Chronic Spinal Cord Injury, Neurogenic Bladder
Conditions
Keywords
electric stimulation
Brief summary
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
Interventions
DEVICEHigh 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.
DEVICELow dose
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
randomized sham-control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Traumatic and non-traumatic SCI performing IC * Up to 2 anticholinergic overactive bladder (OAB) medications * No changes in OAB medications * Neurologic level of injury above T10 * English and Spanish speaking
Exclusion criteria
* Past history of genitourinary diagnoses or surgeries * History of central nervous system (CNS) disorders and/or peripheral neuropathy * Pregnancy * Lower motor neuron bladder * Concern for tibial nerve pathway injury * Absence of toe flexion or AD with electric stimulation * Bladder chemodenervation in past 6 months * Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 3 months | 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 |
| Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary | baseline, 3 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | baseline, 3 months | 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. |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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 | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Control | High Dose |
|---|---|---|---|
| Age, Continuous | 38 years | 41 years | 36 years |
| Asia Impairment Scale Classification A | 28 Participants | 14 Participants | 14 Participants |
| Asia Impairment Scale Classification B | 8 Participants | 2 Participants | 6 Participants |
| Asia Impairment Scale Classification C | 8 Participants | 4 Participants | 4 Participants |
| Asia Impairment Scale Classification D | 6 Participants | 5 Participants | 1 Participants |
| Creatinine | .74 milligrams per decilitre STANDARD_DEVIATION 0.21 | .68 milligrams per decilitre STANDARD_DEVIATION 0.19 | .85 milligrams per decilitre STANDARD_DEVIATION 0.23 |
| Number of Overactive Bladder medications | 1.3 medications STANDARD_DEVIATION 0.5 | 1.2 medications STANDARD_DEVIATION 0.4 | 1.4 medications STANDARD_DEVIATION 0.5 |
| Number of Participants with Bladder and Kidney Imaging | 30 Participants | 14 Participants | 16 Participants |
| Number of Participants with imaging pathology Bladder stones | 1 Participants | 0 Participants | 1 Participants |
| Number of Participants with imaging pathology Hydronephrosis | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with imaging pathology Hydroureter | 1 Participants | 0 Participants | 1 Participants |
| Number of Participants with imaging pathology Nephrolithiasis | 4 Participants | 1 Participants | 3 Participants |
| Number of Participants with Tetraplegia | 23 Participants | 10 Participants | 13 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 50 participants | 25 participants | 25 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 43 Participants | 21 Participants | 22 Participants |
| Years from injury to cystometrogram | 10.3 years | 8.9 years | 10.8 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 4 / 25 | 6 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: Baseline, 3 months
Population: Data were not collected for 9 participants in the high dose arm. Data were not collected for 4 participants in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Dose | Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | Stable | 8 Participants |
| High Dose | Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | Improved | 7 Participants |
| High Dose | Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | Worse | 1 Participants |
| Control | Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | Stable | 7 Participants |
| Control | Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | Improved | 11 Participants |
| Control | Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline | Worse | 3 Participants |
Primary
Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary
Time frame: baseline, 3 months
Population: Data were not collected from 11 participants in the high dose arm. Data were not collected for 7 participants in the control arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary | 0 Participants |
| Control | Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary | 0 Participants |
Primary
Number of Participants With Reduction in Bladder Medication
Time frame: baseline, 3 months
Population: Data were not collected for 5 participants in the high dose arm. Data were not collected for 3 participants in the control arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants With Reduction in Bladder Medication | 19 Participants |
| Control | Number of Participants With Reduction in Bladder Medication | 15 Participants |
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.
Time frame: baseline, 3 months
Population: Data were not collected for 8 participants in the high dose arm. Data were not collected for 4 participants in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Dose | Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | stable | 4 Participants |
| High Dose | Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | improved | 6 Participants |
| High Dose | Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | worse | 7 Participants |
| Control | Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | stable | 6 Participants |
| Control | Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | improved | 4 Participants |
| Control | Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline | worse | 11 Participants |
Secondary
Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey
Time frame: baseline, 3 months
Population: Data were not collected for 5 participants in the high dose arm. Data were not collected for 3 participants in the control arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey | 0 Participants |
| Control | Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey | 0 Participants |
Secondary
Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study
Time frame: baseline, 3 months
Population: Data were not collected for 5 participants in the high dose arm. Data were not collected for 4 participants in the control arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose | Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study | 12 Participants |
| Control | Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study | 14 Participants |