Hi there, and welcome to the AUGS Urogynecology Webinar Series. I'm Dr. Christine Beccaro, a member of the AUGS Education Committee and moderator for today's webinar. Today's webinar is titled, Use of Radiofrequency Energy in the Vaginal Canal and on the Vulva, Therapeutic and Aesthetic Indications and Outcomes. Our speaker today is Dr. Mickey Karam. Dr. Karam is an internationally renowned urogynecologist and pelvic surgeon. He is board certified in obstetrics and gynecology and female pelvic medicine and reconstructive surgery. He completed his fellowship training in urogynecology and reconstructive surgery at Harbor UCLA School of Medicine. He is currently the director of urogynecology and reconstructive surgery at the Christ Hospital and clinical professor of obstetrics and gynecology at the University of Cincinnati School of Medicine. He is the past editor-in-chief of the International Urogynecology Journal and the consumer publication Women's Health Today and is past president of AUGS. He has published more than 200 scientific articles and book chapters and has co-authored numerous textbooks, including Urogynecology and Reconstructive Pelvic Surgery, The Atlas of Pelvic Anatomy and Gynecologic Surgery, and the Pelvic Surgery Video Atlas, all published by Elsevier. Dr. Karam has directed a number of postgraduate teaching courses throughout the United States, Europe, Asia, South America, and Australia. Dr. Karam has been designated by Good Housekeeping Magazine as one of the best doctors in America for women. That is quite a CV. Here we go. Reminders, before we begin, I'd like to review some housekeeping items. This presentation will last around 60 minutes. The first 45 minutes will consist of lecture and the last 10 to 15 minutes of the webinar will be dedicated to Q&A. This webinar is being recorded and live streamed. A recording of this webinar will be made available in the AUGS e-learning portal. Please use the Q&A feature of the Zoom webinar to ask any of the speakers questions. We will answer them at the end of the presentation. Use the chat feature if you have any technical issues. AUGS staff will be monitoring the chat and can assist. All right. Now that that's out of the way, Dr. Karam, I'm going to turn it over to you, and I am going to share your slides momentarily. All right, lots of clicking here. Okay. Can you see your slides? I can. Thank you. All right. Thank you very much, Christine. It's really a pleasure to participate in this lecture series. So I'm going to talk about radiofrequency energy that we've been using and studying for going on five years right now. Next slide, please. These are my financial disclosures. The device that I'll be speaking to is made by a company called InMode, and I am a speaker and clinical consultant for them. Next slide. So the objectives of the talk are going to review the various energy sources that have been used in the vaginal canal and on the vulva. And basically, I'm going to take you through the history of this. I think it's important to understand how this all got started, where we've been, what's occurring in regards to perceptions in the FDA. And then we'll get into specific ways that radiofrequency impacts the vaginal epithelium and the vulvar skin, discuss how that differentiates from traditional CO2 and erbium YAG lasers. And then most importantly, we'll talk about what I feel are reasonable therapeutic and aesthetic indications for these various applications. Next slide. So the first thing we have to discuss is terminology. And it's really unfortunate because I really hate the term vaginal rejuvenation. It's a term that means nothing, has no real designation. But unfortunately, I think I've lost the battle because that is the term that resonates most with consumers. But what I want you to think about moving forward as a medical provider of this potentially is looking at how to utilize these energy sources for a therapeutic indication versus a cosmetic indication, virtues for sexual enhancement. I think all of these are potential utilizations of this. But to keep talking about vaginal rejuvenation of this all-inclusive entity that we use for energy sources is really not scientific and not in our best interest. Next slide. So let's start the little trek through history. This is kind of where the terminology all started. We're going back into the late 90s now. David Matlock is an OB-GYN in Beverly Hills who basically trademarked the term laser vaginal rejuvenation. He was not doing anything near what we're talking about today. He was actually using a CO2 laser to do what is really a vaginoplasty, if you will, vaginal tightening. But he was a very, very good businessman in regards to promoting this, and he started training people on this, and this is how the term got out. Next slide. A few years later, many gynecologists were talking about this, and again, it wasn't really well-described or well-understood. Most of us were kind of ignoring it. At the time, Rachel Pauls was with me at Good Samaritan Hospital, and