Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- change of quality of life after electrostimulation
研究概览
简要总结
The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.
Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •stress, urge or mixed incontinence with indication of perineal reeducation
- •follow in gynecology
排除标准
- •incontinence due to neurological disorders
- •younger than 18 years old
- •pregnancy
- •patient with pace-maker
- •patient with gynecological cancer
- •patient who don't understand the electrical stimulation procedure
结局指标
主要结局
change of quality of life after electrostimulation
时间窗: 2 months
Change from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with "contilife" questionnaire
次要结局
- change of urinary handicap after electrostimulation(2 months)
- satisfaction after electrostimulation(2 months)