NCT02423486已完成不适用
The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
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
- 66
- 试验地点
- 1
- 主要终点
- Rate comparison of complete recovery in stress pad test after 12 weeks of treatment
研究概览
简要总结
The aim of this study is to compare the efficacy between Electromagnetic Stimulation therapy and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary Incontinence patient.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient with Stress Urinary Incontinence, over 20
- •Leakage over 2g in stress pad test
- •Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
排除标准
- •Mixed Urinary Incontinence which is dominant in urge urinary incontinence.
- •True incontinence
- •Overflow incontinence
- •Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline.
- •Urinary tract infection found In urine test.
- •Patient who had pelvic organ prolapse.
- •Patient who had inserted pacemaker.
- •Pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period.
- •Disorder in Neurosystem like stroke, multiple sclerosis, spinal injury, Parkinson's disease .
- •Patient who will participate in other clinical trial during this study.
- •Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
研究组 & 干预措施
Electromagnetic stimulation therapy
Experimental
Electromagnetic stimulation therapy group
干预措施: Electromagnetic stimulation therapy (BIOCON-2000) (Device)
Electromagnetic stimulation therapy with biofeedback
Experimental
Electromagnetic stimulation therapy with biofeedback group
干预措施: Electromagnetic stimulation therapy with biofeedback (Device)
结局指标
主要结局
Rate comparison of complete recovery in stress pad test after 12 weeks of treatment
时间窗: 12 weeks
Complete recovery is defined as urinary leakage below than 2 gram in stress pad test.
次要结局
- Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment(12 weeks)
- Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment(12 weeks)
- Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment(12 weeks)
- Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment(12 weeks)
- Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment(12 weeks)
研究者
研究点 (1)
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