Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

NCT ID: NCT06661057

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vivally system

Group Type: EXPERIMENTAL

Vivally system stimulation

Intervention Type: 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.

Interventions

Vivally 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mission Connect

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Argyrios Stampas, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Argyrios Stampas, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center and Houston

Other Identifiers

HSC-MS-24-0834

Identifier Type: -

Identifier Source: org_study_id