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

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Multiple Sclerosis
• Interventions: Other: magnetic stimulation

• Registration Number: NCT03434873
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2018-02
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-14
• Last Update Submitted: 2018-02-14
• Study First Posted: 2018-02-15
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• Urinary tract infections
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cortical magnetic stimulation	magnetic stimulation	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
Sacral magnetic stimulation	magnetic stimulation	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

Primary Outcome Measures

Name	Time	Method
Change from baseline Post-void residual urine after treatment	1-7 days after treatment	Measured by ultrasound It is the volume of urine left in the bladder at the completion of micturition Measured in milliliters (mL)
Change from baseline King's Health QoL questionnaire score after treatment	1-7 days 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.
Change from baseline Maximum Cystometric Capacity (MCC) after treatment	1-7 days 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
Change from baseline Maximum Flow Rate (Qmax) after treatment	1-7 days after treatment	Measured by urodynamic evaluation Measured in milliliters per second (mL/sec) It is the maximum measured value of the flow rate
Change from baseline Detrusor pressure at maximum flow rate (Pdet @Qmax) after treatment	1-7 days 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