Neurogenic Bladder
Conditions
Keywords
spinal cord injury, tibial nerve stimulation
Brief summary
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.
Interventions
DEVICEVivally system stimulation
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.
Sponsors
Mission Connect
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Injury level above T10. * Diagnosis of neurogenic bladder (Performing intermittent catheterization). * English or Spanish Speaker. * Toe flexion upon tibial nerve stimulation with transcutaneous electric stimulation. * No adverse events during the Vivally 5-minute trial
Exclusion criteria
* Intradetrusor Botulinum Toxin within six months. * Presence of urinary tract infection (UTI) symptoms. * Pregnancy or breastfeeding. * Known allergy to electrode or device materials. * Known intolerance to leg electric stimulation * Patient with no smartphone access. * Pain/discomfort or adverse reaction with the trial of toe flexion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Continuous, daily monitoring throughout the 12-week study | Pain is scored on linear scale from 0(no pain)-10(worst pain), higher score indicating worse outcome |
| Patient-Reported Implementation Feedback as assessed by a survey | end of study (12 weeks from baseline) | — |
| Safety as assessed by the adverse events self reported by participant | Continuous, daily monitoring throughout the 12-week study | patient-reported adverse events, including changes in spasticity, their bowel programs, urinary tract infections, autonomic dysreflexia, and all other concerning changes |
| 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 | — |
| 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 | — |
| Implementation Barriers as assessed by a survey | end of study (12 weeks from baseline) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Changes in Bladder Program | Weekly during the 12-week study | Documentation of any changes made to the bladder management program |
| Number of caregivers who were satisfied as assessed by the interview | end of study (12 weeks from baseline) | — |
| Patient-Reported Comfort as assessed by the participant survey | Daily during the 4-week optimization period | — |
| System Fidelity as assessed by the degree to which the the Avation electric stimulation system was used as intended by patients | end of study (12 weeks from baseline) | This is assessed by the the number of times participant used the device per month |
| 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) | — |
| Number of clinicians who were satisfied as assessed by the interview | end of study (12 weeks from baseline) | — |
| Patient-Reported Usability as assessed by the participant survey | Daily during the 4-week optimization period | — |
| 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) | Baseline, 4 weeks, 8 weeks and 12 weeks | 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 |
| Change in Quality of Life as assessed by the Incontinence Quality of Life Questionnaire(I-QOL) | Baseline, 4 weeks, 8 weeks and 12 weeks | 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. |
| Change in Quality of Life as assessed by the Neurogenic Bowel Dysfunction (NBD) score | Baseline, 4 weeks, 8 weeks and 12 weeks | 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. |
| Patient satisfaction as assessed by a survey | End of study (12 weeks form baseline) | 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 |
| Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot | Weekly during the 12-week study | — |
Outcome results
None listed