An interventional study of Collection of a urine sample and Magnetic Resonance Imaging of the bladder in Spina Bifida, sponsored by Rennes University Hospital. Recruiting at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Prevention
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Collection of a urine sample · Diagnostic Test: Magnetic Resonance Imaging of the bladder
Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)
Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)
Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score
Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or \>5 (high risk)) and the rate of urinary biomarkers.
Time frame: 1 day
Galloway score
Change in Galloway score from baseline to 1 year based on change in urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2
Time frame: 1 year
Success or failure of treatment
The success of the treatment will be assessed at 1 year after its implementation according to an hybrid criteria : In the event of a Patients Global Impression of Improvement for Incontinence questionnaire \< 3 and/or a Galloway score reduction of 1 or 2, the treatment will be considered successful.
Time frame: 1 year
Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers
The relationship between the success of the treatment implemented at inclusion and the level of the urinary biomarkers Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 at inclusion will be studied.
Time frame: 1 year
Bladder hypocompliance based on metabolomic profile at inclusion
Presence or absence of bladder hypocompliance on urodynamic assessment at baseline, based on metabolomic profile at baseline.
Time frame: 0 day
Bladder hypocompliance based on MRI radiomic markers at inclusion
Presence or absence of bladder hypocompliance on the urodynamic work-up at inclusion, based on MRI radiomic markers at inclusion.
Time frame: 0 day
Bladder hypocompliance based on MRI radiomic markers at 1 year
Presence or absence of bladder hypocompliance on urodynamic assessment at 1 year according to MRI radiomic markers at 1 year
Time frame: 1 year
Presence of biomarkers on bladder histological specimens
Presence of Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 biomarkers on bladder histological specimens based on levels of urinary Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 biomarkers respectively.
Time frame: From enrollment to 1 year
Plan to share: Undecided
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