Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 232
- 试验地点
- 5
- 主要终点
- Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.
研究概览
简要总结
The investigators plan to conduct this multi-center, three-armed, randomized controlled trial to evaluate the efficacy of electroacupuncture (EA), compared with sham electroacupuncture (SA) and waiting list (WL) on participants with stress-predominant mixed urinary incontinence (MUI).
详细描述
MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recommends to initiate treatment targeted at predominant component of MUI. However, as to whether the interventions for stress urinary incontinence (SUI) can be effectively generalized to stress-predominant MUI, there is still no powerful evidence to support it. It is necessary to seek for interventions specific to stress-predominant MUI. Results of previous studies indicated that acupuncture might help to relieve the incontinence symptoms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MUI by the coexistence of SUI and urgency urinary incontinence (UUI) symptoms in accordance with EAU guideline;
- •Female participants aged between 35 and 75;
- •Stress index > urge index in accordance with Medical, Epidemiologic, and Social aspects of Aging(MESA) questionnaire；
- •Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEF documented in 3-day voiding diary;
- •Less than 12 micturition episodes in average 24 hours documented in 3-day voiding diary;
- •Positive cough stress test;
- •Urine leakage > 1 g in 1-hour pad test;
- •Voluntary participation in the trial and signed written informed content.
排除标准
- •Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) and neurogenic bladder;
- •Uncontrolled symptomatic urinary tack infection;
- •Tumor in urinary system and pelvic organ;
- •Pelvic organ prolapse ≥ degree Ⅱ；
- •Residual urine volume ≥ 100ml；
- •History of treatments targeted at UI, such as acupuncture, PFMT and medications in the previous one month;
- •History of surgery targeted at UI or in pelvic floor, including hysterectomy;
- •Uncontrolled diabetes or severe high blood pressure;
- •Nervous system diseases that may hamper the function of urinary system, such as Multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina nerve injury, or multiple system atrophy;
- •Severe heart, lung, brain, liver, kidney, mental illness, coagulation dysfunction or with obvious cognitive dysfunction
- •Installed cardiac pacemaker;
- •Inconvenient or unable to walk, run, go up and down stairs;
- •Allergy to metal, severely fear of acupuncture needles or unbearable to EA;
- •Pregnant at present, plan to conceive in future one year, at lactation period or within 12 months after childbirth.
结局指标
主要结局
Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.
时间窗: week 8
The stress IEF will be documented in 3-day voiding diary.
次要结局
- Proportion of participants with at least 50% reduction of urinary leakage amount from baseline.(week 8)
- Change of urinary leakage amount from baseline(week 8)
- Change of mean 24-hour IEF from baseline.(week 4，week 8, week 20 and week 32.)
- Proportion of participants with at least 50% reduction of mean 24-hour IEF from baseline(week 4，week 8, week 20 and week 32)
- Change of total and sub-score of Overactive Bladder Questionnaire short form (OAB-q SF) from baseline(week 4，week 8, week 20 and week 32)
- Change of mean 24-hour stress IEF from baseline(week 4，week 8, week 20 and week 32.)
- Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline.(week 4，week 20 and week 32)
- Change of total and sub-score of International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) from baseline.(week 4，week 8, week 20 and week 32)
- Change of mean 24-hour pad consumption from baseline(week 4，week 8, week 20 and week 32)
- Proportion of participants with adequate improvement assessed by Patient global impression improvement (PGI-I).(week8, week 20)
- Change of mean 24-hour urgency episodes from baseline(week 4，week 8, week 20 and week 32)
- Change of mean 24-hour micturition episodes from baseline(week 4，week 8, week 20 and week 32)
研究者
Liu Zhishun
Dean of Acupuncture Department of Guang'anmen Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences