nctId: NCT06336564 id: 71168623.6.0000.5544 briefTitle: Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2026-12 date: 2024-03-28 date: 2024-03-28 name: Centro de Atenção ao Assoalho Pélvico class: OTHER 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. conditions: Menopause conditions: Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Pelvic floor muscle training name: Microablative Radiofrequency measure: Resolution or improvement of episodes of urinary loss assessed by pad test measure: Resolution or improvement of episodes of urinary loss assessed by urinary diary measure: Number of patients with tolerability related to treatment assessed by Likert Scale. measure: Number of patients with adverse effects related to treatment assessed by histopathology. measure: Resolution or improvement of episodes of urinary loss assessed by questionnaire. measure: Recovery of vaginal health assessed by Vaginal Index Maturation measure: Recovery of vaginal health assessed by vaginal pH measure: Improvement of Sexual Function assessed by Female Sexual Function Index measure: Improvement of quality of life assessed by Short-Form Health Survey (SF-36) measure: Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire. measure: Degree of patient satisfaction using a five-point Likert scale. measure: Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS) sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Atenção ao Assoalho Pelvico city: Salvador state: Ba zip: 40.290-000 country: Brazil lat: -12.97111 lon: -38.51083 hasResults: False