Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
Primary Purpose
Neurogenic Bladder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulsed electromagnetic field therapy device
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Bladder focused on measuring Myelomeningocele, Pulsed electromagnetic field therapy
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.
Sites / Locations
- South Valley University, Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
the medical care and standard care only group
the medical care and standard care + P.E.M.F group
Arm Description
Group (A) received medical care and standard urotherapy only.
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.
Outcomes
Primary Outcome Measures
The mean (SD) maximum urinary flow rate (Q max)
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 urinary flow rate (Q max)
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)
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 cystometric capacity (MCC)
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
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) of incidence of first uninhibited detrusor contraction
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 Outcome Measures
Full Information
NCT ID
NCT04187027
First Posted
November 26, 2019
Last Updated
October 13, 2021
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04187027
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder
Keywords
Myelomeningocele, Pulsed electromagnetic field therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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).
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the medical care and standard care only group
Arm Type
No Intervention
Arm Description
Group (A) received medical care and standard urotherapy only.
Arm Title
the medical care and standard care + P.E.M.F group
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
pulsed electromagnetic field therapy device
Intervention Description
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 Measure Information:
Title
The mean (SD) maximum urinary flow rate (Q max)
Description
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).
Time Frame
maximum urinary flow rate (Q max) was assessed at day 0.
Title
The mean (SD) maximum urinary flow rate (Q max)
Description
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).
Time Frame
maximum urinary flow rate (Q max) was assessed at day 90.
Title
The mean (SD) maximum cystometric capacity (MCC)
Description
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)
Time Frame
maximum cystometric capacity (MCC) was assessed at day 0.
Title
The mean (SD) maximum cystometric capacity (MCC)
Description
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)
Time Frame
maximum cystometric capacity (MCC) was assessed at day 90.
Title
The mean (SD) of incidence of first uninhibited detrusor contraction
Description
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
Time Frame
first uninhibited detrusor contraction was assessed at day 0.
Title
The mean (SD) of incidence of first uninhibited detrusor contraction
Description
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
Time Frame
first uninhibited detrusor contraction was assessed at day 90.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A. Abo-zaid, PhD
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed E. Ali, PhD student
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qina
ZIP/Postal Code
83523
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17136485
Citation
Choe JH, Choo MS, Lee KS. Symptom change in women with overactive bladder after extracorporeal magnetic stimulation: a prospective trial. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Aug;18(8):875-80. doi: 10.1007/s00192-006-0261-0. Epub 2006 Nov 30.
Results Reference
background
PubMed Identifier
8795398
Citation
Sheriff MK, Shah PJ, Fowler C, Mundy AR, Craggs MD. Neuromodulation of detrusor hyper-reflexia by functional magnetic stimulation of the sacral roots. Br J Urol. 1996 Jul;78(1):39-46. doi: 10.1046/j.1464-410x.1996.00358.x.
Results Reference
background
PubMed Identifier
17581924
Citation
Ikeda Y, Fry C, Hayashi F, Stolz D, Griffiths D, Kanai A. Role of gap junctions in spontaneous activity of the rat bladder. Am J Physiol Renal Physiol. 2007 Oct;293(4):F1018-25. doi: 10.1152/ajprenal.00183.2007. Epub 2007 Jun 20.
Results Reference
background
PubMed Identifier
22400020
Citation
Dorsher PT, McIntosh PM. Neurogenic bladder. Adv Urol. 2012;2012:816274. doi: 10.1155/2012/816274. Epub 2012 Feb 8.
Results Reference
background
PubMed Identifier
29071144
Citation
Fergany LA, Shaker H, Arafa M, Elbadry MS. Does sacral pulsed electromagnetic field therapy have a better effect than transcutaneous electrical nerve stimulation in patients with neurogenic overactive bladder? Arab J Urol. 2017 Mar 29;15(2):148-152. doi: 10.1016/j.aju.2017.01.007. eCollection 2017 Jun.
Results Reference
background
PubMed Identifier
12409874
Citation
Madersbacher H. Neurogenic bladder dysfunction in patients with myelomeningocele. Curr Opin Urol. 2002 Nov;12(6):469-72. doi: 10.1097/00042307-200211000-00004.
Results Reference
background
PubMed Identifier
18703879
Citation
Baradaran N, Ahmadi H, Nejat F, El Khashab M, Mahdavi A. Nonneural congenital abnormalities concurring with myelomeningocele: report of 17 cases and review of current theories. Pediatr Neurosurg. 2008;44(5):353-9. doi: 10.1159/000149900. Epub 2008 Aug 15.
Results Reference
result
PubMed Identifier
24498490
Citation
Larijani FJ, Moghtaderi M, Hajizadeh N, Assadi F. Preventing kidney injury in children with neurogenic bladder dysfunction. Int J Prev Med. 2013 Dec;4(12):1359-64.
Results Reference
result
PubMed Identifier
9146656
Citation
Wu HY, Baskin LS, Kogan BA. Neurogenic bladder dysfunction due to myelomeningocele: neonatal versus childhood treatment. J Urol. 1997 Jun;157(6):2295-7.
Results Reference
result
PubMed Identifier
15892823
Citation
Kim JW, Kim MJ, Noh JY, Lee HY, Han SW. Extracorporeal pelvic floor magnetic stimulation in children with voiding dysfunction. BJU Int. 2005 Jun;95(9):1310-3. doi: 10.1111/j.1464-410X.2005.05524.x.
Results Reference
result
PubMed Identifier
15098220
Citation
Bycroft JA, Craggs MD, Sheriff M, Knight S, Shah PJ. Does magnetic stimulation of sacral nerve roots cause contraction or suppression of the bladder? Neurourol Urodyn. 2004;23(3):241-5. doi: 10.1002/nau.20009.
Results Reference
result
PubMed Identifier
23070089
Citation
Juszczak K, Kaszuba-Zwoinska J, Thor PJ. Pulsating electromagnetic field stimulation of urothelial cells induces apoptosis and diminishes necrosis: new insight to magnetic therapy in urology. J Physiol Pharmacol. 2012 Aug;63(4):397-401.
Results Reference
result
PubMed Identifier
23641451
Citation
Ellsworth P, Cone EB. Neurogenic detrusor overactivity: an update on management options. R I Med J (2013). 2013 Apr 1;96(4):38-40.
Results Reference
result
PubMed Identifier
23025445
Citation
Amarante MA, Shrensel JA, Tomei KL, Carmel PW, Gandhi CD. Management of urological dysfunction in pediatric patients with spinal dysraphism: review of the literature. Neurosurg Focus. 2012 Oct;33(4):E4. doi: 10.3171/2012.7.FOCUS12232.
Results Reference
result
PubMed Identifier
15928511
Citation
Quek P. A critical review on magnetic stimulation: what is its role in the management of pelvic floor disorders? Curr Opin Urol. 2005 Jul;15(4):231-5. doi: 10.1097/01.mou.0000172395.54643.4d.
Results Reference
result
PubMed Identifier
14501247
Citation
Takahashi S, Kitamura T. Overactive bladder: magnetic versus electrical stimulation. Curr Opin Obstet Gynecol. 2003 Oct;15(5):429-33. doi: 10.1097/00001703-200310000-00012.
Results Reference
result
Learn more about this trial
Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
We'll reach out to this number within 24 hrs