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NCT Number: NCT07264868

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury (SCI) Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder (NB) Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From 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.

  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

    Time frame: Week 8

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

  5. Physician acceptability of Injectrode device as assessed by a survey

    Time frame: Week 8

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

  6. Participant acceptability of Injectrode device as assessed by a survey

    Time frame: Week 8

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

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

    Time frame: Week 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.

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

  5. Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort.

    Time frame: baseline, Week 4, and Week 8

  6. Change in the presence or absence of leaks during urodynamics.

    Time frame: baseline, Week 4, and Week 8

  7. Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling.

    Time frame: baseline, Week 4, and Week 8

  8. Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency/ desire to void.

    Time frame: Baseline, Week 4, and Week 8

  9. Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort.

    Time frame: Baseline, Week 4, and Week 8

  10. Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure.

    Time frame: baseline, Week 4, and Week 8

  11. Change in the number of incontinence episodes as self-reported in the bladder diary.

    Time frame: Baseline, Week 4, and Week 8

  12. Change in the frequency of catheterization as self-reported in the bladder diary.

    Time frame: Baseline, Week 4, and Week 8

  13. Change in the volume of catheterization as self-reported in the bladder diary.

    Time frame: Baseline, Week 4, and Week 8

Study contacts

Contact information is provided by the study sponsor or research team.

Argyrios Stampas, MD

CONTACT

[email protected]

(713) 797-5938

Danira Garcia Gutierrez

CONTACT

[email protected]

(713) 797-7133

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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