Measuring urine S1P to detect overactive bladder in people with multiple sclerosis
Prospective Study Evaluating the Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis
University Hospital, Toulouse · NCT06161376
We will test whether measuring a urine molecule called sphingosine 1-phosphate (S1P) can indicate bladder overactivity in people with multiple sclerosis who are undergoing urodynamic testing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06161376 on ClinicalTrials.gov |
What this trial studies
This observational study will measure urinary S1P levels in French patients with multiple sclerosis who are scheduled for urodynamic evaluation at Toulouse University Hospital. Urine samples will be collected and analyzed for S1P and compared with simultaneous urodynamic measurements of detrusor activity. Patients with active urinary tract infection, pregnancy, legal guardianship restrictions, or specific pelvic/bladder conditions are excluded. The aim is to confirm whether urinary S1P correlates with invasive urodynamic findings and could serve as a noninvasive biomarker.
Who should consider this trial
Good fit: Ideal candidates are French residents with multiple sclerosis who are enrolled in the social security system and are scheduled for urodynamic testing without active urinary infection or exclusionary pelvic/bladder conditions.
Not a fit: Patients with anatomical subvesical obstruction, urothelial carcinoma, interstitial cystitis, prior augmentation cystoplasty, untreated urinary tract infection, or those not undergoing urodynamic testing are unlikely to benefit.
Why it matters
Potential benefit: If successful, a urine S1P test could provide a noninvasive way to detect detrusor overactivity and reduce reliance on invasive urodynamic testing.
How similar studies have performed: Preliminary work at Toulouse University Hospital suggests a link between urinary S1P and detrusor activity, but this biomarker has not yet been validated in larger or multicenter cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * French residents enrolled in the social security system * Patients diagnosed with multiple sclerosis (according to McDonald 2017 criteria), whether receiving treatment or not * Patients scheduled for urodynamic assessment as part of their management Exclusion criteria: * Pregnant or lactating females * Patients under legal guardianship * Untreated urinary tract infection at the time of inclusion * Known anatomical subvesical obstruction Known pelvic floor disorder Urothelial carcinoma Interstitial cystitis Augmentation cystoplasty
Where this trial is running
Toulouse
- Toulouse Hospital — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Xavier Game, MD — University Hospital, Toulouse
- Study coordinator: Xavier Game, MD
- Email: game.x@chu-toulouse.fr
- Phone: 05 61 32 33 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis