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

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 Overview

• Status: Recruiting
• Conditions: Spina Bifida
• Intervention / Treatment: Biological: Collection of a urine sample; Diagnostic test: Magnetic Resonance Imaging of the bladder

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LOÏC JACOB; Phone Number: 0299282555; Email: loic.jacob@chu-rennes.fr

Study Locations

• France
  • CHU de Rennes
    • Rennes, CHU de Rennes, France, 35033
      • Recruiting
      • Rennes University Hospital
      • Contact: Emmanuelle SAMSON, MD; Phone Number: 33299289763; Email: emmanuelle.samson@chu-rennes.fr
      • Contact: Benoit Peyronnet, MD; Email: Benoit.PEYRONNET@chu-rennes.fr
      • Principal Investigator: Emmanuelle SAMSON, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study volunteers	Biological: Collection of a urine sample; Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year); Diagnostic test: Magnetic Resonance Imaging of the bladder; Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Galloway score	Change in Galloway score from baseline to 1 year based on change in urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2	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.	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.	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.	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.	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	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.	From enrollment to 1 year

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: NeuroSphinx

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): July 18, 2027
• Study Completion (Estimated): July 18, 2028

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Spina Bifida; upper urinary tract; urinary biomarker; Galloway score; urodynamic work-up; urethrocystography
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Dysraphism
• Other Study ID Numbers: 35RC20_9746_SPINLESS; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No