NCT06661057

Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2024-10-28
• Last updated: 2025-03-28

Regulatory

• FDA-regulated device study