Skip to content

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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04187027
Enrollment
40
Registered
2019-12-05
Start date
2025-05-27
Completion date
2025-12-10
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurogenic Bladder

Keywords

Myelomeningocele, Pulsed electromagnetic field therapy

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.

Interventions

DEVICEpulsed electromagnetic field therapy device

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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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).

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The mean (SD) maximum urinary flow rate (Q max)maximum urinary flow rate (Q max) was assessed at day 0.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 0.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)
The mean (SD) of incidence of first uninhibited detrusor contractionfirst uninhibited detrusor contraction was assessed at day 0.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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026