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Warning: Though screenshots on this presentation give ideas about various ways of doing the O-Shot® procedure, watching this video does not qualify you to do the procedure nor offer enough information to do the procedure properly. That training can be found either online or with hands-on training (depending on your credentials) by calling our office at 1-888-920-5311
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Marco Pelosi:
Our next speaker is the one and only, the master chef of PRP, Dr. Charles Runels. He’s going to talk about the O-Shot®, O-Shot® procedure variations, and, importantly, what you need to know about the FDA.
Charles Runels:
I think most of you guys are using PRP now. And there’s a lot of research out and a lot of different techniques.
But the way the PRP works will vary based on where you put it. And there are some people that just aren’t going to get well from PRP. So I thought it might be useful to review that together with what the FDA has to say.
This whole presentation, including the slides, including what I’m recording here, is available to you for free, when I’m done. Use it any way you want. You don’t have to give me credit for it. Go preach it and try to get people well, you don’t have to even mention my name. And that’s where you can pick it up. I’ll give you that later, it’s at that website.
The premise is that, if tissue is made of cells, then if you can make the cells better, you can make the tissue better. And you guys can sculpt with a scalpel, the tissue is to you, what marble would’ve been to the great Rodin. So I’m just the guy, I’m not the smartest guy in the room, I’m the guy that’s going to tell you how to make the marble healthier so that when you do your sculpture, it works better.
Since there’s little systemic effect of PRP it needs to be put in the right place for it to work. So injection techniques matter, and there’s a lot of discussion about which technique is the best.
What is PRP?
So, what is PRP? There’s a lot of discussion about that as well. If you go deep into the science, everything from washing the platelets to drawing the plasma after aerobic exercise. So there’s an infinite number of variables.
If you go look online, there are over 50,000 papers about how to use beta blockers for Congestive Heart Failure. So the first step is just showing you it works, then there’s an infinite number of variables that leaders, like you guys, need to do to figure out the best way to make it work.
But for this presentation, PRP is just any plasma that has a platelet concentration more than whole blood. There are more than 15,000 papers published regarding PRP, with no serious sequelae. So we’re pretty safe.
Again, what I’m reporting to you, much of it came from many people in this room or in our group [Cellular Medicine Association]. We have 4,000 physicians in more than 50 countries. I’m just reporting what’s in research. I’ve read at least 10,000 of those papers. And so, again, I’m not the smartest person here, but I’m a good reporter. And so I’m hoping you’ll get some tips from the different techniques that are out there.
Our little group does education, research, and patient education as well. So I hope you’ll consider joining us, here’s a list of some of the things we’ll touch on [today].
Stress Urinary Incontinence
Start with Stress Urinary Incontinence. The standard striated urogenital sphincter accounts for one-third of the closing, resting pressure of the sphincter, from Delancey.
And if you look at the sphincter, this is just a sketch I made from some of his work, you can see, it varies in proximal to the bladder. As you guys know, in three circles, the urethra only, and by the time they get to the introitus, it encircles both the urethra and vagina.
And the urethra abuts the vagina, so the wall of the urethra touches the wall of the vagina, and then it becomes further away as you get more proximal to the bladder. I think it is important you think about technique. So for the Striated Urogenital Sphincter, the number of muscle fibers in the sphincter decreases with age, the number of innovating nerves decreases with age, and the function of the Striated Urogenital Sphincter is damaged by childbirth.
So some questions are, do the muscle fibers go down cause of the lack of blood flow? Or do they decrease the innervation? Or are they independent? And so I’m not sure what those answers are, because I haven’t researched yet, but it begs further questions like, with voluntary cables maybe they’re not so helpful if you don’t have nerves going to the muscle.
And, also, since the striated muscle in the sphincter can be helped by PRP, from the Sports Medicine Literature, and we get neurogenesis from PRP, perhaps that might be a good strategy. So just think about some of the strategies.
Here is just a selection of papers. Again, I know you can’t read that, but you can get them all from that link, I’ll give it to you at the end.
Demonstrating neurogenesis from PRP. Here’s a selection of papers showing muscle revival from PRP, from the Sports Medicine Literature. And here is a sampling of papers showing the PRP helps with Stress Urinary Continence. Here’s a selection of paper showing that a magnet helps your immune continence.
The urethra, the wall of the urethra has a vascular plexus. I think it’s helpful to remember they’re arteriovenous anastomoses, and the urethra actually of the woman has a function of developing tumescence, just like with a man. And so then, you can speculate that if you’re able to inject that wall with PRP it may contribute to the benefits that you see with Stress Incontinence. Here are more papers about neovascularization from PRP.
Also, there’s a longitudinal, smooth muscle that you guys know that runs beneath the striated muscle, which you can’t contract. You can’t exercise that up with either a magnet or with volunteer Kegels, but you can inject it with PRP. And, again, PRP has been shown to improve muscle function. So that’s a possibility.
Urge Incontinence
With Urge Incontinence, as you guys know, in some cases there are some problems with the local nerves there. And so, as we mentioned, PRP helps rebuild nerves. This is where we only do our injection for a classic O-Shot right at that junction where the urethral wall and the vaginal wall touch. We usually put about four millimeters there. And you can imagine that with hydro, that’s a lot of volume for that space. So you would fill the space and you would also potentially hydrodissect, at least partially, into the urethral wall, if you’re good at doing it. Just like there’s a picture.
We have videos that are open, you guys can go to the link when we’re done, and we’ll show you how to get these videos. That’s a screenshot showing if you go just to the other side of the hymenal remnant, you avoid hearts line, it doesn’t hurt, and then you’re able to hide dissect that space.
Another technique recently came out of the literature, where you inject into the edge of your urethra, five injections of one CCs each. And who knows which is the best. All I’m trying to do is to get you guys to think that techniques matter.
Obviously, I think our technique works better for the reasons I said, but you’ll see other techniques here. And I want to be shown where I’m wrong. Again, I’m a reporter. I don’t sell kits. I don’t sell PRP. Sometimes I wonder if these procedures might not work with whole blood or even saline. So I don’t know, those are some of the questions we need to answer.
Mid-Urethral Slings
Now, let’s talk about Mid-Urethral Slings. This is from the Journal of Sexual Medicine. What they did, recognized that one in 11 people who get a Mid-Urethral Sling, the m.u.s. affects their sexual functioning.
One in 11!!
So they said, well, let’s figure out why that’s happening.
So they put Mid-Urethral Slings into cadavers, and then they sectioned the area. And they saw that they were destroying the nerve and glandular tissue from the female prostate, the Skene’s glands, whatever you want to call it.
They were destroying blood vessels. And so obviously, a Sling, I’m not here to preach against Slings, but I’m here to preach there may be a way to help some of the side effects or maybe prevent them, by using PRP, because we know it helps some of those tissue types.
And, again, if you read their description, they’re looking at the space right where we’re putting our PRP, where the sling goes, and demonstrating that damage.
Dyspareunia
For Dyspareunia, here, are some of the problems.
Lichen Sclerosus
You guys know [lichen sclerosus], has all these different etiologies and qualities. There’s a picture of it. You guys know what it looks like. Autoimmune is thought to be a big part of Lichen Sclerosus.
Here is just a sampling of some of the papers that show a down-regulation of autoimmune response from PRP. Here is a selection of papers showing that PRP helps Lichen Sclerosus. Just a selection.
Here is a selection of papers showing that PRP helps with scaring.
These are before and after pictures from one of the studies we published with Andrew Goldstein, the two blinded dermatopathologists—showing benefit from PRP in women with Lichen Sclerosus.
There’s one of the actual patients there.
Kathleen Posey published a study where she did something similar to what you saw with Dr. Red Alinsod, yesterday, where she freed up the clitoris. But instead of it phimosising back, she injected that area with PRP and then six weeks later, on the right.
On the left, she had been seven years about sexual intercourse with her husband, who loved her dearly and stayed with her and got the reward, because she’s been now like this for years, but she’s getting PRP about once a year, off the clobetasol which she had been on for many years.
This is a picture from my lovely fiancé, which the picture on the left is a woman soldier who marched with this, bleeding and cracking with every step. And she only had sex with her husband in the dark. He didn’t even know what this looked like until after my fiancé, first micro-needle and ejected with PRP, a slight variation. Then six weeks later, freed up the clitoris because the tissues are now healthier. And re-injected, used UV light which we also know helps, and micro-needle with PRP, and did our traditional O-Shot® procedure.
And this woman is loving sex and she turned on the lights now, after years of not turning on the lights. And just grinning and bearing it. Her husband didn’t even know she had it.
Post-Mesh Pain, we know PRP helps with scaring. And here are some of the papers that show. Helps with wound healing. And the review, this paper reviews studies that show that PRP helps with mesh pain.
The technique that I heard talked about among the group and that I see in the literature is just injecting the area. Some people are using the old school method of nerve block, for inflammation.
Interstitial Cystitis.
Here’s the rationale behind it. Chronic inflammation into bacterial, into penal infection. Here’s a sampling of the papers that show that PRP helps with Chronic Interstitial Cystitis, sampling. Technique is usually just some people are doing intra-vesicular injections, but with our group, we found we just do our traditional O-Shot in the place where I showed you, right there. And they’ll get better.
Post-Episiotomy Pain.
Again, you’re dealing with a wound. Usually it’s every six weeks you infiltrate the area that get better.
You guys know how you’re treating Vaginismus with dilators and Botox. Some people are adding PRP. I think you’ll probably see a study coming out from showing that when you add PRP to the traditional area, somehow the muscle seems to be recovering.
For Pelvic Floor Tenderness, instead of just injecting or trying triamcinolone, the Sports Literature documents, injecting tender muscles with PRP. Usually it’s every six weeks, they get worse for the first week after you inject it, they feel worse, and then they get better. Sometimes, again, it takes a little injection.
For Anorgasmia.
This is one of those cases where PRP’s not a magic shop. If you think of it in the systems view, every part of that thing, take away hormones, the orgasm, give the woman a social problem where she’s so broke that she can’t buy food, where she’s running from the bombs. There’s not going be an orgasm, but genitals do take part in orgasm. And so if they have the cause of anorgasmia, is originating in the genitalia, then PRP may help.
And you can’t see it all there, but there are several studies showing PRP helping with dyspareunia and orgasm in people who have dryness and can’t be on hormones because of breast cancer or whatever concerns.
Here’s a selection of papers showing PRP helps with orgasm.
Decreased Arousal
For decreased arousal, it’s a little bit trickier. There’s this negative feedback loop. A woman’s having good sex, something goes wrong, it hurts. The next time she’s more difficult to arouse. It’s not the traditional, arousal, plateau, orgasm, refractory period that with men happens.
Women are more complicated and more beautifully designed. And so if she has repeated negative experiences, it ain’t happening.
Where, again, if you have someone who’s had negative experiences and now take her pain away or make it better, then the next time it’s more easily, like that, it works better.
By the way, Dr. Grafenberg, for whom the G-Spot was named, describes in his writing, observed women, having orgasms just by speaking to them. So, obviously, those women will be at the top of this positive feedback loop.
But anyway, one of the things we do is inject the body of the clitoris, and one of the people in our group who is an interventional radiologist (Dr. David Harshfield) showed with an ultrasound that the PRP does in fact hydrodissect down the corpus cavernosum.
So that’s where we put it. I hope you’ll join our group and see the whole video.
And so the question, in finishing, has the science reached the place where PRP use has become the standard of care?
I think it has, but you have to decide on your own.
FDA & PRP
As regards FDA policies & PRP, it’s real easy.
(see the actual FDA documents here)<–
This is word for word, from their regulatory considerations for human cells, tissues, cellular and tissue-based products.
This has been there. The only thing that recently changed, which would freak everybody out, is they started enforcing this policy.
But the policy they’re enforcing has nothing to do with PRP and they tell it to you right here in black and white. It says, for example, platelet-rich plasma, when taken and given back to the person is not at an HCT/P under the 21 CFA Part 1271 because it’s a blood product.
The FDA does not regulate your spit, your urine, your hair, or your skin.
So the terms are minimal manipulation. Okay, so if you minimal manipulate.
They do regulate devices and I recommend that you use a device that’s made to [FDA approved] put blood back into the body. Otherwise, you’re in scary land [as in take your license off the wall and find another job].
Thank you for having me guys have a great evening.
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