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

Not yet recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: S1P level

• Registration Number: NCT06161376
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2024-12
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
multiple sclerosis	S1P level	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.

Primary Outcome Measures

Name	Time	Method
S1P concentration	Day 0, after 6 months	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.