Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrophy;Vaginal
• Intervention / Treatment: Device: Light Emitting Diode; Device: Sham Light Emitting Diode

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrícia Lôrdelo; Phone Number: 557188592400/3330- 1640; Email: pvslordelo@hotmail.com

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41825-000
      • Recruiting
      • Instituto Patrícia Lordelo
      • Contact: Patrícia Lordelo; Phone Number: +55(71)9 9659-2400; Email: topfisio.topfisio@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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
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
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]

Collaborators and Investigators

• Sponsor: Patricia Lordelo
• Collaborators: University of Messina

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Women; Menopause; Phototherapy
• Other Study ID Numbers: U1111-1201-2342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No