Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.

Study Overview
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Brief Summary
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The objective of the study is to describe the current status of MS patients with urinary disorders in Lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach.

Detailed Description
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All patients will be evaluated by an urologist, then randomized into 2 groups, the first group will benefit from non-invasive investigations and will be treated accordingly, the second group will benefit from an urodynamic assessment and will also be treated accordingly. An evaluation will be made one month, 3 months and 6 months after the first visit.

Official Title
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Prospective Randomized Controlled Trial Comparing the Non-invasive vs the Invasive Investigations in Multiple Sclerosis Patients With Urinary Disorders.

Conditions
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Multiple Sclerosis, Urinary Bladder, Neurogenic, Urodynamics

Intervention / Treatment
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* Diagnostic Test: Non-invasive investigations
* Diagnostic Test: Invasive investigations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MS with urinary symptoms Exclusion Criteria: BPH LUTS Bladder cancer prostate cancer urethral stenosis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel study, where group A receives non-invasive investigations and group B receives Invasive investigations.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-invasive investigations group<br>Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry | Diagnostic Test: Non-invasive investigations<br>* Ultrasound, blood tests, urine analysis and culture, uroflowmetry<br>|
| Experimental: Invasive investigations group<br>urodynamic study including: cystomanometry, pressure flow study, EMG | Diagnostic Test: Non-invasive investigations<br>* Ultrasound, blood tests, urine analysis and culture, uroflowmetry<br>Diagnostic Test: Invasive investigations<br>* Cystomanometry, pressure flow study, EMG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary symptoms | filling and voiding urinary symptoms (UBQMS: Urinary Bothersome Questionnaire in Multiple Sclerosis), Voising Score Ranges from 0 to 3 ( 3 being most severe bother), Filling score ranges from 0 to 3 ( 3 being most severe bother). | 6 months | 
| urinary quality of life | SF-QUALIVEEN: Short Form - health related quality of life questionnaire for urinary disorders in patients with neurological conditions. score ranges from 0 to 4 ( 4 being the worst quality of life). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, Multiple sclerosis, urinary Bladder, Neurogenic, Urodynamics, Randomized controlled trial