Spinal Cord Injuries Clinical Trial
Official title:
Effect of Magnetic Therapy in Bladder Dysfunction and Quality of Life in Paraplegic Patients
Verified date | March 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of physical therapy | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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) |
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