Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
Qualifiers
Non-progressive chronic (>1 year) SCI
Neurologic level of injury T9 and above
Stable over active bladder (OAB) medications (≥3 months)
No contraindication to MRI (per MRI Safety Questionnaire)
Disqualifiers
Ongoing/active genitourinary oncologic diagnoses
History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
Pregnancy or planning to become pregnant.
Lower Motor Neuron bladder
Trial design
Treatments tested in this trial
- iTNS
- Sham iTNS
Treatment groups
21 Participants
are divided into 3 treatment groupsSponsors and collaborators
The University of Texas Health Science Center, Houston
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov