ParaplegiaNCT06169969
Effect Of Magnetic Therapy In Bladder Dysfunction And Quality Of Life In Paraplegic Patients
A study testing magnetic therapy in people with Paraplegia and Spinal Cord Injuries, run by Cairo University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 20 to 35 years, men only
- Conditions the study is for
- Paraplegia, Spinal Cord Injuries
- What is being tested?
- magnetic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2023to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- magnetic therapy
- Keywords
- Magnetic therapy, Paraplegia, Bladder dyssynergia, Quality of life
- Medical subject headings
- Paraplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic therapyDevice
Also called pelvic floor exercises
Kegel exercises
| Study group | Role | What they receive |
|---|---|---|
| Magnetic therapy group | Experimental | receive magnetic therapy plus pelvic floor exercises. Receives: Device: magnetic therapy |
| Pelvic floor exercises group | No intervention | pelvic floor exercises only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Volume at first desire to void in Milliliters.
one of bladder functions using urodynamic testing
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start5 Nov 2023
- Primary completion21 Feb 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaplegiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- post hoc test
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moataz Mohamed Talaat El Semary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169969
- Sponsor's protocol ID
- P.T.REC/012/004741
- Status last verified
- Mar 2024
- First submitted
- 19 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnetic Therapy in Bladder Dysfunction and Quality of Life in Paraplegic Patients
- ClinicalTrials.gov ID
- NCT06169969
- Acronym / sponsor ID
- P.T.REC/012/004741
- Conditions
- Paraplegia, Spinal Cord Injuries
- Keywords
- Magnetic therapy, Paraplegia, Bladder dyssynergia, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- post hoc test
| Arm | Type | Receives |
|---|---|---|
| Magnetic therapy group | Experimental | Device: magnetic therapyreceive magnetic therapy plus pelvic floor exercises. |
| Pelvic floor exercises group | No intervention | –pelvic floor exercises only |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic therapyAlso: pelvic floor exercisesKegel exercises | Device | Magnetic therapy group |
Primary outcome
Bladder Volume at first desire to void in Milliliters.
Time frame: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
one of bladder functions using urodynamic testing
Detrusor pressure At Qmax in Centimeters of water
Time frame: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
one of bladder functions using urodynamic testing
Maximum flow rate in milliliters per second
Time frame: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
one of bladder functions using urodynamic testing
Amplitude per time in millivolts
Time frame: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
EMG Measurement during contraction of pelvic floor muscles
Upper centile amplitude in millivolts
Time frame: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
EMG Measurement during contraction of pelvic floor muscles
Qualiveen short version 8 questions from 1 to 4 (worse if high score)
Time frame: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)
Qualiveen questionnaire short form of quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic therapy in people with Paraplegia and Spinal Cord Injuries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Volume at first desire to void in Milliliters. (time frame: Baseline, pre-intervention then Peri procedurally after 8 weeks and finally "immediately after the intervention (16 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.