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Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause
Sponsor: Centro de Atenção ao Assoalho Pélvico
Summary
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.
Official title: Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause: Randomized Clinical Trial
Key Details
Gender
FEMALE
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-08
Completion Date
2027-12
Last Updated
2024-08-20
Healthy Volunteers
No
Conditions
Interventions
Pelvic floor muscle training
Verbal information will be given about location, function and the correct way to contract the pelvic floor muscles (PFM). Participants will be instructed on how to perform "The Knack", which is a pre-contraction of the PFM during some abdominal effort, such as coughing, sneezing or laughing. The exercises consist of two series of 10 maximum contractions sustained for 5 seconds and 10 seconds of relaxation and two series of 10 maximum rapid contractions with two seconds of maintenance and four seconds of relaxation, with one minute of rest between each series. Participants will be instructed to perform the same exercises at home (twice a day) and to fill out a training diary, allowing researchers to monitor and check whether the exercises are actually being performed. The protocol will be repeated with the researcher three times in total, every 30 to 40 days.
Microablative Radiofrequency
Patients will be placed in the lithotomy position and through speculum examination and under direct vision or guided by colposcope, sequential application of radiofrequency will be carried out on the vaginal walls and introitus. The Wavetronic 6000 Touch device will be used with the Megapulse HF FRAXX system (Loktal Medical Electronics, São Paulo, Brazil), equipped with an electronic energy fractionation circuit, connected to a vaginal pen with 64 microneedles, 200μm in diameter and 1 mm in length, mounted on a Teflon body and divided into a matrix of eight columns with eight needles each. In the vestibule and vaginal opening, 10% lidocaine spray will be applied three minutes before the procedure. Three applications will be carried out in the vagina/vaginal introitus, with an interval of 30 to 40 days.
Locations (1)
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, Brazil