Spinal Cord Injury, Neurogenic Bladder
Conditions
Keywords
electric stimulation, urodynamic study
Brief summary
The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).
Detailed description
In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.
Interventions
10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch 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. Current intensity may vary from patient to patient and will be documented and used in the analysis.
DEVICEControl
10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.
Sponsors
The Institute for Rehabilitation and Research (TIRR)
Baylor College of Medicine
Case Western Reserve University
University of Houston
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Enrollment within 6 weeks of injury * Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord. * Location and transportation available for follow-up appointments
Exclusion criteria
* History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy * Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.) * History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.) * Pregnancy * History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.) * Morbid obesity * Ventilator dependent respiration * Significant autonomic dysreflexia during baseline urodynamic study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infection | about 4 weeks | All infections were urinary tract infections (UTIs). |
| Number of Participants With Skin Irritation | about 4 weeks | Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury. |
| Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital | about 4 weeks | — |
| Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS) | baseline, about 30 minutes | Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's mean change in pain score: \[Average of the post-stimulation measurements for all 10 time points\] minus \[Average of baseline measurements for all 10 time points time point\] = \[mean change in pain score\]. The value reported is the mean of all participants' mean change in pain score. The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Detrusor Pressure as Evaluated by Urodynamic Study | baseline |
| Maximum Bladder Capacity as Evaluated by Urodynamic Study | baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcutaneous Tibial Nerve Stimulation Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.
Transcutaneous Tibial Nerve Stimulation: 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch 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. Current intensity may vary from patient to patient and will be documented and used in the analysis. | 12 |
| Control Control (Sham stimulation).
Control: 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero. | 7 |
| Total | 19 |
Baseline characteristics
| Characteristic | Transcutaneous Tibial Nerve Stimulation | Control | Total |
|---|---|---|---|
| Admission Functional Independence Measure (FIM) bladder item | 1 units on a scale STANDARD_DEVIATION 0 | 1 units on a scale STANDARD_DEVIATION 0 | 1 units on a scale STANDARD_DEVIATION 0 |
| Admission Functional Independence Measure (FIM) cognition subscale | 27.8 units on a scale STANDARD_DEVIATION 5.6 | 29.1 units on a scale STANDARD_DEVIATION 5 | 28.3 units on a scale STANDARD_DEVIATION 5.4 |
| Admission Functional Independence Measure (FIM) motor subscale | 16.7 units on a scale STANDARD_DEVIATION 5.1 | 16.4 units on a scale STANDARD_DEVIATION 5.6 | 16.6 units on a scale STANDARD_DEVIATION 5.3 |
| Age, Continuous | 36.3 years STANDARD_DEVIATION 13.5 | 48.3 years STANDARD_DEVIATION 12.9 | 40.7 years STANDARD_DEVIATION 13.3 |
| American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade B | 2 Participants | 1 Participants | 3 Participants |
| American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade C | 2 Participants | 2 Participants | 4 Participants |
| American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade D | 0 Participants | 1 Participants | 1 Participants |
| Neurologic Level Number | 7.7 units on a scale STANDARD_DEVIATION 6.2 | 8.1 units on a scale STANDARD_DEVIATION 5.3 | 7.8 units on a scale STANDARD_DEVIATION 5.9 |
| Number of Days from Injury | 20.8 days STANDARD_DEVIATION 9.3 | 19.9 days STANDARD_DEVIATION 6.2 | 20.5 days STANDARD_DEVIATION 8.3 |
| Number of Participants with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A | 8 Participants | 3 Participants | 11 Participants |
| Number of Participants with Tetraplegia | 6 Participants | 4 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 12 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 7 |
| other Total, other adverse events | 4 / 12 | 3 / 7 |
| serious Total, serious adverse events | 0 / 12 | 0 / 7 |
Outcome results
Primary
Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)
Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's mean change in pain score: \[Average of the post-stimulation measurements for all 10 time points\] minus \[Average of baseline measurements for all 10 time points time point\] = \[mean change in pain score\]. The value reported is the mean of all participants' mean change in pain score. The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain.
Time frame: baseline, about 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS) | -0.01 units on a scale | Standard Deviation 0.22 |
| Control | Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS) | -0.06 units on a scale | Standard Deviation 0.13 |
Primary
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
Time frame: about 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital | 0 Participants |
| Control | Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital | 0 Participants |
Primary
Number of Participants With Infection
All infections were urinary tract infections (UTIs).
Time frame: about 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Number of Participants With Infection | 4 Participants |
| Control | Number of Participants With Infection | 3 Participants |
Primary
Number of Participants With Skin Irritation
Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.
Time frame: about 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Number of Participants With Skin Irritation | 0 Participants |
| Control | Number of Participants With Skin Irritation | 1 Participants |
Secondary
Maximum Bladder Capacity as Evaluated by Urodynamic Study
Time frame: 2 weeks
Population: One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Maximum Bladder Capacity as Evaluated by Urodynamic Study | 552.6 mL | Standard Deviation 110 |
| Control | Maximum Bladder Capacity as Evaluated by Urodynamic Study | 459.6 mL | Standard Deviation 156.4 |
Secondary
Maximum Bladder Capacity as Evaluated by Urodynamic Study
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Maximum Bladder Capacity as Evaluated by Urodynamic Study | 580 mL | Standard Deviation 45.7 |
| Control | Maximum Bladder Capacity as Evaluated by Urodynamic Study | 571 mL | Standard Deviation 81.3 |
Secondary
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Maximum Detrusor Pressure as Evaluated by Urodynamic Study | 30.6 cm H2O | Standard Deviation 21 |
| Control | Maximum Detrusor Pressure as Evaluated by Urodynamic Study | 33 cm H2O | Standard Deviation 11.1 |
Secondary
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Time frame: 2 weeks
Population: One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Tibial Nerve Stimulation | Maximum Detrusor Pressure as Evaluated by Urodynamic Study | 38.1 cm H2O | Standard Deviation 21.4 |
| Control | Maximum Detrusor Pressure as Evaluated by Urodynamic Study | 44.4 cm H2O | Standard Deviation 21.5 |