Effect of Magnetic Therapy in Bladder Dysfunction and Quality of Life in Paraplegic Patients

Cairo University1 site in 1 country40 target enrollmentNovember 5, 2023

ConditionsParaplegia Spinal Cord Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Paraplegia
Sponsor: Cairo University
Enrollment: 40
Locations: 1
Primary Endpoint: Maximum flow rate in milliliters per second
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Each study subject will undergo baseline urodynamic testing (UDS) at the beginning of the study to confirm the diagnosis of a neurogenic bladder with DSD and establish baseline bladder functions. The study will be divided into two phases: a Treatment phase (16 weeks) and a Follow-up phase (6 weeks). During the treatment phase, each subject will undergo once/week magnetic spinal cord stimulation (MSCS) at 1Hz (low) frequency (40-60% intensity) over the lumbar spine. Once each subject entered the treatment phase of the study and will receive weekly lumbar spinal cord magnetic stimulation for a total of 16 weeks. This 16-week period of MSCS constituted bladder rehabilitation. Each subject will receive non-video urodynamic testing once every four weeks during the treatment phase to monitor progress and ensure that bladder function will not further impaired. After the initial four-week stimulation period, each subject will be asked to attempt volitional urination for 5-10minutes prior to bladder catheterization. the subjects will instruct to keep the environment quiet, relax and focus on voiding

Detailed Description

Forty male Paraplegic patients will be recruited....from outpatients' clinics and their ages from 20 to 35 years and the inclusion criteria for the study will be a stable American Spinal Injury Association Impairment Scale (AISA) A/B, motor complete spinal cord injury between spinal levels T6-T12 present for greater than 1 year, and a documented history of neurogenic bladder requiring intermittent catheterization. Each subject will require to have at least three prior urodynamic studies to confirm the diagnosis of neurogenic bladder with detrusor sphincter dyssynergia (DSD), which was diagnosed with urodynamic study in which a rise in detrusor pressure and concomitant needle EMG activity and rise in urethral pressure were demonstrated Patients with a history of autonomic dysreflexia were excluded from the study. Any patient who will be ventilator dependent, abusing drugs, have musculoskeletal dysfunction (i.e., unstable fractures), cardiopulmonary diseases, active infections or ongoing depression requiring treatment, or have previous exposure to and use of spinal cord stimulation will be excluded from the study. Patients with a history of bladder Botox injection or bladder/sphincter surgeries will be excluded

Registry

clinicaltrials.gov

Start Date

November 5, 2023

End Date

March 4, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Cairo University

Responsible Party

Principal Investigator

Moataz Mohamed Talaat El Semary

Assistant Professor of physical therapy for neurology and neurosurgery

Cairo University

Eligibility Criteria

Inclusion Criteria

•Male Participants ages 20 to 35 years
•Participants will be a stable American Spinal Injury Association Impairment Scale (AISA) A/B.
•Motor incomplete spinal cord injury between spinal levels T6-T
•Participants present for more than 1 year.
•Each participant will require at least three prior urodynamic studies to confirm the diagnosis of neurogenic bladder with detrusor sphincter dyssynergia (DSD), which was diagnosed with urodynamic study.

Exclusion Criteria

•Patients with a history of autonomic dysreflexia.
•Any patient who will be ventilator dependent, abusing drugs, have musculoskeletal dysfunction (i.e., unstable fractures).
•Any patient who will have cardiopulmonary diseases, active infections or ongoing depression requiring treatment, or have previous exposure to and use of spinal cord stimulation.
•Patients with a history of bladder Botox injection or bladder/sphincter surgeries.