Vulvovaginal Atrophy Vaginal Tightening (Descensus Vaginae)

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Vulvovaginal Atrophy Vaginal Tightening (Descensus Vaginae) THE EFFECTIVE, CUTTING-EDGE, HORMONE-FREE LASER TREATMENT FOR VULVOVAGINAL DISEASES VULVOVAGINAL ATROPHY VAGINAL TIGHTENING (DESCENSUS VAGINAE) GENITOURINARY SYNDROME OF MENOPAUSE MILD STRESS URINARY INCONTINENCE The best alternative to hormonal therapy and surgery . Most of the urogenital diseases connected with the menopause follow a reduction in the production of estrogen by the ovaries. This involves the gradual thinning of genital epithelial tissues, vaginal and vulvar mucosa, which reduce in thickness and moistness becoming more fragile, irritable and sensitive to trauma. Hormonal therapy has been for a long time the gold standard for postmenopausal symptoms. Urological symptoms such as Stress Urinary Incontinence deriving from childbirth and natural ageing process and affecting the pelvic floor structure have been historically treated by mean of surgery restoring the vaginal anatomy. Juliet represents a minimally invasive, effective and hormone-free treatment option for all women who do not wish invasive and/or hormone based options. MCL31 IV 100 0117 EN 2 Advantages in application and technology Application Technology . Fast, painless, discreet and easy to use . Er:YAG wavelength for best results and less side effects . No anesthesia necessary . Ablative and sub-ablative mode (thermal mode) . No surgery, minimal downtime . More than 2,000 Er:YAG lasers worldwide . No risk for infection or bleeding . Over 15 years experience in Erbium technology MCL31 IV 100 0117 EN 3 Device specifications Laser: MCL31 Dermablate (Er:YAG), Class 4 Wavelength: 2,940nm Fluence: Max. 250 J/cm² Pulse duration: 100 – 1,000 µs Frequency : 1 – 20 Hz Modes: Gyn C, Gyn W, Ablation, Therm, MicroSpot Handpieces Gyn: Steri-Spot, V-Spot 90°*, V-Spot 360°* Additional handpieces: MicroSpot*, VarioTEAM* Dimensions: 36 x 60 x 93 cm (W x D x H) Weight: Ca. 75 kg * optional MCL31 IV 100 0117 EN 4 Why an Erbium:YAG Laser 100000 10000 1000 Deoxyhemoglobin ] -1 100 Water Protein 10 Melanin 1 Oxyhemoglobin 0.1 Absorption[cm Coefficient 0.01 Scattering 0.001 0.0001 100 200 300 400 500 1000 2000 3000 4000 5000 10000 Wavelength [nm] MCL31 IV 100 0117 EN 5 Why an Erbium:YAG Laser Tissue Ablation (Vaporisation) Heating Er:YAG Necrosis CO2 Er:YAG Laser CO2 Laser 2,940nm: water absorption peak Lower water absorption Ablation layer by layer Deep, uncontrolled ablation Controlled thermic effect, Uncontrolled thermal effect, no thermal damage necrosis areas Cold ablation possible No cold ablation possible MCL31 IV 100 0117 EN 6 Intravaginal handpieces V-Spot* With 90° reflecting gold-coated With 90° or 360°reflecting gold-coated mirror, for SINGLE USE mirror, for MULTIPLE USE Handpiece Optic for Handpieces Optic for Steri-Spot V-Spot * optional MCL31 IV 100 0117 EN 7 Additional handpieces MicroSpot* VarioTEAM* Fractional handpiece Ablative handpiece with 13x13 mm spot and variable cover rate with variable spot size 1-6 mm for the treatment of the vulva, it allows for a for different ablative treatments complete therapy of vulvovaginal disorders in the vulvar area * optional MCL31 IV 100 0117 EN 8 Micro-Spot Technology . Squared spot of 9 x 9mm, consisting of 169 MicroSpots . MicroSpot optic with stable and precise micro lens array technology . Selective treatment of only “fractions” of the tissue in the form of a grid . Triggers skin renewal and collagen formation with rapid wound healing supported by the untreated skin . Very low risk of side effects Laser beam entrance Pattern on the Micro lens array Fractional laser beam treated area MCL31 IV 100 0117 EN 9 Variable pulse length . The adjustable pulse length allows for both cold ablative and thermal treatment . This maximizes the results reducing the amount of sessions to two EPITHELIUM LAMINA PROPRIA MAZ* MAZ* MAZ* GYN C GYN W Pulse length 300 µs 1,000 µs Effect on the tissue Cold ablation Sub-ablative thermal treatment MCL31 IV 100 0117 EN 10 * MAZ = Microscopic ablation zone by Dr. Bettina A. Buhren & Dr. Peter A. Gerber, Hautklinik Düsseldorf Indications 1. Vulvovaginal Atrophy . Women undergoing menopause often experience a number of symptoms including vaginal dryness, itching, painful intercourse, poor lubrication, decreased libido and poor vaginal muscle elasticity and tone . This condition is also described as Vaginal Atrophy and it follows a reduction in the production of estrogen by the ovaries and is found in 10-40% of post-menopausal women. It involves the gradual thinning of genital epithelial tissues, vaginal and vulvar mucosa, which reduces in thickness and becomes more fragile, irritable and sensitive to trauma . Women with untreated vaginal atrophy often suffer from vaginal paresthesia, a feeling of dryness, itching, burning and even pain during sexual intercourse and can be a contributing factor in urinary incontinence and for many women leads to an overall lack of quality of life Premenopausal vaginal tissue Postmenopausal vaginal tissue MCL31 IV 100 0117 EN 11 Indications 2. Vaginal Tightening (First-degree Descensus Vaginae) . Descensus of the vagina occurs when, due to factors like vaginal births, weakness of the connective tissue, heavy physical work, ageing processes and hormone deficiencies, the pelvic floor tissue slackens, leading to a bulging of the vaginal walls . The mild descensus of the vagina is often experienced as an excessively wide vagina and most women refer to it complaining a loss of vaginal tightness . This is directly related to reduction in friction during intercourse and thus to a decrease or loss of sexual gratification. Normal vagina Enlarged vagina MCL31 IV 100 0117 EN 12 Indications 3. Genitourinary Syndrome of Menopause (GSM) . The term Genitourinary Syndrome of Menopause* refers to a complex of symptoms, which are essentially caused by the post-menopausal hormone deficiency described in case of vaginal atrophy . GSM is chronic, if not treated it advances and can interfere with the quality of life . It is estimated that one in two women in menopause is affected by this complex of life-quality-impairing disorders such as vaginal dryness, burning, paresthesia, restricted capacity for sexual pleasure due to decreased lubrication or even pain during intercourse, as well as urinary urgency, dysuria and repeated bladder infections. Genital symptoms: vaginal dryness, burning, irritation . Sexual symptoms: poor lubrication, dyspareunia . Uro-gynecological symptoms: urgency, urge incontinence, dysuria *Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Portman et al., Menopause. 2014 Oct;21(10):1063-8. MCL31 IV 100 0117 EN 13 Indications 4. Mild Stress Urinary Incontinence . The term Stress Urinary Incontinence (SUI) refers to the involuntary loss of urine during coughing, sneezing or physical exertion. The underlying cause of this condition is often the decreased stability of the connective tissue and a loss of support of the urethra . It is a quite widespread disease prevalent in women after their first birth (24% to 29%) and in women undergoing menopause because of the reduction in estrogen production. Similarly, frequent exercise in high-impact activities can cause athletic incontinence to develop . Women with Stress Urinary Incontinence have an altered connective tissue metabolism, which causes decreased collagen production and which may result in insufficient support of the urogenital tract. Normal pelvic floor muscle Weak pelvic floor muscle MCL31 IV 100 0117 EN 14 Mechanism of action . Juliet is a minimally invasive treatment, the goal of which is to restore the original metabolism of connective tissue by stimulating new collagen production . As a result of laser irradiation the intermolecular crosslinks of the triple helix of collagen shorten, which leads to the immediate tightening of collagen fibrils by two-thirds of their length . This leads to an improvement in the condition of the vaginal skin and in the tone of the pelvic muscle, strengthening the vaginal tissue that contributes to support of the interior tissue and wall . The inner mucosa regains elasticity and lubrication, showing improved thickness and softness MCL31 IV 100 0117 EN 15 Mechanism of action The wall of the vagina is composed of the following layers: . Epithelium: internal lining of epithelial tissue made up of squamous epithelial cells . Lamina propria: connective tissue that supports the mucosa and connects it with the muscularis . Muscularis: muscle tissue . Adventitia: connective tissue interlaced with elastic fibers, attaches the vagina to surrounding organs Objective of the laser treatment is to reach the Lamina propria, elastic and rich in collagen that can be stimulated. MCL31 IV 100 0117 EN 16 Mechanism of action . This action continues its beneficial effect even after the treatment is finished: for this reason, many women report further improvements during the first months post-treatment Phase I Phase II Phase III 48 – 72 h 1 Month After 1 month . Early thermal effect . Proliferation . Remodeling . Edema, collagen and elastin . Formation of new collagen . New vascularization, shrinking fibers Improved lubrication MCL31 IV 100 0117 EN 17 Mechanism of action . There are indications in the scientific literature that vaginal laser therapy can lead to an improvement in symptoms of atrophy. Histological studies by Prof. R. Milani of Monza, Italy have already shown how the vaginal epithelium regenerates following laser therapy and further clinical observations
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