Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- South Valley University
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- The mean (SD) of incidence of first uninhibited detrusor contraction
Study 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.
Study Design
- Study Type
- Interventional
- 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).
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
the medical care and standard care only group
Group (A) received medical care and standard urotherapy only.
the medical care and standard care + P.E.M.F group
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.
Intervention: pulsed electromagnetic field therapy device (Device)
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)
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).
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)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammed E. Ali
Lecturer
South Valley University