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

NCT06161376 | Recruiting

• 1 other identifier: RC31/23/0346
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

multiple sclerosis

Patients diagnosed with MS requiring urodynamic assessment will be recruited during outpatient visits at Toulouse University Hospital. Initial consultations will involve questionnaire completion, 72-hour voiding diaries, and urine sample collection just before urodynamic assessments.

Other: S1P level

Interventions

S1P level OTHER

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.

multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with multiple sclerosis

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating females
• Patients under legal guardianship
• Known anatomical subvesical obstruction Known pelvic floor disorder Urothelial carcinoma Interstitial cystitis Augmentation cystoplasty

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse Hospital

Toulouse, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urinary test

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xavier Game, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Game, MD

CONTACT

05 61 32 33 01; game.x@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)