Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K12DK083014 | U.S. NIH Grant/Contract | View source | |
| K23DK118209 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Multiple Sclerosis and Voiding Dysfunction | Experimental | Subjects with Multiple Sclerosis (MS) and voiding dysfunction (VD). In this group 'Transcranial Rotating Permanent Magnet Stimulator (TRPMS)' device will be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Inclusion Criteria for subjects with neurogenic bladder:
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.
Exclusion Criteria:
Exclusion Criteria for subjects with neurogenic bladder:
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| Name | Affiliation | Role |
|---|---|---|
| Rose Khavari, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26067125 | Background | Panicker JN, Fowler CJ, Kessler TM. Lower urinary tract dysfunction in the neurological patient: clinical assessment and management. Lancet Neurol. 2015 Jul;14(7):720-32. doi: 10.1016/S1474-4422(15)00070-8. | |
| 19371782 | Background | Kuhtz-Buschbeck JP, Gilster R, van der Horst C, Hamann M, Wolff S, Jansen O. Control of bladder sensations: an fMRI study of brain activity and effective connectivity. Neuroimage. 2009 Aug 1;47(1):18-27. doi: 10.1016/j.neuroimage.2009.04.020. Epub 2009 Apr 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Full Range | BOLD fMRI T-Value | Baseline to three weeks |
|
Safety was measured by the incidence of patient or investigator-reported adverse events, monitored by the study team and via questionnaires (regarding mood, pain, dizziness, and other sensations) collected at each treatment session. [Time Frame: acute, up to 6 months]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
This is a pilot study with a small sample size of 10 women and no controls. Other potential limitations of this study include the supine position during the fMRI/UDS examination, which could pose difficulty for subjects to void in the scanner. MS is a heterogeneous disease, and the observed changes in outcomes could be a result of historical changes unrelated to treatment, or depending on baseline factors such as location of lesion burdens or duration of MS.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rose Khavari, MD | Houston Methodist Hospital | 7134419118 | rkhavari@houstonmethodist.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2020 | Oct 2, 2023 | Prot_SAP_001.pdf |
Not provided
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Not provided
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
Not provided
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|
| Baseline, after treatment and 4 month follow up |
| 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. | Baseline, after treatment and 4 month follow up |
| 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. | Baseline, after treatment and 4 month follow up |
| 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. | Baseline, after treatment and 4 month follow-up |
| 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). | Baseline, after treatment and 4 month follow up |
| 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). | Baseline, after treatment and 4 month follow up |
| 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. | Baseline, after treatment and 4 month follow up |
| 24769029 | Background | Shy M, Fung S, Boone TB, Karmonik C, Fletcher SG, Khavari R. Functional magnetic resonance imaging during urodynamic testing identifies brain structures initiating micturition. J Urol. 2014 Oct;192(4):1149-54. doi: 10.1016/j.juro.2014.04.090. Epub 2014 Apr 21. |
| 27664581 | Background | Khavari R, Karmonik C, Shy M, Fletcher S, Boone T. Functional Magnetic Resonance Imaging with Concurrent Urodynamic Testing Identifies Brain Structures Involved in Micturition Cycle in Patients with Multiple Sclerosis. J Urol. 2017 Feb;197(2):438-444. doi: 10.1016/j.juro.2016.09.077. Epub 2016 Sep 21. |
| 17293127 | Background | Kuhtz-Buschbeck JP, van der Horst C, Wolff S, Filippow N, Nabavi A, Jansen O, Braun PM. Activation of the supplementary motor area (SMA) during voluntary pelvic floor muscle contractions--an fMRI study. Neuroimage. 2007 Apr 1;35(2):449-57. doi: 10.1016/j.neuroimage.2006.12.032. Epub 2007 Jan 9. |
| 16145475 | Background | Kuhtz-Buschbeck JP, van der Horst C, Pott C, Wolff S, Nabavi A, Jansen O, Junemann KP. Cortical representation of the urge to void: a functional magnetic resonance imaging study. J Urol. 2005 Oct;174(4 Pt 1):1477-81. doi: 10.1097/01.ju.0000173007.84102.7c. |
| 9827764 | Background | Blok BF, Sturms LM, Holstege G. Brain activation during micturition in women. Brain. 1998 Nov;121 ( Pt 11):2033-42. doi: 10.1093/brain/121.11.2033. |
| 9055802 | Background | Blok BF, Willemsen AT, Holstege G. A PET study on brain control of micturition in humans. Brain. 1997 Jan;120 ( Pt 1):111-21. doi: 10.1093/brain/120.1.111. |
