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

NCT ID: NCT06169969

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2024-03-04

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

Conditions

Paraplegia; Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Magnetic therapy group

receive magnetic therapy plus pelvic floor exercises.

Group Type: EXPERIMENTAL

magnetic therapy

Intervention Type: DEVICE

Kegel exercises

Pelvic floor exercises group

pelvic floor exercises only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

magnetic therapy

Kegel exercises

Intervention Type: DEVICE

Other Intervention Names

pelvic floor exercises

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-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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Moataz Mohamed Talaat El Semary

Assistant Professor of physical therapy for neurology and neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004741

Identifier Type: -

Identifier Source: org_study_id