A Better Feminine Life. Studien und White Paper

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1 A Better Feminine Life Studien und White Paper

2 June 2016 FRACTIONAL/PIXEL CO2 LASER THERAPY (FEMILIFT) FOR GENITOURINARY SYNDROME OF MENOPAUSE (GSM): ROUND TABLE DISCUSSION A roundtable discussion, held in Rome on April 19, 2016 and sponsored by the European Society of Aesthetic Gynecology (ESAG), aimed to collect information from gynecologists and urogynecologists around the globe, who bring years of experience in treating thousands of women for genitourinary syndrome of menopause (GSM)-related symptoms. All participants have been using the FemiLift Pixel/Fractionated CO2 laser for several months/years. Yona Tadir M.D. Professor, Obstetrics and Gynecology Beckman Laser Institute and Medical Clinic, University of California, Irvine, USA Introduction Prof. Tadir: Having 40 years of experience with laser in gynecology, and in developing tools and treatment protocols for minimally invasive surgery, I have to admit that my initial reaction to publications on vaginal rejuvenation was somewhat skeptical. The results looked "too good to be true. However, the unprecedented wave of publications, originating from different countries, presenting coinciding results, is convincing. We face a significant breakthrough in women s health. Prospective research protocols ( gov/) indicate that the medical community is taking this new era seriously. In order to collect valuable data, reach reasonable conclusions, and guide future research, we gathered this panel of experts here in Rome, just before the ESAG meeting. Before we start our discussion, I take the liberty to quote Abraham Lincoln who said: You can fool all the people some of the time, and some of the people all the time, but you cannot fool all the people all the time. Tadir: Given that this group of experts already performed thousands of Vaginal Rejuvenation (VR) procedures with the Pixel/fractional CO2 laser (FemiLift), let s discuss the bottom lines. What is your overall impression? What are the main indications for which you find benefits from the FemiLift procedures? Please relate to the learning curve of the device. What level of surgical expertise is needed in order to conduct a safe procedure? 1 ALMA SURGICAL FemiLift

3 Dr. Bader: During the last 4 years, I treated 987 patients in three different clinics, in London, Athens and Dubai. The main indication for which I use the FemiLift is vaginal relaxation and the second most common indication is stress urinary incontinence (SUI). I see some differences in patient preference, namely, patient priorities differ from one culture to another. For example, in the U.K., it is easier to discuss SUI as compared to Greece. In contrast, sexual quality enhancement is more important to the Middle East as compared to everywhere else I practice, as the local culture and habits allow men to marry more than one wife, motivating women to conserve or even enhance their bodies, including the intimate area. The procedure is very simple, both to perform and to teach. No prior surgical skills are needed and once the doctor, be it a gynecologist or dermatologist, performs 3-5 cases, he/she has mastered the procedure. Interestingly and surprisingly, sometimes I find it more difficult to get the gynecologist to adopt the procedure. I am not sure why. But it is a matter of time until it will be widely adapted. Dr. Martinec: I have a busy clinic in Slovenia. Between Sept and Jan. 2014, I performed 332 procedures with the Er:YAG, mainly for SUI and vaginal laxity (VL). In the last 27 months, 388 procedures performed with the FemiLift for these two indications. From the practical and protocol point of view, the procedures are similar. Based on patient feedback I personally prefer the CO2 laser, but this opinion is not based on scientific evaluation. The procedure is very simple and the system is userfriendly. The main indication in which I see benefit for the patients is in treating mild to moderate SUI and in improvement on vaginal laxity and dryness, as well. So far, I treated 388 patients with FemiLift, and analyzed data of 94 patients with follow-up of up to 9 months will be presented tomorrow at the ESAG conference. To give you some highlights of the data analyzed so far: the peak age group was years-old, and 44% of the total number of patients were post-menopausal. The main patient complaints prior to the procedure were leaking urine following coughing, sneezing and physical activity. The most significant improvement was on SUI symptoms after coughing & sneezing. 28% or the treated patients did not have SUI and 47% of the patients experienced an episode of urinary leakage once a week. Regarding VL: among the 94 patients, 52 reported VL pre-treatment. In this group, 16 reported no VL following the treatment. Similar data was reported on the improved vaginal dryness. When I collected the complications and patient complaints of the entire group of 388 treated patients, about 45% had vaginal discharge for 3-7 days after the first treatment session, 80% of them in the first 3 days. Five patients reported uncontrolled urination for hours, two patients reported elevated body temperature for one day, and one patient had mild vaginal adhesions, which I gently treated with hyaluronic acid and confirmed good outcome on follow-up. Just for your information, the oldest patient treated was 92 presenting SUI. This lady was happy with the outcome, mainly because SUI symptoms improved significantly, she felt stronger pelvic support which helped in walking and improved her quality of life. However, because this is not a usual case she was excluded from the data analysis. Prof. Scollo, Dr. Scibilia: From a technical point of view, the laser procedures are very simple and just a low level prior expertise is required. However, the mechanism of tissue remodeling is not clearly understood and requires more basic research in order to develop optimal treatment protocols. Clinically, this treatment concept opens a wide range of potential applications in treating GSM 2 ALMA SURGICAL FemiLift

4 symptoms, including SUI. We evaluated the potential advantage of FemiLift in menopausal cancer patients and currently, based on the Pixel/Fractional CO2 laser concept, we use a dedicated delivery system to treat Lichen Sclerosus (LS) on the vulva. Prof. Femopase: Our reported outcome of 131 patients who met the inclusion criteria for the SUI FemiLift study, ages 35-60, assessed with ICIQ-SF (Short Form of the International Consultation on Incontinence Questionnaire): 82% of the patients reported a significant decrease in the frequency of SUI-related events, and all patients noted improvement in their quality of life as related to their urinary problems. It is an ambulatory, fast painless and easy procedure. Dr. Elias: I agree with the panel experts in all their comments. The FemiLift procedure is easy, and user-friendly, but for the treatment of urinary incontinence, be it SUI, or any other form of urinary leakage, a urogynecologic background is important in order to select the optimal patients for this technique, and select the proper laser protocol to optimize the outcome. I used the Pixel/Fractional CO2 laser for other indications, with good results. These include: dyspareunia caused by vulvar and vaginal atrophy, vaginal tightening in young women, and post-partum dyspareunia. Prof. Tadir: In summing-up all comments it is obvious that SUI is mentioned, however, data published in peerreview journals is minimal. Let s focus on this indication. Dr. Martinec detailed her impressive results with patients who report improved control of urination, and Dr. Elias report on SUI is in-submission for publication. Let me add another piece of information which is not scientific, but interesting. In a recent meeting, two ladies, gynecologists from Dubai, who treated over 1000 women with fractional CO2 laser for vaginal tightening reported that even though urinary incontinence was not the primary indication, many women reported improved control of urination following the procedure.. Prof. Scollo, Dr. Scibilia: For all our SUI patients, we use a stress test, with 300 ml of bladder filling, and a standard questionnaire. A urodynamic test for all patients might be the best way to evaluate the preferred patient selection and the outcome, but this is not practical as a routine test. Currently, for publication purposes, we evaluate the outcome in patients who did have a complete urodynamic evaluation. This will enable us to generate guidelines for patient selection and to predict the duration of the outcome. In our practice, we focus on cancer patients. We noted an improved control of urination in cancer-related menopausal symptoms. This is probably related to their younger average age, and shorter menopausal time as compared to physiologic menopause. Since these patients can t use hormonal alternatives, they are grateful for this alternative and for the improvement in their quality of life. We also closely monitor the duration of effect, to avoid s rebound effect and to decide when to perform a maintenance treatment. Dr. Bader: For the SUI patients, I focus on the upper part of the vaginal wall and perform three laser exposures at OC, under the mid-urethra, and up to 1 cm above and below the upper and lower level, to mimic the concept of the urethral sling. The longest period of follow-up I have done is 3 years post-treatment. An impressive case of cure of type IIa - SUI achieved just after the 2nd session, and maintained for 3 years. This was published as a case report in Hellenic Journal of Obstetrics and Gynecology (HJOG/2015). Dr. Elias: As a trained urogynecologist, I am used to the Blaivas classification. I have found that best results are achieved with no, or minimal prolapse (Blaivas I or IIa). Assessment of pelvic floor damage 3 ALMA SURGICAL FemiLift

5 according to De Lancey, is important for my decision, and I did find the Q-Tip test, as an indication for urethral hypermobility, a good outcome predictor for the FemiLift procedure. Patients with pathological Q-Tip test (over 45o) might have hypermobility and damage to the urethral support. I Follow the concept that patients with urinary incontinence who most benefit from the FemiLift CO2 laser are those without severe damage to the pelvic floor. I treat the entire vaginal wall in all patients, but in the SUI patients, I add an anterior wall protocol, which is an overlapping treatment at OC on the mid anterior urethra. Patients are treated three times, at 4-week intervals, with a follow-up session at 6 months and a touch-up treatment, if needed. It is my impression that patients with hypo-estrogen-related urinary symptoms are cured, or at least experience temporary improvement. Dr. Martinec: My treatment protocol is the same for GSM, with or without urinary incontinence. Some of my GSM patients who did not have urinary problems, reported reduced nocturia following the FemiLift procedure. My standard protocol includes two treatment sessions, 4 weeks apart, and if needed, a 3rd session after six months. The longest post-femilift follow-up in my clinic is 27 months. About 60% of my patients maintain positive results after the 2nd session, and I usually recommend an additional treatment once every 2-3 years. Prof. Scollo - Dr. Scibilia: For vaginal atrophy as part of GSM, the entire vaginal wall is treated. If SUI is the main symptom, only the anterior wall is treated. We always use the Vaginal Health Index Score (VHI-S), assess infections, and in some cases, measure vaginal ph changes. Our longest follow-up is 12 months and the outcome will be reported in the near future. Our protocol includes 3 treatment sessions, at 4-week intervals. At this point, we do not offer a late touch-up session. Prof. Tadir: It is known that several prospective SUI studies are in progress. Once completed, we may learn some new lessons about the physiology of urination. The fractional laser technology may become an important tool in the armamentarium of minimally invasive solutions, in the same way that TVT revolutionized this field in the nineties. Let s move ahead to your experience utilizing the Fractional/Pixel CO2 laser technology on the vulva. Dr. Bader: I use the laser for all external genitalia procedures. The hand probe is used for skin whitening and the focal laser hand piece for cutting and removing the excess tissues, either in labia minora, majora or clitoral hood skin. Lately, I introduced the de-focused hand piece FemiTight for labia majora tightening, and for perineal relaxation correction. Results are good. Dr. Elias: For bleaching and/or tightening of the labia majora, I use the 9X9 dermal probe at high, 5 Hz. 30/60mJ per pixel. I use the 9X9 dermal probe at high, 1-2 Hz, 30/60 mj per pixel, according to pain tolerance, and apply topical anesthetics. For the treatment of introitus atrophy, the FemiLift is turned on Low-10/20mJ 1.5Hz repeat mode and a topical anesthetic is applied. The new de-focused hand piece offers a good option as well. Regarding Lichen Sclerosus (LS), my initial experience with the Pixel technology is very promising. Two postmenopausal patients, resistant to conventional treatment with topical steroids, became asymptomatic shortly after three pixel CO2 laser treatment sessions. Healthy tissue was maintained throughout the 6-month post-treatment period. Histological assessments showed a trophic epithelium with acantotic areas, and without superficial hyperkeratosis. Documentation of these cases has been submitted for publication. 4 ALMA SURGICAL FemiLift

6 Prof. Scollo / Dr. Scibilia: We started using this technology for pathological lesions such as LS, with promising results. Follow-up, which includes clinical findings and histology, is in progress. Rarely, patients reported having local recto-vaginal pain following treatment. Prof. Tadir: Several prospective studies on Lichen Sclerosus are in progress. Based on histologic evaluation, preliminary data indicate tissue healing. Once confirmed, this technology may offer, for the first time, a curative effect, unlike the known symptomatic effect with topical corticosteroids or estrogens. Dr. Martinec: You have the longest experience in this panel with Er:YAG and CO2 laser, and we are looking forward to your presentation at the World Congress tomorrow on The G-Spot issue. Did you get any comments from patients regarding their post-treatment G-Spot orgasm, or questions regarding post-treatment vaginal delivery? Dr. Martinec: Some patients reported better feeling around the clitoris and improved sexual performance. I did not get any complaint, but once I review the literature for my G-Spot presentation, I will add more specific questions for future follow-up. It is my impression that improved vaginal elasticity and tissue relaxation post-treatment, will ease tolerance of pressures during future pregnancies. Prof. Femopase: Proper education, and basic understanding of sexology are the most important tools when we approach the public, and medical professionals who are involved in this sensitive area. This means, disseminating basic knowledge of anatomy and physiology of external genitals, and giving deeper knowledge of universal rights on sexual health. I am convinced that the FemiLift procedures, with its unique tissue effects, above and beyond simple aesthetics practice, might play and important role in sexological intervention. Prof. Tadir: Do you have any recommendations regarding a dedicated informed consent for such fractional laser procedures? Dr. Bader: I routinely use the Pre-FemiLift dedicated disclosure and informed consent. These documents, prepared by Alma Laser, are available for the panel s review. Prof. Tadir: What is the panel s protocol for local anesthetics? Prof. Scollo / Dr. Scibilia: We use lidocaine/ prilocaine (EMLA cream) for treating the distal vagina and vulva. Dr. Elias: I use topical anesthetic cream (5% lidocaine + 7% tetracaine) applied topically on the vulva and introitus, about one hour before the procedure, and local cooling (ice or cryo-zimer device) as I start the procedure. Following treatment, patients are instructed to use anesthetic cream on the external areas, three times a day, for one week. Dr. Martinec: According to my protocol, 23% lidocaine, and 7% tetracaine is applied topically around the introitus area. Prof. Tadir: What is the panel s experience with the need for the FemiLift Slim, the small size probe? Dr. Martinec: It is my estimation that the slim probe is needed in about 5% of patients: mainly post-radiotherapy, or many years post-menopause.. Dr. Elias: It is a very useful device, and I use it in about 30% of my post-menopausal patients. In elderly patients, the standard probe might not be suitable. The disposable cover of the FemiLift probe is ideal to prevent infection and contamination. I recommend performing the procedure with a 5 ALMA SURGICAL FemiLift

7 headphone, to keep the patient relaxed. With no pain, relaxation eases the procedure. Prof. Scollo / Dr. Scibilia: Same experience. We treat many menopausal and oncologic patients and use the slim device in 30% of our procedures. Prof. Tadir: How often you see vaginal discharge post FemiLift procedure? Dr. Bader: Almost all patients are reporting white transparent or pinkish discharge for few days after the treatment. I consider it normal reaction of the tissues to laser energy. Patients advised to ignore unless they have dark yellow or greenish discharge with the typical fishy smell. If Candida infection is diagnosed, this is treat with Fluconazole and FemiLift is delayed. Dr. Martinec: Bloody or white vaginal discharge is seen in about 50% of patients and last for 3-7 days, and treated with hyaluronic acid. Prof. Tadir: Do you have any comment about the way these procedures are marketed? Dr. Bader: Having experience in three different countries, performing FemiLift in London, Athens & Dubai, I do advertise this treatment according to the local mentality, and take into consideration the cultural differences. For example, in Dubai, the concept is more advertisement for vaginal tightening and less for SUI. It happens because some local cultural characteristics. In the Greek society, it is easier to discuss SUI treatment rather than discussing improved sexual life. The UK society is mixed and universal, so marketing is broad. Prof. Scollo / Dr. Scibilia: The doctor s role is just to be honest, to avoid over-expectations while using proper patient selection. Dr. Martinec: My preferred marketing is patient education about SUI and vaginal laxity. I started a new educational program about post-delivery vaginal rehab. Prof. Tadir: Dr. Bader and Dr. Martinec: with your extensive experience, longest follow-up, and educational experience, would you like to make some concluding remarks? Dr. Bader: I have tried the diode 980nm & 1470nm lasers, as well as the Er:YAG. The Pixel/Fractional technology is preferred, it is safe and provides a long-lasting effect. Some other lasers could give you good results, but the fact that CO2 combines minimal ablation and a deeper thermal effect, are the most significant factors contributing to its ability to induce vaginal rejuvenation Dr. Martinec: Having long-term experience with different laser wavelengths, it is my impression that results are better with the CO2 laser. Prof. Femopase: Since 1989 we use the CO2 laser for reconstruction of the external genitalia (labioplasty and reduce tension of the labial glands) which improves orgasmic response. During this time, we performed more than 500 procedures using the conventional laser. We never had any serious complication, as the pudendal nerve runs under deeper anatomical planes. We use two modalities: ablative, to remove excessive tissues, and defocused laser beam to induce thermal effect, causing retraction of areas involved during the orgasmic response. The FemiLift Fractional / Pixel CO2 laser technology - gives us a new dimension in the treatment vaginal and vulvar rejuvenation. Prof. Tadir: Data published so far, and the collective information gathered by experts is convincing, suggesting that we face a game-changer in the 6 ALMA SURGICAL FemiLift

8 treatment of GSM. Basic research on mechanisms of vaginal tissue rejuvenation, and prospective clinical studies are on-going. Once completed, solid data of tissue remodeling may re-define our understanding of vaginal physiology and control of urination. We hear about more innovations such as fractional laser treatment primed by topical estrogen, intra-urethral fractional laser, and studies about the potential healing effect of pathological conditions such as Lichen Sclerosus. These are exciting times for pioneers. I would like to congratulate Dr. Bader for organizing the World Congress of the newly formed E.S.A.G. starting tomorrow, with so many leading figures from all over the world. Participants (in alphabetical order): Dr. Alexandros Bader, MD, FAAOCG, FISCG, FAACS. Director, Reconstructive & Cosmetic Gynecology, London. President of European Society of Aesthetic Gynecology (ESAG). Offices: London, Athens, Dubai. Prof. Scollo Paolo Chairman, Department of Obstetrics and Gynecology, Cannizzaro Hospital, Catania, Italy. President, the Italian Society of Gynecology and Obstetrics. Prof. Femopase Gabriel Catholic University of Cordoba, Medical School. President of the Sexology Society, Cordoba, Argentina Prof. Yona Tadir Beckman Laser Institute and Medical Clinic. University of California, Irvine. USA Dr. Jorge Elias Boenos Aires, Argentina Dr. Martinec Ksenjia Kalliste Medical Center, Slovenia 7 ALMA SURGICAL FemiLift

9 April 2016 THE EFFECT OF VAGINAL CO2 LASER TREATMENT ON STRESS URINARY INCONTINENCE SYMPTOMS Alcalay Menachem1, MD; Bader Alexander2, MD; Ksenija Selih Martinec3, MD; Guy Gutman4, MD Abstract Background Stress urinary incontinence (SUI) in women leads to physical discomfort, deteriorate quality of life and emotional burden. While pelvic floor exercises have been advocated as initial treatment, surgical interventions have demonstrated better efficacy and durable results. However, the possible morbidity of even the most minimally invasive surgical interventions, make many patients reluctant to undergo surgery. Recently, vaginal CO2 laser treatments have been introduced as a conservative option to treat SUI. This study aimed to assess the effect of vaginal CO2 laser on bladder and vaginal symptoms in patients with SUI. Methods This was a retrospective, multi-center evaluation of 133 consecutive patients with SUI symptoms, who underwent vaginal Pixel CO2 laser treatments (FemiLift hand piece, Alma Lasers). Patients were interviewed 3-12 months following completion of treatment to evaluate their symptoms and satisfaction. Results Eighty percent of the 133 participating patients had SUI symptoms and 20% had mixed incontinence symptoms. The 105 patients successfully contacted to complete the posttreatment questionnaires, reported a significant decline in number of pads used per day, with 80.6% of patients requiring no pads following treatment, in contrast to the 47.8% of patients requiring no pads before treatment (p<0.0001). Significant reductions in urinary urgency and frequency were reported, with >97% patients reporting no or mild urgency and frequency following treatment, versus 7.9% and 5.3%, respectively, reporting moderate symptoms before treatment (p=0.03 and 0.04, respectively). In addition, 91.4% of the patients reported no pain during intercourse following laser treatment, while the remaining 8.6% experienced mild pain only (p=0.04). Satisfactory global improvement was reported by 66.7% of the patients, with a higher incidence of such reports among women with SUI versus other types of urinary incontinence. No significant changes in nocturia were noted by patients following treatment. No adverse events were reported by any patients or recorded in patient charts Conclusions The vaginal CO2 laser treatment yielded promising initial results in treatment of stress urinary incontinence symptoms and vaginal symptoms, with no adverse events. The potential benefits of this outpatient treatment include improved patient compliance, alongside a high safety profile. Further studies are needed to prospectively assess the longterm efficacy of the pixelated laser treatment on SUI. 1 Head, Urogynecology Unit, Sheba and Poria Hospital, Israel 2 Director of HB Health Reconstructive & Cosmetic Gynecology department, London, United Kingdom 3 Kalliste Medical Center, Slovenia ⁴ Lis Maternity Hospital, Tel Aviv, Israel 41 ALMA SURGICAL FemiLift

10 Introduction Stress urinary incontinence (SUI) is often initially addressed via pelvic floor exercises and behavioral modification. However, surgical interventions continue to be the mainstay of SUI therapy, as they provide the most effective long-term cure1. Midurethral slings are the most common surgical interventions today for SUI treatment, and are well accepted as minimal invasive procedures. A recent meta-analysis of the prospective randomized controlled trials comparing midurethral slings to Burch or pubovaginal sling showed that mean objective and subjective cure rates for midurethral slings were 86.3% and 71.6%, without significant differences from Burch colposuspension.2 However, these minimal invasive procedures are not free of complications, as reported in a perspective survey of the Nationwide Inpatient Sample database, which included 147,473 SUI surgery patients3. The overall complication rate was 13%, with bleeding (4.4%) and urinary/renal (4.3%) complications being most common. Laser-based treatments have been reported to stimulate collagen neogenesis and skin and tissue remodeling and rejuvenation in wound healing, dermatological, gynecological and dental applications When recruiting this technology for intravaginal gynecological treatments, it is expected to exploit natural healing responses to trigger epithelial tissue regeneration, that may strengthen urethral support. Recent application of endovaginal Er:YAG laser-based treatment to treat SUI symptoms, brought to significant decreases in urinary incontinence severity and to significantly improved quality of life, within one month of treatment, which were maintained throughout the 6-month follow-up period. 15 Improved SUI symptoms, including first sensation, first desire and maximal urethreral closure pressure were reported following application of an Er:YAG laser treatment regimen in 50 female patients. 11 Similarly, distinctive symptomatic improvement was reported following a three-series deployment of the FemiLift CO2 laser to treat SUI symptoms in a 50-year-old woman with a 6-year history of urinary leakage. 16 The aim of this retrospective, multicenter audit, was to assess the efficacy of vaginal CO2 laser treatment in SUI patients. The Technology: The FemiLift CO2 laser (Alma Lasers) delivers energy to the deep submucosal vaginal tissue through a holographic lens, which pixelates the beam into 81 microscopic pixels in a 9x9 mm pattern (Figure 2). The thermal effect is achieved in microscopic columns, while the surrounding tissue remains intact. In consequence, existing fibers contract and neocollagenesis is stimulated, while cells located in the unaffected tissue hastens the healing process, finally leading up to vaginal wall rejuvenation. Ablative Laser Treatment: Treatment was performed in an outpatient setting, without sedation or local anesthetics. The treated area was cleaned of mucus secretion with a gauze pad before treatment. Oral prophylactic antiviral agents to prevent outbreak of herpes simplex virus, were administered. FemiLift (by Alma Lasers) is a CO2 laser with a single-use hygienic probe that delivers pixelated laser energy. The probe, lubricated with baby oil, was set at a low to moderate (Figure 1) energy setting (30-40 mj/pixel) before being positioned under the mid-urethra location, with the laser s energy window oriented at 12 o clock position. It was then rotated by one hour at a time after each laser pulse, between positions 10 o clock to 2 o clock to address the urethra up to the bladder neck. After completing the 10-2 o clock rotation, the handpiece was pulled back by one centimeter and the rotation was repeated. Three such passes were repeated. The energy intensity and pulse durations were only increased if the patient expressed no signs of discomfort. The maximum energy setting was 70 mj/pixel for postmenopausal women and 100 mj/pixel, for premenopausal women. Pulse duration varied ( ms). A minimum interval of 30 days was required between 3 sessions. Methods Patients: Treated patients (n=133) suffered from symptoms of urinary stress incontinence. Patients concomitantly taking medicines that induce photosensitivity, with an active vaginal infection, active urinary infection, diagnosed collagen disease, herpes infection, undergoing corticoid therapies and/or with gynecological oncological pathologies were not treated. Pregnant women were not treated either. Figure 1: FemiLift handpiece with a single-use hygienic probe 2 ALMA SURGICAL FemiLift

11 Questionnaires: Statistical Analysis: Patients were interviewed retrospectively with questionnaires, which included selected questions from the Pelvic Floor Distress Inventory (PFDI) questionnaire, and the 10-cm visual analog scale (VAS) Vulvo Vaginal Atrophy symptoms questionnaires about their symptoms before and after treatment. Patients were interviewed 3-12 months following treatments. Statistical analyses were performed with SAS v9.3 (SAS, SAS Institute Cary, NC USA) software. Study data was tabulated and summarized by data type, continuous variables with a mean and standard deviation and discrete data by a count and percentage. Bowker s test of symmetry was used to assess if there was a statistically significant change in clinical symptoms. A p-value of 0.05 or lower was considered statistically significant. Nominal p-values are presented. Figure 2: Laser beam Split beams Pixel beam splitter Focusing lens Final laser pixel beams The FemiLift CO2 microablative laser. The laser beam is passed through a pixelating holographic lens, forming a 9x9 mm spot size. The thermal effect is achieved in microscopic columns surrounded by spared tissue, from which healthy cells are recruited to accelerate the healing process Results Patients: The patients participating in this survey included women with stress urinary incontinence (72.2%), urge incontinence (1.0%) or mixed urinary incontinence (19.6%) (Table 1). At baseline, 21.1% of patients reported mild to moderate urinary urgency, 24.2% mild to moderate urinary frequency and 10.1% complained of grades mild-moderate nocturia. In addition, before treatment, 52.2% of the patient population reported use of protective pads, with 40.3% requiring two or more pads per day, and 20% reported some degree of vaginal dryness and painful intercourse. Following treatment, significant improvements in urinary urgency and frequency were reported, with 97% of patients reporting no or mild urinary urgency and frequency (p=0.03 and 0.04, respectively) (Table 2). No cases of moderate nocturia were reported post-treatment and only 5 (4.6%) of the 109 evaluated patients reported mild symptoms. Vaginal itching, reported by 8 patients at baseline, manifested 3 ALMA SURGICAL FemiLift following treatment among three patients only. Moreover, the number of reported pads used per day declined significantly, with 80.6% of the treated patients requiring no pads following treatment and the remainder requiring up to two pads per day (p<0.0001, figure 3). Similarly, a 13% rise (p=0.009) in the number of post-treatment reports of no vaginal dryness was observed, with a total of 93.6% patients reporting no dryness and 6.4% reporting mild dryness only. In addition, 91.4% of the patients reported no pain during intercourse following laser treatment, while the remaining 8.6% experienced mild pain only (p=0.04). When assessing the Vulvovaginal Atrophy questionnaire scorings 66.7% of the women reported moderate to significant responses to treatment (Figure 3), with a greater percentage of SUI patients reporting such marked effects (72.9%), when compared to women with other types of urinary incontinence (50%).

12 Discussion Implementation of CO2 (CO2; 10,600 nm) laser therapy has been previously reported in gynecological applications, and has been shown to restore the vaginal epithelium and provide symptomatic relief of vaginal atrophy. 17 Following selective absorption of CO2 illumination by tissue water, increased fibroblast and epithelial cell activity have been reported, with enhanced synthesis and deposition of extracellular matrix and vascular components 18, and eventual improvement in tissue function. The fractionated CO2 laser therapy reported here, maximized therapeutic efficacy, via a long-pulsed, fractionated illumination regimen, yielding deeper, yet safe (<500 microns) penetration and more intense heating of the high water-content submucosa. The resulting thermal and ablative effects led to rejuvenation of the treated tissue and eventual refirming of the vaginal and midurethra structures, as manifested by symptomatic improvement of clinical vaginal and bladder parameters. More specifically, significant patient-rated improvements in urinary urgency and frequency were recorded as well as a 59.1% rise in the number of patients requiring no pads following treatment. Moderate to significant global improvements were noted by 66.7% of the women. Of note, SUI patients were more satisfied with the treatment compared to patients with other types of UI, a difference which may have been incidental due to the small sample size of women with mixed urinary incontinence. Self-managed lifestyle modifications and conservative SUI treatments, such as pelvic floor training, are typically adopted as first-line treatments. While cost-effective and relatively free of side effects, they rely heavily on patient compliance and adherence over time, and have been shown to be of greatest impact in younger patients19 and when performed under supervision and for at least three months. 20 Weighted vaginal cones provides similar efficacy to pelvic floor muscle training, but is associated with a 25% drop-out rate. 21 Occlusive continence devices demand a high degree of patient motivation and clinical trials assessing their effectiveness have reported marked drop-out rates. 1 In addition, as they are typically disposable and replaced after each void and during sexual activity, they incur substantial costs and inconvenience. 1 Most importantly, as the devices fail to treat the underlying problem, they leave patients indefinitely dependent on them to maintain continence. Pharmacological agents have been associated with a high rate of adverse events and unsatisfactory clinical outcomes. In their systematic review of nine trials, evaluating the efficacy and tolerability of duloxetine, a serotonin and noradrenaline reuptake inhibitor, in management among of over 3000 SIU cases, Mariappan et al. report significantly improved quality of life and rates of symptom improvements when compared to placebo-treated patients. However, 71% of the population suffered from side effects, leading to discontinuation of treatment in one in eight patients 22. Stimulation of bladder neck and urethra a-adrenergic receptors, by various pharmacological agents, have led to low cure rates ( 14%), a 19-60% reduction in incontinence and side effects in 5-33% of patients. 23 While the optimal treatment for UI is determined by a spectrum of factors, and will differ between types of UI, there exists a consensus that surgical approaches provide the most effective and enduring therapies. However, they come hand-in-hand with morbidity, cost and inconvenience. There exist over 200 surgical options for SUI management, many of which are associated with poor long-term success rates and are associated with significant complications. While minimally invasive options also exist, few studies have demonstrated their superiority or equivalence to conventional surgery The tension-free vaginal tape method incurs significantly less pain and morbidity, when compared to other surgical options, and has been associated with a high (84.7%) 5-year cure rate, with minimal complications when implemented in 90 SUI patients. 27 Injectable bulking agents have gained popularity, but have failed to demonstrate significant effectiveness over time and come along with significant pain during injection In addition, transient urinary retention and voiding dysfunction following treatment are commonly reported. The CO2 laser-based minimally invasive, outpatient approach, requires no anesthesia and provides immediate results, with no adverse events and no reliance on patient compliance and adherence to treatment regimens. In addition, the unique matrix design of the illuminating pixels and the extended pulse length avoided severe and long-lasting complications (e.g., hypertrophic scarring, ectropion formation, disseminated infection) which have been reported for fractionated laser skin resurfacing devices. 31 While its long-term effectiveness remains to be determined, it reduced clinical symptoms and improved patient quality of life. The limitations of this study include its retrospective nature and the absence of objective evaluations of clinical symptoms. 4 ALMA SURGICAL FemiLift

13 TABLE 1. Patient demographics and baseline characteristics (N=133) AGE (YEARS) Mean (SD) 51.2 (11.7) Min, Max 34.0, 86.0 URINARY INCONTINENCE, n (%) Mixed 26 (19.6) TABLE 2. Clinical symptoms before and after CO2 laser treatment SYMPTOM Pads per day PRETREATMENT % (n) None 47.8 (32) 80.6 (54) (8) 10.5 (7) (21) 9.0 (6) (6) 0.0 (0) Urinary urgency POSTTREATMENT % (n) BOWKER S TEST p= Stress 96 (72.2) Urge 1 (0.8) Unknown 10 (7.5) None 79.0 (90) 82.5 (94) p= Mild 13.2 (15) 14.9 (17) Moderate 7.9 (9) 2.6 (3) Urinary frequency HRT USE PRETREATMENT, n (%) None 2 (1.8) Local 109 (98.2) SEXUAL ACTIVITY PRETREATMENT, n (%) No 17 (14.4) Yes 101(85.60) None 76.1 (86) 82.3 (93) Mild 18.9 (21) 15.0 (17) Moderate 5.3 (6) 2.7 (3) Nocturia None 89.9 (98) 95.4 (104) Mild 7.3 (8) 4.6 (5) Moderate 2.8 (3) 0.0 (0) Vaginal itching None 91.4 (85) 96.8 (90) Mild 5.4 (5) 3.2 (3) Moderate 2.2 (2) 0.0 (0) Severe 1.1 (1) 0.0 (0) Vaginal dryness None 79.6 (74) 93.6 (87) Mild 10.8 (10) 6.5 (6) Moderate 8.6 (8) 0.0 (0) Severe 1.1 (1) 0.0 (0) Dyspareunia None 80.7 (75) 91.4 (85) Mild 11.8 (11) 8.6 (8) Moderate 6.5 (6) 0.0 (0) Severe 1.1 (1) 0.0 (0) p= p= p= p= p= ALMA SURGICAL FemiLift

14 TABLE 3. Vulvovaginal atrophy questionnaire ratings after CO2 laser treatment, by type of urinary incontinence Stress UI Other UI Overall N %# N %# N %# GLOBAL IMPROVEMENT ASSESSMENT* Dysuria** Vaginal Itching** Vaginal Dryness** Dyspareunia** % 18 50% 44 33% % 18 50% 88 67% % % 92 97% % % % % 95 99% % % % 15 94% 95 97% % 1 6.3% 3 3.1% % % 94 99% % % # The presented percentages represent the percentage of each column for each assessed parameter. * 1-10 scale, where 1=no change and 10=significantly better ** 1-10 scale, where 1=absence of symptoms and 10 = symptoms as bad as it could be 6 ALMA SURGICAL FemiLift

15 FIGURE 3. Number of pads used per day before versus after treatment, as reported by patients (p<0.0001) PADS PER DAY Percent of cohort % 80% 60% 40% 20% 0% Pretreatment Posttreatment FIGURE 4. Vulvovaginal atrophy questionnaire ratings after CO2 laser treatment, by type of urinary incontinence Percent of cohort GLOBAL ASSESSMENT Pertreatment Posttreatment GLOBAL ASSESSMENT BY UI TYPE SUI Other Ui No-Mild Change Moderate-Significant Cahnge Percent of cohort Percent of cohort URINARY INCONTINENCE VAGINAL ITCHING SUI Other Ui SUI Other Ui VAGINAL DRYNESS DYSPAREUNIA SUI Other Ui SUI Other Ui ALMA SURGICAL FemiLift

16 References 1. Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S Novara G, Artibani W, Barber MD, et al. Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol. Aug 2010;58(2): Taub DA, Hollenbeck BK, Wei JT, Dunn RL, McGuire EJ, Latini JM. Complications following surgical intervention for stress urinary incontinence: a national perspective. Neurourol Urodyn. 2005;24(7): da Silva JP, da Silva MA, Almeida AP, alombardi Junior I, Matos AP. Laser therapy in the tissue repair process: a literature review. Photomed Laser Surg. Feb 2010;28(1): Sadick NS. Update on non-ablative light therapy for rejuvenation: a review. Lasers Surg Med. 2003;32(2): Harashima T, Kinoshita J, Kimura Y, et al. Morphological comparative study on ablation of dental hard tissues at cavity preparation by Er:YAG and Er,Cr:YSGG lasers. Photomed Laser Surg. Feb 2005;23(1): Loffer FD. Hysteroscopic endometrial ablation with the Nd:Yag laser using a nontouch technique. Obstet Gynecol. Apr 1987;69(4): Alexiades-Armenakas MR, Dover JS, Arndt KA. The spectrum of laser skin resurfacing: nonablative, fractional, and ablative laser resurfacing. J Am Acad Dermatol. May 2008;58(5): ; quiz Woodruff LD, Bounkeo JM, Brannon WM, et al. The efficacy of laser therapy in wound repair: a meta-analysis of the literature. Photomed Laser Surg. Jun 2004;22(3): Lapidoth M, Yagima Odo ME, Odo LM. Novel use of erbium:yag (2,940-nm) laser for fractional ablative photothermolysis in the treatment of photodamaged facial skin: a pilot study. Dermatol Surg. Aug 2008;34(8): Trelles MA, Mordon S, Velez M, Urdiales F, Levy JL. Results of fractional ablative facial skin resurfacing with the erbium:yttriumaluminium-garnet laser 1 week and 2 months after one single treatment in 30 patients. Lasers Med Sci. Mar 2009;24(2): Trelles MA, Shohat M, Urdiales F. Safe and effective one-session fractional skin resurfacing using a carbon dioxide laser device in super-pulse mode: a clinical and histologic study. Aesthetic Plast Surg. Feb 2011;35(1): Trelles MA, Velez M, Mordon S. Correlation of histological findings of single session Er:YAG skin fractional resurfacing with various passes and energies and the possible clinical implications. Lasers Surg Med. Mar 2008;40(3): Fistonic N, Fistonic I, Gustek SF, et al. Minimally invasive, nonablative Er:YAG laser treatment of stress urinary incontinence in women-a pilot study. Lasers Med Sci. Feb Bader A. Non-invasive management and treatment of female stress urinary incontinence with a CO2 laser. HJOG. 2015;14(4): Gaspar A, Addamo G, Brandi H. Vaginal Fractional CO2Laser: A Minimally Invasive Option for Vaginal Rejuvenation. American Journal of Cosmetic Surgery. 2011;28(3): Zerbinati N, Serati M, Origoni M, et al. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. Jan 2014;30(1): Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2010(1):CD Ghaderi F, Oskouei AE. Physiotherapy for women with stress urinary incontinence: a review article. J Phys Ther Sci. Sep 2014;26(9): Herbison P, Plevnik S, Mantle J. Weighted vaginal cones for urinary incontinence. Cochrane Database Syst Rev. 2000(2):CD Reilly MJ, Cohen M, Hokugo A, Keller GS. Molecular effects of fractional carbon dioxide laser resurfacing on photodamaged human skin. Arch Facial Plast Surg. Sep-Oct 2010;12(5): Mariappan P, Alhasso A, Ballantyne Z, Grant A, N Dow J. Duloxetine, a serotonin and noradrenaline reuptake inhibitor (SNRI) for the treatment of stress urinary incontinence: a systematic review. Eur Urol. Jan 2007;51(1): ALMA SURGICAL FemiLift

17 References 23. Clinical Practice Guideline, authors. Urinary Incontinence in Adults. In: Agency for Health Care Policy and Research UDoHaHS, ed Kerr LA. Bulking agents in the treatment of stress urinary incontinence: history, outcomes, patient populations, and reimbursement profile. Rev Urol. 2005;7 Suppl 1:S3-S McDougall EM. Laparoscopic management of female urinary incontinence. Urol Clin North Am. Feb 2001;28(1): , x. 25. Leach GE, Dmochowski RR, Appell RA, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol. Sep 1997;158(3 Pt 1): Haab F, Zimmern PE, Leach GE. Urinary stress incontinence due to intrinsic sphincteric deficiency: experience with fat and collagen periurethral injections. J Urol. Apr 1997;157(4): Herschorn S, Glazer AA. Early experience with small volume periurethral polytetrafluoroethylene for female stress urinary incontinence. J Urol. Jun 2000;163(6): Rofeim O, Yohannes P, Badlani GH. Minimally invasive procedures for urethral incontinence: is there a role for laparoscopy? Int Braz J Urol. Sep-Oct 2002;28(5): Metelitsa AI, Alster TS. Fractionated laser skin resurfacing treatment complications: a review. Dermatol Surg. Mar 2010;36(3): Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Longterm results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S ALMA SURGICAL FemiLift

18 Non Invasive Treatment of SUI with CO2 Laser Author: Alexandros Bader MD, FAAOCG Introduction: Stress Urinary Incontinence (SUI) is defined as involuntary urine leakage. This is a very common phenomenon among young women with history of multiple vaginal deliveries or with one destructive delivery. SUI is considered one of the most distressing problems for young females with a distinct element of quality of life implications. SUI is caused due to the loss of urethral support, usually as a consequence pelvic support structure damage. Histological changes in the vaginal wall structure, also has an important affect on the support system of the urethra underside, especially under the mid urethra. These patients usually report leakage of a small amount of urine during activities that increase abdominal pressure such as coughing, sneezing and lifting of heavy weights. Treatment using non ablative CO2 Laser energy under the mid urethra with a three (3) session repetition once a month shows a distinctive and reportable improvement of the symptoms. Keywords: Stress Urinary Incontinence, CO2 Laser application, FemiLift, collagen remodeling. Case Presentation: Our patient is 50 Years old G1 P1, who gave her vaginal delivery 16 years ago. The patient is complaining of a small amount of urine leakage since 6 years. She reports leakage symptoms during winter time, especially with coughing and sneezing. She describes that she changes 2 to 3 cotton pads a day when her coughing is getting worse. Patient reports one to two drops every time she sneezes or coughs. Patient reports that she practices Kegel exercises for the last 8 months without notable improvement. She decided to visit us because the situation had started to get worse with a noticeable bad impact on her personal life and her selfconfidence. The patient was advised to undergo some tests and exams which would be followed by a discussion regarding the various treatment options. The patient had undergone the following tests and exams: Urinalysis: To confirm non urine infections. Results were negative. Normal Ultrasound: To image the uterus and verify non myomas or any mass in the area. Results were negative Post voidal Ultrasound: To measure any residual urine inside the bladder. Results show non-significant quantity of urine in the bladder

19 Cough test: Done with patient standing and pressure on her knees. We asked her to cough after drinking 1 liter of water. Results show, loss of 2 drops of urine every time the patient was coughing Q Test: To find out if the patient is suffering from hyper mobility of the urethra. Results show tip elevation of only 20%, which is non-indictable to hyper mobility of the urethra Figure 1: Colposcopy Picture of the upper vaginal wall before the 1 st application with Non Ablative CO2 Laser, FemiLift The patient was informed of her various treatment options, with the recommendation to undergo Noninvasive CO2 Laser method FemiLift as the safest treatment option for her case. Consideration of this recommendation was due to the zero down time, the zero pain and most importantly, the fact that she is likely to have the same high improvement percentage or complete healing likelihood as with the surgical option. Method: As explained before, the anatomical defect in this case is the loss of support from complex of tissues under the mid urethra. In our current case, we will target the mid urethral underside space with non-ablative CO2 Laser beam. The application power needs to be strong enough in order to stimulate the collagen and elastic fibers in the sub-mucosal space. With the non- Ablative CO2 FemiLift we have the advantage of non-sharing the tissues in comparison with a fractional CO2 scanners while also working deep enough for better stimulation in comparison to Erbium Lasers. Prior to beginning treatment, we follow a certain protocol. We ask the patient to undergo the following tests: Pap smear. Negative for any cervical or vaginal malignancy, HPV, HSV Pregnancy test: Negative The patient agreed to undergo three (3) sequential sessions, one every four (4) weeks. During the first session, we performed the application under the mid urethra in three positions: 1cm distal of the mid urethra level. Application with 110mj/ppl with high laser mode and 0,5 Hz Directly under the mid urethra. Application with 110mj/ppl with high laser mode and 0,5 Hz

20 1cm before the mid urethral level. Application with 110mj/ppl with high laser mode and 0,5 Hz This protocol was repeated with the same settings for three passes on the same positions during the same session. The treatment has been performed without the use of any kind of anesthesia. The total duration of the application was 20 minutes, to completion. The patient was advised to avoid sexual intercourse for 3 days. The same protocol has been repeated for another two sessions. Four and eight weeks following the 1 st session. Figure 2: Colposcopy Picture of the upper vaginal wall after the 1 st application with Non Ablative CO2 Laser FemiLift Discussion: This case describes treatment of SUI using Femilift a Non ablative CO2 Laser technology. Following several tests and special exams, our patient was considered a good candidate for this treatment. The goal of using this laser technology is to achieve new collagen remodeling and elastic fibers recreation in the tissues under the mid urethra. Laser penetration is safe and does not exceed 500 microns. Using FemiLift a Non ablative CO2 Laser in the mid urethra region gives us the advantage of affecting the tissue with thermal damage for a period of hours after application. This process will create edema in the surrounding tissues; will release chemical mediators causing shrinkage of the collagen. On the main time, the changes in the cellular level are rapid and transient, and are characterized by the production of a small family of proteins termed Heat Shock Proteins (HSP), which can be defined as the temporary change in cellular metabolism. HSP 70, which is commonly found following laser irradiation, could play a role transforming TGF-beta growth factor. TGF-beta is known to be a key element in inflammatory and fibrogenic response. In this process, the fibroblasts are the key cells, since they produce collagen and extracellular matrix. During the proliferation phase (30 days) following application, Fibroblast recruitment will take place with the creation of new dermal molecular and new collagen fibers replacing the old one. The final phase will be the remodeling phase, with placement of mature collagen fibers and increase of collagen fiber strain, to finally achieve new elastic fibers. The goal of treatment is to achieve enough collagen remodeling and fibroblasts recreation to ultimately increase the thickness of the vaginal wall in the area in order to increase the support of the mid urethra underside. This would give the patient continence lasting for

21 approximately 2 years. A memory session one year after the last application is recommended, in order to keep the collagen in continuous recreation. Conclusion: In Conclusion, performing the Stress Urinary Incontinence SUI procedure using FemiLift Non ablative CO2 Laser in three sessions., Complete cure of the symptoms was achieved after the 2 nd session. Patient reported no leakage anymore while coughing or sneezing. Cotton pads test for 2 weeks was negative. Office coughing test was negative. Patient was advised to return after one year for re-assessment and a memory session. Patient Satisfactory Rate: Pain during procedure Pain after procedure Satisfactory after 1 st session Satisfactory after 2 nd session Satisfactory after 3 rd session Figure 3: Colposcopy Picture of the vaginal wall one month after the application of 2nd session of Non Ablative CO2 Laser FemiLift Figure 4: Colposcopy Picture of the vaginal wall one month after the application of 3rd session of Non Ablative CO2 Laser FemiLift

22 Consent: A Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of this consent is available for review if needed. Competing interests: The author declares that he has no competing interests. Literature list: 1. Proff. Roger Dmochowski MD. Surgery for Urine Incontinence. ISBN: Mickey Karram MD. Surgery for Urine Incontinence. ISBN: Assistance Proff. Stuart Reynolds MD. Surgery for Urine Incontinence. ISBN: Capon A & Mordon S. AM Journal of Clinical Dermatology. 2003; 4(1):1-12.

23 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Application of Fractional CO2 Laser (FemiLift ) and improvement in urinary incontinence Authors: Femopase, G; Femopase, S; Alonso Salas, SM Córdoba, Argentina Abstract Introduction. Stress urinary incontinence (SUI) is defined as the involuntary loss of urine associated with physical exertion that causes increased intra-abdominal pressure. SUI prevails in multiparous, peri-menopausal women with a history of difficult births or infants greater than 3,500 kg. Urethral hyper-mobility is a cause of SUI that benefits from the application of fractionated CO2 laser. Its ablative and thermal effects produce retraction, increased submucosal collagen reducing urethral mobility. Materials and methods. This study is quantitative, descriptive transversal. The sample was 183 patients of which 131 met the inclusion criteria. Inclusion criteria: women between 35 and 60 years old, with SUI, history of vaginal deliveries and urethral hyper-mobility. Exclusion criteria: cystocele, obesity, uterine prolapse, mixed urinary incontinence or urgency, recurrent urinary tract infection, collagen diseases, chronic corticosteroid therapy, pregnancy, vaginal herpes virus, gynaecological oncology pathology, vaginal HPV infection, active vaginal infection and patients who have medical treatment that causes photosensitivity. Patients were assessed by the International Consultation on Incontinence Questionnaire: Short Form (ICIQ -SF) before treatment and 90 days after treatment. The procedure is ambulatory, is performed with fractionated CO2 laser (FemiLift) applied at hours 10, 11, 1 and 2 of vagina. Results. The ICIQ - SF allows us to evaluate the frequency of episodes of IUE, the amount of urine lost and changes in their quality of life. The results were: 82% of women decreased the frequency of SUI had to once a week or less, 15% indicated that decreased the frequency to two or three times a week and only 3% did not notice changes. With respect to the amount lost 23% indicated the option no amount lost and 77% small amount lost. All patients noted improvement in their quality of life, either by decreasing the frequency of SUI or decrease in the amount of urine lost. Conclusion. The quality of life of many women affected by SUI therefore should not be considered a minor sign to the medical history. The fractional CO2 laser (FemiLift) allows us to reduce the frequency of episodes and quantity of urine lost, thereby improving the quality of life of these women. It is an ambulatory, fast, painless and simple procedure. Introduction Urinary incontinence (SUI) is defined by the International Continence Society (ICS) as an involuntary loss of urine associated with physical exertion, which causes increased abdominal pressure (coughing, laughing, running, walking, Valsalva maneuver). 1 In the SIU, the intravesical pressure exceeds the urethra, either urethral hypermobility or intrinsic sphincter deficiency. Weak urethral support tissue, producing a drop position of the urethra resulting in increased mobility of the same. 2 3 The prevalence among women varies between 20 and 50% depending on different factors, multiparity, perimenopause and menopause, a history of dystocic deliveries. Age appears to be a risk factor added in conjunction with the above, there has been an increase in prevalence with increasing age Urethral hypermobility is the cause of SIU further benefits from the application of fractional CO2 laser. By influencing the laser in paraurethral vaginal region decreases the mobility of the urethra. Its ablative and thermal effects produce increased vaginal retraction and collagen production. 9

24 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Figure 1. Thermal and ablative effect on vaginal mucosa The SIU affects the quality of life of women by their interference in daily activities. The objectives of this paper were: Evaluate changes in frequency of episodes of SUI in women after application of fractional CO2 laser. Determine changes in the amount of urine that women with SUI lost after application of fractional CO2 laser. Describe changes in the quality of life of women after application of fractional CO2 laser. Materials and methods A quantitative, descriptive transversal study. It was held in the city of Cordoba, Argentina, in the period elapsed between August 2013 and December The sample was 183 patients of which 131 met the inclusion criteria. Inclusion criteria: women between 35 and 60 years old, with SUI, history of vaginal deliveries and urethral hypermobility. Exclusion criteria: cystocele, obesity, uterine prolapse, mixed urinary incontinence or urgency, recurrent urinary tract infection, collagen diseases, chronic corticosteroid therapy, pregnancy, vaginal herpes virus, gynaecological oncology pathology, vaginal HPV infection, active vaginal infection and patients who have medical treatment that causes photosensitivity. Anamnesis was performed, physical examination, BMI was calculated, urine culture was performed. Exclusion were considered positive for those diseases that were previously diagnosed. Patients were assessed by the International Consultation on Incontinence Questionnaire: Short Form (ICIQ -SF) before treatment and 90 days after treatment. 10 The ICIQ-SF consists of four questions that assess in the past four weeks the following: often they leak urine, the amount they think losing, at which leak urine and how it affects their quality of life (the questionnaire was designed for research and general practice). It is considered grade A recommendation by the International Consultation on Incontinence (ICI). The procedure is ambulatory, is performed with fractionated CO2 laser (FemiLift) applied at hours 10, 11, 1 and 2 of vagina. Each application generates 81 spots in an area of 1 by 1 cm. The procedure was repeated three times on each side. Three sessions were held one per month. The results were obtained through a descriptive analysis of the variables. Figure 2. Disposable handpiece

25 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Figure 3. Effect of fractionated laser vaginal mucosa Figure 4. Application of CO2 laser in the vagina Results The ICIQ - SF allows us to evaluate the frequency of episodes of IUE, the amount of urine lost and changes in their quality of life.

26 Presented at: WAMS - IV Congress of Medical Sexology October 2015 The results were: 82% of women decreased the frequency of SUI had to once a week or less, 15% indicated that decreased the frequency to two or three times a week and only 3% did not notice changes. With respect to the amount lost 23% indicated the option no amount lost and 77% small amount lost. All patients noted improvement in their quality of life, either by decreasing the frequency of SUI or decrease in the amount of urine lost. It was considered positive the decrease of 2 points or more in the quality of life score.

27 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Comments The application of fractional CO2 laser can address ambulatory, quick and painless way, those women who do not present indication for surgery. Can be combined with methods that strengthen the muscles of the pelvic floor, changes in hygiene and dietary habits and weight loss should be necesary Despite being a useful instrument in both clinical and research, the ICIQ-SF may be biased as it is a questionnaire in which the subjectivity of who responds strongly influences. However it is an excellent tool to quantify the changes in quality of life Conclusion The quality of life of many women affected by SUI therefore should not be considered a minor sign to the medical history. The fractional CO2 laser (FemiLift) allows us to reduce the frequency of episodes and quantity of urine lost, thereby improving the quality of life of these women. It is an ambulatory, fast, painless and simple procedure. As previously mentioned it should be considered as a treatment option in women with SUI who meet the criteria for their application.

28 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Bibliography 1. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002;21: Espuña Pons, M. Incontinrncia de orina en la mujer, Med Clin (Barc). 2003; 120: Petros, P.E., Woodman, P.J. The Integral Theory of continence, Int Uroginecolo J Pelvic Floor Dysfunct 2008; 19 (1): Tamanini J, Lebrao M, Duarte Y, Santos J, Laurenti R. Analysis of the prevalence of and factors associated with urinary incontinente among elderly people in the Municipality of Sao Paulo, Brazil: SABE Study (Health, Wellbeing and Aging). Cad Saude Pub 2009; 25: Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol 2000; 53: Hunskaar S, Lose G, Sykes D, Voss S. The prevalence of urinary incontinence in women in four European countries. BJU Int 2004; 93: Nihira MA, Henderson N. Epidemiology of urinary incontinence in women. Curr Womens Health Rep 2003; 3: Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet 2003; 82: Cisnero Vela JL, Camacho Martinez F. Laser fuentes de luz pulsada intensa en dermatología y dermocosmetica. Ed. Amolda Caracas, Venezuela. 10. Montserrat Espuña Pons a, Pablo Rebollo Álvarez b, Montserrat Puig Clota a Validation of the Spanish version of the International Consultation on Incontinence Questionnaire-Short Form. A questionnaire for assessing the urinary incontinence. Instituto Clínico de Ginecología, Obstetricia y Neonatología. Hospital Clínic de Barcelona. Universitat de Barcelona. Barcelona. Unidad de Investigación de Resultados en Salud. Hospital Universitario Central de Asturias. Oviedo. España.

29 Presented at: WAMS - IV Congress of Medical Sexology October Pesce F. Current management of stress urinary incontinence. BJU Int 2004; 94 (Suppl 1): M.G. Lucas (chair), D. Bedretdinova, J.L.H.R. Bosch, F. Burkhard, F. Cruz, A.K. Nambiar, C.G. Nilsson, D.J.M.K. de Ridder, A. Tubaro, R.S. Pickard. Guidelines on Urinary Incontinence. European Association of Urology Sanchez, J; Lomanto, A; Gaitan, H; Fino, D. Valor de la historia clinica con relacion a la urodinamia en el diagnostico de la incontinencia urinaria femenina Urol. colomb;8(1):43-51, mayo tab. 14. Espuña Pons M, Puig Clota M. Síntomas del tracto urinario inferior de la mujer y afectación de la calidad de vida. Resultados de la aplicación del King's Health Questionnaire. Actas Urol Esp. 2006; 30: Howard F, Steggall M. Urinary incontinence in women: quality of life and help-seeking. Br J Nurs. 2010; 19: Appendix

30 Presented at: WAMS - IV Congress of Medical Sexology October 2015

31 Laser Vaginal Rejuvenation with Alma Pixel CO2 Interview with Dr. Femopase, Cordoba / Argentina Treatment of genital areas within the aesthetic medicine has not only left any form of tabooing behind it, but has also won a continuous increasing relevance in the past years. Thus in 2012 around surgeries have been performed on the genital area only in Germany. We interviewed Prof. Dr. Gabriel Alberto Femopase from the University of Cordoba, Argentina (UNC) about his practical experiences with usage of the CO₂ Laser in the case of treatments of two different feminine indications. In your clinic you are offering a wide spectrum of surgical and aesthetical surgical procedures. What are these treatments? Prof. Femopase: In our private clinic we offer a range of therapeutic options for pathologies of the lower genital tract, vulvovaginal reconstruction (hypertrophy of labia minora, lifting of the clitoris, vulvar correction, reconstruction of pelvic muscle floor and vaginal tightening with intimate aesthetic Surgery). Another important indication is Stress Urinary Incontinence (SUI) that can be effectively treated. All procedures are done using the FemiLift CO2 Laser System. How important is vaginal tightening or intimate aesthetic surgery to women in the 21st century? Prof. Femopase: The concept of quality of life is now more present in our society and sexual aspects are taken more into account by women. This results in more frequent consultations about restorative surgical alternatives. For example obstetric damages result in hyper-laxity and sensitivity alterations that are generated by damage to regional innervations, hypogastric nerve, pelvic and pudendal. This produces in 80% of women over 40 years of age some degree of sexual sensitive response dysfunction. These procedures are offered as an effective and ethical solution for these conditions. Stress Urinary Incontinence (SUI) is a widespread disease in women. What are your experiences in treating these women with the vaginal probe and the Alma CO2? Prof. Femopase: SUI is another reason for very frequent consultations in daily gynecology and the use of the specially designed Alma device is an excellent option to treat this pathology. The technique is completely outpatient, low cost and does not require anesthesia, giving great results in short and long terms. The alternative to this treatment is surgery. Which patients do you recommend a surgery, which a laser treatment? Prof. Femopase: The surgical procedure is limited exclusively to those patients that present cystocele or rectocele of 2nd or 3rd degree; in all other cases we use the CO2 laser and FemiLift device. Please describe the sequence of the Alma laser treatment. Prof. Femopase: Treatment Protocol: 1. Clean the treated area with gauze sponge to remove extra mucus on the treatment area. 1 ALMA SURGICAL FemiLift Interview

32 2. Wear appropriate eye protection, as well as the medical staff inside the enclosed treatment room/ operating room. Goggles should be OD>7 and labeled for 10,600nm wavelength. 3. Set the initial energy level start-up (set up recommendations for a 30W laser system: High mode, up to 30-50mJ/pixel in the first treatment, Single Pulse). 4. Lubricate the probe with baby oil. 5. Insert a vaginal Probe; Position the hand piece perpendicular to the tissue. Do not apply pressure The hand piece's treatment technique can be either Stationary stacking (for deeper penetration) overlap pulses on the same area, or Multiple Passes - nonoverlap passes. 6. Position the hand piece close to the tissue; trigger a laser pulse by pressing the footswitch. 7. Depth of treatment should be individualized to the tissue current condition and desired resurfacing. 8. Following treatment gently cleanse the treated area from any tissue fragments with a gauze sponge and follow postop care guidelines. 9. If adverse skin effects occur (such as excessive bleeding or swelling), you may either change the pulse mode or reduce the fluency. How can the mechanism of action be explained? Prof. Femopase: Aging and overweight degrades the vaginal tissue s normal collagen and replaces it with abnormal elastic fibers that do not stretch and recoil. This creates tissue laxity. CO2 laser removes the abnormal upper tissue layers, and stimulates new collagen growth in the dermis to effectively restructure and restore it to a state that resembles undamaged tissue. Additionally, microvascularization improves due to the effect of treatment on angiogenesis. As we modify other physiological aspects, we also achieve a rejuvenating effect on the vulvo-vaginal mucosa which leads to a normalization of vaginal ph and vaginal flora. outpatient, high success rate percentage, and quick recovery, not affecting normal activities for the patient. Regarding possible complications, they are nearly inexistent if the professional use the established protocols by our research group together with Alma. Is the laser procedure able to solve the problem of SUI alone or are other actions to be taken? Prof. Femopase: The procedure used for SUI with Alma Lasers are highly safe and effective (with minimal side effects compared with surgical procedures as vaginal sling procedures) but other considerations like hormonal correction could be added to adjust estrogen deficit by hormonal therapies, Kegel exercises to rehabilitate the pelvic floor, etc. What is the ratio of the cost of laser treatment compared to surgery? Prof. Femopase: The cost difference is very big due to the possibility to perform the procedures in outpatient way without the need of hospital stay, anesthesia etc. We also should consider the lower social cost due to patients returning to work and personal activities immediately. Do you use the vaginal laser for other indications? Prof. Femopase: The device is used in all surgical vaginal procedures that require a modification of its tension and improved vaginal blood supply and lubrication. Women that undergo FemiLift treatment will be less susceptible to vaginal infections. In addition FemiLift treatment is associated with a significant improvement of sexual function. Women who suffer from Stress Urinary Incontinence have a good chance to achieve significant improvement with minimal side effects. Which advantages does the laser procedure have? Are there any risks? What are possible side effects? Prof. Femopase: The advantages we obtain by these procedures are many: treatment is pain-free, minimally invasive, 2 ALMA SURGICAL FemiLift Interview Alma Lasers, Ltd. All right reserved.

33 Non Invasive Labia Majora Tightening & Skin Rejuvenation with CO2 Laser FemiTight Alexander Bader 1, MD INTRODUCTION Labia majora are the two prominent longitudinal cutaneous folds located on the outer part of the female genital area, and which extend downward from the mons pubis area to the perineum. Each labium majus has two surfaces, an outer, pigmented surface covered with hair, and an inner, smooth surface, beset with large sebaceous follicles. As with any other human tissue, the natural course of the labia majora often involves tissue atrophy, which is mainly a consequence of normal vaginal ageing and associated poor circulation and loss of hormonal support, or of pregnancy, delivery and significant weight loss in younger women. Atrophy of the tissues in this area manifests by loss of labia volume, flaccidity and ptosis. Protuberant labia majora can lead to functional difficulties in sexual stimulation and satisfaction, complicate hygiene maintenance, influence choice of undergarments and swimsuits and negatively impact self-confidence and self-image. These aesthetic, psychological and/or functional effects often drive women to seek labiaplasty solutions. Labia Majora Plasty can be approached via radical and invasive procedures, in which part of the labia majora skin is surgically removed, while the remaining tissue is lifted and stretched. Yet, these techniques are associated with clinical sequelae, such as nerve ending damage, significant anatomical deformities, scarring and hair growth toward the vaginal entrance, which can further exacerbate patient discomfort and dissatisfaction. An innovative, noninvasive, nonablative, CO2 fractional laser-based therapy has an established dermal rejuvenation effect, stimulated by gentle heating of a region of interest and subsequent selective induction of collagen generation and deposition in the deep tissue layers. The resulting improvement in skin texture and wrinkle scores closely correlates with high patient and physician satisfaction. This case report describes its application toward labia majora remodeling. CASE A 39-year-old woman complained of 5 years of psychological and aesthetic dissatisfaction with the appearance of her labia majora. She reported low self confidence, and embarrassment during gym and swimming activities, as well as during intercourse. She had been practicing a waxing method for hair removal for the last 10 years and had recently begun photoepilative treatment in the vaginal area. The patient had a record of three vaginal deliveries, with no serious medical issues and no record of any kind of invasive procedures in this specific area. On examination, the labia majora lacked normal shape and presented long and deep wrinkles along their surface. The skin showed excessive laxity with poor elasticity. The treatment plan was introduced to the patient as a means of eliciting cosmetic rejuvenation, with no claims to enhance sexual function or gratification. 1 Director of HB Health Reconstructive & Cosmetic Gynecology department, London, United Kingdom 1 ALMA SURGICAL FemiLift case study

34 METHOD A local anesthetic (lidocaine 2% mixed with N/S 0.9% (1:1)) was injected using a 27 G needle. The area was cleaned with an iodine-free antiseptic solution and thoroughly dried. A thin layer of oil was then applied over the entire area to be treated (Figure 1A). The FemiLift-T FemiTight de focus probe (Figure 2), dedicated for labia majora rejuvenation, was then connected to the laser unit and the power was set on the Repeat mode at a fluency of 0.5 sec on time (in-motion) and 0.5 sec off time (in-motion). While continuously pressing the foot pedal, circular movements were made with the hand piece, which was kept in direct contact with the skin throughout (Figure 1B). The laser temperature detector was closely monitored to ensure that the duration of the highest allowed temperature (42ºC) did not exceed 5 sec (Figure 1C). This temperature, for a duration shorter than 5 sec at the same spot, is considered safe for the human tissue. Usually, human tissue is tolerant of temperatures up to 44 C and, very rarely, 46 C. Beyond these levels, serious tissue insult and irreversible reduction in cell viability occur. Rehydration cream was applied immediately after the treatment and the patient was instructed to continue applying cream for 5 days and recommended to perform an assessment for the need for maintenance treatment after 6 months. A C RESULTS AND CONCLUSIONS A single-session deployment of CO2 laser energy significantly enhanced labia majora tissue appearance, as manifested by a distinct lifting effect and improved texture and wrinkle profiles (Figure 3). The procedure was performed in clinic, required a local anesthetic and was completed within 3 minutes. No patient discomfort was reported and the procedure did not involve any downtime; the patient returned to everyday activities immediately thereafter. No special treatment of the area was required following the session. The patient was pleased with the treatment outcome and is expected to benefit from the results for a period of at least 2 years, which is the life-span of high quality collagen. Overall, this minimally invasive approach presents a simple and highly tolerable labia majora lifting modality, with immediate effects on patient comfort, self-image and self-esteem. We recommend that patients apply rehydration cream for 4-5 days after treatment. No restrictions or other special instructions are indicated. The patient can return to daily activities, including gym and sexual intercourse, one day after treatment. Results may be visible immediately after the session, but improve over the 3 to 6 months following treatment, which is the estimated time for new collagen regeneration. A maintenance treatment session every year is recommended, particularly if the patient is seeking to enhance the results. B Figure 2. FemiTight for Labia Majora Tightening A B Figure 1. CO2 laser-based labia majora remodeling treatment. (A) A thin layer of oil was applied over dry skin. (B) The probe was kept in close contact with the skin throughout the procedure and moved in circular motions, while avoid stacking. (C) Skin temperature was closely monitored to avoid overheating (>42 ºC). Figure 3. Labia majora before (A) and after (B) CO2 laserbased labia majora remodeling. 2 ALMA SURGICAL FemiLift case study

35 KEYWORDS Labia majora, relaxation, skin laxity, collagen remodeling, wrinkles removal, Non-Invasive de focused CO 2 Laser REFERENCES 1. Manual of Obstetrics. (3rd ed.). Elsevier. pp Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med 2004;34: Hantash BM, Bedi VP, Kapadia B, et al. In vivo histo-logical evaluation of a novel ablative fractional re-surfacing device. Lasers Surg Med 2007;39: Rahman Z, MacFalls H, Jiang K, et al. Fractional deep dermal ablation induces tissue tightening. Lasers Surg Med 2009;4: Orringer JS, Sachs DL, Shao Y, et al. Direct quanti-tative comparison of molecular responses in pho-todamaged human skin to fractionated and fully ablative carbon dioxide laser resurfacing. Dermatol Surg 2012;38: Fitzpatrick RE. CO2 laser resurfacing. Dermatol Clin 2001;19: ALMA SURGICAL FemiLift case study Alma Lasers, Ltd. All right reserved.

36 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Vaginal application of fractional CO2 laser (FemiLift) and improvement of female sexual response Authors: Femopase, G; Femopase, S; Alonso Salas, SM Córdoba, Argentina Abstract Introduction. A common consultation in women is the feeling of vaginal laxity, referring decreased genital friction during intercourse thus affecting sexual response. Application of fractional CO2 laser (FemiLift), which splits the laser beam into a 9 x 9 matrix of 81 tiny spots, creates thermal and ablative effect on vaginal walls, triggering a significant improvement in the production of collagen within vaginal submucosa. Furthermore, retraction and decreased diameter of the vaginal canal improves friction and traction on bulbo-clitoral organ which improves sexual response. This treatment is outpatient, painless, quick and simple to perform in the office. Materials and Methods. This is a quantitative, descriptive transversal study. The sample consisted of 241 patients aged years. Inclusion criteria are delivery, vaginal laxity, decreased sexual response; this last variable evaluated by the Female Sexual Function Index ( FSFI ). Exclusion criteria were vaginal infection, pregnancy, infection with Herpes Virus, gynaecological oncologic disease, chronic corticosteroid therapy, medication that causes photosensitivity, HPV infection, collagen disease. Results. The sexual response of women through the FSFI before and 60 days after treatment (overall index score) was evaluated. The results were: 80% of women experienced a marked improvement in sexual response (+6 points), 11% reported moderate improvement (4-5 points), 6% slight improvement (2-3 points) and 3% saw no significant changes. On women who experienced a marked improvement in sexual response (80%), 86% reported improvement in orgasmic response, 65% noticed improvement in vaginal lubrication with 54% increased total satisfaction domain score. Conclusion. Vaginal application of fractional CO2 laser (FemiLift) is a minimally invasive technique that significantly improves sexual response of women. This procedure is ambulatory, painless and uncomplicated. Introduction The vaginal laxity is a frequent complaint. This leads to reduced friction and traction on bulbo-clitoral organ generating a decrease in the female sexual response. Orgasm and female sexual response are affected in women who precent vaginal laxity. The sexual response does not depend exclusively on the anatomical indemnity of the genitals, but this is an essential aspect of sexual response. The factors that predispose women to have vaginal laxity contemplate delivery whether dystocic or multiparity, use of forceps, vaginal tears, perimenopause, menopause. At present there are few studies studying orgasmic frequency in women with vaginal laxity. This study aims to assess female sexual response after the application of carbon dioxide laser vaginal split. The thermal and laser ablative effect allows us to improve the vaginal laxity, by retracting and stimulating the formation of collagen. Application of fractional CO2 laser (FemiLift), which splits the laser beam into a 9 x 9 matrix of 81 tiny spots, creates thermal and ablative effect on vaginal walls, triggering a significant improvement in the production of collagen within vaginal submucosa Figure 1. Pixel fractional CO2 laser

37 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Figure 2. Effect of fractionated laser vaginal mucosa The female sexual response was assessed by the FSFI questionnaire, which allows women to express their difficulties objectively. Materials and Methods This is a quantitative, descriptive transversal study. Realized in the city of Cordoba, Argentina, in the period from August 2013 to March The sample consisted of 241 patients aged years. Sampling was systematic of those women who go to the gynecologist. The inclusion criteria were delivery, vaginal laxity, decreased sexual response; this last variable evaluated by the Female Sexual Function Index ( FSFI ) 4. All women were performed anamnesis, physical and gynecological examination, and the FSFI questionnaire to assess sexual response. The FSFI is formed by 19 questions that assess six domains, desire, satisfaction, lubrication, orgasm, pain, excitement. Each domain has its questions with a score generated by a subtotal and the total sum of these arises of the index. This questionnaire was conducted in the first consultation and again at 60 days after application of laser. The questionnaire was completed by each woman at home to do it in this way quietly thinking in all aspects analyzed. This allows us that she realizes of what creates difficulties in their sexual response. The exclusion criteria were vaginal infection, pregnancy, infection with Herpes Virus, gynaecological oncologic disease, chronic corticosteroid therapy, medication that causes photosensitivity, HPV infection, collagen disease. Some of these criteria are part of the contraindications for application of carbon dioxide laser vaginal mucosa. Exclusion were considered positive for those pathologies diagnosed prior to the interview. It should inform the patient about the procedure, its effects and possible complications (burning, vaginal transudate), is performed consent reported. The application of laser procedure involves placing a speculum and cleanse the vaginal walls with a swab. Removing the speculum. Lubricate the handpiece (Femilift) with water based lubricant or saline. The handpiece is placed in the vagina and positioned toward the area where you want to apply laser. In this case, for vaginal laxity, was performed in 3 and 9 hour. This procedure was repeated three times on each side. Three sections were performed one per month.

38 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Figure 3. Application of CO2 laser in the vagina Figure 4. Disposable handpiece

39 Presented at: WAMS - IV Congress of Medical Sexology October 2015 Figure 5. The handpiece has a line along that lets you know the area to affect the laser beam Sixty days after the last application the FSFI questionnaire was performed to assess changes in sexual response of women. Results The sexual response of women through the FSFI before and 60 days after treatment (overall index score) was evaluated. Descriptive statistical analysis of the variables was performed. Figure 6. Overall index evaluation of FSFI

40 Presented at: WAMS - IV Congress of Medical Sexology October 2015 The results were: 80% of women experienced a marked improvement in sexual response (+6 points), 11% reported moderate improvement (4-5 points), 6% slight improvement (2-3 points) and 3% saw no significant changes. Figure 7. FSFI index changes On women who experienced a marked improvement in sexual response (80%), 86% reported improvement in orgasmic response, 65% noticed improvement in vaginal lubrication with 54% increased total satisfaction domain score. Figure 8. Domains generated improvement of FSFI Comments No previous studies have found that analyze changes in female sexual response after the application of fractional CO2 laser with handpiece Femilift. A study entitled vaginal erbium laser for the treatment of genitourinary menopausal syndrome: preliminary results, says that the genitourinary menopausal syndrome affects up to 50% of postmenopausal women. This may interfere with sexual function and quality of life. At the end of treatment the results were significant improvement in symptoms (vaginal dryness and dyspareunia) and 93.4% of patients described the procedure as excellent or good. 5

41 Presented at: WAMS - IV Congress of Medical Sexology October 2015 However to have greater thermal effect, the CO2 laser creates greater stimulation of collagen formation. Conclusion Application of fractional CO2 laser is an outpatient, painless and uncomplicated procedure that improves female sexual response. The effect of laser stimulate collagen production in the vaginal mucosa and to generate retraction in the same. Improved traction on bulbo-clitoral organ improves sexual response. Bibliography 1. Cisnero Vela JL, Camacho Martinez F. Laser fuentes de luz pulsada intensa en dermatología y dermocosmetica. Ed. Amolda Caracas, Venezuela. 2. Alexiades-Armenakas, M. R., J. S. Dover, et al. (2008). "The spectrum of laser skin resurfacing: nonablative, fractional, and ablative laser resurfacing." J Am Acad Dermatol 58(5): ; quiz Jung, C. W. (2008). "Understanding of CO2 laser in dermatology." Journal of dermatology korean society for laser medicine and surgery 12(1): Raymond Rosen, Ph.D., Dept. of Psychiatry, Robert Wood Johnson Medical School, Piscataway, NJ 08854, USA. The Female Sex ual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Fem ale Sex ual Function. Journal of Sex & Marital Therapy, 26: , 2000 Copyright LEVANCINI A, Marco y GAMBACCIANI, Marco. Rev. chil. obstet. ginecol vol.80, n.2, pp ISSN Láser erbium vaginal como tratamiento del síndrome genitourinario de la menopausia: resultados preliminares.

42 Application of vaginal CO2 laser therapy to treat symptoms associated with vulvodynia and vulvar vestibulitis syndrome - A case series Dr. Ronen S. Gold, Attending senior physician at the Urogynecology and Pelvic Floor Reconstruction Unit and Coordinator of Treatment and Surgery of Anal Sphincter Tear After Birth (OASI) Services, Lis Maternity Hospital Tel Aviv Medical Center. Introduction: Generalized vulvodynia is a condition characterized by unexplained chronic or spastic, provoked or unprovoked, localized or widespread vulvar pain and burning sensation, frequently limiting daily activities and sexual function and incurring significant psychological distress. 1,2 The condition has an impact on the lives of up to 16% of the adult female population, with no racial clustering, but incidence rates may be highly underreported due to failure of many women to seek medical help. 3 Vulvar vestibulitis syndrome (VVS) is a subset of vulvodynia, characterized by idiopathic, localized, low tactile, pain and pressure thresholds, and is a common cause of entry dyspareunia in premenopausal women. While the cause remains elusive, increased blood vessel and nerve density is commonly observed. Topical and systemic medicinal treatment options include regular use of local anesthetics, estrogen creams, anticonvulsants, pudendal nerve blocks, tricyclic antidepressants or interferon injections, all of which have shown limited long-term efficacy. 4 Physiotherapy using biofeedback techniques train patients to both strengthen and relax pelvic floor muscles, in efforts to reduce muscle spasms and associated pain. 5 However, these approaches demand patient compliance and adherence, and only yield improvements after months of rigorous treatment. Surgical intervention has a reported success rate ranging between 65-90%, but is associated with a relatively high complication rate, prolonged a wound pain and downtime and can require weeks for full recovery. 6,7 Thus far, no single treatment option has demonstrated broad success among vulvodynia patients, and clinical resolution is typically partial and slow to develop. Laser-based interventions for vulvodynia and VVS management have been gaining popularity, due to their minimally invasive nature and marked efficacy. In fact, laser therapy has reportedly been as effective as vestibulectomy, with complete responses reported in >60% of patients and symptomatic improvement in >90% of patients. 8,9 The specific absorption of long-wavelength lasers by vascular-borne chromophores, is thought to lead to disruption of the highly dense vascular bed and to promote collagen remodeling without inducing macroscopic anatomic alterations. In contrast, the non-ablative CO2 laser energy is heavily absorbed by water, thereby inducing a deep thermal effect, without causing aggressive ablation, and has been successfully integrated in dermatological, gynecological and dental disciplines. A case series of deployment of non-ablative CO2 laser energy to manage typical vulvodynia symptoms is presented below. 1 ALMA SURGICAL FemiLift A Case Series Alma Lasers, Ltd. All right reserved.

43 Method: Women with vulvar or vaginal infection were not treated. Approximately three minutes before the procedure, a full ampule of lidocaine was topically applied to the introitus, to provide anesthetic relief. Note: EMLA cream was not used to avoid creation of an oily barrier and to allow for moderate anesthesia, which then enables intraprocedural patient feedback to prevent burns. Figure 1: FemiLift handpiece with a single-use hygienic probe Each pass involved insertion of the FemiLift probe (Figure 1) into the internal part of the vestibule, and activation (25 mj/pixel, high laser mode, 0.5 Hz) at three consecutive key clock positions, where the affected area is the middle position (e.g. 3, 6 and 9 o clock), followed by activation at the same positions in the external part of the vestibule (15 mj/pixel, high laser mode, 0.5 Hz). One or two more passes were then performed at the same positions; if patient reported intolerable pain, the treatment session was terminated. The total duration of the treatment session was approximately 10 minutes. Patients were advised to avoid sexual intercourse for 48 hours. When necessary, the same protocol was repeated at a second and third treatment session, conducted at four-weeks intervals. VVS symptoms were assessed before and after treatment, using a 10-point visual analog scale (VAS). Case Presentaion: Patient 1: A 45-year old, healthy woman with a history of three pregnancies and two deliveries complained of introital pain (VAS score: 9) at the 12 o-clock position, impacting work and sex life. The condition had failed to respond to numerous previous local treatment regimens. A physical examination showed no sign of infection, normal colposcopy and ruled out diverticula. A threecourse FemiLift treatment regimen led to immediate symptomatic relief, with patient-reported VAS scores of 6 and 4 after the first and second treatment sessions, respectively. A further reduction in pain levels was noted after the third treatment session (VAS: 1-2), and was maintained over the ensuing 5-month period. In addition, the patient reportedly resumed sexual activity after the treatment. Patient 2: A 32-year-old woman, gravida 1, para 1, complaining of vulvodynia (VAS score: 10) since delivery, with normal colposcopy findings and no signs of infection, and who had attempted to achieve improvement by way of local, behavioral and physiotherapeutic techniques, underwent a three-course FemiLift treatment series. A gradual improvement in symptoms was reported over the treatment period, with VAS scores of 7-8, 5 and 3 reported after treatment sessions 1, 2 and 3, respectively. 2 ALMA SURGICAL FemiLift A Case Series Alma Lasers, Ltd. All right reserved.

44 Patient 3: A 36-year-old women, gravida 2, para 2, presented with a two-year history of dyspareunia and pain when sitting (VAS score: 9). The patient was otherwise healthy and had no history of operations, and showed no signs of infection of colposcopic abnormalities. A two-course FemiLift regimen brought to significant symptomatic relief (VAS scores: 7 and 4, after treatment sessions 1 and 2, respectively). Patient 4: A 28-year-old, healthy women with no gestational history, no signs of infection and normal colposcopy test results reported introital pain that had started 5 years earlier. She had attempted various local and physiotherapeutic therapy options, but saw no improvement. A single FemiLift treatment session was sufficient to reduce patient VAS score from 9 to 3. No further treatment sessions were requested. Conclusion: The nonablative CO2 Laser FemiLift procedure for management of vulvodynia and VVS was highly efficacious, and provided immediate relief, that progressively increased with subsequent treatment sessions. No downtime was reported and no patient adherence was required. The treatment method presents a promising means of treating a highly distressing clinical issue which significantly impacts the lives of a high percentage of adult women. Consent: A Written informed consent was obtained from the patients for publication of this case report. A copy of this consent is available for review if needed. References: 1. McKay M. (1989) Vulvodynia A multifactorial clinical problem Arch Dermatol 125(2): Pukall CF, Binik YM, Khalife S. et al. (2002) Vestibular tactile and pain thresholds in women with vulvar vestibuitis syndrome Pain 96(1-2): Harlow B and Stewart E. (2003). A population-based assessment of chronic unexplained vulvar pain: Have we underestimated the prevalence of vulvodynia? Journal of American Medical Women's Association, 58(2), Masheb RM, Nash HM, Brondolo E, and Kerns RD. (2000) Vulvodynia: an introduction and critical review of a chronic pain condition. Pain 86(1-2): Bergeron S and Lord M. (2003) The integration of pelvi-perineal re-education and cognitive-behavioural therapy in the multidisciplinary treatment of the sexual pain disorders. Sexual and Relationship Therapy 18: Tommola P, Unkila-Kallio L, and Paavonen J. (2011) Long-term follow up of posterior vestibulectomy for treating vulvar vestibulitis. Acta Obstet Gynecol Scand, 90(11): Tommola P, Unkila-Kallio L, and Paavonen J. (2010) Surgical treatment of vulvar vestibulitis: a review. Obstet Gynecol Scand, 89(11): Leclair CM, Goetsch MF, Lee KK, et al. (2007) KTP-nd: Yag laser therapy for the treatment of vestibulodynia, a follow-up study. J Repro Med. 52: Reid R, Omoto KM, Precop SL, et al. (1995) Flashlamp-excited dye laser therapy of idiopathic vulvodynia is safe and efficacious. Am J Obstet Gynecol. 172: ALMA SURGICAL FemiLift A Case Series Alma Lasers, Ltd. All right reserved.

45 CO2 laser treatment as an effective and safe means of achieving genital wart excision Dr. Acky Friedman, (M.D, L.L.B) INTRODUCTION Condyloma acuminata, or genital warts, are small growths that develop externally on the genitalia, in the anal area internally in the upper vagina or cervix, and/or in the male urethra. This highly contagious, sexually transmitted condition, caused by the human papillomavirus (HPV) (Arima et al. 2010), has an incubation period of 3 weeks to 8 months (Yanofsky et al. 2012). Women with genital warts are at an increased risk for cervical cancer, underscoring the importance of careful diagnosis and selection of the appropriate treatment. Genital wart therapies include topical preparations that destroy wart tissue, surgical methods that remove wart tissue, and biological approaches that target the virus underlying the condition. Chemical and topical agents can have a caustic or destructive effect on the surrounding healthy tissue and their repetitive use is contraindicated. In addition, some topical preparations cause a burning sensation, pain, inflammation, itching, or erosion of the affected area. Surgical excision of the warts is accompanied by significant patient pain and scarring and is contraindicated for large anal and perianal lesions. Anti-viral therapies are costly and seldom limit recurrence of the condition (Perisic et al, 2004). Overall, cure rates of traditional treatment modalities are low, with incidence of recurrence within 3-12 months of treatment as high as 70% (Jablonska 1998, Yanofsky et al. 2012). Their unsatisfactory efficacy is primarily rooted in their focus on superficial removal of the wart, while the virus remains in a latent state in the epithelial layer. CO2 laser therapies have been often proven to be efficient and safe with low rates of persistence and recurrence (Ferenczy, 1983; Perisic et al, 2004; Azizjalali et al, 2012). Indeed, Bakardzhiev and his colleagues (2012) that treated patients with wide distribution of condylomatous lesions reported on successful eradication accomplished in most of them within one single treatment of CO2 laser. Lastly, CO2 laser vaporization was found associated with lower recurrence rates especially in case of extensive warts and tremendously effective for patients who have not responded to other treatments (Shi H et al,2013). CASE The Technology The Alma CO2 laser with its scanner, LiteScan, provide high-precision and char-free tissue ablation, with well controlled layer by layer vaporization enabling minimal damage to the surrounding tissue (Figure 1) Figure 1. LiteScan Scanner GENITAL WARTS AROUND THE ANUS: A CASE REPORT A male, 28 YO patient, presented with small genital warts around the anus (Figure 2). Local Anesthesia: lidocaine subcutaneous The affected area was sterilized with 70% alcohol. Settings: The Alma CO2 Pixel Laser, with a power of 10 W, dwell time of 2.0 msec, 20mj/pixel. Radiation was usually delivered via the 50mm handpiece for efficient excision. Prophylaxis: Antibiotic cream twice daily for 7 days Follow Up: 1 month Figure 3 shows the area immediately after treatment. The patient did not complain of any discomfort or experience 1 ALMA SURGICAL FemiLift case study

46 any bruising. No side effects were observed and the damage to the surrounding tissue was minimal. The patient got back to the clinic after one month to treat genital warts that grew in a different location in the genital area. Figure 2. Genital warts scattered around the anus Figure 4. Condyloma scattered around the penis shaft Figure 3. Genital warts immediately after CO2 laser treatment Figure 5. Condyloma 1 month following laser treatment. Almost cured. ANOTHER TWO CASES Figure 4 shows a male presenting large genital warts on the shaft of the penis. This male was treated only once with the laser. The genital warts have disappeared within 2 months from treatment. Another case of a male treated with the laser displayed in Figure 5. This male came to the clinic with a few genital warts in the groin. He was treated only once with a laser. 2 ALMA SURGICAL FemiLift case study

47 CONCLUSION Surveillance follow up calls revealed that many of the patients didn t come back for follow up since the treatment was highly effective without recurrence. Carbon dioxide laser vaporization is a safe, cost-effective and time-effective means of addressing the clinical manifestation and underlying cause of genital warts. "Alma CO2 laser is easy to operate in outpatient clinics. The ablative laser, when carefully directed to the field of treatment effectively excises condyloma, reducing its recurrence rate." Dr. Acky Friedman, (M.D, L.L.B) Aesthetics and Dermatology Specialist REFERENCES Alex Ferenczy (1983) Using the laser to treat vulvar condylomata acuminate and intraepidermal neoplasia. Can Med Assoc I voliume 128; p135. Arima Y, Winer RL, Feng Q, et al. (2010) Development of genital warts after incident detection of human papillomavirus infection in young men. J Infect Dis 202: Azizjalali M et al (2012) CO2 Laser therapy versus cryotherapy in treatment of genital warts; a Randomized Controlled Trial (RCT) Iran J Microbiology 4 (4) : Bakardzhiev et al (2012) Treatment of Condyloma Acuminata and Bowenoid papulosis with CO2 laser and imiquimod. Journal of IMAB Annual Proceeding (Scientific Papers) 2012, vol. 18, book 1 Jablonska S (1998) Traditional therapies for the treatment of condylomata acuminata (genital warts) The Australian Journal of Dermatology 39:S2-4. Perisic et al (2004) Treatment of condylomata acuminata surgical excision and CO2 laser vaporization. Acta Dermatoven APA Vol 13 (1), p9 Shi H et al (2013) Dermatology 227(4): Yanofsky VR, Patel RV, Goldenberg G. (2012) Genital warts A comprehensive review J Clin Aesthet Dermatol 5(6): KEY WORDS Condyloma, Genital warts, excision, CO2 laser 3 ALMA SURGICAL FemiLift case study Alma Lasers, Ltd. All right reserved.

48 April 2016 PIXEL CO2 LASER AS A TREATMENT OPTION FOR LICHEN SCLEROSUS Elias AJ1, Galich M1 Abstract Background: Contemporary lichen sclerosus (LS) treatment modalities suffer from dependence on long-term patient compliance and high recurrence rates. The fractional CO2 laser has been applied to treat skin disorders and induce vaginal rejuvenation and may overcome the drawbacks of current treatment options. Cases Two postmenopausal LS patients, resistant to conventional therapies, were treated with fractional CO2 laser. The patients became asymptomatic shortly after the third treatment, and the vulva, introitus and clitoral areas looked healthy throughout the 6-month post-treatment follow-up period. Histological assessments showed a trophic epithelium with acantotic areas, without superficial hyperkeratosis or the hyaline and eosinophilic collagen bands characteristic of LS. Conclusion: If confirmed in a large group of patients, this treatment concept might represent a new strategy for providing more than just symptomatic relief for a myriad of soft tissue conditions. Teaching Points: A. Improved clinical symptoms of Lichen Sclerosus following treatment with fractional CO2 laser. B. Histological changes that represent tissue healing. Introduction Lichen sclerosus (LS) is a chronic, inflammatory skin condition, most commonly occurring in adult women, although it can also be seen in men and children. It primarily affects the genital and perianal regions, where it causes persistent itching and soreness. Scarring after inflammation can lead to severe damage, including fusion of the labia and narrowing of the vaginal opening, if treatment is not initiated at an early stage. Biopsy to rule out squamous cell carcinoma is recommended in all patients suspected of having LS. Spontaneous remission is extremely rare, and affected people have an increased risk of genital cancer. [1,2] Therapeutic agents for LS include topical corticosteroids, which require continuous administration and patient adherence. A review of six treatment protocols is available in the Cochrane library [1]. Surgical approaches include vulvectomy and cryosurgery; however, these procedures leave scars on the damaged tissues and are associated with high recurrence rates. [3] the technique requires use of general anesthesia and a healing period of 6 weeks. The high cost of laser tools and the need to perform such procedures in surgical facilities, have seemingly limited widespread embracement of CO2 laser ablation strategies by physicians and patients. However, advancements in fractionated laser technology, which do not entail use of general anesthesia, and incur minimal superficial ablation alongside thermal cell activation and tissue rejuvenation have raised the popularity of this treatment approach, particularly in clinical dermatologic and plastic surgery procedures [5]. Application of such technology in the vulvo-vaginal area resulted in vaginal rejuvenation, manifested by thickening of vaginal epithelium enriched with collagen and neovascularization in the lamina propria [6]. The histological changes and relief of feminine discomfort, such as vaginal dryness and urinary incontinence, elicited by this technology [7], justify testing it as an alternative treatment for LS. Superficial ablation of LS by means of a CO2 laser has been known for a long time. [3-4] While considered a standard inpatient procedure, 1 Gynestetic, Health and Aesthetics, A center for pathologies of the pelvic floor and feminine cosmetics, Buenos Aires, Argentina 41 ALMA SURGICAL FemiLift

49 Cases Case #1. A 71-year-old woman, treated in our clinic for 8 months, complained of intense vulvar and perianal itching, and presented extensive white lesions in the introitus, vulvar and clitoral areas (Figures 2A, 3); biopsy analysis confirmed LS. Topical therapy with Clobetasol 0.5% and 2% testosterone cream resulted in transient improvement. The patient remained symptomatic for six more 6 months under this treatment, with no sexual activity. Histological assessments revealed hyperkeratosis, dermal hypotrophy, hydropic degeneration of basal epithelial cells, dermo-epidermal clefts, afibrillar papillary dermis with a frosted glass appearance, and inflammatory infiltrate rich in polymorphonuclear band and plasma cells. Fractional CO2 laser therapy was initiated in June Three treatment sessions were conducted at one-month intervals. A topical anesthetic was applied before treatment. Three passes were made at each session, with the laser set at Low (10 Watts) 20 Mjoules by Pixel, 2 Hz in the first and second sessions, and Med (30 Watts) 10 Mjoules by Pixel, 2 Hz in the third session. Moisturizer with anesthetic cream was applied following treatment and for seven days thereafter. The patient became asymptomatic shortly after the third treatment session, and the vulva, introitus and clitoral areas looked healthy, with elastic closure of the introitus (Figures 2B, 4). Tissue appearance was maintained throughout the 6-month post-treatment followup period. Histological assessment of samples collected 45 days following the last treatment showed a trophic epithelium with acanthotic areas, without superficial hyperkeratosis. A number of dermo-epidermal clefts were still apparent. The lamina propia appeared fibrillar and the hylan band typical of LS, was absent. In addition, irregular spaces containing translucent material were observed, as was moderate inflammatory infiltrate. Case #2. A 55-year-old woman, treated in our clinic for almost 3 years, complained of vaginal dryness, dyspareunia, intense itching and a narrow introitus. Extensive white lesions in the introitus, with bilateral symmetric kissing lesions were apparent. Three years of therapy with Clobetasol 0.5%, Platelet Rich Plasma (PRP) - and Testosterone cream 2% did not provide adequate relief; the patient reported transient improvements of itching, and intermittent symptoms. Biopsy confirmed Lichen Sclerosus. Pretreatment histological assessments revealed hyperkeratosis of the epidermis with significant thinning and loss of the normal papillary pattern. Vacuolar degeneration of the basal layer was also evident, yet typically mild, particularly in late stage lesions. Broad condensation of the dermal collagen, inflammatory lymphocytic infiltrate, scattered plasma cells, histiocytes and mast cells were dominant features (Date not shown). In July 2015, the patient started a fractional CO2 treatment course, comprised of three sessions delivered at one-month intervals, under topical anesthesia (Tetracaine-Lidocaine), with three passes at each session. Laser settings at sessions 1 and 2 were Low power (10 Watts) 15 Mjoules by Pixel and at session 3 were Medium power (30 Watts) 20 Mjoules by Pixel. Moisturizer with anesthetic cream was applied following treatments. Shortly following the third treatment session (November 2015), the patient became asymptomatic, and a post-treatment clinical examination demonstrated improvement in the appearance of the introitus, and in elastic opening and closing. Post-treatment histology revealed trophic epithelium with mild acanthosis, and areas with an increased number of cell layers. In addition, the lamina propria contained loose collagen and no hyaline band was observed. The tissue samples featured irregular spaces containing translucent material (image gruyere cheese) in the papillary dermis, mild inflammatory infiltrate and poorly dilated vessels. Masson's trichrome-stained samples exhibited a trophic epithelium, with a fibrillar appearance and light blue staining in the papillary area of the lamina propria, indicating the existence of type III collagen (Date not shown). The patient reported improved sexuality, with occasional dyspareunia. The improved macroscopic appearance and clinical symptoms were maintained throughout the six-month follow-up period. Discussion Lichen sclerosus is diagnosed by typical characteristics, including histological signs of superficial sclerosus, hyperkeratosis, and significant epithelium thinning. Once confirmed, steroids are the first treatment choice, and improvement of symptoms is usually apparent within 2-3 weeks. Topical corticosteroids, as anti-inflammatory agents, provide for symptomatic relief, but fail to restore histological architecture. Other steroid hormones, with or without immunemodulators, are used to address the lack of ovarian hormones in post-menopausal patients. Surgical intervention, including ablative CO2 laser therapy, is typically considered to be a symptomatic treatment as well. However, the histological alterations observed in these two patients such as disintegrating fibrosis, stimulated collagen production in the lamina propria, and disappearance of the hyaline band, suggest a more comprehensive healing effect of the fractional CO2 laser. Recent publications describing fractional CO2 laser therapy as an efficient mean of reversing the typical post-menopausal vaginal wall histology to the premenopausal architecture [7], calls for indepth research to understand the underlying physiologic and pathophysiologic mechanisms. Most publications describing vaginal rejuvenation rely on subjective patient responses to questionnaires, such as the visual analogue scale (VAS), the International Consultation on Incontinence modular Questionnaire (ICIQ-UI), or the Vaginal Health Index Score (VHI-S). 2 ALMA SURGICAL FemiLift

50 Some of these articles describe histological remodeling and vaginal rejuvenation [6] and suggest the involvement of heat shock proteins 43, 47 and 70 in localized increases in specific cytokines, which consequently activate fibroblasts to produce new collagen and new blood vessels [8]. Didactic tools will be necessary to systematically monitor early and late consequences of fractional CO2 laser treatment of LS and similar pathologies and to test the hypothesis that thermal effects in the sup-epithelial layer triggers cellular activation. Such studies will be essential in optimizing treatment protocols for a large variety of conditions involving feminine discomfort. The recent changes in medical terminology from Vulvo-Vaginal Atrophy (VVA) to Genitourinary Syndrome of Menopause (GSM), places emphasis on a large variety of genital symptoms such as dryness, burning, irritation and urinary disorders. Pixel beam splitter Focusing lens Final laser pixel beams If fractionated CO2 laser therapy is confirmed an efficient modality, this treatment concept might represent a new strategy for providing more than just symptomatic relief, by also for eliciting a rejuvenation response, and serving as a platform to define other GSM treatment protocols. The improved quality of life in these two patients who did not respond to conventional medications, justifies prospective studies focusing on laser-modified vaginal histology. FIGURE 1: The FemiLift CO2 microablative laser Laser beam Split beams However, the choice of the new terminology may represent more than just a semantic issue. Progress made in diagnostic and therapeutic technologies will inevitably stimulate in-depth research of external genital diseases and related symptoms. The laser beam is passed through a pixelating holographic lens, forming a 9x9 mm spot size. The thermal effect is achieved in microscopic columns surrounded by spared tissue, from which healthy cells are recruited to accelerate the healing process. FIGURE 2 A - left: pretreatment 3 ALMA SURGICAL FemiLift B - right: post treatment

51 FIGURE 3 A. Histology. 4X magnification. Hyperkeratosis (a), dermal hypotrophy (b) hydropic degeneration of the basal epithelial cells (c), dermo and epidermal clefts (d), homogeneous afibrillar papilae with frosted glass appearance (e), and inflammatory infiltrate of polymorphonuclear band and plasma cells (f). Figure 4. Post-treatment Histology. 4x magnification. Trophic epithelium with acanthosis, without superficial hyperkeratosis (a), some areas with dermo-epidermal clefts (b), Lamina propria appearance fibrillar and absence of scleral band hilaina typical of lichen (c), Irregular spaces containing translucent material (image gruyere cheese) (d), and moderate inflammatory infiltrate. FIGURE 3B. Pre-treatment Histology. 10X magnification. Hyperkeratosis (a), dermal atrophy, hydropic degeneration of the basal epithelial cells (b) dermo epidermal clefts (c) homogeneous papillary dermis, afibrillar with frosted glass appearance and edema (d) and inflammatory infiltrate of polymorphonuclear band and plasma cells (e). FIGURE 4B.: Post-treatment Histology. 10X magnification. Trophic epithelium without superficial hyperkeratosis (a), Persistence in some basal cells hydropic degeneration (b), Persistence of some areas with dermo-epidermal clefts (c), and Lamina Propria fibrillar with Irregular spaces containing translucent material (d). 4 ALMA SURGICAL FemiLift

52 References 1. Chi CC, Kirtschig G, Baldo M, Brackenbury F, Lewis F, Wojnarowska F. Cochrane Database Syst Rev. Topical interventions for genital lichen sclerosus. 2011;7;(12). 2. Pugliese, JM; Morey, AF; Peterson, AC. Lichen Sclerosus: Review of the Literature and Current Recommendations for Management. J Urol, 2007; 178 (6): Abramov Y, Elchalal U, Abramov D, Goldfarb A, Schenker JG. Surgical treatment of vulvar lichen sclerosus: a review. Obstet Gynecol Surv. 1996;51(3): Peterson CM, Lane JE, Ratz JL. Successful carbon dioxide laser therapy for refractory anogenital Lichen Sclerosus. Dermatol Surg. 2004;30(8): Salvatore S, Leone Roberti Maggiore U, Athanasiou S, et al. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015;22(8): Salvatore S, Napi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Maggiore ULR. A 12-week treatment with ftactional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric, 2014;17; Dafforn TR, Della M, Miller AD. The molecular interaction of heat shock protein 47 (Hsp47) and their implications for collagen biosynthesis. J. Biochem 2001;276: Berlin AL, Hussain M, Phelps R, Goldberg DJ. A prospective study of fractional scanned nonsequential carbon dioxide laser resurfacing: a clinical and histopathologic evaluation. Dermatol SUrg. 2009;35: ALMA SURGICAL FemiLift

53 From Dr. David Ghozland, OB/GYN Dear Doctor, For 10 years, I ve prided myself on providing patients with the most innovative technologies and techniques in vaginal reconstructive procedures and gynecological health. Constantly, my team and I strive to offer the greatest result with the fewest risks, the least pain and most minimally invasive techniques. With that mission in mind, I began offering FemiLift in August, I remain impressed. FemiLift not only helps to restore gynecological health, it can improve the quality of patients lives quite dramatically. FemiLift is a sophisticated, precision tool, but a minimally invasive procedure. This means that I can offer FemiLift from the comfort of my Santa Monica office, a tranquil environment that relaxes and assures patients. FemiLift requires no anesthesia and patients can return to work or normal day to day activities after the treatment, two big pluses for my patients. As you can see from the below histologies featuring the vaginal mucosa before and after FemiLift, the epithelium and the filling of the ablated tissue display a healthier, improved tissue that restored metabolic trophism and dynamics of the whole epithelium. (The perimenopause patient histology above shows the vagina mucosa before FemiLift/Pixel CO2 treatment stained with haematoxylin and eosin (H&E) and 60 days following FemiLift treatment.) I m very proud to be one of the first medical professionals in the world to offer this innovative procedure. FemiLift patients have expressed great satisfaction with their results. For that reason, the FemiLift device is and will continue to be an excellent addition to my practice. Dr. David Ghozland, M.D., is a board certified OB/GYN who specializing in women s health concerns. Learn more about Dr. Ghozland and his practice at FE Rev A

54 menschen, ideen, perspektiven Intimchirurgie Der Trend minimalinvasiver Eingriffe wird sich weltweit fortsetzen Operationen im Intimbereich boomen nicht nur in den USA. Weltweit wächst die Zahl der Frauen, die sich chirurgisch die Vagina verengen, die Unschuld erneuern, die Form der Schamlippen mit Laserstrahlen korrigieren oder den G-Punkt durch Injektionen vergrößern lassen. Viele unserer Patientinnen haben uns anvertraut, dass sie mit dem Aussehen ihres Intimbereichs nicht mehr glücklich sind, heißt es etwa auf der Website des Laser Vaginal Rejuvenation Institute, San Antonio. Und weiter: Ladies, Ihr braucht euch jetzt nicht länger zu schämen. Wir können eure Vagina komplett neu formen und verjüngen. Gröne: Lieber Herr Dr. Bader, Eingriffe wie die Korrektur der inneren oder äußeren Schamlippen empören nicht nur Feministinnen. Die Intimchirurgie sei nur das jüngste Beispiel dafür, wie Frauen zur Anpassung an ein Schönheitsideal gezwungen würden. Niemand hat bisher einen Gedanken daran verschwendet. Dann kam einer daher und trumpfte auf: Da ist ja noch ein Körperteil, der keinen Laser abbekommen hat. Lasst uns mal ein bisschen Geld daraus machen, lästert Ophira Edut, Herausgeberin des Buches Body Outlaws. Auch aus der Ärzteschaft gibt es Gegenwind. Das Ethik-Komitee der Amerikanischen Vereinigung der Gynäkologen und Geburtshelfer ist ebenso beunruhigt über die Werbung der neuen Kliniken in populären Magazinen wie Glamour, Harper s Bazaar und Allure. Doch diese Beispiele finden sich nicht nur in den USA, sondern weltweit von Europa bis zu den Philippinen. Sind wir Ärzte insgesamt zu aggressiv mit dem Thema Intimchirurgie nach außen getreten? Bader: Die Sprache der Pornoindustrie und der Medien ist nicht die des Arztes oder Chirurgen. Unangemessenes und unsachgemäßes Auftreten wird hier wie in ganz Europa von den Ärztekammern reguliert und medizinrechtlich schwer sanktioniert. Die Werbung ist bei uns also eher dezent. Die kosmetische und rekonstruktive Vaginalchirurgie ist nicht nur ein Ergebnis der medialen Werbung. Es existiert auch ein Bedürfnis der Patientinnen, ihre Lebensqualität zu verbessern. Die sexuelle Befreiung in der modernen westlichen Gesellschaft ermöglicht es den Menschen, mehr und mehr über ihr Intimleben und sogar über intime Körperregionen zu sprechen. Die Menschen haben nicht mehr nur im Dunkeln Sex und kennen ihre Anatomie sehr gut. Gröne: Offensichtlich wird aber in der Öffentlichkeit das Thema der Intimchirurgie zu sehr auf Design-Vagina reduziert. Dabei beinhaltet die Intimchirurgie in erster Linie die Wiederherstellungschirurgie von Verstümmelungen und die Korrektur anatomischer Fehlbildungen. Dr. Dirk H. Gröne Facharzt für Haut- und Geschlechtskrankheiten in Berlin Dr. Dirk Gröne ist Vorstandsmitglied der ADK und im Beirat der Zeitschrift für die Themen Strategie und internationale Trends zuständig. Dr. Alexandros Bader Facharzt für Gynäkologie und ästhetische Chirurgie. Präsident der European Society of Aesthetic Gynecologiy (ESAG). Direktor des Keep Femina Medical Centers, Athen. Bader: Ich praktiziere unter anderem in Athen. Die Griechen haben rund um das Thema Schönheit eine jahrtausendalte Tradition und ein gesundes Verhältnis zu ihrem Körper. Bereits Frauen der Antike pflegten ihre Schleimhaut mit bleichenden Substanzen und Schüler von Pythagoras berechneten den Körper im goldenen Schnitt. Die Intimchirurgie, und hier voran die Vaginalverjüngung, ist weniger ein Trend der Schönheitsindustrie, als ein weiterer Schritt des Bedürfnisses nach Jugendlichkeit, einem erfüllten Liebesleben und einem gepflegtem Aussehen. Gröne: Weltweit findet man eine hohe Nachfrage nach kosmetischen oder chirurgischen Verschönerungseingriffen, die Laserepilation der Bikinizone, die Brustvergrößerung oder auch die Gestaltung der Vagina. Muss es der Arzt heute normal finden, wenn seine Patientinnen mit einem Playboy -Heft in der Hand ankämen, um dem Arzt zu zeigen, wie sie unten aussehen möchten? Bader: Dieses Verhalten habe ich noch nicht beobachtet. Aber es ist schon richtig, dass die Patientinnen sich oft bereits im Vorfeld eine Meinung zum Thema gemacht haben. Um die Möglichkeiten und vor allem die Grenzen eines chirurgischen Eingriffes zu verdeutlichen, zeigen wir den Patientinnen zuvor Bilderserien. Im Prinzip klären wir die Patientinnen auf und leiten sie an, in ihrer Vorstellung nicht an einem bestimmten 2 ästhetische dermatologie

55 menschen, ideen, perspektiven Modell anzuhaften. Jeder hat ein einzigartiges Erscheinungsbild. Unsere Aufgabe ist es, die Patientinnen gemäß ihrer Symmetrie und der korrekten funktionellen Anatomie zu verbessern. Gröne: Leroy Young, Vorsitzender des Komitees für neue Trends bei der Amerikanischen Gesellschaft für Schönheitschirurgie, glaubt, dass die zunehmende Akzeptanz von Pornografie und die Unsicherheit darüber, was normal ist, die Nachfrage weiter fördern wird. Bader: Die Griechinnen führen bereits seit Jahren die Hitliste verjüngender Operationen in Europa, vor Spanien und Portugal, an. Der Trend minimalinvasiver Eingriffe wird sich durch den technologischen Fortschritt weltweit fortsetzen. Bereits heute sind chirurgische Laser so sanft einzusetzen, dass sichtbare und fühlbare Veränderungen ohne Ausfallszeit erzielt werden können. Es ist also mehr eine Kopfsache und eine Frage der Überwindung sich einem Arzt anzuvertrauen, die die Zahl der Eingriffe noch begrenzt. Gröne: Sie sind ein sehr erfolgreicher Chirurg mit einer beeindruckenden Klinik. Was ist Ihre Motivation, noch zusätzlich in London und Dubai zu operieren? Bader: Das ist einerseits das Vergnügen, sich in beiden Metropolen aufzuhalten, andererseits der Reiz des fremden Standortes. Jede Klinik hat seine eigene Magie mit besonderen Patienten. Ein weiteres Feld der medizinisch relevanten Imtimchirurgie ist die Verengungschirurgie der Vagina aufgrund einer medizinischen Gegebenheit. Meist haben diese Frauen bereits mehrere Kinder zur Welt gebracht und die Schleimhaut hat sich nie komplett davon erholt. In Dubai kommen die Patientinnen oft aus Afrika oder dem Nahen Osten zu mir gejettet, um ihre Familie in der Hochzeitsnacht nicht zu blamieren. Diese Patientinnen stellen wir wieder so her, als wäre zuvor nie etwas passiert und verschönern in der gleichen Sitzung die Form und Farbe der Vagina. In London führen wir häufiger plastisch rekonstruktive Eingriffe nach unehelichem Geschlechtsverkehr und Misshandlungen durch. Die Wiederherstellung der Jungfräulichkeit oder Verfahren der gynäkologisch verjüngenden Eingriffe sind für die Klientel aber auch nicht neu. Gröne: Der Pionier der Chirurgie in der weiblichen Intimzone ist der Kalifornier David L. Matlock. Er prägte die einschlägigen Begriffe und bildet Gynäkologen aus den USA, Kanada, Europa, Südostasien und Australien aus. Seine Mission sei es seit ehedem, Frauen das Rückgrat zu stärken und zu einem erfüllten Liebesleben zu verhelfen, beteuerte Matlock nicht nur zuletzt in der Reality-Show Dr Wie lautet Ihre Mission? Bader: Wir sind da eher nüchtern eingestellt. Es gibt einen Leistungskatalog, den jeder gynäkologische Facharzt oder plastische Chirurg mehr oder weniger gut bedient. Unsere häufigsten Behandlungen sind: Labioplastie, Genital Whitening, Vaginalstraffung, G-Punkt-Augmentation, perineale Narbenkorrektur, Labia-majora-Augmentation und seit zwei Jahren sehr erfolgreich die minimalinvasive Laservaginalverjüngung mit dem FemiLift. Gröne: Hierbei handelt es sich um ein neues Verfahren zur Schleimhautbehandlung mit einem speziell für diesen Körperbereich entwickelten Laserhandstück. Nun gibt es auch andere Verfahren zur Vaginalverengung wie Eigenfett, Filler oder chirurgische Nahttechniken. Wo sehen Sie die Vorteile der Lasermedizin und im Besonderen die des FemiLift -Systems? Bader: Die Indikation entscheidet über die Vorteile einer Technik. Der FemiLift ist ein spezielles Handstück, das die Vaginalschleimhaut über ein definiertes Behandlungsareal erhitzt. Dadurch kommt es zu einer vorhersehbaren Straffung und im Verlauf zu einer Verdichtung des Gewebes. Dieser Effekt geht mit einer Reihe von biologischen Veränderungen einher, die sie nun unterschiedlich benennen können: Verengung, Verjüngung usw. Die eigentliche Indikation ist die Stressharninkontinenz Typ I-II. Hierzu haben wir bereits Fälle publiziert, u. a. in Deutschland, und gerade ein Studienprotokoll bei der Ethikkommission zusammen mit Kollegen aus der Urologie, Gynäkologie und plastischen Chirurgie eingereicht. Der CO 2 -Laser ist aber nicht nur vaginal einzusetzen, sondern verfügt über Inzisionshandstücke und einen ausgezeichneten Scanner zur Behandlung jeder Art von Haut- und Schleimhauttumoren. Dr. Alex Bader, Athens Clinic Mithilfe sanfter Laser können inzwischen Eingriffe ohne längere Ausfallzeiten durchgeführt werden ästhetische dermatologie 3