New and published research on platelet-rich plasma and the O-Shot® procedure for sexual function, incontinence, lichen sclerosus, and other women’s health problems, with links to the papers.
New research examines platelet-rich plasma for healing after episiotomy and perineal tears—and points toward an important area of women’s sexual-health research.
Childbirth changes the female body. Some of those changes resolve within weeks.
Others can persist for months or years.
Women who have experienced an episiotomy or a significant perineal tear during vaginal delivery may be left with tenderness,
painful scar tissue, tightness, altered sensation, pain during intercourse, or other
changes that affect sexual function and quality of life.
For many years, treatment options for these problems have been limited.
Now researchers are investigating a different question:
Could platelet-rich plasma (PRP) help damaged perineal tissue heal?
A scientific paper published in August 2026 provides one of the most useful examinations
of that question to date:
The answer is intriguing—but it is important to understand both what the research
shows and what it does not yet prove.
What Happens During an Episiotomy or Perineal Tear?
An episiotomy is a surgical incision made in the perineum—the tissue
between the vaginal opening and anus—to enlarge the vaginal opening during childbirth.
A perineal tear, by contrast, occurs spontaneously during delivery.
They are related injuries, but they are not the same thing. Tears can range from
relatively superficial injuries involving skin to severe third- or fourth-degree injuries
involving the anal sphincter or rectal lining.
Most women heal normally. But some experience wound infection, separation of the wound,
persistent tenderness or pain, and longer-term sexual problems.
The 2026 review discusses contemporary data showing infection rates of approximately 5–10% following episiotomy in large cohorts. Longer-term complications
can include chronic perineal pain, painful intercourse (dyspareunia)
and impairment of sexual quality of life.
Those longer-term consequences are particularly important.
The goal after childbirth should not merely be closing a wound. Ideally, we want restoration
of healthy, comfortable and functional tissue.
Why Would PRP Potentially Help?
Platelet-rich plasma is prepared from a patient’s own blood.
The blood is processed to concentrate platelets, which release numerous signaling molecules
involved in tissue repair, including platelet-derived growth factor, transforming growth
factor-beta and vascular endothelial growth factor.
These signals participate in processes including angiogenesis—the formation of new blood vessels—modulation of inflammation,
and organized tissue repair.
This is one of the biological principles underlying the O-Shot®,
which uses autologous PRP in female genital tissues.
But biological plausibility alone does not demonstrate that a treatment works.
So the more important question is:
What happens when PRP is actually studied in women with childbirth-related perineal injuries?
A Randomized Trial of PRP After Episiotomy
The Brezeanu review performed an unusually broad literature search and identified a
randomized clinical trial specifically examining PRP after episiotomy.
In that study, 200 first-time mothers undergoing episiotomy were randomized
to PRP treatment or standard treatment. PRP was placed in the episiotomy wound before
skin closure, and 176 women were ultimately analyzed.
The investigators reported:
better early wound-healing scores,
better scar scores,
less pain beginning at one week, and
no cases of wound gaping in the PRP group compared with seven cases in the control group.
Those results are encouraging.
They are not, however, definitive.
The trial was not prospectively registered, did not report a sample-size calculation,
apparently did not blind outcome assessors, lost some participants to follow-up,
and contained inconsistencies in portions of its reported data.
Important: The appropriate interpretation is that this study provides
a promising preliminary signal. It does not, by itself, establish PRP as proven treatment
for episiotomy injury.
What About More Serious Childbirth Tears?
The literature also contains smaller studies and case reports involving more severe
childbirth-related perineal injuries.
A 2026 non-randomized study evaluated PRP following repair of third- and fourth-degree perineal lacerations and reported favorable
wound-healing and continence outcomes.
Published case reports have also described PRP treatment in women with an episiotomy
wound that separated after delivery and in a woman with chronic pain following a deep
episiotomy and second-degree laceration.
Case reports and small non-randomized studies cannot establish effectiveness, but they
add to the rationale for conducting better-controlled studies.
Two New Clinical Trials Are Testing the Question More Rigorously
Perhaps the most important development is that investigators are now testing PRP
prospectively in randomized clinical trials specifically involving childbirth-related
perineal injury.
1. PRP-EpiHeal
PRP-EpiHeal is a randomized controlled trial designed to compare
autologous PRP with standard care following episiotomy.
Its primary endpoint is wound healing at six weeks using the REEDA scale, which evaluates
redness, edema, bruising, discharge and approximation of the wound edges. Secondary
outcomes include pain, wound dehiscence, infection, need for additional suturing and
maternal satisfaction.
A second study, called RELIEVE, broadens the question beyond episiotomy alone.
RELIEVE is designed as a triple-blind, randomized, placebo-controlled trial
evaluating whether a local injection of a woman’s own PRP during repair of a perineal tear and/or episiotomy reduces postpartum perineal pain compared
with saline placebo.
This trial is particularly interesting because it directly includes spontaneous childbirth
tears as well as episiotomies.
PRP has also been investigated in another obstetric wound: the cesarean-section incision.
This evidence cannot simply be assumed to apply to the perineum. Cesarean and perineal
wounds differ in anatomy, bacterial exposure and mechanical stresses.
Nevertheless, favorable findings from cesarean wound and scar research add biological
support to the hypothesis that platelet-derived signaling may influence obstetric wound healing.
One completed clinical study evaluated intraoperative PRP for postoperative scarring
following cesarean delivery:
What Does This Mean for Women Who Had Their Babies Years Ago?
Here we must make another important distinction.
Most of the strongest research described above concerns PRP applied around the time of childbirth and primary wound repair.
That is different from treating a woman months or years later who has an established
episiotomy scar, tenderness, dyspareunia or altered sexual sensation.
The latter question has not yet been answered by large randomized clinical trials.
The authors of the 2026 review specifically identify longer-term outcomes as an important
subject for future research, including:
scar quality,
chronic perineal pain, and
sexual function.
Those may ultimately prove to be among the outcomes that matter most to women.
Where Does the O-Shot® Fit?
The O-Shot® uses a woman’s own platelet-rich plasma in vulvar and
vaginal tissues. It’s the only standardized protocol that’s been around for over a decade and is provided by over 1,000 physicians throughout the U.S. and over 50 countries.
For a woman with persistent symptoms following childbirth—such as scar tenderness,
painful intercourse, altered sensation or other changes in sexual function—it may therefore
be reasonable to discuss PRP as one possible treatment approach after an appropriate
medical examination by one of our O-Shot® providers.
And…the side effects could be better sex and stronger family relations!
What the research does NOT yet prove:
The studies described here do not prove that the O-Shot® repairs an old episiotomy scar
or reverses chronic childbirth-related sexual dysfunction.
What the research does show is that PRP is now being investigated specifically for
childbirth-related perineal healing, that early clinical results provide encouraging
signals, and that researchers consider the question important enough to justify more
rigorous randomized trials.
That represents genuine scientific progress.
The Larger Question
For generations, medicine understandably concentrated on getting mother and baby
safely through childbirth.
But survival is not the only outcome that matters.
What happens to a woman’s comfort, sensation and sexual function after delivery matters too.
An episiotomy or obstetric tear may occur during a few minutes of childbirth, but its effects
can sometimes persist for years.
Regenerative medicine raises the possibility that instead of simply accepting those
consequences, we may eventually be able to improve the way injured tissues heal—or perhaps
help previously injured tissues remodel.
PRP may ultimately prove useful for that purpose, or future rigorous trials may demonstrate
that its effects are more limited than preliminary research suggests.
The scientific answer is not yet settled.
But after decades in which postpartum perineal injury received relatively little regenerative
research, and after 15 years of our O-Shot® providers seeing excellent results, investigators are finally asking the question.
And for women still experiencing the consequences of childbirth years later,
that is a question worth answering.
Considering the O-Shot® After Childbirth?
If you have persistent pain, scar tenderness, discomfort during intercourse,
altered sensation or other sexual changes following childbirth, an experienced
O-Shot® provider can evaluate your symptoms and discuss whether PRP treatment
may be appropriate.
Brezeanu D, Brezeanu A-M, Surdu T-V, Surdu M, Tica V. Platelet-Rich Plasma in Episiotomy Repair: A Critical Appraisal of a Sparse
and Partly Non-Indexed Evidence Base and Rationale for a Randomized Controlled Trial.
Life. 2026;16:1339.
Read the full article
PRP-EpiHeal: Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing.
ClinicalTrials.gov Identifier: NCT07669285.
ClinicalTrials.gov record
RELIEVE: Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy.
ClinicalTrials.gov Identifier: NCT07727213.
ClinicalTrials.gov record
Efficacy of Platelet-Rich Plasma in Improving Postoperative Scarring After Cesarean Delivery.
ClinicalTrials.gov Identifier: NCT06978010.
ClinicalTrials.gov record
Medical information notice:
This article is provided for educational purposes and does not establish that PRP or the
O-Shot® is effective for any particular patient’s episiotomy scar, perineal injury,
postpartum pain, or sexual dysfunction. The O-Shot® has not been established by large
randomized controlled trials as a treatment for chronic episiotomy scars or chronic
postpartum perineal injury. Individual results vary. Persistent postpartum pain or
sexual dysfunction should be medically evaluated because multiple conditions can cause
these symptoms.
What the “Billionaires’ Vagina Club” Reveals About the Future of Women’s Medicine
The headline may sound provocative. The deeper story is about women asking for thoughtful care, physicians considering evidence beyond insurance reimbursement, and the importance of choosing a properly trained O-Shot® provider.
The Times recently followed a journalist through a week of treatments intended to explore women’s sexual wellbeing in midlife. Her visit included care from London physician Dr. Shirin Lakhani, who incorporated the O-Shot® procedure into a broader, individualized program.
The article grew out of a larger media conversation surrounding the so-called “Billionaires’ Vagina Club”—a phrase that has captured attention because wealthy women are increasingly seeking personalized care for sexual function, menopause, urinary symptoms, comfort, pleasure, and quality of life.
But the most important lesson is not about billionaires.
Women should not have to become billionaires to receive thoughtful sexual healthcare. Better medicine should not be reserved for the wealthy.
Why this conversation matters
For generations, many women were told that intimate changes following childbirth, menopause, aging, surgery, or illness were simply things they had to accept. Today, more women are asking direct questions—and looking for physicians willing to discuss those concerns without embarrassment or dismissal.
The attention surrounding the “Billionaires’ Vagina Club” illustrates a broader change in medicine. Patients increasingly want care that takes sexual health seriously as part of overall health.
Medicine has quietly divided into two philosophies
One philosophy begins by asking whether a treatment has FDA approval and whether insurance will reimburse it.
Another begins with additional questions: What does the published evidence show? Is there biologic plausibility? What are the known risks? What does the patient value? Can the treatment be offered carefully, ethically, and with meaningful informed consent?
Neither philosophy necessarily rejects science. They simply begin with different questions.
An important distinction
The FDA regulates drugs and medical devices.
Physician procedures are evaluated differently, through research, professional training, clinical judgment, informed consent, and continuing study.
Insurance coverage is a financial decision; it is not, by itself, proof that a treatment is—or is not—scientifically valid or appropriate for an individual patient.
So, what is the O-Shot® and how does it contribute to the health and function of the “Billionaire’s Vagina”?
The O-Shot® is a specific, trademarked protocol/procedure in which a qualified medical professional prepares platelet-rich plasma from a patient’s own blood and injects it into designated tissues following a standardized technique.
The procedure is not presented as a universal solution, and no responsible physician should promise that every woman will experience the same result. Appropriate evaluation, patient selection, informed consent, technical training, and realistic expectations all matter.
