Randomized Controlled Clinical Trial with CO2 LASER and Thermo-Controlled Radiofrequency in the Treatment of Vaginal Atrophy in Patients After Breast Cancer

INTERVENTION: D26.255.955 E07.632.490.367 G01.358.500.505.810 The group of 9 patients undergoing treatment with CO2 Laser received 3 laser sessions with 30 (+ or‐5 days) intervals. The group of 6 patients undergoing treatment with Thermocontrolled Radiofrequency received 4 sessions of non‐ablative RF ‐ with an interval of 14 (+ or‐5 days) The control group with 9 patients used Vaginal Moisturizer every 3 days for 3 months. CONDITION: N952 vaginal atrophy; atrophic vaginitis; Malignant Neoplasm of Breast; Breast Neoplasms; Laser CO²; Radiofrequency; Vaginal Lubrificants; Genitourinary Syndrome of menopause PRIMARY OUTCOME: The clinical improvement of Vaginal Atrophy will be assessed by VAS, Visual Analogue Scale, which consists of an 11‐point scale, where 0 is the lowest level (no symptoms) and 10 the highest (the worst possible), for 5 symptoms: burning vaginal, itching, dryness, pain during intercourse and pain when urinating. The cytological improvement of Vaginal Atrophy will be observed by the collection of hormonal cytology, with evaluation of the Frost Index and quantification of cells in the basal, intermediate and superficial layers. The increase in the thickness of the vaginal mucosa will be seen by measuring the epithelium in material obtained by biopsies of the vaginal wall before and after intervention. Upon gynecological examination, the researcher will assess the VHIS, Vaginal Health Score Index, with assessment of elasticity, vaginal secretion, pH, epithelium and hydration. The score takes into account the sum of the items where 1 = worst assessment and 5 the best assessment, with score min = 5 and max = 25. SECONDARY OUTCOME: At the end of the study, the Global Satisfaction Index, Likert Scale 5, to assess satisfaction in relation to the applied intervention. It consists of a scale of 1 to 5, where the lowest value is 1 (very satisfied) and the highest is 5 (very dissatisfied). The changes in the vaginal flora will be verified by vaginal secretion culture on Mac Conkey agar, blood agar and chocolate agar as well as by material obtained with slide collections for fresh examination. The improvement in sexual function will be assessed by the FSFI, Female Sexual Function Index. The questionnaire contains 19 questions, subdivided into six (6) domains: desire, excitement, lubrication, orgasm, satisfaction and pain, where the minimum score is 2.0 (severe dysfunction) and the maximum is 36.0 (absence of dysfunction) . The improvement of urinary complaints will be assessed by the ICIQ‐SF, International Consultation on Incontinence Questionaire‐ , where the final score is the sum of questions 3, 4 and 5. If the final score is greater than 8, it is considered to be of high impact, if less than 8 low impact. INCLUSION CRITERIA: Women aged 1 year or more after finishing Radio / Chemotherapy for Breast Cancer; more than a year after spontaneous or medication menopause; no manifestations of active cancer or metastases; who have any symptoms of Vulvovaginal Atrophy (dryness, itching or burning sensation, pain or bleeding during intercourse, recurrent cystitis or dysuria).