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
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring magnetic stimulation, multiple sclerosis
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
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
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
Learn more about this trial
Effect of Motor Cortex Versus Sacral Magnetic Stimulation in Multiple Sclerosis Patients With Urinary Tract Dysfunction
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