Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population (SPINA)

November 20, 2025 updated by: University Hospital, Angers
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients will be selected based on their MRI reports specifying a diagnosis of dysraphism or via diagnostic codes and surgical procedures specific to dysraphism.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dyspraphism
Other: description of the impact
Study of urinary and fecal impact of closed and dysraphism in the pediatric population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of bladder dysfunction
Time Frame: up to 5 years
rate of bladder dysfunction in children with open or closed dysraphism
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary symptoms
Time Frame: up to 5 years
urinary symptoms described by patients
up to 5 years
Fecal symptoms
Time Frame: up to 5 years
fecal symptoms that may be described by patients
up to 5 years
Urinary treatments implemented
Time Frame: up to 5 years
urinary treatments that may be implemented during follow-up
up to 5 years
Fecal treatments implemented
Time Frame: up to 5 years
fecal treatments that may be implemented during follow-up
up to 5 years
Prenatal diagnosis
Time Frame: Baseline
presence or absence of a prenatal diagnosis
Baseline
Clinical signs
Time Frame: Baseline
linical signs that led to the diagnosis of dysraphism
Baseline
general symptoms
Time Frame: Baseline
general symptoms that led to the diagnosis of dysraphism
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Study Chair: Louise RENOULT, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 49RC25_0272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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