Female Stress Incontinence–New Research that Every Gynecologist Should Read

Topics Discussed Include the Following…

*Metanalysis Review of Possible Injectables for Treating Urinary Incontinence in Women
*Urinary Incontinence—The Surprising Truth about Female Athletes
*Is Saline a Placebo?
*The muscle atrophy and nerve degeneration surrounding the female that occurs with aging
*Study Shows O-Shot® Methods Help with Female Stress Incontinence
*Tips for Injecting the Clitoris
*How to Learn the Basics of Writing Emails in Less than 30-Minutes

Video/Recording of CMA Journal Club, Pearl Exchange, & Marketing Tips

Relevant Research, Transcript, Relevant Links

Relevant Research

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

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

Kim, Chul-Ho, Yong-Beom Park, Jae-Sung Lee, and Hyoung-Seok Jung. “Platelet-Rich Plasma Injection versus Operative Treatment for Lateral Elbow Tendinosis: A Systematic Review and Meta-Analysis.” Journal of Shoulder and Elbow Surgery, October 2021, S1058274621007242. https://doi.org/10.1016/j.jse.2021.09.008.

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

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

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

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

Platelet-Rich Plasma for Nerve Regeneration<–

Transcript

Charles Runels: Welcome to the Journal Club with Pearls & Marketing 2021.10.27
Today, I was really proud to get a text from Red Alinsod, alerting me to a study that came out–a really strong article showing that our procedure helps with incontinence.[1]

We’ll come back to this study and I’ll give you a link to it, but I want to back up a little bit and talk about some of the background that I think helps make this study more insightful.

Oh, by the way, I’ll end this call with some ways to use this research. You wouldn’t think you could share. Some of the people new to the group may not have thought about the idea of sharing detailed medical research with your patients as a way to engage them and bring them to your office. There’s a way to do that. I’ll go over that at the end of the call.

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Metanalysis Review of Possible Injectables for Treating Urinary Incontinence in Women

So 50 something pages and they review everything or the main things that have been injected around the periurethral area to help with incontinence and the various different materials that were used[2].

Of course, at the time this was put out, I think it was 2007. We were already doing the O-Shot® procedure.
I did the first O-Shot in 2010, so this was seven years after that, but we weren’t being noticed as much. So it was left out of their review, but some basic principles come out of this.

First of all, some of the things have been just pulled because of the side effects of it. For example, in a study of injectable fat, they had people, two people died in the study from pulmonary embolism.
So hopefully you guys are, are not even thinking about injecting fat around the urethra.

And then in with HA fillers, there’s was a higher incidence of complications. The same with calcium appatite (Coaptite®), several studies showing granuloma formation. This one’s still out and available, but then there are some principles.

First of all, in spite of the tendency, historically, to inject the proximal urethra near the bladder, these authors concluded after reviewing quite a number of different studies that mid urethra injections worked better. They didn’t look at distal urethra where we are injecting, but the proximal urethra or near the ureterovesical junction was not as effective.
So…a long way of saying the looking for something to inject around the urethra to help with incontinence has been ongoing for at least two decades, but the problem’s been finding something that works without noticeable sequela or serious side effects.

Urinary Incontinence—The Surprising Truth about Female Athletes

I also want to talk about this one. I, I think historically we tend to think of incontinence is something that is for people who’ve had babies, but, or for perimenopausal and older, this is one of the studies that of probably at least a dozen that sort of blow that one up, demonstrating that many female athletes who have high impact sports, volleyball, trampoline, running, having incontinence. And depending on the sport, it can be near 100%. I’ll put the link to this one in the chat box[3].

How to Use the Research to Find People Who Need You and Want to Pay You

 

I’ll just stop now and kind of give you a clue about how I turn this into something, to educate our patients.
So marketing really the best marketing is teaching people about their disease and then showing them how to treat the disease.

So that’s a recent article. And when it came out, I posted it. I made a video about the article, which I’ll show you how to do shortly, posted the video to a webpage and then put links to the research, and then had it transcribed. So we go into this in great detail in my workshops, but the basic idea is to do whatever software you use to film your discussion, film the article, as you discuss it, put that in a page and then put it on your website.

Now it needs to go further than that. If you just put a video up on a page on your website, it’ll probably sit there and be seen by not many people. I just posted this one today.

But I’ll shoot out an email tomorrow to bring people to here and this number will go up. So that email part of the deal and how and why I’ll show you that shortly, let’s go back to this.

Is Saline a Placebo?

I mentioned that fat, I’m going to put a link to this one. I mentioned that those people who died from the fat injection, there’s something else about this. And it was for pulmonary embolism, there’s something else about this study though, that’s worth noting the placebo arm had a 21% response rate and they quote the, the idea that, okay, you can have up to a 30% response rate from placebo.[4] To me, that seems like a stretch. When you’re doing things like this isn’t measuring libido with a survey; this is measuring the number of wet pads and, and leaking.

So I don’t think I’m alone in that assessment that maybe their placebo arm, which is saline, was not “doing nothing”, and that perhaps the hydro dissection was actually changing the tissue– as it has been shown to do in other studies.

If you look at the review article, I showed you previously, let me go back to that one. The one that was 50 something pages, it actually pointed that out and, and said, this is, yes, this review article. It made a point of the fact that, well, in this one article, in the fat study that the placebo arm had a 21% or saline had a 21% cure rate or much-improved rate. And so maybe there’s a mechanism we don’t understand. [5] That seems a little high for placebo for a study that’s measuring leaking urine.

So I think the reason for the placebo effect is worth thinking about with one of our lichen sclerosus studies and some of the orthopedic literature, that is a common limitation in PRP studies—what to use as a placebo.

And actually, in one of my favorite studies about Peyronie’s disease, Dr. Virag uses a positive control Xyflex as a positive control rather than use a placebo.

The muscle atrophy and nerve degeneration surrounding the female that occurs with aging

Two weeks ago, we talked about some of the anatomy and what might be happening to help explain why the O-Shot works. And this is one of those studies where they talk about PRP causing neurogenesis[6]. It also calls it.
Usually, when we think about nerve damage, we think maybe pudendal nerve damage from riding a bicycle or something, but DeLancey and others have published studies showing that in Cadaver studies that as women age, they actually lose some of the nerves and the sphincter mechanism around the urethra[7]. And they lose muscle fibers[8].
So we know PRP causes neurogenesis and it activates dormant cells within the muscle to cause myocytes to proliferate.[9]

And that’s been studied in the sports literature and used as a way to help recovery.[10] So with those two things together, it might help explain why our procedure is working. I’ll put a link to this one in the chatbox, too. So this is a, I think a rat study, but nope, this is, this might be one of those Cadaver studies. Anyway, let me put this in the chatbox. And then let’s look at the main paper that I’ve, I’m so excited about that I want you guys to, to know, and then let’s talk about how to educate your patients with it, and then we’ll call tonight. So this is the study. I’ll put the DOI number in the chatbox.

Study Shows O-Shot® Methods Help with Female Stress Incontinence

So these are MD PhD urogynecologist publishing in the journal of, of reconstructive surgery. So this is a high, high impact journal with a very conservative editor and the basic plan, what they did was they…they used it gel kits, not even a double spin centrifuge. They used a gel kit, a Regen kit, and which would give you about five CCs and injected the distal urethra. Thank goodness. But then it’s interesting. They did nine different injections at 10:00, 12:00, two o’clock at three different levels of urethra, one centimeter apart, distal median proximal. And then they were, then they were watched, they had two injections, four to six weeks apart, and then they just followed them for six months, 20 women with significant improvement.

And by the way, these women were chosen because they were women who had opted to have surgery for their incontinence. And so they were enrolled in this study and instead, so these were people who were bothered enough to have scheduled surgery.

And I would argue that again. I’m grateful they did the study, but my thinking is the authors probably have not injected the face, or they would know that injecting PRP a few millimeters from where the previous injection was, is probably NOT necessary. Because PRP is aqueous and spreads easily within a tissue plane, if you inject multiple sites only millimeters apart, it is like pouring water and then feeling like you need to pour water two inches away from where you previously poured it–when you could actually pour it in the one spot and it would spread.
they, they did NOT inject proximal urethra. Thank goodness.

Probably based on the previous studies and, and I’ve lectured the region companies, maybe they sell the most PRP kits of anyone and, and I’m acquaintances with the owner of the company and have lectured for them a couple of times in Venice, Italy (they’re based out of Switzerland).

And they’ve also published other really nice research. If you go to the O-Shot web page and look on the research tab, you’ll see where they’ve published. They sponsored a paper, Regen did that was published in menopause showing that PRP helps dyspareunia due to dryness and menopausal or post breast cancer patients who can’t be on hormones.
So I think they complicated the procedure, by doing more injections than what’s necessary, and they left off the clitoral injection, but otherwise, they did the procedure close to what we do as an O-Shot® procedure. They did the O-Shot without the clitoral injection. And they did more injections than what would’ve actually been needed to spread the PRP within the same area.

So you guys know we put four CCs in the anterior vaginal wall and four CCs into that space spreads. Well, it’s because it’s a, it’s not a round space because it’s a linear hydro dissection sort of distribution, it covers pretty much at least the front or the most distal half of the urethra and spreads laterally, probably a half a centimeter on each side.
So that’s my reason for why they complicated the procedure (and you can easily palpate the area after injection to confirm our method spreads the PRP as described), who knows someone eventually needs to do a study where the locations are varied and the amounts are varied, and try different PRP kits and there are an infinite number variables we could change how, by the way,|

They did activate the PRP as well with calcium chloride—which seems to help increase the chances that the procedure will work for sui. The research is pretty strong on that. We covered that about four weeks ago in journal club. Okay.

David Harshfield: Charles. The interesting thing is that, gosh, I guess 10 years ago, a lot of the journals are trying to sort of discredit PRP for instance, it’s so easy to use and whatnot, and they, they keep coming out of these trials.
This was an elbow trial in JAMA about, gosh, I don’t know, seven years ago I’ll find the link, but the title was PRP no better than placebo for lateral epicondylitis. And we happened to know the editor of JAMA. So we found the gallery proof and we looked into it. And Charles, they had three groups in a control group that got nothing in both the saline injection. They were calling saline the placebo, but sodium is a, is prolotherapy.

It’s different. We like using glucose because glucose is an insulator as far as electrical current. So forth, Sodium makes things speed up. So it’s a little painful, but it’s a treatment in the PRP and the so-called placebo saline were both way better than the controls. And then the punchline was PRP no better than placebo, trying to sort of discredit PRP but at any rate that’s when we figured out wows normal saline is it is a treatment (not a placebo).

Charles Runels: And actually we covered here. I was seeing if I could find it, but yeah, here we go. Here’s a study. Let me pull this up. We covered this a couple of weeks ago where someone did show PRP versus operative treatment for lateral, although tendonitis, the PRP was as good as surgery[11]. And that was published just within the past month.

So for you guys who don’t know, David Harshfield is an interventional radiologist. Who’s very, he’s, he’s published, he’s done research all the way back to the early days of Viagra and, and teaching and, and he’s connected with knowing he has his own group. And he’s very connected with understanding the guidelines of the FDA and such. So thank you for jumping in any other ideas or that you would comment on regarding this particular paper. To me, it just feels good that it made a at a high impact journal. Hopefully some people will, more people start paying attention.

David Harshfield…: I’m kind of interested now, Charles, because what we’re thinking now, platelets actually, all cells do the same thing. Neurons do just slower and platelets are looking like they’re going to be our little peripheral floating neurons. Think about that. So that when we inject them, they act like neurons. They have little secretory granules, just like a nerve would have neuro vesicles at the end to release acetylcholine for instance.
So they are doing a lot more things than what we thought, just, blood clotting and so forth. Platelets are cool, little creatures. They can do a lot of cool stuff

Charles Runels: And we can use them without the paperwork of the FDA because it’s autologous with minimal manipulation (so PRP is a body fluid, not a drug).

So thank you for that. I appreciate you jumping in there, David.

Tips for Injection the Clitoris

Keith asks, he says, when he injects the Corpus, the clitoral corpus cavernosum and Dr. Harshfield actually brought his ultrasound and we, he visualized it didn’t make it into our chapter about the O-Shot® in Red Alinsod and Christine Hamori’s book, you visualized the flow of PRP through the corpus cavernosum and saw a change in the waveform. And we just need to do our own, we need to publish those videos as just a separate case report or something.

But the question is when you do that injection, sometimes you see blanching or you’re seeing blanching and wondering if that you should back off. I know that some of the women have a really tiny, very tiny clitoris.
It’s maybe didn’t have too much volume, in that case, maybe you back off, but actually, I remember right, David, when you were doing that ultrasound, it was, it wasn’t until we had three or four CCs that we started to see it flow into the distal corpus cavernosum and the waveform changed to what you say that you’ve seen when the penis goes from flaccid to erect.

So, what’s you’re thinking about the volumes that we’re injecting into the clitoris?

