Here is the Medscape article to which I refer in the video<–
Here’s a transcript of this video<–
Research about Testosterone in Women
Here is the Medscape article to which I refer in the video<–
Here’s a transcript of this video<–
The PowerPoint Slides for this presentation<–
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Introduction
I wrote this report for one reason: to help you, a physician, take better care of women suffering from difficult-to-treat gynecological problems.
This report does not describe how to cure every woman of every disease. On the contrary, women are suffering from problems for which I have not one new suggestion. For example, there is nothing new here about how to treat ovarian cancer; but you will find a section about how to treat women who suffer from vaginal dryness and the secondary dyspareunia that often plagues women after treatment for breast cancer.
Also, some women who suffer from problems for which I offer solutions will not respond at all to the therapies I suggest; you may implement all of the suggested strategies for a particular problem and still see no improvement in your patient. I know of no therapies in medicine that work perfectly and offer no risk of negative sequelae; the strategies offered in this report are no exception and do not “work” every time.
We never say that antibiotics “don’t work,” even though some people will die from sepsis even when treated with antibiotics; antibiotics do work, but they do not work every time. With a new idea, however, this same standard does not apply. Often both patients and physicians will say, after only one person does not see the benefit, “See, it doesn’t work.”
As with every other therapy in medicine, part of the art of using the therapies described in this report is knowing who may benefit and who may not and using this knowledge to carefully choose who to treat.
On the other hand, most women who are helped by you when you offer the strategies described in this report will consider you to be nothing short of a miracle worker. Let me explain why they will think so.
Thirty years ago, in 1986, while sitting in class at the University of Alabama School of Medicine—that was the moment that I truly comprehended the word “chronic.”
I knew that physicians could not cure all diseases, but when I learned the word chronic and contemplated the gravity of its meaning, I felt deflated. When we label a disease as chronic, we acknowledge that this problem that plagues my patient will never go away—never. The patient and I will cease seriously looking for a cure. Instead, we will agree that since this disease will never go away, our goal will only be to minimize progression and suffering.
So, after labeling a disease as chronic, we quit trying to cure.
I hate the word “chronic.”
People who suffer from chronic conditions often sacrifice hope to the god of despair and start bowing to the god of anger and learned helplessness.
So, if I show you how to actually cure even a small fraction of the disease that you and your patients now consider chronic, then those women will recover the same awe for medicine, yes, even the idea of the miracle of medicine, that people held in the days of the discovery of penicillin and rabies vaccination.
It may help if you consciously acknowledge something right now: you went into medicine because you want to do miracles.
It’s OK.
You and I can talk about it. You don’t have to be embarrassed. Leonardo da Vinci once said, “I want to do miracles.”
If you only wanted to make money, you could have put one-half the effort into real estate, and you would already have over three times the money that you have now. You went into medicine, not for money, but because you want to do miracles—that’s a good thing. And, compared to what the physicians of two hundred years ago could do, you already do miracles.
But, you still have this nagging word, “chronic,” which describes the conditions for which you still are left frustrated, the conditions that remind you that sometimes you cannot do miracles. Chronic conditions sometimes make you feel helpless—your patient still suffers even after you do your best using all that you know.
In this report, I will show you a few places where you can make a woman’s chronic problem go away. Then, you will be rewarded with the prize that enticed you to medicine: the heartfelt “thank you” from someone whom you prompted a miracle.
So, how is this possible?
So, why am I so sure of this promise that you will do miracles that you cannot now do?
Imagine that you are a physician in the days before antibiotics, then after this whole new concept, “antibiotics,” is introduced to you, now you can do things that before you did not think possible. Or imagine that you are a physician in the days before Louis Pasteur and his rabies vaccine. The whole idea of vaccines was new. But, after the idea is introduced, suddenly, you can do things that neither you nor your patients thought possible. Then, after the new idea becomes part of your practice, your job is not done; the job then becomes to take this new idea (“antibiotics” or “vaccines”) and develop it in an infinite number of ways: Where else can it be used. What dosages and routes of delivery work best? For whom does it work, and where does it do more harm than good?
First, there is a new idea. Then, there become lifetimes of investigation about the infinite variety of applications of the idea. First, there comes the idea of vaccines; then, for over a century, physicians have studied new ways to use and make vaccines. First comes the idea of antibiotics; then, we have spent over a century so far discovering and investigating the uses of antibiotics. First, there comes the idea of beta-blockers; then, so far, physicians have published over fifty thousand papers (listed on PubMed) about how to use beta-blockers for congestive heart failure.
Now, most physicians are just now learning the new idea of using regenerative therapies to improve tissue health and thereby cure disease—specifically using platelet-rich plasma (PRP) for this purpose. Over the past two decades (a relatively short time), there has been a mostly quiet revolution in medicine as physicians and patients have discovered that by using cellular therapies, some problems can be treated in ways that until now we considered impossible. Now comes the exploration of the infinite number of ways this new idea, regenerative therapy, can be used.
Until 2010, PRP was mostly talked about in the arena of wound care or post-op recovery of the avascular, hard-to-heal tissues of orthopedics and dentistry.
Now, those ideas about wound healing are being applied to tissue that has not been wounded; and the results have sometimes been amazing. More specifically, by using the same ideas used to heal wounds where there is no wound but where there is unhealthy tissue, there can be remodeling of the unhealthy tissue with new collagen and neovascularization and neurogenesis and a resultant healthier tissue and healing of disease—some of which was thought to be chronically diseased.
Only a decade ago, in the year 2010, I was the first to use these ideas and inject the penis and the clitoral-urethral complex with PRP. Since 2010, largely because of our group, the Cellular Medicine Association, the idea of using PRP for urological and gynecological diseases has developed and become more widely used. Over the past decade, I personally trained over 5,000 doctors in over 50 countries regarding the use of PRP for gynecology and urology. Hundreds of the physicians (and physician extenders) have taught other physicians and have come back to teach me what they have observed.
Also, though I have published studies, hundreds of papers have now been published regarding the use of PRP for urological and gynecological problems.
Do we need more studies?
Of course, we do!
If you search the terms “beta-blocker” and “congestive heart failure” on PubMed, you will find over 50,000 results. But, we were using beta-blockers for congestive heart failure long before we reached the 50,000 mark. Now, we have this new idea of using PRP to restore tissue to health—yes, to cure some urological and gynecological diseases.
I not only acknowledge that we need more research, I implore you to help us do that research. But, at what point do you decide that you will make this idea available as a help to the next woman who visits you in your office?
As with every new idea, the point at which you pick it up as a tool and start using it will depend upon all of the following: (1) How much of what’s known about the basic science have you read? (2) Have you learned the physical skills needed to use the material (PRP cannot be injected haphazardly and work optimally). (3) Have you learned of the technology approved by the FDA for the preparation of PRP for injection back into the body and made this technology easy accessible in your office? (4) Are you keeping up with ongoing research and the changes in FDA policies and implementing such knowledge in your practice?
In short, are you learning about and keeping up in the area of the regenerative possibilities of PRP, or is your brain attacking the new idea the way an antibody attacks a foreign protein?
When the idea of antibiotics for peptic ulcers was introduced, physicians were slow to accept the idea because they already had a way to treat ulcers—surgery and Tagamet. The hindrance to knowledge is not ignorance; it’s the illusion of already knowing.
I hope, for the benefit of your patients and for your own soul satisfaction, you will use this report as a way to jump into this new arena of medicine.
What I offer you in this report is a summary of areas where I think we are at least near the place, if not at the place, where the benefit to risk ratio of using PRP for some conditions warrants that the strategy is used.
You may disagree. That’s OK. But, if I can give you the logic and the science behind the strategy of PRP done in a specific way for certain chronic or hard-to-treat conditions, if I can tell you why after looking at the research, doing some the research, if after treating thousands of patients and talking to physicians who have collectively treated hundreds of thousands of patients, if I can tell you why after all of this I think that PRP, now, should be used for several conditions in carefully selected patients, then I have done my job. Then, I hope that even if you do not agree with me about everything (smart people never agree about everything), I hope you will at least consider helping us move the science forward for the benefit of the women who now live with the word “chronic” and the resultant suffering both physically and psychologically.
To meet the definition of “sexual dysfunction,” a woman must be suffering from both a physical problem and secondary psychological distress.
If a man has erectile dysfunction, he has erectile dysfunction whether or not it bothers him psychologically. But, if a woman has dyspareunia or anorgasmia, she is not considered to suffer with sexual dysfunction unless she is psychologically bothered by the condition. Even with this stricter definition for women compared with men, around 30-40% of women suffer from sexual dysfunction CHRONICALLY!
What you’re doing doesn’t work all the time. So, you tell women to use a vibrator or KY jelly or go see a sex therapist to learn how to have good sex even though it hurts or even though she seldom, if ever, has an orgasm. Or, you tell her to use her steroid cream every day of the rest of her life or take her psychotropic drug for the rest of her life because her lichen sclerosis or interstitial cystitis will never go away.
But, after you read this report, I hope that BECAUSE YOU ARE NOW EXPLORING A WHOLE NEW CLASS OF TREATMENTS, you will realize that SOME (not all) of the women who suffer chronically may be able to know complete relief.
Again, cellular therapies are NOT magic and do not cure everyone of everything. Einstein said, “Either everything is a miracle, or nothing is a miracle.” I’m not sure if your patients will call the results they see when you use the ideas in this report a “miracle,” but they will definitely tell you “thank you.”
And you will drive home from work to your family that you see less than you would like, and will be glad that you studied medicine instead of becoming a stockbroker.
One wonderful thing about PRP is that it has proven to be very safe. Millions of PRP procedures are done every year. Regen alone sells more than a million kits per year, and there are a dozen other manufacturers of PRP kits. And, yet the number of serious sequelae reported in the literature is less than a dozen, and even these are reported in cases where unknown hyaluronic acid fillers were also used.
So, though PRP used for the indications I will show you in this report does not work one hundred percent of the time, you won’t lose sleep worrying about serious sequelae after doing these procedures.
There has been some confusion about the FDA’s stance regarding PRP, but the FDA has been very clear about its policy. The FDA regulates drugs and devices. They do not regulate urine, skin, hair, or blood products, and they do not regulate PRP. When you transfer hair from one part of the scalp to another, the hair belongs to the patient and is not regulated by the FDA. When you draw a patient’s blood, even if you fractionate it with a centrifuge and then give it back to the patient, the blood or the fraction (PRP) belongs to the patient and is not regulated by the FDA
The concepts that make PRP acceptable to use without FDA oversight include the following:
Moreover, the FDA confirmed the above reasoning by specifically stating that they do not regulate PRP.
In this report, you will find specific ideas about how to treat all of the following:
Stress urinary incontinence in women who do not want surgery and not respond to Kegels.
Post-mid-urethral sling sexual dysfunction
Post mesh pain
Interstitial cystitis
Post-episiotomy pain or bleeding
Vaginismus
Pelvic floor tenderness
Anorgasmia
Decreased libido
Of course, you have treatments for all of these conditions already; none of those current treatments in your toolbox go away. But, by adding PRP to your toolbox, as you are about to learn, you may see some very troubling conditions simply go away or greatly improve after years of chronic suffering.
This report does not replace proper training. Those physicians (and physician extenders) who already offer the O-Shot® procedures will find this report to be a helpful review and adjunct to their training.
Those physicians who are considering beginning training with PRP will find this review to be a helpful introduction to the ideas and the techniques and a way to decide to pursue further exploration of the ideas both in training and in well-designed studies.
Only those who have been trained and tested by the Cellular Medicine Association are licensed to use the word “O-Shot®” for advertising the procedures. This is our attempt to require an agreement regarding standards of care where a procedure is done with a blood product that is. not regulated by the FDA.
In comparison with PRP, no board regulates the injection of Botox and hyaluronic acid fillers. The FDA does regulate these products because they are drugs, but there is huge variability in the way they are injected, and there is no medical board that regulates these variations. Worrying that the same variability that is seen with the injection of fillers in the face, if applied to the injection of the genitalia, would result in unacceptable results, the licensees of the Cellular Medicine Association agree to follow guidelines regarding the procedure of PRP preparation and injection. These methods have evolved over the past decade as more research and experience and the number of members has grown.
I hope you will use this experience to the benefit of your patients.
There were at least 3 things that led to the perfect storm that led to the initial design of the O-Shot® procedure:
I.
In January 2000, I started doing clinical trials and offering micromanagement of hormone replacement for women as part of my internal medicine practice. Over the following years, after doing hormone replacement for over three thousand women, I developed a sense of the problems and the usual solutions for women’s sexual dysfunction.
II.
While doing hormone replacement to help the symptoms of menopause, including weight gain, I noticed that some women would want to gain their weight back (even to become overweight again) because when they lost weight in the face, their face looked older. Before JUVEDERM® was approved in the US, I started offering Restylane as a way to restore the youthful shape (that collapsed with weight loss) as part of the way I would encourage women who lost weight to continue their weight loss and to maintain their healthier weight.
III.
I also ran a hospital-based wound care center and developed some expertise in the area of wound healing and tissue growth.
So, with these three interests (women’s hormones and sexual health, cosmetic medicine, and wound healing) when PRP became a part of the conversation for facial cosmetics in the year 2009, I became aware of the technology and immediately wondered if the idea might apply to male and female sexual dysfunction.
So, I started by developing the Vampire Facelift® and the Vampire Breast Lift® as a way to improve facial cosmetics and to study the effects of PRP on tissue; then, I took what I learned there and applied it to the genitalia to design the O-shot® (Orchid Shot™) and the P-Shot® (Priapus Shot®).
Soon after developing the above-mentioned procedures, I teamed up with the members of the Cellular Medicine Association (CMA). We then spent the past decade publishing and teaching ideas regarding using cellular therapies to improve tissue and therefore attenuate or cure disease. Without the brilliance and the bravery of the members of the CMA, the development of the use of PRP for urology and gynecology would be nowhere near what it is now.
Much of what I describe in this report was taught to me by the members of the CMA. Our members publish research, and we meet weekly to share our observations and the research of others, and many of our members offer hands-on training. Here’s where you can learn more about how our organization so that we can support you in your efforts to help your patients to better health using cellular therapies: CellularMedicineAssociation.org
Here are other places where you can find help:
If you are already trained to offer the O-Shot® procedure, you have available to you hundreds of videos and much written (that can be translated into any language with a click of a button) within our members-only website. Here’s where to change your password (if needed):
CellularMedicineAssociation.org/password
Here’s where to log in to the members-only area (use the search box on the side to find videos and written descriptions that expand what is introduced in this report):
OShot.info/members/wp-login.php
Where you can learn more about training to become licensed to offer the O-Shot® procedure (with all its variations) to your patients
Oshot.com/members
Where you can learn more about training to offer the Vampire Facelift® procedure.
VampireFacelift.com/physicians
Where you can learn more about training to offer the Priapus Shot® procedure to help your men patients with erectile dysfunction, Peyronie’s disease, BXO, and recovery from prostate surgery (penile rehabilitation).
PriapusShot.com/physicians
Where you can find our teachers of multiple specialties in countries scattered around the globe.
CellularMedicineAssocation.org/teachers/directory
My goal is to be a perfectly clean pipe that brings to you the best of the ideas that are being developed and researched in the arena of cellular therapies for the purpose of healing women and men. I respect you for making it thus far in this report and hope that (when I deliver in this report the help that I promised) this will be the beginning of our friendship and collaboration. I hope that after you study this report and think about the ideas therein, you will reach out to me and let me know how they helped you and your patients. I hate to see women struggle with gynecological problems, and I love hearing good reports after someone studies our methods and helps a woman to better health and deeper relations. Consider me on call to help clarify or collaborate.
You can email me at DrRunels@Runels.com.
Or, you can text my personal cell phone at 251-648-7704
Hopefully, you will consider it fair that if you have a question that is answered by one of the books I have written, research we have published, or by one of my websites with instructional videos, I refer you to the appropriate material. But, there’s so much still to be learned, and our ideas need more thought and development I’d love to discuss whatever seems helpful to you, even sponsoring research that you may wish to do.
Very best wishes as you work to help your patients find their best health.
Sincerely yours,
Charles
Charles Runels, MD
1-888-920-5311
DrRunels@Runels.com
CellularMedicineAssociation.org
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As a reminder, the horrors of severe lichen sclerosus can include all of the following and more:
In other words, imagine trying to enjoy just about anything while your genitalia is hurting, cracking, itching, and bleeding.
Here’s a photo of what many women who suffer from LS wake to find between their legs in the morning (often) without hope of relief after years of the usual daily clobetasol.
They also can look forward to a ten percent chance of squamous cell carcinoma with the resultant needed vulvectomy.
Lichen sclerosus is thought to be caused by the autoimmune process, hence the usual treatment—a strong topical steroid cream, clobetasol.
Unfortunately, even with clobetasol, many women continue to suffer both the tormenting symptoms and the 10% risk of squamous cell carcinoma. We need a better way.
Since the O-Shot® procedure utilizes PRP, to understand how the procedure may help those suffering from lichen sclerosus, consider all of the following:
In thinking about the use of PRP for use in lichen sclerosus, consider other autoimmune conditions in which PRP has been shown to down-regulate the disease process.
Vitiligo treatment usually involves steroids or melanocyte transplantation, both of which can lead to unsatisfactory results. But, studies showed a dramatic improvement with PRP.
Also, alopecia areata (usually treated with steroids) responded better to PRP than to steroids in more than one study, with more and darker hair follicles when using PRP compared with steroids.
For rheumatoid arthritis (also an autoimmune process), studies demonstrated that PRP did all the following:
alleviated arthritis, and reduced humoral and cellular immune responses, leading to beneficial effects on histological parameters as observed using joint tissue histological staining. CIA mice treated with PRP exhibited downregulated expression of IL-6, IL-8, IL-17A, IL-1β, TNF-α, receptor activator for nuclear factor-κB and IFN-γ in inflammatory tissue. In addition, VEGF, PDGF, IGF‑1 and TGF-β expression in peripheral whole blood was increased following treatment with PRP. The serum concentration of anti-collagen antibody was decreased in PRP-treated CIA mice. In conclusion, CIA mice treated with PRP exhibited beneficial effects, including decreased joint inflammation, cartilage destruction and bone damage, and increased repair (Tong2017).
Even experimental autoimmune encephalitis and Bell’s Palsy (both autoimmune in etiology) have shown benefit from PRP.
With benefit shown in these and other autoimmune conditions, it is within reason that PRP may be of help in attenuating or arresting the autoimmune activity and the resultant progression of signs and symptoms of lichen sclerosus.
With the recurrent cracking, bleeding, and sclerotic changes that plague women with lichen sclerosus (LS), even if the LS is magically turned off, there is still a need to remodel the scarring from the previous activity of the disease.
PRP has been used to treat acne scars, postpartum striae, cleft-palate-repair scars, and even the scars left from devices used to treat breast cancer patients.
With the breast cancer patients, there was even seen an increased survival rate in the women who received the PRP; the authors considered it coincidental even though the benefit was statistical (Eichler2022). It’s too early to claim from this one study that PRP can protect against recurrence of breast cancer; but, similar data was seen with fat transfer for reconstruction after breast cancer. Two studies showed those who received fat (usually mixed with PRP to improve survival of the fat) showed a trend toward prolonged survival; in these two studies, the increased survival was measured but not statistically relevant. Still, these and other studies indicate that PRP is, at worst, safe in the face of women at high risk for recurrence of their breast cancer.
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This discussion regarding the lack of increased risk of neoplasia when using PRP is significant considering that ten percent of women with lichen sclerosus will develop squamous cell carcinoma as part of the progression and ongoing disease activity of the lichen sclerosus. One might postulate that with decreased disease activity that results from the use of PRP in some women, the risk of squamous cell carcinoma might also be decreased.
Even in women who use clobetasol like a religion, women still face a 10% risk of squamous cell carcinoma, and little is known about the effects of chronic use of clobetasol on the recurrence or occurrence of other problems like HPV (since chronic steroids could affect the local immune system). But, the fear that PRP its self may propagate neoplasia should be addressed and has been; as of yet, thousands of studies have indicated that neoplasia is not a risk when PRP is used. A growing number of studies indicate (but do not conclusively prove) that PRP may decrease the risk of neoplasia; long-term follow-up in those with lichen sclerosus needs to be done before we can claim a decreased rate of progression to squamous cell carcinoma in women who use PRP for treatment.
Just pretend for a moment that you have a magic wand and that if you wave that wand over the diseased tissue of a woman suffering from lichen sclerosus, then her disease activity will immediately go quiescent. Now consider this: what if your needle becomes like a magic wand for many women when you fill it with PRP? Now, you wave your magic wand, and the autoimmune process of the lichen sclerosus shuts off.
Does the woman immediately feel immediately well if you instantly turn off the disease activity?
Not at all, because she would still be left with the ravages of the process; before feeling well, she would need to replace sclerotic tissue with healthy tissue, to heal fissures, and to regrow blood vessels into the damaged tissue.
So, in effect, she would need to heal the wounds of the lichen sclerosus before she would enjoy a healthy vulva, even if you magically and instantly shut off the lichen sclerosus. Unfortunately, cortisone (used by most women to treat lichen sclerosus) delays wound healing. In comparison, a material (PRP) that both shuts off the overactive autoimmune process (and therefore shuts off the lichen sclerosus) and also promotes (rather than delaying) the healing of the damaged tissue could provide a remarkable synergy of benefits.
As we have discussed in previous sections of this report, the primary work that led to the widespread use of PRP and to the development of the devices used for the preparation of PRP began in the effort to heal surgical wounds in avascular areas like the cartilage of the knee and the bone in oral surgery. This idea of healing avascular surgical wounds with PRP extended with the publishing of many papers regarding the use of PRP to promote the healing of hard-to-heal wounds in the distal extremities of those suffering from diabetes.
Before using PRP in the genitals, I developed a method of using PRP in the face, the Vampire Facelift® for cosmetic purposes and many papers were published regarding using PRP in the scalp for reviving hair follicles. With cosmetic procedures and with hair regrowth, we are not healing a wound; instead, we are starting the cascade with PRP that would occur if there were a wound, with the result that healthier and younger-appearing tissue develops.
With lichen sclerosus, we not only face an active autoimmune process that creates sclerosis and blood vessel destruction, we also face the secondary wounds of fissures and excoriations. So, using PRP to help heal these wounds could be of great benefit.
When I first met Dr. Andrew Goldstein, he was lecturing to the International Society for Women’s Sexual Health regarding a genetic marker that could predict which women might suffer dyspareunia as a complication of taking birth control pills (yes, this is a known complication). He also revealed to the audience that he was in the process of passing a kidney stone while he was giving the lecture! I found his lecture to be brilliant and his grit to be impressive.
So, after his talk, I approached him about the possibility of doing research together. Knowing of my work with the O-Shot® procedure, he suggested we do a study regarding the use of PRP for lichen sclerosus. At that time, Dr. Casabona had published an article demonstrating that stem cells would improve lichen sclerosus but no one had published anything regarding PRP for LS.
I agreed to sponsor the study on the spot, and we exchanged numbers.
Some months later, we published a study where women suffering from LS were biopsied, treated with PRP, and then surveyed for changes in symptoms and re-biopsied. Two dermatopathologists with much experience with LS were blinded to which was the before and which was the after biopsy. Both the surveys of the women and the biopsies demonstrated a statistical improvement in lichen sclerosus after treatment with PRP. We then extended the numbers of women in the study and published a second paper—also showing a statistical benefit to PRP for LS. These were the first two studies to show the benefit of LS after treatment with PRP using a variation of our O-Shot® procedure.
Then, after our second study, a woman who suffered with lichen sclerosus and who had been greatly helped by PRP, sponsored a third study. In this study (done without my participation), saline was used as a placebo. In other words , the women in one group were injected with PRP and the women in the second group were injected with saline.
Ironically, in this third study (sponsored by a woman who’s LS improved after treatment with PRP), where saline was used as a placebo, there was no statistical difference between the placebo group and the PRP group; but, 50% of the women in the placebo group improved!
In short, both groups got better, and the group that was injected with PRP did better than the saline group; but because there was such a strong response rate in the “placebo” group, there was not a statistical difference between the two and the authors concluded that PRP does not work.
Put another way: a generous woman suffering from LS who got better with PRP paid for a study of treating LS with PRP—and the authors she hired concluded that there was “no benefit” from PRP, the same treatment that got the woman financier well.
I think something more important was shown by the study than that PRP does not help LS: the research further demonstrates the idea shown by others that saline, when used for hydrodissection, is not a placebo. Saline can even be used to treat scars and even to decrease pain.
Especially when saline is injected in such a way that it causes hydrodissection, there can be measurable changes in the tissue resulting from the resultant micro-trauma followed by post-op healing.
So, in this third study, Dr. Goldstein and his collaborators concluded (in contradiction to our previous two studies) that PRP offers no benefit. But, this was a study with biopsies, not simply a survey; I cannot find another study of LS where 50% of the placebo group improved on biopsy. I think that Dr. Goldstein showed something more important than what he reported; I think his study showed that hydrodissection alone precipitates changes (as has been shown with other conditions) that improve LS and that PRP can be used for the hydrodissection for benefits measurably better than saline alone.
In other words, I think what Dr. Goldstein showed was that, with our O-Shot®, there is not simply a biological effect from the growth factors; there is also a mechanical effect—essentially a surgical effect—from the mechanical hydrodissection of injecting the PRP.
I have tremendous respect for Dr. Goldstein and his knowledge of lichen sclerosus, but I think my interpretation of his research can be different than his and still maintain great respect for his work.
Put simply; the O-Shot® is a mechanical procedure combined with a biochemical cascade.
Other studies have since been published showing that PRP can improve lichen sclerosus.
A woman of fifty-three years old came to my office because she had been unable to tolerate her husband’s penis for 7 years because of her lichen sclerosus. She was using daily clobetasol and being followed by her dermatologist with regular visits for the entire 7 years.
In addition to being unable to tolerate more than about two inches of one of my fingers inserted into her vagina because her clitoris was completely covered by her phimosed clitoral hood, she reported that she enjoyed very little pleasure from her attempts to masturbate.
Her husband, who came with her to my office, as is often the case, seemed loving and content but suffered empathetically for his wife because she enjoyed very little sexual pleasure of any kind. There is this idea in some circles that women only want to heal their vagina so they can please their husbands and that we should just leave such women alone, that if it were not for demanding men that they would be just fine; but, if you see only a few women with LS, you realize how very wrong is that idea; husband or no husband, women with LS can lose the ability to enjoy sexual pleasure and often feel broken and alone.
In the following photograph, the first image on the far left shows her vagina on the day she came to my office.
I injected her labia, clitoral hood, the clitoris (through the hood), the entire area, and the anterior vagina wall.
I am not a surgeon, so I sent her to an excellent board-certified gynecologist near my office, Dr. Kathleen Posey, who then dissected out the clitoris—freeing it from the scaring phimosis that had it trapped.
Research has shown that with LS even if the hood is completely phimosed such that the clitoris is unreachable, the clitoris is not directly affected by LS and, when freed, will function normally.
Dr. Posey took the second photo (the one in the middle) on the day she freed the clitoris.
Normally, with such a surgery in a woman suffering from LS, there would likely be a quick recurrence of sclerosis with re-entrapment of the clitoris beneath the LS-diseased clitoral hood.
Instead of the hood re-phimosing, six weeks later, Dr. Posey took the photograph on the far right demonstrating that the hood and labia had grown healthier in appearance, and the woman reported she was having comfortable sex with her husband for the first time in over seven years—off of her clobetasol!
She continues to get a modified O-Shot® from Dr. Posey every year or so and to enjoy comfortable sex.
Dr. Posey went on to treat other women in this way and published her findings (Posey2015).
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Alexandra Runnels, MD, sent photos of a patient who had ten years of Clobetasol and was working as a soldier—imagine marching, and that’s what you have to remind yourself with itching, burning, and bleeding—every time you take a step with your pack.
And then, after stopping the Clobetasol—she achieved the results on the right by using a combination of PRP with micro-needling to the more sclerotic areas and the usual 2-injection O-Shot®, combined with injecting PRP into the area and using daily UVB light, combined with Altar® cream to achieve the much healthier tissue (see below).
The phimosis surgery was done about 8 weeks after the first PRP treatment. Her marriage and her self-image and her life changed for the better.
This summary neither qualifies nor fully instructs in the O-Shot® procedure for lichen sclerosus. Application for training can be found here<-- or by callling the Cellular Medicine Association at 1-888-920-5311
Find the nearest provider of the O-Shot® procedure for licen sclerosus<--
von Krogh G, Dahlman-Ghozlan K, Syrjänen S. Potential human papillomavirus reactivation following topical corticosteroid therapy of genital lichen sclerosus and erosive lichen planus. Journal of the European Academy of Dermatology and Venereology : JEADV. 2002;16(2):130-133. Accessed August 24, 2015. http://www.ncbi.nlm.nih.gov/pubmed/12046814
Most women who undergo a mid-urethral sling (MUS) placement will see an improve sexual function, but 1 in 11 women will suffer a decrease in sexual pleasure after the procedure.
Midurethal sling: Better sex for most women; but 1 in 11 suffers more?
One in 11 suffers more.
So, to better understand the reason for this unwanted result (of decreased sexual pleasure in 1 in 11 women who undergo MUS), Guadet et al. performed mid-urethral slings on cadavers and then sectioned the area to visualize the affected tissue. They reported their results in the Journal of Sexual Medicine in 2018 as follows:
“MUS placement interrupts tissue with glandular, vascular, and neuronal structures within the periurethral space adjacent to the anterior vaginal wall. Disruption of the prostatic glandular tissue and neurovascular structures may be a root cause of orgasmic dysfunction and diminished sexual satisfaction evident in women following MUS implantation.”
Considering the previous description, to correct or prevent the problem, where would you inject a material which increases blood flow, grows nerves and collagen, improves the health of glandular tissue, and has never been reported to form a granuloma or neoplasia?
Also, consider that the material you will inject is aqueous, so it will hydrodissect along the tissue planes, taking the path of least resistance as if you were hydrodissecting with saline. This means you would not need multiple injections since you could use the pressure gradient generated by your syringe to spread the material.
Now, look at the following diagram, the same one we used to describe (in Section 1) what could be the best of the currently published options for the placement of the needle for the injection of PRP for the treatment of stress urinary incontinence (the O-Shot® procedure).
Then take another look at the photograph of the placement of the needle for the O-Shot® procedure:
Now you can see that our O-Shot® procedure is designed to repair exactly where these brilliant investigators documented that the neurovascular damage from a MUS occurs. (Application for further training in the O-Shot® procedure can be found at OShot.info/members (click), this description does not constitute training or license to use the name “O-Shot,” which is protected by the US Patent & Trademark office for license to only those approved by the Cellular Medicine Association.
