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Outcomes of Proactive Management of Children With Myelomeningocele

NCT ID: NCT06301802

Last Updated: 2024-03-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-04

Study Completion Date

2026-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Urologic Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CIC

clean intermittent catheterization

Intervention Type PROCEDURE

Anticholinergic

antimuscarinic once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all patients with myelomeningocele attending Assiut university urology hospital.

Exclusion Criteria

* Associated other urological congenital anomalies (e.g., PUV or bladder exstrophy)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Islam Mahmoud Abdellah

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Elderwy, prof

Role: STUDY_CHAIR

prof of urology assiut university

Locations

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Assiut university hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Islam Mahmoud, DR

Role: CONTACT

[email protected]
00201090088672

Facility Contacts

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Islam Mahmoud, DR

Role: primary

[email protected]
00201090088672

References

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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.

Reference Type BACKGROUND
PMID: 33083093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33861059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35967567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32761898 (View on PubMed)

Other Identifiers

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myelomeningocele management

Identifier Type: -

Identifier Source: org_study_id

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