Genitourinary Syndrome of Menopause
Conditions
Brief summary
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.
Interventions
DEVICERadiofrequency non ablative
The application of RF was performed by physical therapist trained in the technique of radiofrequency through the CAPENERGY 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 41°C radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.
Sponsors
Centro de Atenção ao Assoalho Pélvico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome of Menopause 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cell maturation index | Each 3 months pos treatment, until one year | % cells parabasal, % intermediate cells and superficial cells |
| Change in Vaginal PH | Each 3 months pos treatment, until one year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Visual Scale | one week, one month, three months, six months, nine months and one year | 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 |
| Questionnaire of quality of life specified urinary incontinence | one week, one month, three months, six months, nine months and one year | The ICIQ-SF |
| Female Sexual Function Index | one week, one month, three months, six months, nine months and one year | FSFI |
| Female Genital Self-image Scale | one week, one month, three months, six months, nine months and one year | — |
Countries
Brazil
Outcome results
None listed