Section 3. Lichen Sclerosus

As a reminder, the horrors of severe lichen sclerosus can include all of the following and more:

  • phimosis of the clitoral hood with decreased sensation and anorgasmia
  • decreased blood flow,
  • fissures (pain),
  • itching to the point of torment
  • bleeding & pain with walking,
  • pain, bleeding, & tearing with defecation,
  • pain with urination,
  • pain and bleeding from wearing jeans (any tight clothing),
  • pain, bleeding, and tearing of tissue with sex (dyspareunia), often causing years of being unable to tolerate any penetration even if aroused,
  • secondary loss of libido when sex becomes associated with pain,
  • permanent destruction of the labia (especially in prepubescent girls),
  • all of the above torments can lead to loneliness from broken and strained love relations,
  • which can lead to broken families,
  • depression,
  • loss of self-esteem,
  • an overall painful day-to-day life.

In other words, imagine trying to enjoy just about anything while your genitalia is hurting, cracking, itching, and bleeding.

Here’s a photo of what many women who suffer from LS wake to find between their legs in the morning (often) without hope of relief after years of the usual daily clobetasol.

They also can look forward to a ten percent chance of squamous cell carcinoma with the resultant needed vulvectomy.

Lichen sclerosus is thought to be caused by the autoimmune process, hence the usual treatment—a strong topical steroid cream, clobetasol.

Unfortunately, even with clobetasol, many women continue to suffer both the tormenting symptoms and the 10% risk of squamous cell carcinoma. We need a better way.

Since the O-Shot® procedure utilizes PRP, to understand how the procedure may help those suffering from lichen sclerosus, consider all of the following:

  1. The effects of PRP on the autoimmune process,
  2. The effects of PRP on scaring,
  3. The effects of PRP on wound healing,
  4. How the O-Shot® procedure may be modified to best treat lichen sclerosus.

PRP Down-Regulates the Autoimmune Response

In thinking about the use of PRP for use in lichen sclerosus, consider other autoimmune conditions in which PRP has been shown to down-regulate the disease process.

Vitiligo treatment usually involves steroids or melanocyte transplantation, both of which can lead to unsatisfactory results. But, studies showed a dramatic improvement with PRP.

Also, alopecia areata (usually treated with steroids) responded better to PRP than to steroids in more than one study, with more and darker hair follicles when using PRP compared with steroids.

For rheumatoid arthritis (also an autoimmune process), studies demonstrated that PRP did all the following:

alleviated arthritis, and reduced humoral and cellular immune responses, leading to beneficial effects on histological parameters as observed using joint tissue histological staining. CIA mice treated with PRP exhibited downregulated expression of IL-6, IL-8, IL-17A, IL-1β, TNF-α, receptor activator for nuclear factor-κB and IFN-γ in inflammatory tissue. In addition, VEGF, PDGF, IGF‑1 and TGF-β expression in peripheral whole blood was increased following treatment with PRP. The serum concentration of anti-collagen antibody was decreased in PRP-treated CIA mice. In conclusion, CIA mice treated with PRP exhibited beneficial effects, including decreased joint inflammation, cartilage destruction and bone damage, and increased repair (Tong2017).

Even experimental autoimmune encephalitis and Bell’s Palsy (both autoimmune in etiology) have shown benefit from PRP.

With benefit shown in these and other autoimmune conditions, it is within reason that PRP may be of help in attenuating or arresting the autoimmune activity and the resultant progression of signs and symptoms of lichen sclerosus.

PRP Remodels Scar Tissue into Healthier Tissue

With the recurrent cracking, bleeding, and sclerotic changes that plague women with lichen sclerosus (LS), even if the LS is magically turned off, there is still a need to remodel the scarring from the previous activity of the disease.

PRP has been used to treat acne scars, postpartum striae, cleft-palate-repair scars, and even the scars left from devices used to treat breast cancer patients.

With the breast cancer patients, there was even seen an increased survival rate in the women who received the PRP; the authors considered it coincidental even though the benefit was statistical (Eichler2022). It’s too early to claim from this one study that PRP can protect against recurrence of breast cancer; but, similar data was seen with fat transfer for reconstruction after breast cancer. Two studies showed those who received fat (usually mixed with PRP to improve survival of the fat) showed a trend toward prolonged survival; in these two studies, the increased survival was measured but not statistically relevant. Still, these and other studies indicate that PRP is, at worst, safe in the face of women at high risk for recurrence of their breast cancer.

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This discussion regarding the lack of increased risk of neoplasia when using PRP is significant considering that ten percent of women with lichen sclerosus will develop squamous cell carcinoma as part of the progression and ongoing disease activity of the lichen sclerosus. One might postulate that with decreased disease activity that results from the use of PRP in some women, the risk of squamous cell carcinoma might also be decreased.

Even in women who use clobetasol like a religion, women still face a 10% risk of squamous cell carcinoma, and little is known about the effects of chronic use of clobetasol on the recurrence or occurrence of other problems like HPV (since chronic steroids could affect the local immune system). But, the fear that PRP its self may propagate neoplasia should be addressed and has been; as of yet, thousands of studies have indicated that neoplasia is not a risk when PRP is used. A growing number of studies indicate (but do not conclusively prove) that PRP may decrease the risk of neoplasia; long-term follow-up in those with lichen sclerosus needs to be done before we can claim a decreased rate of progression to squamous cell carcinoma in women who use PRP for treatment.

PRP Promotes Wound Healing

Just pretend for a moment that you have a magic wand and that if you wave that wand over the diseased tissue of a woman suffering from lichen sclerosus, then her disease activity will immediately go quiescent. Now consider this: what if your needle becomes like a magic wand for many women when you fill it with PRP? Now, you wave your magic wand, and the autoimmune process of the lichen sclerosus shuts off.

Does the woman immediately feel immediately well if you instantly turn off the disease activity?

Not at all, because she would still be left with the ravages of the process; before feeling well, she would need to replace sclerotic tissue with healthy tissue, to heal fissures, and to regrow blood vessels into the damaged tissue.

So, in effect, she would need to heal the wounds of the lichen sclerosus before she would enjoy a healthy vulva, even if you magically and instantly shut off the lichen sclerosus. Unfortunately, cortisone (used by most women to treat lichen sclerosus) delays wound healing. In comparison, a material (PRP) that both shuts off the overactive autoimmune process (and therefore shuts off the lichen sclerosus) and also promotes (rather than delaying) the healing of the damaged tissue could provide a remarkable synergy of benefits.

As we have discussed in previous sections of this report, the primary work that led to the widespread use of PRP and to the development of the devices used for the preparation of PRP began in the effort to heal surgical wounds in avascular areas like the cartilage of the knee and the bone in oral surgery. This idea of healing avascular surgical wounds with PRP extended with the publishing of many papers regarding the use of PRP to promote the healing of hard-to-heal wounds in the distal extremities of those suffering from diabetes.

Before using PRP in the genitals, I developed a method of using PRP in the face, the Vampire Facelift® for cosmetic purposes and many papers were published regarding using PRP in the scalp for reviving hair follicles. With cosmetic procedures and with hair regrowth, we are not healing a wound; instead, we are starting the cascade with PRP that would occur if there were a wound, with the result that healthier and younger-appearing tissue develops.

With lichen sclerosus, we not only face an active autoimmune process that creates sclerosis and blood vessel destruction, we also face the secondary wounds of fissures and excoriations. So, using PRP to help heal these wounds could be of great benefit.

PRP Helps Some Women with Lichen Sclerosus (both with and without phimosis)

When I first met Dr. Andrew Goldstein, he was lecturing to the International Society for Women’s Sexual Health regarding a genetic marker that could predict which women might suffer dyspareunia as a complication of taking birth control pills (yes, this is a known complication). He also revealed to the audience that he was in the process of passing a kidney stone while he was giving the lecture! I found his lecture to be brilliant and his grit to be impressive.

So, after his talk, I approached him about the possibility of doing research together. Knowing of my work with the O-Shot® procedure, he suggested we do a study regarding the use of PRP for lichen sclerosus. At that time, Dr. Casabona had published an article demonstrating that stem cells would improve lichen sclerosus but no one had published anything regarding PRP for LS.

I agreed to sponsor the study on the spot, and we exchanged numbers.

Some months later, we published a study where women suffering from LS were biopsied, treated with PRP, and then surveyed for changes in symptoms and re-biopsied. Two dermatopathologists with much experience with LS were blinded to which was the before and which was the after biopsy. Both the surveys of the women and the biopsies demonstrated a statistical improvement in lichen sclerosus after treatment with PRP. We then extended the numbers of women in the study and published a second paper—also showing a statistical benefit to PRP for LS. These were the first two studies to show the benefit of LS after treatment with PRP using a variation of our O-Shot® procedure.

Then, after our second study, a woman who suffered with lichen sclerosus and who had been greatly helped by PRP, sponsored a third study. In this study (done without my participation), saline was used as a placebo. In other words , the women in one group were injected with PRP and the women in the second group were injected with saline.

Ironically, in this third study (sponsored by a woman who’s LS improved after treatment with PRP), where saline was used as a placebo, there was no statistical difference between the placebo group and the PRP group; but, 50% of the women in the placebo group improved!

In short, both groups got better, and the group that was injected with PRP did better than the saline group; but because there was such a strong response rate in the “placebo” group, there was not a statistical difference between the two and the authors concluded that PRP does not work.

Put another way: a generous woman suffering from LS who got better with PRP paid for a study of treating LS with PRP—and the authors she hired concluded that there was “no benefit” from PRP, the same treatment that got the woman financier well.

I think something more important was shown by the study than that PRP does not help LS: the research further demonstrates the idea shown by others that saline, when used for hydrodissection, is not a placebo. Saline can even be used to treat scars and even to decrease pain.

Especially when saline is injected in such a way that it causes hydrodissection, there can be measurable changes in the tissue resulting from the resultant micro-trauma followed by post-op healing.

So, in this third study, Dr. Goldstein and his collaborators concluded (in contradiction to our previous two studies) that PRP offers no benefit. But, this was a study with biopsies, not simply a survey; I cannot find another study of LS where 50% of the placebo group improved on biopsy. I think that Dr. Goldstein showed something more important than what he reported; I think his study showed that hydrodissection alone precipitates changes (as has been shown with other conditions) that improve LS and that PRP can be used for the hydrodissection for benefits measurably better than saline alone.

In other words, I think what Dr. Goldstein showed was that, with our O-Shot®, there is not simply a biological effect from the growth factors; there is also a mechanical effect—essentially a surgical effect—from the mechanical hydrodissection of injecting the PRP.

I have tremendous respect for Dr. Goldstein and his knowledge of lichen sclerosus, but I think my interpretation of his research can be different than his and still maintain great respect for his work. 

Put simply; the O-Shot® is a mechanical procedure combined with a biochemical cascade.

Other studies have since been published showing that PRP can improve lichen sclerosus.

The O-Shot® for Those with Phimosis

A woman of fifty-three years old came to my office because she had been unable to tolerate her husband’s penis for 7 years because of her lichen sclerosus. She was using daily clobetasol and being followed by her dermatologist with regular visits for the entire 7 years.

In addition to being unable to tolerate more than about two inches of one of my fingers inserted into her vagina because her clitoris was completely covered by her phimosed clitoral hood, she reported that she enjoyed very little pleasure from her attempts to masturbate.

Her husband, who came with her to my office, as is often the case, seemed loving and content but suffered empathetically for his wife because she enjoyed very little sexual pleasure of any kind. There is this idea in some circles that women only want to heal their vagina so they can please their husbands and that we should just leave such women alone, that if it were not for demanding men that they would be just fine; but, if you see only a few women with LS, you realize how very wrong is that idea; husband or no husband, women with LS can lose the ability to enjoy sexual pleasure and often feel broken and alone.

In the following photograph, the first image on the far left shows her vagina on the day she came to my office.

I injected her labia, clitoral hood, the clitoris (through the hood), the entire area, and the anterior vagina wall.

I am not a surgeon, so I sent her to an excellent board-certified gynecologist near my office, Dr. Kathleen Posey, who then dissected out the clitoris—freeing it from the scaring phimosis that had it trapped.

Research has shown that with LS even if the hood is completely phimosed such that the clitoris is unreachable, the clitoris is not directly affected by LS and, when freed, will function normally.

Dr. Posey took the second photo (the one in the middle) on the day she freed the clitoris.

Normally, with such a surgery in a woman suffering from LS, there would likely be a quick recurrence of sclerosis with re-entrapment of the clitoris beneath the LS-diseased clitoral hood.

Instead of the hood re-phimosing, six weeks later, Dr. Posey took the photograph on the far right demonstrating that the hood and labia had grown healthier in appearance, and the woman reported she was having comfortable sex with her husband for the first time in over seven years—off of her clobetasol!

She continues to get a modified O-Shot® from Dr. Posey every year or so and to enjoy comfortable sex.

Dr. Posey went on to treat other women in this way and published her findings (Posey2015).

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Alexandra Runnels, MD, sent photos of a patient who had ten years of Clobetasol and was working as a soldier—imagine marching, and that's what you have to remind yourself with itching, burning, and bleeding—every time you take a step with your pack.

And then, after stopping the Clobetasol—she achieved the results on the right by using a combination of PRP with micro-needling to the more sclerotic areas and the usual 2-injection O-Shot®, combined with injecting PRP into the area and using daily UVB light, combined with Altar® cream to achieve the much healthier tissue (see below).

The phimosis surgery was done about 8 weeks after the first PRP treatment. Her marriage and her self-image and her life changed for the better.

O-Shot® Variations for the Treatment of Lichen Sclerosus

  • Techniques: For phimosis, after you dissect the clitoris to freedom, then injecting with PRP and micro-needling the more sclerotic areas seems to work well in about 80% of women with LS.
  • This summary neither qualifies nor fully instructs in the O-Shot® procedure for lichen sclerosus. Application for training can be found here<-- or by callling the Cellular Medicine Association at 1-888-920-5311
  • Not all women respond; if no improvement, they go back on clobetasol.
  • Stop clobetasol 3-5 days before the treatment and see the woman back in 3 to 6 weeks.
  • Reinject on sec0nd visit any active areas.
  • Expect to need to reinject every six to eighteen months.
  • Works in synergy with UV light
  • Have a low threshold for rebiopsy.
  • Bring back at least once every 6 months to revaluate.
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Summary

  • PRP, when injected in some women suffering from lichen sclerosus, provides a dramatic down-regulation of their disease.
  • There is, of yet, no sure-fire “cure” for lichen sclerosus. Not everyone responds to PRP and those who do usually require repeated treatments every nine to eighteen months. Also, not everyone finds complete relief from clobetasol. It does appear that some who do not find relief from clobetasol do find relief from PRP and vice versa.
  • Those who do not respond to PRP should be put back on clobetasol. Those who find complete relief from clobetasol may not need PRP.
  • Biopsies should always be done regularly as we do not yet have a sure way of preventing the progression of lichen sclerosus to squamous cell carcinoma—clobetosol does not completely prevent the progression and it’s unlikely that PRP completely prevents the progression.
  • Studies of other diseases processes (like breast cancer), and over 15,000 published papers on PubMed regarding PRP without complication from neoplasia, indicate that PRP does not increase the risk of neoplasia.
  • If PRP is carcinogenic, then every surgery should be carcinogenic, considering the same growth factors are released from platelets in the healing of a surgical wound as are released from PRP.
  • It seems logical that in the women who respond to the O-Shot® procedure, there would be less risk of squamous cell carcinoma since the disease seems to go quiescent, but we do not yet know if this is the case.

References

Research Regarding the Use of PRP for Autoimmune Disease

  1. Vazquez OA, Safeek RH, Komberg J, Becker H. Alopecia Areata Treated with Advanced Platelet-rich Fibrin Using Micronization. Plast Reconstr Surg Glob Open. 2022;10(1):e4032. doi:10.1097/GOX.0000000000004032
  2. Anitua E, Pino A, Aspe L, et al. Anti-inflammatory effect of different PRGF formulations on cutaneous surface. Journal of Tissue Viability. 2021;30(2):183-189. doi:10.1016/j.jtv.2021.02.011
  3. Huber SC, de Lima Montalvão SA, Sachetto Z, Santos Duarte Lana JF, Annichino-Bizzacchi JM. Characterization of autologous platelet rich plasma (PRP) and its biological effects in patients with Behçet’s Disease. Regen Ther. 2021;18:339-346. doi:10.1016/j.reth.2021.08.010
  4. Rekik M, Mseddi M, Nadine K, Sellami K, Turki H. Efficacy of autologous platelet-rich plasma in the treatment of vitiligo : A 10- patient prospective study. Journal of Cosmetic Dermatology. n/a(n/a). doi:10.1111/jocd.15050
  5. Tong S, Zhang C, Liu J. Platelet-rich plasma exhibits beneficial effects for rheumatoid arthritis mice by suppressing inflammatory factors. Mol Med Rep. 2017;16(4):4082-4088. doi:10.3892/mmr.2017.7091
  6. Seffer I, Nemeth Z. Recovery from Bell Palsy after Transplantation of Peripheral Blood Mononuclear Cells and Platelet-Rich Plasma: Plastic and Reconstructive Surgery - Global Open. 2017;5(6):e1376. doi:10.1097/GOX.0000000000001376
  7. Pototschnig H, Madl MT. Successful Treatment of Alopecia Areata Barbae with Platelet-rich Plasma. Cureus. 2020;12(4):e7495. doi:10.7759/cureus.7495
  8. Trink A, Sorbellini E, Bezzola P, et al. A randomized, double-blind, placebo- and active-controlled, half-head study to evaluate the effects of platelet-rich plasma on alopecia areata. British Journal of Dermatology. 2013;169(3):690-694. doi:10.1111/bjd.12397
  9. Borhani-Haghighi M, Mohamadi Y. The therapeutic effect of platelet-rich plasma on the experimental autoimmune encephalomyelitis mice. J Neuroimmunol. 2019;333:476958. doi:10.1016/j.jneuroim.2019.04.018
  10. Behnia-Willison F, Pour NR, Mohamadi B, et al. Use of Platelet-rich Plasma for Vulvovaginal Autoimmune Conditions Like Lichen Sclerosus. Plast Reconstr Surg Glob Open. 2016;4(11):e1124. doi:10.1097/GOX.0000000000001124
  11. Pensato R, La Padula S. The Effect of Lipofilling and Platelet-Rich Plasma on Patients with Moderate–Severe Vulvar Lichen Sclerosus Who were Non-responders to Topical Clobetasol Propionate: A Randomized Pilot Study. Aesth Plast Surg. Published online May 31, 2022. doi:10.1007/s00266-022-02947-y

Research Showing PRP Remodels Scar Tissue

  1. Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018;4(1):18-24. doi:10.1159/000477353
  2. Gawdat H, El-Hadidy YA, Allam RSHM, Abdelkader HA. Autologous platelet-rich plasma “fluid” versus “gel” form in combination with fractional CO2 laser in the treatment of atrophic acne scars: a split-face randomized clinical trial. Journal of Dermatological Treatment. 2022;0(ja):1-31. doi:10.1080/09546634.2022.2067816
  3. Charles-de-Sá L, Gontijo-de-Amorim NF, Takiya CM, et al. Effect of Use of Platelet-Rich Plasma (PRP) in Skin with Intrinsic Aging Process. Aesthet Surg J. 2018;38(3):321-328. doi:10.1093/asj/sjx137
  4. Eichler C, Üner J, Thangarajah F, et al. Platelet-rich plasma (PRP) in oncological patients: long-term oncological outcome analysis of the treatment of subcutaneous venous access device scars in 89 breast cancer patients. Arch Gynecol Obstet. Published online April 4, 2022. doi:10.1007/s00404-022-06416-4
  5. Number 5 SV 24. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Accessed August 26, 2021. https://www.skintherapyletter.com/dermatology/platelet-rich-plasma-prp/
  6. Sánchez M, Anitua E, Delgado D, et al. Platelet-rich plasma, a source of autologous growth factors and biomimetic scaffold for peripheral nerve regeneration. Expert Opinion on Biological Therapy. 2017;17(2):197-212. doi:10.1080/14712598.2017.1259409

Research Showing the PRP Promotes Wound Healing

  1. Autologous platelet-rich plasma vs conventional dressing in the management of chronic diabetic foot ulcers - PubMed. Accessed March 7, 2022. https://pubmed.ncbi.nlm.nih.gov/35108667/
  2. Pourkarim R, Farahpour MR, Rezaei SA. Comparison effects of platelet-rich plasma on healing of infected and non-infected excision wounds by the modulation of the expression of inflammatory mediators: experimental research. Eur J Trauma Emerg Surg. Published online February 12, 2022. doi:10.1007/s00068-022-01907-0
  3. García-Sánchez JM, Mirabet Lis V, Ruiz-Valls A, Pérez-Plaza A, Sepúlveda Sanchis P, Pérez-del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. Published online October 22, 2021. doi:10.1016/j.burns.2021.10.001
  4. Chicharro-Alcántara D, Rubio-Zaragoza M, Damiá-Giménez E, et al. Platelet Rich Plasma: New Insights for Cutaneous Wound Healing Management. J Funct Biomater. 2018;9(1):10. doi:10.3390/jfb9010010
  5. Spanò R, Muraglia A, Todeschi MR, et al. Platelet-rich plasma-based bioactive membrane as a new advanced wound care tool. Journal of Tissue Engineering and Regenerative Medicine. 2018;12(1):e82-e96. doi:10.1002/term.2357
  6. Saputro ID, Rizaliyana S, Noverta DA. The effect of allogenic freeze-dried platelet-rich plasma in increasing the number of fibroblasts and neovascularization in wound healing. Ann Med Surg (Lond). 2022;73:103217. doi:10.1016/j.amsu.2021.103217
  7. Kelm RC, Ibrahim O. Utility of platelet-rich plasma in aesthetics. Clinics in Dermatology. 2022;40(1):19-28. doi:10.1016/j.clindermatol.2021.08.007

Research Regarding Fat Transfer to the Breast and No Increased Risk of Breast Cancer and that PRP is Safe with a History of Breast Cancer

1. Kaoutzanis, Christodoulos, Minqiang Xin, Tiffany N.S. Ballard, Kathleen B. Welch, Adeyiza O. Momoh, Jeffrey H. Kozlow, David L. Brown, Paul S. Cederna, and Edwin G. Wilkins. “Autologous Fat Grafting After Breast Reconstruction in Postmastectomy Patients: Complications, Biopsy Rates, and Locoregional Cancer Recurrence Rates.” Annals of Plastic Surgery 76, no. 3 (March 2016): 270–75. https://doi.org/10.1097/SAP.0000000000000561.
2. Kronowitz, Steven J., Cosman Camilo Mandujano, Jun Liu, Henry M. Kuerer, Benjamin Smith, Patrick Garvey, Reshma Jagsi, Limin Hsu, Summer Hanson, and Vicente Valero. “Lipofilling of the Breast Does Not Increase the Risk of Recurrence of Breast Cancer: A Matched Controlled Study.” Plastic and Reconstructive Surgery 137, no. 2 (February 2016): 385–93. https://doi.org/10.1097/01.prs.0000475741.32563.50.
3. Eichler C, Baucks C, Üner J, et al. Platelet-Rich Plasma (PRP) in Breast Cancer Patients: An Application Analysis of 163 Sentinel Lymph Node Biopsies. Guan X yuan, ed. BioMed Research International. 2020;2020:1-7. doi:10.1155/2020/3432987d

Research Showing Improvement of Lichen Sclerosus with UVB

Garrido-Colmenero C, Martínez-Peinado CM, Galán-Gutiérrez M, Barranco-Millán V, Ruiz-Villaverde R. Successful response of vulvar lichen sclerosus with NB-UVB. Dermatologic Therapy. 2021;34(2):e14801. doi:10.1111/dth.14801

Research Regarding Steroids Reactivating Papilloma Virus

von Krogh G, Dahlman-Ghozlan K, Syrjänen S. Potential human papillomavirus reactivation following topical corticosteroid therapy of genital lichen sclerosus and erosive lichen planus. Journal of the European Academy of Dermatology and Venereology : JEADV. 2002;16(2):130-133. Accessed August 24, 2015. http://www.ncbi.nlm.nih.gov/pubmed/12046814

Research Showing that PRP Helps Women Suffering from Lichen Sclerosus

  1. Goldstein AT, Mitchell L, Govind V, Heller D. A Randomized Double-Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus. Journal of the American Academy of Dermatology. Published online January 2019. doi:10.1016/j.jaad.2018.12.060
  2. Msc MK, Tolson H, Runels C, Gloth M, Pfau R, Goldstein AT. Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25. http://journals.lww.com/jlgtd/Fulltext/2015/07001/ISSVD2015Abstracts.2.aspx
  3. Casabona F, Gambelli I, Casabona F, Santi P, Santori G, Baldelli I. Autologous platelet-rich plasma (PRP) in chronic penile lichen sclerosus: the impact on tissue repair and patient quality of life. Int Urol Nephrol. 2017;49(4):573-580. doi:10.1007/s11255-017-1523-0
  4. Mitchell L, Goldstein AT, Heller D, et al. Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial. Obstetrics & Gynecology. 2021;137(6):979-987. doi:10.1097/AOG.0000000000004409
  5. Goldstein AT, King M, Runels C, Gloth M, Pfau R. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. Journal of the American Academy of Dermatology. 2017;76(1):158-160. doi:10.1016/j.jaad.2016.07.037
  6. Posey K, Runels C. In-Office Surgery and Use of Platelet Rich Plasma for Treatment of Vulvar Lichen Sclerosus to Alleviate Painful Sexual Intercourse. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25. doi:10.1097/lgt.0000000000000121
  7. ISSVD 2015 Abstracts. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25. doi:10.1097/lgt.0000000000000121
  8. Lee A, Bradford J, Fischer G. Long-term management of adult vulvar lichen sclerosus: a prospective cohort study of 507 women. JAMA Dermatol. 2015;151:1061-1067.
  9. Casabona F, Priano V, Vallerino V, Cogliandro A, Lavagnino G. New surgical approach to lichen sclerosus of the vulva: the role of adipose-derived mesenchymal cells and platelet-rich plasma in tissue regeneration. Plastic and reconstructive surgery. 2010;126(4):210e-211e.
  10. Franic D, Iternička Z, Franić-Ivanišević M. Platelet-rich plasma (PRP) for the treatment of vulvar lichen sclerosus in a premenopausal woman: A case report. Case reports in women’s health. 2018;18:e00062. doi:10.1016/j.crwh.2018.e00062
  11. Smith JG. The journal of the American Academy of Dermatology. International journal of dermatology. 2005;18(6):466-467. http://www.ncbi.nlm.nih.gov/pubmed/19539853
  12. Vittrup G, Mørup L, Heilesen T, Jensen D, Westmark S, Melgaard D. The Quality of Life and Sexuality in Women with Lichen Sclerosus – A Cross Sectional Study. Clinical and Experimental Dermatology. n/a(n/a). doi:10.1111/ced.14893
  13. Tedesco M, Pranteda G, Chichierchia G, al. et. The use of PRP (platelet-rich plasma) in patients affected by genital lichen sclerosus: clinical analysis and results. J Eur Acad Dermatol Venereol. 2019;33:e58-e59.
  14. Marnach ML, Torgerson RR. Therapeutic Interventions for Challenging Cases of Vulvar Lichen Sclerosus and Lichen Planus. Obstetrics & Gynecology. 2021;138(3):374-378. doi:10.1097/AOG.0000000000004498
  15. Behnia-Willison F, Pour NR, Mohamadi B, et al. Use of Platelet-rich Plasma for Vulvovaginal Autoimmune Conditions Like Lichen Sclerosus: Plastic and Reconstructive Surgery - Global Open. 2016;4(11):e1124. doi:10.1097/GOX.0000000000001124
  16. Corazza M, Schettini N, Zedde P, Borghi A. Vulvar Lichen Sclerosus from Pathophysiology to Therapeutic Approaches: Evidence and Prospects. Biomedicines. 2021;9(8):950. doi:10.3390/biomedicines9080950
  17. Krapf JM, Mitchell L, Holton MA, Goldstein AT. Vulvar Lichen Sclerosus: Current Perspectives. IJWH. 2020;Volume 12:11-20. doi:10.2147/IJWH.S191200

