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| Name | Class |
|---|---|
| Mission Connect | UNKNOWN |
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The purpose of this study is to assess and optimize the Avation electric stimulation system output and electromyography (EMG) processing to stimulate the tibial nerve in people with chronic Spinal Cord Injury (SCI) who have foot muscle atrophy and edema, both of which may affect proper device operations, to evaluate the safety, feasibility, and effectiveness of Avation Electric Stimulation System for bladder neuromodulation in people with SCI and identify barriers to implementation of the existing Avation Electric Stimulation System to help with developing it towards a new indication for routine care of SCI NB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivally system | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivally system stimulation | Device | During the first month, participants will do the stimulation at different time points: 1) supine while in bed, 2) seated in the morning, 3) sitting in the afternoon, and 4) sitting in the evening. Participants will measure the circumference of their ankle prior to each use. Participants will use the System for an additional 2 months with the preferred stimulation parameters based on the study team's recommendations from the first month of use. |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency and Reliability of Stimulation Output as assessed by the percentage of sessions where the desired stimulation intensity is achieved (based on EMG waveform consistency) and time of day (morning, afternoon, evening) | Daily during the 4-week optimization period | |
| EMG Waveform Quality as assessed by the number of successful EMG detections per session versus unsuccessful ones | Daily during the 4-week optimization period | |
| Safety as assessed by the Pain score reported on the participant diary | Pain is scored on linear scale from 0(no pain)-10(worst pain), higher score indicating worse outcome | Continuous, daily monitoring throughout the 12-week study |
| Safety as assessed by the adverse events self reported by participant | patient-reported adverse events, including changes in spasticity, their bowel programs, urinary tract infections, autonomic dysreflexia, and all other concerning changes | Continuous, daily monitoring throughout the 12-week study |
| Feasibility as assessed by the number of participants who adhere to the protocol as reported on the patient dairy | Weekly during the 12-week study | |
| Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data | 2 days per month for all three months | |
| Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data | 2 days per month for all three months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Comfort as assessed by the participant survey | Daily during the 4-week optimization period | |
| Patient-Reported Usability as assessed by the participant survey | Daily during the 4-week optimization period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Argyrios Stampas, MD, MS | The University of Texas Health Science Center and Houston | Principal Investigator |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data | 2 days per month for all three months |
| Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data | Once a month for all 3 months |
| Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data | Once a month for all 3 months |
| Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data | Once a month for all 3 months |
| Implementation Barriers as assessed by a survey | end of study (12 weeks from baseline) |
| Patient-Reported Implementation Feedback as assessed by a survey | end of study (12 weeks from baseline) |
| Type and extent of adjustments (none, minor, major) required for System Operation needed for effective stimulation | End of the 4-week optimization period |
| Frequency of adaptations made to the device | End of the 4-week optimization period |
| Number of participants that had adaptations made to the device as assessed by a yes or no questionnaire | End of the 4-week optimization period |
| Change in Quality of Life as assessed by the The Neurogenic Bladder Symptom Score (NBSS) | This is a 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23) for a maximum score of 74, higher scores indicating worse outcome | Baseline, 4 weeks, 8 weeks and 12 weeks |
| Change in Quality of Life as assessed by the Incontinence Quality of Life Questionnaire(I-QOL) | The I-QOL is a 22-item self-reported questionnaire scored on a scale from 0 to 100, with higher scores indicating better quality of life. | Baseline, 4 weeks, 8 weeks and 12 weeks |
| Change in Quality of Life as assessed by the Neurogenic Bowel Dysfunction (NBD) score | The NBD score evaluates symptoms such as incontinence, constipation, and frequency of bowel management interventions. It is scored on a scale from 0 to 47, with higher scores indicating more severe dysfunction. | Baseline, 4 weeks, 8 weeks and 12 weeks |
| Patient satisfaction as assessed by a survey | This is an 8 item questionnaire and each is scored between 1(strongly disagree)-5( strongly agree),maximum score of 40, higher score indicates better satisfaction with the device | End of study (12 weeks form baseline) |
| Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot | Weekly during the 12-week study |
| Patient-Reported Changes in Bladder Program | Documentation of any changes made to the bladder management program | Weekly during the 12-week study |
| Number of caregivers who were satisfied as assessed by the interview | end of study (12 weeks from baseline) |
| Number of clinicians who were satisfied as assessed by the interview | end of study (12 weeks from baseline) |
| System Fidelity as assessed by the degree to which the the Avation electric stimulation system was used as intended by patients | This is assessed by the the number of times participant used the device per month | end of study (12 weeks from baseline) |
| Relative Advantage and Adaptability of the Innovation as assessed by the ratings on the perceived benefits and adaptability of the the Avation electric stimulation system compared to existing treatments | end of study (12 weeks from baseline) |
| 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 |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |