When Warren B. Seiler III, MD, founder of Seiler Skin and the Seiler Skin Aesthetic Institute in Birmingham, Ala., first incorporated platelet-rich plasma (PRP) procedures into his cosmetic laser and injection practice, he thought he’d have no interest in adding sexual health treatments. He has since changed his tune and is glad that he did.
“Aesthetic physicians from all specialties shouldn’t be intimidated by sexual health procedures. Many sexual health options are legitimate and patient demand is high,” said Dr. Seiler, who presented on integrating the O-Shot (Orgasm Shot) and P-Shot (Priapus Shot) into aesthetic practices during the Sexual Health in Aesthetics pre-show course at The Aesthetic Show in Las Vegas (July 11-14, 2019).
Not only that, but sexual health is a relatively untapped and misunderstood market among aesthetic physicians, added Carolyn DeLucia, MD, FACOG, of VSPOT Medi Spa in New York, N.Y.
“Sexual health is still so minimally discussed,” Dr. DeLucia continued. “Physicians think because of the tools we’re using, like lasers and radiofrequency (RF), that it is only for aesthetic reasons. They don’t realize we are trying to make things function better – not just look better.”
According to Dr. DeLucia, who trains and consults with practices on adding turn-key sexual health services, aesthetic physicians are the ideal sexual health providers because they’re already comfortable with the technology – from energy-based devices to PRP. However, they are not as comfortable with the anatomy.
Conversely, gynecologists, who also are adding sexual health services to their practices, tend to be afraid of the technology, but are comfortable with the anatomy, she said.
While there is a learning curve to adding sexual health to an aesthetic practice, it is not an all-or-nothing proposition, Dr. Seiler expressed. Providers might offer some services that they feel comfortable offering and
collaborate with specialists on other sexual health treatments.
For example, Dr. Seiler limits his sexual health practice to the O-Shot for women and the P-Shot for men – both PRP options invented by Vampire Facelift inventor Charles Runels, MD. Literature suggests PRP can help healthier tissue function even better. So, Dr. Seiler took the course with Dr. Runels and slowly incorporated these procedures into his practice. Now, patients are actively seeking him out for these treatments and he is a trainer for Dr. Runels’ Vampire procedures including the O-Shot and P-Shot.
However, Dr. Seiler said he isn’t a one-stop-shop for sexual health and doesn’t intend to be. Rather, he focuses on specific candidates that he feels strongly will benefit from the PRP options. He collaborates with a gynecologist and urologist in town for patients’ hormonal and other workups before administering PRP. And, if he doesn’t think a patient will benefit from the O-Shot or P-Shot only, he’ll refer them to his gynecologist or urologist colleagues as they offer some of the device-based treatments that can provide adjunctive help to the results from PRP. “Practitioners really need to know when they should and should not treat somebody,” he advised.
The spectrum of options for women
Dr. DeLucia, author of a new consumer- focused book on female sexual health called Ultimate Intimacy, says the top three sexual issues on women’s minds are: lack of orgasm, urinary incontinence and vaginal looseness.
While aesthetic providers are probably familiar by now with the EMSCULPT from BTL – the first device to non-invasively strengthen muscle and sculpt the body using patented high-intensity focused electromagnetic (HIFEM) energy – now, there is EMSELLA, a device known as the “kegel throne.” EMSELLA uses HIFEM to non-invasively promote bladder control and reduce urinary incontinence, according to Dr. DeLucia, who presented on the impact of EMSELLA on women’s sexual health during The Aesthetic Show.
The HIFEM technology addresses the unfortunate changes in a woman’s body after childbirth, including vaginal laxity or the feeling of looseness. As a result of these changes, many women experience a loss of friction during intimacy and less satisfaction with intercourse. Having children also weakens muscles on the outside of the pelvic floor.
“We have abdominal muscles that get stretched, and over stretched in some women, resulting in diastasis rectus, which is when the muscles stay separated in the abdomen,” Dr. DeLucia explained. “The interesting thing is that there is a direct correlation to weak- ness of the pelvic floor muscles and weakness of the abdominal muscles, which then leads to urinary incontinence among women."
Starting with EMSCULPT treatments on the abdomen as early as six weeks postpartum reduces diastasis rectus, Dr. DeLucia reported. “The literature in women with longstanding diastasis rectus who were in the EMSCULPT trials noticed a 12% decrease in the diastasis rectus. The significance here is that prior to EMSCULPT, we had nothing to improve this indication without surgery,” she said.
The EMSELLA is a device on which women or men simply sit. It allows the entire pelvic floor to contract 11,200 times in 28 minutes. “It rebuilds pelvic floor muscles to help urinary inconti- nence,” Dr. DeLucia explained.
“I’m doing a study with several sites across the nation, and we are evaluating the effects on sexual response because stronger muscles should naturally lead to an intensification sexually. Early results indicate EMSELLA intensifies the orgasm with better muscular tone and increased blood supply to the area.”
However, Dr. DeLucia’s favorite treatment for orgasmic issues is the O-Shot.
According to Las Vegas-based cosmetic surgeon, Edward Zimmerman, MD, among the benefits of the O-Shot, are that it is nonsurgical, drug-free, relatively fast and painless, can offer almost instantaneous results and has been shown to help urinary incontinence, increase sensitivity, desire and lubrication, and rejuvenate vaginal skin and tissue.
Lasers are another option in the toolbox of sexual health treatments for women.
Allan Y. Wu, MD, FACOG, FACS, FAACS, of the Revive Wellness Center in Torrance and Palm Springs, Calif., presented on preliminary study results from intravaginal therapy with the Er:YAG- based Juliet, from Cutera (Brisbane, Calif.). “The Er:YAG laser is a very well- known laser to soft tissues, like mucosa. It has been used by dental and oral surgeons for some time, and in Europe it has been used intravaginally, without any major incidents or complications,” he said. “Compared to other lasers, this laser seems to be more well-suited for moist mucosal type tissue.”
“Energy can be delivered intravaginally, via laser energy in the form of Er:YAG, fractionated CO2 or fractionated Er:YAG, or via RF energy. It appears that both modalities seem to be efficacious and helpful to patients who are experiencing atrophy and dryness. The question is which technology will have the greatest effect on stress incontinence or minor pelvic support issues. We don’t yet know which will turn out to be the best modality,” Dr. Wu said.
The main advantage of the Juliet is its dual use, Dr. Wu shared. “You can use it not only intravaginally with a probe, but you also can use different adaptors for the skin. The device has been used successfully in our practice for dermal resurfacing and rejuvenation in addition to intravaginal use,” he said.
According to Dr. Wu, Juliet is FDA cleared for “coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery, ENT, gynecology, general surgery, podiatry and ophthalmology (skin around the eyes), but we know that it is efficacious and safe to use for intravaginal treatment because of the fact that it has been used extensively in Europe. We just have to carry over, corroborate and confirm that it is safe in the U.S. And indeed, that is what we are starting to see with the preliminary data that’s coming out,” he said.
In the U.S., Dr. Wu and colleagues are seeing positive effects from Juliet treat- ment to address vulvovaginal atrophy, menopausal symptoms, mild forms of incontinence and dyspareunia. But, just how the Juliet might compare to other sexual health options for women is not yet clear.
Today’s devices treat vaginal laxity in different ways, according to Dr. DeLucia who prefers using EMSELLA or BTL’s Ultra Femme 360 RF device for that indication. However, Dr. DeLucia is hesitant to use laser devices to treat vaginal issues for the long-term.
“We don’t have long-term studies on lasers so I don’t think I’d want to treat someone’s vagina with lasers for 30 years,” she said. “I saw a woman recently who had laxity. In a patient like that I would use RF. It goes a little deeper and doesn’t cause injury to the actual vaginal tissue so there is no downtime. And Ultra Femme 360 requires the least amount of time in the vagina. There are several RF treatments on the market and they all work, but this one is only eight minutes versus others being a minimum 20 to 25 minutes.”
RF choices include monopolar devices, which deliver energy more deeply, and bipolar devices, which deliver energy more superficially.
“The depth of heating depends upon size and type of the electrode used,” noted Dr. Zimmerman.
Among novel, non-ablative CO2 based laser treatments for female wellness, the V-Lase from Lasering USA (San Ramon, Calif.) delivers gentle heat via a proprietary safe and painless method that stimulates new collagen and blood vessel formation in a short 15-minute procedure. Furthermore, there is no downtime, pain, risk of adverse events or consumables. According to users, patients love it because there is no downtime, no bleeding or any discharge. There is no pain and they can go back to their activities right away.
According to Dr. Wu, there remain unanswered questions about how to optimally deliver energy, including RF energy, to vaginal tissue. “Researchers are trying to determine not just what kind of energy is best, but also how much energy is needed and how deeply it needs to be delivered to affect moisturization, tightening of mild pelvic floor prolapse or incontinence-related issues.
“This is still going to continue for prob- ably the next five years. Not all of the devices that are currently on the market are equivalent in terms of their penetration and depth. But, my impression is that we’re probably going to find that we don’t have to go to every single deep layer to give patients a positive benefit,” Dr. Wu theorized. “It may be that just treating superficial areas to affect moisturization and to allow cells to come into the area without hormones could be enough to normalize the anatomy in some of these patients.”
InMode (Lake Forest, Calif., and Richmond Hill, Ontario, Canada), has launched Aviva, a minimally invasive vulva procedure that restores the func- tion and appearance of the vulva by offering a non-excisional alternative to labiaplasty for patients who are not interested in more extensive surgical options. The Aviva is powered by AccuTite and delivers safe and uniform heat to the entire soft tissue matrix of the labia minora, labia majora, clitoral hood, vaginal introitus and perineal body. This innovative procedure can be done under local anesthesia, in an office setting, in less than 20 minutes.
Sherry Thomas, MD, MPH, FACOG, a urogynecologist and surgeon specializing in female pelvic health in Agoura Hills, Calif., believes energy applied on the female pelvic floor is the new frontier for women. Energy-based devices basically do the same thing to tissue on the pelvic floor as on the face. “They increase collagen and elastin, which improves tissue quality, elasticity and thickness,” she expressed.
Nevertheless, physicians treating these patients need to be mindful of under- standing what they’re trying to treat, Dr. Thomas advised.
“We have several things going on in the female pelvic floor other than just laxity and appearance. We have sexual function, urinary and fecal incontinence and we have relaxation with prolapse, which are all very significant medical problems for women,” Dr. Thomas said. “Currently all lasers and RF devices are off label for treating these symptoms.”
Providers who offer off-label sexual health treatments need to obtain patient consent and let patients know that the treatments are off label, as well as provide patients with current FDA recommendations for treating patients’ issues.
“We also need to move forward in collecting data with each device, so we can show what works and what doesn’t and at what energy levels,” Dr. Thomas said.
A concern in the field of sexual health has been that using different energy modalities encourages fibroblast proliferation, according to Dr. Wu. “Some think these devices are not appropriate for the vaginal area, but that concern is unfounded,” he pointed out.
“Any procedure that involves any sort of cutting or energy modality will result in fibroblast proliferation and fibroblast involvement, but that does not mean that these devices automatically cause people to have horrible scars or abnormal sexual function. That’s not what we’re seeing,” Dr. Wu said.
Moreover, bundling of treatments is a popular option. For example, clinicians can bundle the EMSELLA with RF, laser or PRP treatments, according to Dr. Zimmerman, who actually presented on bundled technologies for sexual rejuvenation at The Aesthetic Show.
Another option for women is a physician-prescribed device using red light photobiomodulation therapy. Patients administer the therapy at home. According to a study published in Photobiomodulation, Photomedicine, and Laser Surgery1, photobiomodulation therapy is safe and effective for
treating vaginal tissue for genitourinary syndrome of menopause and stress urinary incontinence.
Researchers used the vSculpt device from Joylux, which is available in the U.K. and Canada. vFit PLUS is the U.S. professional only product and is available nationwide.
Study author Sarah de la Torre, MD, FACOG, NAMS, said she would recommend this technology for women with declining estrogen levels, sexual dissatisfaction and/or urinary incontinence.
“I would recommend women use vFit before opting for any in-office procedures. In an independent study, 95% of women reported improved vaginal wellness after 60 days of use. Many of my patients are so pleased with the result that they find vFit is all they need,” Dr. de la Torre reported.
“I recommend vFit because it allows my patients to improve sexual wellness, from the comfort of home, at a fraction of the cost of other solutions,” she continued. “It is life-changing. An at-home solution like vFit can help improve sexual function, sensation, pleasure, intimacy and confidence at any age.”
What about men?
“At least 20 million men in the U.S. are complaining of erectile dysfunction and more than 87% of men feel their penises are not what they want them to be,” said Paul E. Perito, MD, a urologist in Coral Gables, Fla., who opened a boutique men’s health practice focused on erectile dysfunction nearly 20 years ago, and is now the highest volume penile implanter in the world.
“Even though these men fall into that steep bell curve where they’re perfectly normal (regarding penis size), they’re looking for something to make it bigger with better function. These men are described in the literature as having penile anxiety disorder,” Dr. Perito explained.
Penile implants can help. Dr. Perito developed a minimally invasive penile implant technique called the Perito Implant – a surgery that takes less than 15 minutes and can be performed under any type of anesthesia, with most men fully recovering in three to six weeks.
However, there is also a spectrum of new nonsurgical options, like PRP or medications, as well as investigational devices, that can help men from a functional standpoint. Many of these therapies can be offered in an aesthetic practice but require proper training, Dr. Perito indicated.
“In the last year, across the globe there have been some bad outcomes where people are trying to increase girth using free fat transfer. When I teach
physicians, I tell them that in the right hands you might have a good outcome using free fat transfer, but you can have a catastrophic outcome in the wrong hands,” he warned.
“Free fat transfer also has a relatively high morbidity rate,” Dr. Perito added. “I’ve been working on a treatment option using hyaluronic acid to increase the girth of the penis. We patented a technique that capitalized on mistakes made in the past by urologists trying to use hyaluronic acid. There will be something available on-label perhaps within the next year. This is the only thing that I’d say would be absolutely safe for girth enhancement.”
When it comes to penis length, Dr. Perito noted that some of the older strategies utilized by plastic surgeons are coming back in vogue, including using liposuction or surgical resection at the level of the mons penis. He also feels CoolSculpting (Allergan) for the fat pad above the penis is an area of research surgeons should be investigating.
“These length-gaining methods in the penis are safe and have been described in the literature,” he said.
Dr. Seiler said he has been very successful with the P-Shot in men as a stand- alone treatment for erectile dysfunction.
In Dr. Zimmerman’s experience, the benefits of the P-Shot combined with pumping address many symptoms of erectile dysfunction without surgery or drugs, including girth, length, sensitivity, desire and firmness of erections in patients who are hormonally optimized.
The P-Shot has been shown to improve Peyronie’s disease and studies have shown that it is beneficial to add the penile pump for rehabilitation of Peyronie’s disease and for patients recovering from prostate cancer, he said.
Radial Shockwave Therapy is also proving effective for male sexual well- ness. A recent review article in the Journal of Cosmetic Dermatology concluded that, “Studies and clinical experience suggest that male erectile rejuvenation using low-intensity radial shockwave therapy seems an attractive option. The treatment can be safely, and effectively, delivered by trained staff as part of the total package that is available to men in dermatology and/or medical aesthetic practices.”
Along these lines, a growing number of physicians are successfully using Z Wave from Zimmer MedizinSystems for the treatment of male sexual wellness. While, this device is not FDA cleared for any urological procedures, and this application is considered an off-label use for Z Wave, the device is cleared to increase local blood flow and for the treatment of minor aches and pains.
So, what’s next?
There are great options in the pipe- line for sexual health, according to Dr. Thomas. Among those, autologous skeletal muscle stem cells.
“There are a couple of studies now from Cook Medical on ClinicalTrials.gov, that will probably be available in three to five years from now for stress incontinence. Treatment would work by taking a biopsy from a patient’s thigh, for example, then sending it to Cook Medical, where they’d grow it to 150 million cells. I think this is going to be the future of treating stress urinary incontinence,” she stated.
According to Dr. DeLucia, who is on the medical advisory board for Oranicell, a company she said is on the cutting edge of exosome technology, aesthetic physicians should follow news on the use of exosomes in sexual health.
“The use of exosomes is a whole new realm of treatment that can be isolated from the patient. It could be autologous or derived from discarded portions of the child delivery – basically, amniotic fluid,” Dr. DeLucia continued.
“Exosomes are vesicles that come off of our stem cells and stimulate protein to be created. It is another way to stimulate stem cells without using stem cells,” she shared. “They are going to boost PRP treatments, like the O-Shot, and treatment of vaginal wall lubrication, tone and health.”
References:
1. Lanzafame, R. J., de la Torre, S., Leibaschoff, G. H. (2019, Jul 1). The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes. Retrieved from https://doi. org/10.1089/photob.2019.4618
