JCPM2024.09.03

The following is an edited transcript of the Journal Club with Pearls & Marketing (JCPM) of September 3, 2024, with Charles Runels, MD.  

>-> The pdf of the transcript of this live journal club can be seen here <-<

Topics Covered

• Female Sexual Distress Scale-Revised (FSDS-R)
• Female Sexual Function Index (FSFI)
• Quick overview of the O-Shot® provider membership site
• Reasons for administering the FSFI for every O-Shot® recipient
• What you must learn from magicians to do good medicine
• New Metanalysis, Knee injections: HA vs. Steroids vs. PRP
• Female Sexual Function Index (FSFI) research
• My Gift to You: Software to Quickly Administer and Grade the FSFI of Your Patients
• Scenario One for administering the FSFI with the Free Software: Patient in the Office
• Scenario Two for administering the FSFI with the Free Software: Patient Not in the Office
• Using the FSFI as an Educational Marketing Tool (to help you find the women you could help)
• Marketing Idea Using the FSFI Tool
• Should you add Exosomes to your O-Shot®?

Charles Runels, MD
Author, researcher, and inventor of the Vampire Facelift®, Orchid Shot® (O-Shot®), Priapus Shot® (P-Shot®), Priapus Toxin®, Vampire Breast Lift®, and Vampire Wing Lift®, & Clitoxin® procedures.

Transcript

Female Sexual Distress Scale

If you read the research about female sexual function, you see two surveys being used primarily. One is the Female Sexual Distress Scale, which we’re looking at now (see video).^[1]

It’s the easiest to do because you quickly add it up, and they’re all scored the same, same domains for each question: never, rarely, occasionally, frequently, or always.

The patient can breeze through it very quickly.

If the total score is less than 11, they’re not distressed.

Remember, by definition, not matter what the symptoms, unless the woman is distress by those symptoms, she does not suffer sexual dysfunction.

We have a HIPPA-compliant online survey your patients can do by text message (see the membership site on the dashboard).

Female Sexual Function Index

But if you look at the hardcore research, there seems to be a favoring towards the Female Sexual Function Index, which has 19 questions. Not only are the questions weighted differently, but then, to complicate it even more, you have to multiply the answers by a factor to come up with a score. It’s not graduate-level calculus, but it’s more time-consuming than the FSDS-R.

So, I have a solution for you that I’m going to give you today. If you’re doing the P-Shot®, you should be doing the SHIM score. It’s easy—it’s so easy. It’s five questions graded one through five, and patients just breeze through it. I have it on a piece of paper, they do it, and the score goes in my chart, which is on paper. If you’re doing electronic records, you could still do that very quickly.

But for this one (FSFI), it’s aggravating. I found a place online that was grading it or that would grade it for you, but I didn’t like it because it was full of ads and distracting and just not convenient in a couple of other ways. So, I had someone write some software for us, and I’ll show you; it’s free for you to use and for your patients to use. I’ll show you where to get it in just a moment.

First, here’s a quick overview of our O-Shot® membership site:

After you log in, go to the dashboard. If you’re new to the O-Shot®, hopefully, you’re methodically moving through the course. Just take it a step at a time. And when you’re done, you will know how to do the O-Shot® procedure. Each step is easy. There are a lot of steps, but it’s stuff like, here’s where to put your picture on the website, so it’s not that big a deal if you are already a licensed doctor or physician extender and understand the anatomy.

When you’re finished, you know how to do the procedure.

With the FSDS-R, a higher number means more distress (bad);
with the FSFI, a higher number means better function (good).

Then, take the course on how to do the Clitoxin® procedure, which is an O-Shot®, as your base knowledge. After learning how to do the O-Shot®, you can simply add botulinum toxin to a portion of your O-Shot® procedure.

If you’re like me, you can’t resist moving around the material. And after you’ve been through the courses, you need a reference. So, here’s the material in the course (plus more) divided up in an organized way for you to go look for it as if in a filing cabinet.

But there’s a lot of stuff there. Most of our Journal Clubs can be searched. We now have over 800 videos and millions (literally) of words of content. So, if you get confused, you can always call our office (1-888-920-5311), but the search bar is a good place to go if you have a complicated question.

Reasons for administering the FSFI for every O-Shot® recipient (what to learn from magicians)

When people come back and say, “Well, I’m a little bit better, but I’m not sure, maybe I am, maybe I’m not,” Sometimes documenting helps clarify the results.

As a kid, I studied magic just like a lot of doctors. We grew up wanting to do miracles, and it’s the best you can do is a magic trick as a kid. And if you’re a magician, you know, you must slow down. I don’t care if you make an elephant disappear; you must slow down and let people appreciate the magic or they will quite literally not notice that you just made an elephant disappear. If you move too fast, they don’t even recognize what happened.

In cosmetic work, being a magician means that you have before and after pictures or you do one side of the face, and you let them look at the other before you do that. Or if you’re doing our Vampire Wing Lift® procedure, you do one labia majora, then you hand them the mirror and let them see that before you do the other. But with the sexual function, there’s not a physical mirror to look at.

But these surveys can help you quantify, and sometimes, just by having done this, you will point out to the person that they are indeed better when they may not have realized that they are. And especially with females, the Female Sexual Function Index gives a more granular look. So, if you’re on the dashboard, here’s where you click to get to it (see video).

Here is a very detailed history and physical form (see video), but for a detailed questionnaire that can help you think a lot about your people, it is 18 pages of mostly yes-no questions.

When you go here, it takes you to this page (see video). Some of this is redundant, but you’ll see right here is the Female Sexual Function Index (FSFI) questionnaire. You can print that off if you want, but let’s go over it. If you want to do it this way on paper, you could and then grade it by hand.

Let’s look at the grading system, and then let me show you where I had some software installed so that you don’t have to grade it.

Yes, I still recommend that you do this before every O-Shot® and then on follow-up. I’m about to show you how to administer the survey remotely—by cell phone.

New Metanalysis, Knee injections: HA vs. Steroids vs. PRP

All right, so let me show you some of the research, and then I’ll show you the software.

Okay, before I finish regarding FSFI, I had one paper out in our area of focus (cellular medicine) this week that I thought was worth bringing up. There were a lot more papers, three out this week, about using PRP to help improve fertility by improving the health of the endometrium. This is somewhat redundant too, but we’ve looked at a lot of the individual papers; this was a strong meta-analysis that confirmed what we’ve been talking about for literally years on our Journal Club, which is that with a knee injection, corticosteroids, HA and PRP are about the same when it comes to pain relief short term. In some studies, corticosteroids may win short-term for pain relief. But long-term, hands down, the PRP beats HA and corticosteroids for pain and preservation of the knee.

Long-term, hands down, the PRP beats HA and corticosteroids for pain and preservation of the knee.

So, I’ll give you a link to this one, too, and I won’t go into the details.^{[2] [3] [4] [5]}

We’ve looked at most of the studies in this paper in previous Journal Clubs, but I wanted you to confirm that nothing has changed, and this meta-analysis supports what we’ve been talking about.^[6] 

If you inject knees, this would be a great paper to share with your people. If this is something you want to do. I’ll just put it in the chat box. If you open that up, you’ll have it available.

So, just a quick email or social media post says, “Hey, we’re still doing this. And if you’re taking your weight loss medicine and you want to keep it off, you need to be walking. And if your knees are a problem, here’s confirmation that yes, a year from now, if you use PRP, you will have less degeneration of your joint and less pain than if you get the 25-cent corticosteroid shot that your insurance company wants you to have.”

Okay, so that’s the only new paper I thought out this week that I found to be worth sending out to your patients.

Female Sexual Function Index (FSFI) Research

Here’s some of the research regarding the Female Sexual Function Index.^[7] [8]

That’s the test. 19 questions, and the questions are different. And then look how you score it. 

Not what you want to calculate when you are busy talking with one of your patients (and do you really want to score this after you see the patient or have the results immediately available to discuss with the woman in front of you?\

So, questions one and two are the desired domain. For the desire domain, you multiply the total score by 0.6,

Questions 17, 18, and 19 are pain; you score those by multiplying the individual question scores by 0.4.

 You can see the scoring for each domain is different too. Sometimes it’s one through five, sometimes it’s zero through five, but you take those and multiply it by 0.4.

But the fun thing is you wind up getting a very helpful score for each domain and a total score; it’s fun because the scores are helpful. The FSFI can be more informative than just, “Am I distressed or not?” (the FSDS-R score)

I think it helps to know, in the total scheme of things, whether this person is upset or not because that’s the definition of sexual dysfunction.

If they’re not more than an 11 on a Female Sexual Distress Scale, even if they have other things that are bothering them continually, by definition, by that strictest of definitions, they don’t have female sexual dysfunction.

You can see that manually scoring the FSFI is not something you want to do when you’re 30 minutes behind on your schedule and you have two patients waiting.

What do you do?

My Gift to You: Software to Quickly Administer and Grade the FSFI of Your Patients

If you’re taking care of women, I hope this becomes not only a time saver but a way to quantify better what you’re doing.

