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. 2024 Dec 2;19(12):e0313324.
doi: 10.1371/journal.pone.0313324. eCollection 2024.

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

Silvia Regina Dos Santos Pereira  1 , Raquel Agnelli Mesquita-Ferrari  1 , Luciana Toledo Costa Salviatto  1 , Cícero Dayves da Silva Bezerra  1 , Vanessa Dalapria  1 , Erika da Silva Mello  1 , Luciana Almeida-Lopes  2 , Paulo Sérgio Bossini  2 , Marcela Leticia Leal Gonçalves  3 , Alessandro Melo Deana  1
Affiliations

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

Silvia Regina Dos Santos Pereira et al. PLoS One. .

Abstract

Introduction: 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.

Objective: 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.

Method: 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.

Trial registration: This protocol is registered at ClinicalTrials.gov under the number NCT05557799.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Cellular mechanisms of PBM.
Fig 2
Fig 2. SPIRIT figure for the schedule of enrolment as recommended by 2013 SPIRIT statement.
Fig 3
Fig 3. Test power analysis as a function of effect size and sample size.
Fig 4
Fig 4. Flow-chart of the study.
Fig 5
Fig 5. Laser system used in the study (Therapy XT model—DMC).
Fig 6
Fig 6. Anatomic sites irradiated.
See this image and copyright information in PMC

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