Effect of Spinal Magnetic Stimulation Versus Posterior Tibial Neuromodulation in Treatment of Monosymptomatic Nocturnal Enuresis: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual analogue scale to determine how much the enuresis affected his/her life.
研究概览
简要总结
A prospective randomized trial to study the effect of spinal magnetic stimulation versus posterior tibial neuromodulation in the treatment of monosymptomatic nocturnal enuresis.
详细描述
Nocturnal enuresis is defined as "nighttime bedwetting in children aged five years or older.Currently available treatment options for nocturnal enuresis include medication, wetting alarms, lifestyle changes, sacral magnetic stimulation, and posterior tibial neurmodulation.
Magnetic stimulation is a valid method for stimulation of sacral as functional electrical stimulation. It generates a more powerful and deeper electrical field than that produced by conventional electrical stimulators. So, magnetic stimulation could be considered an attractive form of electrical therapy, being relatively painless, non-invasive and free from side effects.Peripheral neuromodulation is the modulation of the physiologic behavior of the nerve by electrical stimulation. Posterior tibial neuromodulation is an effective method in treatment of urinary incontinence
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
- 5 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects were diagnosed as patients with MNE according to the Diagnostic and statistical manual of mental disorders, 4th revised edition (DSM-IV) (American Psychiatric Association's DSM-IV, 1994): bed-wetting ≥3 times a week; lasting more than 6 months; can control urination during the day but cannot control urination after falling asleep.
排除标准
- •- Patients younger than 5 years old.
- •Patients who have any abnormality in blood or urine biochemistry.
- •Patients with other urinary symptoms.
- •Patients with neurological or endocrinal abnormalities (such as cerebral palsy, spinal cord lesion, peripheral neuropathy or diabetes mellitus)
研究组 & 干预措施
Spinal magnetic stimulation
Spinal magnetic stimulation group will receive repetitive spinal magnetic stimulation sessions for a total of 12 sessions. Using the Neuro-MS/D machine, circular coil will be used to stimulate S2,3 and 4 sacral roots. The outer rim of the coil will be positioned in the midline over the sacral vertebrae (approximately 5 cm above the natal cleft, which approximates to the level of S2) Intensities will be adjusted to 50-70 % of maximal output (2.2 Tesla), stimulation frequency will be fixed at 15 Hz, burst length = 10 seconds, inter-burst interval = 30 seconds with a total of 1500 pulses
干预措施: Rehabilitation (Other)
Neuromodulation
Neuromodulation group will receive 12 sessions of bilateral transcutaneous posterior tibial neuromodulation using (Myomed 632®, Enraf Nonius, Delft, Netherlands) machine, the active rubber surface was placed behind the medial malleolus and the reference electrode was placed 10 cm proximal. Adjustment of the electric current was as follows: continuous current, pulse duration 200 ms, frequency 20 Hz; each session lasts for 30 min. The current intensity was adjusted according to the tolerance of the patient or until the big toe curls into plantar flexion
干预措施: Rehabilitation (Other)
结局指标
主要结局
Visual analogue scale to determine how much the enuresis affected his/her life.
时间窗: three months
Visual analogue scale from zero to ten (zero indicates no effect, 10 indicates severe bothersome
Frequency of bed wetting
时间窗: one month
Number of bed wettings/ week
次要结局
未报告次要终点
研究者
Nehad Mohamed Elshatby Mahmoud
Physician
University of Alexandria