Effect of Motor Cortex Magnetic Stimulation Versus Sacral Magnetic Stimulation in Lower Urinary Tract Dysfunction in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Change from baseline Post-void residual urine after treatment
研究概览
简要总结
This work is intended to assess the effect of repetitive magnetic stimulation on the sacral roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients with the lower urinary tract dysfunction.
详细描述
Twenty Multiple sclerosis patients with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on sacral roots. Another twenty Multiple sclerosis patient with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on motor cortex. Treatment outcome will be assessed and compared between the two groups.
Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses (total duration: 16 minutes) once a day for four consecutive days for two weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Sclerosis patients (diagnosed by McDonald criteria 2010) with lower urinary tract dysfunction
- •Adults more than 18 years
- •Unresponsiveness to medical treatment
- •Urodynamic diagnosis of detrusor overactivity and/or detrusor underactivity and/or detrusor-sphincter dyssynergia
排除标准
- •Urinary tract infections
- •Pregnancy
研究组 & 干预措施
Sacral magnetic stimulation
Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over sacral roots
干预措施: magnetic stimulation (Other)
Cortical magnetic stimulation
Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over motor cortex
干预措施: magnetic stimulation (Other)
结局指标
主要结局
Change from baseline Post-void residual urine after treatment
时间窗: 1-7 days after treatment
Measured by ultrasound It is the volume of urine left in the bladder at the completion of micturition Measured in milliliters (mL)
Change from baseline King's Health QoL questionnaire score after treatment
时间窗: 1-7 days after treatment
questionnaire evaluates the impact of lower urinary tract symptoms on patient's quality of life. High scores represent a worse quality of life, with no cut-off values.
Change from baseline Maximum Cystometric Capacity (MCC) after treatment
时间窗: 1-7 days after treatment
Measured by urodynamic evaluation Measured in millimeters (mL) It is the volume at which the patient states that he/she can no longer delay micturition because of strong desire to void or urgency
Change from baseline Maximum Flow Rate (Qmax) after treatment
时间窗: 1-7 days after treatment
Measured by urodynamic evaluation Measured in milliliters per second (mL/sec) It is the maximum measured value of the flow rate
Change from baseline Detrusor pressure at maximum flow rate (Pdet @Qmax) after treatment
时间窗: 1-7 days after treatment
Measured by urodynamic evaluation Measured in centimeter water (cmH2O) It represents the effect of the active and/or passive forces generated by the detrusor muscle
次要结局
未报告次要终点
研究者
May Maged Abdel-Salhin
Doctor
Cairo University