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

NCT03434873 | Completed DMC

• 1 other identifier: 30091981
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Keywords

magnetic stimulation, multiple sclerosis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Sacral magnetic stimulation

ACTIVE COMPARATOR

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

Cortical magnetic stimulation

ACTIVE COMPARATOR

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

Interventions

magnetic stimulation OTHER

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

Cortical magnetic stimulation; Sacral magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Urinary tract infections
• Pregnancy

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 15, 2018
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 15, 2018

Record last verified: 2018-02