Research Indicating the Saline Is Not Be A Placebo When Used for Hydrodissection

  1. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments A systematic review and meta-analysis of randomized trials | Elsevier Enhanced Reader. doi:10.1016/j.semarthrit.2016.04.003
  2. Sharma R, Gupta M, Rani R. Delineating injectable triamcinolone-induced cutaneous atrophy and therapeutic options in 24 patients—A retrospective study. Indian Dermatol Online J. 2022;13(2):199. doi:10.4103/idoj.idoj48321
  3. Asghar A, Tahir Z, Ghias A, Iftikhar U, Ahmad TJ. Efficacy and Safety of Intralesional Normal Saline in Atrophic Acne Scars. Annals of King Edward Medical University. 2019;25(2). doi:10.21649/akemu.v25i2.2867
  4. Bagherani N, R Smoller B. Introduction of a novel therapeutic option for atrophic acne scars: saline injection therapy. Glob Dermatol. 2016;2(6). doi:10.15761/GOD.1000159
  5. Searle T, Al-Niaimi F, Ali FR. Saline in dermatologic surgery. Journal of Cosmetic Dermatology. 2021;20(4):1346-1347. doi:10.1111/jocd.13996
  6. El-Amawy HS, Sarsik SM. Saline in Dermatology: A literature review. Journal of Cosmetic Dermatology. 2021;20(7):2040-2051. doi:10.1111/jocd.13813
  7. Saltzman BM, Leroux T, Meyer MA, et al. The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. Am J Sports Med. 2017;45(11):2647-2653. doi:10.1177/0363546516680607

 

Section 2. Mid-Urethral Sling Induced Sexual Dysfunction

From Leaking Urethra to Damaged Prostate

Most women who undergo a mid-urethral sling (MUS) placement will see an improve sexual function, but 1 in 11 women will suffer a decrease in sexual pleasure after the procedure.

Midurethal sling: Better sex for most women; but 1 in 11 suffers more?

One in 11 suffers more.

So, to better understand the reason for this unwanted result (of decreased sexual pleasure in 1 in 11 women who undergo MUS), Guadet et al. performed mid-urethral slings on cadavers and then sectioned the area to visualize the affected tissue. They reported their results in the Journal of Sexual Medicine in 2018 as follows:

“MUS placement interrupts tissue with glandular, vascular, and neuronal structures within the periurethral space adjacent to the anterior vaginal wall. Disruption of the prostatic glandular tissue and neurovascular structures may be a root cause of orgasmic dysfunction and diminished sexual satisfaction evident in women following MUS implantation.

Recovering Function (or Preventing Dysfunction) in Regards to MUS

Considering the previous description, to correct or prevent the problem, where would you inject a material which increases blood flow, grows nerves and collagen, improves the health of glandular tissue, and has never been reported to form a granuloma or neoplasia?

Also, consider that the material you will inject is aqueous, so it will hydrodissect along the tissue planes, taking the path of least resistance as if you were hydrodissecting with saline. This means you would not need multiple injections since you could use the pressure gradient generated by your syringe to spread the material.

Now, look at the following diagram, the same one we used to describe (in Section 1) what could be the best of the currently published options for the placement of the needle for the injection of PRP for the treatment of stress urinary incontinence (the O-Shot® procedure).

Then take another look at the photograph of the placement of the needle for the O-Shot® procedure:

Now you can see that our O-Shot® procedure is designed to repair exactly where these brilliant investigators documented that the neurovascular damage from a MUS occurs. (Application for further training in the O-Shot® procedure can be found at OShot.info/members (click), this description does not constitute training or license to use the name “O-Shot,” which is protected by the US Patent & Trademark office for license to only those approved by the Cellular Medicine Association.

My Third Female-Ejaculation Experience, Which Leads to the O-Shot® Procedure

In 1984, while in medical school, one of our professors said to the class, “I do not want anyone to finish at this medical school and still think that female ejaculation is not a real phenomenon.”

Then, he showed us a video of a woman masturbating until she ejaculated.

Watching the video, I thought, “Looks like an interesting party trick; but of what practical benefit does that serve except the knowledge that the female body can ejaculate.”

Years later, a lover demonstrated to me that she could bring herself to masturbation with ejaculation. I still found the phenomenon interesting but not warranting much attention.

Then, it happened.

While I was making love to a woman, she unexpectedly ejaculated for the first time; and, unlike what I had witnessed with the previous two demonstrations (ejaculation while masturbating) when she ejaculated during our lovemaking, not only could I almost feel the deep, soul-shattering depth of her orgasm, but also her demeanor afterward reflected that of a man after ejaculation with calmness, satisfied bliss, and a wanting to connect with me emotionally like I had never witnessed with this woman—perhaps with any woman.

Finally, I took notice.

Up until then, the female orgasms that I had witnessed were associated with women showing varying degrees of pleasure during the orgasm, followed by increased energy and increased hunger for more sex and more orgasms. But, observing my third female ejaculation, the woman afterward showed calmness and peace and greatly decreased energy and complete satisfaction; more importantly, she seemed to drop invisible walls and swing open a wide path from her soul to mine.

I concede that my description of female ejaculation does not provide a scientific-objective explanation of what happened; but hopefully, you will forgive the description when you consider that when I find world-renowned experts in female sexuality and ask them to describe it to me in scientific-objective words, what happens when a woman experiences an orgasm of any kind, I can see their frustration as they give what we both know to be a relatively superficial answer to a profoundly important phenomenon.

So, since there is no good scientific explanation of the frequent orgasms of usual lovemaking (in comparison with a soul-shaking orgasm where the woman sobs, ejaculates and melts her soul into yours), I hope that you will pardon my use of a subjective description where no objective measure exists. Something happens to more easily facilitate a soul connection between a woman and her lover (and maybe even her GOD) when she experiences an ejaculatory orgasm.

After experiencing for the first time this phenomenon of female ejaculatory orgasm during lovemaking, I decided to pay more attention; I began reading all the popular books, the textbooks, and the research that I could find regarding female ejaculation. And, I began learning more about my lover (and subsequent lovers) about how to reproduce and enhance the experience of the female ejaculatory orgasm.

William Osler once told his medical students that if he asked them how long it takes for the fingernail to grow one length, most of them would not give it a second thought; some of them would read about it; and a few of them would grab a silver nitrate stick, make a mark on their proximal thumbnail with the stick, and then measure how long it took for the mark to grow to the end of the finger.

It was in the spirit of the third medical student described by Dr. Olser that I read the books and the research for the next ten-plus years and then took that reading to the bedroom. Over more than a decade, I developed my own ideas about female ejaculation. I even published an online course for men about how to help their female lover to a complete and profound ejaculatory orgasm and have helped thousands of couples with that course.

I tell you about my interest in female ejaculation for only one purpose: to show you that the study of female ejaculation combined with my work providing hormone replacement and menopausal care for over 3,000 women is what set the stage for me to design the O-Shot® procedure.

Then, in early 2010, I was first introduced to the idea of PRP and its possibilities for cosmetic use in the face. Because the stage was set, one of the ideas that occurred to me regarding PRP was to inject it near the distal urethra in the area of the Skene’s glands (female prostate) to see if it would enhance the female ejaculatory orgasm. During this time, I had already developed the P-Shot® and injected my own corpus cavernosi (penis) multiple times, so it seemed reasonable also to inject the female corpus cavernosi and periurethral area as well.

The best I can tell, I was the first to inject (2010) the female periurethral area with PRP.

First, I injected my lover; I had taught her to have an ejaculatory orgasm and wanted to see if things would improve. Afterward, her ejaculatory orgasms grew consistently higher on the Richter scale.

I thought maybe her results were just a placebo effect. Then, knowing that PRP has been shown in multiple studies to remodel scar tissue into a more healthy state, I injected a woman’s periurethral and clitoral area who had been physically abused by her x-husband—leaving her with severe dyspareunia and anorgasmia even after seeing multiple gynecologists.

So, she received the second O-Shot® procedure.

Afterward, not only did her dyspareunia resolve, but also she reported to me that she was able to start running again because her urinary incontinence went away.

I thought, “Why didn’t I think of that?!”

In the process of injecting in the area of the Skene’s glands (or female prostate), I had inadvertently chosen a place that would help urinary incontinence and improve the nerves associated with sexual function and micturition.

Since then, we (members of the Cellular Medicine Association) have found that injecting more proximal to the bladder does not affect the entire urethra as significantly with resultantly less improvement for both urinary incontinence and for sex.

So, my process of designing the place to put the PRP to improve ejaculatory orgasm inadvertently resulted in placing the PRP where it would best help those suffering from urinary incontinence or with sexual dysfunction after a sling.

Summary

  • Most women see an improvement in sexual function after a mid-urethral sling.
  • One in 11 women sees a decrease in sexual function after a sling.
  • Cadaver studies showed that the nerves, Skene’s glands, and blood flow disrupted by the placement of a MUS lie exactly where the PRP is placed when doing the O-Shot® procedure.
  • PRP is aqueous and therefore requires a minimum of injection points if the needle lumen is put into the proper tissue plane to affect best the tissue that needs repair.
  • Meticulous placement of the PRP for improvement of sex after MUS placement is critical to the success of the procedure.
  • Reading this report does not qualify anyone to do an O-Shot® procedure; many critical nuances are beyond the scope of this report.
  • Application for training in the O-Shot® procedure can be found at OShot.info/members.

References

  1. Jang HC, Jeon JH, Kim DY. Changes in Sexual Function after the Midurethral Sling Procedure for Stress Urinary Incontinence: Long-term Follow-up. Int Neurourol J. 2010;14(3):170. doi:10.5213/inj.2010.14.3.170
  2. Gaudet D, Clohosey DG, Hannan JL, et al. 249 Midurethral sling placement disrupts periurethral neurovascular and glandular structures near anterior vaginal wall: Potential role in female sexual dysfunction. The Journal of Sexual Medicine. 2018;15(7):S221-S222. doi:10.1016/j.jsxm.2018.04.214
  3. Runels C. A Pilot Study of the Effect of Localized Injections of Autologous Platelet Rich Plasma (PRP) for the Treatment of Female Sexual Dysfunction. J Women’s Health Care. 2014;03(04). doi:10.4172/2167-0420.1000169
  4. Gaudet D, Clohosey DG, Hannan JL, et al. 249 Midurethral sling placement disrupts periurethral neurovascular and glandular structures near anterior vaginal wall: Potential role in female sexual dysfunction. The Journal of Sexual Medicine. 2018;15(7):S221-S222. doi:10.1016/j.jsxm.2018.04.214
  5. Rodriguez FD, Camacho A, Bordes SJ, Gardner B, Levin RJ, Tubbs RS. Female ejaculation: An update on anatomy, history, and controversies. Clin Anat. 2021;34(1):103-107. doi:10.1002/ca.23654
  6. Pollen JJ, Dreilinger A. Immunohistochemical identification of prostatic acid phosphatase and prostate specific antigen in female periurethral glands.
    Urology. 1984;23(3):303-304. doi:10.1016/S0090-4295(84)90053-0
  7. Korda JB, Goldstein SW, Sommer F. SEXUAL MEDICINE HISTORY: The History of Female Ejaculation. The Journal of Sexual Medicine. 2010;7(5):1965-1975. doi:10.1111/j.1743-6109.2010.01720.x
  8. Tomalty D, Giovannetti O, Hannan J, et al. Should We Call It a Prostate? A Review of the Female Periurethral Glandular Tissue Morphology, Histochemistry, Nomenclature, and Role in Iatrogenic Sexual Dysfunction. Sexual Medicine Reviews. 2022;0(0). doi:10.1016/j.sxmr.2021.12.002
  9. Dietrich W, Susani M, Stifter L, Haitel A. The Human Female Prostate—Immunohistochemical Study with Prostate‐Specific Antigen, Prostate‐Specific Alkaline Phosphatase, and Androgen Receptor and 3‐D Remodeling. The Journal of Sexual Medicine. 2011;8(10):2816-2821. doi:10.1111/j.1743-6109.2011.02408.x
  10. Zavia M. Ultrastructure of the normal adult human female prostate gland (Skene’s gland). :12.
  11. Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018;4(1):18-24. doi:10.1159/000477353
  12. Gawdat H, El-Hadidy YA, Allam RSHM, Abdelkader HA. Autologous platelet-rich plasma “fluid” versus “gel” form in combination with fractional CO2 laser in the treatment of atrophic acne scars: a split-face randomized clinical trial. Journal of Dermatological Treatment. 2022;0(ja):1-31. doi:10.1080/09546634.2022.2067816
  13. Charles-de-Sá L, Gontijo-de-Amorim NF, Takiya CM, et al. Effect of Use of Platelet-Rich Plasma (PRP) in Skin with Intrinsic Aging Process. Aesthet Surg J. 2018;38(3):321-328. doi:10.1093/asj/sjx137
  14. Eichler C, Üner J, Thangarajah F, et al. Platelet-rich plasma (PRP) in oncological patients: long-term oncological outcome analysis of the treatment of subcutaneous venous access device scars in 89 breast cancer patients. Arch Gynecol Obstet. Published online April 4, 2022. doi:10.1007/s00404-022-06416-4
  15. Number 5 SV 24. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Accessed August 26, 2021. https://www.skintherapyletter.com/dermatology/platelet-rich-plasma-prp/
  16. Sánchez M, Anitua E, Delgado D, et al. Platelet-rich plasma, a source of autologous growth factors and biomimetic scaffold for peripheral nerve regeneration. Expert Opinion on Biological Therapy. 2017;17(2):197-212. doi:10.1080/14712598.2017.1259409

Section 1. Urinary Incontinence in Women: A New Way to Avoid Surgery—Why & How it Works

 

The Overlying Most Important Principle in This Report

What diseases could you treat If you had a treatment that could propagate new blood flow, grow nerves, calm the autoimmune response, fight infection, regrow collagen, and enhance glandular function? The answer to that question gives you an idea about the possibilities with platelet-rich plasma (PRP). That idea (together with the current research and the experience of more than three thousand doctors over a decade) is the theme behind the strategies discussed in this report.

Thinking about how antibiotics work helps you consider what conditions may be helped by antibiotics; this consideration of which conditions my be helped and which may not be helped by antibiotics happens so automatically that we may not consciously acknowledge the process.

For example, we would not think about antibiotics for the primary treatment of uterine fibroids because fibroids are not primarily caused by infection; antibiotics only treat infection. But, with a new therapy that is not as well known or understood, we may not be clear about the mechanism of the treatment; therefore, there can be confusion regarding which disease processes the new therapy may be of benefit—leading to inappropriate use and less than expected results.

But, if a new treatment is considered (as with old standards of care) only when the pathology of the disease makes the use of the new therapy appropriate, results will be optimal, and we can avoid the proverbial throwing out the baby with the bathwater when the new therapy “doesn’t work” when we use the new therapy for a problem for which it would not be likely to help.

With this general idea about the relation of the mechanism of therapy and pathology of disease in mind, consider that (except for secondary results, which we will discuss in later sections) the only conditions that PRP may help are those in which strategic injection into tissue will improve the disease by improving the health of the tissue: neovascularization, neurogenesis, collagen production, improvement of glandular function, attenuation of autoimmune processes, fighting infection (all of which PRP has been documented to do).

Striated Urogenital Sphincter Grows Weaker

In considering where improved tissue health might improve stress urinary incontinence in women, first consider the striated component of the urogenital sphincter—it accounts for one-third of the resting urethral closing pressure Delancey2017

Here's my sketch of the striated muscle component—taken from diagrams published by Delancey and others:

Striated Urogenital Sphincter
Striated Urogenital Sphincter

The striated urogenital sphincter completely encompasses the urethra at level one, while, at level three, it encompasses both the urethra and the vagina.

Beneath the striated urogenital sphincter lies smooth muscle that runs longitudinally, which also contributes to the closing pressure.

Just like the striated muscle of the bicep or the thigh, the number of muscle fibers in the urogenital sphincter decreases with age. Also, the number of nerves innervating the sphincter decreases with age.

To complicate matters, even more, the function of the urogenital sphincter is known to be damaged by childbirth.

Does the decrease in innervation lead to the decrease in muscle fibers, or is the decrease in muscle and the decrease in nerves two independently evolving conditions? And does blood flow play a role? I could find no clear answer to these questions. But, whatever your answer to those questions, they prompt corollary ideas such as that the effect of voluntary Kegels may be attenuated by the decreased innervation of the striated muscle (explaining the lack of effectiveness of Kegels in some women).

Treatment Strategies Based on the Functional Anatomy of the Sphincter

Activation of the striated muscle of the sphincter independently of the patient’s volition or the innervation of the muscle (for example, with an Emsella® magnet) would possibly create more contraction than would be possible even with heroic efforts by the woman. This super activation would cause a strengthening of the striated sphincter and an increase in closing pressure.

Also, the sports-medicine literature offers robust support for the idea of using PRP to restore damaged or atrophic muscle. And multiple papers demonstrate neurogenesis propagated by the injection of PRP.

If we propagated neurogenesis and muscle fiber restoration with PRP, then that might be synergistic with Kegels or with magnet therapy or with surgery (if needed).

The Urethral Wall Acts Like a Penis

The urethra wall (not the surrounding tissue, the urethra itself) carries a vascular plexus with AV anastomoses; blood flow can be directed into or away from these venues to inflate or deflate them; so it demonstrates tumescence similar to that of the penis. But in the female urethra, tumescence contributes to the closing pressure of the urethra (not erectile function, as in the man).

Hormones are known to affect this tumescence-like function of the urethra. But, what are hormones but messengers to tell cells what to do? Messages-to-the-cells is exactly what happens when the cells of the urethral wall are exposed to the small peptide chains released from platelets.

PRP was shown in a recent double-blind placebo-controlled study to improve the erectile function of the penis. Since PRP helps with neovascularization in general and has been shown to improve erectile function, it seems logical that PRP may also, when injected into the urethral wall, improve the tumescent function of the urethral wall and the closing pressure of the urethra—resulting in a decrease or resolution of urinary incontinence.

Longitudinal Smooth Muscle of the Urethra

The longitudinal smooth muscle of the urethra also contributes to the closing pressure. The smooth muscle cannot be contracted by either volition or by a magnet, so neither would help strengthen the smooth muscle component of the female urinary sphincter. But, as we have documented with the studies in our bibliography, PRP has been shown to revive muscle fibers. So, injection of the urethral smooth muscle may also account for some of the benefits of PRP seen when it is injected into the periurethral area.

And of course, such benefits of PRP may also be of help post-op from a mid-urethral sling placement. One study documented that the nerves and blood vessels between the anterior vaginal wall and the urethra are damaged by the surgical placement of a mid-urethral sling; and we have just discussed how PRP can repair nerves and blood vessels.

Urge Incontinence

Urge incontinence, multifactorial and often seen in combination with stress incontinence, can be partly secondary to peripheral nerve involvement as previously mentioned. And research supports the idea that PRP may improve the function of those nerves resulting in an improvement in urge incontinence—if the PRP should be deposited in the proper place.

PRP Injection Strategies for the Treatment of Urinary Incontinence

So, it makes sense that all of the above-mentioned ideas, if applied to the urinary sphincter in a female, might show synergistic benefits. Indeed, multiple papers do show that injection of PRP into the periurethral area or into the urethral wall improves stress urinary incontinence.

In these published papers showing benefits for stress urinary incontinence with the injection of PRP, multiple techniques have been used; so, let’s think about some of those techniques while keeping the functional anatomy in mind—looking for the best possible strategy (at least with our present knowledge).

The O-Shot® Procedure for Urinary Incontinence

With our O-Shot® procedure, we usually do two injections, one of which goes into the vaginal wall, hydro-dissecting the entire area.

Four CCs is enough to fill the whole space between the urethra and the vaginal wall and include the urethral wall—if you put the needle where it to needs to go.

Just like with an IV, there's variability, both in technique and with the skill of the person doing the procedure; but if you can put the needle where it belongs, you should be able to put PRP in the areas we’ve described.

The following is a snapshot from one of our instructional videos showing one of the two injections the way we teach the O-Shot® procedure for SUI. By injecting the actual anterior vaginal wall within a few millimeters of the hymenal remnant, you avoid the pain fibers within heart's line, and you're able to fill both the space between urethra and vagina and affect muscle, blood flow, and nerves. This can be done pain-free or near pain-free using the proper technique and only a topical cream for anesthesia.

This method, when done properly, is called the O-Shot® procedure. The procedure can be done in the office using the person’s own blood and without pain in most cases.

I trademarked the term “O-Shot” to prevent variability of techniques with the associated variability of results being pushed upon women. All of the licensed providers of the O-Shot® procedure agree to follow a standard protocol with variations based on disease process. All licensed providers also agree only to use devices to prepare the PRP that has been approved by the FDA for the preparation of PRP to go back into the body. Our licensees are tested and are subject to losing the license to use the name “O-Shot®” in advertising if they fail to follow our standards.

Physicians can apply to receive more detailed instructions and to be licensed to perform the O-Shot® procedure here—>: OShot.com/physicians<—

Example of Another Technique for Curing Urinary Incontinence with PRP

Another group demonstrated (I think in a very brilliant and useful study) the resolution of urinary incontinence with the injection of PRP directly into the urethral wall—in women with objectively-demonstrated severe incontinence.

But, in their method, they report that the procedure was so painful that the subjects had to receive the urethral sphincter injection under intravenous general anesthesia in the operating room.

The following photograph illustrates the injection points:

This is NOT the O-Shot® procedure; the O-Shot® procedure is a method of choosing the proper patient, properly preparing the PRP, and injecting the PRP with the agreed-upon technique after using local anesthesia that gives the best chance of an in-office, pain-free procedure.

But, though these investigators did something other than an O-Shot® procedure, they did help the mission of finding a way to cure or improve female urinary incontinence by demonstrating the possibility of improving the health and function of the urinary sphincter by using a functional-anatomy-based, strategic injection of PRP.

Another third technique (not pictured here) showed benefit for SUI but described injecting 4 cc of PRP spread out in 0.1 ml aliquots for FORTY separate injection points.

Please Help

I have no study showing which of the three separate techniques described above gives the best result. There is no question about which causes the least amount of pain: (1) 40 separate injections vs. (2) five injections into the urethral wall requiring general anesthesia in the operating room vs. (3) the O-Shot® which can be done usually completely pain-free and only requires topical anesthesia and a pain-free lidocaine block in the office.

Though we still do not have a study documenting which works the best of these three techniques (or which of other techniques that you might imagine), hopefully, I have given you a quick version of why I think our method (which we have been doing for a decade with over 100,000 women treated) may be best.

More importantly, what I hope I’ve shown is that there is a need for us to think about carefully and study which might be the best technique because we think technique matters. One of the dangers of having taught and provided the O-Shot® procedure for 11 years is that I may start to believe everything I say...first you show something is feasible, then you have the herculean effort of looking at the infinite number of variables to find the best way.

Please help us study and think about this categorically new way to improve the health and function of the female genitourinary tract.

Summary

  • PRP improves tissue health by collagen production, neovascularization, neurogenesis, attenuation of the autoimmune response, anti-bacterial effects, improving glandular function, and muscle repair.
  • The strategic injection of PRP into areas of damaged tissue with the resultant improvement of health and function of tissue has been demonstrated in thousands of studies over the past two decades.
  • An increasing number of studies show that this principle of injection of PRP into the damaged or aging tissue of the urinary sphincter may help restore urinary continence in some women resistant to other therapies.
  • The injection technique matters since only tissue exposed to the PRP will primarily benefit.
  • Only those licensed by the Cellular Medicine Association (after testing) can legally advertise using the name “O-Shot®.” This is done so that a greater degree of predictability of safety and results can be offered to women who may choose PRP injections as a mode of treatment.
  • The O-Shot® procedure has and will continue to evolve as the research accumulates from the members of the Cellular Medicine Association and others.
  • The O-Shot® procedure is varied based on the functional anatomy and the pathophysiology of the disease process in any individual woman.
  • This report gives an overview of the principles behind the O-Shot® procedure and Emsella therapy but does not constitute training or license to do the procedures.
  • I hope if you are not yet a member of the Cellular Medicine Association (CMA) that you will consider joining our organization and studying our training materials, we need more help thinking about and researching these ideas:
  • If you are already a member of the CMA, I hope you will continue to support our mission by participating in our weekly journal club and sharing your observations with your patients and your thoughts about the current research.

My goal is to be a pipe for the movement of ideas. I continue to be grateful every day for the members of the CMA who have shared ideas that make this report possible. And, most of all, I am grateful for the women who have been patients who have trusted me to teach me; with old ideas and new, the best book is observing and listening to the one woman in front of you who will teach you about her disease and how to make her well—if you listen.

References

Selection of Papers Demonstrating Neurogenesis with PRP

Chung, Eric. “Regenerative Technology to Restore and Preserve Erectile Function in Men Following Prostate Cancer Treatment: Evidence for Penile Rehabilitation in the Context of Prostate Cancer Survivorship.” Therapeutic Advances in Urology 13 (January 1, 2021): 17562872211026420. https://doi.org/10.1177/17562872211026421.

Foy, Christian A., William F. Micheo, and Damien P. Kuffler. “Functional Recovery Following Repair of Long Nerve Gaps in Senior Patient 2.6 Years Posttrauma.” Plastic and Reconstructive Surgery. Global Open 9, no. 9 (September 2021): e3831. https://doi.org/10.1097/GOX.0000000000003831.

Kuffler, Damien P. “Platelet-Rich Plasma and the Elimination of Neuropathic Pain.” Molecular Neurobiology 48, no. 2 (October 2013): 315–32. https://doi.org/10.1007/s12035-013-8494-7.

Sánchez, Mikel, Eduardo Anitua, Diego Delgado, Peio Sanchez, Roberto Prado, Gorka Orive, and Sabino Padilla. “Platelet-Rich Plasma, a Source of Autologous Growth Factors and Biomimetic Scaffold for Peripheral Nerve Regeneration.” Expert Opinion on Biological Therapy 17, no. 2 (February 1, 2017): 197–212. https://doi.org/10.1080/14712598.2017.1259409.

Wu, Yi-No, Chun-Hou Liao, Kuo-Chiang Chen, and Han-Sun Chiang. “Dual Effect of Chitosan Activated Platelet Rich Plasma (CPRP) Improved Erectile Function after Cavernous Nerve Injury.” Journal of the Formosan Medical Association, March 27, 2021. https://doi.org/10.1016/j.jfma.2021.01.019.

Selection of Papers Demonstrating Muscle Revival from PRP

Bernuzzi, Gino, Federica Petraglia, Martina Francesca Pedrini, Massimo De Filippo, Francesco Pogliacomi, Michele Arcangelo Verdano, and Cosimo Costantino. “Use of Platelet-Rich Plasma in the Care of Sports Injuries: Our Experience with Ultrasound-Guided Injection.” Blood Transfusion 12, no. Suppl 1 (January 2014): s229–34. https://doi.org/10.2450/2013.0293-12.

Bubnov, Rostyslav, Viacheslav Yevseenko, and Igor Semeniv. “Ultrasound Guided Injections of Platelets Rich Plasma for Muscle Injury in Professional Athletes. Comparative Study.,” n.d., 5.

Le, Adrian D.K., Lawrence Enweze, Malcolm R. DeBaun, and Jason L. Dragoo. “Platelet-Rich Plasma.” Clinics in Sports Medicine 38, no. 1 (January 2019): 17–44. https://doi.org/10.1016/j.csm.2018.08.001.

Middleton, Kellie K, Victor Barro, Bart Muller, Satosha Terada, and Freddie H Fu. “Evaluation of the Effects of Platelet-Rich Plasma (PRP) Therapy Involved in the Healing of Sports-Related Soft Tissue Injuries.” The Iowa Orthopaedic Journal 32 (2012): 150–63. http://www.ncbi.nlm.nih.gov/pubmed/23576936.

Moraes, Vinícius Y, Mário Lenza, Marcel Jun Tamaoki, Flávio Faloppa, and João Carlos Belloti. “Platelet-Rich Therapies for Musculoskeletal Soft Tissue Injuries.” The Cochrane Database of Systematic Reviews 12 (January 2013): CD010071. https://doi.org/10.1002/14651858.CD010071.pub2.

Selection of Papers Showing Help from PRP Injections for Stress Urinary Incontinence

Athanasiou, Stavros, Christos Kalantzis, Dimitrios Zacharakis, Nikolaos Kathopoulis, Artemis Pontikaki, and Themistoklis Grigoriadis. “The Use of Platelet-Rich Plasma as a Novel Nonsurgical Treatment of the Female Stress Urinary Incontinence: A Prospective Pilot Study.” Female Pelvic Medicine & Reconstructive Surgery 27, no. 11 (November 2021): e668–72. https://doi.org/10.1097/SPV.0000000000001100.

Callewaert, Geertje, Marina Monteiro Carvalho Mori Da Cunha, Nikhil Sindhwani, Maurilio Sampaolesi, Maarten Albersen, and Jan Deprest. “Cell-Based Secondary Prevention of Childbirth-Induced Pelvic Floor Trauma.” Nature Reviews Urology 14, no. 6 (June 2017): 373–85. https://doi.org/10.1038/nrurol.2017.42.

Indian Journal of Medical Ethics. “Cosmetic Surgical Procedures on the Vulva and Vagina - an Overview.” Accessed January 18, 2022. https://ijme.in/articles/cosmetic-surgical-procedures-on-the-vulva-and-vagina-an-overview/.

Ford, Abigail A., Lynne Rogerson, June D. Cody, and Joseph Ogah. “Mid‐urethral Sling Operations for Stress Urinary Incontinence in Women.” Cochrane Database of Systematic Reviews, no. 7 (2015). https://doi.org/10.1002/14651858.CD006375.pub3.

Gorton, E, S Stanton, A Monga, A K Wiskind, G M Lentz, and D R Bland. “Periurethral Collagen Injection: A Long-Term Follow-up Study.” BJU International 84, no. 9 (December 1999): 966–71. http://www.ncbi.nlm.nih.gov/pubmed/10571621.

Joseph, Christine, Kosha Srivastava, Olive Ochuba, Sheila W. Ruo, Tasnim Alkayyali, Jasmine K. Sandhu, Ahsan Waqar, Ashish Jain, and Sujan Poudel. “Stress Urinary Incontinence Among Young Nulliparous Female Athletes.” Cureus 13, no. 9 (September 2021). https://doi.org/10.7759/cureus.17986.

Kirchin, Vivienne, Tobias Page, Phil E. Keegan, Kofi OM Atiemo, June D. Cody, Samuel McClinton, Patricia Aluko, and Cochrane Incontinence Group. “Urethral Injection Therapy for Urinary Incontinence in Women.” The Cochrane Database of Systematic Reviews 2017, no. 7 (July 2017). https://doi.org/10.1002/14651858.CD003881.pub4.

Lee, Patricia E., Rose C. Kung, and Harold P. Drutz. “PERIURETHRAL AUTOLOGOUS FAT INJECTION AS TREATMENT FOR FEMALE STRESS URINARY INCONTINENCE: A RANDOMIZED DOUBLE-BLIND CONTROLLED TRIAL.” Journal of Urology 165, no. 1 (January 2001): 153–58. https://doi.org/10.1097/00005392-200101000-00037.

Long, Cheng-Yu, Kun-Ling Lin, Chin-Ru Shen, Chin-Ru Ker, Yi-Yin Liu, Zi-Xi Loo, Hui-Hua Hsiao, and Yung-Chin Lee. “A Pilot Study: Effectiveness of Local Injection of Autologous Platelet-Rich Plasma in Treating Women with Stress Urinary Incontinence.” Scientific Reports 11, no. 1 (December 2021): 1584. https://doi.org/10.1038/s41598-020-80598-2.

Nikolopoulos, Kostis I., Vasilios Pergialiotis, Despina Perrea, and Stergios K. Doumouchtsis. “Restoration of the Pubourethral Ligament with Platelet Rich Plasma for the Treatment of Stress Urinary Incontinence.” Medical Hypotheses 90 (May 2016): 29–31. https://doi.org/10.1016/j.mehy.2016.02.019.

O’Connor, Eabhann, Aisling Nic an Riogh, Markos Karavitakis, Serenella Monagas, and Arjun Nambiar. “Diagnosis and Non-Surgical Management of Urinary Incontinence &ndash; A Literature Review with Recommendations for Practice.” International Journal of General Medicine 14 (August 16, 2021): 4555–65. https://doi.org/10.2147/IJGM.S289314.

Oshiro, Takuma, Ryu Kimura, Keiichiro Izumi, Asuka Ashikari, Seiichi Saito, and Minoru Miyazato. “Changes in Urethral Smooth Muscle and External Urethral Sphincter Function with Age in Rats.” Physiological Reports 8, no. 24 (2021): e14643. https://doi.org/10.14814/phy2.14643.

PANDIT, MEGHANA, JOHN O. L. DELANCEY, JAMES A. ASHTON-MILLER, JYOTHSNA IYENGAR, MILA BLAIVAS, and DANIELE PERUCCHINI. “Quantification of Intramuscular Nerves Within the Female Striated Urogenital Sphincter Muscle.” Obstetrics and Gynecology 95, no. 6 Pt 1 (June 2000): 797–800. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1192577/.

Perucchini, Daniele, John O.L. DeLancey, James A. Ashton-Miller, Andrzej Galecki, and Gabriel N. Schaer. “Age Effects on Urethral Striated Muscle II. Anatomic Location of Muscle Loss.” American Journal of Obstetrics and Gynecology 186, no. 3 (March 2002): 356–60. https://doi.org/10.1067/mob.2002.121090.

Perucchini, Daniele, John OL DeLancey, James A. Ashton-Miller, Ursula Peschers, and Tripti Kataria. “Age Effects on Urethral Striated Muscle I. Changes in Number and Diameter of Striated Muscle Fibers in the Ventral Urethra.” American Journal of Obstetrics & Gynecology 186, no. 3 (March 1, 2002): 351–55. https://doi.org/10.1067/mob.2002.121089.

Wiśniewska-Ślepaczuk, Katarzyna, Agnieszka Pieczykolan, Joanna Grzesik-Gąsior, and Artur Wdowiak. “A Review of Aesthetic Gynecologic Procedures for Women.” Plastic Surgical Nursing 41, no. 4 (October 2021): 191–202. https://doi.org/10.1097/PSN.0000000000000400.

