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

Primary Purpose

Multiple Sclerosis, Lower Urinary Tract Symptoms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
magnetic stimulation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring magnetic stimulation, multiple sclerosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Sacral magnetic stimulation

    Cortical magnetic stimulation

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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.
    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)
    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
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2018
    Last Updated
    February 14, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03434873
    Brief Title
    Effect of Motor Cortex Versus Sacral Magnetic Stimulation in Multiple Sclerosis Patients With Urinary Tract Dysfunction
    Official Title
    Effect of Motor Cortex Magnetic Stimulation Versus Sacral Magnetic Stimulation in Lower Urinary Tract Dysfunction in Multiple Sclerosis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Lower Urinary Tract Symptoms
    Keywords
    magnetic stimulation, multiple sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sacral magnetic stimulation
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Cortical magnetic stimulation
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    magnetic stimulation
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change from baseline King's Health QoL questionnaire score after treatment
    Description
    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.
    Time Frame
    1-7 days after treatment
    Title
    Change from baseline Post-void residual urine after treatment
    Description
    Measured by ultrasound It is the volume of urine left in the bladder at the completion of micturition Measured in milliliters (mL)
    Time Frame
    1-7 days after treatment
    Title
    Change from baseline Maximum Cystometric Capacity (MCC) after treatment
    Description
    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
    Time Frame
    1-7 days after treatment
    Title
    Change from baseline Maximum Flow Rate (Qmax) after treatment
    Description
    Measured by urodynamic evaluation Measured in milliliters per second (mL/sec) It is the maximum measured value of the flow rate
    Time Frame
    1-7 days after treatment
    Title
    Change from baseline Detrusor pressure at maximum flow rate (Pdet @Qmax) after treatment
    Description
    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
    Time Frame
    1-7 days after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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

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