Light-emitting diode (LED) as a new therapeutic option on symptoms of genitourinary syndrome of menopause: clinical study phase I.

Baqueiro P1, Brasil C1, Gomes T1, Lemos A1, Vieira C1, Alvares C1, Pitia A1, Silva L1, Pires J2, Celino G1, Maia J1, Pina M1, Dantas L1, Ferreira I3, Marianno A1, Teles A1, Brim R1, Machado M4, Moura T4, Barros D1, Fontes A5, Mamede C6, Passos R5, Lordelo P1

Research Type

Clinical

Abstract Category

Conservative Management

Abstract 476
ePoster 7
Scientific Open Discussion Session 32
On-Demand
Female Conservative Treatment Rehabilitation Physiotherapy Clinical Trial
1. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, 2. Centro Universitário Estácio do Ceará, Faculdade IDE, 3. Universidade Salvador, 4. Universidade Salvador - UNIFACS, 5. União Metropolitana para o Desenvolvimento da Educação e Cultura - UNIME, 6. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Universidade do Estado da Bahia
Presenter
A

Alcina Teles

Links

Abstract

Hypothesis / aims of study
Women go through a longer period of post-menopause as life expectancy increases, (1) thus they coexist for a prolonged time with the intrinsic modifications of this life period (2) – genitourinary syndrome of menopause is one of them (GSM). This term includes several changes in the vulvar and vaginal region, and also functional urinary modifications which may cause harm to quality of life and womens' sexual function. The main symptoms are vaginal dryness, decrease in sensibility, burning sensation, and dyspareunia. (2) Up to 50% of post-menopausal women are affected by GSM, yet this syndrome can also affect up to 15% of pre-menopausal women. (1) The intravaginal 405 nm blue light-emitting diode (LED) can be considered as an innovative therapeutic option for treating GSM, according to its benefits that have been previously described by literature – such as the circulatory, regenerating, bactericidal and anti-inflammatory effects – when applied to tissues with histological similarities to the genital region, such as the gastric and oral mucosas. (2) Recent studies have tested the blue LED’s safety and effects in the treatment of healthy women with vaginal candidiasis. (3) Therefore the aim of this study is to evaluate the 405 nm blue LED intravaginal safety and effects upon GSM.
Study design, materials and methods
This is a clinical study phase 1, which precedes the randomized clinical trial in women with GSM symptoms. Women up to 65 years old, who presented at least one of the clinical symptoms of GSM were included (vaginal dryness, pain during sexual intercouse, pruritus, burning sensations, vaginal introitus pain and vaginal laxity). Patients under hormonal replacement therapy (for less than six months), with vaginal infection diagnosis, difficulty in comprehending the proposed instruments used, and neurological degenerative chronic diseases were excluded from the study. 
An initial evaluation consisting of anamnesis, application of the Female Sexual Function Index (FSFI) and Female Genital Self-Image Scale - 7 (FGSIS-7) questionnaires, was made after the patients signed the Informed Consent Form. Furthermore, a subjective evaluation of the symptoms’ therapeutic response – using the Visual Analogue Scale (AVS) – was applied. The scale mentioned required the patients to indicate the improvement of SGM symptoms in a scale of 0 to 10 (0 representing the absence of symptoms, and 10 the symptoms’ maximum presence possible), and relate any adverse symptoms presence during and on the two follow-up periods of treatment. For 8 minutes, the LED was applied intravaginally, using a power of 150 mW/cm2  and a dose of 40.5 J/cm2. The treatment consisted of three sessions with a seven-day interval between each one. Re-Evaluations including the application of the FSFI and FGSIS-7 questionnaires, took place after a month and a week of the treatment’s completion. The presence or absence of adverse effects during the applications and the reports from the participants after a month and a week upon completion of treatment was considered to test the safety of the LED treatment for SGM. Succeeding the end of the treatment participants were questioned about their satisfaction degree regarding the 405 nm LED therapy. Their response was registered using a Likert scale with five points: 1- very unsatisfied; 2- unsatisfied; 3- unaltered; 4- satisfied; 5- very satisfied. The patients signed the Informed Consent Form.
Results
Eleven women were tested, mean age of 55.7 ± 6.27. The majority of patients had finished higher education, was married and self assumed as mixed raced. Only one smoked and two were alcohol addicted. Womens' sexual function increased one week after the treatment in 8 participants (72.7%), and persisted higher in 4 participants (50%) after one month. Genital self-image improved in 8 women (72.7%) one week after the treatment, and also persisted higher in 4 participants (50%) in the end of one month. The results of FSFI and FGSIS-7 questionnaires are described in table 1. The whole sample (100%) complained of vaginal dryness. One week after the end of treatment, seven women (63.6%) had less dryness, and after one month of treatment, 10 participants (90.9%) also improved. GSM symptoms data are described in table 2. There were no report of adverse effects during sessions, nor after one week the therapy ended neither after one month. As described in the 5 point Likert scale of treatment satisfaction, 4 patients (36.3%) were very satisfied, 5 (45.3%) were satisfied and only 2 were unsatisfied after one week the therapy was over. The one month follow up showed that 4 women (36.3%) were very satisfied, 5 (45.3%) were satisfied, 1 was unaltered, and 1 was very unsatisfied with the treatment.
Interpretation of results
Most participants showed increase on sexual function (assessed by FSFI questionnaire), as well as on genital self-image (assessed by FGSIS-7 questionnaire), in both follow-up periods. There was also an improvement in GSM symptoms (specially vaginal dryness) reported by every women of the sample. Even though other GSM symptoms (such as dyspareunia, vaginal introitus pain, burning sensation, pruritus, and vaginal laxity) were not reported by all participants, the ones who reported it, had verified improvements on both follow-up revaluation. The use of 405 nm blue LED is likely to be a safe therapy on the treatment of GSM, due to the lack of adverse symptoms. These findings corroborate to the high level of treatment satisfaction reported by most participants.
Concluding message
The 405 nm blue LED proved to be a safe treatment and also showed a therapeutic effect on the GSM symptoms. Upon the clinical findings, an improvement of the GSM symptoms was reported by the patients (specially in relation to vaginal dryness, sexual function and genital self-image). There was a high satisfaction level within the sample as far as one month after the treatment.
Figure 1 Table 1
Figure 2 table 2
References
  1. Edwards D, Panay N. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: How important is vaginal lubricant and moisturizer composition Climacteric. 2016;19(2):151–61.
  2. Vieira-Baptista P, Marchitelli C, Haefner HK, Donders G, Pérez-López F. Deconstructing the genitourinary syndrome of menopause. Int Urogynecol J. 2017;28(5):675–9.
  3. Pavie MC, Robatto M, Bastos M, Tozetto S, Boas AV, Vitale SG, et al. Blue light-emitting diode in healthy vaginal mucosa—a new therapeutic possibility. Lasers Med Sci. 2019;34(5):921–7.
Disclosures
Funding No funding received Clinical Trial Yes Registration Number ClinicalTrial, U1111-1201-2342 RCT Yes Subjects Human Ethics Committee Bahiana School's Research and Ethics Committee Helsinki Yes Informed Consent Yes
05/12/2021 23:28:56