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NCT Number: NCT04187027

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

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.

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Key information

Conditions

Neurogenic Bladder Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Meningomyelocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Outpatient Clinic, Qina, Qena Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pulsed electromagnetic field therapy device

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.

Primary outcomes

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

    Time frame: 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).

  2. 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).

  3. The mean (SD) maximum cystometric capacity (MCC)

    Time frame: 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)

  4. 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)

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

    Time frame: first 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

  6. 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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2019
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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