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Clinical Trials/NCT04187027
NCT04187027
Active, not recruiting
Not Applicable

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

South Valley University2 sites in 1 country40 target enrollmentMay 27, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurogenic Bladder
Sponsor
South Valley University
Enrollment
40
Locations
2
Primary Endpoint
The mean (SD) of incidence of first uninhibited detrusor contraction
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 27, 2025
End Date
December 10, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed E. Ali

Lecturer

South Valley University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Study Sites (2)

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