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NCT Number: NCT07258654

Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population

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.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

description of the impact

Other

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

Primary outcomes

  1. Rate of bladder dysfunction

    Time frame: up to 5 years

    rate of bladder dysfunction in children with open or closed dysraphism

Secondary outcomes

  1. Urinary symptoms

    Time frame: up to 5 years

    urinary symptoms described by patients

  2. Fecal symptoms

    Time frame: up to 5 years

    fecal symptoms that may be described by patients

  3. Urinary treatments implemented

    Time frame: up to 5 years

    urinary treatments that may be implemented during follow-up

  4. Fecal treatments implemented

    Time frame: up to 5 years

    fecal treatments that may be implemented during follow-up

  5. Prenatal diagnosis

    Time frame: Baseline

    presence or absence of a prenatal diagnosis

  6. Clinical signs

    Time frame: Baseline

    linical signs that led to the diagnosis of dysraphism

  7. general symptoms

    Time frame: Baseline

    general symptoms that led to the diagnosis of dysraphism

Study contacts

Contact information is provided by the study sponsor or research team.

Louise RENOULT

CONTACT

[email protected]

+33241353637

Louise RENOULT

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: SPINA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.