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

Centro de Atenção ao Assoalho Pélvico

Status: Enrolling

Conditions: Genitourinary Syndrome of Menopause

Treatments: Device: Radiofrequency non ablative

Study type: Interventional

Funder types: Other

Identifiers

NCT03506594

Centro de Atenção AP

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

Radiofrequency ON and Kinesiotherapy

Active Comparator group

Description:

The radiofrequency application protocol with the 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.

Treatment:

Device: Radiofrequency non ablative

Radiofrequency OFF and Kinesiotherapy

Placebo Comparator group

Description:

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.

Treatment:

Device: Radiofrequency non ablative