{"id":3271,"date":"2024-04-07T16:29:56","date_gmt":"2024-04-07T16:29:56","guid":{"rendered":"https:\/\/oshot.info\/members\/?p=3271"},"modified":"2026-10-14T19:34:52","modified_gmt":"2026-10-14T19:34:52","slug":"jcpm2024-04-02-clitoxin-orphan-therapeutics","status":"publish","type":"post","link":"https:\/\/oshot.info\/members\/jcpm2024-04-02-clitoxin-orphan-therapeutics\/","title":{"rendered":"JCPM2024.04.02 | Clitoxin\u00ae | &#8220;Orphan Therapeutics&#8221;"},"content":{"rendered":"<div>\n<table class=\"c15\">\n<tbody>\n<tr class=\"c27\">\n<td class=\"c47\" colspan=\"1\" rowspan=\"1\">\n<p class=\"c8\"><span class=\"c46\">Journal Club with Pearls &amp; Marketing 2024.04.02 \u00a0 \u00a0<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/&amp;sa=D&amp;source=editors&amp;ust=1712509824379193&amp;usg=AOvVaw2047oO8bxxCmXnqV6_J-WI\" target=\"_blank\" rel=\"noopener\">Cellular Medicine Association<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p class=\"c42 title\"><span class=\"c29\">JCPM2024.04.02<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">The following is an edited transcript of the<span>\u00a0<\/span><\/span><span class=\"c26 c39\">Journal Club with Pearls &amp; Marketing<\/span><span class=\"c2\">\u00a0(JCPM) of April 2, 2024, with Charles Runels, MD, and Alexandra Runnels, MD, FACOG.<\/span><\/p>\n<p class=\"c5\"><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/cellularmedicineassociation.org\/wp-content\/uploads\/2024\/04\/JCPM2024.04.02edited.pdf\" target=\"_blank\" rel=\"noopener\">&gt;-&gt; The PDF Transcript of the Page Can be Downloaded or Read Here (click) &lt;-&lt;<\/a><\/span><\/p>\n<div style=\"padding: 56.25% 0 0 0; position: relative;\"><iframe style=\"position: absolute; top: 0; left: 0; width: 100%; height: 100%;\" title=\"JCPM2024.04.02 | Clitoxin\u00ae Procedure | &quot;Orphan Therapeutics&quot; | Systems Analysis | Related Research\" src=\"https:\/\/player.vimeo.com\/video\/930165275?badge=0&amp;autopause=0&amp;player_id=0&amp;app_id=58479\" frameborder=\"0\"><\/iframe><\/div>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #0000ff;\">Topics Covered<\/span><\/h1>\n<ul class=\"c36 lst-kix_list_11-0 start\">\n<li class=\"c10 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">Documentation of Results following the O-Shot\u00ae or the Clitoxin\u00ae Procedures<\/span><\/strong><\/em><\/li>\n<li class=\"c10 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">Off-label Prescriptions &amp; \u201cOrphan Therapeutics\u201d<\/span><\/strong><\/em><\/li>\n<li class=\"c10 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">Administering the Female Sexual Function Index to Your Patients<\/span><\/strong><\/em><\/li>\n<li class=\"c10 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">Online Training &amp; Malpractice Insurance for the Clitoxin\u00ae Procedure<\/span><\/strong><\/em><\/li>\n<li class=\"c10 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">Why Using the \u201c\u00ae\u201d Protects Your Patients<\/span><\/strong><\/em><\/li>\n<li class=\"c10 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">What Went Sideway with Our Priapus Toxin\u00ae Procedure &amp; What We Can Do to Make Things Work Better with Clitoxin\u00ae<\/span><\/strong><\/em><\/li>\n<li class=\"c10 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">Who Might Benefit from the Clitoxin\u00ae Procedure (and the Need for a System Analysis Approach)<\/span><\/strong><\/em><\/li>\n<li class=\"c8 c35 li-bullet-0\"><em><strong><span class=\"c19 c32\" style=\"color: #800080;\">More Pearls from Dr. Alex about Doing the Clitoxin\u00ae Procedure<\/span><\/strong><\/em><\/li>\n<\/ul>\n<figure id=\"attachment_2007\" aria-describedby=\"caption-attachment-2007\" style=\"width: 300px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-2007 size-medium\" src=\"https:\/\/cellularmedicineassociation.org\/wp-content\/uploads\/2024\/03\/image12-300x239.jpg\" alt=\"\" width=\"300\" height=\"239\" \/><figcaption id=\"caption-attachment-2007\" class=\"wp-caption-text\">Charles Runels, MD<\/figcaption><\/figure>\n<p class=\"c5\"><span><img decoding=\"async\" title=\"\" src=\"images\/image1.png\" alt=\"\" \/><\/span><\/p>\n<p class=\"c38\"><span class=\"c43\"><a href=\"https:\/\/runels.com\" target=\"_blank\" rel=\"noopener\">Charles Runels, MD<\/a><br \/>\nAuthor, researcher, and inventor of the Vampire Facelift\u00ae, Orchid Shot\u00ae (O-Shot\u00ae), Priapus Shot\u00ae (P-Shot\u00ae), Priapus Toxin\u00ae, Vampire Breast Lift\u00ae, and Vampire Wing Lift\u00ae, &amp; Clitoxin\u00ae procedures.<\/span><\/p>\n<h1 class=\"c42 title\"><span class=\"c29\" style=\"color: #0000ff;\">Transcript<\/span><\/h1>\n<p class=\"c5\"><span class=\"c4\">Welcome to The Journal Club. It's finally time for us to start talking about the<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/clitoxin.com\/&amp;sa=D&amp;source=editors&amp;ust=1712509824340905&amp;usg=AOvVaw1PNWG6IZvJqnLuw_N0q5Rd\" target=\"_blank\" rel=\"noopener\">Clitoxin\u00ae procedure<\/a><\/span><span class=\"c4\">.<\/span><sup class=\"c17\"><a id=\"ftnt_ref1\" href=\"#ftnt1\">[1]<\/a><\/sup><\/p>\n<p class=\"c5\"><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/www.longdom.org\/open-access\/the-clitoral-injection-of-incobotulinumtoxina-for-the-improvement-of-arousal-orgasm-sexual-satisfaction-a-specific-method-and-the--106601.html&amp;sa=D&amp;source=editors&amp;ust=1712509824341689&amp;usg=AOvVaw05uv_mvmE1vu4kLMy-ZXNa\" target=\"_blank\" rel=\"noopener\">Here\u2019s the original article<\/a><\/span><span class=\"c4\">\u00a0so that you have it handy as we discuss implementation.<\/span><sup class=\"c17\"><a id=\"ftnt_ref2\" href=\"#ftnt2\">[2]<\/a><\/sup><\/p>\n<p class=\"c5\"><span class=\"c2\">Three things we were lacking: (1) agree on how to document the results, (2) understand the indications for doing the procedure, and (3) we need a strong source of malpractice insurance\u2014and all of that's now all in place.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Note:<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/&amp;sa=D&amp;source=editors&amp;ust=1712509824342406&amp;usg=AOvVaw3UTPERQjdRuA-EaohaQOPO\" target=\"_blank\" rel=\"noopener\">our office<\/a><\/span><span class=\"c4\">\u00a0is making the certificates that those of you who have taken the test about Clitoxin\u00ae will receive. Those of you who are O-Shot\u00ae providers (who have not yet taken the test) can do that for free<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/oshot.info\/members\/wp-login.php&amp;sa=D&amp;source=editors&amp;ust=1712509824342732&amp;usg=AOvVaw02gc78PEw6_16aPR11PMf2\">by simply logging in, studying the videos and supporting material, and taking the test<\/a><\/span><span class=\"c2\">.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Let\u2019s start with documentation.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Documentation of Results following the O-Shot\u00ae or the Clitoxin\u00ae Procedures<\/span><\/h1>\n<p class=\"c5\"><span class=\"c4\">Here are two articles I've put in the handout section for you to download regarding the Female Sexual Function Index (FSFI).<\/span><sup class=\"c17\"><a id=\"ftnt_ref3\" href=\"#ftnt3\">[3]<\/a><\/sup><span class=\"c4\">\u00a0<\/span><sup class=\"c17\"><a id=\"ftnt_ref4\" href=\"#ftnt4\">[4]<\/a><\/sup><span class=\"c4\">\u00a0I have also used the Female Sexual Distress Scale-Revised (FSDS-R).<\/span><sup class=\"c17\"><a id=\"ftnt_ref5\" href=\"#ftnt5\">[5]<\/a><\/sup><span class=\"c4\">\u00a0<\/span><sup class=\"c17\"><a id=\"ftnt_ref6\" href=\"#ftnt6\">[6]<\/a><\/sup><\/p>\n<p class=\"c5\"><span class=\"c4\">If you look at the original article we did about the O-Shot\u00ae procedure,<\/span><sup class=\"c17\"><a id=\"ftnt_ref7\" href=\"#ftnt7\">[7]<\/a><\/sup><span class=\"c2\">\u00a0we used both scales, and you can do that; but if you wish to simplify and do only one survey, the Female Sexual Function Index is better because it offers perspective on multiple domains: lubrication, arousal, desire, pain, orgasm, and overall satisfaction.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">However, the FSFI is more troublesome to grade than the FSDS-R. The FSFI can look confusing: first, you grade each question, then sort the answers into groups, add the answers, and then multiply by a varying factor to calculate a score for each domain and an overall score. It\u2019s not calculus; it's only adding and multiplying, but it takes a few minutes, which you may not have, so I hired someone to write software that will grade the FSFI for you and hopefully do other useful functions. Again, this article's in your handout.<\/span><sup class=\"c17\"><a id=\"ftnt_ref8\" href=\"#ftnt8\">[8]<\/a><\/sup><\/p>\n<p class=\"c5\"><span class=\"c4\">Here's the other one that talks about the validity of the FSFI, how to administer it, and how to grade it.<\/span><sup class=\"c17\"><a id=\"ftnt_ref9\" href=\"#ftnt9\">[9]<\/a><\/sup><span class=\"c4\">\u00a0<\/span><span class=\"c9\">Remember, documenting results is part of what should be done with any off-label prescription<\/span><span class=\"c4\">, especially something new.<\/span><sup class=\"c17\"><a id=\"ftnt_ref10\" href=\"#ftnt10\">[10]<\/a><\/sup><span class=\"c4\">\u00a0<\/span><sup class=\"c17\"><a id=\"ftnt_ref11\" href=\"#ftnt11\">[11]<\/a><\/sup><span class=\"c2\">\u00a0I'll also put these articles in your handouts.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Off-label Prescriptions &amp; \u201cOrphan Therapeutics\u201d<\/span><\/h1>\n<p class=\"c5\"><span class=\"c4\">We frequently write off-label prescriptions. When you prescribe testosterone to women, that's off-label; when you inject botulinum toxin to help smoker\u2019s lines, bruxism, or crow's feet, that is all off-label. Research shows that 21 to 32% of the prescriptions written by primary care doctors are off-label.<\/span><sup class=\"c17\"><a id=\"ftnt_ref12\" href=\"#ftnt12\">[12]<\/a><\/sup><span class=\"c4\">\u00a0 One study confirmed that<\/span><span class=\"c9\">\u00a097% (ninety-seven) of hospitalized children are prescribed at least one off-label prescription.<\/span><sup class=\"c17\"><a id=\"ftnt_ref13\" href=\"#ftnt13\">[13]<\/a><\/sup><\/p>\n<p class=\"c5\"><span class=\"c4\">Many of the well-documented results and benefits of off-label prescriptions will never become on-label by the FDA because the expense and the difficulty of proving an on-label indication can be beyond profitability in hard-to-study populations like children and women who are pregnant or of childbearing age or therapeutic results that are difficult to prove, like sexual dysfunction in women being improved without agreed upon, easily-measured objective findings (as you have with men); these difficult to bring to on-label population\/indications are classified as<span>\u00a0<\/span><\/span><span class=\"c9\">\u201corphan therapeutics.\u201d<\/span><span class=\"c4\">\u00a0<\/span><sup class=\"c17\"><a id=\"ftnt_ref14\" href=\"#ftnt14\">[14]<\/a><\/sup><span class=\"c2\">\u00a0<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Because of the common use of drugs for some problems, even when there are no on-label indications,<span>\u00a0<\/span><\/span><span class=\"c9\">pharmaceutical companies can be disincentivized to proceed with the expense of obtaining on-label indications<\/span><span class=\"c4\">: why spend vast money for a near-impossible study when doctors are already writing prescriptions for the off-label indication?<\/span><sup class=\"c17\"><a id=\"ftnt_ref15\" href=\"#ftnt15\">[15]<\/a><\/sup><\/p>\n<p class=\"c5\"><span class=\"c2\">For an example of why it is easier to obtain FDA-approved, on-label indications for sexual dysfunction therapies in men than for women, consider that you can measure the severity of Peyronie's disease (and the results of therapy) with a protractor. There is no ruler you can buy at the drugstore to measure sexual function in a woman objectively.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So, for men, you can measure results with a protractor from Walgreens; you do not even need to go to an office supply house. You can determine the effectiveness of Viagra with a yes or no question: \u201cDid your penis become firm enough for penetration?\u201d<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Such is not the case with women. One of the most accepted measures for the difficult task of measuring treatment in women is the Female Sexual Function Index. Within the domains of that tool, the FDA pays special attention to the satisfaction domain\u2014which (to the consternation of those seeking on-label indications for new drugs for women) can sometimes decrease when other domains improve. For example, you could increase a woman's libido, but her satisfaction may decrease because her husband can no longer keep up with her, and in that case (if all women in the study had similar results), the drug would not be approved.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So, by definition, it is difficult and beyond-feasible-expensive to prove effectiveness for the orphan populations and indications, and that is why you will probably never see FDA-approved testosterone for women. That is an orphan indication.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So off-label prescriptions are a necessary and accepted part of medicine, but such prescriptions must be done correctly to protect both patients and their physicians. You don't have to publish a journal article about the results to write off-label prescriptions, but you need research supporting such off-label use, and you must keep records about what happens (objective and subjective findings.<\/span><\/p>\n<p class=\"c33\"><span class=\"c19 c9\">Physicians embrace off-label prescriptions only with science-based strategies and procedures.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Stating the numbers another way, if we had to quit writing all off-label prescriptions, we would lose 21% to 32% of all the prescriptions we write.<\/span><sup class=\"c17\"><a id=\"ftnt_ref16\" href=\"#ftnt16\">[16]<\/a><\/sup><span class=\"c2\">\u00a0So, it\u2019s commonly done. But, when you write off-label prescriptions for women with sexual dysfunction (whether it\u2019s Wellbutrin, testosterone, or BoNT), keep records, and one of the documents to include in your records is the FSFI.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">The instrument does not have many questions (it takes about 5 minutes). However, the FSFI can be confusing to grade. For example, you add the scores from questions one and two and multiply by 0.6 to arrive at a score. So, until we get our software written, I recommend that you use the following website to grade the FSFI (shown to me by my brilliant wife,<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/thescarlettphoenix.com\/about-dr-alex-runnels\/&amp;sa=D&amp;source=editors&amp;ust=1712509824346980&amp;usg=AOvVaw2nqJ5ww9v8zftfLoHPhtkc\" target=\"_blank\" rel=\"noopener\">Alexandra Runnels, MD, FACOG<\/a><\/span><span class=\"c4\">): here\u2019s<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/www.thecalculator.co\/health\/Female-Sexual-Function-Index-(FSFI)-Questionnaire-Calculator-949.html&amp;sa=D&amp;source=editors&amp;ust=1712509824347351&amp;usg=AOvVaw1CxgMef3RaJ54dRwiK2A4c\" target=\"_blank\" rel=\"noopener\">the link<\/a><\/span><span class=\"c4\">.<\/span><sup class=\"c17\"><a id=\"ftnt_ref17\" href=\"#ftnt17\">[17]<\/a><\/sup><span class=\"c2\">\u00a0That website also provides two useful references about the FSFI, one of which I've already given you in the handouts.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Now that you intend to use the FSFI, how do you practically implement this documentation into the flow of your office procedures?<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Administering the Female Sexual Function Index (FSFI)<\/span><\/h1>\n<p class=\"c5\"><span class=\"c2\">Our membership site has a downloadable PDF version of the FSFI on the \u201cHow to Do\u201d page.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">In my office, I print the FSFI and give it to the woman on paper; she fills it out (using a pen, not a computer). Then, I score it. I keep paper charts, so the end of the story\u2014the paper with her handwritten answers, goes in the chart.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">If you have an electronic medical record, I recommend doing this on paper, scanning it into your EMR, and then using the website<\/span><sup class=\"c17\"><a id=\"ftnt_ref18\" href=\"#ftnt18\">[18]<\/a><\/sup><span class=\"c2\">\u00a0to calculate the results\/scores and add that to your notes.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So, documentation of results for the Clitoxin\u00ae procedure (or of the O-Shot\u00ae or testosterone in women) would include the FSFI done the day you do the treatment or sent to your patient by email before her visit (if you want to save time when you're sitting in front of her and instead of waiting for her to fill it out).<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\"><a href=\"https:\/\/www.on2url.com\/app\/adtrack.asp?MerchantID=153781&amp;AdID=1012867\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-2013 size-medium\" src=\"https:\/\/cellularmedicineassociation.org\/wp-content\/uploads\/2024\/03\/image11-211x300.jpg\" alt=\"\" width=\"211\" height=\"300\" \/><\/a>Some of you know, starting in 2003, when I gave up accepting insurance, I had women flying to see me from around the world to my little town because I was early into doing female hormone replacement the way most of you do it now: measuring blood levels and adjusting treatments based on symptoms and normal ranges instead of giving everybody either Premarin or nothing.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Because I was early on (before Suzanne Somers did her first book about hormones), people were flying in from everywhere. But they couldn't fly in, get an order for blood testing, and then return another day. So, in the days before the electronic scheduling and other tools we now use, I would talk on the phone briefly to decide if they were a good match for my practice (that is, if I thought I could help them), and then if they were, I would send them a lab order and they could print off and take to LabCorp; otherwise they'd go to LabCorp and sometimes the staff there couldn't find the order. And I would send the woman all the paperwork to bring when they came to see me in the office. And that works well if they're across the street as well.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I also do SHIM scores on men (pre- and post-procedure) who receive the P-Shot\u00ae procedure.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I confess I don't do the surveys with every procedure; maybe I should, but I don\u2019t\u2014if someone's coming in for their third O-Shot\u00ae, they know they love it, and it's wearing off, and they want another one, I may skip the survey. But if it's a first-time patient, I like to measure at least FSFI, and if you want, in addition, administer the Female Sexual Distress-Revised; it's even faster and easier to score. There are no factors to multiply as with the FSFI.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Alex, because you're keeping paper charts, too, please share some of your tips for documentation.