JCPM2021.09.01EDResearch.PenileRehabilitation.AutologousVsHomologousVsMinimallyManipulated.Peyronies.PE

Topics Discussed Include the Following...

*How to find answers on the membership sites
*The Priapus Shot® procedure for Erectile Dysfunction. Research
*How to Do Unnecessary Things, Hurt Your Patient More, and Make the Priapus Shot® less effective (straight from the research)
*Why the PRP Research Moves Slowly
*Injections to Help Premature Ejaculation
*Priapus Shot® for Penile Rehabilitation
*Autologous, Homologous, Minimally Manipulated
*The Priapus Shot® procedure for Peyronie’s Disease

Video/Recording of CMA Journal Club, Pearl Exchange, & Marketing Tips

Transcript, Relevant Research, & Relevant Links

Transcript

Thank you, guys, for being here. I had several questions this week about the Priapus Shot® and the research supporting what we do. Of course, it's a growing body of research, but there've been a number of papers that came out in the past six months, and I wanted to tie those things together, specifically, (1)

talk about some of the research about applying PRP, using our protocols for erectile dysfunction. (2) Number two, for rehabilitation of the penis post prostate surgery. And (3) number three for Peyronies's disease. Some of the ideas, then I'll take questions.

How to Find Answers to Questions on the Membership Sites

Before I get to that, I also had several questions concerning the O-Shot® procedure, and these questions actually live on the website in a pretty robust, thorough way and much better than I could do answering the phone. So since I wound up referring people to this page, I thought it might be useful to just show you guys how some of the resources that are available to you for being a part of our group.

We've been doing this a decade now and thankfully the combination of the many minds, we're now over 4,000 members; we passed that mark since COVID slowed down; now there are over 4,000 members. The collective of both asking questions, doing research, getting together every week without much exception and talking about, (I think, once I skipped for a Bob Dylan concert and once a hurricane shut me down, but we just didn't have electricity); other than that, we haven't missed many.

Next Workshops with Live Models<---

And those webinars, some of the better ones, or many of the better ones are recorded and transcribed with the transcription searchable. Maybe the people in the group don't know this is available, but one of the questions that happened today I wanted to point out because it's a common question. What happens if the O-Shot doesn't work? What do you do if your person doesn't get better? I wanted to show you where that answer lives and how to head off disappointment by referring something, showing your people this, and then we'll get back to the research.

But I'm just showing you functionality. When you sign into the O-Shot website, the membership side, you're going to be looking at this dashboard. Of course, many of you have already been in the group for a while, so you have a good understanding of how to do the procedure and come up with your own ideas and innovations, depending on what the problem is.

Navigation to Answers to Questions

That's the thing. I want to make it clear. I'm the first person to point out these are not magic shots. These are not magic shots, inaudible 00:02:58. If someone is having dyspareunia inaudible 00:03:02, well, the pathology lives right there in the local tissue and we have something that makes tissue healthier. If they have anorgasmia, that could be any part of the orgasm system, from psychological blockage due to some sort abuse as a child or modal abnormalities, lots of things, other than local tissue.

Depending on the problem makes a big difference about the percentage of the results and the likelihood of a particular patient might get results based on where the etiologies of their person's problem might lie, since their usual, almost always multifactorial was something as complicated as sex.

Anyway, back to what to do, because there is no procedure that's perfect, and so what do you do when the O-Shot doesn't work? If you go and you log onto the dashboard, you'll see this. If you go to this webinar page, you'll see that I posted here, first of all, the difference between an O-Shot® and a G-Shot®. You should know that, because that question comes up a lot, and they are not the same, and we are not aiming for the G spot when we do the O-Shot. We're aiming for, and I explained the difference and why, what thinking is in that video.

Then if you scroll down here, there's this question, what do you do when your first person with an O-Shot doesn't get well? Everything from, first of all, if it's only been two days, they haven't had time, versus the different problems they may have presented with.

And again, I don't claim to be the know-all end-all be-all, I'm far from it. I'm sure many of the things that we're thinking and saying will be proven to be wrong, or hopefully on the path to what's better, but with our best understanding of today, from the research and from talking to 4,000-plus doctors and teaching this almost every month, at least for a decade, my best understanding from curating the ideas of the group for the past decade lives on this website.

Now, if you have a specific problem, you can also go here and search. So if I just put in say, dyspareunia and search, it's going to come up and bring up the transcriptions where we talked about dyspareunia.

Not every video got transcribed, and not every webinar made it to the website, but we do have over 400 videos, and so you'll find lots of conversations.

Then if you just want to see the last one that was posted, say, you get an email and says, "Okay, I just put up a webinar," which will happen after this one, just put up our journal club from last week. You just go to recent posts and you can find the most recent one, so you can see the last one, where we had one of our premier teachers and providers on the group talking about how she treats women who have genital mutilation, and gave a really moving story and some amazing clinical pearls. And I've put the research that backs up what we talked about below it.

Later, when I talk about the research regarding the Priapus Shot®, that's where it will live and I'll have links to all of it. And so, I've shown you where to find the video about what to do, if your first or any of your O-Shots don't work.

Also, I would recommend that you send your people to this recording, which I put here to help answer some of the questions that happen before they get asked. So if you scroll down here, this is just a podcast. And I recommend you listen to this and do your own version of this, either written or recorded, as a podcast or a video, where you put your experience in here. But this is me telling people what reasonably to expect, depending on the procedure and depending on the problem that's being treated.

Hopefully, you found that helpful. Of course, we're always on standby to help you. We have a staff of 10 people, actually, we're down to nine people, depending on...If you want to count our virtual assistants, we're more than that, but people flesh and blood living close enough to report to an office, we have nine full-time people, and others on retainer.

So we have a support staff that's made to help you guys if something comes up that's unusual. Like today, I've got a question that was about an unusual problem. I honestly didn't know the answer, but I went to the research and ask a few other people in the group and we came up with an answer.

Okay. That's our promise to you about how to find the answers, and that same idea would go for all the procedures, you just log in and you can use the search bar to find where we talked about it, if you want to see what we talked about recently, and we do usually cover research that's been out within the past month or two.

And like this one, we talked about research and treating keloid, that's very recent. And we usually have one of our teachers on the call, this one we had inaudible 00:08:42 talking about how he treats scarring and the surgeries he does in combination with how PRPs are used for scarring.

The Priapus Shot® procedure for Erectile Dysfunction. Research

Okay. That's enough about how to find the answers to questions. Let's go into what I think some of the more premier studies are regarding our Priapus Shot procedure since that's... I think, we'll start with this one study, which came out... Oh, it made the cover this year of the Journal of Sexual Medicine. So many of you guys saw it in an email because I was so proud of it. It was like having a picture of your idea of a baby. So you have three sons, and so it's not as fun as having a picture of your baby child, but it's fun to have a picture on the cover of a high-impact magazine that shows a graph, a picture of your brainchild.

This is that study.

How to Do Unnecessary Things, Hurt Your Patient More, and Make the Priapus Shot® less effective (straight from the research)

We briefly mentioned it in a previous webinar, but I wanted to dive a little deeper into it about their study design and tell you why, although I'm grateful for the study because they did show benefit, and this double-one study where this came out of Greece and very well done study, where they used saline as the placebo, which makes me a little nervous, because saline being a physical therapy, if you inject it, it's not exactly a placebo, but they still showed benefit. But I wanted to show you the method and why I think maybe it's wasn't as good, or it's not what I would have done, and why.

They were randomized. They used inaudible 00:10:45, which is a double-spin centrifuge, as you guys know, that part of the criticism of all of the PRP studies, especially the man analyses, is that there's still no real consensus about what exactly PRP is. It's a lot of apples to oranges. And in their conclusion, they even stretch it to say, "Well, we can't really extrapolate this to other PRP preparation systems, which is somewhat true in that a double centrifuge would be much different than say a gel kit, but maybe not that much difference between double centrifuges.

Anyway, that's right, you can't extrapolate to every PRP prep kit, but they did show a benefit.

Okay. With this kit, I can tell you, they've got about five times the concentration of whole blood, doing what they did.

Now, this is the part I wanted you to see. After repairing the injection, they're placed in the supine position, a tourniquet was clipped around the base of the penis. Now some of the people in our group do this, most do not, and I'll show you why I don't. I'm going to show you a picture. You guys, of course, don't need to see a picture because you can visualize it. But if you look at a picture of the penis, if I put a tourniquet right here, we're missing out on treating a good portion of the penis.

Now what really this tells me is that, and I'm just going to speak plainly. I've already prefaced it by saying I may be completely wrong or shown to be wrong down the road, but we've been getting great results without tourniquets. It's not something that I didn't consider the first time I did this, which was on my own penis, now 11 years ago. I thought, well, maybe I put a tourniquet.

The reason I didn't is to think about it. When we do the facelift, we don't put a tourniquet around their neck. And actually, when you do it, you can see that it stays there. And the reason it stays there, is the PRP, which you guys know is activated and then the platelet-rich fiber matrix is formed from this gelatinous matrix that's set up, that's intended.

It's the thrombin cascade. You don't really have to put a tourniquet to keep it from going back into the circulation, but it could be a worry because technically it's an intravascular space.

Now, the other thing that gets batted around sometimes, which I'll just tell you it's going to happen because first, they laugh, and then they take it, and then they bar you from it. That's what happened with a heart catheterization. The radiologist first did it.

And a radiologist who attended my class, an interventional radiologist, just told me once, he said, "Charles, watch. What happened with us was we did it and then the cardiologist took it over."

He says, "Eventually, this is going to be shown and widely done, but then the urologist may want to be the only ones who do it."

That could happen.

If you think about it, and I've already had a couple of urologists suggest, this should only be done under ultrasound.

Now here's my argument against that. What is smaller: Putting a needle into the vein of someone or putting a needle into the corpus cavernosum?

For most guys, I would say that the corpus cavernosum is significantly larger than the veins on their arm and I don't need an ultrasound to do it.

Now, there does need to be some understanding of the anatomy, but if a man can do his on Trimix injection and get a needle into the corpus cavernosum, I do not need an ultrasound to do a Priapus Shot, but I've had some urologists look at me with a straight face and tell me that's the way it should be done. I think that's just a prelude to saying that only urologists should be doing it.

Okay.

The other thing that I think about, back to the tourniquet thing, I think what happens is that those who have injected the face and have seen how PRP behaves, would know that the tourniquet is probably not necessary. Again, these guys are brilliant.

They did the study.

I love them for doing it.

It strengthens our position, but when you read the study, I want you to know why I think maybe they're changing of our method was based upon their having not injected faces for a decade.

Okay.

Then the other thing, and this really makes me cringe more than if someone were scraping their nails across the proverbial blackboard. A total of five cc's was infused in each other corpus cavernosum, get a load of this, by slowly retracting the needle for better distribution of PRP into the rectal tissue over a two-minute period to minimize platelet cell injury.

Are you're getting the picture?

It looks to me like they put a needle, and threaded it through the corpus cavernosum, and then slow ...

My penis is retracting right now.

It's an innie instead of outie.

And then they slowly over two minutes, retrograde injected PRP into the penis.

I mean, okay. So, all right, whatever. I don't know. I think I'm going to leave it at that, but I don't think that's necessary.

These poor guys.

They should have called one of us up and then asked us about ... Or maybe come and watch one of us inject faces to know that when you inject a sponge, it's this corpus spongiosum and the corpus cavernosum is similar with all the sinusoids, you wouldn't have to take a needle, and thread it, and slowly move it out of the sponge to fill it. Just inject it and let it spread well.

Well and what about this minimizing platelet cell injury?

I want the platelets to be injured when I inject them. Actually, I'm going to activate them and make them release those growth factors and put them into the penis very quickly within a minute or two, so while they're still active. This really made me cringe and I didn't want anybody thinking that's the way it should be done.

Again, great respect for these guys, but holy smoke, I'm glad I wasn't one of their patients.

Okay, was performed under sterile conditions without anesthesia. Thank you very much.

Following administration, additional compression of the penis with a dressing placed around the penile shaft. And then, the tourniquet was removed after 20 minutes. Holy smoke…

Tourniquet two minute retrograde per side, without anesthesia, so we got four minutes per total of injecting. And then, you're going to put some sort of compression dressing with a tourniquet at the base for another 20 minutes. And then, they're instructed after the tourniquets removed after 20 freaking minutes, then they go home and take the compression bandage off four hours after the injection.

All right.

What's the idea behind that, the compression bandage? So you don't bruise. Get a clue.

We're making a bruise. We're creating an artificial hematoma.

When you do this, what happens when you get a bruise? Plasma comes out of the blood vessel, activates the thrombin cascade, and you get a bruise or a hematoma. That's all we're doing. The only difference is that we're taking the blood out and because we're fractionating it, instead of just the amount of blood ... Let's say you have a bruise or a hematoma that's a centimeter. Okay. That'd be a cubic milliliter, a milliliter. We're injecting five milliliters, so that'd be five centimeters if it were water. Now, remember, your definition of a millimeter is a cubic centimeter.

You put five cubic centimeter hematoma, but you have, because you fractionated and concentrated the PRP, you had the same amount of growth factors as if you would have had a 60-milliliter hematoma, or a 30-milliliter hematoma the way they probably did this Magellan kit, or 60 milliliters total, which of course, would be fricking amazingly painful. Still, it's a hematoma, and it's going to stay there, and you don't have to create it slowly because you want everything to be activated.

I just wanted to go through how they tortured these poor guys and realize it still worked, everything is great, but we don't have to do it that way.

You guys know we have a better way of doing it.

And I think doing it the way we do, you are actually treating all of the corpus cavernosum, both the part that's outside in the room and the part you can't see that's just as important and necessary for erectile function.

But yay for these guys, I still want to congratulate them. Great study.

I just wished they would have come and done Vampire Facelift® with us for a week or two before they designed these things and tortured these poor guys.

Okay.

But still, cover the fricking Journal of Sexual Medicine. That's huge.

All right. This one I wanted to look at, this is a review of current ... One more about erectile dysfunction and then we'll get to Peyronie's disease and penile rehabilitation. This one, they go through just reviewing, just like it says, current therapies for erectile dysfunction. They have a section for a PRP, which let's see, here we go, which they give us a good review. It's the same criticism, which we deserve. There's a need for standardization of PRP processing methods, which is part of the reason for our group. We've agreed that you should be at least one and a half times, you should activate the PRP with calcium chloride and calcium gluconate, thrombin, or something because we know without activation ...

See that's the other thing. These guys did the slow through the needle, so that means they only had 65% activation by one of the platelet experts that I talked with in Serbia when I was there. And so, they basically undid their centrifuge, if they happen to not activate them all.

There is a need for standardization, which is what we're doing.

The reason for our group, is we're trying to come up with some ideas. At least we're going to use an FDA-approved kit, so we know whatever amount of PRP we think we have, we at least have that. It may be different than someone else's kit, but we know what we did with our kit, which is something. When you look at some of the studies, they're just using yellow tops and pipetting, which is completely non-reproducible because maybe your lab tech pipettes today and everything's fine, and tomorrow they smoke two joints and had a fight with their wife, so their pipette technique is a little different.

I like something that's standardized in an FDA-approved kit, and it's sterilized in a way that you're able to say that this PRP is safe to go back into the body.

That's some standardization, and there's a need for more of it, and we do need more randomized control trials with larger patient samples.

Why the PRP Research Moves Slowly

Part of the hindrance with us, of course, is that we're grassroots. We don't have many millions of dollars, like a drug company. There is no patent on blood and the PRP companies, about all we can have them do when we do our studies, is they'll give us free kits sometimes. That's about it. It's hard to ... One of the Emcyte/PureSpin reps, Jeff Petrillo, gave us some cash for a study, but other than that, I've never gotten anything from anybody other than free tubes for the studies we've done.

So including the Magellan people who did that, who provided the kit for our lichen sclerosus, two of those studies and for the one you just saw that was done at the University of Aristotle in Greece.

Okay, so that's two very nice peer-reviewed articles. One of the Journal of Sexual Medicine, the other out a couple of years ago in Medical Sciences talking about PRP for erectile dysfunction.

Injections to Help Premature Ejaculation

This one, frankly, I haven't done for my patients, but it's coming, and some of the people in our group are doing so I didn't want you not knowing about it, and I wanted to bring it up because we now have some studies talking about it, plural. I'm giving you one of them, and this is peer-reviewed International Journal of Impotence. This is a high-impact journal.

And what they're doing is they're using HA as a way to decrease the sensitivity, and of course, the side effect is the penis gets bigger, which is for most guys, not a bad thing. So this is coming, and you can see some pictures, you can see how they're doing it.

I'm a little bit hesitant to do injections in the glans because technically... With HA, because technically you're putting HA in the intravascular space. I'm less hesitant to put it subdermally for just pure girth, and also it could have some decreased sensitivity in that case, because you're subdermal, not in the intravascular space.

And we know a long, long history of HA not causing neoplasia, and I liked Juvederm Ultra Plus because the granuloma formation is almost zilch and good safety profile.

So I don't teach this, but I wanted you to know about this study. Again, I'll have links to all this when I put it on the website and just showed you how to find it, and it'll be up by next week.

So that's for... I've actually put... I won't show it to you now, but if you go on Amazon, I put one chapter of a book I've been working on about premature ejaculation, and I honestly think the best way to treat it, it's probably not with our injection techniques, but I think adding it, injections, to other things could be very helpful.

So I think that's all I'm going to say about this. Now, the next one, though, I think is extremely, the next two, I think are very important. One about Peyronie's and the other about post-prostate surgery, and then we'll shut the place down the.

Priapus Shot® for Penile Rehabilitation

The first one is about post prostate surgery.

We've been doing this now for a decade. Finally, I love that someone's talking about it.

Reading between the lines, I like people that give us a hard time. Always be grateful for your intellectual enemies, because they make you be smart. They make you smarter. They make you have to think and work and do research and think about your position. So I'm not offended by this, but I also want to walk it through line by line because there's some...

First of all, they rightly point out the legal problems of stem cell therapies in the United States. Be careful. In my opinion, if you're in the US, you should not be saying the word stem cell in relation to your procedures, unless you're talking about how platelet rich plasma recruits themselves from the bone marrow. Unless you have an IRB-approved research protocol.

Autologous, Homologous, Minimally Manipulated

Now, because platelet-rich plasma is autologous and homologous and minimally manipulated, and those three words, if you're not sure what they mean, we have some stuff online that explains that, but briefly autologous, from the person, homologous in that it's doing the same thing where we put it, that it was intended to do had it occurred naturally. So we put it in the penis to help it regenerate neovascularization, neurogenesis, collagen production, which is what it would do if there were an injury. So we're asking it to do what it would normally do, which is homologous. And it makes sense. You shouldn't have to do, we want to, but you don't have to prove that making blood flow, if you treated a wound in the leg, would help a wound in the arm. And by the same token, because PRP is not a drug, you don't have to prove that it would help with those things in the penis if it helps in the leg.

And it's not even off-label because it's not a drug.

Now the kits were made to do PRP for a specific indication, but that's the kit.

The PRP, once it's made, it's not even FDA business. So autologous, homologous use is minimally manipulated in that we haven't done so much to it that it quits being the person's body as what happens with stem cells. So, so that's why it's safe and long, over a decade, close to two decades now of safety, many studies. The safety profile is amazing.

So let's just look at these two paragraphs. The use of PRP to improve erectile function has been reported. Now, remember, we're talking about rehabilitation following prostate cancer treatment or surgery. And of course, this would vary based on the surgery, and hopefully, we'll have more of our urologists, we have quite a number of urologists in our group who will extend these ideas.

So there have been preclinical and clinical studies in vitro, in vivo, and rat studies, it's been shown to work. So promising data with good short-term safety, and he goes through some of the studies that are out there.

Now here's the part where it gets a little bit political, but that's okay. Again, I like people who rough us up a little bit so we think harder. The evidence to support PRP in treatment is not strong especially in the setting of prostate cancer. Well, depends on how you want to define strong. Not strong enough, obviously, that every urologist is doing it. So I'll go with that. But we have now at least a dozen very good studies in high-impact journals. But he's also right that using it as part of a penile rehabilitation protocol post-prostate surgery has not been studied that much.

In other words, we don't know how much it adds to the penile rehabilitation protocol. But we know that it seems to make sense, and when it has been looked at, it seems to help. So I and others in the group, after the person has gone through whatever the urologist intended, and now they're as good as they're going to be, I've put people back through the normal penile rehabilitation protocol, which is daily Cialis, daily vacuum device, and then added in a Priapus Shot with great results. That's not a study, I know, but it makes sense. It's not waving a crow's foot and doing something that's not supported by research.

So my thinking is there's no finish line. There's just a gradual knowing and learning and a gradual, but reluctant, understandably reluctant, acceptance until insurance is paying for it and everybody's doing it.

But if I'm the guy who loves my wife, taking one of the veterans I treated, I'm close to Pensacola, so a lot of veterans live there since there's a base, who have been married for 50 something years, he had prostate surgery, he was several years out, wanted to do another honeymoon with his wife and wanted things to work. So I put him back through the protocol, the usual penile rehabilitation protocol.

He's several years out from his surgery. And within a couple of months using Cialis, he was able to have an erection again. But before the protocol, using Cialis, he was not.

Now, is that worth doing?

I think so. I think it's worth doing, and it doesn't mean that it needs to be that everybody's going to do it. But my thinking is that if there's enough research to support it, it's safe, you have a person sitting in front of you that might benefit, then I say do it.

And he's right, none of these studies were...

This is where it gets political, the medical hype and the commercialization within a limited regulatory framework have deterred high-quality research data. Here's where I'm going to call BS because commercialization doesn't limit high-quality research. Actually, you can't commercialize blood. Commercialization of a drug gives you billions of dollars of research, and add on the fricking Superbowl and gorgeous supermodels who walk in your office and give you an erection trying to get you to write a prescription for something.

So it's the opposite. We will never have that with platelet-rich plasma ever because there's no patent on it.

So this I'm going to call total BS and it should be struck out, the editors should have struck this out because commercialization doesn't limit research. Commercialization helps research. And because we cannot commercialize PRP, we can't do the kind of research we want to do.

But what he really means here is that “It aggravates me that somebody is charging the cash for this instead of doing only whatever Blue Cross Blue Shield decides is appropriate.”

And this is why this sentence is why you must, you very must always swear before whatever's holy to you that you will give every patient all of their money back if they ask you to, because the person who wrote this sentence will crucify you and call an audience to applaud if you keep somebody's money who is not happy.

There's a lot of anger in that.

It's completely wrong because remember, commercialization pays for research, and our little fees that we charge allow us to make a living, but they don't allow us to do half a billion-dollar research as Flibanserin does. So this is a BS sentence, but whatever, I'll forgive them, because it makes us smarter and it makes us want to do whatever research we can afford to do.

Now, none of these studies is designed specifically as part of a penile rehabilitation protocol, which is true, in addition to clinical application and specification of PRP needs to be optimized and standardized.

All that is absolutely true. Okay.

But the bottom line is thankfully it's being talked about, and I'm so grateful this person wrote this article because it's a high-impact journal and the discussion has been going, but now has been brought, you can see this is fairly recent. It's been brought to the forefront and hopefully, you guys, you can see this was this year it came out. So we will just keep doing this discussion and gathering data.

The Priapus Shot® procedure for Peyronie’s Disease

Okay. So now, that last one, and then we'll call it a night, talking about Peyronie's disease. This one's been out for five years now, but it's still my favorite because this guy's a wizard. I have a textbook of sexual medicine and Ronald Virag's pictures in the front of it. This is not a lightweight.

And he did, instead of using a placebo, he used a positive control. He did good ultrasound studies with visualization and showed that PRP worked better than the positive control—Xiaflex.

And he showed that PRP works better than Xiaflex for Peyronie's disease. And the side effect of course, is with PRP or the Priapus Shot, the side effect is you get a better erection, a harder erection on the erection scale. Virag usually documents an average of about an increase in seven on that scale of five to 25 versus Xiaflex where you have a 5% or one in 20 chance of developing a penile fracture.

So Priapus Shot side effect, harder erection.

Xiaflex side effect, fractured penis, limp noodle.

PRP side effect: bruising, cost a couple of grand.

Xiaflex side effect: fractured penis, costs you the price of a nice car, 50 grand.

So not saying Xiaflex goes out the window, but for my thinking, we have a good, strong case in a high-impact journal by a very prominent physician about this.

Now, a couple of things about his methods, then we'll shut it down. He injected them once a week and he injected into the plaque. My thinking, two things about that, if you look at soft tissue studies and there's a lot of them because platelet-rich plasma, as you guys know, has been used in wound care. So there's a lot of studies about PRP and looking at soft tissue. Also, now in the past 10 years in the aesthetics space, look what happens to soft tissue. So full effect is eight to 12 weeks. So to repeat it weekly, to me seems like more than what's needed. It's like fertilizing your lawn before it has a chance because this is growth.

This is not a pharmaceutical effect. It's propagating cell growth. And to do something to propagate growth before you've achieved the optimum growth from procedure number one to procedure number two, in my opinion never hurt anybody.

There's no downside, but perhaps they were treated more frequently than what's necessary.

Secondary, again, no harm done, but if you look, Dr. Virag is doing this, his disclosure is that he was doing it for the region company, Regen Lab. So again, I know the Regen people are ethical, but there's a different motivation than there would be--say with a clinical person like myself in rural Alabama, where having this treatment done every week would be beyond the convenience and budget of many of my patients.

But I'm glad he did it.

And it could be that doing it weekly maybe and made it more likely to work. I'm sure there was a lot to this. I'm just saying that interval doesn't necessarily translate clinically. And I wanted to point that out.

Second thing is that probably the person that I know this to have done more Priapus Shots® than anyone on the planet literally at seven clinics now, all of them doing seven or eight P-shots® per day: when he treats Peyronie's disease, he just does a normal Priapus Shot. In other words, it may not be necessary to inject into the plaque.

I'm not saying it didn't help, perhaps it makes it more likely, but we don't have a study that shows Peyronie's disease injecting into the plaque versus Peyronie's disease just injecting into the corpus cavernosum. It's one of those things we discovered a decade ago accidentally by just trying it in some people years before the study was done, just trying with people and getting great results.

Also, I actually spoke with Dr. Virag. We shared the podium in Venice, and when I asked him, clinically, when he treats a person outside of study, he combines it with a vacuum device because there was a study in the British Journal of Urology showing that 51% of men canceled their surgery for Peyronie's disease if they used a vacuum device twice a day for 12 weeks. So just traction, physical traction, and hyper expansion, and I think it needs to be vacuumed, not a traction device for best results, because you're going to expand the erection more than... It'll be like hyper-inflating a balloon. And then when it goes back to normal, I think there's some correction of some of the scarring and helping with the curvature more than if you just did say traction or try and mix injections.

Okay. So that's the studies I wanted to go over and I'm looking to see if there are any questions. And the penis pump, that's right, they didn't use the penis pump, Elizabeth. By the way, I saw your idea. Great. I won't bring it up today, but one of the leaders and teachers in our group, Elizabeth Owings wrote a book about clitoral anatomy. And she had an idea she sent to me today in an email. So hopefully I'll have her develop it to the place she wants to teach you guys about it.

But yeah, no penis pump in this study. And if you look at these studies, that's part of the study problem, if you go back to penile rehabilitation. The guy's giving us a hard time for not doing the thing, but to really look at the rehab protocol, you'd have a three-variable study. It would be a pump, vacuum device combined with Cialis combined with the Priapus Shot versus one of those things alone.

Yeah. I mean, you see, as we all know, doing multi-variable studies are difficult to show results in, so much so, I guess it's been six years ago now, there was an editorial New England Journal of Medicine talking about this problem and the FDA trying to encourage people to do multi-variable studies, but no one really wants to do them because they cost a lot of money and you wind up having trouble showing what you intended to show.

So I think with that, I don't see any other questions. I just wanted to go over those things. And hopefully, you found that helpful looking at the studies and I'll put links to these what I think to be critical ideas in the membership site and on the research page for you to refer patients to, along with the recording of this meeting. So thank you very much.

You guys have a great night.

Good-bye

Relevant Research

Chung. “A Review of Current and Emerging Therapeutic Options for Erectile Dysfunction.” Medical Sciences 7, no. 9 (August 29, 2019): 91. https://doi.org/10.3390/medsci7090091.
Chung, Eric. “Regenerative Technology to Restore and Preserve Erectile Function in Men Following Prostate Cancer Treatment: Evidence for Penile Rehabilitation in the Context of Prostate Cancer Survivorship.” Therapeutic Advances in Urology 13 (January 1, 2021): 17562872211026420. https://doi.org/10.1177/17562872211026421.
Littara, A., B. Palmieri, V. Rottigni, and T. Iannitti. “A Clinical Study to Assess the Effectiveness of a Hyaluronic Acid-Based Procedure for Treatment of Premature Ejaculation.International Journal of Impotence Research 25, no. 3 (2013). https://doi.org/10.1038/ijir.2013.13.
Poulios, Evangelos, Ioannis Mykoniatis, Nikolaos Pyrgidis, Filimon Zilotis, Paraskevi Kapoteli, Dimitrios Kotsiris, Dimitrios Kalyvianakis, and Dimitrios Hatzichristou. “Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.” Journal of Sexual Medicine 18, no. 5 (May 1, 2021): 926–35. https://doi.org/10.1016/j.jsxm.2021.03.008.
Virag, Ronald, Hélène Sussman, Sandrine Lambion, and Valérie de Fourmestraux. “Evaluation of the Benefit of Using a Combination of Autologous Platelet Rich-Plasma and Hyaluronic Acid for the Treatment of Peyronie’s Disease.” Sexual Health Issues 1, no. 1 (2017). https://doi.org/10.15761/SHI.1000102.

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Charles Runels, MD

 

 

 

 

 

Cellular Medicine Association
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