David Harshfield: I think that’s, that’s the key right there, Charles, is that we, these girls that are so different and we didn’t understand the anatomy, remember Charles, because if you try to look at Grant’s Atlas, they can pretty much draw a penis on one page, and for the female anatomy it’s scattered throughout from this thing to that thing, the Corpus is on this page and 37 page later it’s clitoris and I don’t think we’d ever put it together. And when we also sounded those times with those girls, it was just like a man’s penis, the erectile tissue, the corpus cavernosum is a different size in us, but they act the same way. And it, it, I guess it would be much more volume intensive if you say that. And, but when you’re watching, while you inject, you can see where it goes. PRP has a real interesting phenomenon that it creates vasodilation.

And as most people know, to have an erection, you have to relax. It’s a parasympathetic thing, the smooth muscle relaxes, it slides in the way of the little outflow ducts. And then the erectile tissue feels with what, and then the ejaculation is a sympathetic thing totally different field, but when you’re filling these erectile tissues, I don’t think any of the women were even close to the same volume.

Charles, if I remember the, we were monitoring the, the flow and you’d have a really high systolic and diastolic flow to begin with. And as the Cavernosum filled up and the pressure increased, you just get a little systolic pump bump that diastolic flow would stop meaning there’s no. [inaudible] And women looked exactly to me as the men, men do.

Charles Runels: Yeah. That’s we really need to get that out so people can know. So I think that’s your answer. It depends on the size of the clitoris, Keith. Oh, I just put a link to the, to the paper that you was foreshadowed that you just heard David talk about, but this article that just came out, what was this it’s been within the past month showing that PRP versus operative treatment for lateral tendonitis was as effective as surgery.

David Harshfield: I mean, that was so much more honest study, Charles, because we’re comparing surgery versus biologic, not biologic versus prolotherapy. That was the same thing.

Charles Runels: Yes. And of course, people want to see a double-blind before they think before they want to acknowledge something. But I always like reminding them, there was no double-blind placebo control that I know of for birth control pills. And, and you can’t really do double-blind for many procedures. And there is a component of what we’re doing, which is, we’re saying the same thing. There’s a component.

The O-Shot® procedure isn’t a pharmacological thing where you’re injecting a drug, you’re physically hydrodissecting something. And that’s a procedure, which is why I think it matters how and where you inject it.
And then the hyrodissecion is combined with the cellular effects of what you’re doing (the PRP). But there’s really two things going on. Any comments about that idea?

David Harshfield: I think that it makes me laugh. I think there ought be a double blind control study on parachutes for these knuckleheads, at the think that everything needs a randomized control trial. We’re going to throw you out of an airplane and we’re going to find out if you need a parachute or not, you professors don’t get one.

Charles Runels: I like it.

David Harshfield: But you’re right, Charles. I mean, it goes to the quantum level.
Once you observe something, you change it in the quantum realm. So you back that all the way up to the macro, if you stick a needle in something thing and, and don’t even inject, you’ve changed micro environment.

So microtrauma, that’s how we’re healing. These folks now is we’re inducing little needle, dry needle, perfect example creates every time the needle goes into the tissues, there’s a little drop of blood on the skin. You can wipe that off, but the one on the inside of the skin’s there, it’s a miniature PRP shot. Even if you don’t inject anything.

How to Learn the Basics of Writing Emails in Less than 30-Minutes

Charles Runels: Okay. So let, let’s go over and I’ll show you what I was planning to show you about emails and then we’ll call tonight. That’s really the main study I wanted to show you. Let’s see. Here we go. And yeah. Okay. All right. So when you log into the first of all, there’s this reluctance, I think of doctors to try to sell something and I agree.

Here’s my here’s the philosophy. Just something to, to put in your brain that I think will help you when it comes to something where people need to pay you money for it is that you’re not trying to get anybody to do anything and try to teach your staff the same thing.

You’re not trying to get anyone to do anything. And if you have that mindset, it’s, it’s uncomfortable. It’s not what we want to do as physicians.

But what you can do, and I think which you’re responsible for doing. Patients don’t know about these procedures. And I think it’s the physician’s responsibility to teach people what we’re able to do for them if they don’t know. And then here’s the keyword offer to help that’s it.

So you teach them about their disease. You teach them different options that might be available to them, the risk and benefits, and then offer to help them. That’s all you’re doing. Now the problem that comes in when the thing that you’re one of the things that you think might help them takes an hour to explain, which is why our procedures can be exhausting if you’re trying to teach someone how they might help them.

So that’s how the digital can you with an email or a video that you send to your patients.

How to Use the Medical Research to Find People Who Need You

And I promised you a way to leverage this research. So what I would recommend you do is that, your patients are smart and they can Google things and they may not know every word, but whatever, they can still understand it. And, and make a more informed decision.

So I like actually sending an email, which I’m about to show you a quick way to do that. So if you go to just all the procedures, have this on them. And so if you log into the, to the website and then you go to the marketing page, then I have an a video there about how to write an email in 10 minutes. If it takes you longer than 10 minutes, you’re taking too long. You’re trying to write literature instead of writing notes.

And then here’s a free little book that will also help you (click)<—

And it’s put out by the same people that I use to send emails.
I used to have three different ways. I send emails, but this is the one that I like the best. And they give you some tips about writing emails.

But this video (on the membership sites), which is only 15 minutes long is really the key about how to relax and just get it done. If you’re a member, it’s on all the membership websites.

The idea would be that you send out an email and people want to know new, you’ll hear wall street journal, talk about the New England Journal, or you’ll see CNN mention something that came out in one of the medical journals. You can do the same thing; you can send an email to your people and say, “Hey, this research just came out that shows that PRP might help some women.” And. you always couch it with you can’t get everybody well, but there’s some new research. That’s the news that shows that we might be able to help some women who have incontinence. And here’s a link to the research. And if you’re interested to call me, that’s pretty much how you do it.

And then you can set that up to go automatically, but you shoot something like that out to your people every couple of weeks where you’re letting them know that you’re staying abreast of the current research, and you let them know when you bump into something that might relate to problems they have and how you might take care of them.

And then don’t forget the keyword is then you offer to help them and then…let it go. You’re not trying to get anybody to do anything; you simply start with teaching people about their disease and then offer to help.

If you do this and know your business, you won’t lack for people who are willing to pay you for your services.
And I think with that, let’s shut it down. Any other comments, David, I appreciate you jumping in with that, those ideas about how saline is not really a placebo.

David Harshfield: I love working with Charles cause you know, I do a lot of critical limb ischemia, for instance, trying to save limbs.

And we use PRP and you’re doing the same thing with these other structures. You’re trying to increase vascularization. I, one thing Charles a dawned me after a few years, being an interventionalist always was putting stints in things and I was a plumber and then occurred to me. What we’re doing is restoring the nerve and that’s, what’s creating increased flow both in and out; so that when we use PRP there, it’s restoring the nerve innovation in the local area. And that is going to fix all these other things.

Charles Runels: Beautiful. And you guys have a great night. I’m always honored to be able to share notes with you guys.

Good night.
Thank you, David.
Bye.

[1] Athanasiou et al., “The Use of Platelet-Rich Plasma as a Novel Nonsurgical Treatment of the Female Stress Urinary Incontinence.”
[2] Kirchin et al., “Urethral Injection Therapy for Urinary Incontinence in Women.”
[3] Joseph et al., “Stress Urinary Incontinence Among Young Nulliparous Female Athletes.”
[4] Lee, Kung, and Drutz, “PERIURETHRAL AUTOLOGOUS FAT INJECTION AS TREATMENT FOR FEMALE STRESS URINARY INCONTINENCE.”
[5] Kirchin et al., “Urethral Injection Therapy for Urinary Incontinence in Women.”
[6] Sánchez et al., “Platelet-Rich Plasma, a Source of Autologous Growth Factors and Biomimetic Scaffold for Peripheral Nerve Regeneration.”
[7] PANDIT et al., “Quantification of Intramuscular Nerves Within the Female Striated Urogenital Sphincter Muscle.”
[8] Perucchini et al., “Age Effects on Urethral Striated Muscle I. Changes in Number and Diameter of Striated Muscle Fibers in the Ventral Urethra.”
[9] Moraes et al., “Platelet-Rich Therapies for Musculoskeletal Soft Tissue Injuries.”
[10] Middleton et al., “Evaluation of the Effects of Platelet-Rich Plasma (PRP) Therapy Involved in the Healing of Sports-Related Soft Tissue Injuries.”
[11] Kim et al., “Platelet-Rich Plasma Injection versus Operative Treatment for Lateral Elbow Tendinosis.”

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Charles Runels, MD

 

 

 

 

 

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