Efficacy of using vaginal radiofrequency, vaginal estrogen, or vaginal moisturizer for the treatment of post menopausal vaginal dryness: randomized clinical trial

Not Applicable

Recruiting

• Conditions: Menopause; climacteric; atrophic vaginitis; post menopause; G08.686.157.500; G08.686.157; C13.351.500.894.906.316; G08.686.157.500.625

• Registration Number: RBR-54y5wr
• Lead Sponsor: Faculdade de Ciências Médicas da Universidade Estadual de Campinas, Unicamp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Menopausal women; sexually active; between 30 and 75 years; with at least one of the symptoms of SGM classified as moderate and / or severe.

Exclusion Criteria

The explicit refusal or inability of the woman to participate in the study, and any reasons that prevent the application of the treatment;
BMI 35 kg / m2; Chronic renal failure; Hepatic insufficiency; Tuberculosis; Ascites and anasarca; Febrile conditions of unknown origin; History of estrogen-dependent neoplasias; Active sexually transmitted disease; Cardiovascular diseases such as thrombophlebitis, thrombosis and peripheral arterial disease); Active vaginal infection (bacterial vaginosis or candidiasis); Oncotic cytology altered in the last twelve months, such as atypical squamous cells of significance indeterminate (ASCUS), atypical squamous cells of undetermined significance can not be excluded high-grade intraepithelial lesion (ASC-H), low-grade squamous intraepithelial lesion (LSIL), and lesion
high-grade squamous intraepithelial (HSIL); Vaginal bleeding of unknown cause; active collagen diseases; Pelvic radiation therapy; Metal implants (pacemaker or automatic defibrillator / cardioverter, copper IUD); Not have used in the last month medications known to be impacting collagen metabolism and in the healing process, such as steroidal and nonsteroidal anti-inflammatory drugs; Do not use NSAIDs and AIES in the last month (they affect collagen metabolism and healing); Use of vaginal moisturizers in the last 6 months; Use of local estrogen therapy in the last 6 months; Use of systemic hormonal therapy in the last 6 months; Absolute contraindications to hormonal therapy, according to the Brazilian Consensus on Hormonal Therapy, 2018.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal monopolar focused radiofrequency (VMFR) will correlate with greater clinical efficacy in the treatment of symptoms, when compared to vaginal moisturizer, with results similar to the topical use of vaginal estrogen, through subjective parameters such as visual analogue scale (VAS), validated questionnaires for vaginal atrophy, urinary incontinence and sexual function and through objective parameters such as vaginal maturation index, cytological and histopathological analysis, measured at the beginning and at the end of the study.

Secondary Outcome Measures

Name	Time	Method
It is expected to find greater durability in improving the symptoms of vaginal atrophy with the use of treatment with Vaginal monopolar focused radiofrequency (VMFR).