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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms
• Intervention / Treatment: Other: magnetic stimulation

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sacral 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	Other: 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
Active Comparator: Cortical 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	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: magnetic stimulation, multiple sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urological Manifestations; Multiple Sclerosis; Sclerosis; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 30091981