Clinical trial NCT06661057: Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder
Official title: Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder: A Hybrid Effectiveness-implementation Pilot Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neurogenic Bladder
Keywords: spinal cord injury
tibial nerve stimulation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Mission Connect
First posted: 2024-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Daily during the 4-week optimization period
measure: EMG Waveform Quality as assessed by the number of successful EMG detections per session versus unsuccessful ones
timeFrame: Daily during the 4-week optimization period
measure: Safety as assessed by the Pain score reported on the participant diary
timeFrame: Continuous, daily monitoring throughout the 12-week study
measure: Safety as assessed by the adverse events self reported by participant
timeFrame: Continuous, daily monitoring throughout the 12-week study
measure: Feasibility as assessed by the number of participants who adhere to the protocol as reported on the patient dairy
timeFrame: Weekly during the 12-week study
measure: Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data
timeFrame: 2 days per month for all three months
measure: Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data
timeFrame: 2 days per month for all three months
measure: Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data
timeFrame: 2 days per month for all three months
measure: Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data
timeFrame: Once a month for all 3 months
measure: Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data
timeFrame: Once a month for all 3 months
measure: Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data
timeFrame: Once a month for all 3 months
measure: Implementation Barriers as assessed by a survey
timeFrame: end of study (12 weeks from baseline)
measure: Patient-Reported Implementation Feedback as assessed by a survey
timeFrame: end of study (12 weeks from baseline)
Secondary outcomes:
measure: Patient-Reported Comfort as assessed by the participant survey
timeFrame: Daily during the 4-week optimization period
measure: Patient-Reported Usability as assessed by the participant survey
timeFrame: Daily during the 4-week optimization period
measure: Type and extent of adjustments (none, minor, major) required for System Operation needed for effective stimulation
timeFrame: End of the 4-week optimization period
measure: Frequency of adaptations made to the device
timeFrame: End of the 4-week optimization period
measure: Number of participants that had adaptations made to the device as assessed by a yes or no questionnaire
timeFrame: End of the 4-week optimization period
measure: Change in Quality of Life as assessed by the The Neurogenic Bladder Symptom Score (NBSS)
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change in Quality of Life as assessed by the Incontinence Quality of Life Questionnaire(I-QOL)
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change in Quality of Life as assessed by the Neurogenic Bowel Dysfunction (NBD) score
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Patient satisfaction as assessed by a survey
timeFrame: End of study (12 weeks form baseline)
measure: Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot
timeFrame: Weekly during the 12-week study
measure: Patient-Reported Changes in Bladder Program
timeFrame: Weekly during the 12-week study
measure: Number of caregivers who were satisfied as assessed by the interview
timeFrame: end of study (12 weeks from baseline)
measure: Number of clinicians who were satisfied as assessed by the interview
timeFrame: end of study (12 weeks from baseline)
measure: System Fidelity as assessed by the degree to which the the Avation electric stimulation system was used as intended by patients
timeFrame: end of study (12 weeks from baseline)
measure: 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
timeFrame: end of study (12 weeks from baseline)
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center and Houston
name: Argyrios Stampas, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: