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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorCentro de Atenção ao Assoalho Pélvico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency non ablative

    Device

    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.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Radiofrequency ON and KinesiotherapyActive comparator 1 intervention
Group B: Radiofrequency OFF and KinesiotherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Cell maturation index

% cells parabasal, % intermediate cells and superficial cells

Time frame
Each 3 months pos treatment, until one year
2

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

Time frame
Each 3 months pos treatment, until one year

Secondary outcomes

1

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

Time frame
one week, one month, three months, six months, nine months and one year
2

Questionnaire of quality of life specified urinary incontinence

The ICIQ-SF

Time frame
one week, one month, three months, six months, nine months and one year
3

Female Sexual Function Index

FSFI

Time frame
one week, one month, three months, six months, nine months and one year
4

Female Genital Self-image Scale

Time frame
one week, one month, three months, six months, nine months and one year

Other outcomes

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