Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause

Study Overview
=================
Brief Summary
-----------------
Introduction: The genitourinary menopause syndrome (MMS) affects 50% of postmenopausal women and, due to a decrease in hormone levels, triggers functional changes in the vagina and vagina, and impairment of quality of life and sexual function. Objective: To test the hypothesis that the 405 nm light emitting diode in the treatment of vulvovaginal atrophy is safe and effective, by reducing the symptomatology of the disease and histological alteration of the tissue. Methods: This is a pilot study in 10 volunteers with SGM, followed by a randomized, blinded trial in a sample of 58 individuals that will be performed at the Pelvic Floor Care Center (CAAP). Menopausal women up to 65 years of age and with clinical signs and symptoms of vulvovaginal atrophy syndrome (vaginal dryness and irritation, pruritus, pain or discomfort in intercourse, bleeding after sexual intercourse) and who voluntarily participate in the study will be included. Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, use of pacemaker, pregnant women, those who have performed Oophorectomy or presented ovarian cancer, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them. In the clinical trial, the study group will perform kinesiotherapy and LED. The control group will perform kinesiotherapy and the LED will be turned off. Data collection will be performed initially and after the sessions through self-administered questionnaires containing socio-demographic and clinical information, Medical Outcomes Study 36, Short-Form Health Survey (SF-36), Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction. Expected results: The 405nm LED in the vaginal canal is expected to be safe and effective for SGM.

Official Title
-----------------
Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause: Randomized Controlled Clinical Trial

Conditions
-----------------
Atrophy;Vaginal

Intervention / Treatment
-----------------
* Device: Light Emitting Diode
* Device: Sham Light Emitting Diode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menopausal women up to 65 years of age presence of clinical signs and symptoms of Menopause Genitourinary Syndrome :dryness and irritation of the vagina, pruritus, pain or discomfort in sexual intercourse, bleeding after sexual intercourse voluntarily participate in the research. Exclusion Criteria: patients undergoing hormone replacement for less than 6 months diagnosis of vaginal infection difficulty in understanding the proposed instruments patients with chronic neurological degenerative diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light Emitting Diode<br>Light Emitting Diode in the Treatment of Menopause Genitourinary Syndrome | Device: Light Emitting Diode<br>* Blue light-emitting diode applied to the female genital region for eight minutes, for five sessions, one per week<br>|
| Sham Comparator: Light Emitting Diode Sham<br>Light Emitting Diode device Sham - turned off | Device: Sham Light Emitting Diode<br>* Sham Blue light-emitting diode turned off applied to the female genital region for eight minutes, for five sessions, one per week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal maturation index | Cytological vaginal will be collected at one third lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index | Change from baseline at 3 months | 
| Female Sexual Function Index (FSFI) - Female Version (QS-F) | Measure of quality of sex life. Full Scale Score Range 2-36 - The higher final score, better is the sexual function | Change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pH | pH indicator tape | Change from baseline at 3 months | 
| Urinary symptoms | International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life) | Change from baseline at 3 months | 
| Visual analog scale | Stratification between 0 and 10 (few symptoms to severe symptoms) | Change from baseline at 3 months | 
| Female Genital Self-Image Scale - 7 (FGSIS-7) | Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image) | Change from baseline at 3 months] | 
| Likert scale | Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment) | Change from finished treatment and 3 months after | 
| Sexual Quotients Female Version (QS-F) | Female sex life domain. Scores between 0-100 (higher scores indicate better sex life) Scores between 82-100 score: excellent, 62-80 score: regular, 42-60 score: unfavorable, 22-40 score: regular, 0-20 score: bad | Change from baseline at 3 months | 
| SF-36 | Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life | Change from baseline at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phototherapy, Menopause, Women