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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187027
Recruitment Status : Completed
First Posted : December 5, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammed E. Ali, Ph. D Candidate., 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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Device: pulsed electromagnetic field therapy device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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).
Primary Purpose: Treatment
Official Title: Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: the medical care and standard care only group
Group (A) received medical care and standard urotherapy only.
Experimental: 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.
Device: pulsed 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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187027


Locations
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Egypt
South Valley University, Faculty of Physical Therapy
Qina, Egypt, 83523
Sponsors and Collaborators
South Valley University
Investigators
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Principal Investigator: Nehad A. Abo-zaid, PhD South Valley University, Faculty of Physical Therapy
Principal Investigator: Mohammed E. Ali, PhD student South Valley University, Faculty of Physical Therapy
  Study Documents (Full-Text)

Documents provided by Mohammed E. Ali, Ph. D Candidate., South Valley University:
Publications of Results:

Other Publications:
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Responsible Party: Mohammed E. Ali, Ph. D Candidate., Lecturer, South Valley University
ClinicalTrials.gov Identifier: NCT04187027    
Other Study ID Numbers: P.T.REC/012/002423
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed E. Ali, Ph. D Candidate., South Valley University:
Myelomeningocele
Pulsed electromagnetic field therapy
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Meningomyelocele
Spina Bifida Cystica
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Spinal Dysraphism