Journal Article

Photobiomodulation in post menopause genitourinary syndrome—Study protocol for a randomized, double-blind, controlled clinical protocol

Bossini, Paulo Sérgio, Mello, Erika da Silva, Pereira, Silvia Regina dos Santos, Mesquita-Ferrari, Raquel Agnelli, Bezerra, Cícero Dayves da Silva, Almeida-Lopes, Luciana, Gonçalves, Marcela Leticia Leal, Deana, Alessandro Melo, Dalapria, Vanessa, Salviatto, Luciana Toledo Costa

2024

Overview

Genitourinary Syndrome of Menopause (GSM) defines a set of symptoms associated with an estrogen deficit involving alterations in organs genitourinary and that results in several urinary, genital, and sexual alterations. Brazilian women live about a third of their life after menopause, where hormonal changes occur along with clinical manifestations, characterized by vaginal and vulvar dryness, burning sensation, discomfort, vulvovaginal irritation, lack of lubrication, dyspareunia and urinary incontinence. Fractionated photothermolysis and radiofrequency systems, alone or in combination were tested to improve GSM. The goal of this study is to elaborate a protocol to evaluate the clinical response of patients with symptoms of GSM after the application of photobiomodulation in the vulvar region. In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of GSM will be randomly divided into two groups. The treatment group (n = 30) will receive four consecutive applications, weekly, using DMC laser diode (λ = 808 nm), 4J per point, 100mW of power, 1,016W/cm2, 8 sites in the vulvar region, The Placebo Group (n = 30) will be handled as treated, but with the laser turned off. The quality of life will be assessed using female sexual functioning index (FSFI-6), urinary incontinence questionnaire (ICIQ-SF), Quality of life will be analyzed using the female sexual functioning index (FSFI-6). The intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI). Also, the vaginal temperature will be measured using a thermal camera, the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. With this procedure, we intend to obtain an overall better life quality and diminished symptoms in women with GSM. All assessments will be performed prior to the first irradiation and after the last one. This protocol is registered at ClinicalTrials.gov under the number NCT05557799.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Abnormalities / Amenorrhea / Atrophy / Biology and Life Sciences / Brazil / Clinical trials / Double-Blind Method / Engineering and Technology / Estrogens / Evaluation / Female / Female Urogenital Diseases - therapy / Females / Genitourinary organs / Health aspects / Health care / Humans / Irradiation / Irritation / Lasers / Low-Level Light Therapy - methods / Medical personnel / Medicine and Health Sciences / Menopause / Middle Aged / Photobiology / Physical Sciences / Physical therapy / Placebos / Post-menopause / Postmenopause - physiology / Proteins / Quality assessment / Quality of Life / Radio frequency / Randomized Controlled Trials as Topic / Semiconductor lasers / Sexual disorders / Study Protocol / Syndrome / Transcription factors / Urinary incontinence / Vagina / Vagina - pathology / Vagina - physiopathology / Vagina - radiation effects / Vulva - pathology / Vulva - radiation effects / Womens health