Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
NCT ID: NCT04187027
Last Updated: 2025-12-15
Study Results
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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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-05-27
2025-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the medical care and standard care only group
Group (A) received medical care and standard urotherapy only.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
4 Years
12 Years
ALL
No
Sponsors
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South Valley University
OTHER
Responsible Party
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Mohammed E. Ali
Lecturer
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
Faculty of Physical Therapy, Outpatient Clinic
Qina, Qena Governorate, Egypt
Countries
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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.
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.
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.
Dorsher PT, McIntosh PM. Neurogenic bladder. Adv Urol. 2012;2012:816274. doi: 10.1155/2012/816274. Epub 2012 Feb 8.
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.
Madersbacher H. Neurogenic bladder dysfunction in patients with myelomeningocele. Curr Opin Urol. 2002 Nov;12(6):469-72. doi: 10.1097/00042307-200211000-00004.
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.
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.
Wu HY, Baskin LS, Kogan BA. Neurogenic bladder dysfunction due to myelomeningocele: neonatal versus childhood treatment. J Urol. 1997 Jun;157(6):2295-7.
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.
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.
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.
Ellsworth P, Cone EB. Neurogenic detrusor overactivity: an update on management options. R I Med J (2013). 2013 Apr 1;96(4):38-40.
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.
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.
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.
Other Identifiers
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P.T.REC/012/002423
Identifier Type: -
Identifier Source: org_study_id
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