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Home Neuromodulation for Neurogenic Bladder in Spinal Cord Injury

This study is testing a device called iTNS (transcutaneous tibial nerve stimulation) to see if it's safe and effective for managing neurogenic bladder (bladder problems due to nerve damage) in people with spinal cord injury (SCI). You might be able to join if you are 18-75 years old, have a chronic SCI above T9, and your bladder medications are stable. The study will look at how safe the iTNS device is by tracking any side effects, and how well it works by checking if toe flexion (bending your toes) can be achieved during stimulation. The study plans to enroll 21 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 21 participants. It compares active iTNS to a sham iTNS device, which mimics the real treatment.
What's involved
The iTNS device will be applied continuously for 30 minutes, five times a week. The study will assess safety, accuracy, and reliability from baseline to 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety, accuracy, and reliability from baseline to 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07264868

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Recruiting
NAAges 18–75InterventionalTreatment
The University of Texas Health Science Center, Houston
~21 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:iTNSSham iTNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as assessed by the number of device-related adverse events
Measured over From baseline to 8 weeks
+6 more outcomes measured

Conditions

Spinal Cord Injury (SCI)
Neurogenic Bladder (NB)

Explore related trials

Neurogenic BladderSpinal Cord Injury

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Argyrios Stampas, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Argyrios Stampas, MD
[email protected]
(713) 797-5938
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Safety as assessed by the number of device-related adverse eventsFrom baseline to 8 weeks

    Adverse events include lead migration and fracture, hematoma, wound infection, delayed healing, nerve injury, and autonomic dysreflexia occurrence during the procedure.

  • Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs.From baseline to week 8
  • Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracyFrom baseline to week 8
  • Feasibility of Injectrode procedure as assessed by surveysWeek 8

    Feasibility to check if reproducible training pathway can enable non-interventional physicians to competently perform Injectrode implantation and removal

  • Physician acceptability of Injectrode device as assessed by a surveyWeek 8

    The acceptability survey ranges from 0 - 32, with a higher score indicating greater acceptability of the Injectrode device.

  • Participant acceptability of Injectrode device as assessed by a surveyWeek 8

    The acceptability survey ranges from 0 - 25, with a higher score indicating greater acceptability of the Injectrode device.

  • Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interviewWeek 8

    A semi-structured interview will be conducted with participants and providers to explore their perceptions of the Injectrode treatment. Responses will be summarized using qualitative coding and descriptive statistics of themes.