Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

NCT06661057 | Withdrawn FDA Device

• 1 other identifier: HSC-MS-24-0834
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurogenic Bladder

Keywords

spinal cord injury; tibial nerve stimulation

Outcome Measures

Primary Outcomes (13)

• 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

• 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)

Secondary Outcomes (15)

• 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

• 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

Study Arms (1)

Vivally system

EXPERIMENTAL

Device: Vivally system stimulation

Interventions

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.

Vivally system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Mission Connect: collaborator

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Argyrios Stampas, MD, MS

  The University of Texas Health Science Center and Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 28, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share