Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Evaluation of quality of life improvement using the ICIQ-UI questionnaire
研究概览
简要总结
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 21 and 65 years
- •Voluntarily signed informed consent form
- •Suffers from UI
- •Sexually active
- •FSFI Questionnaire score ≤ 26.55 points
排除标准
- •Suffers from other types of urinary incontinence other than SUI, UUI, MUI
- •Currently lactating
- •Cardiac pacemakers
- •Implanted defibrillators and/or neurostimulators
- •Electronic implants
- •Metal implants, including copper IUD
- •Drug pumps
- •Hemorrhagic conditions
- •Anticoagulation therapy
- •Pregnancy
- •Following recent surgical procedures when muscle contraction may disrupt the healing process
- •Application over areas of the skin which lack normal sensation
研究组 & 干预措施
Treatment Group
Treatment with the investigational device - rPMS
干预措施: rPMS device (Device)
结局指标
主要结局
Evaluation of quality of life improvement using the ICIQ-UI questionnaire
时间窗: 18 months
Evaluation of change in ICIQ-UI score. Decrease of the score will be considered as an improvement.
Evaluation of quality of life improvement using the FSFI questionnaire
时间窗: 18 months
Evaluation of change in FSFI score. Increase of the score will be considered as an improvement.
Evaluation of quality of life improvement using the PISQ-12 questionnaire
时间窗: 18 months
Evaluation of change in PISQ-12 score. Increase of the score will be considered as an improvement.
次要结局
- Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.(18 months)