Laser Vaginal Treatment for GSM
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- subjective measure of change in: the patient's most bothersome symptom
研究概览
简要总结
Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 45-70 years;
- •2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
- •at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness | itching | irritation | soreness/pain | dyspareunia;
- •no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
- •vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.
排除标准
- •Patient is pregnant/lactating
- •unexplained abnormal genital bleeding
- •current acute vaginal/ bladder infection
- •antibiotic use the past 30 days;
- •women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
- •concurrent use of any other new GSM treatment
- •pelvic surgery <3 months
- •current treatment for chronic pelvic pain
研究组 & 干预措施
sham treatment
干预措施: laser vaginal treatment (Procedure)
laser treatment
干预措施: laser vaginal treatment (Procedure)
结局指标
主要结局
subjective measure of change in: the patient's most bothersome symptom
时间窗: Baseline and 3 months after treatment start
The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe
次要结局
未报告次要终点