Patients considering the procedure should review the available research, discuss alternatives, and ask their physician about experience, training, possible benefits, limitations, and risks.
Whenever a medical procedure attracts publicity, people may begin offering treatments that are loosely similar under generic names. That can make it difficult for patients to know who has received training in the original protocol.
The official O-Shot® Provider Directory lists clinicians licensed by the Cellular Medicine Association to offer the trademarked O-Shot® procedure. The directory is designed to help patients locate trained providers rather than relying on an internet advertisement or an unverified claim.
Find a trained O-Shot® provider near you
Begin by consulting the official directory and contacting a listed clinician to arrange a personal medical consultation.
The real lesson from the “Billionaires’ Vagina Club”
The most useful outcome of this media attention may be that women feel more comfortable asking questions. Sexual function, urinary symptoms, pain, dryness, changes after childbirth, and changes associated with menopause deserve respectful medical discussion.
The goal is not luxury medicine. The goal is better medicine: science, skill, honesty, informed patient choice, and a physician willing to listen.
Medical disclaimer: This page is for general educational purposes and does not provide medical advice, diagnosis, or treatment. Results vary. The O-Shot® may not be appropriate for every patient. Consultation with a qualified healthcare professional is required to evaluate symptoms, alternatives, contraindications, potential benefits, and risks.
Some of the Research Supporting the Effectiveness of the O-Shot® Procedure for Treating Stress Urinary Incontinence
Ashton, Leah, Hannah Nakatsuka, Colin M. Johnson, et al. “A Single Injection of Platelet-Rich Plasma Injection for the Treatment of Stress Urinary Incontinence in Females: A Randomized Placebo-Controlled Trial.” Urology 193 (November 2024): 63–68. https://doi.org/10.1016/j.urology.2024.06.047.
Boztepe, Ozlem, and Hannah Warren. “Letter to Editor – A Single Injection of Platelet-Rich Plasma Injection for the Treatment of Stress Urinary Incontinence in Females: A Randomized Placebo-Controlled Trial.” Urology, December 2024, S009042952401118X. https://doi.org/10.1016/j.urology.2024.11.066.
Long, Cheng-Yu. “A Pilot Study: Effectiveness of Local Injection of Autologous Platelet-Rich Plasma in Treating Women with Stress Urinary Incontinence.” Scientific Reports, 2021, 9.
Matz, Ethan L, Amy M Pearlman, and Ryan P Terlecki. “Safety and Feasibility of Platelet Rich Fibrin Matrix Injections for Treatment of Common Urologic Conditions.” Investigative and Clinical Urology 59, no. 1 (2018): 61–65. https://doi.org/10.4111/icu.2018.59.1.61.
Moccia, Felice, Paola Pentangelo, Alessandra Ceccaroni, Antonio Raffone, Luigi Losco, and Carmine Alfano. “Injection Treatments for Vulvovaginal Atrophy of Menopause: A Systematic Review.” Aesthetic Plastic Surgery, ahead of print, August 14, 2023. https://doi.org/10.1007/s00266-023-03550-5.
Prodromidou, Anastasia, Themos Grigoriadis, and Stavros Athanasiou. “Platelet Rich Plasma for the Management of Urogynecological Disorders: The Current Evidence.” Current Opinion in Obstetrics & Gynecology Publish Ahead of Print (August 2022). https://doi.org/10.1097/GCO.0000000000000820.
Runels, Charles. “A Pilot Study of the Effect of Localized Injections of Autologous Platelet Rich Plasma (PRP) for the Treatment of Female Sexual Dysfunction.” Journal of Women’s Health Care 03, no. 04 (2014). https://doi.org/10.4172/2167-0420.1000169.
Sanoulis, Vasileios, Nikolaos Nikolettos, and Nikolaos Vlahos. The Use of Platelet-Rich Plasma in the Gynaecological Clinical Setting. A Review. 18, no. 3 (2019): 11.
Hello, I’m Charles Runels. I’m an internist down in the Gulf Coast. I’ve been taking care of women’s health problems for the past 30 years. And one of the problems that really is serious and can limit women at a time when they’re developing is stress and continence.
Now, the definition of stress incontinence is leaking enough urine that it affects your hygiene (you have to wear a pad) or it’s interfering with your social activities, like sports.
So imagine you’re a young teenager and you’re trying to practice sports, but you can’t do your cheerleading or your volleyball because you’re leaking urine in front of your friends. It can have a profound effect (especially in a developing social young, fragile 13 year old, she’s not as tough as her mother is emotionally, perhaps).
And so that sort of embarrassment can be traumatic enough to limit the things that she should do. And so, instead of doing sports, she’s playing more video games. It’s not something trivial. Okay, it’s not cancer. But it’s not trivial.
Well, there’s been this wrong concept that urinary incontinence to the point that you have to do something to keep from soiling your clothing is a problem that happens after you deliver children. But the truth is that there have been multiple studies showing that, especially young women that have impact sports, like running, volleyball, cheerleading, gymnastics, will develop incontinence to a great degree. One study showed that in Olympic trampoline athletes, all have incontinence.
Well, this was just published this past month where some physicians looked at all the research out there, the significant research involving incontinence in young women who have not had children to see, well, how prevalent is it? And they found that depending on the sport, anywhere from 30 to near a hundred percent of the women participating, had incontinence.
Well, they go through some of the things that people try to make that go away. In reality, what often happens is the young girl just quits doing the sport. But it’s everything from surgeries to medications wearing pads. And it often has to do with the levator muscle, but there are also muscles. The pelvic floor only accounts for about 20% of the common mechanism and there are sphincter muscles around the urethra that are not even technically part of the pelvic floor. So even if you teach the girl to do Kegels, perhaps this is going to help. Doctors aren’t a great help.
And by the way, I’ll put a link to this research below the video so you can see here are the different options. Conservative have to do with voiding before the workout. Well yeah, really? And wearing dark-shaded garments so if you pee on yourself, nobody notices. It doesn’t sound like a very good answer, does it? And you got pelvic floor training, you got Kegels exercises. But again, the pelvic floor is what’s supporting the organs, but it’s not actually technically part of the sphincter mechanism. Biofeedback. Really, you’re going to sign your 13-year-old for biofeedback? And then you have surgery, so there’s not a lot of great options.
And I’m really disappointed that, but not surprised that, because we have something new called the O-Shot® procedure, it wasn’t included in this article. If you go to our website oshot.com, you’ll see, there’s a research page, and I’ll just go ahead and take you there so you can see, there’s a research page because we do have some research showing that using platelet-rich plasma, as it’s done in athletes, will cause the tissue to become more, the muscles to become stronger and restored and the new nerve to grow. I mean, just think about it for a second.
Why should an NFL athlete get better treatment for his knee than your teenage daughter for her incontinence? It’s the same tissue. It’s the blood in her body. You just get the platelets out of it, just like they would for an NFL athlete instead of squirting it in. Here’s some of the research, instead of squirting it into a joint though, it’s placed around the urethra. And if she’s a virgin, it could be done very, very easily without a lot of trauma and emotional upset. It’s pain-free for most people and helps restore that.
Now, of course, it works for mamas too. And the research we’ve done has been in mostly grown women, but just realize there’s another option. I’ll put a link to the research below the video, and also a link to where you can find providers. We’re in 50 something countries and a number of providers. And hopefully, this will be a help to you or someone that you love.
*Materials for Injection Into the Vaginal Wall *What are we injecting: G-Spot or O-Spot (what’s the difference)? *The change in FSFI and FSD-R after the O-Shot® procedure *Dr. Elizabeth Owings discusses the Functional Clitoral Anatomy
Video/Recording of CMA Journal Club, Pearl Exchange, & Marketing Tips
Transcript (relevant links at the bottom of the page)
Review of Materials for Injection into the Vaginal Wall
Charles Runels, MD (00:03):
Thank you guys for being here at the Journal Club with Pearls & Marketing (JCPM). And we have a very special guest tonight, Dr. Elizabeth Owings, who wrote a… She just clicked to me and said she got the wrong link. Okay. Let me send her another link or we’re not going to lose her. Hold on one second. Yeah. Okay. Just sent it to her again. Hopefully she’ll show up. Okay.
Charles Runels, MD (00:35):
So Dr. Owings, amazing, amazing physician who spent several months just studying the anatomy of the clitoris. It’s hard to believe it was actually left out of Grey’s Anatomy for a while. So Dr. Owings will be coming on in about 10 minutes. I’ve been spending a lot of time thinking about the functional anatomy, the way things that are and how we might improve our O-Shot®. Well, this paper just happened to come out, and it was actually brought to my attention by my fiance Alexandra, who’s a gynecologist out there in San Antonio. So thank you Alex, for showing me this.
Charles Runels, MD (01:11):
This came out, as you can see, it was come out in the past month and it was a nice review article that was published in Aesthetic Plastic Surgery about all the different materials that are being squirted into the vagina. Some of it you’ve seen, but having it all fit together in one paper with a very, I think, balanced view of it is helpful. I wanted to point out a couple of things, and you can download it. I’ve put it in the handout section. You just click on the little yellow flower it’ll pop up, and if you open it now, it’ll be still open when the webinar’s over. If not, it’s going to disappear.
Charles Runels, MD (01:55):
So here’s a couple of things that I noticed about this that I’d like to bring to your attention. First of all, this first little review paragraph just lists the things that have been published, and I’d like to point out that maybe multiple injections, I’m being a little picky here, but aren’t always needed. And when they talk about emboli, [inaudible 00:02:19] emboli, that happens, but it happens with HA, and that happens… Pulmonary embolism happens with fat. We haven’t had a pulmonary embolism. We’ve had one episode of blindness from PRP, and that was when it was injected near the eye. And so, except for that one episode, no one’s ever gone blind by injecting in the vagina, although pulmonary emboli have happened injecting fat and HA around the vagina.
Charles Runels, MD (02:51):
So anyway, there’s a nice little overview. I’m just going through it here, and you guys can point out, I’ll unmute the mic if you want to throw something in here. But they do point out that vaginal atrophy happens with estrogen levels being a main cause. Definitely a cause, it’s debatable how much, because there’s definitely a contribution from testosterone, as you guys know, not just estrogen. Many of you have discovered with testosterone creams also help the problem.
Charles Runels, MD (03:27):
And they’re about to quote one of the articles that are published together with some of the other people in our group. But one other thing before we get to that. On page 1232, they mentioned that… They started talking about the G-spot, and this becomes almost like a religion or a belief system more than science, I think. And although there was this study that came out in… Where this fellow, I can’t say his name. I met him. Really nice guy, at one of the [inaudible 00:04:04] courses, he did a series of dissections on cadavers and totally dissected out the G-spot. The reason I’m bringing this out is most people think that maybe it still hasn’t really been shown because there’s no specific tissue that anyone else has been able to find.
What are we injecting: G-Spot or O-Spot?
Charles Runels, MD (04:26):
The only reason I bring it out is that I think technically we’re not injecting the G-spot, and I want to make sure that we’re clear on that because… Hey, I see you, Elizabeth, thank you for jumping on. Because the G-spot, in my opinion, is a functional thing. That if you look at what Dr. Grafenberg talked about back in the fifties, and you really should do a Wikipedia read and then read all the references about Dr. Grafenberg. Amazing, amazing man, amazing story that I won’t get into now. But he thought the whole urethra was the most arousing erotic part of a woman’s body. The spot became more of a later idea. And I think it’s less established. I think most people were tending to talk more about the clitoral urethral complex, which is what Dr. Owings is about to talk about here shortly.
Charles Runels, MD (05:23):
But the G-spot is something that I think you find in the bedroom, I think it varies from woman to woman, and in the same woman, sometimes from moment to moment. But it’s in theory the place where the woman’s most aroused. And I think to point to it on an anatomy chart, it could be how you define it. You can decide that. You can decide your left ear lobe’s the G-spot if you want to, but I think the way Dr. Grafenberg talked about it, it was the most arousing place of the most arousing place. The most arousing spot along the path of the urethra, but really it’s nebulous.
Charles Runels, MD (05:58):
And that’s why with the G-Shot that was out and popular in the US a number of years ago, you had to quote map the vagina and find that place by stimulating the woman’s vagina. And in Europe, this is still done. In some of our offices it’s still done, but this is frowned upon by ACOG now, and you’re putting, I think, your license at risk if you do this in the United States with an HA in the anterior vaginal wall, because of the risk of granuloma. 1 in 40 in one study, that can cause obstruction, necessitating surgery to correct it.
Charles Runels, MD (06:34):
So the O-spot, we need a place to call our place where we put it. You can call it whatever. You can call it the Florida spot. I don’t really care, but calling it the most distal place in the peri-urethral area, between the anterior vaginal wall and the urethra most distal from the bladder, it’s a long-winded thing. So that is the description of it. I like calling it the O-spot. Nobody’s name’s involved, so there’s no ego.
Charles Runels, MD (07:09):
It’s just where we put our shot, and that you can point to on a map. So if you’re going to do the G-Shot, in my opinion, you need to spread the lady’s legs and find where she moans the most, which is… I’m saying it purposefully in a very offensive way, because some people think of it as offensive, even when you say it in a not offensive way. So I like to talk about, we don’t really map out the vagina when we do the O-Shot®, and we’re not looking for the G-spot when we do that. Okay. Now I just wanted to bring that out. Go read about Dr. Grafenberg. Couple of the things. I’m trying to keep to the schedule here. I’ve got about two minutes and I’m going to turn it over to Dr. Owings. There’s a lot more here. Let’s see.
The change in FSFI and FSD-R after the O-Shot® procedure
Charles Runels, MD (07:55):
If you go down to this little graph where they talk about the research we did, and just a couple of things to point out. It’s not apparent from this is that we published this little study. And what I did was I had a patient who used to work in getting universities ready for inspection by the FDA. After she retired from the FDA, where she was an inspector of research projects done by universities, after she retired, then she worked as a consultant on the other side to help people get ready for what she would have done when she worked for the FDA. I loved her, love her still. I saved her life with some stuff I was doing, and so she felt obligated. So I said, okay, let’s go through my charts. I don’t want to even touch the charts. And find women for whom we have a female sexual function index and a female sexual distress scale revised that was filled out plus or minus a few weeks around the 12 week mark. As you can see, 12 to 16 weeks. And we have one before and we have one at that time, because I think that’s when it probably maxes out. And just add it all up and let me see what it shows. My hands are going to be off.
Charles Runels, MD (09:10):
And she did it as meticulously as only an FDA person might do. And thankfully, it showed benefit. You realize I wasn’t even seeking people who were distressed. And ironically, of the two that showed increased distress on the distress scale, I called one of them because her distress scale had gone up, I think from a one to a two. It just bumped from zero distress, basically, to a little bit more distress. And when I asked her why her distress went up, she said, well, I’m having great sex, and now my boyfriend can’t keep up with her. So that was, that was her distress.
Charles Runels, MD (09:51):
The other woman had a divorce right after the shot, and her whole life was distressed. But the bottom line is that we showed some benefit. Obviously there was no placebo, and rightly so, he points that out. But I want you to know how those numbers were generated.
Charles Runels, MD (10:08):
This one, I think very well done. I think it’s complicating it. If you notice the people who were doing the procedures, like the recent one that made the cover of the journal Sexual Medicine, the people who were doing the sex procedures, who have never done this in the face, in my opinion, are complicating it. If you ever squirt PRP in the face, you’ll see, it’s like filling up a sponge. You wouldn’t feel obligated to stick the sponge, if it were small, in three or four different places. You would just put the needle in the sponge and it would fill without lots of sticks, which is what you see when you see PRP spread through the face.
Charles Runels, MD (10:47):
But not having witnessed that, I think some people complicate it, just my opinion. I may be proven to be wrong, but I don’t think you have to put multiple sticks. And I think most of what happens does go along, especially when you’re treating for stress urinary incontinence, but even when you’re treating for sex, because of the sensitivity of the urethra, I think anything away from 12:00 for sure, by the time you get to 2:00 and 10:00, perhaps benefits are rapidly declining. I’ve seen lectures about hyaluronic acid when I lectured in Europe, and many of you on the call now or listening later will know about this, because you live in Europe. We don’t have as yet an HA that’s approved for the vaginal space. The guy who invented [inaudible 00:11:42] came out with one that is, but the recommendation is that it only be used in the posterior vaginal wall for the same reason, I just mentioned. The G-Shot is not recommended, it’s condemned by ACOG, because when you put the HA in the anterior vaginal wall, some not happy things can happen. Where it’s safer in the posterior vaginal wall.
Charles Runels, MD (12:06):
The end point is often pH, which is interesting to us in the States. And you can see people are mixing it with PRP as we are doing in our wing lift. This, again, I think is something that hopefully will eventually be something we’re able to do here. There’s a region kit that comes with an HA as an activator that’s not cross-linked, that is supposed to be available here eventually.
Charles Runels, MD (12:34):
And then the collagen botulinum toxin, I’ll get back to fat as it does lead to embolism. When you get to stem cells, I don’t even like saying that on a microphone now because the FDA is so rambunctious about making sure we don’t talk about stem cells too much. So that’s it. Let’s see if there’s any other notes and we’ll turn this over to Elizabeth. Anyway, hopefully you guys will think about that, and… Oh, I know what else was going to show you. This last little part in the summary, and then I’ll shut this down. The references here are crazy good. So you might want to go through those when you have a Sunday afternoon. This part.
Charles Runels, MD (13:24):
Well, the bottom line is that instead of having one tool, the idea of combining tools is important. We definitely need to standardize it. The double-blind placebo needs to happen, but I think it might need to be a positive control, because saline is not a placebo. If you think about what happens when you power wash your driveway, I’m afraid there may be some disruption of tissue that makes it not a placebo. So in fact, our procedure is part biological by activating pluripotent stem cells with PRP-derived growth factors and cytokines. It’s partly a physical procedure when you’re hydrodissecting tissue. So it’s a little tricky doing a placebo-controlled trial, unless maybe you just stick the needle there. Anyway, I’m playing around with that. I actually stopped one study when I saw another study where the saline placebo worked almost as good as PRP and much better than you would have expected a placebo to work in a histological study.
Charles Runels, MD (14:30):
So I think now let’s unmute Dr. Owings and I have her beautiful pictures that she’s accumulated to help explain some of the function of the anatomy and how it relates to what we just talked about. Let’s see, I see two microphones, Elizabeth. I’m going to unmute them both. There you go. Should be live now.
Elizabeth Owings, MD (14:57):
Okay.
Dr. Elizabeth Owings discusses the Functional Clitoral Anatomy
Dr. Elizabeth Owings, MD
Charles Runels, MD (14:59):
You’re there. There’s something that’s causing an echo. So while she’s flipping that off, just to let you guys know, Dr. Owings is really a… I meet lots of smart people, but she’s one of those Renaissance ladies who has a music degree and plays the piano like Liberace or something, and she’s got so many fricking specialty trainings I can’t track them, and still looking for the new thing to think about. So thankfully some of those new things that she wanted to think about included our procedure. So let me see if I can make this… Yep. There it is. And I’ll just run through this whenever you tell me to, Elizabeth, and we can hear you now beautifully.
Elizabeth Owings, MD (15:47):
Okay. Terrific. Glad you can hear me. Just had two mics, because I didn’t know which one was going to link up right.
Charles Runels, MD (15:53):
[inaudible 00:15:53]. We got it now.
Elizabeth Owings, MD (15:55):
Perfect. So I guess I have been thinking about this. I’ve been thinking about this a lot. Any of you heard me give this talk, my third patient after I was trained in the O-Shot®… And I’ve got general surgery training and we do gynecology rotations and you learn about it in medical school. The third patient had lichen sclerosis. I had never seen it before to recognize it. Yes. Thank you, Charles. But this is a condition where the, the tissues just sort of adhesed together over the clitoris. You can actually feel it underneath there, but you can’t see it. And when you think about how to do an O-Shot®, it’s a bit perplexing and not something that you want to walk into.
Elizabeth Owings, MD (16:36):
My assistant had applied the lidocaine and I just came in to do the procedure. Very straightforward procedure, only it wasn’t. But it prompted me, I realized, I didn’t know nearly what I needed to know about the clitoris. I spent the next month, basically, downloading articles. I didn’t go back to the anatomy textbooks, because I’d already looked at them and they really weren’t helpful to me to really understand what was going on behind the scenes underneath the small, external portion of the clitoris, which is what anatomists tell us that the clitoris is, is just this tiny, external portion. And they’re thinking about… Do I have a pointer?
Charles Runels, MD (17:22):
I can give you the pointer. Hold on a second. Let me see if I can do that.
Elizabeth Owings, MD (17:26):
But just when they, in your anatomy books, they think of the clitoris is… Oh, there you are. Just this, the glans in the shaft. That’s all they think of as the clitoris. You may just want to point, Charles.
Charles Runels, MD (17:51):
Okay, I’ll point for you. All right. Let’s do that.
Elizabeth Owings, MD (17:54):
Okay.
Charles Runels, MD (17:54):
Take it back. Hold on one second. Got it. Okay. I’ll be your pointer.
Elizabeth Owings, MD (17:55):
Okay. Be my pointer. So the glans in the shaft is all it would be pointing at. That’s just that top, just the very, very, part of the glans and the shaft, but not the deep part is what they thought. So the deep part would be the legs of the clitoris that Charles is pointing to now. And you can’t see that from the outside. And so modern anatomists and ancient anatomists don’t really think of that as part of the clitoris. So it’s the easiest for me to understand it is starting with the sameness, the things that are the same about the female anatomy and the male anatomy.
Elizabeth Owings, MD (18:32):
And so the male anatomy, almost everybody has seen an erect penis, an erect phallus. You’re familiar with the fact that it’s firm. It’s supposed to be firm when it’s erect, and what makes it from are these two tubes that fill with blood. When it happens normally, that’s wonderful. And then sometimes people have to take medications to make that blood flow happen. And then sometimes of course, people actually have to take an injection. It’s injected into the tube to make the blood flow in there to make the penis hard. If a man has a penile prosthesis, it’s basically implanted where these tubes are to make it erect.
Elizabeth Owings, MD (19:15):
Well, females have those same tubes. They’re just mostly on the inside. So this is the male, that Charles has pulled up for us. There we go. The big circles on the top, when I was in a microanatomy histology class, they told us to think of the cross section of the penis as looking like a monkey. Two big eyes, and those are those tubes that get hard. And then the part down at the bottom is the part that surrounds the urethra.
Elizabeth Owings, MD (19:43):
And so in the female… And there it is, there we go. That’s a nice picture of how these tubes are very wide open, ready to fill with blood, ready to become engorged. And they actually are joined and are one space towards the end of the penis, towards where the glans of the penis is. And they separate down at the base and in the deep parts of the penis. There’s another picture of it. You got that up at the top, there’s this combined space, there’s a septum, but it’s got a lot of space in there where fluid can flow back and forth. That’s why when you do a Trimix injection for the penis to become erect, you only have to inject in one spot. And that fluid in the medication is active throughout that whole space. When we do our PRP injections, very shortly after it’s injected, it becomes a platelet-rich fiber matrix. It turns into a clot, basically, on the inside, but not the bad kind, not the kind that causes problems. This is the kind that’s basically generating those healing factors so that the function is going to improve.
Elizabeth Owings, MD (20:54):
I just always like to include this slide, because you can see that even in the glans penis, you don’t think of it as a tube. And you’re looking at the microscopic section. There are these big spaces in it. And when you did your Priapus shot, when you did that injection in the tip of the penis, which is a completely separate space from those two tubes that become erect. But when you do that injection in the tip, it doesn’t raise a bleb, it doesn’t raise a wheel. This is a great picture so you can understand that there’s the spongy part that surrounds the urethra, that leads up to the glans, and it’s spongy, even in a very erect penis, the glans will have some give to it. Where the shaft of the penis will not. That’s that those tubes that I was talking about that become erect.
Elizabeth Owings, MD (21:41):
The same thing happens in the clitoris. Those same tissues are all present. I love this picture, because this shows perfectly well where to put that shot. As soon as you see those side to side rugae in the vagina, just inside the hymen, even if you’re not sure if you’re looking at the hymen or not, if you see those lines going side to side, that’s the place where you put your O-Shot®. That is the O-spot.
Elizabeth Owings, MD (22:10):
The same thing on that right picture. You have a really good view now of where that O-Shot® goes, and then all of the deep tissues of the female that are all part of that clitoris. It’s all part of that clitoris complex. So it’s not just the tip, not just [inaudible 00:22:28]. So I just included this picture of me and my son out in front of a [Glendonhall 00:22:32] glacier, and there’s an iceberg down there. So just like they taught us about iceberg, most of it is under the surface. The same is true for the clitoris. Most of it is deep. The part that we see is a very, very small part of it. So go ahead into the next one.
Elizabeth Owings, MD (22:46):
And you can see this pretty well on the slide here. And if you think of this, what you’re looking at is maybe just a longitudinal section of the penis with a foreskin or prepuce surrounding the glans. Then that’s exactly what you’re looking at with the clitoris. And there are those two tubes that are going to make the clitoris hard just like the penis. It doesn’t stand up because of the way it’s constructed. A penis will stand up. The clitoris does not. It will become full and engorged, but it doesn’t stand up, just because of the way it’s constructed. We don’t need to look at that one. I like that next one though.
Elizabeth Owings, MD (23:25):
To just point out, this is a two year old child. This is fully developed. Just exactly like you would see in an adult. Go ahead to that next one. Again, great anatomical picture. The tip of the clitoris with the glans is what you would expect to see on the outside, with little shaft that’s going up. You might see that. But the vast majority of it is deep. So when you put an injection, not in the glans, but just behind the glans, you’re going into that tube, and the fluid will go all the way down. We’ve proven this on ultrasound. The fluid will go all the way down to the deep parts of the clitoris.
Elizabeth Owings, MD (24:04):
This is an MRI. This is a picture closest to the outside, and that’s why we call it the introitus and not the vagina on the line drawing right to the right. So these are 18 year old women who’ve never had a baby. And you can see where the vagina is. I love this MRI picture. Very clearly, you can see where the legs of the clitoris are deep, the glans and the urethral meatus right there with the introitus. That’s good. Just like that. Go ahead. There it goes.
Elizabeth Owings, MD (24:38):
A little bit deeper, the body of the clitoris they’ve got mapped out right there for you. And then the crura coming down side by side, and there’s the bulb of the clitoris. That is analogous to the corpus spongiosum in the male penis. And it’s there. I don’t think I’ve got the photomicrographs, but it exists all the way up to the glans of the penis, just like it does surrounding the urethra to the male. The urethra in the female just comes directly to the outside. It doesn’t have to track up to the glans like it does in the man.
Elizabeth Owings, MD (25:17):
There we go. And then deeper still, at the very top, you’ve got the mons. Right under that is the pubic symphysis, and right under that is the crus of the clitoris, and then the urethra. Under that, sort of with the transverse shape here, is the vagina itself. Go ahead to that next one.
Elizabeth Owings, MD (25:43):
This is one of my favorite views, because you really get an idea… They tilted it, it’s not exactly anterior to posterior. It’s tilted just a little bit so that you can see the entire body of the clitoris. You just get an idea of the glans at the tip, and then these deeper structures, all part of the clitoris that are surrounding the urethra and the vagina. And when you look at this picture, I think that’s when I realized anything that we do that makes those tissues more healthy and lens support to them… You expect your face to sag a little bit after 50 or 60 years, and probably every other tissue in your body is as well. So if you’re lending any support at all to these tissues, it’s going to support the urinary continence mechanism. It doesn’t make the muscle any tighter. It’s just lending support to these structures. They’re going to become not necessarily more engorged, but there’s just going to be more just basic tissue tone. Go ahead.
Charles Runels, MD (26:47):
Let me just throw one thing in there, Elizabeth.
Charles Runels, MD (26:51):
We have an MRI study that’s listed on the reference page of the O-Shot® that showed where a female radiologist, she did MRIs just like this of women who have trouble with orgasm and women who easily orgasm, and there was a correlation with the size of the clitoris and the distance of the clitoris to the vagina. So the bigger the clitoris, and the closer to the vagina, the more it correlated directly with ability to orgasm. So just stressing I like this picture as well, because the idea of anatomy just being for surgeons maybe isn’t right, because we all have to think about how the parts work together. I think that this picture explains why just talking about a spot maybe as the main thing isn’t exactly so accurate.
Charles Runels, MD (27:47):
It shows where this clitoral urethral complex, it also points out why the answer to, if you’re going to treat urinary incontinence, do you still treat the clitoris? I think there’s two reasons why you do. One is, as you’ll see in these upcoming micrographs, but especially the one that Elizabeth just pointed out, there was some contribution to the clitoris to the continence mechanism. And then of course if you’re going to treat sex, do you still treat around the urethra, because of what we just talked about with Dr. Grafenberg. Of course you do that as well. So I always treat both, whether the complaint’s sex or incontinence. And I think, as you just pointed out, Dr. Owings, that picture tells a lot.
Elizabeth Owings, MD (28:36):
The other thing that I’ve noticed is even if people don’t complain, if something improves, when they see you again, they will let you know. So maybe urinary incontinence wasn’t the chief complaint, but when they come back in six weeks or six months or a year, maybe it’s time for another one, or maybe I had more than one patient that said, “Well, I thought I knew how good sex could be, but it was never as good as this. And I don’t know how good it can be. Let’s do it again. Let’s have another O-Shot®.” More than one, and not all young, healthy people. One of my earliest clients was a 65 year old woman, and she was just really excited with how positive her sex life could be. Thanks for moving me on here.
Charles Runels, MD (29:28):
That was an accident, actually. Finish your story. That was an accident.
Elizabeth Owings, MD (29:33):
That was the end of it. She did not have a lot of complaints. She just wanted some improvements in the sexual function characteristic, but urinary continence got better, and sex got a lot better. And when she came back, I actually treated her nipples, because at that point, I didn’t know if it would be beneficial or not. She did not have any problems with her nipples. She had normal sensation, had never had surgery on her nipples, but she had better sexual arousal from nipple stimulation. It was not just a part of her sexual response. In her words, it was off the chart. The party line for PRP is going to be two or three weeks for the start, and then three months for full effect. She hunted me down in the gym at six weeks, because we went to the same gym, and said, “That nipple thing is amazing. I had no idea that was possible.”
Charles Runels, MD (30:28):
Wonderful. It’s good [inaudible 00:30:29] that. And you and I can go all night, I love it, with stories, but I’ve had some men want their nipples done. And second point is that if someone comes in and talks about, I just want it for urinary incontinence, we all know it, but I think it’s worth bringing it out in the light that can we all agree that sometimes people lie about sex, or they’re embarrassed to talk about sex, and they might use it incontinence as a ticket to be there as we often have our patients do, but they’re just embarrassed to say about the sex part. So it’s another reason why I always treat the clitoris, even if they’re there for incontinence.
Elizabeth Owings, MD (31:08):
Well, exactly. And this is my slide of the title Why Girls Don’t Compare Parts. It’s just that the clitoris, which is the part that’s external is so small and so deeply hidden between the labia minora and the labia majora, there’s a prepuce there. It’s just hard to see. But the truth is, if you look at it, if this is what you do for a living and actually you are paying attention, it looks exactly like a little penis. How do you make it bigger? You give the woman testosterone. And that’s the sex change. Surgeons taught us that. I think it’s probably a slide later on.
Elizabeth Owings, MD (31:48):
I went ahead and looked at the gross anatomy. What do the surgeons who were doing the dissections, what are they seeing? What does it really look like underneath the skin? And so you can see there’s the glans of the clitoris and the clitoral body, which we’re used to seeing on the outside. And then those deeper structures that crus, the bulb, and the way they wrap around. Wrap around the urethra with the vaginal vestibule right underneath it. They’re just right there together. Go ahead. Same thing here, a little bit kind of from the side, the crus is sort of coming down. This long, long leg that comes down straight.
Charles Runels, MD (32:24):
I really like this picture. It really I think shows how everything’s laid on top of each other.
Elizabeth Owings, MD (32:28):
And the bulb actually comes a little bit forward, and the vaginal introitus is sort of all the way on the right side of the screen there with the bulb in the middle, and then the clitoral crus on the side there. That bulb is wrapped right around the vagina with the crus just outside of it.
Charles Runels, MD (32:49):
Beautiful.
Elizabeth Owings, MD (32:51):
It’s the same picture. They’ve just turned it a little bit further.
Charles Runels, MD (32:58):
So I just want to rant shortly. How many of our colleagues think about the vagina as just a simple tube that leads to the cervix where you can deposit some semen? And how many people are taught all the way through college that that’s kind of what it is. And yet, when you see the elegance of the functional anatomy and what’s happening when there’s a penis here or what’s happening when various sexual or non-sexual activities go on. Obviously we all know it’s much more complicated than that, but I think showing and talking about this with our patients is very helpful. And with our colleagues.
Elizabeth Owings, MD (33:41):
Right. So again, it’s just a little bit of a different view, but the same concept. These pictures, I like, because you really get an idea. If you take the urethra and you look at the tissues around it, what are you looking at? And the answer is, so the urethra is kind of that hole in the middle. It’s got a U in it, and around it, you may see this. It’s erectile tissues around it. That’s where the deep areas of the clitoris are directly overlying the urethra. And then on top of that is the layer of muscle. And when that muscle is what’s responsible for our urinary… Well, that, and all the other structures. There’s no muscle that wraps all the way around the urethra like there is in the man. I’ve got a slide about that later. In the woman it’s just this band of muscle that’s listed up at the top and this… Go ahead to the next one. There we go.
Elizabeth Owings, MD (34:38):
SM is muscle. That’s it. And I counted it, because I’m that person. It’s about 30 cell layers thick. It’s not very thick. If you buy broccoli, that’s got that big thick, rubber band around it, it’s about that width, and about that thickness. It’s very thin, it’s not nearly as strong as that rubber band is, but it’s just not a very big muscle. And that is responsible for sort of pinching off the urethra against the anterior vaginal wall. So anything that you’re doing that’s going to lend some support to those structures on the on the inside, whether it’s the anterior vaginal wall, placing a platelet-rich fiber matrix right in between those tissues, that’s what you did with that deeper injection and the O-Shot®, when you can even actually feel it. It feels like a Walnut in there. That is going to support those structures for urinary continence. And I believe that that’s why the effects for continence are almost immediate.
Charles Runels, MD (35:44):
Elizabeth, something that I haven’t talked about that I’ve been trying to find more reasoning and a clearer picture about is that if you go to the sports medicine literature, PRP has been talked about quite a bit. It’s still debated about how effective it is, but when you injure muscle, as you know from your many surgery residencies, that it can turn to atrophy, it can be infiltrated with adipocytes or scar tissue. And instead of growing new muscle back, you’re left with this weaker structure. But you have a lot of research now showing that PRP can activate these stem cells that live within the muscle, mostly in the periphery of the muscle, that are just waiting to be activated to regenerate when there’s injury or stress.
Charles Runels, MD (36:42):
I’ve started to wonder if perhaps some of what we’re seeing with our great results with incontinence in my person is both the bulk that you just talked about and perhaps that we’re actually making these intricate muscles that we’ve just lumped together as the pelvic floor, but actually there’s all these different intricacies that are almost like the mast of a ship or something, with ropes going lots of different directions and lots of different opinions about which is pulling what. But the fun thing is when you just flood the whole area with PRP, and then you do your kegels or not, or you do your [inaudible 00:37:23] or not, we could be doing sports medicine in this muscle inadvertently, and without maybe thinking about it except when you show us these pictures and we say, “Oh yeah. Well, the erectile tissue’s important, the muscles are important. The blood flow is important. The nerves are important in both stress and urge incontinence.” And thankfully we have a material that makes all those things better.
Elizabeth Owings, MD (37:50):
It’s true. I’ve been blown away from the very beginning about what’s possible with platelet-rich plasma, and you can go back and forth about platelet-rich, platelet-poor, activated, not activated, leukocyte-rich and leukocyte-poor. It doesn’t matter. Ultimately, I find myself asking, can a human being, various functions, various portions be made better than they were with this as an adjunct? And I think the answer is very often yes. It’s not necessarily predictable who or where, but very often, yes. And I’ve had this more than once. “It’s never been like this before.” And that’s a happy thing for me.
Elizabeth Owings, MD (38:30):
This picture, this line drawing is my line drawing of the… The cross section is through the urethra that you just looked at the slides of just a minute ago, so that you can see there’s a spot right in between where the urethra is. The one big blob on your left is sort of the bladder. Ureter is behind that, and the vagina sort of underneath that. And then there’s this tract in between, and Charles talked about hydrodissection and we know that when we put our PRP in there, there is going to be some hydrodissection just based on where that is. I don’t think that alone would explain any urinary continence improvement, but I don’t know. I definitely don’t have the data on that.
Elizabeth Owings, MD (39:12):
But what this picture is just shows the darker area of the urethra is where all that erectile tissue is that I tried to show you in the cross section. And then a little bit further than that, a little bit closer to the end of the urethra is where that muscle is. Now, a lot of people have proven this. Going further back in there with your platelet-rich plasma does not make a better continence procedure. You still want your O-Shot® to go in the O-spot. That’s where you want your PRP to go, is just inside the most distal portion of the urethra, underneath the urethra just inside the vagina, just at that most distal point. Climbing in deeper does not do you any good. It does not help the patient.
Elizabeth Owings, MD (40:09):
It’s a beautiful artistic rendition that my friend Kent Rush did for the book. There’s some good pictures, but you just get the idea again. The clitoral legs are on the outside, and the bulbs are right there around the vagina itself. Go ahead to the next one. Same song. Second verse. Keep going.
Elizabeth Owings, MD (40:31):
This is the male sphincter. There’s really a sphincter. That’s that deep magenta thing marked SS around the urethra that’s marked U. It is truly a sphincter. It’s a band of muscle that goes all the way around the urethra. Women don’t have that. And the good news for men though, the P-Shot®, it can actually help that work better as well. I’ve helped a lot of people with, they’re just not functioning well, especially after prostate surgery. I’m not sure these men are getting what I would consider informed consent, but I don’t know. Anyway, the problems I think are much more common than people are led to believe. You may say that the incidence of this or that side effect is only 20%, but if it happens to you, it’s a hundred percent. So anyway, next slide.
Charles Runels, MD (41:21):
[crosstalk 00:41:21] placebo controlled study that I pushed out in another email with rats. And of course, with rats, you don’t have to worry about a placebo effect, and you can harvest the penis. But this is the third one I’ve seen where they looked at that, or they tried to model prostate surgery with nerve injury and injected the penis with PRP, and the other group got saline and then harvested the penis, and they saw repair. So anyway, I’m hoping one day, at least by the time my grandkids are grown, that PRP will be routinely part of the rehabilitation protocol [inaudible 00:42:03] prostate surgery.
Elizabeth Owings, MD (42:04):
I agree. So this female corpus spongiosum, let me just tell you why I included this slide. There is still a pervasive myth. It’s been in the medical literature for decades, for well over 50 years, that there’s no corpus spongiosum, but the glans of the clitoris comes off the corpus cavernosum because there is no corpus spongiosum. Once you know what the deeper structures are, and you’ve seen some of these photomicrographs, that’s obviously not true.
Elizabeth Owings, MD (42:40):
Somehow, Charles, this is… It’s slid off sideways.
Charles Runels, MD (42:48):
Oh, I did something wrong. I don’t know what I did.
Elizabeth Owings, MD (42:52):
So what they’ve done is given this woman testosterone and all portions of the clitoris have hypertrophied, including the corpus spongiosum. So the glans is pulled up by a suture at the very, very top. Point it up at the top. That’s it, right there. And the long strand right there would be what in a male would be surrounding the urethra. That would be the corpus spongiosum. This is a photo micrograph. It’s hard, I wish I had the pointer, but the bottom line is the corpus cavernosum are these two big round things, but the corpus spongiosum is there through the entire length of the clitoris all the way up. It’s submucosal, meaning if you’re looking at the outside of the vulva, you won’t know it’s there. You would have to do a dissection, but it’s there. The whole way.
Elizabeth Owings, MD (43:51):
Go ahead with the next one. This is [Ashazinsky 00:43:55], the guy with the hardest name to say, who said he dissected these out. I think you can probably only do this in Poland. Eight consecutive cadavers. And he dissected out this thing he called the G-spot. There’s an ongoing debate. If you go to PubMed.org, and just put in G-spot and anatomy probably it’ll come up. Helena O’Connell, the lady who did, I think, some of the gross anatomy dissections, and maybe the MRIs too, I can’t remember. I think she was also a partner on that study. Has gone through and done all these dissections and said there’s no such thing as the G-spot. But the debate rages on.
Elizabeth Owings, MD (44:39):
So if you look at this nice picture he gave us, because this thing that he found, which looks sort of like a thrombosed hemorrhoid, it is deep inside the vagina and right near the bladder. And so that might make you think, well, this is going to work better for sex if I go really, really deep with my O-Shot®. And again, it doesn’t. It doesn’t work for sex, and it doesn’t work better for incontinence. I don’t know why.
Elizabeth Owings, MD (45:06):
There you go. Those were those pictures for the lichen sclerosis. You won’t harm anyone by putting PRP in that. That is actually the treatment. I thought I could learn this, and I really think they belong in a center of excellence. I refer everybody to Kathleen Posey in Mandeville, Louisiana on the north shore above New Orleans. Someone once listened to my lecture, what you’ve heard so far, and said, “Well, we know why women have urinary incontinence. It’s because when they have a baby that this is torn and that is torn.” Which it set my teeth on edge because it’s obvious to me that there are plenty of women who’ve never had a baby that have urinary incontinence. And if I go to PubMed and just type in urinary incontinence, and nulliparous, I get a whole couple of… I don’t even remember how many. You should go look at it. Articles about where people have looked at this.
Elizabeth Owings, MD (46:07):
So anyway, we’re biased. We think that if you’ve haven’t had a baby, then you shouldn’t have as much incontinence as if you have had a baby. If you’re in shape, then you should not have incontinence. And if you’re out of shape, then that’s more likely. And if you’re old, then you should have more than young. And that’s not quite what we found at all, if you look at all these reviews from 1% to 42%, depending on various factors. Heavy women seem to have it worse. Childhood bed wetters and people who engage in high-impact exercise are more likely to. Even women without babies who’ve had… Go ahead to the next one. So even we find that women 18 to 40 who’ve never had a baby, are active and have a low BMI may have up to 23% urinary incontinence. Go ahead.
Elizabeth Owings, MD (47:01):
30% in athletes versus 13% in controls. These are young women, roughly median age, 19. 372 athletes and 372 age match controls. Their risk factors were high-level sport, a history of urinary tract infections, had family history of urinary incontinence, and constipation. And I think the family history of urinary incontinence goes along with maybe some anatomic features. History of constipation, I think probably as well as high impact exercise goes along with increased abdominal pressure. You’ve got all this pressure. Just think about jumping on a trampoline, just like jogging. A woman with urinary incontinence may never jog again. She may just walk. So that’s something that you can use to reach people and reach their pain. If they’re changing their lifestyle because of urinary incontinence, that’s a big deal. Go ahead.
Charles Runels, MD (47:56):
I think you just made a big point. How much leaking do you have to have before it counts as incontinence? Sort of like the question, how big does a boat need to be before it’s a ship? It has to be so big you cannot carry it across land. Now it’s a ship, not a boat. And the answer to how much leaking before you have incontinence… For you guys on the call, I haven’t tried to define that… Is if it interferes with your hygiene or your lifestyle. So you have to start wearing a pad or change your clothes, obviously, hygiene. If you stop something that you normally like to do, like your gymnastics or cheerleading as a teenager, which is 1 in 20 teenagers, in college people, or you can’t sit through your meeting at work, you’re changing your lifestyle. That’s incontinence.
Elizabeth Owings, MD (48:44):
Yeah. So many of these are similar. Go ahead and see if you can find a sister study. It’s not too much further ahead. Yeah, sisters. I love this. So they took post-menopausal women, and one sister had never had a baby and one sister had had a baby, and they found that the incidence was exactly the same. 47 versus 49%. That is not statistically significantly different.
Charles Runels, MD (49:08):
Totally unsurprising, huh?
Elizabeth Owings, MD (49:11):
Yeah. And then sisters had a high concordance. They were very likely to have the same situation. If one had normal continence, then the other one probably did. And the same thing for incontinence. Go ahead. And then the elite trampolinists. So this was fun. So 80% of the… These were 12 to 22 year olds. Mean age was 15. 80% during training, they would leak about an ounce. Started after two and a half years of training.
Elizabeth Owings, MD (49:41):
And if they put a pad in and tested, they found that it was a hundred percent over the age of 15 were leaking during their training event. So it’s not a sphincter, that urinary incontinence mechanism. There are a lot of parts to it. It’s much more sort of like a siphon, like a valve and not a sphincter. Because it can be overcome, just like the valves and the veins in your leg can be overcome if there’s enough pressure. So that’s what I wanted to say there.
Elizabeth Owings, MD (50:12):
Thinking about this in the future and how to teach this and how to think about this, I’ve been thinking about models. I think that’s where I’m going to be going. The direction I’m going to be taking is making a form of model where some of these parts can be snapped together and then unsnapped so that you’ve got not just a visual, but you can actually hold things in your hand and go, “Oh, this is how this goes together.” With perhaps various stages in, because it’s the same, maybe at eight weeks gestation, it’s exactly the same. You can’t tell the difference, whether it’s a male or a female. They are the same at that point, from the standpoint of what the tissues look like. And these changes come over time. Lots and lots of influences, and over the weeks, between 7, 10 weeks or so, things are changing so that eventually you can tell the difference, which is a boy and which is a girl. Usually. Those ultrasound people get it wrong sometimes.
Charles Runels, MD (51:20):
I’ve never seen such a low dropout rate. You’ve held everybody’s attention. I think this is the best clitoral anatomy… and I’ve heard others… lecture I’ve ever heard. And could I just have an email that people could contact, because I know that you teach classes. Dr. Owings will do a one-off class if someone wants to go follow her around and see how she thinks about her business. She’s in several different cities with her practice, so there’s some menu there to choose from. Could I just type an email address into the chat box so they can reach out to you?
Elizabeth Owings, MD (51:55):
Sure. That’d be great. E as in Elizabeth, P as in Patricia, Owings, O-W-I-N-G-S @gmail.com.
Charles Runels, MD (52:03):
Okay.
Elizabeth Owings, MD (52:03):
Am I supposed to do that or are you going to do that?
Charles Runels, MD (52:06):
I just typed it in. It’s all there. Thank you so much for being on the call. Anything else you want to throw out there before I shut it down?
Elizabeth Owings, MD (52:12):
No. No. Just looking forward to hearing from everybody. Thank you so much for your attention.
Charles Runels, MD (52:16):
Thank you, Elizabeth. You have a wonderful night.
Charles Runels MD started out as small town internist with a passion for science, a drive to excel and a knack for marketing. His career has been shaped by a series of challenges.
Today his name is synonymous with the most popular platelet rich plasma (PRP) procedures in the specialties of cosmetic dermatology, gynecology and urology. But that’s only the tip of the iceberg.
Relax and enjoy the fascinating story of a talented entrepreneur.
_____________________
I was looking through the most recent research about stress incontinence, and saw this really important paper that came out of Adelaide, Australia from some of our colleagues down that way. Stress incontinence is really a severe problem that people don’t think about. They think about it more of as a hygiene problem. But when you have stress incontinence, it interferes with your life. You have trouble sleeping. It can make it difficult to exercise, so you have weight gain. You’re up in the night, trying to urinate, so you’re not as rested the next day. It interferes with your focus at work. So it can be a problem that really changes your life.
That’s the definition of stress incontinence, if it’s a hygiene problem or it interferes with your life. It’s pretty common. Close to half of the women that are 50 and up, and it’s 1 in 20 of women in their twenties, so it’s a really common problem. It’s worth looking at because all the things that have been tried are useful. Some women are able to help this with Kegels. The surgeries are still an important tool that should be used when necessary. The mid-urethral sling, 90% of people get good results with that, only 10% have problems or have it fail. But the problem is that, with the surgery, there is some risk to the nerves that are involved with sexual response. And of course diapers are a last resort.
So there’s this new thing called the O-Shot®, where you use plasma, PRP, to inject it in the right place. These authors, they combine the use of our O-Shot® with a laser. So the lasers usually go about the thickness of a business card, not much thicker than that. So it’s not a really deep laser, but it’s enough to cause some changes and improvement in the structure and the health of the tissue, especially when you combine it with our O-Shot®.
So let’s look at what happened. I think this summarizes it the best. If you look at this picture, in the beginning, at baseline, the people who participated, 62% percent of them were frequently bothered by their incontinence, and 37% were bothered daily. But by the time they finished the study, it was more that shifted quite dramatically, so that you can see that many of them were not bothered at all or occasionally, and only 10% were daily, where it was more like 100% were either daily or frequently in the beginning.
The fun thing about this procedure is that, the procedure being both the laser and combination with the O-Shot®, is that the downside is minimal so that if it doesn’t work, you can still go to surgery. But if it does work, and we’re seeing over 90% effectiveness with either the O-Shot® alone or combined with the laser, and when it works, you see great results, with the side effect of sex getting better.
So I think it’s worth discussing this research with your physician. If you want to find someone who’s expert at the O-Shot®, check out our list of providers on our directory, those who are actually licensed to perform the procedure under the standards that we’ve come up with. So check out the research, read it, and share it with your doctor.
So stress incontinence is a really serious problem that can affect your life and in ways that are sometimes difficult to deal with it, both in your personal and your business life. It can make it difficult to focus at work. It makes it difficult to get through a meeting, difficult to travel without stopping, it wakes you up at night, it makes it hard to exercise because you might be leaking urine and you’re not sleeping well so it makes it hard to feel rested during the day so it’s a significant problem and a lot of research going on trying to find an in between.
The pills that you take can sometimes cause anticholinergics can cause trouble with constipation, trouble thinking and associated with dementia and surgery is a viable option but all of us would like to avoid surgery if we can. So here’s a really interesting study where they looked at successfully using autologous drive muscle STEM cells. Autologous muscle drives cells to grow, not STEM cells, but muscle drives cells to grow the bulk of the sphincter that helps a woman control her urine and actually it’s not a circumferential sphincter like a man, it’s more like a flap which makes it more difficult to hold urine and that flap is only a few cells thick so increasing the strength, just like you strengthen your bicep might help with that and that’s exactly what they showed; significant increase in sphincter volume as in a larger bicep muscle instead of larger sphincter volume or muscle to hold the urine in when compared with the placebo group.
So check this out. It’s not something that’s mainstream yet as far as being able to offer but you might want to talk with an alternative which does something similar which is using PRP. In the athletic committees have sometimes even banned platelet rich plasma because not only does it heal tissue, but can add sometimes strength to the muscle.
So it’s possible that one of the reasons our O-Shot is improving incontinence is because platelet rich plasma can increase the muscle strength as well as improve the health and the blood flow around the tissue. So a side effect could be improved sexuality response with orgasm or ability to have orgasm. So you might want to talk with your physician about this if they’re not a provider, there’s training on the website and we have a list of licensed providers on the website that are already trained, agreed to follow strict criteria and with the FDA approved devices.
It’s not for everybody but that’s who I would contact to find out more information about this or talk with your physician about becoming certified or licensed to do the procedure. Hope you find it helpful and you’ll share this idea with your physician or with someone who might be suffering with incontinence.
Charles Runels, MD: So urinary incontinence can be an extremely family and social disruption for you. Surprisingly common, it’s around half of the people by the time they reach 50. Half of women have incontinence and incontinence defining as interfering with your social life or your hygiene. You know a few drops doesn’t matter, but if you’re having to stop doing the things that you do or wear a pad that’s incontinence. And then occurs in one in 20 women in their twenties about 5% of women in their twenties. So young women may have to stop their cheerleading or their gymnastics because of incontinence. It’s not just from childbirth or from aging.
So it’s really important that we find better answers. We have surgical solutions, but before we go to surgery it’s nice if we can find something more quickly or acting with less trouble and less downtime.
So people are starting to look at using lasers. This is a really nice study that was published this month. Obstetrics and Gynecology Reproductive Biology, respected journal where they talk about using a laser. Now, the interesting about these lasers is that the depth of them is about the depth of two or three pieces of paper. It’s actually more shallow than a business card. So it’s really, a tiny pinpoint laser made holes that are in a grid, but it’s no deeper than several pieces of paper. So it’s reasonably safe and in the right hands it can really change lives.
So these people did this study showing that not only did it help many women with their incontinence, but it also as a side effect helped their sexuality. So worth looking at if you have this problem and asking your doctor about.
Now most of the leaders, and the thought leaders using lasers to help with urinary incontinence are also combining it with platelet rich plasma and a procedure called the O-Shot. And it seems to enhance the effects of it.
Lasers have been known to improve the results and the speed of healing for facial lasers for 15 years. So we’re seeing the same thing when you combine the laser with PRP. So ask your doctor about it. If you want to know more about it, there’s some links below this video to check out. Hope you find this helpful.
Charles Runels. Somewhere around one in eight women in the United States will eventually suffer with the effects of breast cancer. Thankfully most women who have breast cancer will survive it, but unfortunately they survive with some problems that might plague their love life. One of those is dyspareunia, or painful sexual intercourse, due to the fact that vagina may be dry with hormonal changes that are secondary to the treating of breast cancer. So it might be helpful to look at a couple of papers involving that.
This paper was published in SKINmed here on PubMed. You can see the whole paper if you click up here and find it. But these guys talked about using platelet rich plasma and how it uses the same technology, or the same bowel Segler strategies, that are used in the face and in growing hair, to help the tissue of the vagina become healthier, even when there’s no estrogen. Which it’s better to have estrogen on board, but if you can’t have it because of breast cancer, as much as you would like, this is a great way to help the tissue become healthier and more moist. And so this is one paper that talked about it.
Another one of my favorite research papers appeared in Menopause, a highly respected journal, where they use platelet rich plasma and documented that the pain from the sex went down because they were lubricating better after having an O sharp procedure done. So I highly recommend you forward this to anyone you know who may be struggling with this. There’s … breast cancer is … it’s not just about the cancer. It’s how it affects families and love relationships. So it’s a serious problem. And there are other ways to do it. You could use a lubrication, you could use lidocaine cream, but it seems to me nothing would be better than actually making the tissue healthier. So I’ll put links to this research below the video, and I hope you’ll share it with anyone who might be helped.
You might’ve seen this episode of the Housewives of Orange County that came out this month. A lot of press has been out and discussing what happened with Shannon Storms, and why she got the shot and what might be possible with it. I think might be helpful to actually go to the medical research and look at this paper that came out this year about actually seeing what happens with the behavior, and the sex drive and, the whole life of people who have platelet rich plasma injected into actually the ovaries.
So what this study did was they injected ovaries with PRP, which is just a … It’s the concentrate of the growth factors in the platelets of someone’s blood. And then they documented that the ovary started to create new hormones and creating a younger mindset within the woman’s body. Obviously your ovaries do more than make eggs.
They have to do with metabolism and how you think, and how things work. So they documented an improvement you see and clarity of thinking. Lots of things happened by waking up the ovaries. There’s also been recent studies showing that you can use platelet rich plasma to help a post-menopausal woman sometimes produce fertile eggs again.
But now what we do with our O-Shot®, what Shannon had, was instead of using it in the ovary, or instead of using in the face like with our vampire facelift, we’re using it in the genital tissue to restore blood flow and nerve function, and improve the sexuality and the urinary continence of women who might have problems with those things.
If you think this might be of help to you, I will put a link to the research below the video and also there’s a link to find one of our providers who would be happy to talk with you about it. I hope you found this helpful and you’ll send it to someone whom you think might be helped by it.
Hello, I’m Charles Runels. I’m a physician who’s been taking care of women, thousands of women for the past 20 years, and I’d like to talk with you about a really serious problem, which is how to have comfortable, enjoyable sexual relations as a woman who has survived breast cancer.
They say around one in eight women will struggle with breast cancer. It’s personal to me because I have women in my family who have fought breast cancer and I’ve taken care of a hundreds of women who have suffered with the problem. And imagine what happens in the heartache from having survived the cancer, and now having pain when you try to have sexual relations with your husband.
Well, the things that have been tried for that are legion because it’s a really disheartening thing. Unlike say, lack of desire or trouble with orgasm, pain will cause people to start to avoid each other. So, a woman can be deeply in love with her husband and start to avoid him because she loves him and doesn’t want to say no to him. Yet, if she says yes, there’s pain. And so, love becomes associated with pain.
What a horrible thing.
So what’s been tried are things like lubricants and numbing medicine. But imagine that, you’re going to have sex but you’re going to put on lidocaine cream so you can’t feel the sex. It’s been a really difficult problem to solve. You can put the woman back on hormones, but now she has comfortable sex, but has to worry more about recurrence of her breast cancer.
So, I was looking at this research which pointed out some of the … this is just out recently, and it points out that there are people now who are doing laser therapies, and they mentioned this warning, some of the laser companies about using this as a way to treat the problem. Actually to expand upon that, the warning was not having to do with the possibilities of it helping so much as it had to do with the laser companies making claims to try to sell the laser that were not approved by the FDA.
So physicians who are using these lasers are often getting great results. It’s just that the person actually selling the laser or the companies were not following proper guidelines. So, that’s a possibility that’s fairly recent that could be used in place of some of the estrogen therapies.
So, we’re having a really wonderful result with this. Over 85% of our women are getting better with this after an O-Shot® placed in the anterior vaginal wall to wake up the Skene’s glands (or the periurethral glands) and help that tissue become healthier and for more comfortable sex to happen without having to be on estrogen.
I recommend that you contact one of our O-Shot® providers and discuss, it may not be right for you. I’m obviously not your physician, but I want you to be aware of this as a possibility, and I hope that you find it helpful for you or someone you love. You’ll find links to this research below this video.
**The first study with biopsies showing benefit from PRP for lichen sclerosus (using the O-Shot® techniques). The dermatopathologists were blinded to the before and after treatments and benefit was shown… click to read<—(scroll to the next to last abstract)
**More research about lichen sclerosus treatment with PRP click to read<–
**Combining PRP with surgery for clitoral-hood phimosis from lichen sclerosus using O-Shot® techniques… Click to read<– (it’s on page S14)
A video that shows more and gives some details…
Find provider who will consider treating lichen sclerosus with PRP (RESULTS WILL VARY)… click<–(see the legend)
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.
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.
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.
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.
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.
1. Does the PRP always come from the patient’s own blood?
Always Always ALWAYS the PRP comes from the patient’s own blood. And the FDA approved kits are disposable, so we are always using a new kit to prepare the blood and then throw that kit away before we treat the next woman. Most of us even process the blood in the same room with the patient so that they can see that it’s always their blood. Hence, there is zero chance of them catching something from another person.
2. What year did the O-Shot originate and how many professionals have been trained to give it in the US?
Dr. Runels did the first O-Shot alone with his lover in early 2011 (after first treating many faces and treating his own penis (with the Priapus Shot® procedure) and the penis of other men—the anatomy and cell biology of the penis mirror the clitoris). Since then, over 1,000 physicians in the US alone representing most states (and other providers in over 50 countries) have been trained, and he’s trained faculty from 5 different medical schools in the US alone.
3. I’ve read about complications if PRP in general isn’t prepared correctly, but what are the potential side-effects related to the O-Shot?
2 Parts to this answer.
1. Serious side effects (infection, granuloma, scaring, death) do NOT happen (at least none reported after MILLIONS of PRP injections).
Anything can happen anytime. And no procedure is perfect (even antibiotics fail 1 in 5 times for those hospitalized with pneumonia). Also, the most simple of procedures can lead to complications. Patients can crash their car driving to the office…so just driving to the doctor’s office has a risk. But, if someone saw a life-threatening reaction to PRP—anywhere it may be injected other than the eye—it would be the first reported case.
Another important point…we are creating a “hematoma” of sorts by injecting blood into an area. This is not a drug, like morphine where the cells of the body start reacting differently, This procedure encourages healthy tissue growth.
During the first phase there can be side effects (good and bad) from the fluid injected and the resultant vasodilitation etc.
The actual benefits from the procedure happen with new cell growth which takes 3 to 12 WEEKS or more (in orthopedic procedures the full effects can be 6 to 12 MONTHS).
So, both side effects and benefits are likely to be temporary until the 12 week mark, then you have a better idea of the effects of the procedure. Even after that, there can be continued changed due to remodeling of the tissue prompted by the PRP.
Any benefits, problems, or side-effects seen in the first 3 weeks, are likely to be from the PRP injected —which all goes away! It’s the effects of the new cell growth that provide the lasting effects.
.
Of the over 9,000 research papers published on PubMed (click to see) about PRP, there has been no serious life-threatening side effects in any of those papers, which makes sense because you’re injecting the blood component that’s normally made to repair tissue. So, we are injecting what the body would normally make to recover from surgery. Regen alone (one of the suppliers of FDA-approved PRP prep kits) sells over one MILLION kits per year—so the number of procedures being done in general number in the millions.
2. We have seen a variety of less serious (nonlife threatening) side effects with the O-Shot® [Orgasm Shot®] procedure.
a. Women with recurrent vaginal herpes see the frequency and severity of recurrence go DOWN (they suffer less). The “side effect’ here is a GOOD effect. This decrease in outbreaks makes sense because PRP enhances the body’s immune system against foreign pathogens. The platelet activation is normally a part of the wound healing process, so it makes sense that there’s intelligence about the response (not a simple-minded growth of whatever’s there like if you throw fertilizer on your lawn). This goes along with the fact that those with acromegaly and abnormally high levels of growth hormone have 25% less cancer than the general population. There are healing effects in the growth factors that make the results good from normal tissue and detrimental to pathogens and abnormal tissue (hence the effect of helping scars go away by remodeling the tissue back to a more normal configuration click).
b. Some women see hyper-sexuality that can be very very intense requiring almost constant sexual activity and not relieved well by orgasm. This happens in less than 1% and has never persisted more than a few days.
c. We’ve seen 6 or so reported cases (in over 50,000 procedures) of decreased ability to have and orgasm. We think this is happening from the effects of the edema caused by the injection. PRP has been shown to heal nerve tissue (click to read), so the PRP should not be damaging to the sensation. Is there micro damage in these women from the needle? Possibly, but not likely since there are multiple small nerve fibers, not one main nerve in the area we inject. Could the decreased sensation in these six women be related to something else going on with the woman? For example, one woman said the procedure caused back pain, but on a closer interview, it turns out that she and her husband were having such vigorous sex after the shot from her improved libido that she had a muscle injury that got better with a few days rest. Another woman thought the procedure CAUSED urinary incontinence, but on a closer interview, she simply had ejaculation with orgasm for the first time. Still, for some reason, we’ve seen sensation go DOWN instead of up in 6 reported cases, In all cases except one, the sensation came back to normal after 3-12 weeks.
d. The development of ejaculation with some orgasms.
e. Urgency, and frequency of urination for a few days.
f. Pain during injection. Usually, we can keep the pain at or near zero, but sometimes, just like at the dentist, the anesthetic may not be perfect.
g. Spotting after the injection. It IS and injection in the vaginal opening—where there’s much blood flow—so we she may see a few spots of blood.
h. Sexual arousal with urination for a few days.
i. There can be a change in the relationship. When a woman’s libido goes up, if her partner is not healthy, there can become a mismatch in sexual libido. If she now wants to have sex more than her partner, that can cause some tension. Better sex does not always mean a more peaceful relationship, though with most couples it does help.
k. If the woman is being treated for sexual problems and suffers with urinary incontinence, she will often see the “side effect” of the urinary incontinence going away.
Not all women will qualify for this research project. Please consider helping if you do qualify.
Filling out the following form applies you for the option to participate in a double blind placebo controlled study of the use of the O-Shot® for the treatment of female sexual dysfunction. Your treatment, should you be accepted, will be free. Your information will never be shared. If you qualify, you may be contacted by text message or by phone.
We need more research to help women cure sexual dysfunction. There will be other projects; filling out this form tells us that you may be interested in participating (not all will qualify for this study but we will notify you of future studies). Become a hero to your daughters and nieces and to all women of future generations by helping us with this research.
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.
I’m going to go through a whirlwind look at research that’s been done where people have used PRP to help with sex. Much of the research has been done by the people in our group, and I’ve described many of them in this room who have done this research. It’s a for-profit organization, but we pay for research, we pay for education, we pay for marketing for our providers. Just to echo what you just heard, sex is much more than about just having fun. Rainer Maria Rilke said it’s just so correlated to the creative experience that it’s affecting how we do our work, how you do your presentation, and how – of course – relationships and families.
I want to echo that sentiment, and remind us that back in 1980, if you look in ‘Urology’ – this was ‘Urology’ 1980 – the most common cause for erectile dysfunction was thought to be 85% psychogenic. Here’s a quote from ‘Urology’ where urologists were encouraged to become counselors, because most of erectile dysfunction was thought to be psychogenic. Of course, I’m echoing the penis stuff because if you take a penis and shrink it and unzip it, that becomes a clitoris. I’m thinking most of the research will eventually apply to that. Certainly, our attitude is applying because we’re back in the … We’re not, I’m preaching to the choir, but many of our colleagues are back in the 1980’s and saying the main thing we have for sexuality for women is counseling.
My thinking that perhaps, as you guys do, some of the pathology that applies to the penis may apply to the clitoris, and maybe some of these women are suffering from actual genital histopathology, not just psychogenic problems. We have this one FDA approved drug now for female sexual dysfunction that’s a psych drug, flibanserin. It’s a useful drug, but obviously, we need much more and maybe we should think in terms of systems, like we do for the rest of the body.
Platelet Rich Plasma.
Obviously, this is not a new idea. This is from, this month, over 9,000 papers indexed in PubMed about platelet rich plasma. Our orthopedic colleagues, our dentist, our facial plastic surgeons have worked with this, and all we have to do is take their ideas and then hopefully people in this room will extend what I’m about to show you and just take those ideas and adapt them to the genital space. Here’s some of the growth factors we know about. There are many more. They have these effects. These are good things for the genitalia. Down-regulating autoimmune response, proliferation of fibroblasts, new angiogenesis, the adipocytes enlarge and multiply – think labia majora, collagen production, neurogenesis and maybe some glandular function.
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.
We have commercially available methods for preparing it, within 5 or 10 minutes of the bedside, and the devices are FDA approved. So you guys don’t get confused, obviously the FDA does not approve your procedures. That’s a doctor business. They don’t approve blood that belongs to you, just like your spit and your saliva and your skin. They tried, at one time, to control eggs and the gynecologists said, “Hell no.” So they don’t control eggs and they don’t control blood, but you should use an FDA approved device if you do this [approved for preparation of PRP to go back into the body].
Autoimmune Disease
Here’s some of the ideas about down-regulating autoimmune response. We have split-scalp studies showing that PRP helps alopecia areata better than triamcinolone. More hair growth that comes in thicker. Here’s rat studies looking at rheumatoid arthritis. What do we have in the genital space? We have lichens sclerosus. We did some before and after pictures where you use stem cells mixed with PRP, and before and after pictures show improvement. Of course, that’s two variables because you have stem cells and you have the PRP.
We took the same idea and just used PRP. Andrew Goldstein worked with me on this, and we had two blinded dermatopathologists. The protocol was biopsy, PRP, wait six weeks later, another PRP injection, and then six weeks after that, another biopsy. Two blinded dermatopathologists out of George Washington University did not know the before or the after. We showed statistical improvement in both the histology and symptomatology. Here’s our histology. You can see obviously, that’s the same magnification and we’re showing decreased hyperkeratosis. That’s obviously healthier tissue. A layperson could tell that’s better. Of course if you look at the gross pictures, lady on the left as you guys know, she has pain wearing her blue jeans. The lady on the right is back to making love to her husband. They’ve invited me into their close Facebook groups and I saw a post a few months ago. Quote says, “I was sitting next to my husband, whom I love, last night. I was afraid to hold his hand because I was afraid he would become aroused and I’m bleeding and hurting today.” That’s what you guys are helping.
We published that in ‘Lower Genital Tract Disease’. We extended it because it worked. We published this past January in the journal of the American Academy of Dermatology. You have some science to go do this now.
One of our providers, Kathleen Posey, who’s a gynecologist out of New Orleans, took this idea and then she said, “Let’s do some dissection in the office”, and she presented this in Argentina, published it in the same journal ‘Lower Genital Tract Disease’. Here’s one of her patients, where you can introduce [inaudible 00:06:44]. It had been 12 years since she had had sexual intercourse, penis and vagina intercourse, with her loving husband … 12 years. She was being followed by a dermatologist on high dose clobetasol. Kathleen dissected it out in the office and then injected PRP … 8 weeks later, she’s having comfortable sex with her husband. She’s now 3 years out. She’s had to be treated with PRP, not repeat surgery … PRP now, 2 other times a year apart to maintain that result. She now has a series of 60 or so patients that she’s now going to publish with similar results, where she’s dissecting out – as you guys know how to do – treating the [inaudible 00:07:27], but then following that with PRP injections to help the healing and decease the autoimmune response.
That same doctor, Casabona, repeated his study with lichen sclerosus in men [BXO], and showed with just PRP alone … This study of 45 men with repeat treatments … It is cumulative, 2 to 10 treatments, the same thing. All of them stopped their steroids. None of them started back. Only one went on to have circumcision.
Peyronie’s
Peyronie’s disease, another autoimmune disease … This came out this month out of Wake Forest, where they took men and they followed their results with Peyronie’s disease. Not only did their Peyronie’s improve statistically, but they also improved their erectile dysfunction by 5 on that scale of 5 to 25 that the urologists use. For some reason, thankfully, they threw in one woman just for good measure, and showed that it helped her incontinence. They just tucked that in as an aftermath.
Ronald Virag, as you guys know as the legendary vascular surgeon who was first to present the idea of intracavernosal injections for erectile dysfunction, out of Paris. His big thing now is PRP for Peyronie’s. He just published a study where he showed that this is comparing PRP with Xiapex, which is a $50,000 series of injections, FDA approved version of collagenase. He showed that PRP works better with few side effects. There’s a risk of about 1 in 30, that actually go from a bent pencil to a fractured pencil and a limp noodle. You don’t see that with PRP. You see the side effect is the erectile function improves. He showed the same thing, actually, in his studies that erectile dysfunction improves by an average of about 7 on that 5 to 25 point scale.
Wound Healing/Scar Resolution
Let’s think about the [inaudible 00:09:29] literature. Look at this, there’s so much of this out there. This is looking at post-operative adhesions, lots of studies looking at scarring with microneedling and PRP. This is a split-face study comparing PRP with microneedling verus PRP … Excuse me, microneedling with saline or Vitamin C serum and split-faced studies in PRP wins. Dr. Sclafani did some studies in the cosmetic space looking at increased collagen production and fibroblast activity, and never a neoplasia documented. People worry about that. This is not indiscriminate blindness blind growth. You don’t worry about carcinogenesis when you do surgery and it’s the same PRP that’s causing healing. There’s actually some helpful immune processes that go on, that you could argue actually might help prevent cancer. I’m not going to make that argument but it might need to be made one day.
If you look further, here’s a wound healing study looking at reepithelialized exposed bone and tendon of the foot and ankle. When I took that and applied, this is a hypertrophic scar that was a year old from cortisone, and then using PRP and Juvederm or HA filler, this is a few days later, a month later, and that’s a year later. Now, take that and think, “How could I use that in the genitourinary space?” Doing that anecdotally, we have many of the members of our group are seeing help with episiotomy scars or dyspareunia, pelvic foreplay instead of injecting that pelvic floor tenderness with triamcinolone. Physiatrist for the past ten years has been using PRP, your sports medicine doctors. Now, when you palpate it, consider injecting with PRP instead. Dyspareunia from mesh and that unknown dyspareunia, we’re seeing this is where we need you guys to help extend the research. The science is there that it should help and it seems to be helping. Not 100%, but about 80% in people with dyspareunia.
Mesh Pain
Here is a look at a gentleman who did … He took the mesh out and then he patched the hole with a gel form of PRP and showed benefit. We’re finding anecdotally – no one’s done this study yet, here’s another one for you to pick up … I’m giving you low hanging fruit. We’re seeing anecdotally that if you inject in the distribution of the pudendal nerve, which seems to be inflamed in some women with mesh pain, that their pain will frequently go from 9 out of 10 down to 1 or 2 out of 10, without even taking the mesh out. Just another place where we need some research done.
Interstitial Cystitis
Here, we have rat studies looking at inflammation. Let’s think about this one. Here’s a rat study where they modeled cystitis and we are seeing in chronic interstitial cystitis without even infiltrating the bladder, just infiltrating in the periurethral space, some of our women are getting better. I’ve had two separate urologists call me and say, “Charles, I can’t believe it. I was doing this and expecting not this to happen. I have these patients now who have had chronic interstitial cystitis pain for years, and it’s gone.” Not 1005 but finding out who’s going to respond and who’s not and why, there’s a lot of variables that need to be thought about that you guys will hopefully do the research.
Penis Growth
Here’s a study that came out in the ‘Journal of Sexual Medicine’, where a guy took … the [inaudible 00:12:51] men who have an erection of 3 inches or less and then he treated them with PRP, combined with a pump, and showed that if you repeated it every time you did it, it grew by about 7 millimeters. I’ve always thought if I could give you a guarantee half an inch to an inch with anything, I’d get my picture on a postage stamp. I don’t have that yet, but I can tell you that we’re seeing about 60% of the time we do this procedure, men will see some sort of growth.
If you look at the neovascular space, there was a study out of Southern California that was published in the ‘Journal of Sexual Medicine’ where they transferred adipocyte stem cells to the penis of diabetic rats. They showed new endothelial cell growth and increased nitric oxide activity in the dorsal nerve. Would that be helpful in the clitoris? Probably, but the interesting thing is the adipocyte-derived stem cells were attacked and they died. The postulate was the improvement was from the growth factors.
Penile Rehabilitation and Erectile Dysfunction
I have seen what [inaudible 00:13:52] have seen in that when you inject this in the penis, erectile function goes up on the average of about 5 to 7 per injection. Think about nerve repair. We have rat studies modeling prostrate surgery, showing that the nerves improved with PRP and so we have, again, another clear place where we need studies if you add this now to the usual protocol for rehabilitating the penis post-prostate surgery … would you see benefit? We have seen that in some of our patients who are a year or two out who failed the rehabilitation part of that. Would that help your patients who have, say, numbness and decreased function from riding their bikes too much, or trauma? I don’t know, but it’s worth thinking about and publishing research about.
In thinking about where to put this, where we do our O-Shot, when we do PRP to the anterior vaginal wall, we’re putting it as distal from the bladder as possible. We found that it works better. We’re essentially making a liquid sling. Think infiltrating and getting ready to put in the mesh. That’s what we’re doing. Very simple, only we’re using a material that has never caused a granuloma ever. Doing that, frequently our patients will have their incontinence go away that day from the actual liquid and as it’s replaced with new tissue, it never recurs. Usually, you’ll have to repeat the procedure at a year or two out depending on the etiology. Sometimes it lasts longer.
The interesting idea is what might be happening with those [inaudible 00:15:21]. They become more active, and does that help with sexual function? The other place we put it is in the actual corpus cavernosum of the clitoris. We use [inaudible 00:15:29] ultrasound visualization and see it flow down into the body of the clitoris by the pubic ramus and the wave form goes to what you see in a flaccid penis to what you see in an erect penis.
Improved Orgasm & Libido in Women
That’s my time, almost done. Just 30 more seconds. Here’s a pilot study we did where we showed that in women with female sexual distress, that it dropped by an average of 10 and female sexual function went up by 5 when you do what I just showed you. Here’s a study that Dr. Neto, who may be here, published where he looked at incontinence and sexual function down in Brazil and showed that 94% of the people loved it. The question here is how would you combine it with your energy source? It works great in the face if you do laser and follow it with PRP … better results, faster healing. Is it going to … We need people to help us work out the algorithms. Not everybody has laxity, but when you have something, when do you use which treatment and when do you combine it with PRP? We need those answers, because I don’t have them yet. This is possible helps.
I am done. Thank you very much for having me. I put all these references at that website, if you want to go download them. Thank you. You guys have a wonderful conference.
Dr. Marco Pelosi III: Thank you Charles. Beautiful
Not all women will qualify for this research project. Please consider helping if you do qualify.
Filling out the following form applies you for the option to participate in a double blind placebo controlled study of the use of the O-Shot® for the treatment of female sexual dysfunction. Your treatment, should you be accepted, will be free. Your information will never be shared. If you qualify, you may be contacted by text message or by phone.
We need more research to help women cure sexual dysfunction. There will be other projects; filling out this form tells us that you may be interested in participating (not all will qualify for this study but we will notify you of future studies). Become a hero to your daughters and nieces and to all women of future generations by helping us with this research.
Though I invented the O-Shot (R) procedure, I count that as worthless unless physicians and nurse practitioners actually learn to do the procedure and offer it to suffering women around the world.
Charles Runels, MD
Inventor of the O-Shot (R) Procedure
Physicians (& physician extenders), if you are interested in applying to join our group of providers or in simply learning more about the procedure, please supply your information in the following form. I will personally provide (1) a printed copy of the book (Activate the Female Orgasm System: The Story of O-Shot®), (2) relevant research, (3) explanatory videos & (4) make my self and my staff available to you by phone.
Sex educators & family counselors are critical to the healing process and I would be honored to also supply information to you (only physicians and their extenders can do the procedure).
The following video explains the history and some of the logic of this research…now open for the enrollment of 30 women suffering with lichen sclerosus (free treatment for those who qualify)….
Here’s the official details of the study as approved by the Institutional Review Board….
You are being contacted because have expressed interest in participating in a research trial using Platelet-rich plasma (PRP) for the skin disease lichen sclerosus. PRP is a platelet concentrate that helps to speed up tissue healing, without serious side effects, in a very wide range of medical conditions such as diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP works because of its high level of proteins that help with wound healing. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects. As the PRP is prepared from your own blood, there are no risks of allergic reactions, transfusion reactions, or infections (HIV, Hepatitis, etc). We will be enrolling 30 women with active, biopsy proven, lichen sclerosus. This is a placebo-controlled study so you will have a 66.6% chance of getting the PRP and 33.3% chance to get the placebo. Neither you, nor the study doctor, will know if you will get the PRP or placebo. The study is only being conducted at the Center for Vulvovaginal Disorders in Washington, DC. There will be 4 study visits in a 14 weeks period. Small biopsies will be performed at the beginning and end of the study. PRP will be injected in areas of active lichen sclerosus two times during the study. No additional treatments will be allowed for 12 weeks prior to enrolling in the study and during the 14 weeks of the study. No compensation will be provided for participation in the trial. Please read the informed consent at www.CVVD.org/research_studies very carefully before contacting Leia Mitchell at DRG.CVVD@gmail.com. Please be aware that the Center for Vulvovaginal Disorders is the only center conducting this study and its only being conducted in our Washington DC office. If you cannot travel to Washington DC for the 4 visits, you will not be able participate in this study. It is also possible that you may have to come in prior to the study for one visit to confirm that you have active lichen sclerosus. Lastly, we cannot give you referrals for treatment by other physicians.
Sincerely,
Ms. Leia Mitchell The Center for Vulvovaginal Disorders
If interested in participating in this current project (only 30 will be accepted) then do 3 things…
1. If you have lichen sclerosus and can travel to this address 4 times (click to see where you’ll be going), then fill out the following form (this is password protected in a HIPPA compliant encrypted server. Only Dr. Runels, Dr. Goldstein, and his staff have access to the data)…
If interested in participating in future research with lichen sclerosus or other female sexual dysfunctions, or in being kept up to date about result, then fill out the following form….
