NCT00910338已完成不适用
Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KYU-SUNG LEE
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.
研究概览
简要总结
Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stress urinary incontinence
- •Standard pad test > 2gram
排除标准
- •Women with:
- •Mixed urinary incontinence of which urgency incontinence is dominant
- •True incontinence
- •Overflow incontinence
- •Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
- •Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
- •Pelvic organ prolapse which the stage is at least 2
- •Proven urinary tract infection during screening period
- •Pacemaker
- •Pregnant women
- •Neurogenic voiding dysfunction
结局指标
主要结局
Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.
时间窗: After 12 weeks of treatment
次要结局
- Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.(After 12 weeks of treatment)
- Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).(After 12 weeks of treatment)
研究者
研究点 (3)
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