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.
Clinical complaint of urinary incontinence associated to Genitourinary Syndrome of Menopause.
Negative cervical oncotic cytology, within the last 3 years.
Patients with cognitive deficit;
Patients with chronic degenerative neurological diseases;
Post-void residue greater than 50 ml;
Carriers of a pacemaker and implantable cardioverter defibrillator;
Parallel
Pelvic floor muscle training
Other interventionVerbal 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
DevicePatients 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.
Resolution or improvement of episodes of urinary loss assessed by pad test
Participants will perform the one-hour Pad Test to diagnose and quantify urinary loss. Initially, the absorbent will be placed in a closed plastic bag and weighed on a precision electronic scale (Denver Instrument®). Then, the participant will be instructed to put on the pad, drink 500 ml of water in a maximum of 15 minutes and remain at rest for another 15 minutes, this phase represents 30 minutes of the test. In the other 30 minutes, the participant will be asked to perform certain standardized activities simulating activities of daily life (going up and down stairs, sitting down and standing up ten times, coughing ten times, picking up objects from the floor five times, running in the same place for one minute and washing the hands under running water for one minute).
Resolution or improvement of episodes of urinary loss assessed by urinary diary
Participants will be instructed to keep a voiding diary at home for three days to record water intake, urinary volume and the number of incontinence episodes, as well as episodes of urgency and nocturnal enuresis.
Number of patients with tolerability related to treatment assessed by Likert Scale.
Likert scale of 3 points will be asked to the patients: 1) impossible to tolerate the treatment, 2) not nice, but possible to tolerate, 3) very tolerable.
Number of patients with adverse effects related to treatment assessed by histopathology.
To evaluate the safety in tissue effect of FRAXX, samples of vaginal tissue will be obtained through a biopsy taken from the lateral walls, in the middle third of the vagina, for histopathological study. Procedure carried out under colposcopic vision, using a 3mm loop attached to the radiofrequency device, "surgery" mode, removing a small vaginal fragment.
Recovery of vaginal health assessed by Vaginal Index Maturation
The cytological evaluation will be carried out using a vaginal smear collected from the lateral vaginal wall with a spatula ; the percentage of superficial (%S), intermediate (%I) and parabasal (P%) cells are counted and the mucosa is then classified according to the Vaginal Maturation Index (VMI) of the Meisel formula \[(1, 0 x %S) + (0.5 x %I) + (0.0 x %P)\] as atrophic, hypotrophic or eutrophic.
Recovery of vaginal health assessed by vaginal pH
Vaginal pH will be measured with a pH indicator strip between 0 and 14 (MColorpHastTM, Merck, Germany), placed in contact with the mucosa of the middle third of the vaginal canal, with the help of a speculum.
Improvement of Sexual Function assessed by Female Sexual Function Index
A self-administered questionnaire, which proposes to evaluate female sexual response in the domains: sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction and pain. It presents 19 questions that assess sexual function in the last four weeks and presents scores for each component. For each question there is a response pattern, between 0 and 5 in an increasing order, except for questions about pain, where the score is reversed. The domain that presents a score equal to zero means that the interviewee did not report sexual intercourse in the last four weeks. Individual scores are obtained by summing the items that comprise each domain (simple score), which are multiplied by the factor of that domain and provide the weighted score. The final score (total score: minimum of 2 and maximum of 36) is obtained by adding the weighted scores for each domain. The cut-off is: \> or = 26 points - no sexual dysfunction; bellow 26 - sexual dysfunction.
Improvement of quality of life assessed by Short-Form Health Survey (SF-36)
It consists of 36 items that encompass 8 domains: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects and mental health. It presents a final score from 0 to 100, where zero represents the worst general health status and 100 the best general health status.
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