If you look at that paper my wife Alex and I just published, we only reported that the Female Sexual Function Index improved in all domains after Clitoxin® (except pain was not as good). The total and the individual domain scores went crazy, better than FDA-approved drugs on the market (and better than the off-label therapies, too).^[9] [10]

If you look at the original article we published about the O-Shot®,^[11] we did both Female Sexual Distress and Female Sexual Function Index.

Hold on a second. I want you to have this because this is the classic paper on the FSFI test. Okay, there it is. It’s in your handout section if you want to download it. This by Rosen, came out 24 years ago. It talks about the Female Sexual Distress, Female Sexual Function Index, and how they came to depend on it.^[12]

Okay, let me show you the software I made for you, and then hopefully you can teach me something, or if you have any questions, I’ll answer them, and we’ll call it a night.

I’ll probably wind up putting this in other places, but I have it in an easy-to-remember domain.

Scenario One for administering the FSFI with the Free Software: Patient in the Office

One scenario might be that you could text this link to your patient before they come to the office, or you could have an iPad where they and you pull up this webpage at the office and have someone fill it out.

I don’t know about you, but sometimes, just something that takes an extra five minutes for me, I won’t do it if I’m in the middle of seeing patients. If you go to oshot.info/members/fsfi, all are in lowercase; it is not password protected. I don’t want you to fiddle with passwords while seeing patients.

There is nothing for sale, no ads, and nothing to buy. It is not password-protected.

Scenario Two for administering the FSFI with the Free Software: Patient Not in the Office

Another scenario is (since it works on a cell phone), you could text the link to them they could fill it out on their cell phone at home and text you a screenshot of the score (they could also fill it out on their cell phone while they’re sitting there waiting for their blood to spin, getting ready to do your O-Shot® or Clitoxin® procedure.

So there are the instructions (see the web page).

Thought about leaving the instructions out: Do we really need to tell people that stimulation includes foreplay with a partner, masturbation, or fantasy? I don’t know, but I put that there. Bill Clinton had trouble figuring it out, so maybe our patients will, too.

So, we define sex right there (for our patients and for Bill Clinton). And then you see, I’ve already taken the test to check it. If they needed to retake it, they just clicked the “retake test” hyperlink, and then the quiz restarted.

Demonstration of the Software

I will randomly pick answers and go through it so you can see what happens.

This is the same scoring system and set of questions as the one in that PDF file I showed you. Because your patients are not members of our provider group, a lot of what you see over here that’s for our “members only” is not going to show up; it’s just going to be mostly the test. Some of it will, but everything that might show up would reconfirm the validity of what you’re doing.

19 questions. It is such a hassle to grade this thing by hand.

Okay. Using the software, you then submit the answers, and boom, you have it.

So, if they were sitting in the office, you could have them take a screenshot of that result and text it to you (to click and drag into their EMR), or you could scratch down the domain scores into your paper chart. In this demonstration, you can see the desire score was 3.6. Those are your scores for each of the domains and there’s the total score.

You can also see their answers to each of the questions.

The few places I’ve found a way to grade FSFI online that would do this for me were distracting and pestering me with ads.

It took a couple of months, but I hired someone to write this software for us.

And this is a present to you.

Using the FSFI as an Educational Marketing Tool (to help you find the women you could help)

This electronic FSFI could also be used as a marketing tool.

For example, you could have a webpage that talks about female sexual dysfunction and female sexual normal function. If you put that same link in there, oshot.info/members/fsfi, in lower case, if you put that link into a text message or on a web page or a social media post, then people could go to the survey and find out how they compare and if they could use your help.

And if you told them on your web page or on our social media post that anything less than 20 is the average of most women who complain about their sex and most women having good sex are over 30 or more, then they’re going to wonder, “Well, where am I?”

They could do this and then have objective numbers to facilitate their decision and discussions with their spouse about whether to see you.

You will think of 16 other ways to use this tool.

I’ll put it in the chat box, answer your questions, and call it a night.

As I said, this took some time, and it wasn’t like coding the space launch or something, but it took a couple of months, and I hope you guys find it worth using.

Questions

Does it give the patient a report analysis?

Yep. It gives them a chart of the different domains with their scores.

Let’s see, where was that? It gives them that but doesn’t give them anything more detailed.

Hopefully, it will make them curious about how you can help them and want to have a conversation with you about how to improve things.

The Orgasm System

Remember, it’s a system. I still don’t hear many people using this word, but I hope we start to talk more and more about the female orgasm system.

 For sex to work properly, to work very well, everything in that picture needs to be working.

Let’s pick something. Pelvic floor muscles are not working right. They’re in pain. You’ve got dyspareunia, labia, you lichen sclerosus; you’ve got pain, your hood’s phimosed, or you’ve had genital mutilation. You pick anything on there. Any one of those hormones makes any one of those things go wrong, and you’re going to have trouble with sex.

So, what I hope happens is when these domains come up like that, you can say, “Yeah, we got the O-Shot® that can help with lubrication, but for arousal, you might also need some testosterone. Maybe we need some counseling, sexual counseling,” like that, it prompts a conversation.

It’s not an AI sort of app where it tries to take your place and have that conversation instead of you doing it.

Pete says I have a quick question. Let’s see. “Are there contraindications P-Shot®?

The basic rule I follow is, could this person have surgery, and could they have an injection?

Could have surgery and still be able to heal?

For example, if they have high-dose corticosteroids, I wouldn’t do it because they’re not going to heal well.

If they can have a shot, though, if someone’s on an anticoagulant, for example, you may not want to do intra-abdominal surgery, but you can give them an injection.

So those are the basic rules I follow. If someone has factor V deficiency, the question is, could you give them an injection?

You might want to go easy on the pump (it would increase bruising in this case); I’ll sometimes do that. But as a rule, if they can have an injection and they can heal the wound, I’ll do a P-Shot®.

If you go to the Clitoxin® page and look at the research we just published here, the results are framed in terms of the Female Sexual Function Index and how it improves with each.^[13]

My wife (Alexandra Runnels, MD, FACOG), my co-author, did this math. The Female Sexual Index total changed by eight with the botulinum toxin alone and by 12 when we added the PRP. 

Flibanserin and bremelanotide, two drugs that are FDA-approved for female sexual dysfunction, barely beat the placebo in a meta-analysis that looked at placebo across multiple studies.^[14] 

So, when talking to women about their FSFI scores, you get to integrate what’s possible (and what’s not possible) because of what we’re doing.

There’s a reason not to teach too much online: I want them to come to you for a more accurate assessment. If you feel like I should add more, maybe we can.

Marketing Idea using the FSFI Tool

But if you want to discuss the details further, you could create your own webpage. Put a link to the one I just gave you on your page, and then have your video or whatever you want to say about the test right there (see video), and send your people to your page.

So let’s see if I can find something. I think I did something like that or started it on the Clitoxin® page, but I haven’t finished it yet.

But see, it’s just a link. This is clitoxin.com Female Sexual Function Index. I built this today, and it just got the link, but I’m giving you a demonstration. I can have your video that talks about Clitoxin® research, and this is what it did. If you want to see more, go here to see the research.

But if you want to see how you fall into that scale, click here.

And then when they do, boom, they’re back taking the test. Okay. Let’s see what other questions we have.

And I think that’s, I know, in my case, the main reason for not doing the Female Sexual Function Index, both as a document and as an education tool, documenting results before and after, educating people about where they might be about their sisters, about what the research says: it’s just a time factor. But now, if I can click something and say to them, “Please, fill that out on your iPhone while I’m spinning your blood,” it makes life much easier.

Are you using Exosomes in your O-Shot procedure?

All right, I think there were a couple of other questions.

I’m not using exosomes yet. The best I can tell is that if you do exosomes, you can’t talk about it because the FDA doesn’t like it yet.

I know people are doing it. I’m not telling you not to do it, I’m just saying I don’t do it. We’ve gotten great results without it and all the research we’ve done.

Salespeople (and some providers) will say, “If you’re over 60, your PRP doesn’t work.”

My answer to that is, “Well, you can have surgery over 60, and my skin still heals, and things still work, so I’d rather not have to think about the FDA knocking on my door.”

But I know I’m old school. So, I don’t do stem cells, exosomes, amnion, or anything else that is a dog whistle for the FDA to visit me. I stopped when the FDA started cracking skulls and taking people to jail.

There’s a website where the FDA tells patients what to ask when they’re in your office getting stem cells or exosomes.

They give them a script, saying, “Can you show me the institutional review board study that you’re involved in while doing this therapy?”

Thousands are doing it, but I’ve had three-letter people knock on my door (FDA, IRS, DEA, FBI); it’s not fun. So, I don’t do anything I can’t talk about on the billboard.

Okay, I hope that’s helpful to you guys. Thank you for being on the call.

I’ll tweak where our new FSFI tool lives and probably put it in different places on the O-Shot® website, and you guys can run with it. It’s yours to use however you wish.

You all have a good night.

References

Belk, John W., Darby A. Houck, Connor P. Littlefield, Matthew J. Kraeutler, Andrew G. Potyk, Omer Mei-Dan, Jason L. Dragoo, Rachel M. Frank, and Eric C. McCarty. “Platelet-Rich Plasma versus Hyaluronic Acid for Hip Osteoarthritis Yield Similarly Beneficial Short-Term Clinical Outcomes: A Systematic Review and Meta-Analysis of Level I and II Randomized Controlled Trials.” Arthroscopy 0, no. 0 (November 13, 2021). https://doi.org/10.1016/j.arthro.2021.11.005.

Bensa, Alessandro, Alessandro Sangiorgio, Angelo Boffa, Manuela Salerno, Giacomo Moraca, and Giuseppe Filardo. “Corticosteroid Injections for Knee Osteoarthritis Offer Clinical Benefits Similar to Hyaluronic Acid and Lower than Platelet-Rich Plasma: A Systematic Review and Meta-Analysis,” September 1, 2024. https://doi.org/10.1530/EOR-23-0198.

Cole, Brian J., Vasili Karas, Kristen Hussey, David B. Merkow, Kyle Pilz, and Lisa A. Fortier. “Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-Articular Biology for the Treatment of Knee Osteoarthritis.” The American Journal of Sports Medicine 45, no. 2 (February 21, 2017): 339–46. https://doi.org/10.1177/0363546516665809.

DeRogatis, Leonard, Anita Clayton, Diane Lewis-D’Agostino, Glen Wunderlich, and Yali Fu. “Validation of the Female Sexual Distress Scale-Revised for Assessing Distress in Women with Hypoactive Sexual Desire Disorder.” The Journal of Sexual Medicine 5, no. 2 (February 1, 2008): 357–64. https://doi.org/10.1111/j.1743-6109.2007.00672.x.

Idres, Fatima A, and Michel Samaan. “Intra-Articular Platelet-Rich Plasma vs. Corticosteroid Injections Efficacy in Knee Osteoarthritis Treatment: A Systematic Review,” 2023.

Peng, Yu-Ning, Jean-Lon Chen, Chih-Chin Hsu, Carl P. C. Chen, and Areerat Suputtitada. “Intra-Articular Leukocyte-Rich Platelet-Rich Plasma versus Intra-Articular Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Meta-Analysis of 14 Randomized Controlled Trials.” Pharmaceuticals 15, no. 8 (August 7, 2022): 974. https://doi.org/10.3390/ph15080974.

“Research – Clitoxin®.” Accessed September 9, 2024. https://clitoxin.com/research/.

Rosen, R., C. Brown, and J. Heiman. “The Female Sexual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Female Sexual Function.” J Sex Marital Ther 26 (2000). https://doi.org/10.1080/009262300278597.

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.

Runels, Charles, and Alexandra Runnels. “The Clitoral Injection of IncobotulinumtoxinA for the Improvement of Arousal, Orgasm & Sexual Satisfaction- A Specific Method and the Effects on Women.” Journal of Women’s Health Care 13, no. 3 No. 715 (March 20, 2024). https://doi.org/10.35248/2167-0420.24.13.715.

Wiegel, Markus, Cindy Meston, and Raymond Rosen. “The Female Sexual Function Index (FSFI): Cross-Validation and Development of Clinical Cutoff Scores.” Journal of Sex & Marital Therapy 31, no. 1 (January 2005): 1–20. https://doi.org/10.1080/00926230590475206.

Tags

Female Sexual Function, Female Sexual Distress Scale, Female Sexual Function Index, O-Shot®, P-Shot®, SHIM score, Clitoxin®, botulinum toxin, PRP, fertility, endometrium, corticosteroids, HA, pain relief, knee injection, meta-analysis, journal club, sexual dysfunction, female orgasm, dyspareunia, lichen sclerosus, sexual counseling, testosterone, Vampire Wing Lift®, before-and-after pictures, electronic records, software, research, patient surveys, sex hormones, FDA compliance, exosomes, stem cells, amnion.

Helpful Links

=> Next Hands-On Workshops with Live Models <=

=> Dr. Runels Botulinum Blastoff Course <=

=> FSFI Online Administrator and Calculator <=

=> The Cellular Medicine Association (CMA): Who we are <=

=> Apply for Online Training for Multiple PRP Procedures <=

=> Help with Logging into Membership Websites <=

=> The software I use to send emails: ONTRAPORT (free trial) <= 

=> Sell O-Shot® products: You make 10% with links you place; shipped by the manufacturer), this explains and here’s where to apply <=

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