NCT02747641已完成不适用
Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Vulvovaginal Atrophy (VVA)
研究概览
简要总结
The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking
- •Woman, age 35 to 70 yrs, menopausal
- •Provided written Informed Consent
- •Exhibiting VVA and/or SUI symptoms (mild or moderate SUI, according to severity index developed by Sandvik.)
- •Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
- •Normal PAP smear (up to 1 year prior to baseline)
- •Vaginal canal, introitus and vestibule free of injuries and bleeding
- •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
- •Severe prolapse (POP>= grade 3)
- •Use of photosensitive drugs
- •Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
- •Any serious disease, or chronic condition, that could interfere with the study compliance
- •Acute or actively present within the last 2 months HPV/HSV
- •Undiagnosed vaginal bleeding
- •Urge or overflow incontinence
- •Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
- •Patients with immune system diseases.
- •Patients with allergic reaction to laser.
- •Obese women (BMI >30)
- •Patient unable to follow post-treatment instructions
- •History of keloid formation
- •Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
- •A history of thrombophlebitis
- •A history of acute infections
- •A history of heart failure
- •Previously undergone reconstructive pelvic surgery
- •Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
- •Any medical condition that in the investigators opinion would interfere with the patients participation in the study
研究组 & 干预措施
treatment
Other
only one arm
干预措施: Pixel CO2 Laser System (Procedure)
结局指标
主要结局
Vulvovaginal Atrophy (VVA)
时间窗: 6 months
Utilizing Bachman Vaginal Health Index
次要结局
未报告次要终点
研究者
研究点 (1)
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