<\/span><\/p>\n<p class=\"c5\"><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/thescarlettphoenix.com\/about-dr-alex-runnels\/&amp;sa=D&amp;source=editors&amp;ust=1712509824349111&amp;usg=AOvVaw2hIk4Z3h0s9YAIAzODtWVA\" target=\"_blank\" rel=\"noopener\">Alexandra Runnels, MD, FACOG:<\/a><\/span><\/p>\n<figure id=\"attachment_2008\" aria-describedby=\"caption-attachment-2008\" style=\"width: 300px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-2008 size-medium\" src=\"https:\/\/cellularmedicineassociation.org\/wp-content\/uploads\/2024\/03\/image2-300x188.jpg\" alt=\"\" width=\"300\" height=\"188\" \/><figcaption id=\"caption-attachment-2008\" class=\"wp-caption-text\">Alexandra Runnels, MD, FACOG<\/figcaption><\/figure>\n<p class=\"c5\"><span class=\"c2\">I'm here; can you hear me?<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Charles Runels, MD:<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Yes, we can.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Alexandra Runnels, MD, FACOG:<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I also use paper charts, and I have the same feeling about EMRs that you do, and probably everybody on this call has. I have suffered through many EMR implementations, and it gives me a seizure to even think about using an EMR. So, I also have paper charts that I use, and if they're scheduled for an appointment for an O-Shot\u00ae or now for Clitoxin\u00ae, when they come in, their paperwork is done right off the bat. They're handed a piece of paper to fill out, as far as the FSFI questionnaire, and they fill it out as part of \"We're checking in.\"<span>\u00a0<\/span><\/span><span><img decoding=\"async\" title=\"\" src=\"images\/image7.png\" alt=\"A close-up of a person smiling Description automatically generated\" \/><\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I could send it to them ahead of time. I've tried doing forms before they show up, but people don't do them that consistently. So, I keep it simple and do it that way. And Christy (my nurse) is wonderful and helpful. She assures that the patients get the paperwork done.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Charles Runels, MD:<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Okay, so after you get the form filled out on paper, does Christy enter their answers into the website and grade them? When are you doing that?<\/span><span><img decoding=\"async\" title=\"\" src=\"images\/image3.png\" alt=\"\" \/><\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Alexandra Runnels, MD, FACOG:<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">That happens sometimes while they're sitting in front of me (I enter it into the website to score it) and sometimes after they've left, especially if it's their first time to fill it out and they're coming back for another visit later. But moving forward, I want to start using it more to manage expectations of the procedures that we're doing. I haven't used it for that purpose, but that is part of my plan.<\/span><sup class=\"c17\"><a id=\"ftnt_ref19\" href=\"#ftnt19\">[19]<\/a><\/sup><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Online Training &amp; Malpractice Insurance for the Clitoxin\u00ae Procedure<\/span><\/h1>\n<p class=\"c5\"><span class=\"c2\">Charles Runels, MD:<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Okay, a quick note about insurance. Let me swap over to a different website. When you go to<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/oshot.info\/members\/wp-login.php&amp;sa=D&amp;source=editors&amp;ust=1712509824350888&amp;usg=AOvVaw3dn4b-0wXGuTvp5BhRmAam\">our O-Shot\u00ae membership site<\/a><\/span><span class=\"c2\">, go to the dashboard if you ever get lost. It may be worth going through this step-by-step course even if you've been in the group a while. The steps look voluminous, but many only take a few seconds. This course gives you the best chance of success with the O-Shot\u00ae procedure.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">And then, to learn how to do the Clitoxin\u00ae procedure,<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/oshot.info\/members\/wp-login.php&amp;sa=D&amp;source=editors&amp;ust=1712509824351306&amp;usg=AOvVaw2f4-LN-tNV_SYDmwMQXSru\">you go here<\/a><\/span><span class=\"c4\">, and it's just a few videos.<\/span><sup class=\"c17\"><a id=\"ftnt_ref20\" href=\"#ftnt20\">[20]<\/a><\/sup><span class=\"c4\">\u00a0(For those who are not yet O-Shot\u00ae providers, the application for online training can be found here:<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/oshot.info\/members&amp;sa=D&amp;source=editors&amp;ust=1712509824351728&amp;usg=AOvVaw1jxKymh2FZUufJyu3aAsik\">https:\/\/oshot.info\/members<\/a><\/span><span class=\"c2\">.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I don't have the test automated yet. Copy and paste the questions, add your answers, and then email us the answers, and we'll send you the certificate.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">And no matter who you're using for your malpractice carrier,<span>\u00a0<\/span><\/span><span class=\"c30 c31\">the best option for explaining it to them to get coverage (because we have over a decade of success with minimal unwanted sequelae) is to tell them this is an add-on to the O-Shot\u00ae (which it is).<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">You're still injecting in the same places. You're just adding BoNT to the clitoral injection (not to the anterior vaginal wall), which has been used for at least two decades in the bladder and for vaginismus in women of childbearing age. You're just using BoNT in addition to the PRP, and you're putting it in a different place (the clitoris) than where BoNT has been routinely used.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">If your carrier hesitates, here\u2019s what to do: Study our materials and answer the questions; we will shoot you a certificate; go to our legal page and download our consent form and ask your attorney to modify it for your practice and location; then contact our recommended carrier, and he will likely write your policy for either just the Clitoxin\u00ae procedure or for your whole practice (he will want to see your certificate from us and see your consent form).<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">We're not offering licensing to advertise the Clitoxin\u00ae procedure to anyone not in our O-Shot\u00ae provider group. If you're doing O-Shot\u00ae's, you already have certain licensing criteria that allow you to study the materials. Then, you've passed hands-on or online confirmation of your understanding of that material and got a certificate. This definite protocol with testing is one reason why our reputation has increased for over a decade.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Why Using the \u201c\u00ae\u201d Protects Your Patients<\/span><\/h1>\n<p class=\"c5\"><span class=\"c2\">And another tip: I need to edit this. Clitoxin is no longer a TM (\u2122); it's an R (\u00ae). That is super important.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">This happened with Priapus Toxin\u00ae. And pay careful attention to this. Please. The<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/&amp;sa=D&amp;source=editors&amp;ust=1712509824353065&amp;usg=AOvVaw1fKppN9A-l9MgrjPpURyR2\" target=\"_blank\" rel=\"noopener\">CMA<\/a><\/span><span class=\"c2\">\u00a0spends a million dollars, plus or minus a hundred grand every year, running off people who want to pretend to be us.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Note: To make an R symbol (\u00ae) on a Mac. You push \u201coption\u201d and then the R key, which pops the \u00ae into the copy. That should go everywhere you put the word Clitoxin\u00ae and preferably the word \u201cprocedure\u201d after it, because that emphasizes that it's not just a shot..<\/span><\/p>\n<p class=\"c23\"><span class=\"c19 c9\">This is a procedure. The injection is only a part of the procedure.<\/span><\/p>\n<p class=\"c8\"><span class=\"c6\">And it isn't just a shot. You must prepare the BoNT. You must know how to prepare the combination if you combine it with platelet-rich plasma (PRP)\u2014including how to prepare the PRP. You must know when and when not to do the procedure, how to follow up, and more. So, it's not just a shot that you can teach to someone who might give B12 shots for you in the office; they cannot just blindly do the Clitoxin\u00ae procedure for anyone who walks in.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">What Went Sideway with Our Priapus Toxin\u00ae Procedure &amp; What We Can Do to Make Things Work Better with Clitoxin\u00ae<\/span><\/h1>\n<p class=\"c5\"><span class=\"c4\">Because we (the<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/&amp;sa=D&amp;source=editors&amp;ust=1712509824354062&amp;usg=AOvVaw16SuDUw3NByr5VHe7uCZ-S\" target=\"_blank\" rel=\"noopener\">CMA<\/a><\/span><span class=\"c2\">) were so efficient at rolling Priapus Toxin\u00ae, when the trademark examiner (at the US Patent &amp; Trademark Office) looked at it, he said, \"This is a generic word because look at all these people who are doing it.\"<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">So, we checked all the names he gave us as evidence that it had gone generic. \u00a0Every name he gave us (as evidence that it was a generic name) was one of our providers, so it had not gone generic. But, because we had such rapid dissemination of the idea, the trademark examiner initially balked a<\/span><span>\u00a0<\/span><span class=\"c2\">t granting us the R symbol and wanted to claim it was generic. That would not have happened had all our providers used the R symbol after the name, indicating their understanding that this is a trademark name and that they're a licensee.