Multiple Sclerosis, Neurogenic Bladder, Voiding Dysfunction
Conditions
Keywords
Neurogenic bladder, Functional Neuroimaging, Transcranial Rotating Permanent Magnet Stimulator (TRPMS)
Brief summary
The goal of this study is to identify brain centers specifically associated with initiation of voiding in patients with neurogenic bladder dysfunction. Currently there is no study that has evaluated brain centers involved in initiation of voiding in patients with neurogenic voiding dysfunction. Patients with neurogenic bladder secondary to etiologies such as Multiple Sclerosis, Parkinson's disease, and Cerebrovascular accidents will be recruited in this study. Patients will be categorized into 2 groups, those who have trouble emptying their bladder and those who urinate appropriately. Our existing and unique functional magnetic resonance imaging (fMRI)/ urodynamics (UDS) platform is an ideal platform to identify brain regions involved in bladder emptying disorders as seen in patients with neurogenic bladder dysfunction and will be used for this study. After characterizing brain regions involved in bladder emptying, the investigator propose to use noninvasive transcutaneous magnetic stimulation in a subset of patients with voiding dysfunction in aim 3.
Detailed description
Difficulty in bladder emptying (Voiding dysfunction,VD) is a costly urinary condition that leads to urinary tract infections/stones, sepsis, bladder loss, and permanent kidney damage. VD can be present in patients with or without neurologic/brain disorders. Currently the only available therapies for VD include bladder catheters or intermittent self-catheterization. Catheterization is a burden especially in patients with nerve damage, hand skills may be limited. The cost and morbid side effects of catheterizations in patients (blood in the urine, pain, trauma, strictures, and infections) requires investigators to develop new therapies that are beyond the bladder. Such new therapies could target the brain (where bladder control is located). In this proposal, investigators plan to further characterize the brain regions involved in bladder emptying for each patient and ,perform brain modulation, targeting these regions as a possible therapy for VD. Patients with bladder dysfunction will be divided into two groups: Group 1: patients with VD; and Group 2: patients without VD. Specific Aim 1: To evaluate brain pattern in both groups and compare them to each other at the time of bladder emptying. Specific Aim 2: To evaluate reliability of the nerve fibers in the brain and see whether damage to these fibers is related to difficulty emptying the bladder. Specific Aim 3: To perform non-invasive brain stimulation on specific regions of the brain responsible for bladder control to improve bladder emptying. This study is an interventional Study: The investigators have completed a well-powered study on twenty-seven female MS patients during their bladder storage phase. Aims 1 and 2 use the data from previously completed trial and investigators will perform additional imaging analysis on it. Aim 3 is a new and small trial in which investigators planned to modulate the regions of the brain that are related to bladder control. Approximately 16 study participants will be enrolled at Houston Methodist, and 16 throughout the study.
Interventions
DEVICETranscranial Rotating Permanent Magnet Stimulator (TRPMS)
TRPMS is a wearable non-invasive transcranial rotating permanent magnet stimulator. It has been determined to be a Non Significant Risk device by the FDA. The amount and frequency of therapy are prescribed by the physician, and the device is custom configured to the patient to deliver the required amount of treatment. The device does not turn on until it is time for the treatment. It consists of three main parts: Neoprene cap with microstimulator(s), stimulator console (device controller box) and the tablet with TRPMS app which activates the console. The neoprene cap prevents the microstimulator(s) from coming in direct contact with the scalp. Microstimulators deliver the magnetic stimulation to the brain based on a prescription program uploaded in the stimulator controller.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for subjects with neurogenic bladder: * Patients with clinical diagnosis of neurogenic bladder * History of any neurologic illness or injury (including but not limited to spinal cord injury, Multiple Sclerosis, Stroke, spina bifida, Parkinson's, major spine surgery) * 18 years or older Specifics for MS patients: Adult female patients with clinically stable MS \[Expanded Disability Status Score (EDSS) ≤6.5\], with bladder symptoms ≥3 months, will be screened. Patients will be considered to have VD if they have an increased Postvoid Residual (≥ 20% Maximum Cystometric Capacity). Patients who perform self-catheterization will be included in the VD category as well.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain Activity After Treatment Measured Using Functional MRI | Baseline to three weeks | Here we measured changes in brain activation in modulated brain regions of interest (ROI) via blood oxygen level-dependent (BOLD) signals during strong desire to void and voiding initiation (attempt). We determined if there was a significant increase or decrease in activity (voxel signal) after treatment using the following criteria: 1) increase in activation was defined as T-value greater than 2.074 and 2) decrease in activation was defined as T-value less than 2.074. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment | Baseline, after treatment and 4 month follow up | Objective clinical assessments included changes in post void residual (PVR) and bladder capacity in participants after treatment. PVR measures the volume of urine (cc/mL) that is left after voiding. BC measures the volume of urine (cc/mL) the bladder has a capacity to hold. % PVR/BC measures how much of the overall volume is left after voiding, showing how efficient a voiding is before and after treatment. |
| Changes in Non-instrumented Uroflow Variable Qmax Following Treatment | Baseline, after treatment and 4 month follow up | The objective clinical assessment included changes in non-instrumented uroflow variables such as Qmax, in participants after treatment as compared to baseline. Qmax values reported here correspond to the peak urine flow (mL/s) seen during uroflowmetry testing. |
| Changes in Liverpool Nomogram Following Treatment | Baseline, after treatment and 4 month follow-up | The objective clinical assessment included changes in non-instrumented uroflow variables such as Liverpool nomogram in participants after treatment as compared to baseline. The Liverpool nomogram provides normal reference ranges for the maximum and average urine flow rates over a wide range of voided volumes. It is presented as a percentile ranking depending on the flow rate and voided volume for each participant. |
| Changes in Objective Clinical Outcomes Following Treatment | Baseline, after treatment and 4 month follow up | The objective clinical assessment included changes in post void residual (PVR), voided volume (VV) and bladder capacity (BC) in participants after treatment as compared to baseline. PVR measures the volume of urine (cc/mL) that is left after voiding. VV measures the volume of urine that is voided (cc/mL). BC measures the volume of urine (cc/mL) the bladder has a capacity to hold, this value is calculated by adding the VV + PVR values obtained. |
| Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | Baseline, after treatment and 4 month follow up | Our subjective clinical assessment included changes in validated questionnaires. This assessment has 8 questions and is used to assess how bothersome urinary symptoms are and quality of life. We report raw scores here for questions pertaining to voiding symptoms. Questions 1-7 have the following score range: 0-5 (with the highest score associated with worse symptoms). The last question pertains to quality of life and has a score range of: 0-6 (with the highest score associated with very reduced quality of life). |
| Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | Baseline, after treatment and 4 month follow up | Our subjective clinical assessment included changes in validated questionnaires. This assessment has 24 questions that measure bladder symptoms across 3 different domains: incontinence (score range: 0-29), storage and voiding (score range: 0-22), and consequences (score range: 0-23); the highest score is associated with worse symptoms. The last question focuses on quality of life scored from 0 (pleased) to 4 (unhappy). We report raw scores here for all domains and QoL. |
| Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | Baseline, after treatment and 4 month follow up | Our subjective clinical assessment included changes in validated questionnaires. This assessment has 6 questions and is used to assess life quality and symptom distress for urinary incontinence in women. We report raw scores here for questions pertaining to voiding symptoms. Each question has the following score range: 0-4 (with the highest score associated with worse symptoms). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Multiple Sclerosis and Voiding Dysfunction Subjects with Multiple Sclerosis (MS) and voiding dysfunction (VD). In this group 'Transcranial Rotating Permanent Magnet Stimulator (TRPMS)' device will be used.
Transcranial Rotating Permanent Magnet Stimulator (TRPMS): TRPMS is a wearable non-invasive transcranial rotating permanent magnet stimulator. It has been determined to be a Non Significant Risk device by the FDA.
The amount and frequency of therapy are prescribed by the physician, and the device is custom configured to the patient to deliver the required amount of treatment. The device does not turn on until it is time for the treatment. It consists of three main parts: Neoprene cap with microstimulator(s), stimulator console (device controller box) and the tablet with TRPMS app which activates the console. The neoprene cap prevents the microstimulator(s) from coming in direct contact with the scalp. Microstimulators deliver the magnetic stimulation to the brain based on a prescription program uploaded in the stimulator controller. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Subjects With Multiple Sclerosis and Voiding Dysfunction |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 53.40 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Changes in Brain Activity After Treatment Measured Using Functional MRI
Here we measured changes in brain activation in modulated brain regions of interest (ROI) via blood oxygen level-dependent (BOLD) signals during strong desire to void and voiding initiation (attempt). We determined if there was a significant increase or decrease in activity (voxel signal) after treatment using the following criteria: 1) increase in activation was defined as T-value greater than 2.074 and 2) decrease in activation was defined as T-value less than 2.074.