In 1984, while in medical school, one of our professors said to the class, “I do not want anyone to finish at this medical school and still think that female ejaculation is not a real phenomenon.”
Then, he showed us a video of a woman masturbating until she ejaculated.
Watching the video, I thought, “Looks like an interesting party trick; but of what practical benefit does that serve except the knowledge that the female body can ejaculate.”
Years later, a lover demonstrated to me that she could bring herself to masturbation with ejaculation. I still found the phenomenon interesting but not warranting much attention.
Then, it happened.
While I was making love to a woman, she unexpectedly ejaculated for the first time; and, unlike what I had witnessed with the previous two demonstrations (ejaculation while masturbating) when she ejaculated during our lovemaking, not only could I almost feel the deep, soul-shattering depth of her orgasm, but also her demeanor afterward reflected that of a man after ejaculation with calmness, satisfied bliss, and a wanting to connect with me emotionally like I had never witnessed with this woman—perhaps with any woman.
Finally, I took notice.
Up until then, the female orgasms that I had witnessed were associated with women showing varying degrees of pleasure during the orgasm, followed by increased energy and increased hunger for more sex and more orgasms. But, observing my third female ejaculation, the woman afterward showed calmness and peace and greatly decreased energy and complete satisfaction; more importantly, she seemed to drop invisible walls and swing open a wide path from her soul to mine.
I concede that my description of female ejaculation does not provide a scientific-objective explanation of what happened; but hopefully, you will forgive the description when you consider that when I find world-renowned experts in female sexuality and ask them to describe it to me in scientific-objective words, what happens when a woman experiences an orgasm of any kind, I can see their frustration as they give what we both know to be a relatively superficial answer to a profoundly important phenomenon.
So, since there is no good scientific explanation of the frequent orgasms of usual lovemaking (in comparison with a soul-shaking orgasm where the woman sobs, ejaculates and melts her soul into yours), I hope that you will pardon my use of a subjective description where no objective measure exists. Something happens to more easily facilitate a soul connection between a woman and her lover (and maybe even her GOD) when she experiences an ejaculatory orgasm.
After experiencing for the first time this phenomenon of female ejaculatory orgasm during lovemaking, I decided to pay more attention; I began reading all the popular books, the textbooks, and the research that I could find regarding female ejaculation. And, I began learning more about my lover (and subsequent lovers) about how to reproduce and enhance the experience of the female ejaculatory orgasm.
William Osler once told his medical students that if he asked them how long it takes for the fingernail to grow one length, most of them would not give it a second thought; some of them would read about it; and a few of them would grab a silver nitrate stick, make a mark on their proximal thumbnail with the stick, and then measure how long it took for the mark to grow to the end of the finger.
It was in the spirit of the third medical student described by Dr. Olser that I read the books and the research for the next ten-plus years and then took that reading to the bedroom. Over more than a decade, I developed my own ideas about female ejaculation. I even published an online course for men about how to help their female lover to a complete and profound ejaculatory orgasm and have helped thousands of couples with that course.
I tell you about my interest in female ejaculation for only one purpose: to show you that the study of female ejaculation combined with my work providing hormone replacement and menopausal care for over 3,000 women is what set the stage for me to design the O-Shot® procedure.
Then, in early 2010, I was first introduced to the idea of PRP and its possibilities for cosmetic use in the face. Because the stage was set, one of the ideas that occurred to me regarding PRP was to inject it near the distal urethra in the area of the Skene’s glands (female prostate) to see if it would enhance the female ejaculatory orgasm. During this time, I had already developed the P-Shot® and injected my own corpus cavernosi (penis) multiple times, so it seemed reasonable also to inject the female corpus cavernosi and periurethral area as well.
The best I can tell, I was the first to inject (2010) the female periurethral area with PRP.
First, I injected my lover; I had taught her to have an ejaculatory orgasm and wanted to see if things would improve. Afterward, her ejaculatory orgasms grew consistently higher on the Richter scale.
I thought maybe her results were just a placebo effect. Then, knowing that PRP has been shown in multiple studies to remodel scar tissue into a more healthy state, I injected a woman’s periurethral and clitoral area who had been physically abused by her x-husband—leaving her with severe dyspareunia and anorgasmia even after seeing multiple gynecologists.
So, she received the second O-Shot® procedure.
Afterward, not only did her dyspareunia resolve, but also she reported to me that she was able to start running again because her urinary incontinence went away.
I thought, “Why didn’t I think of that?!”
In the process of injecting in the area of the Skene’s glands (or female prostate), I had inadvertently chosen a place that would help urinary incontinence and improve the nerves associated with sexual function and micturition.
Since then, we (members of the Cellular Medicine Association) have found that injecting more proximal to the bladder does not affect the entire urethra as significantly with resultantly less improvement for both urinary incontinence and for sex.
So, my process of designing the place to put the PRP to improve ejaculatory orgasm inadvertently resulted in placing the PRP where it would best help those suffering from urinary incontinence or with sexual dysfunction after a sling.
What diseases could you treat If you had a treatment that could propagate new blood flow, grow nerves, calm the autoimmune response, fight infection, regrow collagen, and enhance glandular function? The answer to that question gives you an idea about the possibilities with platelet-rich plasma (PRP). That idea (together with the current research and the experience of more than three thousand doctors over a decade) is the theme behind the strategies discussed in this report.
Thinking about how antibiotics work helps you consider what conditions may be helped by antibiotics; this consideration of which conditions my be helped and which may not be helped by antibiotics happens so automatically that we may not consciously acknowledge the process.
For example, we would not think about antibiotics for the primary treatment of uterine fibroids because fibroids are not primarily caused by infection; antibiotics only treat infection. But, with a new therapy that is not as well known or understood, we may not be clear about the mechanism of the treatment; therefore, there can be confusion regarding which disease processes the new therapy may be of benefit—leading to inappropriate use and less than expected results.
But, if a new treatment is considered (as with old standards of care) only when the pathology of the disease makes the use of the new therapy appropriate, results will be optimal, and we can avoid the proverbial throwing out the baby with the bathwater when the new therapy “doesn’t work” when we use the new therapy for a problem for which it would not be likely to help.
With this general idea about the relation of the mechanism of therapy and pathology of disease in mind, consider that (except for secondary results, which we will discuss in later sections) the only conditions that PRP may help are those in which strategic injection into tissue will improve the disease by improving the health of the tissue: neovascularization, neurogenesis, collagen production, improvement of glandular function, attenuation of autoimmune processes, fighting infection (all of which PRP has been documented to do).
In considering where improved tissue health might improve stress urinary incontinence in women, first consider the striated component of the urogenital sphincter—it accounts for one-third of the resting urethral closing pressure Delancey2017
Here’s my sketch of the striated muscle component—taken from diagrams published by Delancey and others:
The striated urogenital sphincter completely encompasses the urethra at level one, while, at level three, it encompasses both the urethra and the vagina.
Beneath the striated urogenital sphincter lies smooth muscle that runs longitudinally, which also contributes to the closing pressure.
Just like the striated muscle of the bicep or the thigh, the number of muscle fibers in the urogenital sphincter decreases with age. Also, the number of nerves innervating the sphincter decreases with age.
To complicate matters, even more, the function of the urogenital sphincter is known to be damaged by childbirth.
Does the decrease in innervation lead to the decrease in muscle fibers, or is the decrease in muscle and the decrease in nerves two independently evolving conditions? And does blood flow play a role? I could find no clear answer to these questions. But, whatever your answer to those questions, they prompt corollary ideas such as that the effect of voluntary Kegels may be attenuated by the decreased innervation of the striated muscle (explaining the lack of effectiveness of Kegels in some women).
Activation of the striated muscle of the sphincter independently of the patient’s volition or the innervation of the muscle (for example, with an Emsella® magnet) would possibly create more contraction than would be possible even with heroic efforts by the woman. This super activation would cause a strengthening of the striated sphincter and an increase in closing pressure.
Also, the sports-medicine literature offers robust support for the idea of using PRP to restore damaged or atrophic muscle. And multiple papers demonstrate neurogenesis propagated by the injection of PRP.
If we propagated neurogenesis and muscle fiber restoration with PRP, then that might be synergistic with Kegels or with magnet therapy or with surgery (if needed).
The urethra wall (not the surrounding tissue, the urethra itself) carries a vascular plexus with AV anastomoses; blood flow can be directed into or away from these venues to inflate or deflate them; so it demonstrates tumescence similar to that of the penis. But in the female urethra, tumescence contributes to the closing pressure of the urethra (not erectile function, as in the man).
Hormones are known to affect this tumescence-like function of the urethra. But, what are hormones but messengers to tell cells what to do? Messages-to-the-cells is exactly what happens when the cells of the urethral wall are exposed to the small peptide chains released from platelets.
PRP was shown in a recent double-blind placebo-controlled study to improve the erectile function of the penis. Since PRP helps with neovascularization in general and has been shown to improve erectile function, it seems logical that PRP may also, when injected into the urethral wall, improve the tumescent function of the urethral wall and the closing pressure of the urethra—resulting in a decrease or resolution of urinary incontinence.
The longitudinal smooth muscle of the urethra also contributes to the closing pressure. The smooth muscle cannot be contracted by either volition or by a magnet, so neither would help strengthen the smooth muscle component of the female urinary sphincter. But, as we have documented with the studies in our bibliography, PRP has been shown to revive muscle fibers. So, injection of the urethral smooth muscle may also account for some of the benefits of PRP seen when it is injected into the periurethral area.
And of course, such benefits of PRP may also be of help post-op from a mid-urethral sling placement. One study documented that the nerves and blood vessels between the anterior vaginal wall and the urethra are damaged by the surgical placement of a mid-urethral sling; and we have just discussed how PRP can repair nerves and blood vessels.
Urge incontinence, multifactorial and often seen in combination with stress incontinence, can be partly secondary to peripheral nerve involvement as previously mentioned. And research supports the idea that PRP may improve the function of those nerves resulting in an improvement in urge incontinence—if the PRP should be deposited in the proper place.
So, it makes sense that all of the above-mentioned ideas, if applied to the urinary sphincter in a female, might show synergistic benefits. Indeed, multiple papers do show that injection of PRP into the periurethral area or into the urethral wall improves stress urinary incontinence.
In these published papers showing benefits for stress urinary incontinence with the injection of PRP, multiple techniques have been used; so, let’s think about some of those techniques while keeping the functional anatomy in mind—looking for the best possible strategy (at least with our present knowledge).
With our O-Shot® procedure, we usually do two injections, one of which goes into the vaginal wall, hydro-dissecting the entire area.
Four CCs is enough to fill the whole space between the urethra and the vaginal wall and include the urethral wall—if you put the needle where it to needs to go.
Just like with an IV, there’s variability, both in technique and with the skill of the person doing the procedure; but if you can put the needle where it belongs, you should be able to put PRP in the areas we’ve described.
The following is a snapshot from one of our instructional videos showing one of the two injections the way we teach the O-Shot® procedure for SUI. By injecting the actual anterior vaginal wall within a few millimeters of the hymenal remnant, you avoid the pain fibers within heart’s line, and you’re able to fill both the space between urethra and vagina and affect muscle, blood flow, and nerves. This can be done pain-free or near pain-free using the proper technique and only a topical cream for anesthesia.
This method, when done properly, is called the O-Shot® procedure. The procedure can be done in the office using the person’s own blood and without pain in most cases.
I trademarked the term “O-Shot” to prevent variability of techniques with the associated variability of results being pushed upon women. All of the licensed providers of the O-Shot® procedure agree to follow a standard protocol with variations based on disease process. All licensed providers also agree only to use devices to prepare the PRP that has been approved by the FDA for the preparation of PRP to go back into the body. Our licensees are tested and are subject to losing the license to use the name “O-Shot®” in advertising if they fail to follow our standards.
Physicians can apply to receive more detailed instructions and to be licensed to perform the O-Shot® procedure here—>: OShot.com/physicians<—
Another group demonstrated (I think in a very brilliant and useful study) the resolution of urinary incontinence with the injection of PRP directly into the urethral wall—in women with objectively-demonstrated severe incontinence.
But, in their method, they report that the procedure was so painful that the subjects had to receive the urethral sphincter injection under intravenous general anesthesia in the operating room.
The following photograph illustrates the injection points:
This is NOT the O-Shot® procedure; the O-Shot® procedure is a method of choosing the proper patient, properly preparing the PRP, and injecting the PRP with the agreed-upon technique after using local anesthesia that gives the best chance of an in-office, pain-free procedure.
But, though these investigators did something other than an O-Shot® procedure, they did help the mission of finding a way to cure or improve female urinary incontinence by demonstrating the possibility of improving the health and function of the urinary sphincter by using a functional-anatomy-based, strategic injection of PRP.
Another third technique (not pictured here) showed benefit for SUI but described injecting 4 cc of PRP spread out in 0.1 ml aliquots for FORTY separate injection points.
I have no study showing which of the three separate techniques described above gives the best result. There is no question about which causes the least amount of pain: (1) 40 separate injections vs. (2) five injections into the urethral wall requiring general anesthesia in the operating room vs. (3) the O-Shot® which can be done usually completely pain-free and only requires topical anesthesia and a pain-free lidocaine block in the office.
Though we still do not have a study documenting which works the best of these three techniques (or which of other techniques that you might imagine), hopefully, I have given you a quick version of why I think our method (which we have been doing for a decade with over 100,000 women treated) may be best.
More importantly, what I hope I’ve shown is that there is a need for us to think about carefully and study which might be the best technique because we think technique matters. One of the dangers of having taught and provided the O-Shot® procedure for 11 years is that I may start to believe everything I say…first you show something is feasible, then you have the herculean effort of looking at the infinite number of variables to find the best way.
Please help us study and think about this categorically new way to improve the health and function of the female genitourinary tract.
My goal is to be a pipe for the movement of ideas. I continue to be grateful every day for the members of the CMA who have shared ideas that make this report possible. And, most of all, I am grateful for the women who have been patients who have trusted me to teach me; with old ideas and new, the best book is observing and listening to the one woman in front of you who will teach you about her disease and how to make her well—if you listen.
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Samuels, Julene B., Andrea Pezzella, Joseph Berenholz, and Red Alinsod. “Safety and Efficacy of a Non‐Invasive High‐Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life.” Lasers in Surgery and Medicine 51, no. 9 (November 2019): 760–66. https://doi.org/10.1002/lsm.23106.
Silantyeva, Elena, Dragana Zarkovic, Evgeniia Astafeva, Ramina Soldatskaia, Mekan Orazov, Marina Belkovskaya, Mark Kurtser, and Academician of the Russian Academy of Sciences. “A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data.” Female Pelvic Medicine & Reconstructive Surgery 27, no. 4 (April 2021): 269–73. https://doi.org/10.1097/SPV.0000000000000807.
Araujo-Gutierrez, Raquel, Jeffrey L. Van Eps, Jacob C. Scherba, Albert Thomas Anastasio, Fernando Cabrera, Cory J. Vatsaas, Keith Youker, and Joseph S. Fernandez Moure. “Platelet Rich Plasma Concentration Improves Biologic Mesh Incorporation and Decreases Multinucleated Giant Cells in a Dose Dependent Fashion.” Journal of Tissue Engineering and Regenerative Medicine 15, no. 11 (2021): 1037–46. https://doi.org/10.1002/term.3247.
Bindal, Priyadarshni, Nareshwaran Gnanasegaran, Umesh Bindal, Nazmul Haque, Thamil Selvee Ramasamy, Wen Lin Chai, and Noor Hayaty Abu Kasim. “Angiogenic Effect of Platelet-Rich Concentrates on Dental Pulp Stem Cells in Inflamed Microenvironment.” Clinical Oral Investigations 23, no. 10 (October 2019): 3821–31. https://doi.org/10.1007/s00784-019-02811-5.
Li, Yuan, Shan Mou, Peng Xiao, Guining Li, Jialun Li, Jing Tong, Jiecong Wang, Jie Yang, Jiaming Sun, and Zhenxing Wang. “Delayed Two Steps PRP Injection Strategy for the Improvement of Fat Graft Survival with Superior Angiogenesis.” Scientific Reports 10 (March 23, 2020): 5231. https://doi.org/10.1038/s41598-020-61891-6.
Nolan, Grant Switzer, Oliver John Smith, Susan Heavey, Gavin Jell, and Afshin Mosahebi. “Histological Analysis of Fat Grafting with Platelet‐rich Plasma for Diabetic Foot Ulcers—A Randomised Controlled Trial.” International Wound Journal 19, no. 2 (June 24, 2021): 389–98. https://doi.org/10.1111/iwj.13640.
Norooznezhad, Amir Hossein. “Decreased Pain in Patients Undergoing Pilonidal Sinus Surgery Treated with Platelet-Rich Plasma Therapy: The Role of Angiogenesis.” Advances in Skin & Wound Care 33, no. 1 (January 2020): 8. https://doi.org/10.1097/01.ASW.0000615376.97232.0a.
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Sclafani, Anthony P., and Steven A. McCormick. “Induction of Dermal Collagenesis, Angiogenesis, and Adipogenesis in Human Skin by Injection of Platelet-Rich Fibrin Matrix.” Archives of Facial Plastic Surgery 14, no. 2 (April 2012): 132–36. https://doi.org/10.1001/archfacial.2011.784.
Zhang, X.-L., K.-Q. Shi, P.-T. Jia, L.-H. Jiang, Y.-H. Liu, X. Chen, Z.-Y. Zhou, Y.-X. Li, and L.-S. Wang. “Effects of Platelet-Rich Plasma on Angiogenesis and Osteogenesis-Associated Factors in Rabbits with Avascular Necrosis of the Femoral Head.” European Review for Medical and Pharmacological Sciences 22, no. 7 (April 2018): 2143–52. https://doi.org/10.26355/eurrev20180414748.
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Gaudet, D., D.G. Clohosey, J.L. Hannan, S.W. Goldstein, N. Szell, B.R. Komisarek, M.A. Harvey, et al. “249 Midurethral Sling Placement Disrupts Periurethral Neurovascular and Glandular Structures near Anterior Vaginal Wall: Potential Role in Female Sexual Dysfunction.” The Journal of Sexual Medicine 15, no. 7 (July 2018): S221–22. https://doi.org/10.1016/j.jsxm.2018.04.214.
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Includes all of the following:
*Marketing
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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.
Into play is 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].
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 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.
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.
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.
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.
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.
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.
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
The O-Shot (TM) procedure provides a very specific way of using growth factors to stimulate multi-potent stem cells to generate healthier and more functional tissue in the areas of sexual response and urinary continence within the vagina (G-Spot, O-Spot, Skene’s Glands, urethra, and vaginal wall).
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