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Withdrawn

Withdrawn.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

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.

Conditions: Neurogenic Bladder
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 group	Role	What they receive
Vivally system	Experimental	Not described Receives: Device: Vivally system stimulation

What is being measured

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

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
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
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
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
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
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
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
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
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
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
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
Implementation Barriers as assessed by a survey
Measured: end of study (12 weeks from baseline)
Patient-Reported Implementation Feedback as assessed by a survey
Measured: end of study (12 weeks from baseline)

Secondary outcomes (15)

Patient-Reported Comfort as assessed by the participant survey
Measured: Daily during the 4-week optimization period
Patient-Reported Usability as assessed by the participant survey
Measured: Daily during the 4-week optimization period
Type and extent of adjustments (none, minor, major) required for System Operation needed for effective stimulation
Measured: End of the 4-week optimization period
Frequency of adaptations made to the device
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: End of study (12 weeks form baseline)
Qualitative assessment of edema or skin changes as assessed by photos of lower leg and foot
Measured: Weekly during the 12-week study
Patient-Reported Changes in Bladder Program
Documentation of any changes made to the bladder management program
Measured: Weekly during the 12-week study
Number of caregivers who were satisfied as assessed by the interview
Measured: end of study (12 weeks from baseline)
Number of clinicians who were satisfied as assessed by the interview
Measured: 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
Measured: 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
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 Dec 202430 Nov 2026

First posted28 Oct 2024
Study start1 Dec 2024 (estimated)
Primary completion30 Nov 2026 (estimated)
Study completion30 Nov 2026 (estimated)

Why it stopped: Industry partner decided not proceed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neurogenic BladderStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
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All Neurogenic Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder: A Hybrid Effectiveness-implementation Pilot Trial
ClinicalTrials.gov ID: NCT06661057
Acronym / sponsor ID: HSC-MS-24-0834
Conditions: Neurogenic Bladder
Keywords: spinal cord injury, tibial nerve stimulation
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Industry partner decided not proceed
Enrolment: 0 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Mission Connect
Study start: 1 Dec 2024 (estimated)
Primary completion: 30 Nov 2026 (estimated)
Study completion: 30 Nov 2026 (estimated)
First posted: 28 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vivally system	Experimental	Device: Vivally system stimulation

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vivally system stimulationDuring 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.	Device	Vivally system

Primary outcome

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
Time frame: 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
Safety as assessed by the adverse events self reported by participant
Time frame: 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
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
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)

15 secondary outcomes

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)
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)
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Change in Quality of Life as assessed by the Neurogenic Bowel Dysfunction (NBD) score
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Patient satisfaction as assessed by a survey
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
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
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)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Neurogenic Bladder

Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Argyrios Stampas, MD, MS principal investigator

The University of Texas Health Science Center and Houston

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.