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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neurogenic Bladder

Intervention / Treatment
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* Device: pulsed electromagnetic field therapy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: the medical care and standard care only group<br>Group (A) received medical care and standard urotherapy only. | |
| Experimental: the medical care and standard care + P.E.M.F group<br>Group (B) which received the same medical care and standard urotherapy in addition to pulsed electromagnetic field therapy that applied for 20 min, ,three times / weak for three successful months. | Device: pulsed electromagnetic field therapy device<br>* magnetic field stimulation (MFS) is a novel technique for stimulating the nervous system non-invasively, which can activate deep neural structures via induced electric currents, without pain and discomfort. Also, several clinical trials including placebo-controlled studies have shown that MFS of the pelvic floor and sacral roots is effective for overactive bladder (OAB). MFS induces inhibitory effects on detrusor overactivity in a similar manner to electrical stimulation, with significant clinical advantages. MFS of the sacral nerve roots could be a promising alternative treatment for OAB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean (SD) maximum urinary flow rate (Q max) | 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). | maximum urinary flow rate (Q max) was assessed at day 0. | 
| The mean (SD) maximum urinary flow rate (Q max) | 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). | maximum urinary flow rate (Q max) was assessed at day 90. | 
| The mean (SD) maximum cystometric capacity (MCC) | 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) | maximum cystometric capacity (MCC) was assessed at day 0. | 
| The mean (SD) maximum cystometric capacity (MCC) | 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) | maximum cystometric capacity (MCC) was assessed at day 90. | 
| The mean (SD) of incidence of first uninhibited detrusor contraction | 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 | first uninhibited detrusor contraction was assessed at day 0. | 
| The mean (SD) of incidence of first uninhibited detrusor contraction | 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 | first uninhibited detrusor contraction was assessed at day 90. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myelomeningocele, Pulsed electromagnetic field therapy