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NCT06161376 Clinical Trial

Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— SEP-1  

Official title:
Prospective Study Evaluating the Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06161376
Other study ID # RC31/23/0346
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2023
Est. completion date December 2027

Study information
Verified date November 2023
Source University Hospital, Toulouse
Contact Xavier Game, MD
Phone 05 61 32 33 01
Email game.x@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to establish a link between urinary Sphingosine 1-Phosphate (S1P) levels and detrusor activity in multiple sclerosis (MS) patients. MS often involves urological symptoms, primarily overactive bladder. The gold standard for evaluation and treatment monitoring is invasive urodynamic testing. Preliminary research at Toulouse University Hospital suggests urinary S1P levels may be a potential biomarker for detrusor activity in MS. This study aims to confirm this potential biomarker's utility.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• S1P level
Patients will undergo urinary S1P level assessments before treatment, 6 weeks post-injection, and following any symptomatic changes that may lead to another urodynamic assessments.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Outcome
Type Measure Description Time frame Safety issue
Primary S1P concentration To compare of the urinary concentration of S1P related to creatinine in urine sample, as a function of the detrusor activity determined at BUD, before and after a first intra-detrusor injection of botulinum toxin. Day 0, after 6 months
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