The Efficacy and Safety of an Additional Vaginal Laser Treatment in Women Previously Treated With Laser for Gynecological Indications.
试验速览
- 阶段
- 不适用
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Length of effect
研究概览
简要总结
Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.
详细描述
The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previously treated with 3 laser treatments.
- •Clear PAP test from the last 3 years.
排除标准
- •Vaginal bleeding of unknown source.
- •Vaginal surgery in the past 9 months.
结局指标
主要结局
Length of effect
时间窗: From the treatment session up to 6 months post-treatment
The duration of symptom improvement.
次要结局
- Female sexual function index(From the treatment session up to 6 months post-treatment)
- Sexual intercourse(From the treatment session up to 6 months post-treatment)
- Urinary distress index(From the treatment session up to 6 months post-treatment)
研究者
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus