Vaginal Dryness after Breast Cancer. Treatment with the O-Shot® Procedure

Full Transcript Below...

Charles Runels: Let's talk about something that I hate, I really hate, it's dyspareunia or pain with sexual intercourse in women who's already suffered with breast cancer. Imagine the loneliness of having already gone through all the treatments for breast cancer, and now that you've survived, and you've lived through radiation, perhaps chemotherapy, perhaps surgery, and now you're left with the inability to use estrogens that are needed to maintain the lubrication that's involved with comfortable, sexual, intercourse.

Unlike decreased arousal, where a woman who loves her husband can accommodate, or decreased orgasm, where a woman can still enjoy sexual intercourse without orgasm, dyspareunia makes a woman actually avoid her husband. Her fear is often that if she arouses the husband, then the husband becomes more frustrated. I hear of women who will even avoid touching or holding their husband's hand, even though she loves him, because of fear of arousing him, and then causing frustration because they can't have sex. The things that have been tried for this ... The thing is, it separates lovers.

Now, who am I? My name is Charles Runels, I'm the inventor of the O-Shot® Procedure, so I'll just tell you right now, we're coming to talking about how that might be a solution to this problem. I've been treating women for sexual disfunction for the past 18 years. I've been a physician for 20 plus years, and I've done research in the area and I think we have something to maybe help.

But let's go ahead and talk more about what's been tried, and we'll get to what's new. If you look at a search on PubMed, which is the main way for finding research that physicians use worldwide. If you look at the different solutions that come up, not a lot of research in general, when you search dyspareunia and breast cancer, but if you look at the answers, it's really very frustrating.

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The conclusion of this one is, "Breast cancer survivors with menopausal dyspareunia ..." In other words, they cannot use estrogens for fear of recurrence of the breast cancer ... "can have comfortable intercourse after applying liquid lidocaine." So, she's back to accommodating, but not necessarily enjoying, and I'm not saying this is a horrible thing, it doesn't mean it's not something that can be used. But, if you look at the research that's shown here, it involves basically, numbing things. It can get on her lover, and so they both are able to now put their genitals together which allow some closeness, but it really doesn't allow the pleasure of sex, like it could be if you just made the pain go away instead of numbing it down.

So you look at this other one. Look at what they're recommending here ... Aqueous lidocaine. Not so good. These are the most relevant searches for this problem. If you look at this one, "Olive oil, exercises, and moisturizers." So, when it comes right down to it, it's a long way of saying that the current best practices are a combination of lubricating, numbing, and some sort of counseling. Counseling as in learning how to stay close without the pleasure of sexual intercourse.

My hats off to all the research that's gone into finding a solution. I'm not angry at the solutions or the people that have tried to find these solutions. I'm very angry that this is the best we have. Starting about eight years ago, I started using Platelet Rich Plasma (PRP), first to inject Platelet Rich Plasma into the genital urinary space, and we published some research about that, which you can find if you go to O-Shot®.info or O-Shot®.com, it wants ... Puts you on the same web page, and then click on research. When you click on the research, you'll see a list of various things that can be done to help with sexual dysfunction, and other problems secondary to that effect ... Wait a minute ... Then, at the top of that, you'll see a paper that we publish, this is me, and we talk about all the reasoning why using Platelet Rich Plasma maybe of help, and we showed that we were able to decrease female sexual distress significantly, extremely significantly by using Platelet Rich Plasma to cause rejuvenation of the tissue. Platelet Rich Plasma has been demonstrated in multiple studies. Look how many studies you have with Platelet Rich Plasma. Over 10,000 the last time I looked.

Yeah, there you go. 9,987 papers about Platelet Rich Plasma. This is not some new thing, and they go back over 20 years. It's been known to help with healing of hard-to-heal tissue. The dentists have use it quite a bit. Orthopedic surgeons trying to heal. Both of those specialties have to heal bone and cartilage, with not a good blood supply. And so it's been used in that arena, and in 2010 I started using it for the vaginal periurethral space and we published this study soon thereafter.

Now, there's a new ... We've been seeing this help for the past eight years, but a new study came out supporting it, and I want to get to demonstrate and talk more about what they did with this study, where they used Platelet Rich Plasma combined with hyaluronic acid for the treatment of vulva vaginal atrophy in post-menopausal women. You can see here they did not .... It wasn't just about the atrophy. They followed dyspareunia, and saw female sexual distress improved significantly with that treatment. I propose that it would have improved much, much more had they used our protocol. But still, it was statistically significant. So we're back to my protocol, but let's ... Let me break this down to what we initially did in our study, so that you can understand what they did.

In the study that we did, we took the Platelet Rich Plasma and then ... which you get by doing a centrifuge, and then the centrifuge separates out Platelet Rich Plasma from the red cells, and I can show you a picture of what that looks like right here. So you start off with a tube that looks like just a tube full of blood, has an anticoagulant in it, and then when you get through with the centrifuge, you'll have red cells at the bottom, but instead of a buffy coat and platelets on top of it, and plasma on top of it, there's a gel that separates them so that now they'll remove the plasma and inject it into the area. So, it mimics what happens every time you have surgery or injury. This is not a new idea, it happens every time you have to heal a wound that the platelets release growth factors, and then those growth factors cause recruitment and activational plural potent stem cells that migrate from the bone marrow and heal the tissue.

This is very well known in the orthopedic and dental space, so much so that it's quit being about whether it works or not, it's the best way to use it. You can see here's one from the National Journal of Implant Dentistry, where looking at using calcium chloride to activate the Platelet Rich Plasma. Now, what does activation means of this FDA approved, and what does this all mean?

Your blood does not require approval by the FDA. It's your blood. Just like your saliva, your hair and your skin. But if you're going to isolate a part of the blood for re-injection to a human body, you should use a device that's FDA approved for that purpose. Those devices vary based upon method that isolates the platelets and how the platelets are activated. For example, this one uses a gel that I just showed you, and to separate it. But others use filters, and double centrifuges and pipe fitting techniques and all sorts of things, so, that's not the only way to do it. This one has a gel that separates. There's the gel ... the red cells from the plasma, and then the plasma's re-injected.

Activation is widely accepted within the orthopedic and dental literature as being helpful, because it tells the platelets to release all those growth factors. That activation can be done with vacuum, calcium chloride, calcium gluconate, and with a hyaluronic acid filler, like Juvederm or the orthopedic versions, like Hyalgan, because the platelets interpret that to being a form of collagen, which causes the platelets to release those growth factors and cytokines.

This particular kit has a small amount of hyaluronic acid, which is again like a Juvederm, or Restylane, or Hyalgan, or Synvisc, or all hyaluronic acids, that comes with the kit, there are other kits that come with calcium chloride. Some kits don't come with anything, and you have to add the calcium chloride or the calcium gluconate, or the HA yourself. So, this kit was sponsored by a company that makes a kit ... Region makes a kit, that comes with an HA. The point I'm making is that there's really two variables here, right? They're injecting two things. Platelet concentrate, which they're calling ... That's the word they're using for Platelet Rich Plasma, and hyaluronic acid. That's two different variables. So, don't let that confuse you though, because the HA is just a way of activating, and you never cause rejuvenation of tissue of any significant degree with an HA, although there is a mild effect. The major effect is from Platelet Rich Plasma.

Now, how do I know this, and what's my background? In addition to inventing the O-Shot®, also invented the Vampire Facelift®. This was something that most people don't know, but when I was experimenting this, which Kim Kardashian did, and many celebrities have now done, when I was inventing this, I was actually doing this as a way to figure out how to use it in the genital urinary space. Now, of course out of it came a useful cosmetic procedure, but as a wound care physician, I had already been looking at this in other arenas. For example, this one. Where PRP is used in combination with a HA for healing a wound, and others like it, where ... But others like it, for example this one. Using PRP combined with an HA, and it helps heal wounds. But it's the PRP that's active and you have many, many studies showing PRP as a stand-alone for healing wounds.

So, if you go to PubMed and you put in Platelet Rich Plasma, and then you put wounds behind it, or wound healing, you get lots of stuff and most of these don't use an HA as part of the process. And you can see it's all about it heals muscle, there's collagen, there's new blood flow, and so it's really a very well-documented way of regenerating tissue, all tissue types, nerve, blood flow, collagen, even fat cells.

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There's 1,700 studies. Back to what we're doing here with the dyspareunia secondary to dryness from lack of hormones, particularly estrogen, in the case of someone who's had breast cancer, what we're doing is using the PRP to recruit plural potent stem cells that grow the new tissue, and the HA as an activator. Go into more detail about what the studies show. They measured vaginal health index, which you can see I said that ought to do with fluid, the PH, the moisture, and they did a Xylocaine cream, but we use a Bupivacaine/Lidocaine/Tetracaine cream that works I think better than this. So, our pain ratio would be different. They injected four CCs in the vestibule in the first three centimeters of the vagina using a point-by-point technique. This is not needed. This would hurt more, because you ... PRP spreads so easily through the tissue. You don't have to do so many injection points. In the posterior vaginal wall, and the posterial wall of the introitus.

You can see here where they're putting the injections. The thing about this is that it's missing out on the anterior wall. Now, why would they skip the anterior wall? The reason is that there are multiple studies showing that HAs in the anterior vaginal wall, hyaluronic acid in the anterior vaginal wall can cause granulomas, it can lead to obstruction. That's not a good thing. But by leaving out the anterior vaginal wall, you miss rejuvenating the Skene's glands of the periurethral glands. Let me show you where those live.

If you look at the cross section through the vagina and urethra, the Skene's glands or the periurethral glands are very near the opening here on the front side of the vagina. So, if you're doing all the injections back here, it's not going to do anything with that. So, why is that important? Why is the Skene's glands or the periurethral glands important?

Actually, let me get this where you can see it better. Here's the urethra, here's the vagina, here's the periurethral glands or the Skene's glands. Here's another picture of it showing you where it may open up just near the opening of the urethra. Here's another view of it, showing the Skene's glands are right there, all of it on the front side, but these guys if you go back and look are injecting on the back side. That's not a bad thing, they help the woman, but it's a less than it could be thing. Now, had they injected the anterior vaginal wall, actually my feeling is that there's not enough HA in that particular kit to cause a problem. I've used it, it's a good kit, I don't think it's enough to cause a problem.

But, I don't know that I'd want to risk it in someone without a study showing that I'm not going to see granulomas, like [Swissman 00:16:15] demonstrated before. So, when we do our O-Shot®, we inject PRP here, but we do not use an HA, so we use a PRP that's activated with calcium chloride, like we talked about over here, using calcium chloride instead of an HA to activate. Back to our study, when they did this they activated with an HA and now this platelets have released their growth factors, we don't even care about the platelets anymore, the growth factors are in the plasma, and that's what gets injected here, after it's been activated.

If you look what happens, it's pretty spectacular that the effect of it ... Now, this is PH and vaginal health, and you can see it levels off at about three months, which is what you see in most soft tissue studies. When they ask the women would you like to repeat it, 19 out of 20 of them said that they would. But then if you go back and you think well wow, what if they would have actually injected here, just like the men's prostrate excretes a lot of fluid, it's the main thing that makes the fluid when a man ejaculates, a woman's Skene's glands do as well. We actually have women who ejaculate for the first time after using PRP in the anterior vaginal wall. I think they miss some of the benefits. When we did our study, we had a larger improvement of female sexual distress than they did ... they saw with their study.

But, I'm still very grateful. It's a good study that shows that PRP with an HA can help, but I'm telling you, we've been doing it for eight years, and PRP injected the way we do with our O-Shot® does more than an improvement ... The improvement in the female sexual distress that was shown here. So what the heck is the female sexual distress scale? This is what it looks like. You can see the most you could get ... The more of the ... All these questions, 13 questions are answered, and each question has a maximum of four, with a higher score means you're having more problems. So, if you're worried about your sex not at all, it gets a zero, all the time gets a four. So, the most you could get was four times 13 and we were able to see a large percentage of our people go from distressed to not distressed when we used PRP the way we do with the O-Shot®, which is anterior vaginal wall and the clitoris.

It's a really important study. I think it backs up what we're doing. But, I think that we have a better technique that we can use. I think if you want to know more about it as a patient, you would go to our O-Shot® website, which you just type in O-Shot®.com, or dot info either way, it gets you there. O-Shot®.com. Then, when you're there, if you click on ... You could read all about it. Read the research. You could see if you go to research thing here, you can see me covering other research projects that have to do with what we've done like in necrosis, urinary incontinence, all sorts of things. There's a chapter about it in this textbook, and you can see some lectures where I've lectured various places.

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That's the place to read the research. If you want to see one of our providers, almost every page has a place on it somewhere that says that. Click here to find provider, and then once you're there just click on your country, or your state and it will show you people in that area, or if you give it permission to know where you are, it will just show them nearest to farthest away. So, we have multiple countries, and multiple states here. So almost every state, and 50-something countries. Now, if you're looking for someone who does other things, like treats lichen, use radio frequency, a laser, or has Emsella machine, then you'll see those icons by their name as an indication that they treat that. So, this doctor for example uses laser and treats Lichen Sclerosus. This means that they're a teacher for us, and I think that's all you need to know. That's where you go obviously, nothing works all the time ever, ever. Results do vary, so you should speak with your physician and speak with one of our physicians about being treated this way.

Now, if you're a physician, you go here, under physicians and there's a place to get free information. You just fill this out, and we'll send it to you. Tell me where your office is, and you can get any kind of free information you want. If you actually want to go ahead and apply for either online or hands-on training, you go to O-Shot®.info/members, and that's where we list a place for you to apply to become a member of our provider group. We have a very specific way of doing this. As you can see, [inaudible 00:21:22] every way that you inject PRP matters, and we have a very specific method that we teach. As a matter of fact, if you don't see someone listed on our directory, then they're not licensed to use our name, and they may be doing something better, but more likely they're doing something not as effective. I highly recommend you use someone off of this list, and if someone's using our name O-Shot® and not on this list, they're pretending to be part of our group when they're not. So, you can make your own conclusions about what that means morally.

Anyway, here's where you would apply, O-Shot®.info/members, if you're interested in being part of us. This is under the umbrella of the Cellular Medicine Association, where we do research. We spend hundreds of thousands of dollars every year doing research in the areas of female and male sexual dysfunction. We have teachers around the world. We also have online training that you can apply for. I hope that's helpful to you. I think this is really important research, and I'm very grateful to these guys for doing this. But, there's a lot more to know and we would love to help you learn more about it, whether you're a teacher or a provider. Thank you very much for your attention.

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Questions about the O-Shot® Procedure (and on-going research)

1. Does the PRP always come from the patient's own blood?

Always Always ALWAYS the PRP comes from the patient’s own blood.  And the FDA approved kits are disposable, so we are always using a new kit to prepare the blood and then throw that kit away before we treat the next woman. Most of us even process the blood in the same room with the patient so that they can see that it’s always their blood.  Hence, there is zero chance of them catching something from another person.


2. What year did the O-Shot originate and how many professionals have been trained to give it in the US?

Dr. Runels did the first O-Shot alone with his lover in early 2011 (after first treating many faces and treating his own penis (with the Priapus Shot® procedure) and the penis of other men—the anatomy and cell biology of the penis mirror the clitoris). Since then, over 1,000 physicians in the US alone representing most states (and other providers in over 50 countries) have been trained, and he's trained faculty from 5 different medical schools in the US alone.

Faculty of the Cellular Medicine Association (click to see) have trained many more physicians world-wide.

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3. I've read about complications if PRP in general isn't prepared correctly, but what are the potential side-effects related to the O-Shot?

2 Parts to this answer.

1. Serious side effects (infection, granuloma, scaring, death) do NOT happen (at least none reported after MILLIONS of PRP injections). 

Anything can happen anytime. And no procedure is perfect (even antibiotics fail 1 in 5 times for those hospitalized with pneumonia). Also, the most simple of procedures can lead to complications. Patients can crash their car driving to the office…so just driving to the doctor’s office has a risk. But, if someone saw a life-threatening reaction to PRP—anywhere it may be injected other than the eye—it would be the first reported case.
Another important point...we are creating a "hematoma" of sorts by injecting blood into an area. This is not a drug, like morphine where the cells of the body start reacting differently, This procedure encourages healthy tissue growth.
During the first phase there can be side effects (good and bad) from the fluid injected and the resultant vasodilitation etc.
The actual benefits from the procedure happen with new cell growth which takes 3 to 12 WEEKS or more (in orthopedic procedures the full effects can be 6 to 12 MONTHS).
So, both side effects and benefits are likely to be temporary until the 12 week mark, then you have a better idea of the effects of the procedure. Even after that, there can be continued changed due to remodeling of the tissue prompted by the PRP.
Any benefits, problems, or side-effects seen in the first 3 weeks, are likely to be from the PRP injected ---which all goes away!  It's the effects of the new cell growth that provide the lasting effects.
.
Of the over 9,000 research papers published on PubMed (click to see) about PRP, there has been no serious life-threatening side effects in any of those papers, which makes sense because you’re injecting the blood component that’s normally made to repair tissue. So, we are injecting what the body would normally make to recover from surgery. Regen alone (one of the suppliers of FDA-approved PRP prep kits) sells over one MILLION kits per year—so the number of procedures being done in general number in the millions.
With the numbers of procedures being done, the safety profile is shockingly very very good.  For example, in comparison with PRP, three THOUSAND people per year die from bleeding from aspirin (click).
2. We have seen a variety of less serious (nonlife threatening) side effects with the O-Shot® [Orgasm Shot®] procedure.
a. Women with recurrent vaginal herpes see the frequency and severity of recurrence go DOWN (they suffer less). The "side effect' here is a GOOD effect. This decrease in outbreaks makes sense because PRP enhances the body’s immune system against foreign pathogens. The platelet activation is normally a part of the wound healing process, so it makes sense that there’s intelligence about the response (not a simple-minded growth of whatever’s there like if you throw fertilizer on your lawn).  This goes along with the fact that those with acromegaly and abnormally high levels of growth hormone have 25% less cancer than the general population. There are healing effects in the growth factors that make the results good from normal tissue and detrimental to pathogens and abnormal tissue (hence the effect of helping scars go away by remodeling the tissue back to a more normal configuration click).
b. Some women see hyper-sexuality that can be very very intense requiring almost constant sexual activity and not relieved well by orgasm. This happens in less than 1% and has never persisted more than a few days.
c. We’ve seen 6 or so reported cases (in over 50,000 procedures) of decreased ability to have and orgasm. We think this is happening from the effects of the edema caused by the injection. PRP has been shown to heal nerve tissue (click to read), so the PRP should not be damaging to the sensation. Is there micro damage in these women from the needle? Possibly, but not likely since there are multiple small nerve fibers, not one main nerve in the area we inject.  Could the decreased sensation in these six women be related to something else going on with the woman? For example, one woman said the procedure caused back pain, but on a closer interview, it turns out that she and her husband were having such vigorous sex after the shot from her improved libido that she had a muscle injury that got better with a few days rest.  Another woman thought the procedure CAUSED urinary incontinence, but on a closer interview, she simply had ejaculation with orgasm for the first time.  Still, for some reason, we’ve seen sensation go DOWN instead of up in 6 reported cases, In all cases except one, the sensation came back to normal after 3-12 weeks.
d. The development of ejaculation with some orgasms.
e. Urgency, and frequency of urination for a few days.
f. Pain during injection. Usually, we can keep the pain at or near zero, but sometimes, just like at the dentist, the anesthetic may not be perfect.
g. Spotting after the injection. It IS and injection in the vaginal opening—where there’s much blood flow—so we she may see a few spots of blood.
h. Sexual arousal with urination for a few days.
i. There can be a change in the relationship. When a woman’s libido goes up, if her partner is not healthy, there can become a mismatch in sexual libido. If she now wants to have sex more than her partner, that can cause some tension. Better sex does not always mean a more peaceful relationship, though with most couples it does help.
j. There may be something unexpected happen that we’ve not yet seen. So, we have a consent form that includes mostly possible side effects that we’ve not seen.
k. If the woman is being treated for sexual problems and suffers with urinary incontinence, she will often see the "side effect" of the urinary incontinence going away.
l. If a woman receives the O-Shot® for treatment of urinary incontinence, she will often see the side effect of increased sex drive and increased intensity and increased frequency of orgasm (unlike a mid-urethral sling which can sometimes damage the nerves and decrease orgasmic ability and intensity).

Research

Not all women will qualify for this research project. Please consider helping if you do qualify.

Filling out the following form applies you for the option to participate in a double blind placebo controlled study of the use of the O-Shot® for the treatment of female sexual dysfunction. Your treatment, should you be accepted, will be free. Your information will never be shared. If you qualify, you may be contacted by text message or by phone.

This previous pilot study showed benefit (click to see) but we need more detailed data with a placebo-controlled study (which is the purpose of the present study).

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We need more research to help women cure sexual dysfunction. There will be other projects; filling out this form tells us that you may be interested in participating (not all will qualify for this study but we will notify you of future studies). Become a hero to your daughters and nieces and to all women of future generations by helping us with this research.

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O-Shot® for Improved Sexual Function. International Society of Cosmetogynecology. Vegas 2018

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Transcript

Dr. Marco Pelosi III: Our next speaker is probably best described as the Michael Jordan of platelet rich plasma, Dr. Charles Runels from Alabama, that pioneered the O-Shot® [Orgasm Shot®], the Vampire [Face]lift®, the P-Shot® [Priapus Shot®], and he's taken all the abuse and he's given the world some very, very useful procedures for everyone. He's going to talk about the studies he did and the studies done in platelet rich plasma in regards to sexual function. Dr. Runels, it's a pleasure to have you here.

Dr. Runels: Thank you for having me.

I'm going to go through a whirlwind look at research that's been done where people have used PRP to help with sex. Much of the research has been done by the people in our group, and I've described many of them in this room who have done this research. It's a for-profit organization, but we pay for research, we pay for education, we pay for marketing for our providers. Just to echo what you just heard, sex is much more than about just having fun. Rainer Maria Rilke said it's just so correlated to the creative experience that it's affecting how we do our work, how you do your presentation, and how - of course - relationships and families.

I want to echo that sentiment, and remind us that back in 1980, if you look in 'Urology' - this was 'Urology' 1980 - the most common cause for erectile dysfunction was thought to be 85% psychogenic. Here's a quote from 'Urology' where urologists were encouraged to become counselors, because most of erectile dysfunction was thought to be psychogenic. Of course, I'm echoing the penis stuff because if you take a penis and shrink it and unzip it, that becomes a clitoris. I'm thinking most of the research will eventually apply to that. Certainly, our attitude is applying because we're back in the ... We're not, I'm preaching to the choir, but many of our colleagues are back in the 1980's and saying the main thing we have for sexuality for women is counseling.

My thinking that perhaps, as you guys do, some of the pathology that applies to the penis may apply to the clitoris, and maybe some of these women are suffering from actual genital histopathology, not just psychogenic problems. We have this one FDA approved drug now for female sexual dysfunction that's a psych drug, flibanserin. It's a useful drug, but obviously, we need much more and maybe we should think in terms of systems, like we do for the rest of the body.

Platelet Rich Plasma.

Obviously, this is not a new idea. This is from, this month, over 9,000 papers indexed in PubMed about platelet rich plasma. Our orthopedic colleagues, our dentist, our facial plastic surgeons have worked with this, and all we have to do is take their ideas and then hopefully people in this room will extend what I'm about to show you and just take those ideas and adapt them to the genital space. Here's some of the growth factors we know about. There are many more. They have these effects. These are good things for the genitalia. Down-regulating autoimmune response, proliferation of fibroblasts, new angiogenesis, the adipocytes enlarge and multiply - think labia majora, collagen production, neurogenesis and maybe some glandular function.

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There's never, in all those 9,000 papers, I still cannot find one serious side effect. No granulomas, no serious infection. PRP is what your body makes to heal when you do your surgeries and help prevent infection. Obviously, there are always certain things that can happen, bruising and such, but if you have a serious life-threatening complication from PRP, you will have the first recorded in all of that 9,000 plus papers. That's a nice thing.

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We have commercially available methods for preparing it, within 5 or 10 minutes of the bedside, and the devices are FDA approved. So you guys don't get confused, obviously the FDA does not approve your procedures. That's a doctor business. They don't approve blood that belongs to you, just like your spit and your saliva and your skin. They tried, at one time, to control eggs and the gynecologists said, "Hell no." So they don't control eggs and they don't control blood, but you should use an FDA approved device if you do this [approved for preparation of PRP to go back into the body].

Autoimmune Disease

Here's some of the ideas about down-regulating autoimmune response. We have split-scalp studies showing that PRP helps alopecia areata better than triamcinolone. More hair growth that comes in thicker. Here's rat studies looking at rheumatoid arthritis. What do we have in the genital space? We have lichens sclerosus. We did some before and after pictures where you use stem cells mixed with PRP, and before and after pictures show improvement. Of course, that's two variables because you have stem cells and you have the PRP.

We took the same idea and just used PRP. Andrew Goldstein worked with me on this, and we had two blinded dermatopathologists. The protocol was biopsy, PRP, wait six weeks later, another PRP injection, and then six weeks after that, another biopsy. Two blinded dermatopathologists out of George Washington University did not know the before or the after. We showed statistical improvement in both the histology and symptomatology. Here's our histology. You can see obviously, that's the same magnification and we're showing decreased hyperkeratosis. That's obviously healthier tissue. A layperson could tell that's better. Of course if you look at the gross pictures, lady on the left as you guys know, she has pain wearing her blue jeans. The lady on the right is back to making love to her husband. They've invited me into their close Facebook groups and I saw a post a few months ago. Quote says, "I was sitting next to my husband, whom I love, last night. I was afraid to hold his hand because I was afraid he would become aroused and I'm bleeding and hurting today." That's what you guys are helping.

We published that in 'Lower Genital Tract Disease'. We extended it because it worked. We published this past January in the journal of the American Academy of Dermatology. You have some science to go do this now.

One of our providers, Kathleen Posey, who's a gynecologist out of New Orleans, took this idea and then she said, "Let's do some dissection in the office", and she presented this in Argentina, published it in the same journal 'Lower Genital Tract Disease'. Here's one of her patients, where you can introduce [inaudible 00:06:44]. It had been 12 years since she had had sexual intercourse, penis and vagina intercourse, with her loving husband ... 12 years. She was being followed by a dermatologist on high dose clobetasol. Kathleen dissected it out in the office and then injected PRP ... 8 weeks later, she's having comfortable sex with her husband. She's now 3 years out. She's had to be treated with PRP, not repeat surgery ... PRP now, 2 other times a year apart to maintain that result. She now has a series of 60 or so patients that she's now going to publish with similar results, where she's dissecting out - as you guys know how to do - treating the [inaudible 00:07:27], but then following that with PRP injections to help the healing and decease the autoimmune response.

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That same doctor, Casabona, repeated his study with lichen sclerosus in men [BXO], and showed with just PRP alone ... This study of 45 men with repeat treatments ... It is cumulative, 2 to 10 treatments, the same thing. All of them stopped their steroids. None of them started back. Only one went on to have circumcision.

Peyronie's

Peyronie's disease, another autoimmune disease ... This came out this month out of Wake Forest, where they took men and they followed their results with Peyronie's disease. Not only did their Peyronie's improve statistically, but they also improved their erectile dysfunction by 5 on that scale of 5 to 25 that the urologists use. For some reason, thankfully, they threw in one woman just for good measure, and showed that it helped her incontinence. They just tucked that in as an aftermath.

Ronald Virag, as you guys know as the legendary vascular surgeon who was first to present the idea of intracavernosal injections for erectile dysfunction, out of Paris. His big thing now is PRP for Peyronie's. He just published a study where he showed that this is comparing PRP with Xiapex, which is a $50,000 series of injections, FDA approved version of collagenase. He showed that PRP works better with few side effects. There's a risk of about 1 in 30, that actually go from a bent pencil to a fractured pencil and a limp noodle. You don't see that with PRP. You see the side effect is the erectile function improves. He showed the same thing, actually, in his studies that erectile dysfunction improves by an average of about 7 on that 5 to 25 point scale.

