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

NCT03506594 | Recruiting

• 1 other identifier: Centro de Atenção AP
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Numeric Visual Scale

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

• Questionnaire of quality of life specified urinary incontinence

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

• Female Sexual Function Index

  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

Study Arms (2)

Radiofrequency ON and Kinesiotherapy

ACTIVE COMPARATOR

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.

Device: Radiofrequency non ablative

Radiofrequency OFF and Kinesiotherapy

PLACEBO COMPARATOR

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

Interventions

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.

Radiofrequency OFF and Kinesiotherapy; Radiofrequency ON and Kinesiotherapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (1)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

Related Publications (1)

• Pinheiro C, Costa T, Amorim de Jesus R, Campos R, Brim R, Teles A, Vilas Boas A, Lordelo P. Intravaginal nonablative radiofrequency in the treatment of genitourinary syndrome of menopause symptoms: a single-arm pilot study. BMC Womens Health. 2021 Oct 30;21(1):379. doi: 10.1186/s12905-021-01518-8.

  PMID: 34717608 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 24, 2018
• Study Start: April 1, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 20, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)