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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
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)
Time frame: Daily during the 4-week optimization period
EMG Waveform Quality as assessed by the number of successful EMG detections per session versus unsuccessful ones
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 days per month for all three months
Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Once a month for all 3 months
Implementation Barriers as assessed by a survey
Time frame: end of study (12 weeks from baseline)
Patient-Reported Implementation Feedback as assessed by a survey
Time frame: end of study (12 weeks from baseline)
Patient-Reported Comfort as assessed by the participant survey
Time frame: Daily during the 4-week optimization period
Patient-Reported Usability as assessed by the participant survey
Time frame: Daily during the 4-week optimization period
Type and extent of adjustments (none, minor, major) required for System Operation needed for effective stimulation
Time frame: End of the 4-week optimization period
Frequency of adaptations made to the device
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: End of study (12 weeks form baseline)
Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot
Time frame: Weekly during the 12-week study
Patient-Reported Changes in Bladder Program
Documentation of any changes made to the bladder management program
Time frame: Weekly during the 12-week study
Number of caregivers who were satisfied as assessed by the interview
Time frame: end of study (12 weeks from baseline)
Number of clinicians who were satisfied as assessed by the interview
Time frame: 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
Time frame: 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
Time frame: end of study (12 weeks from baseline)