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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06301802
Other study ID # myelomeningocele management
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 4, 2024
Est. completion date March 15, 2026

Study information

Verified date March 2024
Source Assiut University
Contact Islam Mahmoud, DR
Phone 00201090088672
Email doctorislam672@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Spina bifida birth prevalence in Africa is 0.13%. Myelomeningocele (MMC) represents the most frequent and most severe cause of NB in children. Treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. Damage of the renal parenchyma in children with NB is preventable given adequate evaluation, follow-up and proactive management. Proactive management was defined as use of clean intermittent catheterization (CIC), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. The proactive approach to treat SB (CIC and pharmacotherapy) has contributed to decreasing chronic kidney disease (CKD). Myelomeningocele is considered a complex congenital disease. Hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. Currently, children with spina bifida in Egypt must visit multiple different locations to access the complex care they need. Here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 15, 2026
Est. primary completion date March 10, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all patients with myelomeningocele attending Assiut university urology hospital. Exclusion Criteria: - Associated other urological congenital anomalies (e.g., PUV or bladder exstrophy)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CIC
clean intermittent catheterization
Drug:
Anticholinergic
antimuscarinic once daily

Locations

Country Name City State
Egypt Assiut university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Cui X, Zhao Z, Zhang T, Guo W, Guo W, Zheng J, Zhang J, Dong C, Na R, Zheng L, Li W, Liu Z, Ma J, Wang J, He S, Xu Y, Si P, Shen Y, Cai C. A systematic review and meta-analysis of children with coronavirus disease 2019 (COVID-19). J Med Virol. 2021 Feb;93(2):1057-1069. doi: 10.1002/jmv.26398. Epub 2020 Sep 28. — View Citation

Elagami H, Abbas TO, Evans K, Murphy F. Management of neuropathic bladder secondary to spina bifida: Twenty years' experience with a conservative approach. Front Pediatr. 2022 Jul 29;10:913078. doi: 10.3389/fped.2022.913078. eCollection 2022. — View Citation

Oumer M, Taye M, Aragie H, Tazebew A. Prevalence of Spina Bifida among Newborns in Africa: A Systematic Review and Meta-Analysis. Scientifica (Cairo). 2020 Oct 6;2020:4273510. doi: 10.1155/2020/4273510. eCollection 2020. — View Citation

Sager C, Barroso U Jr, Bastos JM Netto, Retamal G, Ormaechea E. Management of neurogenic bladder dysfunction in children update and recommendations on medical treatment. Int Braz J Urol. 2022 Jan-Feb;48(1):31-51. doi: 10.1590/S1677-5538.IBJU.2020.0989. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary upper tract affection percentage of patients developing upper tract dilatation and febrile UTI 2 years
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