Neurogenic BladderNCT04187027
Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
A study testing pulsed electromagnetic field therapy device in people with Neurogenic Bladder, run by South Valley University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- pulsed electromagnetic field therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 27 May 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
South Valley University, Faculty of Physical Therapy
Qina, Qena Governorate, 83523
Faculty of Physical Therapy, Outpatient Clinic
Qina, Qena Governorate, 85325
About this study
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.
Read the 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.
- Conditions
- Neurogenic Bladder
- Being tested
- pulsed electromagnetic field therapy device
- Keywords
- Myelomeningocele, Pulsed electromagnetic field therapy
- Medical subject headings
- Urinary Bladder, Neurogenic, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed electromagnetic field therapy deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| the medical care and standard care only group | No intervention | Group (A) received medical care and standard urotherapy only. |
| the medical care and standard care + P.E.M.F group | Experimental | 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. Receives: Device: pulsed electromagnetic field therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: maximum urinary flow rate (Q max) was assessed at day 0.
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).
Measured: maximum urinary flow rate (Q max) was assessed at day 90.
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)
Measured: maximum cystometric capacity (MCC) was assessed at day 0.
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)
Measured: maximum cystometric capacity (MCC) was assessed at day 90.
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
Measured: first uninhibited detrusor contraction was assessed at day 0.
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
Measured: first uninhibited detrusor contraction was assessed at day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start27 May 2025
- Primary completion19 Nov 2025
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed E. Ali, South Valley University
- Investigators
- Nehad A. Abo-zaid, PhD, Principal investigator, South Valley University, Faculty of Physical TherapyMohammed E. Ali, PhD student, Principal investigator, South Valley University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187027
- Sponsor's protocol ID
- P.T.REC/012/002423
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2019
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1007/s00192-006-0261-0. Epub 2006 Nov 30.
PubMed 17136485Sheriff 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.
PubMed 8795398Ikeda 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.
PubMed 17581924Dorsher PT, McIntosh PM. Neurogenic bladder. Adv Urol. 2012;2012:816274. doi: 10.1155/2012/816274. Epub 2012 Feb 8.
PubMed 22400020Fergany 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.
PubMed 29071144Madersbacher H. Neurogenic bladder dysfunction in patients with myelomeningocele. Curr Opin Urol. 2002 Nov;12(6):469-72. doi: 10.1097/00042307-200211000-00004.
PubMed 12409874Baradaran 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.
PubMed 18703879Larijani 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.
PubMed 24498490Wu HY, Baskin LS, Kogan BA. Neurogenic bladder dysfunction due to myelomeningocele: neonatal versus childhood treatment. J Urol. 1997 Jun;157(6):2295-7.
PubMed 9146656Kim 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.
PubMed 15892823Bycroft 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.
PubMed 15098220Juszczak 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.
PubMed 23070089Ellsworth P, Cone EB. Neurogenic detrusor overactivity: an update on management options. R I Med J (2013). 2013 Apr 1;96(4):38-40.
PubMed 23641451Amarante 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.
PubMed 23025445Quek 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.
PubMed 15928511
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
- ClinicalTrials.gov ID
- NCT04187027
- Acronym / sponsor ID
- P.T.REC/012/002423
- Conditions
- Neurogenic Bladder
- Keywords
- Myelomeningocele, Pulsed electromagnetic field therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| the medical care and standard care only group | No intervention | –Group (A) received medical care and standard urotherapy only. |
| the medical care and standard care + P.E.M.F group | Experimental | Device: pulsed electromagnetic field therapy deviceGroup (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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulsed electromagnetic field therapy devicemagnetic 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. | Device | the medical care and standard care + P.E.M.F group |
Primary outcome
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).
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).
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)
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)
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 17136485Choe 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.
- Background: PubMed 8795398Sheriff 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.
- Background: PubMed 17581924Ikeda 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.
- Background: PubMed 22400020Dorsher PT, McIntosh PM. Neurogenic bladder. Adv Urol. 2012;2012:816274. doi: 10.1155/2012/816274. Epub 2012 Feb 8.
- Background: PubMed 29071144Fergany 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.
- Background: PubMed 12409874Madersbacher H. Neurogenic bladder dysfunction in patients with myelomeningocele. Curr Opin Urol. 2002 Nov;12(6):469-72. doi: 10.1097/00042307-200211000-00004.
- Results publication: PubMed 18703879Baradaran 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 publication: PubMed 24498490Larijani 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 publication: PubMed 9146656Wu HY, Baskin LS, Kogan BA. Neurogenic bladder dysfunction due to myelomeningocele: neonatal versus childhood treatment. J Urol. 1997 Jun;157(6):2295-7.
- Results publication: PubMed 15892823Kim 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 publication: PubMed 15098220Bycroft 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 publication: PubMed 23070089Juszczak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nehad A. Abo-zaid, PhD principal investigator
South Valley University, Faculty of Physical Therapy
Mohammed E. Ali, PhD student principal investigator
South Valley University, Faculty of Physical Therapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed electromagnetic field therapy device in people with Neurogenic Bladder, run by South Valley University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean (SD) maximum urinary flow rate (Q max) (time frame: maximum urinary flow rate (Q max) was assessed at day 0.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187027, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.