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Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population

Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07258654
Acronym
SPINA
Enrollment
210
Registered
2025-12-02
Start date
2026-02-01
Completion date
2026-12-01
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Dysraphism, Dysraphism, Open Dysraphism

Keywords

dysraphism, spina

Brief summary

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

OTHERdescription of the impact

Study of urinary and fecal impact of closed and dysraphism in the pediatric population

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of bladder dysfunctionup to 5 yearsrate of bladder dysfunction in children with open or closed dysraphism

Secondary

MeasureTime frameDescription
Fecal symptomsup to 5 yearsfecal symptoms that may be described by patients
Urinary treatments implementedup to 5 yearsurinary treatments that may be implemented during follow-up
Fecal treatments implementedup to 5 yearsfecal treatments that may be implemented during follow-up
Urinary symptomsup to 5 yearsurinary symptoms described by patients
Clinical signsBaselinelinical signs that led to the diagnosis of dysraphism
general symptomsBaselinegeneral symptoms that led to the diagnosis of dysraphism
Prenatal diagnosisBaselinepresence or absence of a prenatal diagnosis

Contacts

Primary ContactLouise RENOULT
louise.renoult@chu-angers.fr+33241353637
Backup ContactLouise RENOULT
louise.renoult@chu-angers.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026