Spinal Cord Injury (SCI)NCT07264868
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
A study testing iTNS in people with Spinal Cord Injury (SCI) and Neurogenic Bladder (NB), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury (SCI), Neurogenic Bladder (NB)
- What is being tested?
- iTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Anticoagulation treatment or prophylaxis
- Advanced peripheral vascular disease (gangrene, amputation, etc.)
- History of intolerance to electrical stimulation, particularly of the leg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Argyrios Stampas, MD, 713-797-5938, argyrios.stampas@uth.tmc.edu
Danira Garcia Gutierrez, (713) 797-7133, Danira.GarciaGutierrez@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury (SCI), Neurogenic Bladder (NB)
- Being tested
- iTNS, Sham iTNS
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTNSDevice
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 iTNSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral iTNS | Experimental | participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation Receives: 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. Receives: Device: iTNS; Device: Sham iTNS |
| Sham iTNS | Sham comparator | participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use. Receives: Device: Sham iTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 8 weeks
Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs.
Measured: From baseline to week 8
Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
Secondary outcomes (13)
Number of participants for whom bladder medication dosage reduced
Measured: from baseline to 8 weeks
Change in magnitude of dosage of medication
Measured: from baseline to 8 weeks
Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20.
Measured: Baseline, Week 4, and Week 8
Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics.
Measured: baseline, Week 4, and Week 8
Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort.
Measured: baseline, Week 4, and Week 8
Change in the presence or absence of leaks during urodynamics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, Week 4, and Week 8
Change in the number of incontinence episodes as self-reported in the bladder diary.
Measured: Baseline, Week 4, and Week 8
Change in the frequency of catheterization as self-reported in the bladder diary.
Measured: Baseline, Week 4, and Week 8
Change in the volume of catheterization as self-reported in the bladder diary.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start7 May 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Argyrios Stampas, MD, The University of Texas Health Science Center, Houston
- Investigators
- Argyrios Stampas, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264868
- Sponsor's protocol ID
- HSC-MS-25-0582
- Other IDs
- CDMRP-SC240085
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial
- ClinicalTrials.gov ID
- NCT07264868
- Acronym / sponsor ID
- HSC-MS-25-0582
- Conditions
- Spinal Cord Injury (SCI), Neurogenic Bladder (NB)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 7 May 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral iTNS | Experimental | Device: iTNSparticipants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation |
| Unilateral iTNS | Active comparator | Device: iTNS, Device: Sham iTNSparticipants 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. |
| Sham iTNS | Sham comparator | Device: Sham iTNSparticipants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTNSThe 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 | Bilateral iTNS, Unilateral iTNS |
| Sham iTNSThe 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. | Device | Sham iTNS, Unilateral iTNS |
Primary outcome
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.
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
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
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
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.
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.
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.
13 secondary outcomes
Number of participants for whom bladder medication dosage reduced
Time frame: from baseline to 8 weeks
Change in magnitude of dosage of medication
Time frame: from baseline to 8 weeks
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
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
Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort.
Time frame: baseline, Week 4, and Week 8
Change in the presence or absence of leaks during urodynamics.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, Week 4, and Week 8
Change in the number of incontinence episodes as self-reported in the bladder diary.
Time frame: Baseline, Week 4, and Week 8
Change in the frequency of catheterization as self-reported in the bladder diary.
Time frame: Baseline, Week 4, and Week 8
Change in the volume of catheterization as self-reported in the bladder diary.
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Argyrios Stampas, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTNS in people with Spinal Cord Injury (SCI) and Neurogenic Bladder (NB), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Argyrios Stampas, MD ((713) 797-5938, argyrios.stampas@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by the number of device-related adverse events (time frame: From baseline to 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.