Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of a urine sample, Magnetic Resonance Imaging of the bladder.
- Who it may be relevant to
- Registry conditions: Spina Bifida. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly. The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated. Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.
Interventions
- Biological Collection of a urine sample
Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year) - Diagnostic test Magnetic Resonance Imaging of the bladder
Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)
Primary outcome measures
- Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score [Time frame: 1 day]
Secondary outcome measures (7)
- Galloway score [Time frame: 1 year]
- Success or failure of treatment [Time frame: 1 year]
- Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers [Time frame: 1 year]
- Bladder hypocompliance based on metabolomic profile at inclusion [Time frame: 0 day]
- Bladder hypocompliance based on MRI radiomic markers at inclusion [Time frame: 0 day]
- Bladder hypocompliance based on MRI radiomic markers at 1 year [Time frame: 1 year]
- Presence of biomarkers on bladder histological specimens [Time frame: From enrollment to 1 year]
Eligibility criteria
Inclusion criteria
- Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre;
- Written consent to participate in the research.
- Compulsory membership of a social security scheme
Exclusion criteria
- Patients with a non-continuous trans ileal urinary diversion ;
- Patients with enterocystoplasty;
- Untreated bacteriuria at the time of urodynamic assessment and urine sample collection;
- History of urinary tract tumour;
- History of histologically proven interstitial cystitis;
- Persons under legal protection (safeguard of justice, curatorship, guardianship);
- Persons deprived of their liberty.
- Women claiming to be pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Rennes University Hospital — Rennes
Identifiers
NCT: NCT06041334 · 35RC20_9746_SPINLESS · IDRCB