Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Vaginal maturation index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Vaginal maturation index
时间窗: Change from baseline at 3 months
Cytological vaginal will be collected at one third lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Female Sexual Function Index (FSFI) - Female Version (QS-F)
时间窗: Change from baseline at 3 months
Measure of quality of sex life. Full Scale Score Range 2-36 - The higher final score, better is the sexual function
次要结局
- Likert scale(Change from finished treatment and 3 months after)
- Vaginal pH(Change from baseline at 3 months)
- Female Genital Self-Image Scale - 7 (FGSIS-7)(Change from baseline at 3 months])
- Sexual Quotients Female Version (QS-F)(Change from baseline at 3 months)
- SF-36(Change from baseline at 3 months)
- Urinary symptoms(Change from baseline at 3 months)
- Visual analog scale(Change from baseline at 3 months)
研究者
Patricia Lordelo
Principal Investigator
Centro de Atenção ao Assoalho Pélvico