: So that's why I think that it's important still, learning how to do the TURP, I think, is so important because that adds it. I tell some of my residents that the Aquablation really helps me do a better TURP.
Alan Wein: What do you tell the patient about the percentages of incontinence and the percentages of erectile dysfunction and retrograde ejaculation with the Aquablation?
Bruce Kava: So with the Aquablation, theoretically you shouldn't have any incontinence. We put the probe, we park it right at the verumontanum. And the way the water jet is designed when it comes out, it can't go beyond the veru. So if you sit there, you're going to leave the tissue in front of it, and there's still a millimeter or two. And if you're preserving the ejaculatory ducts at that point, it's only doing a butterfly resection around that area. So your chances of having incontinence is extremely low. Now, I did make a couple of adjustments for patients who've had radiation therapy, and I did Aquablation on those patients after radiation therapy. I parked it a little bit further up because I really did want to spare a lot of that apical tissue.
But I think as far as incontinence goes, it's very, very low.
As far as erectile dysfunction goes, because it's using room temperature water as opposed to thermal energy or electrical current, the chance of erectile dysfunction is very, very low as well. Ejaculatory dysfunction, I usually tell the patients that if you look at the data from the literature, anywhere between 80 to 85% of patients will be able to preserve the ejaculatory function. I tell them that because I also tell them that I can't guarantee on any individual case that... And I've done it the same way in many cases, and I found out that some patients did have ejaculation afterwards and others didn't. So I'm not really sure why exactly. I don't think that we have that exactly honed in perfectly.
Alan Wein: Got it. Well, that was really informative. And again, thanks for your expertise and thanks for doing such a complete explanation of why you think Aquablation is basically one of the real go-to procedures of the future. So thanks so much for joining us today, Bruce.
Bruce Kava: Thank you so much. Really appreciate it. Thank you. I'm honored. Thank you.