Clinical trial NCT06041334: Evaluation of MuLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Official title: Evaluation of MuLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spina Bifida
Keywords: Spina Bifida
urinary biomarker
upper urinary tract
Galloway score
urodynamic work-up
urethrocystography
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: NeuroSphinx
First posted: 2023-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score
timeFrame: 1 day
Secondary outcomes:
measure: Galloway score
timeFrame: 1 year
measure: Success or failure of treatment
timeFrame: 1 year
measure: Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers
timeFrame: 1 year
measure: Bladder hypocompliance based on metabolomic profile at inclusion
timeFrame: 0 day
measure: Bladder hypocompliance based on MRI radiomic markers at inclusion
timeFrame: 0 day
measure: Bladder hypocompliance based on MRI radiomic markers at 1 year
timeFrame: 1 year
measure: Presence of biomarkers on bladder histological specimens
timeFrame: From enrollment to 1 year
Other outcomes:
Locations:
city: Rennes cedex 9
country: France
facility: Rennes University Hospital
state: CHU de Rennes
Study officials:
References: