Spinal Cord InjuriesTTNS1yrNCT04350359
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
A study testing Variable-dose TTNS Protocol 5 x week, Fixed-dose TTNS Protocol and Variable-dose TTNS Protocol 2 x week in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Variable-dose TTNS Protocol 5 x week, Fixed-dose TTNS Protocol and Variable-dose TTNS Protocol 2 x week
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2020to 11 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18-75 years old
- Traumatic or non-traumatic SCI
- Admitted to inpatient rehabilitation within 6 weeks
- T9 level of injury and above who are at greatest risk of morbid NGB
- Regionally located to allow follow-up
- English or Spanish speaking
Who cannot join
- History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
- History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
- History of peripheral neuropathy
- pre-SCI symptoms of peripheral neuropathy (numbness and/or tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.)
- Pregnancy
- Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy
Show all 9Show fewer
- concern for tibial nerve pathway injury
- absence of toe flexion or autonomic dysreflexia during electric stimulation test
- Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
TIRR Memorial Hermann Research Center
Houston, Texas, 77030
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.
Read the detailed description
The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly.
Based on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. The experimental group will use a submotor "variable dose." The fixed-dose group will use submotor at current intensity at 1mA and designated as "fixed-dose."
TTNS will be used 5 days weekly, per our pilot trial. At 4-months post-SCI, the subject will be instructed to switch to 2x daily if he or she was randomized into the variable dose group of 2 days weekly and thus continue to doing so for the remainder of study participation. Because there is support in the literature for reduced doses of tibial nerve stimulation required for maintenance (1-3x weekly), the RCT includes this frequency comparison arm. All subjects will continue for 1-year post-SCI.
Additionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.
- Conditions
- Spinal Cord Injuries
- Being tested
- Variable-dose TTNS Protocol 5 x week, Fixed-dose TTNS Protocol, Variable-dose TTNS Protocol 2 x week
- Keywords
- electric stimulation, SCI, spinal cord injury, neurogenic bladder
- 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.
Variable-dose TTNS Protocol 5 x weekDevice
Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
Fixed-dose TTNS ProtocolDevice
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury.
Variable-dose TTNS Protocol 2 x weekDevice
At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.
| Study group | Role | What they receive |
|---|---|---|
| Variable-dose TTNS Protocol 5 x week | Active comparator | TTNS protocol: Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
All participants will be instructed to use the device for 30 minutes, 5 days per week for the first 4 months post-sci. Receives: Device: Variable-dose TTNS Protocol 5 x week |
| Fixed-dose TTNS protocol | Active comparator | Fixed-dose protocol: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes.
Both variable-dose TTNS and fixed-dose TTNS protocol participants will be instructed to use the device for 30 minutes, 5 days per week. Receives: Device: Fixed-dose TTNS Protocol |
| Variable-dose TTNS Protocol 2 x week | Active comparator | At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study. Receives: Device: Variable-dose TTNS Protocol 2 x week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
we expect bladder capacity to be maintained in those with effective TTNS
Measured: Baseline
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
we expect bladder capacity to be maintained in those with effective TTNS
Measured: 4 months post SCI
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
we expect bladder capacity to be maintained in those with effective TTNS
Measured: 1 year post SCI
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Evidence of TTNS mechanism expected in those with effective TTNS
Measured: Baseline
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Evidence of TTNS mechanism expected in those with effective TTNS
Measured: 4 months post SCI
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Evidence of TTNS mechanism expected in those with effective TTNS
Measured: 1 year post SCI
Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on change in urodynamic studies at baseline and 4-months
Measured: Baseline, 4 months, 1 year post SCI
Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey
Comparing I-QOL upon discharge from rehabilitation, 4-months post-injury and 1-year post-injury using incontinence QOL (I-QOL) survey, between and within both arms of the study
Measured: At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.
Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)
Changes in Neurogenic Bladder Symptom Scores. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms) where a lower score indicates a better outcome.
Measured: Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.
Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes
Maintaining frequency of catheterization (count per day) and volumes per void (ml per collection)
Measured: 2 days at the end of each month for 1 year.
Secondary outcomes (7)
Change in diastolic pressure during bladder filling
Measured: Baseline, 4 months, 1 year post SCI
Change in systolic pressure during bladder filling
Measured: Baseline, 4 months, 1 year post SCI
Number of participants that show episodes of Autonomic Dysreflexia (AD) during bladder filling
Measured: Baseline
Number of participants that show episodes of AD during bladder filling
Measured: 4 months
Number of participants that show episodes of AD during bladder filling
Measured: 1 year post SCI
Change in parasympathetic nervous system (PNS) activity differences during bladder filling as assessed by high frequency (HF) spectral component
Measured: Baseline, 4 months, 1 year post SCI
Change in sympathetic nervous system (SNS)activity differences during bladder filling as assessed by high frequency (HF) spectral component
Measured: Baseline, 4 months, 1 year post SCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start8 Jun 2020
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Factorial
- Model description
- A prospective, double-blinded, randomized trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- MedStar National Rehabilitation Network, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Argyrios Stampas, MD, The University of Texas Health Science Center, Houston
- Investigators
- Argyrios Stampas, MD, Principal investigator, UTHealth and TIRR Mermorial HermannSuzanne Groah, MD, Principal investigator, MedStar National Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350359
- Sponsor's protocol ID
- HSC-MS-19-0756
- Acronym
- TTNS1yr
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. doi: 10.1089/neu.2004.21.1355.
PubMed 15672627Weld KJ, Dmochowski RR. Association of level of injury and bladder behavior in patients with post-traumatic spinal cord injury. Urology. 2000 Apr;55(4):490-4. doi: 10.1016/s0090-4295(99)00553-1.
PubMed 10736489Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.
PubMed 19403235Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
PubMed 15672628Chaabane W, Guillotreau J, Castel-Lacanal E, Abu-Anz S, De Boissezon X, Malavaud B, Marque P, Sarramon JP, Rischmann P, Game X. Sacral neuromodulation for treating neurogenic bladder dysfunction: clinical and urodynamic study. Neurourol Urodyn. 2011 Apr;30(4):547-50. doi: 10.1002/nau.21009.
PubMed 21488095Chen G, Liao L, Li Y. The possible role of percutaneous tibial nerve stimulation using adhesive skin surface electrodes in patients with neurogenic detrusor overactivity secondary to spinal cord injury. Int Urol Nephrol. 2015 Mar;47(3):451-5. doi: 10.1007/s11255-015-0911-6. Epub 2015 Jan 22.
PubMed 25609546del Popolo G, Mencarini M, Nelli F, Lazzeri M. Controversy over the pharmacological treatments of storage symptoms in spinal cord injury patients: a literature overview. Spinal Cord. 2012 Jan;50(1):8-13. doi: 10.1038/sc.2011.110. Epub 2011 Nov 1.
PubMed 22042300Canbaz Kabay S, Kabay S, Mestan E, Cetiner M, Ayas S, Sevim M, Ozden H, Karaman HO. Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results. Neurourol Urodyn. 2017 Jan;36(1):104-110. doi: 10.1002/nau.22868. Epub 2015 Sep 9.
PubMed 26352904Sirls ER, Killinger KA, Boura JA, Peters KM. Percutaneous Tibial Nerve Stimulation in the Office Setting: Real-world Experience of Over 100 Patients. Urology. 2018 Mar;113:34-39. doi: 10.1016/j.urology.2017.11.026. Epub 2017 Nov 28.
PubMed 29196071Fougere RJ, Currie KD, Nigro MK, Stothers L, Rapoport D, Krassioukov AV. Reduction in Bladder-Related Autonomic Dysreflexia after OnabotulinumtoxinA Treatment in Spinal Cord Injury. J Neurotrauma. 2016 Sep 15;33(18):1651-7. doi: 10.1089/neu.2015.4278. Epub 2016 Apr 13.
PubMed 26980078Sievert KD, Amend B, Gakis G, Toomey P, Badke A, Kaps HP, Stenzl A. Early sacral neuromodulation prevents urinary incontinence after complete spinal cord injury. Ann Neurol. 2010 Jan;67(1):74-84. doi: 10.1002/ana.21814.
PubMed 20186953de Seze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Game X, Amarenco G. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011 Mar;30(3):306-11. doi: 10.1002/nau.20958. Epub 2011 Feb 8.
PubMed 21305588McDonald JW 3rd, Sadowsky CL, Stampas A. The changing field of rehabilitation: optimizing spontaneous regeneration and functional recovery. Handb Clin Neurol. 2012;109:317-36. doi: 10.1016/B978-0-444-52137-8.00020-6.
