NCT06354244招募中不适用
Effects of Electroacupuncture of Different Treatment Frequency in Chronic Urinary Retention Caused by Lower Motor Neuron Lesions: a Prospective Cohort Study
Guang'anmen Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The response rate.
研究概览
简要总结
The aim of this study is to compare the effects of electroacupuncture of different frequency in patients with chronic urinary retention caused by lower motor neuron lesions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with urinary retention caused by lower motor neuron lesions (e.g., sacral plexus, cauda equina, or sacral cord lesions).
- •18 years or older.
- •Baseline post void residuals (PVR) ≥150 mL.
- •The course of urinary retention ≥1 month.
- •Having normal bladder sensation.
- •Using clean intermittent catheterization (CIC), indwelling catheterization (IC), manual assisted voiding including putting pressure on abdomen, or cystostomy catheterization.
- •Signed informed consent and voluntary participation in the study.
排除标准
- •Having a lower urinary tract obstruction, such as bladder neck contracture, urethral stricture, prostatic hyperplasia, or large urinary stones that can cause obstruction.
- •Having any type of malignant tumors not removed.
- •Having severe systemic disorders not controlled.
- •Having implanted electrodes of cardiac pacemaker, pudendal nerve stimulation, bladder stimulation, or SNM.
- •Pregnancy or lactation.
- •Eletroacupuncture treatment duration < 2 weeks.
结局指标
主要结局
The response rate.
时间窗: Week 12.
Responders are defined as patients whose post void residuals (PVR) reduced by 50% or more from baseline.
次要结局
- The response rate.(Week 4, Week 8 and Week 24.)
- The change in the proportion of patients reporting severe urinating difficulty from baseline.(Week 4, Week 8,Week 12 and Week 24.)
- The change in the proportion of patients having stool retention from baseline.(Week 4, Week 8,Week 12 and Week 24.)
- The change in the proportion of patients requiring catheterization from baseline.(Week 4, Week 8,Week 12 and Week 24.)
- The proportion of patients reporting much better or moderately better regarding the Patient Global Impression of Improvement (PGI-I).(Week 4, Week 8,Week 12 and Week 24.)
- The change in post void residuals (PVR) from baseline.(Week 4, Week 8,Week 12 and Week 24.)
- The proportion of patients having recurrent symptomatic UTI, hydroureter, or hydronephrosis.(Week 4, Week 8,Week 12 and Week 24.)
研究者
Liu Zhishun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究点 (1)
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