protocolSection identificationModule nctId: NCT06336564, orgStudyIdInfo id: 71168623.6.0000.5544, briefTitle: Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Centro de Atenção ao Assoalho Pélvico, class: OTHER, descriptionModule briefSummary: Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM., conditionsModule conditions: Menopause, conditions: Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic floor muscle training, interventions name: Microablative Radiofrequency, outcomesModule primaryOutcomes measure: Resolution or improvement of episodes of urinary loss assessed by pad test, primaryOutcomes measure: Resolution or improvement of episodes of urinary loss assessed by urinary diary, primaryOutcomes measure: Number of patients with tolerability related to treatment assessed by Likert Scale., primaryOutcomes measure: Number of patients with adverse effects related to treatment assessed by histopathology., primaryOutcomes measure: Resolution or improvement of episodes of urinary loss assessed by questionnaire., secondaryOutcomes measure: Recovery of vaginal health assessed by Vaginal Index Maturation, secondaryOutcomes measure: Recovery of vaginal health assessed by vaginal pH, secondaryOutcomes measure: Improvement of Sexual Function assessed by Female Sexual Function Index, secondaryOutcomes measure: Improvement of quality of life assessed by Short-Form Health Survey (SF-36), secondaryOutcomes measure: Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire., secondaryOutcomes measure: Degree of patient satisfaction using a five-point Likert scale., secondaryOutcomes measure: Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS), eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Atenção ao Assoalho Pelvico, city: Salvador, state: Ba, zip: 40.290-000, country: Brazil, geoPoint lat: -12.97111, lon: -38.51083, hasResults: False