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

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506594
• Other study ID #: Centro de Atenção AP
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: June 20, 2026

Study information

• Verified date: May 2024
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 20, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Syndrome

Intervention

Device:
• Radiofrequency 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.

Locations

Country	Name	City	State
Brazil	Centro de Atenção ao Assoalho Pelvico	Salvador	Ba

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cell maturation index	% cells parabasal, % intermediate cells and superficial cells	Each 3 months pos treatment, until one year
Primary	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	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
Secondary	Questionnaire of quality of life specified urinary incontinence	The ICIQ-SF	one week, one month, three months, six months, nine months and one year
Secondary	Female Sexual Function Index	FSFI	one week, one month, three months, six months, nine months and one year
Secondary	Female Genital Self-image Scale		one week, one month, three months, six months, nine months and one year