PubMed 23098722Stampas A, Tansey KE. Spinal cord injury medicine and rehabilitation. Semin Neurol. 2014 Nov;34(5):524-33. doi: 10.1055/s-0034-1396006. Epub 2014 Dec 17.
PubMed 25520024Stampas A, York HS, O'Dell MW. Is the Routine Use of a Functional Electrical Stimulation Cycle for Lower Limb Movement Standard of Care for Acute Spinal Cord Injury Rehabilitation? PM R. 2017 May;9(5):521-528. doi: 10.1016/j.pmrj.2017.03.005. No abstract available.
PubMed 28526124
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
- ClinicalTrials.gov ID
- NCT04350359
- Acronym / sponsor ID
- TTNS1yr / HSC-MS-19-0756
- Conditions
- Spinal Cord Injuries
- Keywords
- electric stimulation, SCI, spinal cord injury, neurogenic bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- MedStar National Rehabilitation Network, The Methodist Hospital Research Institute
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 17 Apr 2020 (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 if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.
Detailed description
The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly.
Based on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. The experimental group will use a submotor "variable dose." The fixed-dose group will use submotor at current intensity at 1mA and designated as "fixed-dose."
TTNS will be used 5 days weekly, per our pilot trial. At 4-months post-SCI, the subject will be instructed to switch to 2x daily if he or she was randomized into the variable dose group of 2 days weekly and thus continue to doing so for the remainder of study participation. Because there is support in the literature for reduced doses of tibial nerve stimulation required for maintenance (1-3x weekly), the RCT includes this frequency comparison arm. All subjects will continue for 1-year post-SCI.
Additionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A prospective, double-blinded, randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Variable-dose TTNS Protocol 5 x week | Active comparator | Device: Variable-dose TTNS Protocol 5 x weekTTNS protocol: Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. All participants will be instructed to use the device for 30 minutes, 5 days per week for the first 4 months post-sci. |
| Fixed-dose TTNS protocol | Active comparator | Device: Fixed-dose TTNS ProtocolFixed-dose protocol: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. Both variable-dose TTNS and fixed-dose TTNS protocol participants will be instructed to use the device for 30 minutes, 5 days per week. |
| Variable-dose TTNS Protocol 2 x week | Active comparator | Device: Variable-dose TTNS Protocol 2 x weekAt the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 years old
- Traumatic or non-traumatic SCI
- Admitted to inpatient rehabilitation within 6 weeks
- T9 level of injury and above who are at greatest risk of morbid NGB
- Regionally located to allow follow-up
Key exclusion criteria (9 listed)
- History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
- History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
- History of peripheral neuropathy
- pre-SCI symptoms of peripheral neuropathy (numbness and/or tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.)
- Pregnancy
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 |
|---|---|---|
| Variable-dose TTNS Protocol 5 x weekElectrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. | Device | Variable-dose TTNS Protocol 5 x week |
| Fixed-dose TTNS ProtocolToe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury. | Device | Fixed-dose TTNS protocol |
| Variable-dose TTNS Protocol 2 x weekAt the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study. | Device | Variable-dose TTNS Protocol 2 x week |
Primary outcome
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
Time frame: Baseline
we expect bladder capacity to be maintained in those with effective TTNS
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
Time frame: 4 months post SCI
we expect bladder capacity to be maintained in those with effective TTNS
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
Time frame: 1 year post SCI
we expect bladder capacity to be maintained in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time frame: Baseline
Evidence of TTNS mechanism expected in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time frame: 4 months post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time frame: 1 year post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.
Time frame: Baseline, 4 months, 1 year post SCI
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on change in urodynamic studies at baseline and 4-months
Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey
Time frame: At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.
Comparing I-QOL upon discharge from rehabilitation, 4-months post-injury and 1-year post-injury using incontinence QOL (I-QOL) survey, between and within both arms of the study
Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)
Time frame: Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.
Changes in Neurogenic Bladder Symptom Scores. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms) where a lower score indicates a better outcome.
Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes
Time frame: 2 days at the end of each month for 1 year.
Maintaining frequency of catheterization (count per day) and volumes per void (ml per collection)
7 secondary outcomes
Change in diastolic pressure during bladder filling
Time frame: Baseline, 4 months, 1 year post SCI
Change in systolic pressure during bladder filling
Time frame: Baseline, 4 months, 1 year post SCI
Number of participants that show episodes of Autonomic Dysreflexia (AD) during bladder filling
Time frame: Baseline
Number of participants that show episodes of AD during bladder filling
Time frame: 4 months
Number of participants that show episodes of AD during bladder filling
Time frame: 1 year post SCI
Change in parasympathetic nervous system (PNS) activity differences during bladder filling as assessed by high frequency (HF) spectral component
Time frame: Baseline, 4 months, 1 year post SCI
Change in sympathetic nervous system (SNS)activity differences during bladder filling as assessed by high frequency (HF) spectral component
Time frame: Baseline, 4 months, 1 year post SCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 15672627Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. doi: 10.1089/neu.2004.21.1355.
- Background: PubMed 10736489Weld KJ, Dmochowski RR. Association of level of injury and bladder behavior in patients with post-traumatic spinal cord injury. Urology. 2000 Apr;55(4):490-4. doi: 10.1016/s0090-4295(99)00553-1.
- Background: PubMed 19403235Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.
- Background: PubMed 15672628Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
- Background: PubMed 21488095Chaabane W, Guillotreau J, Castel-Lacanal E, Abu-Anz S, De Boissezon X, Malavaud B, Marque P, Sarramon JP, Rischmann P, Game X. Sacral neuromodulation for treating neurogenic bladder dysfunction: clinical and urodynamic study. Neurourol Urodyn. 2011 Apr;30(4):547-50. doi: 10.1002/nau.21009.
- Background: PubMed 25609546Chen G, Liao L, Li Y. The possible role of percutaneous tibial nerve stimulation using adhesive skin surface electrodes in patients with neurogenic detrusor overactivity secondary to spinal cord injury. Int Urol Nephrol. 2015 Mar;47(3):451-5. doi: 10.1007/s11255-015-0911-6. Epub 2015 Jan 22.
- Background: PubMed 22042300del Popolo G, Mencarini M, Nelli F, Lazzeri M. Controversy over the pharmacological treatments of storage symptoms in spinal cord injury patients: a literature overview. Spinal Cord. 2012 Jan;50(1):8-13. doi: 10.1038/sc.2011.110. Epub 2011 Nov 1.
- Background: PubMed 26352904Canbaz Kabay S, Kabay S, Mestan E, Cetiner M, Ayas S, Sevim M, Ozden H, Karaman HO. Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results. Neurourol Urodyn. 2017 Jan;36(1):104-110. doi: 10.1002/nau.22868. Epub 2015 Sep 9.
- Background: PubMed 29196071Sirls ER, Killinger KA, Boura JA, Peters KM. Percutaneous Tibial Nerve Stimulation in the Office Setting: Real-world Experience of Over 100 Patients. Urology. 2018 Mar;113:34-39. doi: 10.1016/j.urology.2017.11.026. Epub 2017 Nov 28.
- Background: PubMed 26980078Fougere RJ, Currie KD, Nigro MK, Stothers L, Rapoport D, Krassioukov AV. Reduction in Bladder-Related Autonomic Dysreflexia after OnabotulinumtoxinA Treatment in Spinal Cord Injury. J Neurotrauma. 2016 Sep 15;33(18):1651-7. doi: 10.1089/neu.2015.4278. Epub 2016 Apr 13.
- Background: PubMed 20186953Sievert KD, Amend B, Gakis G, Toomey P, Badke A, Kaps HP, Stenzl A. Early sacral neuromodulation prevents urinary incontinence after complete spinal cord injury. Ann Neurol. 2010 Jan;67(1):74-84. doi: 10.1002/ana.21814.
- Background: PubMed 21305588de Seze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Game X, Amarenco G. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011 Mar;30(3):306-11. doi: 10.1002/nau.20958. Epub 2011 Feb 8.
- Individual participant dataSharing planned: No
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Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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. This study is not recruiting at the moment.
Argyrios Stampas, MD principal investigator
UTHealth and TIRR Mermorial Hermann
Suzanne Groah, MD principal investigator
MedStar National Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable-dose TTNS Protocol 5 x week, Fixed-dose TTNS Protocol and Variable-dose TTNS Protocol 2 x week in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 2 sites 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 6 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: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintained bladder capacity as assessed by the Urodynamics study measured in ml (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350359, which also lists 29 linked publications.
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 21 Aug 2026.