Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population

NCT ID: NCT07258654

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-12-01

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.

Conditions

Dysraphism; Open Dysraphism; Closed Dysraphism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dyspraphism

description of the impact

Intervention Type: OTHER

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

Interventions

description of the impact

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

Intervention Type: OTHER

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

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise RENOULT

Role: STUDY_CHAIR

University Hospital, Angers

Central Contacts

Louise RENOULT

Role: CONTACT

louise.renoult@chu-angers.fr

+33241353637

Louise RENOULT

Role: CONTACT

louise.renoult@chu-angers.fr

Other Identifiers

49RC25_0272

Identifier Type: -

Identifier Source: org_study_id