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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434873
• Other study ID #: 30091981
• Status: Completed
• Phase: N/A
• First received: February 2, 2018
• Last updated: February 14, 2018
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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