Efficacy of fractional Radiofrequency Microablation in the treatment of vaginal dryness, burning and itching of women with Breast Cancer: a randomized trial

Not Applicable

Recruiting

• Conditions: Genitourinary menopause syndrome; sexual dysfunction; menopause; breast cancer; N89.8; F52.9

• Registration Number: RBR-78mt53
• Lead Sponsor: niversidade Estadual de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Antecedente pessoal de câncer de mama;apresentar ressecamento vaginal associada ou não a dispareunia, ardência ou prurido vaginal;menopausa fisiológica com tempo de amenorreia superior a doze meses.

Exclusion Criteria

Current chemotherapy treatment for breast cancer; pacemaker use; presence of genital prolapses; decompensated heart disease; cognitive impairment; peripheral or central neurological disorders; presence of any other cancer; presence of cervical dysplasia; urinary or vaginal infection active; decompensated metabolic diseases; patients currently in use or within the last six months of some vaginal therapy; positive serology for HIV, hepatitis bece genital condylomatosis; previous pelvic radiotherapy; previous surgery on the vagina.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome:<br>Score above 15 by the Vaginal Health Index (VHI) that will be applied 30 days after the last radiofrequency session and 12 weeks after the start of vaginal moisturizer use.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome:<br>Score above 65 by calculating the vaginal maturation index (MV) or Meisels index that will be applied 30 days after the last radiofrequency session and 12 weeks after the start of vaginal moisturizer use.<br>;Secondary outcome:<br>Score above 26 by the FSFI (Sexual Function Index) questionnaire that will be applied 30 days after the last radiofrequency session and 12 weeks after the start of vaginal moisturizer use.