Wound Healing/Scar Resolution

Let's think about the [inaudible 00:09:29] literature. Look at this, there's so much of this out there. This is looking at post-operative adhesions, lots of studies looking at scarring with microneedling and PRP. This is a split-face study comparing PRP with microneedling verus PRP ... Excuse me, microneedling with saline or Vitamin C serum and split-faced studies in PRP wins. Dr. Sclafani did some studies in the cosmetic space looking at increased collagen production and fibroblast activity, and never a neoplasia documented. People worry about that. This is not indiscriminate blindness blind growth. You don't worry about carcinogenesis when you do surgery and it's the same PRP that's causing healing. There's actually some helpful immune processes that go on, that you could argue actually might help prevent cancer. I'm not going to make that argument but it might need to be made one day.

If you look further, here's a wound healing study looking at reepithelialized exposed bone and tendon of the foot and ankle. When I took that and applied, this is a hypertrophic scar that was a year old from cortisone, and then using PRP and Juvederm or HA filler, this is a few days later, a month later, and that's a year later. Now, take that and think, "How could I use that in the genitourinary space?" Doing that anecdotally, we have many of the members of our group are seeing help with episiotomy scars or dyspareunia, pelvic foreplay instead of injecting that pelvic floor tenderness with triamcinolone. Physiatrist for the past ten years has been using PRP, your sports medicine doctors. Now, when you palpate it, consider injecting with PRP instead. Dyspareunia from mesh and that unknown dyspareunia, we're seeing this is where we need you guys to help extend the research. The science is there that it should help and it seems to be helping. Not 100%, but about 80% in people with dyspareunia.

Mesh Pain

Here is a look at a gentleman who did ... He took the mesh out and then he patched the hole with a gel form of PRP and showed benefit. We're finding anecdotally - no one's done this study yet, here's another one for you to pick up ... I'm giving you low hanging fruit. We're seeing anecdotally that if you inject in the distribution of the pudendal nerve, which seems to be inflamed in some women with mesh pain, that their pain will frequently go from 9 out of 10 down to 1 or 2 out of 10, without even taking the mesh out. Just another place where we need some research done.

Interstitial Cystitis

Here, we have rat studies looking at inflammation. Let's think about this one. Here's a rat study where they modeled cystitis and we are seeing in chronic interstitial cystitis without even infiltrating the bladder, just infiltrating in the periurethral space, some of our women are getting better. I've had two separate urologists call me and say, "Charles, I can't believe it. I was doing this and expecting not this to happen. I have these patients now who have had chronic interstitial cystitis pain for years, and it's gone." Not 1005 but finding out who's going to respond and who's not and why, there's a lot of variables that need to be thought about that you guys will hopefully do the research.

Penis Growth

Here's a study that came out in the 'Journal of Sexual Medicine', where a guy took ... the [inaudible 00:12:51] men who have an erection of 3 inches or less and then he treated them with PRP, combined with a pump, and showed that if you repeated it every time you did it, it grew by about 7 millimeters. I've always thought if I could give you a guarantee half an inch to an inch with anything, I'd get my picture on a postage stamp. I don't have that yet, but I can tell you that we're seeing about 60% of the time we do this procedure, men will see some sort of growth.

If you look at the neovascular space, there was a study out of Southern California that was published in the 'Journal of Sexual Medicine' where they transferred adipocyte stem cells to the penis of diabetic rats. They showed new endothelial cell growth and increased nitric oxide activity in the dorsal nerve. Would that be helpful in the clitoris? Probably, but the interesting thing is the adipocyte-derived stem cells were attacked and they died. The postulate was the improvement was from the growth factors.

Penile Rehabilitation and Erectile Dysfunction

I have seen what [inaudible 00:13:52] have seen in that when you inject this in the penis, erectile function goes up on the average of about 5 to 7 per injection. Think about nerve repair. We have rat studies modeling prostrate surgery, showing that the nerves improved with PRP and so we have, again, another clear place where we need studies if you add this now to the usual protocol for rehabilitating the penis post-prostate surgery ... would you see benefit? We have seen that in some of our patients who are a year or two out who failed the rehabilitation part of that. Would that help your patients who have, say, numbness and decreased function from riding their bikes too much, or trauma? I don't know, but it's worth thinking about and publishing research about.

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In thinking about where to put this, where we do our O-Shot, when we do PRP to the anterior vaginal wall, we're putting it as distal from the bladder as possible. We found that it works better. We're essentially making a liquid sling. Think infiltrating and getting ready to put in the mesh. That's what we're doing. Very simple, only we're using a material that has never caused a granuloma ever. Doing that, frequently our patients will have their incontinence go away that day from the actual liquid and as it's replaced with new tissue, it never recurs. Usually, you'll have to repeat the procedure at a year or two out depending on the etiology. Sometimes it lasts longer.

The interesting idea is what might be happening with those [inaudible 00:15:21]. They become more active, and does that help with sexual function? The other place we put it is in the actual corpus cavernosum of the clitoris. We use [inaudible 00:15:29] ultrasound visualization and see it flow down into the body of the clitoris by the pubic ramus and the wave form goes to what you see in a flaccid penis to what you see in an erect penis.

Improved Orgasm & Libido in Women

That's my time, almost done. Just 30 more seconds. Here's a pilot study we did where we showed that in women with female sexual distress, that it dropped by an average of 10 and female sexual function went up by 5 when you do what I just showed you. Here's a study that Dr. Neto, who may be here, published where he looked at incontinence and sexual function down in Brazil and showed that 94% of the people loved it. The question here is how would you combine it with your energy source? It works great in the face if you do laser and follow it with PRP ... better results, faster healing. Is it going to ... We need people to help us work out the algorithms. Not everybody has laxity, but when you have something, when do you use which treatment and when do you combine it with PRP? We need those answers, because I don't have them yet. This is possible helps.

I am done. Thank you very much for having me. I put all these references at that website, if you want to go download them. Thank you. You guys have a wonderful conference.

Dr. Marco Pelosi III: Thank you Charles. Beautiful

More about the Cellular Medicine Association

O-Shot® Research<--
P-Shot® Research<--

Upcoming Workshops With Live Models<--

Drs. Andrew Goldstein & Charles Runels Discuss O-Shot® Research

Discussed in the Video...

New Research. Double Blind Placebo Controlled Study

Not all women will qualify for this research project. Please consider helping if you do qualify.

Filling out the following form applies you for the option to participate in a double blind placebo controlled study of the use of the O-Shot® for the treatment of female sexual dysfunction. Your treatment, should you be accepted, will be free. Your information will never be shared. If you qualify, you may be contacted by text message or by phone.

This previous pilot study showed benefit (click to see) but we need more detailed data with a placebo-controlled study (which is the purpose of the present study).

Other related research (click)<--

We need more research to help women cure sexual dysfunction. There will be other projects; filling out this form tells us that you may be interested in participating (not all will qualify for this study but we will notify you of future studies). Become a hero to your daughters and nieces and to all women of future generations by helping us with this research.

If you are on a cell phone,
then click here to see the survey (click)<--
If you are on a desk top, then you can fill out the questionnaire here...

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Lichen Sclerosus. New Research

The following video explains the history and some of the logic of this research...now open for the enrollment of 30 women suffering with lichen sclerosus (free treatment for those who qualify)....

Here's the official details of the study as approved by the Institutional Review Board....


You are being contacted because have expressed interest in participating in a research trial using Platelet-rich plasma (PRP) for the skin disease lichen sclerosus. PRP is a platelet concentrate that helps to speed up tissue healing, without serious side effects, in a very wide range of medical conditions such as diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP works because of its high level of proteins that help with wound healing. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects. As the PRP is prepared from your own blood, there are no risks of allergic reactions, transfusion reactions, or infections (HIV, Hepatitis, etc).
We will be enrolling 30 women with active, biopsy proven, lichen sclerosus. This is a placebo-controlled study so you will have a 66.6% chance of getting the PRP and 33.3% chance to get the placebo. Neither you, nor the study doctor, will know if you will get the PRP or placebo. The study is only being conducted at the Center for Vulvovaginal Disorders in Washington, DC. There will be 4 study visits in a 14 weeks period. Small biopsies will be performed at the beginning and end of the study. PRP will be injected in areas of active lichen sclerosus two times during the study. No additional treatments will be allowed for 12 weeks prior to enrolling in the study and during the 14 weeks of the study. No compensation will be provided for participation in the trial.
Please read the informed consent at www.CVVD.org/research_studies very carefully before contacting Leia Mitchell at DRG.CVVD@gmail.com. Please be aware that the Center for Vulvovaginal Disorders is the only center conducting this study and its only being conducted in our Washington DC office. If you cannot travel to Washington DC for the 4 visits, you will not be able participate in this study. It is also possible that you may have to come in prior to the study for one visit to confirm that you have active lichen sclerosus. Lastly, we cannot give you referrals for treatment by other physicians.

Sincerely,

Ms. Leia Mitchell
The Center for Vulvovaginal Disorders


If interested in participating in this current project (only 30 will be accepted) then do 3 things...

1. If you have lichen sclerosus and can travel to this address 4 times (click to see where you'll be going), then fill out the following form (this is password protected in a HIPPA compliant encrypted server. Only Dr. Runels, Dr. Goldstein, and his staff have access to the data)...

2. Click to read the consent form <--

3. Send an email to the following address...
drg.cvvd@gmail.com

If interested in participating in future research with lichen sclerosus or other female sexual dysfunctions, or in being kept up to date about result, then fill out the following form....

Thank you very much for your trust,

Charles Runels, MD
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Clitoral Size related to a woman’s ability to have an orgasm?

New research shows that clitoral size correlates strongly with a woman's ability to have an orgasm.

=== >>  Here's where to read the research.

This helps explain why the O-Shot (R) procedure works.

You can learn more about the procedure here (click here).

Charles Runels, MD
Inventor of the O-Shot (R) procedure