Method
vulvar, Vulvar Lichen Sclerosus, vulvar disease
DISEASE, VULVAR LICHEN SCLEROSUS, VULVAR DISEASE
This is a randomized clinical trial to assess the feasibility and equivalence of fractional COThe sample consisted of 20 women assisted at the vulva clinic of the Gynecology Service of HU/ UFJF.For the sample calculation of an experimental study with an estimate of the proportion for 2 independent groups, with the purpose of evaluating the equivalence of the laser and the standard treatment, the following parameters were accepted: alpha error of 5%, test power 95%, success estimation in the control group of 40% and 1:1 ratio. A minimum sample size of 20 subjects (10 in each group) was estimated. Women with Vulvar Lichen Sclerosus diagnosed by histopathological evaluation of vulvar biopsy were included, and women who were already under treatment for this condition at the time of the survey or those who had used any form of treatment for the disease in 30 days prior to the outpatient appointment were excluded from the survey. Women with other diagnoses of vulvar disease identified in the biopsy were also excluded.Additional file The study was developed in the period between March 27, 2019 and March 18, 2020, with completion of the proposed treatment. The patients were reevaluated 12 months after the end of the treatment.After signing the Informed Consent Form, the identification form was filled out, obtaining epidemiological data. Then the patients answered the WHOQOL-BREF questionnaire [The patients in the Clobetasol group were instructed to use a daily night application of Clobetasol ointment (Clobetasol Propionate 0.05%) in the first month, followed by night applications on alternate days in the second month, and a night application on two consecutive days of the same week (Saturdays and Sundays) in the third month. Since then, the use was guided according to the patient's needs, not exceeding twice a week.Patients in the Laser group underwent three sessions of fractional COThe groups were followed up on a monthly basis. During each follow-up visit, the patient was examined by the responsible researcher, not knowing the patient's treatment group, with completion of the vulva morphological/anatomical manifestations evaluation form, according to the criteria proposed by Sheinis and Selk [After the end of the treatment, all patients underwent a new vulva biopsy, in a contralateral region to the first biopsy performed and answered the life quality questionnaire again, in addition to a questionnaire developed by the researchers themselves to evaluate the improvement of symptoms, satisfaction with the treatment, and the degree of difficulty found to perform it. These forms of evaluation were defined and chosen due to the absence of validated dimensions in the country with the same objective.Subsequently, a new evaluation was performed 12 months after the end of the instituted treatment; with the application of quality of life questionnaires, and the patient's perception of the treatment.The data were entered into the SPSS 14.0 software. Categorical variables were described as absolute and relative frequencies.Participants who lost follow-up appointments were considered as flaws and therefore their statuses were kept similar to the last assessment for all variables.For the association between categorical independent variables (sociodemographic, clinical, and patient perception) and dependent variable (type of treatment) Pearson's chi-square test was used, complemented with Fisher's test, when necessary. In the case of quantitative variables, normality was evaluated using the Kolmogorov–Smirnov test, and normality was assumed. Thus, quantitative variables (current and diagnosed ages and domains of the WHOQOL-BREF) were associated with the type of treatment by the Student's t-test.Spearman correlation was performed to assess the relationship between the extent of vulvar disease and the patient's perception before and after treatment.The Wilcoxon test for dependent samples and ordinal responses was used to assess histopathological characteristics before and after treatment. The significance level was 5%.