Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury (SCI); Neurogenic Bladder (NB)
• Intervention / Treatment: Device: iTNS; Device: Sham iTNS

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Argyrios Stampas, MD; Phone Number: (713) 797-5938; Email: argyrios.stampas@uth.tmc.edu
• Study Contact Backup: Name: Danira Garcia Gutierrez; Phone Number: (713) 797-7133; Email: Danira.GarciaGutierrez@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Argyrios Stampas, MD; Phone Number: 713-797-5938; Email: argyrios.stampas@uth.tmc.edu
      • Contact: Danira Garcia Gutierrez; Phone Number: (713) 797-7133; Email: Danira.GarciaGutierrez@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral iTNS; participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation	Device: iTNS; 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.
Active Comparator: Unilateral iTNS; participants will receive one active and one sham tibial nerve stimulation (TNS) device. The treatment will only be delivered to the leg with the active device.	Device: iTNS; 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.; Device: Sham iTNS; 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.
Sham Comparator: Sham iTNS; participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use.	Device: Sham iTNS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 8 weeks
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 accuracy		From baseline to week 8
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	Week 8
Physician acceptability of Injectrode device as assessed by a survey	The acceptability survey ranges from 0 - 32, with a higher score indicating greater acceptability of the Injectrode device.	Week 8
Participant acceptability of Injectrode device as assessed by a survey	The acceptability survey ranges from 0 - 25, with a higher score indicating greater acceptability of the Injectrode device.	Week 8
Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview	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.	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants for whom bladder medication dosage reduced	from baseline to 8 weeks
Change in magnitude of dosage of medication	from baseline to 8 weeks
Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20.	Baseline, Week 4, and Week 8
Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics.	baseline, Week 4, and Week 8
Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort.	baseline, Week 4, and Week 8
Change in the presence or absence of leaks during urodynamics.	baseline, Week 4, and Week 8
Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling.	baseline, Week 4, and Week 8
Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency/ desire to void.	Baseline, Week 4, and Week 8
Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort.	Baseline, Week 4, and Week 8
Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure.	baseline, Week 4, and Week 8
Change in the number of incontinence episodes as self-reported in the bladder diary.	Baseline, Week 4, and Week 8
Change in the frequency of catheterization as self-reported in the bladder diary.	Baseline, Week 4, and Week 8
Change in the volume of catheterization as self-reported in the bladder diary.	Baseline, Week 4, and Week 8

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Congressionally Directed Medical Research Programs
• Investigators: Principal Investigator: Argyrios Stampas, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Trauma, Nervous System; Urinary Bladder Diseases; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: HSC-MS-25-0582; CDMRP-SC240085 (Registry Identifier: CDMRP-eBRAP Log Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes