Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Study volunteers
Intervention: Collection of a urine sample (Biological)
Study volunteers
Intervention: Magnetic Resonance Imaging of the bladder (Diagnostic Test)
Outcomes
Primary Outcomes
Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score
Time Frame: 1 day
Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or \>5 (high risk)) and the rate of urinary biomarkers.
Secondary Outcomes
- Galloway score(1 year)
- Success or failure of treatment(1 year)
- Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers(1 year)
- Bladder hypocompliance based on metabolomic profile at inclusion(0 day)
- Bladder hypocompliance based on MRI radiomic markers at inclusion(0 day)
- Bladder hypocompliance based on MRI radiomic markers at 1 year(1 year)
- Presence of biomarkers on bladder histological specimens(From enrollment to 1 year)