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NCT06661057 | NOT YET RECRUITING | Neurogenic Bladder

Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder
Sponsor:

The University of Texas Health Science Center, Houston

Information provided by (Responsible Party):

Argyrios Stampas, MD

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.

Condition or disease

Neurogenic Bladder

Intervention/treatment

Vivally system stimulation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder: A Hybrid Effectiveness-implementation Pilot Trial
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

Location Details

NCT06661057

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How to Participate

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Locations

Not yet recruiting

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030