DysraphismSPINANCT07258654
Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population
An observational study of Dysraphism and Open Dysraphism, run by University Hospital, Angers.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Dysraphism, Open Dysraphism, Closed Dysraphism
- What is being tested?
- description of the impact
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- treated or cared for at Angers University Hospital for spinal dysraphism between January 1, 2014, and December 31, 2024
Who cannot join
- Differential diagnosis of dysraphism
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Louise RENOULT contact
About this study
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
- Being tested
- description of the impact
- Keywords
- dysraphism, spina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
description of the impactOther
Study of urinary and fecal impact of closed and dysraphism in the pediatric population
| Study group | Role | What they receive |
|---|---|---|
| Dyspraphism | Not described Receives: Other: description of the impact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bladder dysfunction
rate of bladder dysfunction in children with open or closed dysraphism
Measured: up to 5 years
Secondary outcomes (7)
Urinary symptoms
urinary symptoms described by patients
Measured: up to 5 years
Fecal symptoms
fecal symptoms that may be described by patients
Measured: up to 5 years
Urinary treatments implemented
urinary treatments that may be implemented during follow-up
Measured: up to 5 years
Fecal treatments implemented
fecal treatments that may be implemented during follow-up
Measured: up to 5 years
Prenatal diagnosis
presence or absence of a prenatal diagnosis
Measured: Baseline
Clinical signs
linical signs that led to the diagnosis of dysraphism
Measured: Baseline
general symptoms
general symptoms that led to the diagnosis of dysraphism
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysraphismStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Louise RENOULT, Study chair, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258654
- Sponsor's protocol ID
- 49RC25_0272
- Acronym
- SPINA
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Urinary Impact of Spinal Dysraphism in the Pediatric Population
- ClinicalTrials.gov ID
- NCT07258654
- Acronym / sponsor ID
- SPINA / 49RC25_0272
- Conditions
- Dysraphism, Open Dysraphism, Closed Dysraphism
- Keywords
- dysraphism, spina
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyspraphism | – | Other: description of the impact |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- treated or cared for at Angers University Hospital for spinal dysraphism between January 1, 2014, and December 31, 2024
Key exclusion criteria (1 listed)
- Differential diagnosis of dysraphism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| description of the impactStudy of urinary and fecal impact of closed and dysraphism in the pediatric population | Other | Dyspraphism |
Primary outcome
Rate of bladder dysfunction
Time frame: up to 5 years
rate of bladder dysfunction in children with open or closed dysraphism
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise RENOULT contact
Louise RENOULT study chair
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Dysraphism and Open Dysraphism, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise RENOULT (+33241353637, louise.renoult@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bladder dysfunction (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.