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Note: The symbol can be written like this: (R). Or, it can be written like this: \u00ae.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Yes, the examiner could have just visited<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/oshot.info\/members\/directory&amp;sa=D&amp;source=editors&amp;ust=1712509824354896&amp;usg=AOvVaw2sF8zs-JMTPymTVEe7kX4d\">our directory<\/a><\/span><span class=\"c4\">\u00a0and quickly confirmed that everyone he identified as an infringer was someone in our group, but it's government workers; not that that's a bad thing, but there's no profit incentive for the examiner to do that. So, I must make their job very easy. The \u00ae symbol used by our members makes it possible for us to keep our names<\/span><sup class=\"c17\"><a id=\"ftnt_ref21\" href=\"#ftnt21\">[21]<\/a><\/sup><span class=\"c2\">\u00a0from going generic and, therefore, be able to keep every Joe Blow person with a hair salon from claiming to be offering our procedures.<\/span><\/p>\n<p class=\"c5\"><span class=\"c19 c26\">Without the enforcement of our trademarks, if somebody wanted, they could say Clitoxin\u00ae and make up anything, like it\u2019s painting fingernail polish on the end of a clitoris. They could make up whatever they wanted for any of our names. A Vampire Facelift\u00ae could be putting red clay on your face.<\/span><\/p>\n<p class=\"c33\"><span class=\"c19 c9\">Without trademark enforcement, people would be hurt by those doing crazy things\u2014using our good reputation to lure people to injury.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">The only reason our names maintain their value is (1) the quality of our providers, (2) the effectiveness of our protocols, and (3) because we spend a million dollars a year running off people who use our trademarked names to advertise sometimes bad medicine illegally.<\/span><sup class=\"c17\"><a id=\"ftnt_ref22\" href=\"#ftnt22\">[22]<\/a><\/sup><\/p>\n<p class=\"c5\"><span class=\"c2\">So when you roll this out on your website, if you have a Mac, hold down the \u201coption\u201d button and then push the \u201cR,\u201d and stick \u00ae behind the word\u2014Clitoxin\u00ae.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I'll have to correct some of our web pages because we still have the \u2122 sign, and recently, we secured the \u00ae.<\/span><\/p>\n<p class=\"c5\"><span class=\"c19 c26\">A Lawyer Pearl: The approval timing by the government agencies for intellectual properties (like the \u00ae) varies based on the country. Some are faster than others. We don't have the \u00ae in every country yet. But once it's approved in any country (because any country can look at this website), it gets an \u00ae.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Our<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/clitoxin.com\/&amp;sa=D&amp;source=editors&amp;ust=1712509824356550&amp;usg=AOvVaw3oca8iqeq2WCzNl3MuAxpO\" target=\"_blank\" rel=\"noopener\">Clitoxin.com<\/a><\/span><span class=\"c2\">\u00a0website will evolve. Hopefully, you (our CMA members) will start sending me videos about the procedure that you made. I'll push this (the video of our initial presentation) back to a research page and put videos made by our providers on the home page, and I think we'll probably get some press as well\u2014which we will also feature.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I have not yet completed the press release. I haven't pushed the buttons (to make it go viral) yet because I want you guys to be ready when I do.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Who Might Benefit from the Clitoxin\u00ae Procedure (and the Need for a Systems Analysis Approach)<\/span><\/h1>\n<p class=\"c5\"><span class=\"c2\">I would also be grateful if you could help me with this, Alex. I know I harp on this a lot, but this is important: systems analysis.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">As an example of the importance of systems analysis, there was a woman who saw a plastic surgeon in New Orleans for dyspareunia (someone not in our group), and the plastic surgeon had a new vaginal laser. He did the laser on her in hopes it would help her dyspareunia, but her pain worsened.<span>\u00a0<\/span><\/span><span><img decoding=\"async\" title=\"\" src=\"images\/image4.png\" alt=\"A drawing of a person Description automatically generated\" \/><\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Then, the woman (a petite Japanese lady) saw one of our providers, and our O-Shot\u00ae provider (a gynecologist) discovered that the petite lady was married to King Kong. So, she did not need a tighter vagina. She needed an O-Shot\u00ae to help her with dyspareunia and a dilator, and she soon enjoyed pain-free sex with more intense orgasms with her husband.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">In other words, just like every other part of medicine, there should be a systems analysis\u2014not a magic-bullet approach to our patients. And most of you guys do think this way.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">This is my sketch of the female orgasm system thus far.<span>\u00a0<\/span><\/span><\/p>\n<p class=\"c5\"><span><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-medium wp-image-2026\" src=\"https:\/\/cellularmedicineassociation.org\/wp-content\/uploads\/2024\/04\/image4-208x300.png\" alt=\"\" width=\"208\" height=\"300\" \/><img decoding=\"async\" title=\"\" src=\"images\/image2.png\" alt=\"\" \/><\/span><span class=\"c2\">Clitoxin\u00ae came out of my three-year pursuit of coming up with a neat poster that summarizes everything that's involved in the sexual or orgasmic response.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">This is one of the websites that feeds us patients. And I'll put this in the chat box, too. It's mostly tongue-in-cheek, but whatever. It's half fun and half serious. However, I have a website called<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/orgasmcollege.com\/&amp;sa=D&amp;source=editors&amp;ust=1712509824358447&amp;usg=AOvVaw3S1t3qJbSn7zimBSkgFDVv\" target=\"_blank\" rel=\"noopener\">Orgasm College<\/a><\/span><sup class=\"c17\"><a id=\"ftnt_ref23\" href=\"#ftnt23\">[23]<\/a><\/sup><span class=\"c4\">\u00a0and a course called the<span>\u00a0<\/span><\/span><span class=\"c3 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/orgasmcollege.com\/femaleorgasmsystem\/&amp;sa=D&amp;source=editors&amp;ust=1712509824358997&amp;usg=AOvVaw3w10wsT_shOIRIQHUEYGte\" target=\"_blank\" rel=\"noopener\">Female Orgasm System<\/a><\/span><span class=\"c4\">.<\/span><sup class=\"c17\"><a id=\"ftnt_ref24\" href=\"#ftnt24\">[24]<\/a><\/sup><span class=\"c2\">\u00a0 Eventually, I think I'll issue diplomas to people who pass the test on this, but it has been two or three years now that I wake up meditating on this. That led to figuring out Clitoxin\u00ae because when I started looking at the autonomic system, it connected to the midbrain, where the arousal center is.<\/span><span><img decoding=\"async\" title=\"\" src=\"images\/image5.jpg\" alt=\"A book cover with a rocket launch Description automatically generated\" \/><\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">But any one of those circles on that chart could go away and goof up sex; every component of the system is necessary for the system to work.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">For example, let's pick the hood. The clitoral hood could be phimosed from lichen sclerosus\u2014preventing normal stimulation of the clitoris, which could goof up your sex.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Pick something else. You could have a pelvic floor muscle that's hurting. In the pituitary, you could have a microadenoma causing hyperprolactinemia or a micro-infarction (from head trauma) causing growth hormone deficiency. Or, you could have hypo or hyperthyroidism. Or your thinking brain could be telling you scary things because you were abused, and you're remembering what happened to you as a child. You could have a spinal cord lesion. Any one of these hormones could be goofed up. You could be eating supplements that are making you anxious or depressed. You can go on and on.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Any circle on that diagram of the system could be goofed up and goof up your sex. So the idea that I could say, \"Just inject botulinum toxin in the clitoris, and it could fix any circle (any component and any broken feedback loop),\" would be ludicrous.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">And so would it be if I said the same about an O-Shot\u00ae (PRP done in our specific way) or a labiaplasty or a vaginal laser or a testosterone shot or psychotherapy. There is no one treatment that would correct everything that could go wrong with any one of those parts of the orgasm system.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Remember, a system is a collection of individual components with feedback loops that work together to accomplish a purpose.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So, let's quickly look at something. Here's a primary view of the respiratory system. As an ER doctor (which I did for 12 years), shortness of breath is a commonly heard complaint. If someone comes in with dyspnea, it could be a foreign body in the trachea, laryngeal spasm, or angioedema of the larynx caused by an allergic reaction. It could be an abscess in the pharynx. It could be a collapsed lung (usually seen in a tall, skinny teenage boy). It could be bronchitis, pneumonia, or bronchospasm, or pulmonary edema. It could be anemia or profound anemia. It could be cyanide poisoning. You could go on and on.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So, when someone shows up with dyspnea, you use your history and physical exam, meditate on which part or parts of the system are broken, and then choose the right therapy.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">It could also be (with dyspnea) that they're suffering an anxiety attack, in which case maybe they need medications or they need psychotherapy or hypnosis. But I won't offer family therapy for a foreign body in the right mainstream bronchus where the kid breathed in a penny. And I think it's just as ludicrous to do family psycho-sex therapy on someone who's got a tearing, hurting episiotomy scar that might be helped by a platelet-rich plasma (an O-Shot\u00ae). On the other hand, after you make them better, they may need therapy because now the sex is so good the husband can't keep up. So, there's always room for improvement in the art of lovemaking, so counseling can always help. But it\u2019s not the magic bullet, nor is the Clitoxin\u00ae procedure.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">If you go back to the system, imagine not being sick. Imagine increasing your VO2 max to where you have the ultimate respiratory system, and you can run a marathon on Pike's Peak at 14,000 feet. In that case, you are not moving from sickness to well, but rather form well, but even better. In that case, you will consider how to tune up every part of the system. You'll train at altitude, so you get an erythrocytosis. You may even dope and illegally take a transfusion right before you run. You might use a bronchodilator, on and on. So, in the same way, we can think about female sexual function in terms of pathology, which is the way I recommend you think about it, or we can think about making good sex into something beyond what most think possible. \u00a0That\u2019s a legitimate idea, but I don't think that we should advertise this as a way to make normal better, although people will come to you for that. And it will sometimes do that. I don't think it's the best marketing. It sets you up. Just like you don't advertise testosterone to make normal men able to pick up heavier weights or look prettier in the mirror, you can advertise it for erectile dysfunction and depression.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So, in the same way, I think you think about this in terms of what you can help with it. Well, if you look at the study that we did, which is also in your handouts, you'll see that (it was Alex's patient) the woman who was postmenopausal and not hormonally replaced and having pain still had some improvement (after the Clitoxin\u00ae procedure), but she had the least impressive improvement of those who completed our survey; while those who were premenopausal or postmenopausal and hormonally replaced, but still not happy with their sexual response, they did the best.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">So I think for pain or for the woman who's not hormonally replaced, especially if her testosterone is still low or she has hyperprolactinemia, they're not going to do as well with just the botulinum toxin injected into the clitoris. On the other hand, our full-blown<span>\u00a0<\/span><\/span><span class=\"c13 c24\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/oshot.info\/&amp;sa=D&amp;source=editors&amp;ust=1712509824361462&amp;usg=AOvVaw3h8jr_PXgFic-KKChe04G9\">O-Shot\u00ae procedure<\/a><\/span><span class=\"c2\">, including the anterior vaginal wall or strategically placed PRP in the pelvic floor or the posterior fornix and other places where pain might occur, as we've discussed for a decade now, might be helpful.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">More Pearls from Dr. Alex about Doing the Clitoxin\u00ae Procedure<\/span><\/h1>\n<p class=\"c5\"><span class=\"c2\">But pearl's about doing that when you combine the two, which I think will be most of your patients, but if you spin a gel kit, you'll get about six CC's because the woman won't have a crit of 50. It's more likely to be 40. So you'll take two of that and combine it with botulinum toxin the way we show you how in that video, and that goes in the clitoris, and then the other four still goes in the anterior vaginal wall and other places. But you don't put the botulinum toxin in with that. And we don't know. We haven't done this study, but my suspicion is, because we're injecting anterior vaginal wall near the urethral sphincter and probably into certain layers of that sphincter, if you're going where we suggest, which is the most distal part of the urethra, you might be going into the urethral sphincter where relaxation of muscle is not such a good idea.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">So it might occur to you, \"Oh, if putting botulinum toxin, the clitoris activates the autonomic nervous system and increases arousal, then let's put it in the anterior vaginal wall as well.\" And you may try that on your wife or your mother, and they'll be okay if they start peeing on the floor, but I recommend you not do that with your patients. So the combination procedure would be botulinum toxin just in the clitoral part, combined with the PRP and then only PRP in the anterior vaginal wall. Alex, I've been talking too long. What else would you say on anything that I've just said?<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Alexandra Runnels, MD, FACOG:<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">I love the last thing you said. I think it's important that everybody hears it because it probably could get confusing since when we do the Priapus Toxin\u00ae, we put it everywhere, in the glands and in the corpus cavernosum. So, I think it's a great point. It's amazing that females are continent in the first place with the little, short urethras that we have, and the continence mechanism is still mysterious in women. So, I agree that as far as being cautious about getting botulinum toxin into that urethral sphincter, I think that's an important point.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">The other thought that I had while you were talking about pain is another patient who came to see me for a clitoral hood release. She had adhesions between her clitoral hood and her clitoris and a long history of strange pain, pelvic pain, and clitorodynia. I talked to her about everything I could do for her and did an O-Shot\u00ae. I put Clitoxin\u00ae in her clitoris, and I regret doing that for her because it did what it does for everybody that I've seen. It increases blood flow and clitoral engorgement and sensation. But for her, sensation is such an issue that she's struggled with trying to figure out what to do with the painful sensations that are now amplified. So, I think it is a good lesson for me and everybody else on this call to hear, and I think for her, I wish I had just done a regular O-Shot\u00ae.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Charles Runels, MD:<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Okay, that makes sense. That reconfirms what we just said: it's probably not the best thing for pain. In a previous journal club, you talked about a woman who was scheduled for fat transfer to labia majora, canceled after Clitoxin\u00ae because the increased blood flow caused increased volume and rigor, and she got a healthier-looking labia majora after injecting the botulinum toxin into the clitoris. So, it makes sense that if someone has a clitoris that's struggling underneath phimosis and then there's more circulation, there might be more discomfort. But I'm sure you'll take care of that with your clitoral release, and everything's going to be wonderful.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Summary<\/span><\/h1>\n<p class=\"c5\"><span class=\"c2\">That covers it, Alex. Unless you have something else, we'll shut it down.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">We talked about indications for the Clitoxin\u00ae procedure. To summarize, this would not be for pain. I like to think of this gradual increase in arousal until it's desire. And then there's this extreme urge to have sex, and then there's sex and then orgasm. And then, in men, there might be a refractory period. In women, not so much. Maybe there are more and more orgasms, but it's not zero to 60 in one second.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">If this is working the way we think it is and the way it appears to be working, with the Clitoxin\u00ae procedure, we are raising the baseline threshold, so the woman is quicker to become aroused as if the midbrain is already at a slightly aroused state (or at least very near arousal) all the time.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">We also know that multiple studies, starting in the 1950s, have shown that botulinum toxin (BoNT) causes neurogenesis and collagenesis neovascularization. Multiple wound care studies have been done.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">We also know that BoNT causes smooth muscle relaxation with increased blood flow, and that may be all that's happening with our Clitoxin\u00ae\u00a0procedure, but (because the results with PDE5Is in women were modest at best) we're suspicious that effects on the autonomic nervous system by the BoNT (through activation of the parasympathetic ganglion lining the vaginal wall and subsequently activation of the arousal center in the hypothalamus) may play a significant part in the mechanism of action. And that's not a big stretch because all that would be necessary for that to happen is for the BoNT to behave in the clitoris for sexual dysfunction as it behaves in the procerus for migraine (where it migrates along the axon to activate the trigeminal ganglion and block the pain fibers from the meninges and increase parasympathetic tone).<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Also, using a systems analysis approach, Clitoxin\u00ae is not likely to help a woman with very low testosterone levels or who suffers from pelvic floor pain, but it might help a woman with dyspareunia from dryness who cannot be on hormones because of breast cancer, or a woman for whom you've done everything else that you can do with decreased arousal or orgasm.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Maybe that same woman who cannot be on hormones might be helped by our O-Shot\u00ae combined with Clitoxin\u00ae by raising that baseline arousal level. We don't know.<\/span><\/p>\n<p class=\"c33\"><span class=\"c9 c19\">Keep the picture of the female orgasm system in mind<br \/>\nrealizing that<br \/>\nall we are doing with the Clitoxin\u00ae combined with the O-Shot\u00ae procedure is making the tissue healthier in the vaginal wall,<br \/>\nalso, in the periurethral area,<br \/>\n(neurogenesis, neovascularization, and muscle strengthening of the urinary sphincter),<br \/>\nand increasing blood flow in the clitoris,<br \/>\nand activating the midbrain<br \/>\nthrough the inferior hypogastric plexus<br \/>\nby way of the ganglion<br \/>\nin the lateral vaginal wall.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">That's what we think is happening.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Regarding<span>\u00a0<\/span><\/span><span class=\"c30\">pearls<span>\u00a0<\/span><\/span><span class=\"c2\">for the Clitoxin\u00ae procedure, some women want the botulinum toxin (no PRP). I would steer them away from that because the PRP increased the effectiveness of the botulinum neurotoxin by 50%; however, maybe they had an O-Shot\u00ae last week or last month. And so they only need the Clitoxin\u00ae procedure.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">When you do the Clitoxin\u00ae procedure combined with the O-Shot\u00ae procedure, do not add the botulinum toxin to the anterior vaginal wall part of the procedure.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">Obtain our<span>\u00a0<\/span><\/span><span class=\"c30\">certificate of training<\/span><span class=\"c4\">\u00a0for Clitoxin\u00ae and the<span>\u00a0<\/span><\/span><span class=\"c30\">consent form<\/span><span class=\"c4\">\u00a0with your letterhead and<span>\u00a0<\/span><\/span><span class=\"c30\">edited by your attorney<\/span><span class=\"c2\">\u00a0to facilitate malpractice coverage. The contact info for a potential carrier is on our website.<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">For<span>\u00a0<\/span><\/span><span class=\"c30\">documentation<\/span><span class=\"c2\">, I gave you the link for the Female Sexual Function Index (FSFI) to grade it. That text and the score should go in your chart.<\/span><\/p>\n<p class=\"c5\"><span class=\"c30\">Our Clitoxin\u00ae certificate will only be offered to O-Shot\u00ae providers<\/span><span class=\"c2\">\u00a0and mailed within two business days of completing our online test or a hands-on workshop. So, if you are already an O-Shot\u00ae provider, log in to the membership site and take the test so we can get the certificate to you. Then, an icon will appear with your name on the directory so the women who may be helped will know how to find you.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Alex, add whatever you think would help, and then we will end our meeting.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Alexandra Runnels, MD, FACOG:<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">We covered a lot.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">Charles Runels, MD:<\/span><\/p>\n<p class=\"c5\"><span class=\"c4\">All right, well, I want to brag on you.<span>\u00a0<\/span><\/span><span class=\"c9\">This research would not have happened without Alex. She's a statistician. She's brilliant. She's an excellent surgeon. And she's got a deep understanding of this procedure and what happens when you do it. So, thank you, Alex<\/span><span class=\"c2\">, and I appreciate you being on the call.<\/span><\/p>\n<p class=\"c5\"><span class=\"c2\">\u00a0Okay, you guys have a good day. Bye-bye.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">References<\/span><\/h1>\n<p class=\"c8 c20\"><span class=\"c6\">Carpenter, Janet S., Susan D. Reed, Katherine A. Guthrie, Joseph C. Larson, Katherine M. Newton, R. Jane Lau, Lee A. Learman, and Jan L. Shifren. \u201cUsing an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Sexual Medicine<\/span><span class=\"c6\">\u00a03, no. 1 (March 1, 2015): 7\u201313. https:\/\/doi.org\/10.1002\/sm2.53.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Ciorniciuc, Viorel. \u201cFemale Sexual Function Index (FSFI) Questionnaire Calculator.\u201d https:\/\/www.thecalculator.co. Accessed April 4, 2024. https:\/\/www.thecalculator.co.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">\u201cClitoxin\u00ae \u2013 Botulinum Toxin for Improved Sexual Function in Women.\u201d Accessed April 7, 2024. https:\/\/clitoxin.com\/.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Derogatis, Leonard R., Dennis A. Revicki, Raymond C. Rosen, Robert Jordan, Johna Lucas, and Carl Spana. \u201cPsychometric Validation of the Female Sexual Distress Scale-Desire\/Arousal\/Orgasm.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Journal of Patient-Reported Outcomes<\/span><span class=\"c6\">\u00a05, no. 1 (December 2021): 100. https:\/\/doi.org\/10.1186\/s41687-021-00359-1.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Moulis, Florence, Genevi\u00e8ve Durrieu, and Maryse Lapeyre-Mestre. \u201cOff-Label and Unlicensed Drug Use in Children Population.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Therapies<\/span><span class=\"c6\">\u00a073, no. 2 (April 2018): 135\u201349. https:\/\/doi.org\/10.1016\/j.therap.2018.02.002.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">\u201c\u2018Off-Label\u2019 and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices Guidance for Institutional Review Boards and Clinical Investigators,\u201d January 1998. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Orgasm College<\/span><span class=\"c14\">TM<\/span><span class=\"c6\">. \u201cOrgasm College<\/span><span class=\"c14\">TM<\/span><span class=\"c6\">.\u201d Accessed April 5, 2024. https:\/\/orgasmcollege.com\/.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Radley, David C., Stan N. Finkelstein, and Randall S. Stafford. \u201cOff-Label Prescribing Among Office-Based Physicians.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Archives of Internal Medicine<\/span><span class=\"c6\">\u00a0166, no. 9 (May 8, 2006): 1021. https:\/\/doi.org\/10.1001\/archinte.166.9.1021.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Rosen, C. Brown, J. Heiman, S. Leib, R. \u201cThe Female Sexual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Female Sexual Function.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Journal of Sex &amp; Marital Therapy<\/span><span class=\"c6\">\u00a026, no. 2 (April 2000): 191\u2013208. https:\/\/doi.org\/10.1080\/009262300278597.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">runels, Author. \u201cFemale Orgasm System.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Orgasm College<\/span><span class=\"c16\">TM<\/span><span class=\"c6\">\u00a0(blog), July 27, 2023. https:\/\/orgasmcollege.com\/femaleorgasmsystem\/.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Runels, Charles. \u201cA Pilot Study of the Effect of Localized Injections of Autologous Platelet Rich Plasma (PRP) for the Treatment of Female Sexual Dysfunction.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Journal of Women\u2019s Health Care<\/span><span class=\"c6\">\u00a003, no. 04 (2014). https:\/\/doi.org\/10.4172\/2167-0420.1000169.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Runels, Charles, and Alexandra Runnels. \u201cThe Clitoral Injection of IncobotulinumtoxinA for the Improvement of Arousal, Orgasm &amp; Sexual Satisfaction- A Specific Method and the Effects on Women.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Journal of Women\u2019s Health Care<\/span><span class=\"c6\">\u00a013, no. 3 No. 715 (March 20, 2024). https:\/\/doi.org\/10.35248\/2167-0420.24.13.715.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">\u201cTraining for the Clitoxin\u00ae Procedure | Scribe.\u201d Accessed April 5, 2024. https:\/\/scribehow.com\/shared\/Training_for_the_Clitoxinr_Procedure__afrs2OHIQA2wGtAD7wsOgA.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Van Norman, Gail A. \u201cOff-Label Use vs Off-Label Marketing\u00a0of\u00a0Drugs.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">JACC: Basic to Translational Science<\/span><span class=\"c6\">\u00a08, no. 2 (February 27, 2023): 224\u201333. https:\/\/doi.org\/10.1016\/j.jacbts.2022.12.011.<\/span><\/p>\n<p class=\"c8 c20\"><span class=\"c6\">Wiegel, Markus, Cindy Meston, and Raymond Rosen. \u201cThe Female Sexual Function Index (FSFI): Cross-Validation and Development of Clinical Cutoff Scores.\u201d<span>\u00a0<\/span><\/span><span class=\"c19 c26\">Journal of Sex &amp; Marital Therapy<\/span><span class=\"c6\">\u00a031, no. 1 (January 2005): 1\u201320. https:\/\/doi.org\/10.1080\/00926230590475206.