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Completed

NCT Number: NCT03434873

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Lower Urinary Tract Symptoms Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 15, 2018
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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