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

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ClinicalTrials.gov Identifier: NCT03434873
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
May Maged Abdel-Salhin, Cairo University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Lower Urinary Tract Symptoms Other: magnetic stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Motor Cortex Magnetic Stimulation Versus Sacral Magnetic Stimulation in Lower Urinary Tract Dysfunction in Multiple Sclerosis Patients
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from baseline King's Health QoL questionnaire score after treatment [ Time Frame: 1-7 days 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.


  2. Change from baseline Post-void residual urine after treatment [ Time Frame: 1-7 days after treatment ]
    Measured by ultrasound It is the volume of urine left in the bladder at the completion of micturition Measured in milliliters (mL)

  3. Change from baseline Maximum Cystometric Capacity (MCC) after treatment [ Time Frame: 1-7 days 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

  4. Change from baseline Maximum Flow Rate (Qmax) after treatment [ Time Frame: 1-7 days after treatment ]
    Measured by urodynamic evaluation Measured in milliliters per second (mL/sec) It is the maximum measured value of the flow rate

  5. Change from baseline Detrusor pressure at maximum flow rate (Pdet @Qmax) after treatment [ Time Frame: 1-7 days 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: May Maged Abdel-Salhin, Doctor, Cairo University
ClinicalTrials.gov Identifier: NCT03434873    
Other Study ID Numbers: 30091981
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Keywords provided by May Maged Abdel-Salhin, Cairo University:
magnetic stimulation, multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Lower Urinary Tract Symptoms
Pathologic Processes
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