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

Not Applicable

Completed

• Conditions: Neurogenic Bladder
• Interventions: Device: pulsed electromagnetic field therapy device

• Registration Number: NCT04187027
• Lead Sponsor: South Valley University

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.

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-02-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the medical care and standard care + P.E.M.F group	pulsed electromagnetic field therapy device	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.

Primary Outcome Measures

Name	Time	Method
The mean (SD) of incidence of first uninhibited detrusor contraction	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)	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)	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)

Trial Locations

Locations (1)

South Valley University, Faculty of Physical Therapy; 🇪🇬 Qina, Egypt