Electric Stimulation for Neurogenic Bladder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an electric stimulation treatment, specifically the Vivally system stimulation, to help people with spinal cord injuries manage neurogenic bladder issues. The goal is to determine if this system can safely and effectively improve bladder control by stimulating a nerve in the leg. The trial targets individuals with a spinal injury above the T10 level who use catheters for bladder function. Participants should also notice toe movement when their tibial nerve is stimulated. As an unphased trial, this study offers a unique opportunity for participants to contribute to pioneering research that could enhance bladder management solutions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have had Intradetrusor Botulinum Toxin within the last six months, you cannot participate.
What prior data suggests that the Avation electric stimulation system is safe for bladder neuromodulation in people with SCI?
Research has shown that the Vivally system is generally safe. In one study, patients experienced better bladder control without major safety issues after 12 weeks. Another study found that the type of nerve stimulation used by the Vivally system is usually safe for treating bladder problems. However, while the results are positive, some evidence suggests that the overall health benefits of this technology are not yet fully proven. Overall, current data indicates that the Vivally system is well-tolerated, but individual experiences may differ.12345
Why are researchers excited about this trial?
Unlike standard treatments for neurogenic bladder, which often involve medications or catheterization, the Vivally system employs electric stimulation to improve bladder function. This non-invasive method targets the neural pathways involved in bladder control, potentially offering a more natural way to manage symptoms without the need for drugs. Researchers are excited about this approach because it could reduce reliance on traditional interventions and improve the quality of life for patients by addressing the root of the problem more directly.
What evidence suggests that the Avation Electric Stimulation System is effective for neurogenic bladder in people with spinal cord injury?
Research has shown that the Vivally system, which participants in this trial will receive, can greatly improve symptoms of overactive bladder (OAB). In studies, many people using the Vivally system noticed improvements compared to those who did not receive any real treatment. The device stimulates a nerve in the leg, helping to control bladder function. Users have also reported a better quality of life and high satisfaction after using the device. While evidence supports its effectiveness for OAB, the effectiveness for bladder issues in people with spinal cord injuries is still under investigation.12467
Who Is on the Research Team?
Argyrios Stampas, MD, MS
Principal Investigator
The University of Texas Health Science Center and Houston
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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