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Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

ConditionsSpinal Cord Injury (SCI)Neurogenic Bladder (NB)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • iTNS

    Device

    The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.

  • Sham iTNS

    Device

    The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.

Treatment groups

21 Participants
are divided into 3 treatment groups
Group A: Bilateral iTNSExperimental treatment 1 intervention
Group B: Unilateral iTNSActive comparator 2 interventions
Group C: Sham iTNSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
From baseline to 8 weeks
2

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

Time frame
From baseline to week 8
3

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

Time frame
From baseline to week 8
4

Feasibility of Injectrode procedure as assessed by surveys

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

Time frame
Week 8

Secondary outcomes

1

Number of participants for whom bladder medication dosage reduced

Time frame
from baseline to 8 weeks
2

Change in magnitude of dosage of medication

Time frame
from baseline to 8 weeks
3

Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20.

Time frame
Baseline, Week 4, and Week 8
4

Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics.

Time frame
baseline, Week 4, and Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
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