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Diane Newman: Welcome to UroToday and our online medical education program. I'm Diane Newman, a urology nurse practitioner. I'm really excited today because I'm pleased to introduce to you a colleague of mine, Dr. Amy Pearlman, a board-certified urologist.

I got to know Amy when she did her urology residency at Penn Urology, University of Pennsylvania, several years ago. But now she practices in South Florida and is the co-founder of Prime Institute. Thank you, Amy, for coming on and sharing with us your services that you're providing there to men.

Amy Pearlman: It's such a delight to be here with you today, Dr. Newman. Thank you so much for having me. The next topic I want to discuss with you today, Dr. Newman, is traction therapy. And I have one product up here, and this is called the RestoreX device. This is what we would consider to be a second-generation traction device.

And in terms of why traction therapy matters, especially after something like prostate cancer treatment, is because in real time, the penis changes, not only in girth but also in length. And not every man understands that when they're going into surgery or really any therapy. And they sort of wake up or they look down one day and they say, my penis is not the same. It used to be different.

And I think that we have to stop telling patients the following: you're no longer 19 years old, and you're not going to have the penis that you used to have. Dr. Newman, I just don't think that that message is acceptable in the current day. And the reason I say that—and I know that's a strong statement to say—is because we actually have tools and technologies now where people don't have to accept those changes in their body.

Will their penis be exactly what it was many years ago? Not necessarily. But can it get better? 100%. So I want to talk about traction therapy because it's something that many of us, as we go through our urology training, are not necessarily taught about, and it doesn't require a prescription. So we, as a healthcare provider, may not have any sort of role in that process. But over the years, I've had so many men ask me, I'm kind of frustrated with the length of my penis. I used to be longer. What do you have to offer?

And so often, I told people, your penile length or your penis is normal. It's within the normal limits. It's within that nice bell-shaped curve. And we don't have any safe options. But that is no longer the case. When I first heard of traction therapy, to be honest with you, I thought it was a little ridiculous. And a lot of the protocols for the first-generation devices really have people using the devices for up to eight hours a day.

And I'm sure there are some really motivated men that will use it for up to eight hours. But the majority of men, that is just not going to fit into their day-to-day. The other question is whether or not those devices actually work to improve penile lengthening, and there's actually not much research to support their use.

So about 10 years ago, Dr. Landon Trost—who, if you don't know him, is one of the most genuine, authentic people I've ever met in my life—was working on this review paper to look at traction devices because he had been recommending them for patients with things like Peyronie's disease or penile curvature. And when he really delved into the literature, he realized there really wasn't evidence to support their use.

But he didn't just accept that. He went to the engineers at the Mayo Clinic, where he was at the time, and said, we need to figure something out, and we need to design something that can actually provide traction to the penis and improve both penile curvature and penile lengthening. So that's when he really started this journey.

And it was probably about, I would say, maybe around 2018 that I was at the American Urological Association meeting. And I remember I was attending one of the plenary sessions, and they were presenting on the traction device, on this device. And again, I thought it was a little bit ridiculous. But over the last five or so years, as I've been having more of my patients use this device, and more importantly, as they've come back to see me in follow-up, and I ask them about their experiences using traction therapy, some of my happiest patients have used traction.

I don't have the same anatomy as the majority of my patients. So when I think about how I'm going to counsel the next patient, so much of it—yes, it's based on the research and the guidelines—but so much of it is based on the experience of my last 5, 10, 20 patients with these devices. And that's how I kind of counsel future patients.

So let's talk about the elephant in the room. This looks like a medieval torture device. So I'm just going to put that out there.

Diane Newman: I'm glad you said that because when I saw that, I said, now wait a minute, what is that?

Amy Pearlman: So in my office, I have all these products out. You can see some of the demo products right here. I have all the demo products out in my office because most of my patients have never seen—they may have heard of some of these devices, but they've never seen them. And if I were just to explain a traction device with words, a lot of them would be nervous. They wouldn't know exactly what I'm talking about. And when they actually purchase this device and saw it, they might be scared to use it.

So one of my biggest missions with my patients is to talk about each component, how it works, and if they have issues at home, they bring it in, and I show them how to use it in the office. Now, what separates this device from the other first-generation traction devices out there? One of the things is that it allows for dynamic stretching.

If we, let's say, are stretching our hamstrings, and we're on the ground, and we're leaning forward, and we're trying to touch our toes, we don't get to that full stretch the first time we do it. We kind of lean in, and then as our muscles relax, we can lean in more. But a lot of the traction devices out there, you have to already set the device to where you want the penis to be in its stretch, and it doesn't allow for that dynamic stretching.

Versus this one—so how this works is in the non-erect, so in the flaccid state, the penis would go in through here, open this up, clamp this down, and we'll go through some of these other things shortly. And so then you stretch it like this. And as the penis—as those ligaments stretch and as the penis stretches—it allows the penis to stretch in real time. So that's really one of the big differentiators with this device. The other—

Diane Newman: Do men have discomfort with this or what do they say that—I guess they do it very slowly as far as stretching it?

Amy Pearlman: Yeah, so once the penis is in here, you can actually—you push this out. There are these rods. And so this allows for stretch. And then it's spring-loaded. So then you would go like this, and then that really places the penis under traction. Yeah.

But this part right here comes out. So it allows for, depending on the length of the penis, different size rods can be used as well there. Now I'm so glad you brought up that question about comfort because that's really the biggest concern. And that's where I have had patients come in. It's usually my engineering patients who are so motivated, and they say, I really like this device, but it's just too uncomfortable. What tips and tricks do you have to optimize comfort?

So I had a patient ask me that. And so I reached out to the inventor, Dr. Landon Trost, and I said, Landon, what advice do you have that I could tell my patients so that they can actually use the device? So one thing that has been a game changer has been these makeup pads. And now they actually come in the RestoreX kits; you don't have to buy them separately. Before they came in the kits, I would actually have people buy them from Amazon.

But it perfectly fits. It has a little strap here. And so you put it on the bottom part of this clamp because if you think about how the penis is going to set into this device, the bottom part where the frenulum is is typically the most sensitive area of the penis. So then when you put the penis in here and you clamp down, you're really protecting that sensitive area. Now, I know you are going to be squishing the glans or the tip of the penis here. But the glans was made to displace blood. So it is OK.

And when they've actually done studies to look at blood flow, even with this penis being clamped down, there still is blood flow to the tip of the penis when it is clamped. It's kind of like if someone is out in the yard and they're doing some gardening and it's been a while since they've done that. They might get some calluses on their hand. It's really the same thing for this device. The first few times that someone is using it, they might get some irritation or maybe some skin changes on the tip of their penis. But that's kind of just part of those initial stages and that will get better.

The other thing that can be really helpful is the kit also comes with Coban wrap. And so to minimize slippage of the penis out of this device, the man can simply wrap some of this Coban around the top part of that clamp. And then also, you'd wrap some of this Coban actually around the tip of the penis as well, and that will help keep the penis in place.

Now, the recommended protocol—and a lot of the studies look at 30 minutes twice a day. When they've done studies, though, looking at 30, 60, and 90 minutes—and by the way, when companies and researchers come up with these protocols of like 30 minutes, 60 minutes, 90 minutes, when I asked Dr. Trost, I said, how did you come up with those numbers? He said, you just have to start somewhere. And we didn't know. So those are the numbers that we started with.

But when they looked at 30, 60, and 90 minutes in terms of penile lengthening, there really wasn't much difference between the 30 and the 90 minutes. So I asked Dr. Trost, I said, so what do you tell your patients, what is that protocol? And he says he recommends his patients use this device for 30 minutes a day, five or more days a week for three months. And what the studies also show is when they look at patients even further out from that three months, they tend to maintain what they've gained.

Now you may ask, so what can people gain? Can they gain inches back in terms of penile length? Well, first of all, we have to understand who were the patients that were studied in the RestoreX clinical trials. And it's mainly three patient populations. It's men who have Peyronie's disease or penile curvature, it's men who have diabetes, and it's men who are post-prostatectomy. And they've looked at lengthening in those groups.

