Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause

Study Overview
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Brief Summary
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The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal. All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell maturation index and questionnaires. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Capenergie brand device with capacitive transfer method using non-ablative handle with active electrode intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the posterior wall of vagina.

Official Title
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Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause

Conditions
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Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Device: Radiofrequency non ablative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome and who agree to voluntarily participate in the research. Exclusion Criteria: will be excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of cooper and women under hormone therapy under six months

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiofrequency ON and Kinesiotherapy<br>The radiofrequency application protocol with CAPENERGY device, which has two electrodes: an active one, which will be introduced into the vagina, using a condom and gel to the emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The temperature used in the treatment will be 41° C, which this parameter will be placed in the equipment, maintained for 2 minutes at the anterior wall and 2 others minutes at the posterior wall. Five RF sessions will be performed, with a seven-day interval between them. For the application, participants will be placed in supine position. The session will be quick, with an average duration of 20 minutes. Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given. | Device: Radiofrequency non ablative<br>* The application of RF was performed by physical therapist trained in the technique of radiofrequency through the Capenergy® brand device with capacitive transfer method using non-ablative handle with active electrode placed intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer and when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.<br>|
| Placebo Comparator: Radiofrequency OFF and Kinesiotherapy<br>The patient will be in supine decubitus, the vaginal probe of the radiofrequency apparatus will be introduced, with the gel previously heated. The radiofrequency will be off. Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given. | Device: Radiofrequency non ablative<br>* The application of RF was performed by physical therapist trained in the technique of radiofrequency through the Capenergy® brand device with capacitive transfer method using non-ablative handle with active electrode placed intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer and when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cell maturation index | % cells parabasal, % intermediate cells and superficial cells | Each 3 months pos treatment, until one year | 
| Change in Vaginal PH | During the fertile years of life, the vaginal pH ranges from 3.5 to 4.5. At menopause, vaginal Ph increases to above 4.5. The higher the vaginal Ph, the greater the degree of atrophy | Each 3 months pos treatment, until one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Visual Scale | Will be evaluated vaginal dryness, pain during intercourse, vaginal laxity, burning sensation and itching, on a scale of 0 to 10, being 0 asymptomatic and 10 the maximum of symptoms | one week, one month, three months, six months, nine months and one year | 
| Questionnaire of quality of life specified urinary incontinence | The ICIQ-SF | one week, one month, three months, six months, nine months and one year | 
| Female Sexual Function Index | FSFI | one week, one month, three months, six months, nine months and one year | 
| Female Genital Self-image Scale |  | one week, one month, three months, six months, nine months and one year |