Urologic DiseasesNCT06301802
Outcomes of Proactive Management of Children With Myelomeningocele
An observational study of Urologic Diseases, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- CIC and Anticholinergic
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2024to 15 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients with myelomeningocele attending Assiut university urology hospital.
Who may be able to join
- all patients with myelomeningocele attending Assiut university urology hospital.
Who cannot join
- Associated other urological congenital anomalies (e.g., PUV or bladder exstrophy)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut, 11571
Islam Mahmoud, DR, 00201090088672, doctorislam672@gmail.com
About this study
Official title: Urological Outcomes of Proactive Management of Children With Myelomeningocele
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.
- Conditions
- Urologic Diseases
- Being tested
- CIC, Anticholinergic
- Keywords
- myelomeningocele
- Medical subject headings
- Urologic Diseases, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CICProcedure or surgery
clean intermittent catheterization
AnticholinergicDrug
antimuscarinic once daily
What is being measured
The primary outcome is the main question the study is designed to answer.
upper tract affection
percentage of patients developing upper tract dilatation and febrile UTI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start4 Mar 2024
- Primary completion10 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mahmoud Abdellah, Assiut University
- Investigators
- Ahmad Elderwy, prof, Study chair, prof of urology assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301802
- Sponsor's protocol ID
- myelomeningocele management
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33083093Sager 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.
PubMed 33861059Elagami 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.
PubMed 35967567Cui 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.
PubMed 32761898
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urological Outcomes of Proactive Management of Children With Myelomeningocele
- ClinicalTrials.gov ID
- NCT06301802
- Acronym / sponsor ID
- myelomeningocele management
- Conditions
- Urologic Diseases
- Keywords
- myelomeningocele
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 8 Mar 2024 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with myelomeningocele attending Assiut university urology hospital.
Key inclusion criteria (1 listed)
- all patients with myelomeningocele attending Assiut university urology hospital.
Key exclusion criteria (1 listed)
- Associated other urological congenital anomalies (e.g., PUV or bladder exstrophy)
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 |
|---|---|---|
| CICclean intermittent catheterization | Procedure or surgery | – |
| Anticholinergicantimuscarinic once daily | Drug | – |
Primary outcome
upper tract affection
Time frame: 2 years
percentage of patients developing upper tract dilatation and febrile UTI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 33083093Oumer 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.
- Background: PubMed 33861059Sager 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.
- Background: PubMed 35967567Elagami 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.
- Background: PubMed 32761898Cui 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.
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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.
Ahmad Elderwy, prof study chair
prof of urology assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases, run by Assiut University at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Islam Mahmoud, DR (00201090088672, doctorislam672@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper tract affection (time frame: 2 years). 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 NCT06301802, which also lists 4 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 8 Mar 2024.