Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A questionaire to measure the severity of lower urinary tract symptoms (male/female)
研究概览
简要总结
The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent from late complications. The present study is to evaluate the efficacy of electrical pudendal nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible patients will be involved and divided into EPNS or TES group according to their location of medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS). The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine volume.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18+ years;
- •Diagnosed as NLUTD;
- •Incomplete spinal cord injury (SCI), including but not limited to conus medullaris syndrome, cauda equina syndrome, etc.;
- •Radical pelvic surgery: including but not limited to total hysterectomy etc.;
- •Informed consent signed.
排除标准
- •Anatomical bladder outlet obstruction (e.g., prostate enlargement, tumors);
- •NLUTD induced by stroke, multiple sclerosis, HIV, diabetes mellitus, drug, and inflammation or tumor of central nervous system etc.;
- •Lower urinary tract infections;
- •Unwillingness to participate.
研究组 & 干预措施
Electrical pudendal nerve stimulation
Electrical pudendal nerve stimulation At a frequency of 2.0 Hz and a moderate intensity (25~35 mA); 60 minutes three times a week for a total of four weeks
干预措施: Electrical pudendal nerve stimulation (Device)
Transvaginal electrical stimulation
At a current intensity of < 60 mA (as high as possible to get a contraction) and frequencies of 15 Hz and 85 Hz (alternate 3-min periods of stimulation); 30 min three times a week for a total of four weeks.
干预措施: Transvaginal electrical stimulation (Device)
结局指标
主要结局
A questionaire to measure the severity of lower urinary tract symptoms (male/female)
时间窗: 1.5 years
次要结局
- A questionaire to evaluate the Qol(1.5 years)
- Residual urine volume(1.5 years)