Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause

Patricia Lordelo

Status: Enrolling

Conditions: Atrophy;Vaginal

Treatments: Device: Light Emitting Diode; Device: Sham Light Emitting Diode

Study type: Interventional

Funder types: Other

Identifiers

NCT04902794

U1111-1201-2342

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

74 participants in 2 patient groups

Light Emitting Diode

Experimental group

Description:

Light Emitting Diode in the Treatment of Menopause Genitourinary Syndrome

Treatment:

Device: Light Emitting Diode

Light Emitting Diode Sham

Sham Comparator group

Description:

Light Emitting Diode device Sham - turned off

Treatment:

Device: Sham Light Emitting Diode