Therapeutic Effect of Sacral Root Stimulation on Nocturnal Enuresis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- the number of bedwetting/week
研究概览
简要总结
The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.
详细描述
The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis. Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects diagnosed as patients with primary monosymptomatic nocturnal enuresis according to the Diagnostic and statistical manual of mental disorders, 4th revised edn (DSM-IV)
排除标准
- •We exclude any patient with pacemakers or any metallic devices
- •Patients with evidence of urinary tract infection.
研究组 & 干预措施
Real group
The real group received biphasic rSMS using a Magstim Super Rapid (Magstim, Whitland, UK) stimulator connected to a 120-mm outer diameter figure-of-8 air film cooling coil positioned in the midline over the sacral vertebrae (approximately 5 cm above the natal cleft, which approximates to the level of S2). Stimulation was delivered at 15 Hz at 50% of maximum stimulator output (10 seconds on and 30 seconds off) with a total of 1500 pulses and the hand of the coil upward. The stimulation was repeated for 10 sessions, 5 sessions per week and 2 days off.
干预措施: rSMS in treatment of Nocturnal Enuresis (Device)
Sham Group
The control group received sham rSMS stimulation using the same coil, the same session frequency, in the same setting, but the coil was tilted 90.
干预措施: rSMS in treatment of Nocturnal Enuresis (Device)
结局指标
主要结局
the number of bedwetting/week
时间窗: 2.5 months
Measurment of number of bedwetting/week one month before session, session, after first and second week of stimulation and one month later
次要结局
- VAS(1.5 month)
- Quality of life assessment(1.5 month)
研究者
Eman M. Khedr
Clinical professor
Assiut University