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Fractional CO2 Laser Versus Promestriene and Lubricant in Genitourinary Syndrome of Menopause: a Randomized Clinical Trial

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Fractional CO2 Laser Versus Promestriene and Lubricant in Genitourinary Syndrome of Menopause: a Randomized Clinical Trial CE: T.M.; MENO-D-18-00425; Total nos of Pages: 8; MENO-D-18-00425 Menopause: The Journal of The North American Menopause Society Vol. 26, No. 8, pp. 000-000 DOI: 10.1097/GME.0000000000001333 ß 2019 by The North American Menopause Society Fractional CO2 laser versus promestriene and lubricant in genitourinary syndrome of menopause: a randomized clinical trial Carlos A. Politano, MD, Lucia Costa-Paiva, MD, PhD, Luiza B. Aguiar, MD, Helymar C. Machado, MSc, and Luiz F. Baccaro, MD, PhD Abstract Objective: The aim of this study was to compare the effects of fractional CO2 laser therapy, promestriene, and vaginal lubricants on genitourinary syndrome treatment and sexual function in postmenopausal women. Methods: We performed a randomized clinical trial including 72 postmenopausal women over the age of 50 years. The women were randomized into three intervention groups to receive one of the following treatments: three sessions of intravaginal fractional CO2 laser therapy; 10 mg of intravaginal promestriene cream 3 times a week; and vaginal lubricant application alone. Vaginal maturation, Vaginal Health Index (VHI) score, and Female Sexual Function Index (FSFI) were evaluated at baseline and after 14 weeks of therapy. Results: We observed an improvement in the vaginal elasticity, volume, moisture, and pH in the CO2 laser and promestriene groups. The VHI score at 14 weeks was higher in the CO2 laser group (mean score 18.68) than in the promestriene (15.11) and lubricant (10.44) groups (P < 0.001). Regarding vaginal maturation, basal cells were reduced and superficial cells were increased after treatment. This improvement was more significant in the CO2 laser group (P <0.001). The FSFI score only showed improvement in the desire and lubrication domains in the CO2 laser group. There were no differences in total FSFI score among the three treatment groups. There were no adverse effects associated with any of the treatments. Conclusions: The use of fractional CO2 laser therapy to treat genitourinary syndrome resulted in better short- term effects than those of promestriene or lubricant with respect to improving the vaginal health in postmenopausal women. Key Words: CO2 laser – Dyspareunia – Female sexual function – Genitourinary syndrome – Postmenopausal – Promestriene – Vulvovaginal atrophy. enitourinary syndrome of menopause (GSM) is These changes can lead to dyspareunia, burning, fissuring, characterized by a variety of menopausal, genital and postcoital bleeding, and can negatively affect sexual G (dryness, burning, and irritation), sexual (lack of function.1 lubrication, discomfort/pain, impaired function), and urinary Topical estrogens are the most common and effective treat- symptoms (urgency, dysuria). GSM, a new term, was created ments for GSM symptoms and can be administered in several to replace vulvovaginal atrophy (VVA) because it is more forms, including creams, tablets, suppositories, and rings; accurate, all-encompassing, and acceptable to patients.1-3 however, no specific treatment regimen has been shown to Decreased circulating estrogen causes thinning of the be superior to others.4 The beneficial effects are more evident vaginal epithelium, reduces its collagen content and hyalini- during the therapeutic administration only.5 The safety of low- zation, decreases its elastin content, increases the connective dose vaginal estrogen therapy (ET) is concerning to survivors tissue density, and reduces the vascularity of the vagina. of estrogen-dependent neoplasias. In these women, nonhor- monal vaginal lubricants and moisturizers used during sexual intercourse may be preferred as an initial therapy.6-8 Received December 14, 2018; revised and accepted January 24, 2019. In 2014, the SmartXide CO2 laser was cleared by the US From the Department of Obstetrics and Gynecology, Faculty of Medical Sciences, State University of Campinas-UNICAMP Campinas, Sa˜o Food and Drug Administration (FDA) for ‘‘incision, excision, Paulo, Brazil. vaporization and coagulation of body soft tissue in medical Funding/support: None. specialties including gynecology.’’9 In 2014, Salvatore et al Financial disclosure/conflicts of interest: None reported. performed the first pilot study using the fractional CO2 laser to Clinical Trial Registration: The study protocol was approved by the treat vaginal atrophy. They reported an improvement in GSM Ethics Committee of the Faculty of Medical Sciences-UNICAMP under 10 number (CAAE: 56634016.0.0000.5404). This study was cataloged in symptoms among postmenopausal women. Additional laser the Brazil Platform and Registry of Clinical Trials (Rebec) under the systems have since become available for the treatment of UTN identifier U1111-1220-1620. GSM.11 Address correspondence to: Lucia Costa-Paiva, MD, PhD, Department of Obstetrics and Gynecology-CAISM/Unicamp, Alexander Fleming 101, Current GSM treatments, although effective in the short Campinas, Sao Paulo, Brazil. E-mail: [email protected] term, are associated with relapses and low compliance rates. Menopause, Vol. 26, No. 8, 2019 1 Copyright ß 2019 The North American Menopause Society. Unauthorized reproduction of this article is prohibited. CE: T.M.; MENO-D-18-00425; Total nos of Pages: 8; MENO-D-18-00425 POLITANO ET AL Thus, new therapeutic options are needed to overcome the Trials (Rebec) under the UTN identifier U1111-1220-1620. inconvenience of vaginal administration, poor efficacy rates, All participants signed an informed consent form before the and potential contraindications to VVA of current therapies. start of data collection. Although laser technology seems to be another option for Seventy-two postmenopausal women were enrolled from the treating GSM, long-term efficacy and safety data remain UNICAMP Menopause Outpatient Clinic, social media, or were scarce; the available data are primarily from observational patients at an outpatient clinic associated with the first author studies with no comparison groups and only short-term (C.A.P.). The inclusion criteria were the following: women follow-up. Despite this, vaginal lasers in clinical practice aged 50 to 70 years; physiological amenorrhea for at least have been disseminated and this practice received strong 12 months; symptoms of vaginal dryness with or without dys- criticism from regulatory agencies such as the FDA,12 and pareunia, vaginal burning, or pruritus; and no use of hormonal the criticism was further endorsed by medical societies such medications to treat vaginal symptoms in the prior 6 months. as The North American Menopause Society (NAMS).13 Participants were excluded for any of the following reasons: Thus, well-designed research to better delineate specific previous bilateral oophorectomy; body mass index (BMI) <18.5 applications of this technology is desirable before advocating or >30 kg/m2; contraindications to local estrogen use, including its universal use for the treatment of GSM. Currently, there recent myocardial infarction, severe hypertension, diabetes mel- are no studies comparing vaginal promestriene with vaginal litus, thromboembolic disorders, previous breast or endometrial laser therapy for GSM or sexual function. Therefore, our cancer, or abnormal postmenopausal bleeding. Women under- objective was to compare the effects of fractional CO2 laser going behavioral treatment for depression or taking antidepres- therapy, vaginal promestriene, and vaginal lubricants in the sant medications, those with any other psychiatric disorders, treatment of genitourinary syndrome and sexual function in HIV-positive women on antiretroviral therapy, women with a postmenopausal women. history of previous radiation therapy, and women with prior surgery for stress urinary incontinence were also excluded. METHODS Sample size Study interventions and randomization At the time that this protocol was developed, there were no Seventy-two women were randomly assigned to one of studies comparing CO2 lasers with estrogen and vaginal the three treatment groups. Thus, 24 women in each group lubricant therapies. Thus, results of open prospective pilot received one of the following treatments for 12 weeks: intervention study using fractional CO2 laser treatment Intravaginal fractional CO2 laser: three sessions performed 2 2 showed changes in Vaginal Health Index (VHI) before and at 30-day intervals (using the SmartXide V LR, Mon- after treatment were used as the basis for the present study alisa Touch [DEKA Laser, Florence, Italy]). protocol.16 The number of patients needed for the study was Vaginal cream containing promestriene: one vaginal calculated based on a standard deviation (SD) of 2.5, a applicator containing 1 g of cream and 10 mg of prom- estriene (Eurofarma Laboratorie S.A, Brazil) adminis- difference of 2 points in the VHI, a significance level of tered 3 times a week. 5%, and a power of 80%. To account for the potential loss of Lubricant gel: water-based lubricant (KY—Johnson & John- participants during the follow-up period, an initial sample son, New Brunswick, NJ) applied with sexual activity. of at least 20 patients was adopted for each group. A post hoc analysis was also performed, and the power of the sample was The participants were randomized to one of the three calculated based on the data obtained to evaluate the effect of treatments in a 1:1:1 ratio based on a computer-generated CO2 laser compared with other treatment regimens. Compar- randomization list that was prepared by a statistician. The isons were based on the changes in total VHI score, which led participant numbers
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