Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause

NCT ID: NCT04902794

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Light Emitting Diode

Light Emitting Diode in the Treatment of Menopause Genitourinary Syndrome

Group Type: EXPERIMENTAL

Light Emitting Diode

Intervention Type: 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 - turned off

Group Type: SHAM_COMPARATOR

Sham Light Emitting Diode

Intervention Type: DEVICE

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

Interventions

Light Emitting Diode

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

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: collaborator

Patricia Lordelo

OTHER

Sponsor Role: lead

Responsible Party

Patricia Lordelo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Instituto Patrícia Lordelo

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Patrícia Lôrdelo

Role: CONTACT

pvslordelo@hotmail.com

557188592400/3330- 1640

Facility Contacts

Patrícia Lordelo

Role: primary

topfisio.topfisio@hotmail.com

+55(71)9 9659-2400

Other Identifiers

U1111-1201-2342

Identifier Type: -

Identifier Source: org_study_id