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

NCT06169969 | Completed DMC

• 1 other identifier: P.T.REC/012/004741
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Paraplegia; Spinal Cord Injuries

Keywords

Magnetic therapy; Paraplegia; Bladder dyssynergia; Quality of life

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

Magnetic therapy group

EXPERIMENTAL

receive magnetic therapy plus pelvic floor exercises.

Device: magnetic therapy

Pelvic floor exercises group

NO INTERVENTION

pelvic floor exercises only

Interventions

magnetic therapy DEVICE

Kegel exercises

Also known as: pelvic floor exercises

Magnetic therapy group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: ISLAMIC ISSUES
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Paraplegia; Spinal Cord Injuries

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of physical therapy for neurology and neurosurgery

Model Details: post hoc test

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 14, 2023
• Study Start: November 5, 2023
• Primary Completion: February 21, 2024
• Study Completion: March 4, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)