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

October 13, 2021 updated by: Mohammed E. Ali, Ph. D Candidate., South Valley University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Qina, Egypt, 83523
        • South Valley University, Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
maximum urinary flow rate (Q max) was assessed at day 0.
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).
maximum urinary flow rate (Q max) was assessed at day 90.
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)
maximum cystometric capacity (MCC) was assessed at day 0.
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)
maximum cystometric capacity (MCC) was assessed at day 90.
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
first uninhibited detrusor contraction was assessed at day 0.
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
first uninhibited detrusor contraction was assessed at day 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/002423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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