Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

ConditionSpina Bifida
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorRennes University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Collection of a urine sample

    Biological/Vaccine

    Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)

  • Magnetic Resonance Imaging of the bladder

    Diagnostic test

    Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Study volunteersOther 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.