Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline
研究概览
简要总结
The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).
详细描述
The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment.
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
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
- •Exhibiting VVA symptoms
- •Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
- •Have not had procedures in the anatomical area through 6 months prior to treatment
- •Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
排除标准
- •• Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
- •Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
- •Any serious disease, or chronic condition, that could interfere with the study compliance
- •Previously undergone reconstructive pelvic surgery
- •Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
- •A history of thrombophlebitis
- •A history of acute infections
- •A history of heart failure
- •Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
- •Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
- •Taking medications that are photosensitive
- •A history of keloid formation
结局指标
主要结局
The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline
时间窗: Baseline and at follow up visit at 12 months post last treatment
The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS).
次要结局
未报告次要终点