Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sciton
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Change from baseline in Vaginal Maturation Index (VMI)
研究概览
简要总结
This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of Menopause.
详细描述
Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue health may lead to improvement of symptoms of Genitourinary Syndrome of Menopause (GSM). This multi-centered, 18-month prospective clinical trial will evaluate the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (HFL) as an alternative non-surgical, non-hormonal treatment for symptoms of GSM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy biological female aged between 40 to 70 years
- •Is post-menopausal with a AND b OR c
- •No menses for at least 12 months
- •Follicle-stimulating hormone (FSH) level over 40mlU/mL
- •Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement
- •Is experiencing at least two self-reported symptoms of GSM, such as
- •Vaginal irritation in absence of infection
- •Chronic burning sensation
- •Chronic itching in the absence of infection
- •Recurring urinary tract infections (UTIs)
- •Vaginal dryness during sexual activity
- •Pain during sexual activity (dyspareunia)
- •Has been experiencing symptoms of GSM for greater than 3 months
- •Is unable due to medical contraindication or unwilling to receive hormone-based vaginal therapy
- •Normal and up-to-date pap smear if applicable
- •Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve
- •Can read, understand and sign informed consent form
排除标准
- •Undiagnosed abnormal genital bleeding
- •Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
- •Previous use of topical estrogen therapy within the last 3 months
- •Has used vaginal creams, moisturizers, lubricants or homeopathic preparations or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment
- •History of heart failure
- •Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q)
- •Has an active sexually transmitted infection (STI)
- •Has signs or symptoms of vaginitis/vulvitis
- •Has signs or symptoms of acute urinary tract infection (UTI)
- •Has participated in any clinical trial involving an investigational drug or procedure within the past 30 days
- •The investigator feels that for any reason the subject is not eligible to participate in the study
结局指标
主要结局
Change from baseline in Vaginal Maturation Index (VMI)
时间窗: 12 months
An objective assessment of vaginal hormone response as well as overall hormonal environment by calculating a ratio of parabasal cells, intermediate cells, and superficial cells
次要结局
- Change from baseline in Female Sexual Function Index (FSFI)(12 months)
- Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA)(12 months)
- Change from baseline in Clinical Photography(12 months)
- Change from baseline in Histology(12 months)
- Change from baseline in Vaginal Health Index Score (VHIS)(12 months)