Time frame: Baseline to three weeks
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R posterior cingulate cortex | 3.913861 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L thalamus | 2.753587 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L caudate nucleus | 4.684247 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L hippocampus | 3.027731 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L putamen | 3.695211 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L precentral gyrus | -3.990877 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R precentral gyrus | -4.272436 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L insula lobe | -2.769022 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R precentral gyrus | 4.393749 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L superior temporal gyrus | 3.324719 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L middle temporal gyrus | 4.935463 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R middle temporal gyrus | 5.257658 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L inferior temporal gyrus | 4.281283 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L supramarginal gyrus | 3.906453 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R supramarginal gyrus | 5.236864 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L inferior occipital gyrus | 3.065269 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R superior occipital gyrus | 4.129290 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R middle occipital gyrus | 4.078387 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L inferior frontal gyrus (p. Orbitalis) | 4.038723 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L inferior frontal gyrus (p. Triangularis) | 4.274477 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L inferior frontal gyrus (p. Opercularis) | 2.819778 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R inferior frontal gyrus (p. Orbitalis) | 3.072036 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R inferior frontal gyrus (p. Triangularis) | 3.645947 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L cerebellum | 4.210466 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L rectal gyrus | 4.637410 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R rectal gyrus | 3.535679 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L superior medial gyrus | 3.402534 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R superior medial gyrus | 3.136795 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L superior frontal gyrus | 2.455777 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R superior frontal gyrus | 3.053638 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L middle frontal gyrus | 3.798942 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R middle frontal gyrus | 3.897008 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L supplementary motor area | 2.518869 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R supplementary motor area | 4.614616 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L paracentral lobule | 3.324731 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R paracentral lobule | 5.114769 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R superior parietal lobule | 4.184497 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R inferior parietal lobule | 4.545515 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L superior orbital gyrus | 3.721826 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L middle orbital gyrus | 5.286532 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L calcarine gyrus | 3.551130 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L anterior cingulate cortex | 4.160711 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L middle cingulate cortex | 3.181774 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R angular gyrus | 4.111778 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L thalamus | 3.140146 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R thalamus | 3.255678 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L precuneus | 4.921595 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R caudate nucleus | 3.857368 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L putamen | 3.188081 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L amygdala | 2.479540 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R insula lobe | 3.000530 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L rolandic operculum | 2.860924 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L hippocampus | -4.078490 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R hippocampus | -3.109341 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R fusiform gyrus | -3.328545 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R rolandic operculum | -3.971051 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R thalamus | 3.373487 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L precuneus | 4.345939 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R precuneus | 3.767377 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L superior frontal gyrus | -3.345682 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L middle frontal gyrus | -2.921264 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R cerebellum | -3.007422 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R fusiform gyrus | -6.306071 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L postcentral gyrus | 4.999096 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R postcentral gyrus | 4.028872 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: L precentral gyrus | 4.425272 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R superior temporal gyrus | 3.313340 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R middle orbital gyrus | 3.078467 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R calcarine gyrus | 3.512251 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R middle cingulate cortex | 3.946584 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Voiding initiation: R precuneus | 4.093221 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: L inferior frontal gyrus | 2.759234 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: L superior temporal gyrus | 3.423569 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: L inferior temporal gyrus | 3.000987 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: L middle temporal gyrus | 3.094914 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: R middle temporal gyrus | 4.046153 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: L inferior parietal lobule | 2.950705 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: R inferior parietal lobule | 4.215242 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: R paracentral lobule | 2.799833 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong desire to void: R superior parietal lobule | 4.003400 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R supplementary motor area | 4.317012 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L postcentral gyrus | 5.520249 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R postcentral gyrus | 5.455663 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L angular gyrus | 3.369907 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R supramarginal gyrus | 4.578173 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L superior medial gyrus | 3.745239 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L inferior occipital gyrus | 5.683107 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: L middle cingulate cortex | 3.782596 BOLD fMRI T-Value |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Brain Activity After Treatment Measured Using Functional MRI | Strong Desire to void: R middle cingulate cortex | 3.693368 BOLD fMRI T-Value |
Comparison: Strong desire to void: L inferior frontal gyrusp-value: <0.05Student's t-test
Comparison: Desire to void: L superior temporal gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L inferior temporal gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L middle temporal gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: R middle temporal gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L inferior parietal lobulep-value: <0.05Student's t-test
Comparison: Strong desire to void: R inferior parietal lobulep-value: <0.05Student's t-test
Comparison: Strong desire to void: R paracentral lobulep-value: <0.05Student's t-test
Comparison: Strong desire to void: R superior parietal lobulep-value: <0.05Student's t-test
Comparison: Strong desire to void: R supplementary motor areap-value: <0.05Student's t-test
Comparison: Strong desire to void: L postcentral gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: R postcentral gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L angular gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: R supramarginal gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L superior medial gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L inferior occipital gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L middle cingulate cortexp-value: <0.05Student's t-test
Comparison: Strong desire to void: R middle cingulate cortexp-value: <0.05Student's t-test
Comparison: Strong desire to void: R posterior cingulate cortexp-value: <0.05Student's t-test
Comparison: Strong desire to void: L thalamusp-value: <0.05Student's t-test
Comparison: Strong desire to void: R thalamusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L precuneusp-value: <0.05Student's t-test
Comparison: Strong desire to void: R precuneusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L caudate nucleusp-value: <0.05Student's t-test
Comparison: Strong desire void: L hippocampusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L hippocampusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L putamenp-value: <0.05Student's t-test
Comparison: Strong desire to void: L precentral gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: R precentral gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L insula lobep-value: <0.05Student's t-test
Comparison: Strong desire to void: L superior frontal gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: L middle frontal gyrusp-value: <0.05Student's t-test
Comparison: Strong desire to void: R cerebellump-value: <0.05Student's t-test
Comparison: Strong desire to void: R fusiform gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L postcentral gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R postcentral gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L precentral gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R precentral gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L superior temporal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R superior temporal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L middle temporal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R middle temporal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L inferior temporal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L supramarginal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R supramarginal gyrusp-value: <0.05Student's t-test
Comparison: Voiding Initiation: L inferior occipital gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R superior occipital gyrusp-value: <0.05Student's t-test
Comparison: Voiding Initiation: R middle occipital gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L inferior frontal gyrus (p. Orbitalis)p-value: <0.05Student's t-test
Comparison: Voiding initiation: L inferior frontal gyrus (p. Triangularis)p-value: <0.05Student's t-test
Comparison: Voiding initiation: L inferior frontal gyrus (p. Opercularis)p-value: <0.05Student's t-test
Comparison: Voiding initiation: R inferior frontal gyrus (p. Orbitalis)p-value: <0.05Student's t-test
Comparison: Voiding initiation: R inferior frontal gyrus (p. Triangularis)p-value: <0.05Student's t-test
Comparison: Voiding initiation: L cerebellump-value: <0.05Student's t-test
Comparison: Voiding initiation: L rectal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R rectal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L superior medial gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R superior medial gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L superior frontal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R superior frontal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L middle frontal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R middle frontal gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L supplementary motor area (SMA)p-value: <0.05Student's t-test
Comparison: Voiding initiation: R SMAp-value: <0.05Student's t-test
Comparison: Voiding initiation: L paracentral lobulep-value: <0.05Student's t-test
Comparison: Voiding initiation: R paracentral lobulep-value: <0.05Student's t-test
Comparison: Voiding initiation: R superior parietal lobulep-value: <0.05Student's t-test
Comparison: Voiding initiation: R inferior parietal lobulep-value: <0.05Student's t-test
Comparison: Voiding initiation: L superior orbital gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L middle orbital gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R middle orbital gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R calcarine gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L calcarine gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L anterior cingulate cortexp-value: <0.05Student's t-test
Comparison: Voiding initiation: L middle cingulate cortexp-value: <0.05Student's t-test
Comparison: Voiding initiation: R middle cingulate cortexp-value: <0.05Student's t-test
Comparison: Voiding initiation: R angular gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L thalamusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R thalamusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L precuneusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R precuneusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R caudate nucleusp-value: <0.05Student's t-test
Comparison: Voiding initiation: L putamenp-value: <0.05Student's t-test
Comparison: Voiding initiation: L amygdalap-value: <0.05Student's t-test
Comparison: Voiding initiation: R insula lobep-value: <0.05Student's t-test
Comparison: Voiding initiation: L rolandic operculump-value: <0.05Student's t-test
Comparison: Voiding initiation: L hippocampusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R hippocampusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R fusiform gyrusp-value: <0.05Student's t-test
Comparison: Voiding initiation: R rolandic operculump-value: <0.05Student's t-test
Secondary
Changes in Liverpool Nomogram Following Treatment
The objective clinical assessment included changes in non-instrumented uroflow variables such as Liverpool nomogram in participants after treatment as compared to baseline. The Liverpool nomogram provides normal reference ranges for the maximum and average urine flow rates over a wide range of voided volumes. It is presented as a percentile ranking depending on the flow rate and voided volume for each participant.
Time frame: Baseline, after treatment and 4 month follow-up
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Liverpool Nomogram Following Treatment | Liverpool Nomogram baseline | 34.00 Percentile | Standard Deviation 36.12 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Liverpool Nomogram Following Treatment | Liverpool Nomogram post-treatment | 62.80 Percentile | Standard Deviation 32.9 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Liverpool Nomogram Following Treatment | Liverpool Nomogram 4 month follow-up | 49.63 Percentile | Standard Deviation 36.23 |
Comparison: Liverpool nomogram percentile - baseline vs post-treatmentp-value: 0.13t-test, 2 sided
Comparison: Liverpool nomogram percentile - baseline vs 4 month follow-upp-value: 0.26t-test, 2 sided
Secondary
Changes in Non-instrumented Uroflow Variable Qmax Following Treatment
The objective clinical assessment included changes in non-instrumented uroflow variables such as Qmax, in participants after treatment as compared to baseline. Qmax values reported here correspond to the peak urine flow (mL/s) seen during uroflowmetry testing.
Time frame: Baseline, after treatment and 4 month follow up
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Non-instrumented Uroflow Variable Qmax Following Treatment | Qmax at baseline | 22.2 mL/sec | Standard Deviation 14.76 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Non-instrumented Uroflow Variable Qmax Following Treatment | Qmax post-treatment | 31.00 mL/sec | Standard Deviation 15.17 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Non-instrumented Uroflow Variable Qmax Following Treatment | Qmax at 4 month follow-up | 25.50 mL/sec | Standard Deviation 14.25 |
Comparison: Qmax - baseline vs post-treatmentp-value: 0.19t-test, 2 sided
Comparison: Max - baseline vs 4 month follow-upp-value: 0.91t-test, 2 sided
Secondary
Changes in Objective Clinical Outcomes Following Treatment
The objective clinical assessment included changes in post void residual (PVR), voided volume (VV) and bladder capacity (BC) in participants after treatment as compared to baseline. PVR measures the volume of urine (cc/mL) that is left after voiding. VV measures the volume of urine that is voided (cc/mL). BC measures the volume of urine (cc/mL) the bladder has a capacity to hold, this value is calculated by adding the VV + PVR values obtained.
Time frame: Baseline, after treatment and 4 month follow up
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | Voided volume baseline | 188.1 mL | Standard Deviation 112.21 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | Voided volume post-treatment | 218.80 mL | Standard Deviation 110.12 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | Voided volume 4 month follow-up | 189.88 mL | Standard Deviation 106.32 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | PVR baseline | 193.10 mL | Standard Deviation 83.46 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | Bladder capacity baseline | 381.20 mL | Standard Deviation 152.37 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | Bladder capacity post-treatment | 317.50 mL | Standard Deviation 144.11 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | Bladder capacity 4 month follow-up | 350.63 mL | Standard Deviation 226.32 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | PVR post-treatment | 98.70 mL | Standard Deviation 89.37 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Objective Clinical Outcomes Following Treatment | PVR 4 month follow-up | 160.70 mL | Standard Deviation 142.93 |
Comparison: Voided volume - baseline vs post-treatmentp-value: 0.45t-test, 2 sided
Comparison: Voided volume - baseline vs 4 month follow-upp-value: 0.39t-test, 2 sided
Comparison: PVR - baseline vs post-treatmentp-value: 0.014t-test, 2 sided
Comparison: PVR - baseline vs 4 month follow-upp-value: 0.66t-test, 2 sided
Comparison: Bladder capacity - baseline vs post-treatmentp-value: 0.31t-test, 2 sided
Comparison: Bladder capacity - baseline vs 4 month follow-upp-value: 0.001t-test, 2 sided
Secondary
Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment
Objective clinical assessments included changes in post void residual (PVR) and bladder capacity in participants after treatment. PVR measures the volume of urine (cc/mL) that is left after voiding. BC measures the volume of urine (cc/mL) the bladder has a capacity to hold. % PVR/BC measures how much of the overall volume is left after voiding, showing how efficient a voiding is before and after treatment.
Time frame: Baseline, after treatment and 4 month follow up
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment | %PVR/BC (at baseline) | 54.04 Percentage | Standard Deviation 17.48 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment | %PVR/BC (post-treatment) | 29.46 Percentage | Standard Deviation 22.08 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in %Post-Void Residual/Bladder Capacity (PVR/BC) Following Treatment | %PVR/BC (at 4 month follow-up) | 42.08 Percentage | Standard Deviation 18.97 |
Comparison: % PVR/BC - baseline vs post-treatmentp-value: 0.004t-test, 2 sided
Comparison: %PVR/BC - baseline vs 4 month follow-upp-value: 0.038t-test, 2 sided
Secondary
Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire
Our subjective clinical assessment included changes in validated questionnaires. This assessment has 8 questions and is used to assess how bothersome urinary symptoms are and quality of life. We report raw scores here for questions pertaining to voiding symptoms. Questions 1-7 have the following score range: 0-5 (with the highest score associated with worse symptoms). The last question pertains to quality of life and has a score range of: 0-6 (with the highest score associated with very reduced quality of life).
Time frame: Baseline, after treatment and 4 month follow up
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q3 post-treatment | 2.90 Score on a scale | Standard Deviation 1.52 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q3 4 month follow-up | 3.00 Score on a scale | Standard Deviation 1.77 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q7 post-treatment | 2.20 Score on a scale | Standard Deviation 0.92 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q8 post-treatment | 3.50 Score on a scale | Standard Deviation 1.35 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q8 4 month follow-up | 2.75 Score on a scale | Standard Deviation 1.98 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q3 baseline | 4.30 Score on a scale | Standard Deviation 1.57 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q5 baseline | 2.60 Score on a scale | Standard Deviation 1.84 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q5 post-treatment | 2.30 Score on a scale | Standard Deviation 1.89 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q5 4 month follow-up | 1.88 Score on a scale | Standard Deviation 1.73 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q7 baseline | 2.80 Score on a scale | Standard Deviation 1.14 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q7 4 month follow-up | 2.13 Score on a scale | Standard Deviation 1.36 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - American Urological Association Symptom Score (AUASS) Questionnaire | AUSS Q8 baseline | 4.20 Score on a scale | Standard Deviation 1.69 |
Comparison: AUASS Q3 - baseline vs post-treatmentp-value: 0.044t-test, 2 sided
Comparison: AUASS Q3 - baseline vs 4 month follow-upp-value: 0.017t-test, 2 sided
Comparison: AUASS Q5 - baseline vs post-treatmentp-value: 0.54t-test, 2 sided
Comparison: AUASS Q5 - baseline vs 4 month follow-upp-value: 0.503t-test, 2 sided
Comparison: AUASS Q7 - baseline vs post-treatmentp-value: 0.023t-test, 2 sided
Comparison: AUASS Q7 - baseline vs 4 month follow-upp-value: 0.049t-test, 2 sided
Comparison: AUASS Q8 - baseline vs post-treatmentp-value: 0.089t-test, 2 sided
Comparison: AUASS Q8 - baseline vs 4 month follow-upp-value: 0.161t-test, 2 sided
Secondary
Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire
Our subjective clinical assessment included changes in validated questionnaires. This assessment has 24 questions that measure bladder symptoms across 3 different domains: incontinence (score range: 0-29), storage and voiding (score range: 0-22), and consequences (score range: 0-23); the highest score is associated with worse symptoms. The last question focuses on quality of life scored from 0 (pleased) to 4 (unhappy). We report raw scores here for all domains and QoL.
Time frame: Baseline, after treatment and 4 month follow up
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Incontinence) baseline | 11.70 Score on a scale | Standard Deviation 5.91 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Incontinence) post-treatment | 9.00 Score on a scale | Standard Deviation 6.11 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Consequences) post-treatment | 4.60 Score on a scale | Standard Deviation 2.5 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Consequences) 4 month follow-up | 5.63 Score on a scale | Standard Deviation 1.06 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (QoL) baseline | 2.80 Score on a scale | Standard Deviation 1.32 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (QoL) post-treatment | 2.10 Score on a scale | Standard Deviation 1.1 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Incontinence) 4 month follow-up | 9.88 Score on a scale | Standard Deviation 6.15 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Storage and Voiding) baseline | 15.00 Score on a scale | Standard Deviation 2.62 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Storage and Voiding) post-treatment | 14.10 Score on a scale | Standard Deviation 2.56 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Storage and Voiding) 4 month follow-up | 11.88 Score on a scale | Standard Deviation 2.17 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (Consequences) baseline | 5.00 Score on a scale | Standard Deviation 2.05 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Neurogenic Bladder Symptom Score (NBSS) Questionnaire | NBSS (QoL) 4 month follow-up | 1.50 Score on a scale | Standard Deviation 1.31 |
Comparison: NBSS (Incontinence) - baseline vs post-treatmentp-value: 0.01t-test, 2 sided
Comparison: NBSS (Incontinence) - baseline vs 4 month follow-upp-value: 0.41t-test, 2 sided
Comparison: NBSS (Storage and Voiding) - baseline vs post-treatmentp-value: 0.32t-test, 2 sided
Comparison: NBSS (Storage and Voiding) - baseline vs 4 month follow-upp-value: 0.02t-test, 2 sided
Comparison: NBSS (Consequences) - baseline vs post-treatmentp-value: 0.34t-test, 2 sided
Comparison: NBSS (Consequences) - baseline vs 4 month follow-upp-value: 0.61t-test, 2 sided
Comparison: NBSS (QoL) - baseline vs post-treatmentp-value: 0.02t-test, 2 sided
Comparison: NBSS (QoL) - baseline vs 4 month follow-upp-value: 0.07t-test, 2 sided
Secondary
Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire
Our subjective clinical assessment included changes in validated questionnaires. This assessment has 6 questions and is used to assess life quality and symptom distress for urinary incontinence in women. We report raw scores here for questions pertaining to voiding symptoms. Each question has the following score range: 0-4 (with the highest score associated with worse symptoms).
Time frame: Baseline, after treatment and 4 month follow up
Population: Eleven patients were eligible and consented to participate. One withdrew before baseline scan, and 10 received the treatment and completed all their scans and assessments (July 2019 - December 2020) and were included in the analysis. Amongst 8 patients who completed their 4-month follow-ups, 1 could not return for an in-person visit and only her validated questionnaires were collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q1 baseline | 3.10 Score on a scale | Standard Deviation 1.45 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q1 post-treatment | 2.70 Score on a scale | Standard Deviation 1.25 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q1 4 month follow-up | 1.88 Score on a scale | Standard Deviation 1.46 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q2 baseline | 2.50 Score on a scale | Standard Deviation 1.51 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q2 post-treatment | 2.20 Score on a scale | Standard Deviation 1.48 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q2 4 month follow-up | 1.50 Score on a scale | Standard Deviation 1.2 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q5 baseline | 3.30 Score on a scale | Standard Deviation 1.06 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q5 post-treatment | 2.20 Score on a scale | Standard Deviation 1.55 |
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis | Changes in Subjective Clinical Outcomes Following Treatment - Urinary Distress Inventory, Short Form (UDI-6) Questionnaire | UDI-6 Q5 4 month follow-up | 1.38 Score on a scale | Standard Deviation 1.3 |
Comparison: UDI-6 Q1 - baseline vs post-treatmentp-value: 0.4t-test, 2 sided
Comparison: UDI-6 Q1 - baseline vs 4 month follow-upp-value: 0.086t-test, 2 sided
Comparison: UDI-6 Q2 - baseline vs post-treatmentp-value: 0.54t-test, 2 sided
Comparison: UDI-6 Q2 - baseline vs 4 month follow-upp-value: 0.19t-test, 2 sided
Comparison: UDI-6 Q5 - baseline vs post-treatmentp-value: 0.04t-test, 2 sided
Comparison: UDI-6 5 - baseline vs 4 month follow-upp-value: 0.026t-test, 2 sided