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

Full Transcript of Video & Link to Published Research Follows...

Charles Runels: Let's talk about something that I hate, I really hate, it's dyspareunia or pain with sexual intercourse in women who are already suffered from 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 dysfunction 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 help maybe.

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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.

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 can 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.

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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 at 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 used it quite a bit. Orthopedic surgeons are 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 after that.

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 are 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 posterior 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 these 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 researching 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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Charles Runels, MD