LED light in the treatment of genitourinary syndrome of menopause in breast cancer survivors: preliminary results of a randomized clinical trial

Cerentini T1, Barros D2, Teles A3, Anunciação E3, Gomes T2, Nery L4, Lopes J4, Ferreira R5, Pavie M3, Coutinho J3, Piason L3, Fernades V3, Oliveira C6, Sodré D3, Gally M3, Vilas Boas A3, Lordelo P3

Research Type

Clinical

Abstract Category

Conservative Management

Best in Category Prize: Conservative Management
Abstract 13
Products, Devices and Innovative Therapies
Scientific Podium Short Oral Session 2
Thursday 8th September 2022
09:50 - 09:57
Hall K1/2
Female Incontinence Sexual Dysfunction
1. Federal University of Health Sciences of Porto Alegre, 2. Bahiana School of Medicine and Public Health, 3. Bahiana School of Medicine and Public Health / IPL, 4. ahiana School of Medicine and Public Health / IPL, 5. ahiana School of Medicine and Public Health / IPL / INOI, 6. Bahiana School of Medicine and Public Health / IPL / UNEB
In-Person
Presenter
M

Maria Clara Pavie

Links

Abstract

Hypothesis / aims of study
Genitourinary Syndrome of Menopause (GSM) is characterized by a set of physical signs and symptoms associated with estrogen deficiency, such as vulvovaginal dryness, burning, dyspareunia, and urinary symptoms. These symptoms associated with side effects of oncological treatment, that induce functional changes in the vagina, decrease quality of life and sexual function [1]. The Light Emitting Diode (LED) is a phototherapy instrument non-invasive, athermic, and safe, potentially capable of stimulating the epithelium, as it can provide fibroblast stimulation and increase microcirculation, restoring the quality of vaginal tissue [2]. We hypothesize that the use of LED has the potential to promote an increase in the vaginal mucosa, leading to improvement of symptoms of Genitourinary Syndrome of Menopause (GSM). The aim of this study is to evaluate the impact of blued light LED in reducing atrophy of the vaginal mucosa, evolution of symptoms, quality of life and safety in breast cancer survivors with Genitourinary Syndrome of Menopause.
Study design, materials and methods
This is a double-blind, randomized clinical trial that evaluated women with a history of breast cancer stage 0-III with at least one sign and symptom of GSM. Inclusion in the study was performed after completion of the cancer treatment (surgery, chemotherapy and radiotherapy) and also in those undergoing adjuvant hormone therapy regardless the class of medication used. Exclusion criteria were having taken topical or systemic hormone replacement therapy with estrogen or testosterone during the last 6 months, pregnancy, inability of understanding the proposed evaluation instruments, progression to metastasis disease during the protocol, the presence of vaginal infection or chronic neurological degenerative diseases that preclude to be on gynecological position. The presence of GSM was established by the identification of at least one symptom and a sign characterized on inspection of pelvic structures by an experienced physiotherapist. Vaginal pH measurement was performed with MColorpHast™ tape, Merck, Darnstadt-Germany, with possibility of immediate inclusion in the study if pH > 5.0. For participants with pH  measurement <5.0 was awaited the cytological study to confirm the condition of hypotrophy or atrophy of the vaginal mucosa. The patients were evaluated by Vaginal Maturation Index (VMI) and Vaginal Health Index (VHI) and answered three questionnaires: International Consultation on Incontinece Questionnaire-Short Form (ICIQ-SF), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4), and Likert scale before and after 3 weeks, 2 and 3 months of treatment. The participant was randomly divided into two groups, 1:1, to either the sham session  procedure or Intracavitary active LED with the Model Energy equipment of the DGM® brand (patent number: BR BR 10 2017 026980 9). The protocol consisted of 5 weekly sessions of 8 minutes of 405nm LED, 1.66W/m2,  or sham, both associated with pelvic floor muscle training, in the same day. The study was carried out in a physiotherapy clinic with a specialized urogynecology service. The sample size was established using a Winpepi calculator (version 11.65): 74 patients, 37 in each group, would be enough to detect a difference of 10 points in the VMI (considering a standard deviation of 15 and 8 in each group) [3]. The patients signed the informed consent form and the study was approved by the Ethical Committee.
Results
At the moment, the sample consists of 71 randomized women and 57 completed treatment, 30 in the LED group and 27 in the sham. The mean ages were 53.1(±7.9) and 50.5(±8.3) years in the LED and sham groups, respectively (p=0.36). There was no difference in sociodemographic or clinical characteristics. The VHI from LED group was 15.7 and sham group 14.6 (p = 0.25); the median baseline VMI from LED group was 44 and from sham group was 21.5 (p = 0,54). There was an increase in the domains of physical and  social health and total score in the LED group in the first reassessment, however, with  no difference in the inter group tests and at the end of the 3 evaluations. Similarly, there  was an improvement in the ICIQ-SF scores and in the VHI in the first  evaluation of the LED group, with no difference in the final analysis. In both groups there was a predominance of satisfied or very satisfied patients in the end of the treatment.
Interpretation of results
Our findings can be explained by the fact that most patients are classified as having severe atrophy and, consequently, it is not possible to verify a change in VMI. In the other rand, the pelvic floor exercises performed by both groups may have been the factor causing satisfaction in both groups, since it leads to an increase in the vaginal health index, causing an increase in vaginal lubrication, a decrease in dryness and friability, resulting from increased tissue perfusion. Finally, with the preliminary sample, the large sample loss, and the high standard deviation may have been the main factor associated with the non-identification of differences between the groups.
Concluding message
Blue light-emitting diode was shown to be safe and well tolerated without adverse events, however, in this study it was not possible to demonstrate the presence of a lasting effect of the exposure of this intervention in GSM.
Figure 1
Figure 2
References
  1. Faubion, S. S., Larkin, L. C., Stuenkel, C. A., Bachmann, G. A., Chism, L. A., Kagan, R., ... & Kingsberg, S. A. (2018). Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from The North American Menopause Society and The International Society for the Study of Women's Sexual Health. Menopause, 25(6), 596-608.
  2. Pavie, M. C., Robatto, M., Bastos, M., Tozetto, S., Boas, A. V., Vitale, S. G., & Lordelo, P. (2019). Blue light-emitting diode in healthy vaginal mucosa—a new therapeutic possibility. Lasers in Medical Science, 34(5), 921-927.
  3. Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas. 2016;84:75–80.
Disclosures
Funding None Clinical Trial Yes Registration Number NCT03833726 RCT Yes Subjects Human Ethics Committee Bahiana School of Medicine and Publica Health Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100203
DOI: 10.1016/j.cont.2022.100203

29/11/2022 13:13:57