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Neuromodulation Device

Electric Stimulation for Neurogenic Bladder

N/A
Waitlist Available
Led By Argyrios Stampas, MD, MS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Injury level above T10
Diagnosis of neurogenic bladder performing intermittent catheterization
Must not have
Intradetrusor Botulinum Toxin within six months
Presence of urinary tract infection (UTI) symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks and 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve a device that stimulates the tibial nerve in people with chronic Spinal Cord Injuries (SCI) to help with bladder control issues. The study will assess the safety and

Who is the study for?
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.
What is being tested?
The study tests the Avation Electric Stimulation System's ability to stimulate the tibial nerve and improve bladder function in SCI patients. It aims to assess safety, feasibility, effectiveness, and identify barriers to its routine use.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort or skin irritation at the stimulation site, adverse reactions to electric stimulation like muscle twitching or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My spinal cord injury is above the T10 level.
Select...
I use a catheter sometimes due to bladder nerve issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had Botox injections in my bladder in the last 6 months.
Select...
I am experiencing symptoms of a urinary tract infection.
Select...
I experienced pain or discomfort during the toe flexion test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety as assessed by the Pain score reported on the participant diary
Safety as assessed by the adverse events self reported by participant
Secondary study objectives
Change in Quality of Life as assessed by the Incontinence Quality of Life Questionnaire(I-QOL)
Change in Quality of Life as assessed by the Neurogenic Bowel Dysfunction (NBD) score
Change in Quality of Life as assessed by the The Neurogenic Bladder Symptom Score (NBSS)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vivally systemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,429 Total Patients Enrolled
Mission ConnectUNKNOWN
Argyrios Stampas, MD, MSPrincipal InvestigatorThe University of Texas Health Science Center and Houston
~13 spots leftby Nov 2026
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