Electric Stimulation for Neurogenic Bladder
Trial Summary
What is the purpose of this 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.
Research Team
Argyrios Stampas, MD, MS
Principal Investigator
The University of Texas Health Science Center and Houston
Eligibility Criteria
This trial is for individuals with chronic Spinal Cord Injury who experience bladder control issues (neurogenic bladder). Participants should have muscle weakness or swelling in the foot, which could impact device use. Specific eligibility details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Avation electric stimulation system for bladder neuromodulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Vivally system stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Mission Connect
Collaborator