Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause

NCT04902794 | Unknown DMC

• 1 other identifier: U1111-1201-2342
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophy;Vaginal

Keywords

Phototherapy; Menopause; Women

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Vaginal pH

  Change from baseline at 3 months

• Urinary symptoms

  Change from baseline at 3 months

• Visual analog scale

  Change from baseline at 3 months

• Female Genital Self-Image Scale - 7 (FGSIS-7)

  Change from baseline at 3 months]

• Likert scale

  Change from finished treatment and 3 months after

Study Arms (2)

Light Emitting Diode

EXPERIMENTAL

Light Emitting Diode in the Treatment of Menopause Genitourinary Syndrome

Device: Light Emitting Diode

Light Emitting Diode Sham

SHAM COMPARATOR

Light Emitting Diode device Sham - turned off

Device: Sham Light Emitting Diode

Interventions

Light Emitting Diode DEVICE

Blue light-emitting diode applied to the female genital region for eight minutes, for five sessions, one per week

Light Emitting Diode

Sham Light Emitting Diode DEVICE

Sham Blue light-emitting diode turned off applied to the female genital region for eight minutes, for five sessions, one per week

Light Emitting Diode Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patricia Lordelo: lead
• University of Messina: collaborator

Study Sites (1)

Instituto Patrícia Lordelo

Salvador, Estado de Bahia, 41825-000, Brazil

RECRUITING

Central Study Contacts

Patrícia Lôrdelo

CONTACT

557188592400/3330- 1640; pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 26, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)