NCT06301802

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 4, 2024

Last Update Submit

March 4, 2024

Conditions

Urologic Diseases

Keywords

myelomeningocele

Outcome Measures

Primary Outcomes (1)

  • upper tract affection

    percentage of patients developing upper tract dilatation and febrile UTI

    2 years

Interventions

CICPROCEDURE

clean intermittent catheterization

AnticholinergicDRUG

antimuscarinic once daily

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with myelomeningocele attending Assiut university urology hospital.

You may qualify if:

  • all patients with myelomeningocele attending Assiut university urology hospital.

You may not qualify if:

  • Associated other urological congenital anomalies (e.g., PUV or bladder exstrophy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 11571, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 33083093BACKGROUND

  • 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.

    PMID: 33861059BACKGROUND

  • 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.

    PMID: 35967567BACKGROUND

  • 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.

    PMID: 32761898BACKGROUND

MeSH Terms

Conditions

Urologic DiseasesMeningomyelocele

Interventions

Cholinergic Antagonists

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cholinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Ahmad Elderwy, prof

    prof of urology assiut university

    STUDY CHAIR

Central Study Contacts

Islam Mahmoud, DR

CONTACT

00201090088672doctorislam672@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

March 4, 2024

Primary Completion

March 10, 2026

Study Completion

March 15, 2026

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

EG(1)