she wrote this editorial in the international journal Nip, Tuck, and Rejuvenate, the latest frontier for the gynecologic surgeon. And it was, again, this sort of area that some were tiptoeing around about how to make things feel better, how to make things look better. But again, in general, mainstream OB-GYN was really not paying much attention to this. Next slide. Few years later, ACOG actually came out with a formal committee opinion on vaginal rejuvenation and cosmetic vaginal surgery. They basically said things like vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, are surgical procedures being offered by some practitioners. They went on to say that these are not adequately described or studied, and you need to be very, very careful when you talk to patients about this. Next slide. Shirella Glacier then wrote an editorial, The Illusive Quest for the Perfect Vagina. Again, basically saying that we're kind of overstating this and, you know, what is the perfect vagina, and this Barbie doll look really shouldn't be anything that we should consider. So again, you know, we're now at 2008, 2009, again, nobody's really paying much attention to this. Next slide. My involvement came in 2014 when Stefano Salvatore, who's a urogynecologist at San Rafael Hospital, he was on our editorial board when I was the editor of the International Urogynecology Journal. He approached me and said he'd been working with this group of physicians, Alberto Caliguero is a histopathologist, Rosella Nappi is an academic gynecologist interested in sexual medicine, and Nicola Zerbinati is an academic dermatologist. They had been working with a CO2 laser company out of Florence, Italy called DECA, and they basically put together the first series of patients utilizing this CO2 laser, which was specifically created for use in the vaginal canal. And they studied it in patients who had vaginal atrophy, or now what we call general urinary syndrome and menopause. Next slide. And they published their preliminary success in Climacteric with really excellent results as basically the first non-hormonal therapy for vaginal atrophy, or GSM. They were looking for someone to study in the United States. Next slide. And again, the results were very impressive. They were taking patients who had significant vaginal atrophy, and you can see here one of the studies that they did shortly after their clinical study was a histopathology study. And you can see here that they showed tremendous improvements in vaginal epithelium, maturation index, a thickening of the vaginal crypts, hyperkeratinization. The slide on the right basically could be the histology of a 35-year-old. So this was pretty exciting stuff. Next slide. Again, they showed excellent outcomes in a variety of things, burning, itching, dryness, dyspareunia, laxity. Next slide. Eric Sokal and I then did the first U.S. trials and basically almost duplicated their results. This is our study that we published in Menopause with one-year outcomes. And this was the beginning of a real medical indication for an energy source in the vaginal canal. Next slide. As you're all well aware, the prevalence of GSM, which is basically a symptom complex, is very high. It impacts about a half of postmenopausal women by the time they're three to five years postmenopausal. And in contrast to vasomotor and systemic symptoms, GSM will not spontaneously remit after you stop the hormones. And up until this time, obviously, the only way to treat this was to replace the estrogen locally in the vaginal canal. And this is obviously a very, very large market now. You have a variety of estrogen products. You have Asfine, you have Invexi, you have DHEA and precursors to estrogen. So it's a very, very big, large disease state that women suffer from. Next slide. This is just one study that shows the prevalence of GSM at four years out is almost 55 percent of women. Next slide. Here the presence of vaginal dryness, again, 50 percent of women by the time they're three years postmenopausal. Next slide. And then you have patients who have a variety of cancers that require that you knock out their estrogen. Most notably, that's breast cancer patients, but other cancers as well. And these patients really can't take estrogen. So there's definitely a huge, huge clinical need for a non-hormonal solution or a non-hormonal option for this very common problem. Next slide. The pathogenesis of this is very straightforward. Over time, you get a reduction of blood flow. You can hit – next slide. And then you get morphologic changes, changes in the maturation index. And then you get changes in the milieu or the environment of the vagina. So over time, basically, the vagina becomes thin, dry, very, very sensitive. You get irritative bladder symptoms in the form of urgency, frequency and dysuria as there's estrogen receptors throughout the urethra and the bladder. The vagina goes from being very acidic to being alkaline. The lactobacilli goes away. The glycogen goes away. As the pH changes, the prevalence of chronic cystitis rises because the defense mechanisms to keep the gut bacteria in the vagina and in the pararectal space all require that lactobacilli. So as that acidity goes away, the floodgates open up and these patients start to develop recurrent urinary tract infections as well, which isn't really discussed very much. Next slide. Breast cancer patients, again, very, very devastating that these patients have to deal with this. We've done very well with breast cancer. You can see here the five-year survivals are now close to 90%, if not even higher. We diagnose it now almost 300,000 times a year. Probably the most rewarding thing I've done in my entire career is treat a young breast cancer patient that's 35, 36 years old who is now cured of her breast cancer but has lost the ability to have any intimacy with her husband or partner. To be able to give them that back with treating their vaginal canal with an energy source is extremely rewarding. Next slide. When this started to get out, all of a sudden there was a huge influx of companies that make energy sources. Here you can see the Mona Lisa Touch was initially marketed through a company in the United States called Sinasur. Again, it was the only laser specifically created for use in the vaginal canal. Then you had all of these other lasers that are used aesthetically, started to create a handpiece for the vaginal canal. You had Femilift, you had Cineron with Intima, Luminous. And then, next slide, you had Erbium YAG lasers, which really can't do this except if they add a diode to make it act like a CO2 laser. But then you had a bunch of these lasers being promoted aggressively. Next slide. And then you had radiofrequency energy. Now understand, radiofrequency is heat energy versus lasers, obviously, are light energy. Up until about four years ago, it was all basically bulk heating. Thermiva, Viveve are monopolar bulk heating. Botiva or Forma V is bipolar heating. Temperature is monopolar heating. And I'm going to talk about the first radiofrequency device that penetrates the vaginal canal, which is a vaginal morpheus, which is basically microneedling of the vaginal canal. Next slide. What was really concerning is that aesthetic surgeons, dermatologists and plastic surgeons were really aggressively entering into this space. You can see here that in 2015 to 2016, there was a 23% rise in the volume of labioplasties. And this is a piece out of the Plastic Surgery Journal in which they say, plastic surgeons and aesthetic practices are suited to provide non-surgical vaginal rejuvenation as part of a comprehensive rejuvenation of the genitalia. And again, talking about this without any understanding of what GSM is, various causes of dyspareunia, again, really these surgeons with all due respect are very, very good salesmen. And so basically what was happening is a woman would come into a plastic surgeon's office, for example, for a Botox injection of her forehead. And she would then get sold on a vaginal rejuvenation procedure. They'd say, Mrs. Smith, you know, we've got a special this month on vaginal rejuvenation and for, you know, $3,000, we can rejuvenate your vagina. And they would take whatever energy source they had that had the vaginal applicator and start putting it in vaginas, again, not really knowing what was happening. Next slide. And this is where this became very gimmicky and really, really was frowned upon by academic medicines. But more importantly, next slide, the FDA came out with very aggressive warning letters to all of these companies in July of 2018, basically saying, hey, you don't have any indications for any of this stuff. You really cannot promote this for any specific indication or for any specific disease state. And so they all had to redo all their marketing materials. And basically all you could say is that your energy source maybe coagulates tissue or heats tissue. You can't really designate it as treating anything specific. Next slide. So let's talk a little bit about the differences between light and heat on vaginal and vulvar skin. And these are observations, but what I've observed in a nutshell is the vagina is extremely receptive to these energy sources. It responds very, very well, very quick with nowhere near the damage that you see in the skin. It's truly remarkable. Now the vulva also responds, but is more aligned with skin, albeit it does respond better, quicker with less trauma as well. So the vagina doesn't really differentiate what the energy source is. And that's important because I'm gonna share with you now what we can do with RF that we could never do with a CO2 laser in regards to penetration. Next slide. So again, we get back to rejuvenation versus truly describing what we're doing. So now I'm gonna share with you some of the things that we've seen in regards to therapeutic indications, where we're at with this, what we've published or presented at national meetings and talk to you about where we're going with all of this. Next slide. So unfortunately, because this is not an area