NCT02819336已完成不适用
Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial
Kyunghee University4 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Total Urgency and Frequency Score (TUFS)
研究概览
简要总结
This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged over 19 years old
- •Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years
- •Twice or more of urination with 3 to 4 points of PPIUS* at baseline OR 13 points or more of K-IPSS*
- •Any volunteers who signed the informed consent forms
排除标准
- •We will exclude any patients with
- •Once or more of post-voiding residual > 200 ml per day
- •Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision
- •Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year
- •Cognitive impairment with less than 23 points of MMSE-K* examination
- •Acute or chronic lower urinary tract infection examined by urine culture
- •Urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history
- •Any severe diseases in lower urinary tract based on medical history and screening examination
- •Coagulation disorders based on medical history
- •Peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history
- •Psychiatric diseases based on medical history
- •Fear of acupuncture based on questionnaire test
- •Pregnancy based on urine test
- •Any other inappropriate reasons on which the primary or sub investigators do not let the patients participate in the trial
- •Abbreviations PPIUS; Patient Perception of Intensity of Urgency Scale K-IPSS; The Korean version of International Prostate Symptom Scale MMSE-K; The Korean version of Mini-Mental State Examination
结局指标
主要结局
Total Urgency and Frequency Score (TUFS)
时间窗: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The patients will be asked to fill the scale about their perception of urgency intensity (24 hours before the 1st session and after the last session, respectively) by themselves. They have to record every time of urination and select one of the 5 levels in perception of urgency intensity (0=No urgency, 1=Mild urgency, 2=Moderate urgency, 3=Severe urgency, 4= urgency incontinence) for 24 hours at baseline and the end of the treatment, respectively.
次要结局
- International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)(at least 15 days (at most 21 days) (at baseline and the end of the treatment))
- The Korean version of International Prostate Symptom Scale (K-IPSS)(at least 15 days (at most 21 days) (at baseline and the end of the treatment))
- The Lower urinary track system Outcome Score (LOS)(at least 15 days (at most 21 days) (at baseline and the end of the treatment))
- Adverse events report(intraoperative)
研究者
Lee Eui-ju
Professor
Kyunghee University
研究点 (4)
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