<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Tags<\/span><\/h1>\n<p class=\"c8\"><span class=\"c6\">Charles Runels MD, Alexandra Runels MD, Clitoxin\u00ae, O-Shot\u00ae, Female Sexual Function Index, FSFI, female sexual distress, documentation, off-label prescriptions, malpractice insurance, botulinum toxin, PRP (Platelet Rich Plasma), erectile dysfunction, Peyronie's disease, sexual function measurement, EMR (Electronic Medical Records), malpractice coverage, trademark protection, sexual health, pain management, arousal enhancement, neurogenesis, collagenesis, neovascularization, smooth muscle relaxation, breast cancer patients, hormone replacement, sexual dysfunction, labiaplasty, vaginal laser, testosterone treatment, pelvic floor pain, libido enhancement, orgasm system, sexual response, hormone levels, sexual satisfaction, sexual therapy, respiratory system analogy, systemic approach to sexual health, urinary incontinence, vaginal health, sexual arousal, vaginal wall injection, anterior vaginal wall, urethral sphincter, parasympathetic ganglion, hypogastric plexus, neurogenic effects, clitoral health, sexual wellness, medical documentation, hormone therapy contraindications, patient expectations, procedure outcomes, patient counseling, medical research, healthcare innovation<\/span><\/p>\n<h1 class=\"c0\"><span class=\"c18\" style=\"color: #800080;\">Helpful Links<\/span><\/h1>\n<p class=\"c8\"><span>\ud83e\udc6a\u00a0<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/accma.memberlodge.org\/page-925782&amp;sa=D&amp;source=editors&amp;ust=1712509824370736&amp;usg=AOvVaw0m-THMedPYp8GQgpBpbmpQ\" target=\"_blank\" rel=\"noopener\">Next Hands-On Workshops with Live Models<\/a><\/span><span class=\"c6\">\u00a0\ud83e\udc68<\/span><\/p>\n<p class=\"c8\"><span>\ud83e\udc6a\u00a0<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/www.on2url.com\/app\/adtrack.asp?MerchantID%3D153781%26AdID%3D1012867&amp;sa=D&amp;source=editors&amp;ust=1712509824371336&amp;usg=AOvVaw1Yq_WeJPEfwlZAzOcPQ_bt\" target=\"_blank\" rel=\"noopener\">Dr. Runels<span>\u00a0<\/span><\/a><\/span><span class=\"c3\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/www.on2url.com\/app\/adtrack.asp?MerchantID%3D153781%26AdID%3D1012867&amp;sa=D&amp;source=editors&amp;ust=1712509824371585&amp;usg=AOvVaw165sIhrGzUTUSRTbGFidSE\" target=\"_blank\" rel=\"noopener\">Botulinum Blastoff Course<\/a><\/span><span class=\"c6\">\u00a0\ud83e\udc68<\/span><\/p>\n<p class=\"c8\"><span>\ud83e\udc6a\u00a0<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/&amp;sa=D&amp;source=editors&amp;ust=1712509824372011&amp;usg=AOvVaw1jxaWNFlkUWW6vn-OMuAea\" target=\"_blank\" rel=\"noopener\">The Cellular Medicine Association (who we are<\/a><\/span><span class=\"c6\">) \ud83e\udc68<\/span><\/p>\n<p class=\"c8\"><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/procedures\/&amp;sa=D&amp;source=editors&amp;ust=1712509824372427&amp;usg=AOvVaw2jbODC0A8qv2eeLa51taV7\" target=\"_blank\" rel=\"noopener\">\ud83e\udc6a Apply for<span>\u00a0<\/span><\/a><\/span><span class=\"c3\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/procedures\/&amp;sa=D&amp;source=editors&amp;ust=1712509824372642&amp;usg=AOvVaw3eJh9gp6OKrk3_lWY_UqQP\" target=\"_blank\" rel=\"noopener\">Online Training for Multiple PRP Procedures<\/a><\/span><span class=\"c6\">\u00a0\ud83e\udc68<\/span><\/p>\n<p class=\"c8\"><span>\ud83e\udc6a<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/password\/&amp;sa=D&amp;source=editors&amp;ust=1712509824373045&amp;usg=AOvVaw3jr6f4gq4FlNIrX5YNFQ_t\" target=\"_blank\" rel=\"noopener\">\u00a0Help with<span>\u00a0<\/span><\/a><\/span><span class=\"c3\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/password\/&amp;sa=D&amp;source=editors&amp;ust=1712509824373244&amp;usg=AOvVaw3bwuiwS1bdIC8B_Pcp1DDC\" target=\"_blank\" rel=\"noopener\">Logging into Membership Website<\/a><\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/cellularmedicineassociation.org\/password\/&amp;sa=D&amp;source=editors&amp;ust=1712509824373455&amp;usg=AOvVaw19tvIc5Tfv-8KW6p06oKb3\" target=\"_blank\" rel=\"noopener\">s<\/a><\/span><span class=\"c6\">\u00a0\ud83e\udc68<\/span><\/p>\n<p class=\"c8\"><span>\ud83e\udc6a\u00a0<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/ontraport.com\/Cellular-Medicine-Association-&amp;sa=D&amp;source=editors&amp;ust=1712509824373969&amp;usg=AOvVaw3tyfUs_DtDTaWKPMvjQcJV\" target=\"_blank\" rel=\"noopener\">The software I use to send emails: ONTRAPORT (free trial)\ud83e\udc68<\/a><\/span><\/p>\n<p class=\"c8\"><span>\ud83e\udc6a Sell O-Shot\u00ae products: You make 10% with links you place; shipped by the manufacturer),\u00a0<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/www.loom.com\/share\/dcd9fe2284a746a199fd7d5cc42d5f61?sid%3Df5a33b4b-a3ee-4fb1-b13e-2273718dce9b&amp;sa=D&amp;source=editors&amp;ust=1712509824374433&amp;usg=AOvVaw3yVXppXB8yf7eadvUeNHuu\" target=\"_blank\" rel=\"noopener\">this explains<\/a><\/span><span>\u00a0and\u00a0<\/span><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/oshotwomen.leaddyno.com\/&amp;sa=D&amp;source=editors&amp;ust=1712509824374683&amp;usg=AOvVaw0XDx4tGAOFdoZ4mQQIg75T\" target=\"_blank\" rel=\"noopener\">here\u2019s where to apply<\/a><\/span><span class=\"c6\">\u00a0\ud83e\udc68<\/span><\/p>\n<div>\n<p><a id=\"t.0b7d53af54dcc2bd0f3d83aaa5c2991380498ec2\"><\/a><a id=\"t.1\"><\/a><\/p>\n<table class=\"c15\">\n<tbody>\n<tr class=\"c27\">\n<td class=\"c1\" colspan=\"1\" rowspan=\"1\">\n<p class=\"c8\"><span class=\"c13\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/runels.com\/&amp;sa=D&amp;source=editors&amp;ust=1712509824380352&amp;usg=AOvVaw0SwTbSKI4HRmpOc9aNWSJR\" target=\"_blank\" rel=\"noopener\">Charles Runels, MD<\/a><\/span><\/p>\n<p class=\"c8\"><span class=\"c6\">1-888-920-5311<\/span><\/p>\n<\/td>\n<td class=\"c40\" colspan=\"1\" rowspan=\"1\">\n<p class=\"c44\"><span>Page\u00a0<\/span><span>\u00a0of<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<hr class=\"c22\" \/>\n<div>\n<p class=\"c8\"><a id=\"ftnt1\" href=\"#ftnt_ref1\">[1]<\/a><span class=\"c7\">\u00a0\u201cClitoxin\u00ae \u2013 Botulinum Toxin for Improved Sexual Function in Women.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt2\" href=\"#ftnt_ref2\">[2]<\/a><span class=\"c7\">\u00a0Runels and Runnels, \u201cThe Clitoral Injection of IncobotulinumtoxinA for the Improvement of Arousal, Orgasm &amp; Sexual Satisfaction- A Specific Method and the Effects on Women.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt3\" href=\"#ftnt_ref3\">[3]<\/a><span class=\"c7\">\u00a0Rosen, C. Brown, J. Heiman, S. Leib, \u201cThe Female Sexual Function Index (FSFI).\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt4\" href=\"#ftnt_ref4\">[4]<\/a><span class=\"c7\">\u00a0Wiegel, Meston, and Rosen, \u201cThe Female Sexual Function Index (FSFI).\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt5\" href=\"#ftnt_ref5\">[5]<\/a><span class=\"c7\">\u00a0Carpenter et al., \u201cUsing an FSDS-R Item to Screen for Sexually Related Distress.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt6\" href=\"#ftnt_ref6\">[6]<\/a><span class=\"c7\">\u00a0Derogatis et al., \u201cPsychometric Validation of the Female Sexual Distress Scale-Desire\/Arousal\/Orgasm.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt7\" href=\"#ftnt_ref7\">[7]<\/a><span class=\"c7\">\u00a0Runels, \u201cA Pilot Study of the Effect of Localized Injections of Autologous Platelet Rich Plasma (PRP) for the Treatment of Female Sexual Dysfunction.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt8\" href=\"#ftnt_ref8\">[8]<\/a><span class=\"c7\">\u00a0Wiegel, Meston, and Rosen, \u201cThe Female Sexual Function Index (FSFI).\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt9\" href=\"#ftnt_ref9\">[9]<\/a><span class=\"c7\">\u00a0Rosen, C. Brown, J. Heiman, S. Leib, \u201cThe Female Sexual Function Index (FSFI).\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt10\" href=\"#ftnt_ref10\">[10]<\/a><span class=\"c7\">\u00a0\u201c\u2018Off-Label\u2019 and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices Guidance for Institutional Review Boards and Clinical Investigators.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt11\" href=\"#ftnt_ref11\">[11]<\/a><span class=\"c7\">\u00a0Van Norman, \u201cOff-Label Use vs Off-Label Marketing\u00a0of\u00a0Drugs.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt12\" href=\"#ftnt_ref12\">[12]<\/a><span class=\"c7\">\u00a0Radley, Finkelstein, and Stafford, \u201cOff-Label Prescribing Among Office-Based Physicians.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt13\" href=\"#ftnt_ref13\">[13]<\/a><span class=\"c7\">\u00a0Moulis, Durrieu, and Lapeyre-Mestre, \u201cOff-Label and Unlicensed Drug Use in Children Population.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt14\" href=\"#ftnt_ref14\">[14]<\/a><span class=\"c7\">\u00a0Van Norman, \u201cOff-Label Use vs Off-Label Marketing\u00a0of\u00a0Drugs.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt15\" href=\"#ftnt_ref15\">[15]<\/a><span class=\"c7\">\u00a0Van Norman.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt16\" href=\"#ftnt_ref16\">[16]<\/a><span class=\"c7\">\u00a0Van Norman.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt17\" href=\"#ftnt_ref17\">[17]<\/a><span class=\"c7\">\u00a0Ciorniciuc, \u201cFemale Sexual Function Index (FSFI) Questionnaire Calculator.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt18\" href=\"#ftnt_ref18\">[18]<\/a><span class=\"c7\">\u00a0Ciorniciuc.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt19\" href=\"#ftnt_ref19\">[19]<\/a><span class=\"c7\">\u00a0Since our study showed that FSFI total scores went up by 12 when BoNT combined with PRP was used, that score could be used as an estimate of what the woman\u2019s sexual function might be like after the procedure\u2014assuming best-case scenarios.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt20\" href=\"#ftnt_ref20\">[20]<\/a><span class=\"c7\">\u00a0\u201cTraining for the Clitoxin\u00ae Procedure | Scribe.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt21\" href=\"#ftnt_ref21\">[21]<\/a><span class=\"c7\">\u00a0Vampire Facelift\u00ae, Vampire Facial\u00ae, O-Shot\u00ae, Orchid Shot\u00ae, Priapus Shot\u00ae, P-Shot\u00ae, Vampire Breast Lift\u00ae, Vampire Wing Lift\u00ae, Vampire Hand Lift\u00ae, Vampire Hair\u00ae, Priapus Toxin\u00ae, &amp; Clitoxin\u00ae are all trademarks licensed only to member of the Cellular Medicine Association.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt22\" href=\"#ftnt_ref22\">[22]<\/a><span class=\"c7\">\u00a0This $1,000,000 per year is spent (1) for in-house staff handling reports and gathering data, (2) for our trademark attorney in Chicago to litigate when needed, and (3) for<span>\u00a0<\/span><\/span><span class=\"c13 c28\"><a class=\"c11\" href=\"https:\/\/www.google.com\/url?q=https:\/\/brandshield.com\/&amp;sa=D&amp;source=editors&amp;ust=1712509824377797&amp;usg=AOvVaw1BbnRen2egjxj7VX1yTQMs\" target=\"_blank\" rel=\"noopener\">Brandshield.com<\/a><\/span><span class=\"c7\">\u2014we average the takedown of 1.6 websites or social media accounts<span>\u00a0<\/span><\/span><span class=\"c41\">per business day<\/span><span class=\"c7\">\u00a0from the people who use our trademarked names illegally.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt23\" href=\"#ftnt_ref23\">[23]<\/a><span class=\"c7\">\u00a0\u201cOrgasm College<\/span><span class=\"c12\">TM<\/span><span class=\"c7\">.\u201d<\/span><\/p>\n<\/div>\n<div>\n<p class=\"c8\"><a id=\"ftnt24\" href=\"#ftnt_ref24\">[24]<\/a><span class=\"c7\">\u00a0runels, \u201cFemale Orgasm System.\u201d<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Journal Club with Pearls &amp; Marketing 2024.04.02 \u00a0 \u00a0Cellular Medicine Association JCPM2024.04.02 The following is an edited transcript of the\u00a0Journal Club with Pearls &amp; Marketing\u00a0(JCPM) of April 2, 2024, with Charles Runels, MD, and Alexandra Runnels, MD, FACOG. &gt;-&gt; The PDF Transcript of the Page Can be Downloaded or Read Here (click) &lt;-&lt; Topics Covered [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[1311,47],"tags":[311,594,89,221,704,897,40,228,138,973,20,916,166],"class_list":["post-3271","post","type-post","status-publish","format-standard","hentry","category-botulinum-toxin","category-journal-club","tag-botulinum-toxin","tag-clitoxin","tag-dyspareunia","tag-erectile-dysfunction","tag-female-sexual-dysfunction","tag-injection-technique","tag-o-shot","tag-peyronies-disease","tag-prp","tag-regenerative-medicine","tag-research","tag-testosterone","tag-urinary-incontinence"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p6W8NG-QL","jetpack-related-posts":[{"id":4996,"url":"https:\/\/oshot.info\/members\/jcpm2026-05-26-new-definitions-female-sexual-dysfunction\/","url_meta":{"origin":3271,"position":0},"title":"JCPM2026.05.26 | New Definitions (Female Sexual Dysfunction)","author":"Charles Runels, MD","date":"June 5, 2026","format":false,"excerpt":"Journal Club with Pearls & Marketing 2026.05.26 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u00a0Cellular Medicine Association The following is an edited transcript of the Journal Club with Pearls & Marketing\u00a0(JCPM) of May 26, 2026, with Charles Runels, MD.\u00a0\u00a0 >-> The PDF transcript of this live journal club can\u2026","rel":"","context":"In &quot;Journal Club&quot;","block_context":{"text":"Journal Club","link":"https:\/\/oshot.info\/members\/category\/journal-club\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/cellularmedicineassociation.org\/wp-content\/uploads\/2025\/07\/image5-300x239.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":5150,"url":"https:\/\/oshot.info\/members\/clitoxin\/","url_meta":{"origin":3271,"position":1},"title":"CLITOXIN\u00ae","author":"Will Runels","date":"July 1, 2026","format":false,"excerpt":"-->Click to read or download a PDF Transcript of the above video that includes diagrams and scientific references<-- Important Legal Disclaimer: This is an off-label use of botulinum toxin; no results are ever guaranteed (no therapy works every time). If considered, it should only be done by a physician who\u2026","rel":"","context":"In &quot;Botulinum Toxin (Clitoxin\u00ae, Priapus Toxin\u2122)&quot;","block_context":{"text":"Botulinum Toxin (Clitoxin\u00ae, Priapus Toxin\u2122)","link":"https:\/\/oshot.info\/members\/category\/botulinum-toxin\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/clitoxin.com\/wp-content\/uploads\/2024\/04\/clitoxin-logo-1-300x69.jpeg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":3263,"url":"https:\/\/oshot.info\/members\/jcpm2024-02-26-clitoxin-procedure-history-pearls\/","url_meta":{"origin":3271,"position":2},"title":"JCPM2024.02.26  Clitoxin\u00ae Procedure History &#038; Pearls","author":"Charles Runels, MD","date":"March 30, 2024","format":false,"excerpt":"Journal Club with Pearls & Marketing 2024.03.26 \u00a0 \u00a0Cellular Medicine Association JCPM2024.03.26 The following is an edited transcript of the\u00a0Journal Club with Pearls & Marketing\u00a0(JCPM) of March 26, 2024, with Charles Runels, MD, and Alexandra Runnels, MD, FACOG. \u00a0 >-> PDF transcript of this page may be found here <-<\u2026","rel":"","context":"In &quot;Botulinum Toxin (Clitoxin\u00ae, Priapus Toxin\u2122)&quot;","block_context":{"text":"Botulinum Toxin (Clitoxin\u00ae, Priapus Toxin\u2122)","link":"https:\/\/oshot.info\/members\/category\/botulinum-toxin\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/cellularmedicineassociation.org\/wp-content\/uploads\/2024\/03\/image12-300x239.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":3135,"url":"https:\/\/oshot.info\/members\/jcpm2023-12-05-peyronies-birth-control-pills-sexual-dysfunction-prp-devices-serious-warning\/","url_meta":{"origin":3271,"position":3},"title":"JCPM2023.12.05 Peyronie&#8217;s | Birth Control Pills &#038; Sexual Dysfunction | PRP Devices (serious warning)","author":"Charles Runels, MD","date":"December 10, 2023","format":false,"excerpt":"Topics Discussed Include the Following... Penile Rehabilitation after Prostate Surgery (new research supports the use of our P-Shot\u00ae procedure). Research on Platelet-Rich Plasma (PRP) in men in the bedroom The Role of Testosterone in Women's Sexual Function and the Impact of Birth Control Pills The Use of O-Shots\u00ae\u00a0in Improving Female\u2026","rel":"","context":"In &quot;Journal Club&quot;","block_context":{"text":"Journal Club","link":"https:\/\/oshot.info\/members\/category\/journal-club\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/vampirefacelift.com\/members\/wp-content\/uploads\/2021\/08\/O-Shot_Oil_bottle-300x300.jpeg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":5219,"url":"https:\/\/oshot.info\/members\/jcpm2026-08-18-alopecia-areata-female-sexual-dysfunction-o-shot-procedure\/","url_meta":{"origin":3271,"position":4},"title":"JCPM2026.08.18 | Alopecia Areata | Female Sexual Dysfunction | O-Shot\u00ae Procedure","author":"Charles Runels, MD","date":"August 28, 2026","format":false,"excerpt":"JCPM2026.08.18 The following is an edited transcript of the Journal Club with Pearls & Marketing (JCPM) of August 18, 2026, with Charles Runels, MD. >-> The PDF transcript of this live journal club can be seen here <-< Topics Covered Revisiting a Study We Have Covered Before They Changed Where\u2026","rel":"","context":"In &quot;Aesthetics &amp; Hair&quot;","block_context":{"text":"Aesthetics &amp; Hair","link":"https:\/\/oshot.info\/members\/category\/aesthetics-hair\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":3478,"url":"https:\/\/oshot.info\/members\/jcpm2024-09-03-female-sexual-function-index-fsfi\/","url_meta":{"origin":3271,"position":5},"title":"JCPM2024.09.03 | Female Sexual Function Index | FSFI |","author":"Charles Runels, MD","date":"September 9, 2024","format":false,"excerpt":"Journal Club with Pearls & Marketing 2024.09.03 \u00a0 \u00a0Cellular Medicine Association JCPM2024.09.03 The following is an edited transcript of the\u00a0Journal Club with Pearls & Marketing\u00a0(JCPM) of September 3, 2024, with Charles Runels, MD. \u00a0 >-> The pdf of the transcript of this live journal club can be seen here <-<\u2026","rel":"","context":"In &quot;Botulinum Toxin (Clitoxin\u00ae, Priapus Toxin\u2122)&quot;","block_context":{"text":"Botulinum Toxin (Clitoxin\u00ae, Priapus Toxin\u2122)","link":"https:\/\/oshot.info\/members\/category\/botulinum-toxin\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/cellularmedicineassociation.org\/wp-content\/uploads\/2024\/03\/image12-300x239.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"jetpack_likes_enabled":true,"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/posts\/3271","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/comments?post=3271"}],"version-history":[{"count":2,"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/posts\/3271\/revisions"}],"predecessor-version":[{"id":3276,"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/posts\/3271\/revisions\/3276"}],"wp:attachment":[{"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/media?parent=3271"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/categories?post=3271"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/oshot.info\/members\/wp-json\/wp\/v2\/tags?post=3271"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}