Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Symptom scoring on Urge-Urinary Distress Inventory questionnaire
研究概览
简要总结
Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.
详细描述
5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urine incontinence refractory to traditional treatment
排除标准
- •Arrhythmia, pacemaker implantation
研究组 & 干预措施
experimental group
Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays.
干预措施: FMS (Magstim rapid2) (Device)
sham group
sham FMS, 5 Hz, 20 min per day, for 10 weekdays.
干预措施: FMS (Magstim rapid2) (Device)
结局指标
主要结局
Symptom scoring on Urge-Urinary Distress Inventory questionnaire
时间窗: up to 5 months
次要结局
- Cystometry and stress urethral pressure profile as measures of objective incontinence improvement(up to 5 months)
研究者
vghtpe user
Po-Yi Tsai MD
Taipei Veterans General Hospital, Taiwan