跳至主要内容
临床试验/NCT04187027
NCT04187027进行中(未招募)不适用

Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele

South Valley University4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
4
主要终点
The mean (SD) of incidence of first uninhibited detrusor contraction

研究概览

简要总结

This study was conducted to assess the efficacy of pulsed electromagnetic field therapy on neurogenic bladder in children with myelomeningocele .Intervention: A pretest-post test controlled study was conducted in out-patient clinic in faculty of physical therapy Cairo university.

详细描述

Myelomeningocele is the most common cause of neurogenic bladder in children. Bladder function in these children is affected by disordered innervation of detrusor muscle and external urethral sphincter that may lead to hydronephrosis. Thirty myelomeningocele children with neurogenic bladder were enrolled in this study and were assessed for eligibility. Their aged between 4 and 12 years. They were divided randomly into two groups. Group (A) which is the control group received medical care and standard urotherapy only. And Group (B) which is the study group received medical care and standard urotherapy in addition to pulsed electromagnetic field therapy for three successful months. All children were assisted using urodynamic studies before and after three months of intervention.

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
Single (Outcomes Assessor)

盲法说明

Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (control group) and Group B (study group).

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • their age was ranging from four to twelve years.
  • children participated in this study were from both sexes.
  • all children with stable medical and psychological status and had the same socioeconomic status.
  • they were able to follow the verbal commands or instructions.

排除标准

  • children with visual or auditory problems.
  • children with any neurological manifestation rather than spina bifida.
  • medically unstable children especially with cardiovascular disorders, or mentally retarded children.
  • children with any sign of urinary tract infection, or any implanted metal.
  • uncooperative children.

结局指标

主要结局

The mean (SD) of incidence of first uninhibited detrusor contraction

时间窗: first uninhibited detrusor contraction was assessed at day 90.

Detrusor hyperreflexia (DH) is a frequently occurring condition. The symptomatology is characterized by frequency, urgency and urge incontinence. DH is defined as involuntary, uninhibited detrusor contractions

The mean (SD) maximum urinary flow rate (Q max)

时间窗: maximum urinary flow rate (Q max) was assessed at day 90.

Measurement of maximum urinary flow rate (Qmax) is widely used in the assessment of men complaining of lower urinary tract symptoms (LUTS). Although Qmax varies with age and voided volume (V. void), a reduced flow rate can be used clinically to suggest the presence of bladder outlet obstruction (BOO).

The mean (SD) maximum cystometric capacity (MCC)

时间窗: maximum cystometric capacity (MCC) was assessed at day 90.

Maximum cystometric capacity in patients with normal sensation, is the volume at which the patient feels he/she can no longer delay micturition (has a strong desire to void)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed E. Ali

Lecturer

South Valley University

研究点 (4)

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