Zhou, Shukui, Kaile Zhang, Anthony Atala, Oula Khoury, Sean V Murphy, Weixin Zhao, and Qiang Fu. “Stem Cell Therapy for Treatment of Stress Urinary Incontinence: The Current Status and Challenges,” n.d. https://doi.org/10.1155/2016/7060975.

Zubieta, Maria, Rebecca L. Carr, Marcus J. Drake, and Kari Bø. “Influence of Voluntary Pelvic Floor Muscle Contraction and Pelvic Floor Muscle Training on Urethral Closure Pressures: A Systematic Literature Review.” International Urogynecology Journal 27, no. 5 (May 2016): 687–96. https://doi.org/10.1007/s00192-015-2856-9.

Lee, Ping-Jui, Yuan-Hong Jiang, and Hann-Chorng Kuo. “A Novel Management for Postprostatectomy Urinary Incontinence: Platelet-Rich Plasma Urethral Sphincter Injection.” Scientific Reports | 11 (123AD): 5371. https://doi.org/10.1038/s41598-021-84923-1.

Chiang, Ching-Hsiang, and Hann-Chorng Kuo. “The Efficacy and Mid-Term Durability of Urethral Sphincter Injections of Platelet-Rich Plasma in Treatment of Female Stress Urinary Incontinence.” Frontiers in Pharmacology 13 (February 8, 2022): 847520. https://doi.org/10.3389/fphar.2022.847520.

Selection of Papers Demonstrating Improvement of SUI with Magnet (Emsella®)

Azparren, Javier, and Judson Brandeis. “HIFEM PROCEDURE ENHANCES QUALITY OF LIFE OF ELDERLY MEN WITH POST-PROSTATECTOMY INCONTINENCE,” n.d., 6.

Evans, Kimberly, and Julene B Samuels. “FEMALE URINARY INCONTINENCE AND SEXUAL FUNCTION AFTER THE HIFEM® PROCEDURE,” n.d., 2.

Gözlersüzer, Özlem, Bestami Yalvaç, and Basri Çakıroğlu. “Investigation of the Effectiveness of Magnetic Field Therapy in Women with Urinary Incontinence: Literature Review.” Urologia Journal, January 9, 2022, 03915603211069010. https://doi.org/10.1177/03915603211069010.

He, Qing, Kaiwen Xiao, Liao Peng, Junyu Lai, Hong Li, Deyi Luo, and Kunjie Wang. “An Effective Meta-Analysis of Magnetic Stimulation Therapy for Urinary Incontinence.” Scientific Reports 9 (June 24, 2019): 9077. https://doi.org/10.1038/s41598-019-45330-9.

Samuels, Julene B. “HIFEM TECHNOLOGY – THE NON-INVASIVE TREATMENT OF URINARY INCONTINENCE,” n.d., 7.

Samuels, Julene B., Andrea Pezzella, Joseph Berenholz, and Red Alinsod. “Safety and Efficacy of a Non‐Invasive High‐Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life.” Lasers in Surgery and Medicine 51, no. 9 (November 2019): 760–66. https://doi.org/10.1002/lsm.23106.

Silantyeva, Elena, Dragana Zarkovic, Evgeniia Astafeva, Ramina Soldatskaia, Mekan Orazov, Marina Belkovskaya, Mark Kurtser, and Academician of the Russian Academy of Sciences. “A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data.” Female Pelvic Medicine & Reconstructive Surgery 27, no. 4 (April 2021): 269–73. https://doi.org/10.1097/SPV.0000000000000807.

Another Selection of Papers Showing Neovacularization from PRP

Araujo-Gutierrez, Raquel, Jeffrey L. Van Eps, Jacob C. Scherba, Albert Thomas Anastasio, Fernando Cabrera, Cory J. Vatsaas, Keith Youker, and Joseph S. Fernandez Moure. “Platelet Rich Plasma Concentration Improves Biologic Mesh Incorporation and Decreases Multinucleated Giant Cells in a Dose Dependent Fashion.” Journal of Tissue Engineering and Regenerative Medicine 15, no. 11 (2021): 1037–46. https://doi.org/10.1002/term.3247.

Bindal, Priyadarshni, Nareshwaran Gnanasegaran, Umesh Bindal, Nazmul Haque, Thamil Selvee Ramasamy, Wen Lin Chai, and Noor Hayaty Abu Kasim. “Angiogenic Effect of Platelet-Rich Concentrates on Dental Pulp Stem Cells in Inflamed Microenvironment.” Clinical Oral Investigations 23, no. 10 (October 2019): 3821–31. https://doi.org/10.1007/s00784-019-02811-5.

Li, Yuan, Shan Mou, Peng Xiao, Guining Li, Jialun Li, Jing Tong, Jiecong Wang, Jie Yang, Jiaming Sun, and Zhenxing Wang. “Delayed Two Steps PRP Injection Strategy for the Improvement of Fat Graft Survival with Superior Angiogenesis.” Scientific Reports 10 (March 23, 2020): 5231. https://doi.org/10.1038/s41598-020-61891-6.

Nolan, Grant Switzer, Oliver John Smith, Susan Heavey, Gavin Jell, and Afshin Mosahebi. “Histological Analysis of Fat Grafting with Platelet‐rich Plasma for Diabetic Foot Ulcers—A Randomised Controlled Trial.” International Wound Journal 19, no. 2 (June 24, 2021): 389–98. https://doi.org/10.1111/iwj.13640.

Norooznezhad, Amir Hossein. “Decreased Pain in Patients Undergoing Pilonidal Sinus Surgery Treated with Platelet-Rich Plasma Therapy: The Role of Angiogenesis.” Advances in Skin & Wound Care 33, no. 1 (January 2020): 8. https://doi.org/10.1097/01.ASW.0000615376.97232.0a.

Saputro, Iswinarno Doso, Sitti Rizaliyana, and Dhitta Aliefia Noverta. “The Effect of Allogenic Freeze-Dried Platelet-Rich Plasma in Increasing the Number of Fibroblasts and Neovascularization in Wound Healing.” Annals of Medicine and Surgery 73 (January 3, 2022): 103217. https://doi.org/10.1016/j.amsu.2021.103217.

Sclafani, Anthony P., and Steven A. McCormick. “Induction of Dermal Collagenesis, Angiogenesis, and Adipogenesis in Human Skin by Injection of Platelet-Rich Fibrin Matrix.” Archives of Facial Plastic Surgery 14, no. 2 (April 2012): 132–36. https://doi.org/10.1001/archfacial.2011.784.

Zhang, X.-L., K.-Q. Shi, P.-T. Jia, L.-H. Jiang, Y.-H. Liu, X. Chen, Z.-Y. Zhou, Y.-X. Li, and L.-S. Wang. “Effects of Platelet-Rich Plasma on Angiogenesis and Osteogenesis-Associated Factors in Rabbits with Avascular Necrosis of the Femoral Head.” European Review for Medical and Pharmacological Sciences 22, no. 7 (April 2018): 2143–52. https://doi.org/10.26355/eurrev20180414748.

An Optional Technique for Injecting PRP for Incontinence

Chiang, Ching-Hsiang, and Hann-Chorng Kuo. “The Efficacy and Mid-Term Durability of Urethral Sphincter Injections of Platelet-Rich Plasma in Treatment of Female Stress Urinary Incontinence.” Frontiers in Pharmacology 13 (February 8, 2022): 847520. https://doi.org/10.3389/fphar.2022.847520

The Effects of Mid-Urethral Sling Placement on the Tissue of the Female Prostate and Female Sexual Function

Gaudet, D., D.G. Clohosey, J.L. Hannan, S.W. Goldstein, N. Szell, B.R. Komisarek, M.A. Harvey, et al. “249 Midurethral Sling Placement Disrupts Periurethral Neurovascular and Glandular Structures near Anterior Vaginal Wall: Potential Role in Female Sexual Dysfunction.” The Journal of Sexual Medicine 15, no. 7 (July 2018): S221–22. https://doi.org/10.1016/j.jsxm.2018.04.214.

 

PRP for Improved Sexual Function. International Society for Cosmetogynecology

International Society for Cosmetogynecology<--

Cellular Medicine Association<--

Transcript

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

Dr. Runels: Thank you for having me.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr. Marco Pelosi III: Thank you Charles. Beautiful

More about the Cellular Medicine Association

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

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O-Shot® Research. New Study. Double-Blind Placebo Controlled

Here's the link to copy and paste into a facebook page, tweet, & send a link to your patients (with the following note..."New research underway to help women with sex. Please forward so that we may find participants")...

Click here and then click the facebook, twitter, Google plus links
to let your patients know about this research (click)<---

Here's where to find the research already published...
click<--

Here's our list of certified teachers (soon to be updated with new people)...
click

Here's the new text (Chapter 15 O-Shot® goes well with Chapters 16 & 17 which discuss the use of the O-Shot® in combination with laser and with radiofrequency...

Thank you very much!
More good stuff coming soon!

Charles

Charles Runels, MD
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