Clinical trial NCT04187027: Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
Official title: Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bladder
Keywords: Myelomeningocele
Pulsed electromagnetic field therapy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The mean (SD) maximum urinary flow rate (Q max)
timeFrame: maximum urinary flow rate (Q max) was assessed at day 0.
measure: The mean (SD) maximum urinary flow rate (Q max)
timeFrame: maximum urinary flow rate (Q max) was assessed at day 90.
measure: The mean (SD) maximum cystometric capacity (MCC)
timeFrame: maximum cystometric capacity (MCC) was assessed at day 0.
measure: The mean (SD) maximum cystometric capacity (MCC)
timeFrame: maximum cystometric capacity (MCC) was assessed at day 90.
measure: The mean (SD) of incidence of first uninhibited detrusor contraction
timeFrame: first uninhibited detrusor contraction was assessed at day 0.
measure: The mean (SD) of incidence of first uninhibited detrusor contraction
timeFrame: first uninhibited detrusor contraction was assessed at day 90.
Secondary outcomes:
Other outcomes:
Locations:
city: Qina
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
Study officials:
affiliation: South Valley University, Faculty of Physical Therapy
name: Nehad A. Abo-zaid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Valley University, Faculty of Physical Therapy
name: Mohammed E. Ali, PhD student
role: PRINCIPAL_INVESTIGATOR
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