Category: Public Lecture

  • Botulinium Toxin for Female Sexual Dysfunction – A Review (ISCG 2023)

    The following was posted in 2023. A more up-to-date description (with the research) can be seen here (click)<–

    1. Video of ISCG 2023 Lecture on Botox for Sexual Dysfunction
    2. Relevant Links
    3. References

    1. Video of Lecture: a preview of Clitoxin™ …  the use of botulinum toxin to improve sexual dysfunction in females.    Studies are underway; they are not yet available for patients except as part of a study.


    2. Relevant Links

    Update—new data here<–

    The PowerPoint Slides for this presentation<–

    See the Complete ISCG Meeting<—

    Priapus Toxin™<–

    P-Shot® <–

    O-Shot® <–

    Cellular Medicine Association <–

    Dr. Runels Botox Blastoff Course<–

    Next Hands-on Workshops with Live Models<–

    To be notified regarding possible patient participation in future studies of female sexual dysfunction…

    3. References

    Botox for Migraines

    Chan, Tommy Lik Hang. “OnabotulinumtoxinA Improves Quality of Life in Chronic Migraine: The PREDICT Study.” Canadian Journal of Neurological Sciences / Journal Canadien Des Sciences Neurologiques 49, no. 4 (July 2022): 477–78. https://doi.org/10.1017/cjn.2021.159.

    Escher, Claus M., Lejla Paracka, Dirk Dressler, and Katja Kollewe. “Botulinum Toxin in the Management of Chronic Migraine: Clinical Evidence and Experience.” Therapeutic Advances in Neurological Disorders 10, no. 2 (February 2017): 127–35. https://doi.org/10.1177/1756285616677005.

    “FDA Official Recomendations Regarding Botox.” FDA, n.d. https://www.accessdata.fda.gov/ drugsatfda_docs/label/2011/103000s5236lbl.pdf.

    Ramachandran, Roshni, and Tony L Yaksh. “Therapeutic Use of Botulinum Toxin in Migraine: Mechanisms of Action.” British Journal of Pharmacology 171, no. 18 (September 2014): 4177–92. https://doi.org/10.1111/bph.12763.

    Zandieh, Ali, and Fred Michael Cutrer. “OnabotulinumtoxinA in Chronic Migraine: Is the Response Dose Dependent?” BMC Neurology 22, no. 1 (December 2022): 218. https://doi.org/10.1186/s12883-022-02742-x.

    Botox for Erectile Dysfunction

    Abdelrahman, Islam Fathy Soliman, Amr Abdel Raheem, Yaser Elkhiat, Abdelrahman A. Aburahma, Tarek Abdel-Raheem, and Hussein Ghanem. “Safety and Efficacy of Botulinum Neurotoxin in the Treatment of Erectile Dysfunction Refractory to Phosphodiesterase Inhibitors: Results of a Randomized Controlled Trial.” Andrology 10, no. 2 (2022): 254–61. https://doi.org/10.1111/andr.13104.

    El-Shaer, Waleed, Hussein Ghanem, Tamer Diab, Ahmed Abo-Taleb, and Wael Kandeel. “Intra-Cavernous Injection of BOTOX® (50 and 100 Units) for Treatment of Vasculogenic Erectile Dysfunction: Randomized Controlled Trial.” Andrology 9, no. 4 (2021): 1166–75. https://doi.org/10.1111/andr.13010.

    Emura, Fabián, and David Peura. “Interview with Barry J. Marshall. Winner of the Nobel Prize in Medicine for the Discovery of Helicobacter Pylori,” n.d., 8.

    Giuliano, Francois, Pierre Denys, and Charles Joussain. “Effectiveness and Safety of Intracavernosal IncobotulinumtoxinA (Xeomin®) 100 U as an Add-on Therapy to Standard Pharmacological Treatment for Difficult-to-Treat Erectile Dysfunction: A Case Series.” Toxins 14, no. 4 (April 16, 2022): 286. https://doi.org/10.3390/toxins14040286.

    Giuliano, Francois, Charles Joussain, and Pierre Denys. “Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport®) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction—Case Studies.” Toxins 11, no. 5 (May 21, 2019): 283. https://doi.org/10.3390/toxins11050283.

    Habashy, Engy, and Tobias S. Köhler. “Botox for Erectile Dysfunction.” The Journal of Sexual Medicine 19, no. 7 (July 2022): 1061–63. https://doi.org/10.1016/j.jsxm.2022.03.216.

    Phan, Kevin, Shannon Younessi, Danielle Dubin, Matthew J. Lin, and Hooman Khorasani. “Emerging off‐label Esthetic Uses of Botulinum Toxin in Dermatology.” Dermatologic Therapy 35, no. 1 (January 2022). https://doi.org/10.1111/dth.15205.

    Porter, Dr Mark. “Botox: The New Viagra? It’s One Way to Treat Erectile Dysfunction,” sec. times2. Accessed November 8, 2022. https://www.thetimes.co.uk/article/botox-could-help-men-beat-erectile-dysfunction-here-s-what-to-know-8x2vvt9c7.

    Shehri, Zaed Ghassan, Issam Alkhouri, Mohammad Y Hajeer, Ibrahim Haddad, and Mohamad Husam Abu Hawa. “Evaluation of the Efficacy of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle for the Treatment of Nocturnal Bruxism: A Randomized Controlled Clinical Trial.” Cureus, December 4, 2022. https://doi.org/10.7759/cureus.32180.

    Botox Safety

    Arnon, Stephen S., Robert Schechter, Thomas V. Inglesby, Donald A. Henderson, John G. Bartlett, Michael S. Ascher, Edward Eitzen, et al. “Botulinum Toxin as a Biological WeaponMedical and Public Health Management.” JAMA 285, no. 8 (February 28, 2001): 1059–70. https://doi.org/10.1001/jama.285.8.1059.

    Bhatia, K P, A Munchau, P D Thompson, M Houser, V S Chauhan, M Hutchinson, A H V Shapira, and C D Marsden. “Generalised Muscular Weakness after Botulinum Toxin Injections for Dystonia: A Report of Three Cases.” Journal of Neurology, Neurosurgery & Psychiatry 67, no. 1 (July 1, 1999): 90–93. https://doi.org/10.1136/jnnp.67.1.90.

    Dhaked, Ram Kumar, Manglesh Kumar Singh, Padma Singh, and Pallavi Gupta. “Botulinum Toxin: Bioweapon & Magic Drug.” The Indian Journal of Medical Research 132, no. 5 (November 2010): 489–503. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3028942/.

    Frevert, Jürgen. “Content of Botulinum Neurotoxin in Botox®/Vistabel®, Dysport®/Azzalure®, and Xeomin®/Bocouture®.” Drugs in R&D 10, no. 2 (July 2010): 67–73. https://doi.org/10.2165/11584780-000000000-00000.

    Hefter, Harald, and Sara Samadzadeh. “The Necessity of a Locally Active Antidote in the Clinical Practice of Botulinum Neurotoxin Therapy: Short Communication.” Medicina 58, no. 7 (July 14, 2022): 935. https://doi.org/10.3390/medicina58070935.

    Naumann, Markus, and Joseph Jankovic. “Safety of Botulinum Toxin Type A: A Systematic Review and Meta-Analysis.” Current Medical Research and Opinion 20, no. 7 (July 2004): 981–90. https://doi.org/10.1185/030079904125003962.

    Nigam, P K, and Anjana Nigam. “BOTULINUM TOXIN.” Indian Journal of Dermatology 55, no. 1 (2010): 8–14. https://doi.org/10.4103/0019-5154.60343.

    Omprakash HM, and Rajendran SC. “Botulinum Toxin Deaths: What Is the Fact?” Journal of Cutaneous and Aesthetic Surgery 1, no. 2 (2008): 95–97. https://doi.org/10.4103/0974-2077.44169.

    Stephens, Martin L, and Michael Balls. “LD50 Testing of Botulinum Toxin for Use as a Cosmetic,” no. 2 (2005): 5.

    Botox for Female Sexual Dysfunction

    Dick, Brian, Caleb Natale, Amit Reddy, Kole Prasad Akula, Ayad Yousif, and Wayne J. G. Hellstrom. “Application of Botulinum Neurotoxin in Female Sexual and Genitourinary Dysfunction: A Review of Current Practices.” Sexual Medicine Reviews 9, no. 1 (January 1, 2021): 57–63. https://doi.org/10.1016/j.sxmr.2020.01.003.

     

    Khunda, Aethele, Carol McCormick, and Paul Ballard. “Sacral Neuromodulation and Sexual Function: A Systematic Review and Meta-Analysis of the Literature.” International Urogynecology Journal 30, no. 3 (March 2019): 339–52. https://doi.org/10.1007/s00192-018-3841-x.

     

    Nazik, Hakan, Murat Api, Hakan Aytan, and Raziye Narin. “A New Medical Treatment With Botulinum Toxin in Persistent Genital Arousal Disorder: Successful Treatment of Two Cases.” Journal of Sex & Marital Therapy 40, no. 3 (May 4, 2014): 170–74. https://doi.org/10.1080/0092623X.2013.788109.

     

    Shawer, Sami, Aethele Khunda, Gareth J. Waring, and Paul Ballard. “Impact of Intravesical OnabotulinumtoxinA (Botox) on Sexual Function in Patients with Overactive Bladder Syndrome: A Systematic Review and Meta-Analysis.” International Urogynecology Journal, January 13, 2022. https://doi.org/10.1007/s00192-021-05072-7.

    P-Shot® Research

    Bosma-Den Boer, Margarethe M., Marie Louise Van Wetten, and Leo Pruimboom. “Chronic Inflammatory Diseases Are Stimulated by Current Lifestyle: How Diet, Stress Levels and Medication Prevent Our Body from Recovering.” Nutrition and Metabolism 9 (2012). https://doi.org/10.1186/1743-7075-9-32.

    Casabona, Francesco, Ilaria Gambelli, Federica Casabona, Pierluigi Santi, Gregorio Santori, and Ilaria Baldelli. “Autologous Platelet-Rich Plasma (PRP) in Chronic Penile Lichen Sclerosus: The Impact on Tissue Repair and Patient Quality of Life.” International Urology and Nephrology 49, no. 4 (April 2017): 573–80. https://doi.org/10.1007/s11255-017-1523-0.

    Chung. “A Review of Current and Emerging Therapeutic Options for Erectile Dysfunction.” Medical Sciences 7, no. 9 (August 29, 2019): 91. https://doi.org/10.3390/medsci7090091.

    Chung, Eric. “Medical Sciences A Review of Current and Emerging Therapeutic Options for Erectile Dysfunction,” 2019, 1–11.

    Everts, Peter, Kentaro Onishi, Prathap Jayaram, José Fábio Lana, and Kenneth Mautner. “Platelet-Rich Plasma: New Performance Understandings and Therapeutic Considerations in 2020.” International Journal of Molecular Sciences 21, no. 20 (October 21, 2020): 7794. https://doi.org/10.3390/ijms21207794.

    Garcia, MM, TM Fandel, G Lin, AW Shindel, L Banie, CS Lin, and TF Lue. “Treatment of Erectile Dysfunction in the Obese Type 2 Diabetic ZDF Rat with Adipose Tissue-Derived Stem Cells.” The Journal of Sexual Medicine 7, no. 1 Pt 1 (January 2010): 89–98. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2904063/.

    Israeli, Joseph M., Soum D. Lokeshwar, Iakov V. Efimenko, Thomas A. Masterson, and Ranjith Ramasamy. “The Potential of Platelet-Rich Plasma Injections and Stem Cell Therapy for Penile Rejuvenation.” International Journal of Impotence Research, November 6, 2021, 1–8. https://doi.org/10.1038/s41443-021-00482-z.

    Kumar, C.S. “265 Combined Treatment of Injecting Platelet Rich Plasma With Vacuum Pump for Penile Enlargement.” The Journal of Sexual Medicine 14, no. 1 (January 2017): S78. https://doi.org/10.1016/j.jsxm.2016.11.174.

    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.

    Littara, A., B. Palmieri, V. Rottigni, and T. Iannitti. “A Clinical Study to Assess the Effectiveness of a Hyaluronic Acid-Based Procedure for Treatment of Premature Ejaculation.” International Journal of Impotence Research 25, no. 3 (2013). https://doi.org/10.1038/ijir.2013.13.

    Liu, Ming-Che, Meng-Lin Chang, Ya-Chun Wang, Wei-Hung Chen, Chien-Chih Wu, and Shauh-Der Yeh. “Revisiting the Regenerative Therapeutic Advances Towards Erectile Dysfunction.” Cells 9, no. 5 (May 19, 2020): 1250. https://doi.org/10.3390/cells9051250.

    Matz, Ethan L, Amy M Pearlman, and Ryan P Terlecki. “Safety and Feasibility of Platelet Rich Fibrin Matrix Injections for Treatment of Common Urologic Conditions.” Investigative and Clinical Urology 59, no. 1 (January 2018): 61–65. https://doi.org/10.4111/icu.2018.59.1.61.

    Matz, Ethan L., Kyle Scarberry, and Ryan Terlecki. “Platelet-Rich Plasma and Cellular Therapies for Sexual Medicine and Beyond.” Sexual Medicine Reviews 10, no. 1 (January 2022): 174–79. https://doi.org/10.1016/j.sxmr.2020.07.001.

    Poulios, Evangelos, Ioannis Mykoniatis, Nikolaos Pyrgidis, Filimon Zilotis, Paraskevi Kapoteli, Dimitrios Kotsiris, Dimitrios Kalyvianakis, and Dimitrios Hatzichristou. “Platelet-Rich Plasma (PRP) Improves Erectile Function: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.” Journal of Sexual Medicine 18, no. 5 (May 1, 2021): 926–35. https://doi.org/10.1016/j.jsxm.2021.03.008.

    Raheem, Amr Abdel, Giulio Garaffa, Tarek Abdel Raheem, Michelle Dixon, Amanda Kayes, Nim Christopher, and David Ralph. “The Role of Vacuum Pump Therapy to Mechanically Straighten the Penis in Peyronie’s Disease.” BJU International 106, no. 8 (2010): 1178–80. https://doi.org/10.1111/j.1464-410X.2010.09365.x.

    Ruffo, A., M. Franco, E. Illiano, and N. Stanojevic. “Effectiveness and Safety of Platelet Rich Plasma (PrP) Cavernosal Injections plus External Shock Wave Treatment for Penile Erectile Dysfunction: First Results from a Prospective, Randomized, Controlled, Interventional Study.” European Urology Supplements 18, no. 1 (March 2019): e1622–23. https://doi.org/10.1016/S1569-9056(19)31175-3.

    Schirmann, A., E. Boutin, A. Faix, and R. Yiou. “Pilot Study of Intra-Cavernous Injections of Platelet-Rich Plasma (P-Shot®) in the Treatment of Vascular Erectile Dysfunction.” Progrès En Urologie, June 2022, S1166708722001300. https://doi.org/10.1016/j.purol.2022.05.002.

    Shaher, Hussein, Abdallah Fathi, Salah Elbashir, Shabieb A. Abdelbaki, and Tarek Soliman. “Is Platelet Rich Plasma Safe And Effective In Treatment Of Erectile Dysfunction? Randomized Controlled Study.” Urology, February 2023, S0090429523000742. https://doi.org/10.1016/j.urology.2023.01.028.

    Siroky, Mike B., and Kazem M. Azadzoi. “Vasculogenic Erectile Dysfunction: Newer Therapeutic Strategies.” Journal of Urology 170, no. 2S (August 2003). https://doi.org/10.1097/01.ju.0000075361.35942.17.

    Towe, Maxwell, Akhil Peta, Russell G. Saltzman, Navin Balaji, Kevin Chu, and Ranjith Ramasamy. “The Use of Combination Regenerative Therapies for Erectile Dysfunction: Rationale and Current Status.” International Journal of Impotence Research, July 12, 2021, 1–4. https://doi.org/10.1038/s41443-021-00456-1.

     

    O-Shot® Research

    Agar, N. S., and T. Stephens. “Reduced Glutathione–a Comparative Study of Erythrocytes from Various Species of Marsupials in Australia.” Comparative Biochemistry and Physiology. A, Comparative Physiology 52, no. 4 (December 1, 1975): 605–6. https://doi.org/10.1016/s0300-9629(75)80008-9.

    Cardozo, Linda, and David Staskin, eds. Textbook of Female Urology and Urogynecology. Fourth edition. Boca Raton: CRC Press, Taylor & Francis Group, 2017.

    Handy, Ariel B., Amelia M. Stanton, and Cindy M. Meston. “Understanding Women’s Subjective Sexual Arousal Within the Laboratory: Definition, Measurement, and Manipulation.” Sexual Medicine Reviews 6, no. 2 (2018): 201–16. https://doi.org/10.1016/j.sxmr.2017.11.001.

    Hersant, Barbara, Mounia SidAhmed-Mezi, Yazid Belkacemi, Franklin Darmon, Sylvie Bastuji-Garin, Gabrielle Werkoff, Romain Bosc, et al. “Efficacy of Injecting Platelet Concentrate Combined with Hyaluronic Acid for the Treatment of Vulvovaginal Atrophy in Postmenopausal Women with History of Breast Cancer.” Menopause 25, no. 10 (2018): 1. https://doi.org/10.1097/GME.0000000000001122.

    Jb, Neto. “O-Shot: Platelets Rich Plasma in Intimate Female Treatment,” 2017, 4.

    Jhang, Jia-Fong, Shu-Yu Wu, Teng-Yi Lin, and Hann-Chorng Kuo. “Repeated Intravesical Injections of Platelet-Rich Plasma Are Effective in the Treatment of Interstitial Cystitis: A Case Control Pilot Study.” LUTS: Lower Urinary Tract Symptoms 11, no. 2 (2019): O42–47. https://doi.org/10.1111/luts.12212.

    Long, Cheng-Yu. “A Pilot Study: Effectiveness of Local Injection of Autologous Platelet-Rich Plasma in Treating Women with Stress Urinary Incontinence.” Scientific Reports, 2021, 9.

    Matz, Ethan L, Amy M Pearlman, and Ryan P Terlecki. “Safety and Feasibility of Platelet Rich Fibrin Matrix Injections for Treatment of Common Urologic Conditions.” Investigative and Clinical Urology 59, no. 1 (January 2018): 61–65. https://doi.org/10.4111/icu.2018.59.1.61.

    Merhi, Zaher, Serin Seckin, and Marco Mouanness. “REPRODUCTIVE ENDOCRINOLOGY: CASE STUDY Intraovarian PRP Injection Improved Hot Flashes in a Woman With Very Low Ovarian Reserve.” Accessed July 7, 2021. https://doi.org/10.1007/s43032-021-00655-7.

    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 1, 2016): 29–31. https://doi.org/10.1016/j.mehy.2016.02.019.

    Prodromidou, Anastasia, Themos Grigoriadis, and Stavros Athanasiou. “Platelet Rich Plasma for the Management of Urogynecological Disorders: The Current Evidence.” Current Opinion in Obstetrics & Gynecology Publish Ahead of Print (August 18, 2022). https://doi.org/10.1097/GCO.0000000000000820.

    Prodromidou, Anastasia, Dimitrios Zacharakis, and Stavros Athanasiou. “The Emerging Role on the Use of Platelet-Rich Plasma Products in the Management of Urogynaecological Disorders,” 2021. https://doi.org/10.1177/15533506211014848.

    Prodromidou, Anastasia, Dimitrios Zacharakis, Stavros Athanasiou, Athanasios Protopapas, Lina Michala, Nikolaos Kathopoulis, and Themos Grigoriadis. “The Emerging Role on the Use of Platelet-Rich Plasma Products in the Management of Urogynaecological Disorders.” Surgical Innovation, April 28, 2021, 15533506211014848. https://doi.org/10.1177/15533506211014848.

    Runels, Charles. “A Pilot Study of the Effect of Localized Injections of Autologous Platelet Rich Plasma (PRP) for the Treatment of Female Sexual Dysfunction.” Journal of Women’s Health Care 03, no. 04 (2014). https://doi.org/10.4172/2167-0420.1000169.

    Sanoulis, Vasileios, Nikolaos Nikolettos, and Nikolaos Vlahos. “The Use of Platelet-Rich Plasma in the Gynaecological Clinical Setting. A Review.” Hellenic Journal of Obstetrics and Gynecology 18, no. 3 (July 3, 2019): 55–65. https://doi.org/10.33574/hjog.1766.

    Sharp, Gemma, Pascale Maynard, Christine A Hamori, Jayson Oates, David B Sarwer, and Jayashri Kulkarni. “Measuring Quality of Life in Female Genital Cosmetic Procedure Patients: A Systematic Review of Patient-Reported Outcome Measures.” Aesthetic Surgery Journal 40, no. 3 (February 17, 2020): 311–18. https://doi.org/10.1093/asj/sjz325.

    Zheng, Zhifang. “Materials Selection for the Injection into Vaginal Wall for Treatment of Vaginal Atrophy,” 2021, 11.

  • 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

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