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

NCT ID: NCT04187027

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-27

Study Completion Date

2025-12-10

Brief Summary

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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

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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.

Conditions

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Neurogenic Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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).

Study Groups

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the medical care and standard care only group

Group (A) received medical care and standard urotherapy only.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

pulsed electromagnetic field therapy device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed E. Ali

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nehad A. Abo-zaid, PhD

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Physical Therapy

Mohammed E. Ali, PhD student

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Physical Therapy

Locations

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South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, Egypt

Site Status

Faculty of Physical Therapy, Outpatient Clinic

Qina, Qena Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 17136485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8795398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17581924 (View on PubMed)

Dorsher PT, McIntosh PM. Neurogenic bladder. Adv Urol. 2012;2012:816274. doi: 10.1155/2012/816274. Epub 2012 Feb 8.

Reference Type BACKGROUND
PMID: 22400020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29071144 (View on PubMed)

Madersbacher H. Neurogenic bladder dysfunction in patients with myelomeningocele. Curr Opin Urol. 2002 Nov;12(6):469-72. doi: 10.1097/00042307-200211000-00004.

Reference Type BACKGROUND
PMID: 12409874 (View on PubMed)

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.

Reference Type RESULT
PMID: 18703879 (View on PubMed)

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.

Reference Type RESULT
PMID: 24498490 (View on PubMed)

Wu HY, Baskin LS, Kogan BA. Neurogenic bladder dysfunction due to myelomeningocele: neonatal versus childhood treatment. J Urol. 1997 Jun;157(6):2295-7.

Reference Type RESULT
PMID: 9146656 (View on PubMed)

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.

Reference Type RESULT
PMID: 15892823 (View on PubMed)

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.

Reference Type RESULT
PMID: 15098220 (View on PubMed)

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.

Reference Type RESULT
PMID: 23070089 (View on PubMed)

Ellsworth P, Cone EB. Neurogenic detrusor overactivity: an update on management options. R I Med J (2013). 2013 Apr 1;96(4):38-40.

Reference Type RESULT
PMID: 23641451 (View on PubMed)

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.

Reference Type RESULT
PMID: 23025445 (View on PubMed)

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.

Reference Type RESULT
PMID: 15928511 (View on PubMed)

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.

Reference Type RESULT
PMID: 14501247 (View on PubMed)

Other Identifiers

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P.T.REC/012/002423

Identifier Type: -

Identifier Source: org_study_id

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