Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07264868

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Led by The University of Texas Health Science Center, Houston · Updated on 2026-05-11

21

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center, Houston

Lead Sponsor

C

Congressionally Directed Medical Research Programs

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.

CONDITIONS

Official Title

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-progressive chronic spinal cord injury lasting more than 1 year
  • Neurologic injury level at T9 or above
  • Stable on overactive bladder medications for at least 3 months
  • No MRI contraindications
  • English or Spanish speaking
  • Able to tolerate and evoke bilateral toe flexion with transcutaneous tibial nerve stimulation (self or assisted)
  • Pass the competency checklist to perform or direct transcutaneous tibial nerve stimulation
Not Eligible

You will not qualify if you...

  • Active or ongoing genitourinary cancer diagnoses
  • History of other central nervous system disorders or peripheral neuropathy
  • Pregnant or planning to become pregnant
  • Diagnosed with lower motor neuron bladder
  • History of bladder surgery such as augmentation cystoplasty
  • Received botulinum toxin-A injections in the bladder within 6 months prior to enrollment
  • Current anticoagulation treatment or prophylaxis
  • Advanced peripheral vascular disease (e.g., gangrene or amputation)
  • History of intolerance to electrical stimulation, especially of the leg

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

Research Team

A

Argyrios Stampas, MD

CONTACT

D

Danira Garcia Gutierrez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury | DecenTrialz