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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR003168 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Experimental |
| |
| Control | Other | Low dose TTNS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose | Device | 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 the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reduction in Bladder Medication | baseline, 3 months | |
| Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | The Neurogenic Bladder Symptom (NBSS) Score is a questionnaire that measures bladder symptoms, with total score ranging from 0 to 74; a higher score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported categorically as follows: Stable: A score change within + 5 or -5 points (not including 5) Worse: A score increase of 5 points or more from baseline Improved: A score decrease of 5 points or more from baseline These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change | Baseline, 3 months |
| Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary | baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | The Incontinence Quality of Life questionnaire assesses the impact of urinary incontinence on a person's quality of life. The total score ranges from 0 to 100, a lower score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported as categorically as follows: Stable: A score change within +4 or -4 points (not including 4) Worse: A score decrease of 4 or more points from baseline Improved: A score increase of 4 or more points from baseline These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Argyos Stampas, MD | UTHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15672627 | Background | 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. | |
| 10736489 | Background | Weld 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | High Dose: 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 the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used. |
| FG001 | Control | Low dose TTNS Low dose: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | High Dose: 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 the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Reduction in Bladder Medication | Data were not collected for 5 participants in the high dose arm. Data were not collected for 3 participants in the control arm. | Posted | Count of Participants | Participants | baseline, 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose | High Dose: 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 the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
The COVID-19 pandemic imposed constraints on participants' ability to travel and communicate, leading to dropouts, as well as affecting research staffing and the ability to perform research.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Argyrios Stampas, MD | The University of Texas Health Science Center at Houston | 713-797-5938 | argyrios.stampas@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2020 | Mar 18, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2019 | Apr 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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randomized sham-control trial
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The Study is designed to look at the difference in "high dose" group, which will be submotor amperage, compared to "low dose" which will be set to 1 mA. Both groups will need to stimulate the tibial nerve and visualize toe movement, and then decrease to the amperage of either "high dose" or "low dose." Both groups will use the device for 30 minutes, 5 days per week. A urodynamic study will be performed to measure bladder capacity, sensations while filling, and detrusor pressures before starting using the device and one last time at the end of the study.
We are also conducting surveys to describe differences in preferences with using bladder medications versus devices.
|
|
| Low dose | Device | Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes |
|
|
| baseline, 3 months |
| Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey | baseline, 3 months |
| Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study | baseline, 3 months |
| 19403235 | Background | Stohrer 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. |
| 15672628 | Background | Anderson 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. |
| 21488095 | Background | Chaabane 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. |
| 25609546 | Background | Chen 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. |
| 23098722 | Background | McDonald 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. |
| 25520024 | Background | Stampas 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. |
| 28526124 | Background | Stampas 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. |
| 30284350 | Background | Stampas A, Korupolu R, Zhu L, Smith CP, Gustafson K. Safety, Feasibility, and Efficacy of Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury Neurogenic Bladder: A Randomized Control Pilot Trial. Neuromodulation. 2019 Aug;22(6):716-722. doi: 10.1111/ner.12855. Epub 2018 Oct 3. |
| 22042300 | Background | del 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. |
| 26352904 | Background | Canbaz 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. |
| 29196071 | Background | Sirls 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. |
| 26980078 | Background | Fougere 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. |
| 20186953 | Background | Sievert 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. |
| 21305588 | Background | de 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. |
| 26904417 | Background | Sanford MT, Suskind AM. Neuromodulation in neurogenic bladder. Transl Androl Urol. 2016 Feb;5(1):117-26. doi: 10.3978/j.issn.2223-4683.2015.12.01. |
| 30837835 | Background | Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019. |