| 17439897 | Background | Centonze D, Petta F, Versace V, Rossi S, Torelli F, Prosperetti C, Rossi S, Marfia GA, Bernardi G, Koch G, Miano R, Boffa L, Finazzi-Agro E. Effects of motor cortex rTMS on lower urinary tract dysfunction in multiple sclerosis. Mult Scler. 2007 Mar;13(2):269-71. doi: 10.1177/1352458506070729. Epub 2007 Jan 29. |
| 36321777 | Background | Choksi D, Schott B, Tran K, Jang R, Hasan KM, Lincoln JA, Jalali A, Karmonik C, Salazar B, Khavari R. Disruption of specific white matter tracts is associated with neurogenic lower urinary tract dysfunction in women with multiple sclerosis. Neurourol Urodyn. 2023 Jan;42(1):239-248. doi: 10.1002/nau.25075. Epub 2022 Nov 2. |
| 34694911 | Result | Khavari R, Tran K, Helekar SA, Shi Z, Karmonik C, Rajab H, John B, Jalali A, Boone T. Noninvasive, Individualized Cortical Modulation Using Transcranial Rotating Permanent Magnet Stimulator for Voiding Dysfunction in Women with Multiple Sclerosis: A Pilot Trial. J Urol. 2022 Mar;207(3):657-668. doi: 10.1097/JU.0000000000002297. Epub 2021 Oct 25. |
| 36568960 | Result | Jang Y, Tran K, Shi Z, Christof K, Choksi D, Salazar BH, Lincoln JA, Khavari R. Predictors for outcomes of noninvasive, individualized transcranial magnetic neuromodulation in multiple sclerosis women with neurogenic voiding dysfunction. Continence (Amst). 2022 Dec;4:100517. doi: 10.1016/j.cont.2022.100517. Epub 2022 Oct 19. |
| 35842826 | Result | Shi Z, Karmonik C, Soltes A, Tran K, Lincoln JA, Boone T, Khavari R. Altered bladder-related brain network in multiple sclerosis women with voiding dysfunction. Neurourol Urodyn. 2022 Sep;41(7):1612-1619. doi: 10.1002/nau.25008. Epub 2022 Jul 17. |
| 33757581 | Derived | Tran K, Shi Z, Karmonik C, John B, Rajab H, Helekar SA, Boone T, Khavari R. Therapeutic effects of non-invasive, individualized, transcranial neuromodulation treatment for voiding dysfunction in multiple sclerosis patients: study protocol for a pilot clinical trial. Pilot Feasibility Stud. 2021 Mar 24;7(1):83. doi: 10.1186/s40814-021-00825-z. |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of participants | Count of Participants | Participants |
|
| Transcranial Rotating Permanent Magnet Stimulator (TRPMS) in Subjects With Multiple Sclerosis |
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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL | Baseline, after treatment and 4 month follow up |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Percentage | Baseline, after treatment and 4 month follow up |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/sec | Baseline, after treatment and 4 month follow up |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Percentile | Baseline, after treatment and 4 month follow-up |
|
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, after treatment and 4 month follow up |
|
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, after treatment and 4 month follow up |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, after treatment and 4 month follow up |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
Not provided
Not provided
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Voided volume 4 month follow-up |
|
|
| PVR baseline |
|
|
| PVR post-treatment |
|
|
| PVR 4 month follow-up |
|
|
| Bladder capacity baseline |
|
|
| Bladder capacity post-treatment |
|
|
| Bladder capacity 4 month follow-up |
|
|
| t-test, 2 sided |
Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) |
| 0.39 |
Threshold for statistical significance used P-value <0.05 |
| Other |
| PVR - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.014 | Threshold for statistical significance used P-value <0.05 | Other |
| PVR - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.66 | Threshold for statistical significance used P-value <0.05 | Other |
| Bladder capacity - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.31 | Threshold for statistical significance used P-value <0.05 | Other |
| Bladder capacity - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.001 | Threshold for statistical significance used P-value <0.05 | Other |
|
| %PVR/BC (at 4 month follow-up) |
|
|
| t-test, 2 sided |
Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) |
| 0.038 |
Threshold for statistical significance used P-value <0.05 |
| Other |
|
| Qmax at 4 month follow-up |
|
|
| t-test, 2 sided |
Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) |
| 0.91 |
Threshold for statistical significance used P-value <0.05 |
| Other |
|
| Liverpool Nomogram 4 month follow-up |
|
|
| t-test, 2 sided |
Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) |
| 0.26 |
Threshold for statistical significance used P-value <0.05 |
| Other |
|
| UDI-6 Q1 4 month follow-up |
|
|
| UDI-6 Q2 baseline |
|
|
| UDI-6 Q2 post-treatment |
|
|
| UDI-6 Q2 4 month follow-up |
|
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| UDI-6 Q5 baseline |
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| UDI-6 Q5 post-treatment |
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| UDI-6 Q5 4 month follow-up |
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| t-test, 2 sided |
Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) |
| 0.086 |
Threshold for statistical significance used P-value <0.05 |
| Other |
| UDI-6 Q2 - baseline vs post-treatment | t-test, 2 sided | Paired t-test. | 0.54 | Threshold for statistical significance used P-value <0.05 | Other |
| UDI-6 Q2 - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.19 | Threshold for statistical significance used P-value <0.05 | Other |
| UDI-6 Q5 - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.04 | Threshold for statistical significance used P-value <0.05 | Other |
| UDI-6 5 - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.026 | Threshold for statistical significance used P-value <0.05 | Other |
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| AUSS Q3 4 month follow-up |
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| AUSS Q5 baseline |
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| AUSS Q5 post-treatment |
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| AUSS Q5 4 month follow-up |
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| AUSS Q7 baseline |
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| AUSS Q7 post-treatment |
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| AUSS Q7 4 month follow-up |
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| AUSS Q8 baseline |
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| AUSS Q8 post-treatment |
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| AUSS Q8 4 month follow-up |
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| t-test, 2 sided |
Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) |
| 0.017 |
Threshold for statistical significance used P-value <0.05 |
| Other |
| AUASS Q5 - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.54 | Threshold for statistical significance used P-value <0.05 | Other |
| AUASS Q5 - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.503 | Threshold for statistical significance used P-value <0.05 | Other |
| AUASS Q7 - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.023 | Threshold for statistical significance used P-value <0.05 | Other |
| AUASS Q7 - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.049 | Threshold for statistical significance used P-value <0.05 | Other |
| AUASS Q8 - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.089 | Threshold for statistical significance used P-value <0.05 | Other |
| AUASS Q8 - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.161 | Threshold for statistical significance used P-value <0.05 | Other |
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| NBSS (Incontinence) 4 month follow-up |
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| NBSS (Storage and Voiding) baseline |
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| NBSS (Storage and Voiding) post-treatment |
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| NBSS (Storage and Voiding) 4 month follow-up |
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| NBSS (Consequences) baseline |
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| NBSS (Consequences) post-treatment |
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| NBSS (Consequences) 4 month follow-up |
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| NBSS (QoL) baseline |
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| NBSS (QoL) post-treatment |
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| NBSS (QoL) 4 month follow-up |
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| t-test, 2 sided |
Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) |
| 0.41 |
Threshold for statistical significance used P-value <0.05 |
| Other |
| NBSS (Storage and Voiding) - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.32 | Threshold for statistical significance used P-value <0.05 | Other |
| NBSS (Storage and Voiding) - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.02 | Threshold for statistical significance used P-value <0.05 | Other |
| NBSS (Consequences) - baseline vs post-treatment | t-test, 2 sided | Paired t-test | 0.34 | Threshold for statistical significance used P-value <0.05 | Other |
| NBSS (Consequences) - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.61 | Threshold for statistical significance used P-value <0.05 | Other |
| NBSS (QoL) - baseline vs post-treatment | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.02 | Threshold for statistical significance used P-value <0.05 | Other |
| NBSS (QoL) - baseline vs 4 month follow-up | t-test, 2 sided | Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations) | 0.07 | Threshold for statistical significance used P-value <0.05 | Other |