that isn't very well regulated and because it's all cash pay and because physicians spend a significant amount of money on the energy source, they unfortunately promote it for almost everything under the sun. There's a perception that vaginal rejuvenation will tighten the vagina. It'll treat incontinence. It'll make sex better. It'll make the vagina look better and feel tighter. The skin will tighten in the labia. And then there's disease states like lichen sclerosis, like GSM, like a variety of other things that basically really haven't been studied. It's almost to the point that when a woman says, I feel I'm too loose, vaginal rejuvenation. I feel I'm too tight, vaginal rejuvenation. There's nothing that unfortunately many of these practitioners will say no to. Next slide. So specific therapeutic indications, next slide, are definitely general urinary syndrome and menopause. This is the Mona Lisa touch laser. And I'm gonna share with you how this procedure works for GSM and how much of the vagina you're actually treating. So when you do this procedure, you take the laser to the top of the vagina and you slowly rotate and withdraw. And if you were to theoretically take this vagina out and lay it like a piece of carpet, you're maybe treating 10 to 12% of the surface area of the vagina. And the laser is penetrating at a stack three, which is the highest stack that's available, about 700 microns. It's less than a millimeter. Now we know that this, in my opinion, does significantly create an inflammatory reaction. That inflammatory reaction starts to initiate new collagen growth. With the new collagen growth, there's the release of a transidate and you get lubrication. You get new blood vessels to support the collagen. And you basically address the issues of dryness, change in pH of the vagina, and the maturation index with GSM. With that said, there are a couple of recent studies, level one studies that showed that this was not any better than a sham procedure. I can just tell you, I've been treating GSM patients with the CO2 lasers, 2015, and patients that have a good indication, mostly it's gonna be dyspareunia due to their atrophy, do very well with this. Next slide. Now this is the radiofrequency microneedling device. This is the vaginal morpheus. It penetrates to one, two, and three millimeters. And we've studied this, we've studied this in a cadaver. It's very safe to penetrate to three millimeters. Next slide. And in contrast to the laser, we do a stamping technique here. So we stamp the vagina three times. We stamp it at three millimeters, we stamp it at two millimeters, and we stamp it at one millimeter. And so in contrast to 700 microns that you're going, which is about as deep as you can go with a laser, we're going to three millimeters. And if you were to theoretically take this vagina out and lay it out like a piece of carpet, you're easily treating 85 to 90% of the surface area of the vagina. And I can just tell you that deeper is better and treating more surface area of the vagina is better. And I say that because I've seen results in patients who have not done well with the laser that we've come in and been able to improve their GSM with a more aggressive microneedling device like this. But more importantly, we're seeing significant improvements in bladder function. And this is leading me to my next discussion about how this is being used now to potentially treat overactive bladder. Next slide. So the area that we're treating underneath the bladder is the area that houses autonomic nerve plexuses. And again, we've studied this in a cadaver. Autonomic nerve plexuses that sit between the proximal urethra and vaginal epithelium and the trigone and vaginal epithelium. And these autonomic nerve plexuses start to be present at a depth of about three millimeters all the way up to eight millimeters. So we initially did a study with the traditional commercially available three millimeter microneedling device on patients with OAB and saw reasonably good success. But realizing after a cadaver study that the majority of the plexus was deeper, we then created a prototype and just finished our pilot study. Not just finished, we've got one year data on our pilot study of 32 women where we penetrated the seven millimeters. And the success was extremely encouraging. Very, very good outcomes. Next slide. So at the present time, I think there's a huge opportunity to treat genital urinary syndrome of menopause. You will get some success with RF therapy around stress incontinence. It's hard to really state what the durability of this will be, but in general, mild to moderate cases when treated with three treatment sessions as we do with GSM, you'll get a significant improvement. It's really not going to be a good treatment for more severe cases of stress incontinence. Patients who leak urine at low volumes, patients who leak urine have an empty supine stress test. The real indication around the bladder, as I said, is overactive bladder. We're continuing to study that. So sit tight. I'm gonna present to you here in a second the abstract that we just presented at the AUGS meeting. And we're now with the FDA to hopefully get an IDE to do a formal study for an indication for overactive bladder. Mixed incontinent patients. This is a really, really interesting application because it's one treatment that treats all. You also have a tremendous amount of GSM patients who have stress, urge, or mixed incontinence. So it's a good one treatment for all of these patients versus giving them drugs and potentially doing other things. You'll see significant improvements across the board in these patients, especially with mixed incontinence. Chronic cystitis in postmenopausal women. Again, that's all atrophy or GSM. We're in the process of putting together a series on this. This has been a very, very successful treatment modality for us because these patients, it's difficult for them to be compliant with estrogen. Many times, a lot of them are large patients and have dexterity problems, not able to deliver the vaginal estrogen appropriately. They have a uterus. We have to limit how much estrogen we've given them. So when I have patients that are not, we're not adequately treating them with replacing their estrogen, we offer them this. And unfortunately, it's out of pocket, but many of them are willing to pay this. There's lots of data now on using a CO2 laser for lichen sclerosis. We're just initiating a radiofrequency study, and I think it's going to show similar results. We're going to penetrate to probably a millimeter, which is going to be deeper than what CO2 laser penetrates, because they only use stack one or stack two usually for the fractional CO2 lasers for lichen sclerosis. So I think that's going to be an entity. We all struggle with this because we really only have clobetazole. So there's definitely a role for an energy source here. So I think these are the current clinically applicable potential applications for this at the present time. Next slide. This is just our data on radiofrequency vaginal morpheus. It's in press in the Journal of Sexual Medicine. We had very good success at one year out with not only the treatment of the GSM symptoms, but also the treatment of the bladder dysfunction with significant improvements in the UDI6, significant improvements in FSFI. And again, you don't see the improvements in bladder function with the CO2 laser. You'll see the improvements in the GSM, but the outcomes here were excellent in both aspects. Of GSM, as well as the bladder dysfunction. Next slide. This is using traditional bipolar RF therapy with patient education and pelvic floor rehab in patients with mixed incontinence. Again, this is just using bulk heating, using biofeedback and pelvic floor physical therapy and patient education. Just educating a patient on how to appropriately use her muscles. And again, this is data that's in the Journal of Gynecologic Surgery. Again, a very, very reasonable thing to try in mixed incontinence patients. Next slide. This is that abstract that I just presented that we presented at the iUGA meeting this year. Next slide. And this is the abstract we just presented at August of last month or the month before. I'll quickly go through this because I think this is a very, very exciting area that could be available in the near future. This is a very simple procedure. It's done in an office setting. It's non-invasive. It just requires some numbing of the anterior vaginal wall. It takes about seven to 10 minutes to do. Next slide. And again, the mechanism of action here is that the microneedles are penetrating and ablating the autonomic nerves that are responsible for bladder contractility and bladder sensitivity. Three of our patients in this study had what would be considered painful bladder. They met criteria to be part of the study and all three of them had a significant improvement in their bladder pain as well because again, we feel that these are the same nerve plexuses. Again, we have an extensive cadaver study that's in press now in neurourology and neurodynamics that really describes this anatomy. It's really the first time anybody's described the neuroanatomy of the anterior vaginal wall as it relates to the undersurface of the trigone and the proximal urethra. As I said, these nerve plexuses are as close to three millimeters from the vaginal epithelium, most dense between five and eight millimeters inside the vaginal epithelium. So these microneedles are actually penetrating into the detrusor muscle underneath the trigone, into the proximal urethra. It's very, very safe. We didn't have one adverse event or one patient that had any issues with the treatment short of a little irritation for a day or two. Next slide. Again, I'll go through this quickly, but these were patients who had to meet certain criteria to be present. Next slide. Again, the treatment was all through the vagina, just numbing up the vagina. The treatment was what we call a burst mode. Every time you hit the foot pedal, the needles would burst to seven millimeters and then five millimeters and then three millimeters. We did it at 30 watts and we did it about 100 pulses, which took, as I said, about seven to 10 minutes. Next slide. These are our outcomes that we used. Next slide. And you can see here across the board, we had significant improvements in everything that we studied in these 32 patients. Next slide. With basically almost a complete, a complete cure of their urgency that you can see here. It was down to almost zero at three months. Now we've got six month data that we're submitting and we're in the process of completing our 12 month data. It seems to appear that between six and 12 months, the therapy does seem to wear off, very analogous to a Botox injection. Next slide. And again, these were our results up to three months that we just published and we're in the process of publishing our six month data. Next slide. So again, this is the first study to use RF energy through the vaginal canal. There are a few other studies that have used RF energy through the urethra and into the bladder, but this is much more invasive, much more ablative with lots more adverse events related to UTIs and potential injury to the bladder and the urethra. Next slide. Next slide. So again, we get back to these indications. As I said right now, I think currently available devices, the microneedling or even the bulk heating or CO2 laser, excellent for GSM. I'm really, I feel strongly that the two RCTs that showed that there was no difference between the laser and the sham, really didn't treat patients that appropriately needed this. These patients, most of them for this need to be sexually active and have symptoms. The other area that we see a lot of improvement is in the irritative bladder symptoms that I think many of us misdiagnose for overactive bladder. These are patients who have a lot of urgency and frequency that are postmenopausal, but it's not urgency-frequency like, I got to get to the toilet. It's urgency-frequency that's irritative. And these patients do very, very well with this. I think mild to moderate cases of stress incontinence, if these are patients who really have, you know, not gotten what they wanted from pelvic floor physical therapy, really don't want anything invasive, I think this can be offered to them. Overactive bladder, at 3 millimeters, you'll see some success, but hopefully there'll be a 7-millimeter probe available to you in the near future. I think this is a very reasonable thing to do in mixed incontinence patients. Again, if they don't want to stay on drugs and they're not interested in traditional stress incontinence procedures, it's a simple treatment, especially if it's in conjunction with GSM. Chronic cystitis in postmenopausal women and lichen sclerosis, I think both need formal data, but my perception is that these are areas that will be very successfully treated with radiofrequency energy. Next slide. I'm going to finish up with some things that we're doing aesthetically. This is a concept of utilizing an external RF device that has an internal probe that's underneath the skin, and you basically transfer heat between the two probes and it shrinks the tissue. This is technology that InMode developed for the face, it's called FaceTite, for the body called BodyTite, where you basically, again, bring these two probes together. And then they developed a smaller probe for around the eyes called Accutite. Well, a very astute gynecologist named Henry Ramirez took the Accutite probe and described basically a non-surgical labioplasty. And I'm going to show you, this is with his permission, I'm going to show you some of his pictures and the way that this concept works. Next slide. So again, you're bringing superficial skin, compressing it into the subdermal fat, creating some coagulation and shrinkage of the tissue. Next slide. And then after you do this procedure, you take their traditional Morpheus 8, which is their face Morpheus, and you microneedle the skin of the vulva, and it really creates a nice, you'll see a nice shiny tightening of the mons, the labia majora, and you'll get about a 20% reduction in the size of the labia minora. And again, all of this is done in an office setting, non-surgical, very little downtime. Next slide. This is the Morpheus 8 that you do at the completion of the procedure. Next slide. So this is the concept here. You penetrate, you have to use hydrodistension and anesthetic. This is tumescent, what plastic surgeons do. This is analogous to how we hydrodistend the vagina for our repairs. So you tumesce all of this area, and then go ahead and hit, this is a little video, Christine, that you should be able to play. Yeah, and you just basically move this in and out. Here the machine gives you three beeps when you reach temperature, and once you reach temperature you move on. So we would treat the entire mons here, and then we'd come down and treat the labia minora, the labia majora, and then I also treat around the perineum, and truly get some objective tightening of the genital hiatus with this. This is called Aviva. It's a procedure that's marketed within this Empower platform that has the vaginal Morpheus as well. Again, compliments of Henry, he's got some nice pictures that he's given me permission to show you, so I'm going to show you a series of before and after pictures and patients that have had this procedure. Next slide. So again, you can see here, there's tightening. To me, the big advantage is not so much the labia minora, but really the majora. A lot of patients will feel like their majora is sagging and wrinkled, as you can see here, and I think it's mutilating to do a labia majora labioplasty. There are people that do this, and I would not recommend it. So again, it's non-surgical. You can get a nice smoothening of the majora. Next slide. You can see again here, you get a good reduction in the minora, nice tightening. Next slide. More of the same. Next slide. And again, this takes maybe a half hour, 45 minutes. The tumescent is nothing to be concerned about. It's very, very easy to tumesce this area. They stay inflamed for a couple of weeks, but really the only restriction during that time is probably no intercourse. Patients go back to work within a day or two. We don't know the durability of this. Henry seems to think that one treatment is good for at least a year, but we don't really have much data beyond that. Next slide. Again, you can see the wrinkling effect nicely is addressed. Next slide. And I think that's the last one. Next slide. No. Next slide. Okay. So as we finish up here, I hope I've been able to provide you a little bit of insight regarding this. Next slide. So this is the technology adoption lifecycle that we talk about for a drug or a device. I think these concepts have been very, very gimmicky and appropriately so. There's more and more data coming out now, and this is the chasm that when a device or a drug crosses this chasm, it becomes mainstream. And I think that's happening here. I think there's more and more data that's going to support real therapeutic indications and more and more data coming out to actually promote how best to improve things cosmetically. With that, there'll be some sexual enhancement that occurs as well. I'm very optimistic and hopeful that these will be mainstream office procedures that we can offer to our patients in the near future. Next slide. So I appreciate your attention, and I'm happy to answer any questions if there are any. Thank you so much, Dr. Karam. I have a ton of questions. As your moderator, taking a bunch of notes that whole time. Thank you so much for all your innovation and research in this area and for pushing our field forward. I'm just going to rapid fire them at you. So for patients that come to you for GSM, let's say garden variety, don't have breast cancer history, how do you decide between this therapy and standard local vaginal hormones? What's your conversation like with the patient? So basically, most women are amendable to vaginal estrogen. So I use a lot of vaginal estrogen. I'm a firm believer. I like creams. I like to make sure that they can... I see patients that come in that say they've been on creams and it hasn't helped. It's because they're putting it in the distal vagina. It's just sitting in the distal vagina. I use dilators a lot. To successfully treat GSM, whether it's with estrogen or whether it's with a device, you have to appreciate that you've got a cycle that's developed. Patients develop dyspareunia and then they develop tight levators. There's a mental inhibition that they know it's going to be painful. So as we treat the skin, you have to also start to convince the muscle and the mind of that. Most of my energy sources, my laser and RF patients are referred in by, by far, my biggest referral source is medical oncologists that treat breast cancer. And then there's still a tremendous perception, albeit it's a false perception, that women have around estrogen based on the travesties of the WHI. So I really don't sell the energy sources. I say if you don't want to take estrogen or you haven't done well with estrogen, this is a therapy that works very well. Yeah. I appreciate your comment. And you were the one that actually taught me this a long time ago, which was a fingertip application to the distal vagina with estrogen. I think that's, again, patients that use the applicator only, their upper vagina looks beautiful, but the lower vagina is the part that's really causing the irritation. Thank you for that. We've got a bunch of activity in the chat. So one participant said that they've been doing this for two and a half years. I'll give you a minute. Yeah. And has noticed granulation tissue in a couple of patients. Have you noticed that or is that something that you've seen? Doing a RF device or a laser device? It wasn't clear. No, I've never seen anything like that. Never seen any granulation tissue. I think it was called a MV8 or M8V, I'm sorry, M8V, Morpheus 8. Okay. A vaginal Morpheus. Yeah. Yeah. So that's what I just showed. Again, I've never seen any granulation tissue from that. Okay. Sounds good. Another question I have just again about, like you eloquently discussed how vaginal estrogen changes the pH of the vagina and the microbiome, and also laser, a vaginal canal laser can do the same thing. Do you think, what do you think the crossover is, if any, of treating OIB just by changing the microbiome and the pH of the vagina versus a nerve ablation? Do you think there's an overlap or do you think it's purely- Yeah, I don't think that that's going to really impact. I think to impact OIB, you really have to get in the vicinity of those autonomic nerves. You mentioned, so let's say a patient is really happy with their therapy, the vaginal canal radiofrequency for OIB and GSM, and they want to keep coming back. You mentioned about every six to 12 months would be kind of the repeat, is that three treatments again? No. So for the OIB and the IDE that we're hoping to get, that's just one treatment, analogous again to how you'd look at a Botox injection. Our pilot study, we had good success up through six months, and then at six months we started to see a deterioration and we'd expect it to wear off. So that's just one treatment. Now, GSM and the way we've treated stress incontinence in the past is a series of three treatments and those treatments for GSM are about four to six weeks apart. I've got good long-term data now, especially with the CO2 laser, that you'll get durability for about a year. Some women get it even for longer than that. And in perpetuity, you can just do one treatment a year moving forward from that. I don't have long-term data on RF yet, but I would assume it would be similar. I would love it, but I know it's hard to get IDEs on multiple indications, but the IC patient, like you mentioned in the study, that two of them kind of were IC patients potentially and they got improvement from them, I think it was the Morpheus RF for deflation. So do you think there's another indication pathway for IC? Absolutely. In fact, we're just starting a pilot study on that. Nice, because I think those patients also, just like the lichen sclerosis patients, haven't had a lot of headway in a while. So that would be... Yeah, no, you're absolutely right. And I think that there's definitely a high potential there. Perfect. Another bit in the chat here. So again, back to the Morpheus 8V, wanted to know your experience with that product and lichen sclerosis and recurrent UTIs. So again, I don't have any data. I have not used it for lichen sclerosis yet. I'm told by some of the other consultants that work for NMODE that they use it, but I'm not aware of any, and there's no published data. Now there's probably a half a dozen CO2 laser studies now that have shown that you'll get some improvement. We actually have one study that we did here at Christ Hospital using the CO2 laser. Nice. Can you describe a little bit, because I loved the Aviva pictures before and after, but I didn't quite understand how the labia minora were treated. Can you just describe that a little bit? Yeah, you have to aggressively temes, so you inject it and it basically expands the minora. And it's the same thing. You pass the internal probe into the... You basically do three passes. You go to the lateral side of the labia minora, pass it a couple of times, and then the tip of the labia minora, pass it a couple of times, and then the medial side of the labia minora. But you have to really hydrodistend the area to allow the space to get in. And the same thing with the periclitoral skin, if you've got a lot of periclitoral skin. That'd be a really great video. I know how much you like videos. Yeah, no, no. We've got a lot. I just wasn't technically savvy enough to show it here. That's okay. So, I guess I'm just... Any concern with injury to the clitoris during these procedures? I'm very conservative. You mean during like the Aviva? Aviva, yeah. Yeah. No, I mean, as long as you stay away from the actual clitoris, there's no issues with the periclitoral skin and it's very safe. Okay. Amazing. Well, I don't see any more activity in the chat. Is there anything else you would like to add before I give my final concluding remarks? No, I think I'm good. Thanks for inviting me to do this. Well, amazing. Thank you for your time. It's really appreciated. So, on behalf of AUGS, I'd like to thank Dr. Karam for this excellent webinar. Be sure to register for upcoming webinars on January 22nd. Join Dr. Allison Wyman as she presents a webinar titled, Become the CEO of Your Life, How to Build an Independent Private Practice. Follow AUGS on Twitter and Instagram and check our website for information on all upcoming webinars. Thank you again for a great evening and lots of activity in the chat. Thanking you, Dr. Karam. And with that, happy holidays to everyone. Thank you. Thanks. Bye.

Urogynecology

Radiofrequency

Vaginal canal

Therapeutic applications

Aesthetic applications

GSM treatment

Overactive bladder

Pelvic surgery

Patient education