| 16458733 | Background | Dubeau CE. The aging lower urinary tract. J Urol. 2006 Mar;175(3 Pt 2):S11-5. doi: 10.1016/S0022-5347(05)00311-3. |
| 17466735 | Background | Schurch B, Denys P, Kozma CM, Reese PR, Slaton T, Barron R. Reliability and validity of the Incontinence Quality of Life questionnaire in patients with neurogenic urinary incontinence. Arch Phys Med Rehabil. 2007 May;88(5):646-52. doi: 10.1016/j.apmr.2007.02.009. |
| 29184133 | Background | Welk B, Lenherr S, Elliott S, Stoffel J, Presson AP, Zhang C, Myers JB. The Neurogenic Bladder Symptom Score (NBSS): a secondary assessment of its validity, reliability among people with a spinal cord injury. Spinal Cord. 2018 Mar;56(3):259-264. doi: 10.1038/s41393-017-0028-0. Epub 2017 Nov 29. |
| 29257742 | Background | Welk B, Carlson K, Baverstock R. A pilot study of the responsiveness of the Neurogenic Bladder Symptom Score (NBSS). Can Urol Assoc J. 2017 Dec;11(12):376-378. doi: 10.5489/cuaj.4833. Epub 2017 Nov 1. No abstract available. |
| 21218187 | Background | Ibrahim JG, Molenberghs G. Missing data methods in longitudinal studies: a review. Test (Madr). 2009 May 1;18(1):1-43. doi: 10.1007/s11749-009-0138-x. |
| 12964174 | Background | Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. |
| 18453793 | Background | Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x. |
| 11807312 | Background | Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS. 2002 Jan 25;16(2):269-77. doi: 10.1097/00002030-200201250-00017. |
| 28239781 | Background | Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26. |
| BG001 | Control | Low dose TTNS Low dose: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants with Tetraplegia | Count of Participants | Participants |
|
| Number of Participants with imaging pathology | 9 participants in the high dose arm did not receive Bladder and Kidney imaging. 11 participants in the control arm did not receive Bladder and Kidney imaging. | Count of Participants | Participants |
|
| Number of Participants with Bladder and Kidney Imaging | Count of Participants | Participants |
|
| Years from injury to cystometrogram | Data were not collected from participant in the high dose arm. | Median | Inter-Quartile Range | years |
|
| Number of Overactive Bladder medications | Mean | Standard Deviation | medications |
|
| Creatinine | Data were not collected for 18 participants in the high does arm. Data were not collected for 14 participants in the control arm. | Mean | Standard Deviation | milligrams per decilitre |
|
| Asia Impairment Scale Classification | The Asia Impairment Scale (AIS) categorizes spinal cord injury severity based on sensory and motor function loss. AIS Classification: A = Complete: No motor/sensory function in the sacral segments S4-S5 B = Incomplete: Sensory but not motor function below the neurological level, includes the sacral segments S4-S5 C = Incomplete: Below the neurological level, motor function preserved and more than 50% of key muscles have a muscle grade < 3 D = Incomplete: Below the neurological level, motor function persevered and at least 50% of key muscles have a muscle grade ≥3 | Count of Participants | Participants |
|
| OG001 |
| Control |
Low dose TTNS Low dose: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes |
|
|
| Primary | Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | The Neurogenic Bladder Symptom (NBSS) Score is a questionnaire that measures bladder symptoms, with total score ranging from 0 to 74; a higher score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported categorically as follows: Stable: A score change within + 5 or -5 points (not including 5) Worse: A score increase of 5 points or more from baseline Improved: A score decrease of 5 points or more from baseline These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change | Data were not collected for 9 participants in the high dose arm. Data were not collected for 4 participants in the control arm. | Posted | Count of Participants | Participants | Baseline, 3 months |
|
|
|
| Primary | Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary | Data were not collected from 11 participants in the high dose arm. Data were not collected for 7 participants in the control arm. | Posted | Count of Participants | Participants | baseline, 3 months |
|
|
|
| Secondary | Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | The Incontinence Quality of Life questionnaire assesses the impact of urinary incontinence on a person's quality of life. The total score ranges from 0 to 100, a lower score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported as categorically as follows: Stable: A score change within +4 or -4 points (not including 4) Worse: A score decrease of 4 or more points from baseline Improved: A score increase of 4 or more points from baseline These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change. | Data were not collected for 8 participants in the high dose arm. Data were not collected for 4 participants in the control arm. | Posted | Count of Participants | Participants | baseline, 3 months |
|
|
|
| Secondary | Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey | Data were not collected for 5 participants in the high dose arm. Data were not collected for 3 participants in the control arm. | Posted | Count of Participants | Participants | baseline, 3 months |
|
|
|
| Secondary | Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study | Data were not collected for 5 participants in the high dose arm. Data were not collected for 4 participants in the control arm. | Posted | Count of Participants | Participants | baseline, 3 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 4 |
| 25 |
| EG001 | Control | Low dose TTNS Low dose: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes | 0 | 25 | 0 | 25 | 6 | 25 |
| Pressure injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| COVID | General disorders | Non-systematic Assessment |
|
Not provided
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Worse |
|
| worse |
|