Outcomes of Proactive Management of Children With Myelomeningocele

Urologic Diseases Clinical Trial

Official title:

Urological Outcomes of Proactive Management of Children With Myelomeningocele

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301802
• Other study ID #: myelomeningocele management
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Meningomyelocele
• Urologic Diseases

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