Study of the effects of the fractional radiofrequency and microneedling in long-term on the outer region of the vagina in menopausal wome

Not Applicable

• Conditions: Other noninflammatory disorders of vagina Menopausal and female climacteric states; N95.1

• Registration Number: RBR-32jnbm
• Lead Sponsor: niversidade Federal do Rio Grande do Norte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

In the inclusion criteria, participants must be between 55 and 65 years of age, with flaccidity in the vulvar region, post-menopausal period of up to 5 years, who had 2 to 3 normal births, not practicing physical activity, not being able to use hormone replacement therapy and with the ability to understand and preserve local sensitivity.

Exclusion Criteria

Exclusion criteria will apply to all participants who are pregnant, breastfeeding 3 months before treatment or planning to become pregnant during the study period, with active sexually transmitted disease, acute bacterial or viral infection, pacemaker carriers or other implanted electrical devices, malignant tumor, weakened immune system, collagen diseases, continuously using anti-inflammatory drugs, dermatological condition that requires systemic or topical therapy in the area of treatment and metallic implants. Participants who do not agree with the procedures, have a sensitivity disorder during therapy, or do not adapt to the schedules and procedures will be discontinued from the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in vaginal sagging; through the Vaginal Laxity Questionnaire (VLQ) and photographs after 10 days, 01 month, 03 months, 06 months; on the basis of a change of at least 5% in changes during revaluations.;Improvement in menopausal symptoms and quality of life; using the Blatt and Kupperman menopausal index (IMBK) and the EQ-5D questionnaire, after 10 days, 01 months, 03 months, 06 months; from the verification of a variation of at least 5% in the scores during the revaluations.

Secondary Outcome Measures

Name	Time	Method
There will be no secondary outcomes.