Photobiomodulation in Post Menopause Genitourinary Syndrome - Study Protocol for a Randomized, Double-blind, Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Changes in the Female Sexual Function Index (FSFI)
研究概览
简要总结
The goal of this project is to evaluate the clinical response of patients with symptoms of genitourinary menopause syndrome after the application of photobiomodulation in the vagina and its introit. METHOD: In this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of PGS will be selected. Participants included in the study will be randomly divided into two groups: group A, which will receive photobiomodulation with a vaginal diode laser and its introit and group B (placebo) with the laser device turned off. Both treatments will be maintained for 4 consecutive weeks.The treatment group (n=30) will receive four consecutive applications, using laser diode DMC (808 nm), 4J per point, 100mW of power, 510mW/cm², beam area of 0.2cm², 8 sites in the external vagina, for the 40s in each site, once per week for 4 weeks. The Placebo Group (n=30) will be handled as treated, but with the laser turned off. Quality of life will be analyzed using the female sexual functioning index (FSFI-6), the urinary incontinence questionnaire (ICIQ-SF), the intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI) and compared between groups. Also, the vaginal temperature will be measured using a thermal camera, as well as the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. The data will be tested for normality using the Shapiro Wilks test and, if they present a parametric distribution, they will be represented by means of their respective means and standard deviations.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Neither the participant nor the outcome assessor will know to which group the participant belongs, seeing as laser application will be simulated in the placebo group.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved);
- •With one or more symptoms of UGS (dyspareunia, dryness, irritation and vaginal burning and/or discomfort, vaginal atrophy, vaginal and vulvar dryness, dysuria, frequency, recurrent urinary infections);
- •With complaints of stress and/or urge urinary incontinence;
- •Who have cervical cytopathology (Pap smear) within the normal range performed in the last year and are not in use of hormonal medication to treat menopausal symptoms in the last 6 months.
排除标准
- •Participants with explicit refusal of the patient to participate in the researc;
- •History of bilateral oophorectomy and diseases such as: recent AMI (Acute Myocardial Infarction), neoplasms, history of thrombosis, liver failure, uncontrolled genital bleeding, genital condylomatosis, active genital herpes, lower genital tract surgeries that make treatment impossible.
结局指标
主要结局
Changes in the Female Sexual Function Index (FSFI)
时间窗: Baseline and the 4 weeks of treatment.
The FSFI or female sexual function index is a specific and multidimensional questionnaire to assess female sexual response, accessing 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain evaluated in 19 questions about sexual activity in the last 4 weeks. In order to obtain the total score of the scale, the scores for each domain are added up, and for higher scores, better sexual function is considered, and the threshold for sexual dysfunction is a score of 2678. Based on the value of the total score, it would be possible discriminate between populations at higher and lower risk of experiencing sexual dysfunction.
次要结局
- Changes in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)(Baseline and the 4 weeks of treatment.)
- Changes in Urinary Loss using Ped-Test(Baseline, the 4 weeks of treatment and 90 days after treatment.)
- Changes in Vulva Temperature(Baseline and and once a week for 4 weeks)
- Changes in the Vaginal Health Index Score(Baseline and the 4 weeks of treatment.)
- Changes in the Vaginal pH(Baseline and the 4 weeks of treatment.)
- Changes in Pain using a Visual Analog Scale (VAS)(Baseline and the 4 weeks of treatment.)
- Changes in the Pelvic Floor Muscles (PFMs)(Baseline and once a week for 4 weeks)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho