Effect Of Magnetic Therapy In Bladder Dysfunction And Quality Of Life In Paraplegic Patients

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

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Paraplegia
• Intervention / Treatment: Device: magnetic therapy

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of physical therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

IInclusion 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-T12.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetic therapy group; receive magnetic therapy plus pelvic floor exercises.	Device: magnetic therapy; Kegel exercises; Other Names: pelvic floor exercises
No Intervention: Pelvic floor exercises group; pelvic floor exercises only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Volume at first desire to void in Milliliters.	one of bladder functions using urodynamic testing	Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
Detrusor pressure At Qmax in Centimeters of water	one of bladder functions using urodynamic testing	Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
Maximum flow rate in milliliters per second	one of bladder functions using urodynamic testing	Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
Amplitude per time in millivolts	EMG Measurement during contraction of pelvic floor muscles	Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
Upper centile amplitude in millivolts	EMG Measurement during contraction of pelvic floor muscles	Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
Qualiveen short version 8 questions from 1 to 4 (worse if high score)	Qualiveen questionnaire short form of quality of life	Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2023
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): March 4, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Paraplegia; Magnetic therapy; Bladder dyssynergia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Paraplegia
• Other Study ID Numbers: P.T.REC/012/004741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No