Effect of Motor Cortex Versus Sacral Magnetic Stimulation in Multiple Sclerosis Patients With Urinary Tract Dysfunction

Study Overview
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Brief Summary
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This work is intended to assess the effect of repetitive magnetic stimulation on the sacral roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients with the lower urinary tract dysfunction.

Detailed Description
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Twenty Multiple sclerosis patients with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on sacral roots. Another twenty Multiple sclerosis patient with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on motor cortex. Treatment outcome will be assessed and compared between the two groups. Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses (total duration: 16 minutes) once a day for four consecutive days for two weeks.

Official Title
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Effect of Motor Cortex Magnetic Stimulation Versus Sacral Magnetic Stimulation in Lower Urinary Tract Dysfunction in Multiple Sclerosis Patients

Conditions
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Multiple Sclerosis, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Other: magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple Sclerosis patients (diagnosed by McDonald criteria 2010) with lower urinary tract dysfunction Adults more than 18 years Unresponsiveness to medical treatment Urodynamic diagnosis of detrusor overactivity and/or detrusor underactivity and/or detrusor-sphincter dyssynergia Exclusion Criteria: Urinary tract infections Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sacral magnetic stimulation<br>Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over sacral roots | Other: magnetic stimulation<br>* Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks<br>|
| Active Comparator: Cortical magnetic stimulation<br>Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks, over motor cortex | Other: magnetic stimulation<br>* Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline King's Health QoL questionnaire score after treatment | questionnaire evaluates the impact of lower urinary tract symptoms on patient's quality of life. High scores represent a worse quality of life, with no cut-off values. | 1-7 days after treatment | 
| Change from baseline Post-void residual urine after treatment | Measured by ultrasound It is the volume of urine left in the bladder at the completion of micturition Measured in milliliters (mL) | 1-7 days after treatment | 
| Change from baseline Maximum Cystometric Capacity (MCC) after treatment | Measured by urodynamic evaluation Measured in millimeters (mL) It is the volume at which the patient states that he/she can no longer delay micturition because of strong desire to void or urgency | 1-7 days after treatment | 
| Change from baseline Maximum Flow Rate (Qmax) after treatment | Measured by urodynamic evaluation Measured in milliliters per second (mL/sec) It is the maximum measured value of the flow rate | 1-7 days after treatment | 
| Change from baseline Detrusor pressure at maximum flow rate (Pdet @Qmax) after treatment | Measured by urodynamic evaluation Measured in centimeter water (cmH2O) It represents the effect of the active and/or passive forces generated by the detrusor muscle | 1-7 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic stimulation, multiple sclerosis