Actively Recruiting
Evaluation of Multimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Led by Rennes University Hospital · Updated on 2025-12-22
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Rennes University Hospital
Lead Sponsor
N
NeuroSphinx
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating urinary biomarkers to see if they can predict damage to the upper urinary tract and kidneys in patients with spina bifida. This study focuses on the biomarkers TIMP-2 and MMP-2, which may be linked to kidney degradation but have not yet been proven. The risk of upper urinary tract damage will be assessed using the Galloway score, which is based on urodynamic studies and retrograde urethrocystography performed regularly on these patients. Participants will have their urinary biomarkers measured at the time of their routine urodynamic assessment. The study includes collection of urine samples at inclusion and after one year to analyze biomarkers and metabolomics. A subset of adult patients will also undergo Magnetic Resonance Imaging (MRI) of the bladder at inclusion and after one year to assess bladder conditions through radiomic markers. During the study, participants will be monitored for the association between urinary biomarker levels and the Galloway score. Researchers will track treatment success or failure over one year and evaluate bladder hypocompliance through metabolomic profiles and MRI markers. The presence of biomarkers in bladder tissue will also be examined from enrollment through one year. The total participation involves assessments at inclusion and at one year with monitoring of clinical and imaging outcomes.
CONDITIONS
Brief Title
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with spina bifida seen at the multidisciplinary spina bifida rare disease reference centre
- Written consent to participate in the research
- Must have compulsory membership of a social security scheme
You will not qualify if you...
- 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 such as safeguard of justice, curatorship, or guardianship
- Persons deprived of their liberty
- Women claiming to be pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants provide urine samples and, if applicable, undergo Magnetic Resonance Imaging of the bladder for assessment of urinary biomarkers and bladder condition.
1 visit (in-person)
Duration - 1 year
Participants are followed for 1 year with urine sample collection and, for some, repeat MRI to monitor biomarkers and bladder health.
1 visit at 1 year (in-person)
Trial Site Locations
Total: 1 location
1
Rennes University Hospital
Rennes, CHU de Rennes, France, 35033
Actively Recruiting
Research Team
L
LOÏC JACOB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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