Menu
Not yet recruiting NCT07258654

Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population

Observational Dysraphism Open Dysraphism Closed Dysraphism

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 →

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