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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06169969
• Other study ID #: P.T.REC/012/004741
• Status: Completed
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: March 4, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 4, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paraplegia
• Spinal Cord Injuries

Intervention

Device:
• magnetic therapy
Kegel exercises

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)