Effect of the heat transmitted by a waves device for the treatment of vulvar lichen sclerosus

Not Applicable

• Conditions: vulvar lichen sclerosus - response of treatments; N00-N99

• Registration Number: RBR-10z85rcz
• Lead Sponsor: Faculdade de Medicina da Universidade Federal do Rio Grande do Sul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Study Completion: 2021-11-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

women with clinical suspicion of vulvar lichen sclerosus, whose diagnosis is confirmed by biopsy, wich accept to participate in the study and sign the term of consent

Exclusion Criteria

vulva cancer at inicial biopsy, diagnosis other than lichen sclerosus in the inicial biopsy, current treatment with topical steroid in the vulva, transplanted, pregnant or lactating women and hiv carriers.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anatomophatological modification of the biopsy of the vulva before and 30 days after the end of the treatment. The findings expected are increased ephitelial maturation, improvement of the organization of the basal layer, mucosal thickening, enlarged granular layer, neocolagenesis, increased number of fibroblasts, increased stromal density and reduction of the inflammatory process. Because there are not studies about radiofrequency in the treatment of vulvar lichen sclerosus, later statistical analysis will assess its effectiveness, with statistical significance set at 5%.

Secondary Outcome Measures

Name	Time	Method
assessment of the impact of the disease oh sexuality before and after treatment, through the Female Sexual Function Index (FSFI) form. Later statistical analysis will assess its effectiveness, with statistical significance set at 5%.;evaluation of itchy, painful or vulvar discomfort and difficulty in vaginal penetration before, during and after treatment. A visual pain scale, graded from zero to ten and with color variation from each symptom at each visit will be used. Because there are not studies about radiofrequency in the treatment of vulvar lichen sclerosus, later statistical analysis will assess its effectiveness, with statistical significance set at 5%.