Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

NCT07264868 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-25-0582CDMRP-SC240085
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury (SCI); Neurogenic Bladder (NB)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (13)

• 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

Study Arms (3)

Bilateral iTNS

EXPERIMENTAL

participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation

Device: iTNS

Unilateral iTNS

ACTIVE COMPARATOR

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; Device: Sham iTNS

Sham iTNS

SHAM COMPARATOR

participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use.

Device: Sham iTNS

Interventions

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.

Bilateral iTNS; Unilateral iTNS

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.

Sham iTNS; Unilateral iTNS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Argyrios Stampas, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Argyrios Stampas, MD

CONTACT

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

Danira Garcia Gutierrez

CONTACT

(713) 797-7133; Danira.GarciaGutierrez@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: May 7, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)