The Efficacy and Safety of Electroacupuncture for Urinary Function of Patients With CUR Secondary to Lower Motor Neuron Lesion: A Multi-center Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The proportions of responders of postvoid residual urine (PVR)
研究概览
简要总结
Chronic Urinary Retention (CUR) is defined as a non-painful bladder which remains palpable or percussible after the patient has passed urine by International Continence Society. Postvoid residual urine volume ≥300 mL seems to be widely accepted.
CUR may be caused by a variety of diseases and events including injury of sacral plexus, cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral neuropathy due to diabetes, etc.. Aforementioned injuries generally affect lower motor neuron causing detrusor underactivity, acontractile detrusor or detrusor areflexia. The prevalence varies by different causes of lower motor neuron lesion. The symptoms of patients are voiding difficulty, bladder distention, bladder without sensation and overflow incontinence.
A multi-center randomized sham-controlled trial will be conducted. The aim of this study is to assess the efficacy and safety of electroacupuncture for urinary function of patients with CUR caused by lower motor neuron lesion.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have chronic urinary retention caused by lower motor neuron damage.
- •Age 18 to 75 years.
- •Have chronic urinary retention caused by injury of sacral plexus, cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral neuropathy due to diabetes.
- •Have postvoid residual urine volume 300 mL or more and sensation of bladder.
- •Bladder contractile index is more than 100 or more.
- •Duration of disease is more than 3 months.
- •Intermittent clean catheterization or indwelling catheterization.
- •Sign informed consent and participate in the study voluntarily.
排除标准
- •Have urinary retention due to bladder outlet obstruction (bladder neck contracture, urethral stricture, prostate cancer, prostatic hyperplasia, etc.)
- •Have urinary system tumors or stones.
- •Have detrusor underactivity due to other non-lower motor neurogenic disease.
- •Have bowel and urinary disorder due to lesions or injuries of thoracic spinal cord, cervical spinal cord and brain.
- •After suprapubic cystostomy.
- •Have heart, liver, kidney, mental disorders or coagulation disorders.
- •Have been implanted a cardiac pacemaker, sacral nerve stimulation electrode, pudendal nerve stimulation electrode, or bladder stimulation electrode.
- •During pregnancy or in lactation.
研究组 & 干预措施
Electroacupuncture
Bilateral Shenshu (BL23), Ciliao (BL32), Zhongliao (BL33), Huiyang (BL35), and Sanyinjiao (SP6) will be inserted by the needles (0.30 mm in diameter, 75 mm in length or 0.40 mm diameter, 100 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China).
干预措施: Electroacupuncture (Other)
Sham electroacupuncture
Sham Bilateral Shenshu (BL23), Ciliao (BL32), Zhongliao (BL33), Huiyang (BL35), and Sanyinjiao (SP6) will be inserted by the needles (0.20 mm in diameter, 25 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China).
干预措施: Sham electroacupuncture (Other)
结局指标
主要结局
The proportions of responders of postvoid residual urine (PVR)
时间窗: week 12
The responder is defined as a participant with a decline of 50% or more from baseline in the PVR volume after spontaneous urination. The PVR volume is the average value of 2 times of the same measurement method with the interval of 6 hours to 3 days.
次要结局
- The change of the bladder contractile index (BCI)(week 12)
- The proportions of responders of postvoid residual urine (PVR)(week 36)
- The satisfactory spontaneous urination responders(week 36)
- The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)(week 36)
- The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)(week 36)
- The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization(week 36)
- The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries(week 36)
- The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)(week 36)
- The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis(week 36)
- The change of the urodynamic parameters from baseline(week 12)
- The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization(week 12)
- The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization(week 24)
- The proportions of responders of postvoid residual urine (PVR)(week 6)
- The proportions of responders of postvoid residual urine (PVR)(week 24)
- The satisfactory spontaneous urination responders(week 12)
- The change from baseline of the number of catheterizations per day measured by the 7-day voiding diaries for patients with intermittent clean urethral catheterization(week 6)
- The satisfactory spontaneous urination responders(week 24)
- The proportion of patients with increase of 50% or more from baseline of the maximum flow rate (Qmax)(week 12)
- The proportion of patients with increase of 2 ml/s from baseline of the maximum flow rate (Qmax)(week 12)
- The proportion of patients with increase of 50% or more from baseline of the voiding efficiency (VE) measured by the 7-day voiding diaries(week 12)
- The change form baseline of Short Form of a Urinary Quality of Life Questionnaire (SF-Qualiveen)(week 12)
- The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis(week 12)
- The proportion of patients without recurrent symptomatic urinary tract infection, vesical calculus and hydronephrosis(week 24)
研究者
Liu Zhishun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences