Effect of Electroacupuncture for Women With Urgency-predominant Mixed Urinary Incontinence: a Three Armed Non-inferior Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
研究概览
简要总结
The study is to determine the effect of electroacupuncture in female patients with urgency-predominant mixed urinary incontinence. A three-arm non-inferior randomized controlled trial (RCT) using electroacupuncture, sham electroacupuncture and solifenacin with a total sample of 282 is proposed.
The hypothesis is that the improvement (difference in number of urgency urinary incontinence episodes between baseline and 12-week evaluation) in the electroacupuncture group would be 50% or less of the difference in the improvement between the Solifenacin and the sham electroacupuncture groups.
详细描述
Mixed urinary incontinence (MUI) features complaint or involuntary loss of urine associated with urgency and also with effort or physical exertion or on sneezing or coughing. It is regarded as urgency-predominant mixed urinary incontinence (UMUI) when sudden sensation of voiding accompanied by uncontrolled incontinence domains the symptoms. UMUI can bring shame and inconvenience to patients.
As first-line medicine for urge-predominant urinary incontinence, Solifenacin can reduce urgency urinary incontinence episodes in 24 hours. However, the side effects tend to bring about poor compliance among patients.
Acupuncture might be effective in treating UMUI. Previous research indicated that electroacupuncture might be noninferior to pelvic floor muscle training plus Solifenacin in reducing the urgency incontinence episodes of UMUI women. However, that study didn't focuse on UMUI exclusively, thus unable to decide whether electroacupuncture is effective in the treatment of UMUI.
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 (Investigator, Outcomes Assessor)
盲法说明
participants in electroacupuncture and sham electroacupuncture groups are blinded, and solifenacin group is open.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients diagnosed with mixed urinary incontinence in accordance with EAU guideline by history intaking and physical examination[8];
- •Age between 18 and 80 years old;
- •Urgency index greater than stress index by MESA questionnaire[12];
- •At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary;
- •With MUI for at least 3 months, and more than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary;
- •Positive cough test;
- •A voluntarily-signed written informed content.
排除标准
- •Having pure stress urinary incontinence, pure urgency urinary incontinence, overflow urinary incontinence or neurogenic bladder;
- •Uncontrolled urinary tract infection;
- •Tumor in urinary system or pelvic organs;
- •Pelvic organ prolapse≥degreeⅡ;
- •Residual urine volume≥100ml;
- •Maximum flow rate<15ml/s;
- •Treated incontinence by acupuncture or positive medications, such as antimuscarinic drug within the past 1 month;
- •Underwent surgery of anti-incontinence or in pelvic area, metrectomy included;
- •Complication of uncontrolled diabetes and severe hypertension;
- •Complicated diseases in nerves system that could hamper hypourethral function, such as Multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, cauda equina nerve injury and multiple system atrophy;
- •Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
- •Installed a cardiac pacemaker;
- •Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis, angle-closure glaucoma;
- •Allergic to metal or intolerant to the stimulation of electroacupuncture;
- •Already with child or plan to conceive in the future 1 year, or within 1 year after delivery.
研究组 & 干预措施
electroacupuncture group
Acupoints of bilateral Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) are stimulated by Huatuo Brand disposable needles and SDZ-V electronic apparatus.
干预措施: electroacupuncture (Device)
sham electroacupuncture group
Sham acupoints 1 cun(≈15mm) horizontally outwardly lateral to BL33 and BL35, and 0.5 cun(≈10mm) horizontally behind SP6 are stimulated superficially with a small electricity current by needles of 0.30×40mm size and SDZ-V electronic apparatus.
干预措施: sham electroacupuncture (Device)
Solifenacin group
subjects will orally take Solifenacin 5-10mg per day.
干预措施: Solifenacin (Drug)
结局指标
主要结局
Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
时间窗: week 12
3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
次要结局
- Proportion of subjects with complete resolution of urgency urinary incontinence episodes in average 24 hours based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- Change of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF ) score from baseline.(week 4, week 8, week 12, week 24, week 36)
- Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.(week 4, week 8, week 24, week 36)
- Change of urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- Change of voiding episodes in average 24 hours from baseline based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- Proportion of subjects with at least 50% reduce of urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- Change of pad consuming in average 24 hours from baseline based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- volume change of water intake in average 24 hours from baseline based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- Change of Overactive bladder questionnaire short form (OABq-SF) score from baseline.(week 4, week 8, week 12, week 24, week 36)
- Change of residual urinary volume from baseline tested by abdominal B-ultrasound.(week 12)
- Proportion of subjects with at least 50% reduce of urgency urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- Change of voiding episodes graded as 3/4 in average 24 hours from baseline based on the Patient Perception of Intensity of Urgency Scale( PPIUS).(week 4, week 8, week 12, week 24, week 36)
- Change of nocturia episodes in average 24 hours from baseline based on 3-day voiding diary.(week 4, week 8, week 12, week 24, week 36)
- Proportion of subjects with adequate improvement assessed by Patient global impression improvement (PGI-I).(week 12, week 36)
研究者
Liu Zhishun
Principle investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences