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Neurogenic BladderNCT06661057

Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

A study testing Vivally system stimulation in people with Neurogenic Bladder, run by The University of Texas Health Science Center, Houston.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neurogenic Bladder
What is being tested?
Vivally system stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2024to 30 Nov 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder: A Hybrid Effectiveness-implementation Pilot Trial

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.

Being tested
Vivally system stimulation
Keywords
spinal cord injury, tibial nerve stimulation
Medical subject headings
Urinary Bladder, Neurogenic, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vivally system stimulationDevice

    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.

Study groups in NCT06661057
Study groupRoleWhat they receive
Vivally systemExperimentalNot described
Receives: Device: Vivally system stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Daily during the 4-week optimization period

  2. EMG Waveform Quality as assessed by the number of successful EMG detections per session versus unsuccessful ones

    Measured: Daily during the 4-week optimization period

  3. 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

    Measured: Continuous, daily monitoring throughout the 12-week study

  4. 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

    Measured: Continuous, daily monitoring throughout the 12-week study

  5. Feasibility as assessed by the number of participants who adhere to the protocol as reported on the patient dairy

    Measured: Weekly during the 12-week study

  6. Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data

    Measured: 2 days per month for all three months

  7. Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data

    Measured: 2 days per month for all three months

  8. Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data

    Measured: 2 days per month for all three months

  9. Effectiveness for Bladder Control as assessed by the changes in volume of catheterization reported in the voiding diary data

    Measured: Once a month for all 3 months

  10. Effectiveness for Bladder Control as assessed by the changes in frequency of catheterization reported in the voiding diary data

    Measured: Once a month for all 3 months

  11. Effectiveness for Bladder Control as assessed by the number of episodes of incontinence reported in the voiding diary data

    Measured: Once a month for all 3 months

  12. Implementation Barriers as assessed by a survey

    Measured: end of study (12 weeks from baseline)

  13. Patient-Reported Implementation Feedback as assessed by a survey

    Measured: end of study (12 weeks from baseline)

Secondary outcomes (15)

  1. Patient-Reported Comfort as assessed by the participant survey

    Measured: Daily during the 4-week optimization period

  2. Patient-Reported Usability as assessed by the participant survey

    Measured: Daily during the 4-week optimization period

  3. Type and extent of adjustments (none, minor, major) required for System Operation needed for effective stimulation

    Measured: End of the 4-week optimization period

  4. Frequency of adaptations made to the device

    Measured: End of the 4-week optimization period

  5. Number of participants that had adaptations made to the device as assessed by a yes or no questionnaire

    Measured: End of the 4-week optimization period

  6. 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

    Measured: Baseline, 4 weeks, 8 weeks and 12 weeks

  7. 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.

    Measured: Baseline, 4 weeks, 8 weeks and 12 weeks

  8. 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.

    Measured: Baseline, 4 weeks, 8 weeks and 12 weeks

  9. 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

    Measured: End of study (12 weeks form baseline)

  10. Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot

    Measured: Weekly during the 12-week study

  11. Patient-Reported Changes in Bladder Program

    Documentation of any changes made to the bladder management program

    Measured: Weekly during the 12-week study

  12. Number of caregivers who were satisfied as assessed by the interview

    Measured: end of study (12 weeks from baseline)

  13. Number of clinicians who were satisfied as assessed by the interview

    Measured: end of study (12 weeks from baseline)

  14. 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

    Measured: end of study (12 weeks from baseline)

  15. 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

    Measured: end of study (12 weeks from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Why it stopped: Industry partner decided not proceed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06661057
Sponsor's protocol ID
HSC-MS-24-0834
Status last verified
Mar 2025
First submitted
15 Oct 2024
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vivally system stimulation in people with Neurogenic Bladder, run by The University of Texas Health Science Center, Houston.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Daily during the 4-week optimization period). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06661057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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