RecruitingNot Applicable

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

United States21 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) * English or Spanish speaking * Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted) * Pass the tTNS competency checklist to perform or direct performance of tTNS. Exclusion Criteria: * 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 * Restorative bladder surgery such as augmentation cystoplasty * Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed) * Anticoagulation treatment or prophylaxis * Advanced peripheral vascular disease (gangrene, amputation, etc.) * History of intolerance to electrical stimulation, particularly of the leg

What they're measuring

Safety as assessed by the number of device-related adverse events

Timeframe: From baseline to 8 weeks

Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs.

Timeframe: From baseline to week 8

Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy

Timeframe: From baseline to week 8

Feasibility of Injectrode procedure as assessed by surveys

Timeframe: Week 8

Physician acceptability of Injectrode device as assessed by a survey

Timeframe: Week 8

Participant acceptability of Injectrode device as assessed by a survey

Timeframe: Week 8

Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview

Timeframe: Week 8

Trial details

NCT IDNCT07264868

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Argyrios Stampas, MD

(713) 797-5938 argyrios.stampas@uth.tmc.edu

View on ClinicalTrials.gov More Spinal Cord Injury (SCI) trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety as assessed by the number of device-related adverse events

Timeframe: From baseline to 8 weeks

Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs.

Timeframe: From baseline to week 8

Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy

Timeframe: From baseline to week 8

Feasibility of Injectrode procedure as assessed by surveys

Timeframe: Week 8

Physician acceptability of Injectrode device as assessed by a survey

Timeframe: Week 8

Participant acceptability of Injectrode device as assessed by a survey

Timeframe: Week 8

Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview

Timeframe: Week 8