Trial Outcomes & Findings for The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury (NCT NCT02573402)
NCT ID: NCT02573402
Last Updated: 2018-09-10
Results Overview
All infections were urinary tract infections (UTIs).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
about 4 weeks
Results posted on
2018-09-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 Participants
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.
|
Control
n=7 Participants
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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 13.5 • n=12 Participants
|
48.3 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 13.3 • n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=12 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=12 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=19 Participants
|
|
Neurologic Level Number
|
7.7 units on a scale
STANDARD_DEVIATION 6.2 • n=12 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 5.9 • n=19 Participants
|
|
Number of Days from Injury
|
20.8 days
STANDARD_DEVIATION 9.3 • n=12 Participants
|
19.9 days
STANDARD_DEVIATION 6.2 • n=7 Participants
|
20.5 days
STANDARD_DEVIATION 8.3 • n=19 Participants
|
|
Admission Functional Independence Measure (FIM) motor subscale
|
16.7 units on a scale
STANDARD_DEVIATION 5.1 • n=12 Participants
|
16.4 units on a scale
STANDARD_DEVIATION 5.6 • n=7 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 5.3 • n=19 Participants
|
|
Admission Functional Independence Measure (FIM) bladder item
|
1 units on a scale
STANDARD_DEVIATION 0 • n=12 Participants
|
1 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
1 units on a scale
STANDARD_DEVIATION 0 • n=19 Participants
|
|
Admission Functional Independence Measure (FIM) cognition subscale
|
27.8 units on a scale
STANDARD_DEVIATION 5.6 • n=12 Participants
|
29.1 units on a scale
STANDARD_DEVIATION 5 • n=7 Participants
|
28.3 units on a scale
STANDARD_DEVIATION 5.4 • n=19 Participants
|
|
Number of Participants with Tetraplegia
|
6 Participants
n=12 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=19 Participants
|
|
Number of Participants with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A
|
8 Participants
n=12 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=19 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade B
|
2 Participants
n=12 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=19 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade C
|
2 Participants
n=12 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=19 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade D
|
0 Participants
n=12 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: about 4 weeksAll infections were urinary tract infections (UTIs).
Outcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Number of Participants With Infection
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: about 4 weeksNumber of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.
Outcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Number of Participants With Skin Irritation
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: about 4 weeksOutcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline, about 30 minutesParticipants 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.
Outcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)
|
-0.01 units on a scale
Standard Deviation 0.22
|
-0.06 units on a scale
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
|
30.6 cm H2O
Standard Deviation 21
|
33 cm H2O
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.
Outcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=11 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
|
38.1 cm H2O
Standard Deviation 21.4
|
44.4 cm H2O
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Maximum Bladder Capacity as Evaluated by Urodynamic Study
|
580 mL
Standard Deviation 45.7
|
571 mL
Standard Deviation 81.3
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.
Outcome measures
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=11 Participants
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.
|
Control
n=7 Participants
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.
|
|---|---|---|
|
Maximum Bladder Capacity as Evaluated by Urodynamic Study
|
552.6 mL
Standard Deviation 110
|
459.6 mL
Standard Deviation 156.4
|
Adverse Events
Transcutaneous Tibial Nerve Stimulation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transcutaneous Tibial Nerve Stimulation
n=12 participants at risk
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.
|
Control
n=7 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Deep Vein Thrombosis/Pulmonary Embolism
|
0.00%
0/12 • About 4 weeks
|
14.3%
1/7 • Number of events 1 • About 4 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
33.3%
4/12 • Number of events 4 • About 4 weeks
|
42.9%
3/7 • Number of events 3 • About 4 weeks
|
|
Skin and subcutaneous tissue disorders
Pressure Injury
|
0.00%
0/12 • About 4 weeks
|
14.3%
1/7 • Number of events 1 • About 4 weeks
|
Additional Information
Argyrios Stampas, MD
The University of Texas Health Science Center at Houston
Phone: (713) 797-5007
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place