And so when you look at those patients, people on average can gain 1.6 cm with using this therapy. Is that inches? No. But so many of the guys there, they're looking for some improvement. And so 1.6 cm for a man after prostate cancer surgery can be a game changer, can really do a lot for his confidence. When they ask these men as well, would you recommend it to a friend, would you do this treatment regimen again, the majority of them, nearly all of them would, for both of those.

So do I think that every man with ED or with penile size concerns or after prostate cancer treatment is going to use a penis pump and a traction device and take tadalafil and do all of these things? Dr. Newman, I don't think every man is going to do it. But I do think every man deserves understanding all of their options so they can decide, OK, at one month post-op, what am I going to do.

But it's also important to re-engage them at regular intervals because maybe at three months post-op, they might want to do something else. And maybe six months and 12 months later, they might want to do something else. So it's really this constant conversation when it comes to the options.

Diane Newman: No, and you're exactly right. And it's so important to inform them what's available. But also, what I like about this whole thing with the traction therapy is it's really non-invasive. I'm sure you hear the literature as far as men trying to do injections, adding different types of tissue to lengthen their penis.

And there's a lot of adverse events with that that can be a lot of complications. So this is non-invasive. And you're right, if someone wants to do it, that's fine. But I'm really excited because I actually never heard of this. Yeah, so this is really something new to me.

Amy Pearlman: Yeah, it's non-invasive. It can be done in the comfort of one's home. When I think about the options that I can offer patients, sure, efficacy is really important. But it is not the number one driver. The number one driver to me offering an intervention is safety profile. If something is very effective but I can hurt someone in the process, that is a problem.

If something, let's say, is less effective than maybe other treatments but I can't hurt them, patients like that. My patients come to me because they want the safest options available. And this device, this traction device, has an incredible safety profile.

Now would I have someone starting out just all of a sudden go and do 30 minutes a day? No, I would have them start off slow. They can try with five minutes and then slowly work their way up to that 30-minute mark.

Diane Newman: So there is research on the use of this device then in the literature?

Amy Pearlman: Yes, and that's one of my—I think my favorite things about this device, because Dr. Trost wants to be as far away from the snake oil as possible. And so when he was working with the engineers first at Mayo, he said, one, if we can't make a device that can be beneficial with using it for 90 minutes or less a day, then this is going to be a moot point, and I'm not even going to proceed with this. So that was a key thing on the timing—compliance.

But what I also love so much about the work that he's been doing is they are studying this device in different patient populations, and they actually have evidence behind their technology. Now, when I asked him, I said, OK, so you've studied those three populations—diabetic patients, men after prostate cancer surgery, and men with Peyronie's disease.

But Dr. Trost, what about the normal dude walking down the street who doesn't have any of those conditions, who just wants a safe option for penile lengthening? Can you help him? And, in his typical fashion of not overselling anything, he said, admittedly, we haven't studied that patient population to date. But when he was designing these clinical trials, he did what a lot of researchers don't do.

So most of us, we want to see great outcomes when we're testing something. So we're going to choose like the easiest patient population where we think we're going to really be able to see statistically significant changes. And he chose the three most difficult patient populations that he treats. And so he said, if I can help those guys, I can probably help the normal guys walking down the street who don't have those conditions. But it's really still to be determined.

But I do discuss penis pumps and traction therapy with nearly all of my patients, irrespective of their comorbid conditions. And I've had a lot of people get some benefit, and it puts some of that onus on them. I think they feel accountable. They have some skin in the game when they're doing it themselves at home. And as healthcare providers, we don't have to be everything and do everything for all of our patients.

Part of it might just be us educating them, teaching them how to use it. But then a lot of the work is actually done at home, which I think is good and bad for some patients.

Diane Newman: Well, thank you so much. That was really informative. And I mean, you really taught me something here because I did not realize that. But to me, though, this is such an option. Like you say, you have something to offer these men who are so upset with what's going on with their anatomy, and they really don't know what to do. So it's really nice that you can provide this new device, this new treatment actually for that. So thanks so much.

Amy Pearlman: Absolutely.