Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: description of the impact.
- Who it may be relevant to
- Registry conditions: Dysraphism, Open Dysraphism, Closed Dysraphism. Basic parameters: up to 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Spinal dysraphisms are defined as a congenital malformation characterized by a defect in the closure of the neural tube in the caudal region. They are divided into two groups: open dysraphisms, where the skin covering is absent; and closed dysraphisms, where the skin abnormality is less obvious and diagnosis is sometimes more difficult. Both open and closed dysraphisms can cause a variety of neurological disorders, including urinary and fecal dysfunction, which is often more severe in open dysraphisms than in closed dysraphisms, which sometimes go unnoticed and may only become symptomatic during growth. As a result, urinary and fecal repercussions in closed dysraphisms are sometimes overlooked, and the literature on this subject remains scarce. The hypothesis is that a better understanding of the urinary and fecal repercussions of closed dysraphisms would allow for more appropriate and standardized follow-up of these children. The main objective of the study is to describe the urinary impact on children with spinal dysraphism, as well as how they are managed.
Interventions
- Other description of the impact
Study of urinary and fecal impact of closed and dysraphism in the pediatric population
Primary outcome measures
- Rate of bladder dysfunction [Time frame: up to 5 years]
Secondary outcome measures (7)
- Urinary symptoms [Time frame: up to 5 years]
- Fecal symptoms [Time frame: up to 5 years]
- Urinary treatments implemented [Time frame: up to 5 years]
- Fecal treatments implemented [Time frame: up to 5 years]
- Prenatal diagnosis [Time frame: Baseline]
- Clinical signs [Time frame: Baseline]
- general symptoms [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- treated or cared for at Angers University Hospital for spinal dysraphism between January 1, 2014, and December 31, 2024
Exclusion criteria
- Differential diagnosis of dysraphism
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07258654 · 49RC25_0272