Randomized Controlled Clinical Trial with CO2 LASER and Thermo-Controlled Radiofrequency in the Treatment of Vaginal Atrophy in Patients After Breast Cancer

Phase 1

• Conditions: vaginal atrophy; atrophic vaginitis; Malignant Neoplasm of Breast; Breast Neoplasms; Laser CO²; Radiofrequency; Vaginal Lubrificants; Genitourinary Syndrome of menopause; N952

• Registration Number: RBR-5gg73gq
• Lead Sponsor: PONTÍFICE UNIVERSIDADE CATÓLICA DO PARANÁ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-09
• Study Start: 2021-02-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Women aged 1 year or more after finishing Radio / Chemotherapy for Breast Cancer; more than a year after spontaneous or medication menopause; no manifestations of active cancer or metastases; who have any symptoms of Vulvovaginal Atrophy (dryness, itching or burning sensation, pain or bleeding during intercourse, recurrent cystitis or dysuria).

Exclusion Criteria

Use of systemic or topical hormone replacement therapy in the last 12 months; acute urinary infection; recurrent active or viral genital infection (Herpes or HIV); vaginal prolapse> grade II; use of vaginal lubricants in the last 30 days; serious or psychiatric illnesses; use of psychotropic drugs; are using pacemakers, orthoses or prostheses in the case of patients undergoing Radiofrequency; do not be able to attend the clinic on the days previously determined.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The clinical improvement of Vaginal Atrophy will be assessed by VAS, Visual Analogue Scale, which consists of an 11-point scale, where 0 is the lowest level (no symptoms) and 10 the highest (the worst possible), for 5 symptoms: burning vaginal, itching, dryness, pain during intercourse and pain when urinating.;Upon gynecological examination, the researcher will assess the VHIS, Vaginal Health Score Index, with assessment of elasticity, vaginal secretion, pH, epithelium and hydration. The score takes into account the sum of the items where 1 = worst assessment and 5 the best assessment, with score min = 5 and max = 25.;The cytological improvement of Vaginal Atrophy will be observed by the collection of hormonal cytology, with evaluation of the Frost Index and quantification of cells in the basal, intermediate and superficial layers.;The increase in the thickness of the vaginal mucosa will be seen by measuring the epithelium in material obtained by biopsies of the vaginal wall before and after intervention.