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

• ClinicalTrials.gov Identifier: NCT03506594
• Recruitment Status: Recruiting
• First Posted: April 24, 2018
• Last Update Posted: February 11, 2022
• Sponsor: Centro de Atenção ao Assoalho Pélvico
• Information provided by (Responsible Party): Centro de Atenção ao Assoalho Pélvico

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Genitourinary Syndrome of Menopause	Device: Radiofrequency non ablative	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause
• Actual Study Start Date: April 1, 2018
• Actual Primary Completion Date: December 1, 2018
• Estimated Study Completion Date: December 20, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Radiofrequency ON and Kinesiotherapy; The radiofrequency application protocol with 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; The application of RF was performed by physical therapist trained in the technique of radiofrequency through the Capenergy® brand 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 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.
Placebo Comparator: Radiofrequency OFF and Kinesiotherapy; 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; The application of RF was performed by physical therapist trained in the technique of radiofrequency through the Capenergy® brand 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 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.

Outcome Measures

Primary Outcome Measures :

1. Change in Cell maturation index [ Time Frame: Each 3 months pos treatment, until one year ]
   % cells parabasal, % intermediate cells and superficial cells
2. Change in Vaginal PH [ Time Frame: 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 Outcome Measures :

1. Numeric Visual Scale [ Time Frame: 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
2. Questionnaire of quality of life specified urinary incontinence [ Time Frame: one week, one month, three months, six months, nine months and one year ]
   The ICIQ-SF
3. Female Sexual Function Index [ Time Frame: one week, one month, three months, six months, nine months and one year ]
   FSFI
4. Female Genital Self-image Scale [ Time Frame: one week, one month, three months, six months, nine months and one year ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome 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

Contacts and Locations

Locations

Brazil

Centro de Atenção ao Assoalho Pelvico; Recruiting

Salvador, Ba, Brazil, 40.290-000

Contact: Patricia V Lordelo, Phd +5571988592400 pvslordelo@hotmail.com

Sponsors and Collaborators

Centro de Atenção ao Assoalho Pélvico

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pinheiro C, Costa T, Amorim de Jesus R, Campos R, Brim R, Teles A, Vilas Boas A, Lordêlo 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.

• Responsible Party: Centro de Atenção ao Assoalho Pélvico
• ClinicalTrials.gov Identifier: NCT03506594
• Other Study ID Numbers: Centro de Atenção AP
• First Posted: April 24, 2018
• Last Update Posted: February 11, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Syndrome; Disease; Pathologic Processes