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

• ClinicalTrials.gov Identifier: NCT04187027
• Recruitment Status: Completed
• First Posted: December 5, 2019
• Last Update Posted: January 13, 2020
• Sponsor: South Valley University
• Information provided by (Responsible Party): Mohammed E. Ali, Ph. D Candidate., South Valley University

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Egypt

South Valley University, Faculty of Physical Therapy

Qina, Egypt, 83523

Sponsors and Collaborators

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

  Study Documents (Full-Text)

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

Study Protocol and Statistical Analysis Plan  [PDF] November 28, 2019

More Information

Publications of Results:

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. Review.

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. Review.

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.

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.

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. Review.

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. Review.

Takahashi S, Kitamura T. Overactive bladder: magnetic versus electrical stimulation. Curr Opin Obstet Gynecol. 2003 Oct;15(5):429-33. Review.

Other Publications:

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. 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.

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. 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. Review.

• 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
• Last Update Posted: January 13, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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