Clinical trial NCT04902794: Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause
Official title: Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophy;Vaginal
Keywords: Phototherapy
Menopause
Women
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
Collaborators: name: University of Messina
First posted: 2021-05-26
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Vaginal maturation index
timeFrame: Change from baseline at 3 months
measure: Female Sexual Function Index (FSFI) - Female Version (QS-F)
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Vaginal pH
timeFrame: Change from baseline at 3 months
measure: Urinary symptoms
timeFrame: Change from baseline at 3 months
measure: Visual analog scale
timeFrame: Change from baseline at 3 months
measure: Female Genital Self-Image Scale - 7 (FGSIS-7)
timeFrame: Change from baseline at 3 months]
measure: Likert scale
timeFrame: Change from finished treatment and 3 months after
measure: Sexual Quotients Female Version (QS-F)
timeFrame: Change from baseline at 3 months
measure: SF-36
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Instituto Patrícia Lordelo
state: Bahia
Study officials:
References: