Trial Outcomes & Findings for Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation (NCT NCT04074616)
NCT ID: NCT04074616
Last Updated: 2024-10-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
baseline, 3 months
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Dose
n=25 Participants
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.
|
Control
n=25 Participants
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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=25 Participants
|
41 years
n=25 Participants
|
38 years
n=50 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
7 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=25 Participants
|
21 Participants
n=25 Participants
|
43 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
|
Number of Participants with Tetraplegia
|
13 Participants
n=25 Participants
|
10 Participants
n=25 Participants
|
23 Participants
n=50 Participants
|
|
Number of Participants with imaging pathology
Hydronephrosis
|
0 Participants
n=16 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
0 Participants
n=30 Participants • 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.
|
|
Number of Participants with imaging pathology
Nephrolithiasis
|
3 Participants
n=16 Participants • 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.
|
1 Participants
n=14 Participants • 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.
|
4 Participants
n=30 Participants • 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.
|
|
Number of Participants with imaging pathology
Bladder stones
|
1 Participants
n=16 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
1 Participants
n=30 Participants • 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.
|
|
Number of Participants with imaging pathology
Hydroureter
|
1 Participants
n=16 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
1 Participants
n=30 Participants • 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.
|
|
Number of Participants with Bladder and Kidney Imaging
|
16 Participants
n=25 Participants
|
14 Participants
n=25 Participants
|
30 Participants
n=50 Participants
|
|
Years from injury to cystometrogram
|
10.8 years
n=24 Participants • Data were not collected from participant in the high dose arm.
|
8.9 years
n=25 Participants • Data were not collected from participant in the high dose arm.
|
10.3 years
n=49 Participants • Data were not collected from participant in the high dose arm.
|
|
Number of Overactive Bladder medications
|
1.4 medications
STANDARD_DEVIATION 0.5 • n=25 Participants
|
1.2 medications
STANDARD_DEVIATION 0.4 • n=25 Participants
|
1.3 medications
STANDARD_DEVIATION 0.5 • n=50 Participants
|
|
Creatinine
|
.85 milligrams per decilitre
STANDARD_DEVIATION .23 • n=7 Participants • Data were not collected for 18 participants in the high does arm. Data were not collected for 14 participants in the control arm.
|
.68 milligrams per decilitre
STANDARD_DEVIATION .19 • n=11 Participants • Data were not collected for 18 participants in the high does arm. Data were not collected for 14 participants in the control arm.
|
.74 milligrams per decilitre
STANDARD_DEVIATION .21 • n=18 Participants • Data were not collected for 18 participants in the high does arm. Data were not collected for 14 participants in the control arm.
|
|
Asia Impairment Scale Classification
A
|
14 Participants
n=25 Participants
|
14 Participants
n=25 Participants
|
28 Participants
n=50 Participants
|
|
Asia Impairment Scale Classification
B
|
6 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
8 Participants
n=50 Participants
|
|
Asia Impairment Scale Classification
C
|
4 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
8 Participants
n=50 Participants
|
|
Asia Impairment Scale Classification
D
|
1 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
6 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: Data were not collected for 5 participants in the high dose arm. Data were not collected for 3 participants in the control arm.
Outcome measures
| Measure |
High Dose
n=20 Participants
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.
|
Control
n=22 Participants
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
|
|---|---|---|
|
Number of Participants With Reduction in Bladder Medication
|
19 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Data were not collected for 9 participants in the high dose arm. Data were not collected for 4 participants in the control arm.
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
Outcome measures
| Measure |
High Dose
n=16 Participants
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.
|
Control
n=21 Participants
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
|
|---|---|---|
|
Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline
Stable
|
8 Participants
|
7 Participants
|
|
Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline
Improved
|
7 Participants
|
11 Participants
|
|
Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline
Worse
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 monthsPopulation: Data were not collected from 11 participants in the high dose arm. Data were not collected for 7 participants in the control arm.
Outcome measures
| Measure |
High Dose
n=14 Participants
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.
|
Control
n=18 Participants
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
|
|---|---|---|
|
Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: Data were not collected for 8 participants in the high dose arm. Data were not collected for 4 participants in the control arm.
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.
Outcome measures
| Measure |
High Dose
n=17 Participants
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.
|
Control
n=21 Participants
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
|
|---|---|---|
|
Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline
stable
|
4 Participants
|
6 Participants
|
|
Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline
improved
|
6 Participants
|
4 Participants
|
|
Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline
worse
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: Data were not collected for 5 participants in the high dose arm. Data were not collected for 3 participants in the control arm.
Outcome measures
| Measure |
High Dose
n=20 Participants
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.
|
Control
n=22 Participants
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
|
|---|---|---|
|
Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: Data were not collected for 5 participants in the high dose arm. Data were not collected for 4 participants in the control arm.
Outcome measures
| Measure |
High Dose
n=20 Participants
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.
|
Control
n=21 Participants
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
|
|---|---|---|
|
Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study
|
12 Participants
|
14 Participants
|
Adverse Events
High Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose
n=25 participants at risk
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.
|
Control
n=25 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
16.0%
4/25 • 3 months
|
24.0%
6/25 • 3 months
|
|
Injury, poisoning and procedural complications
Pressure injury
|
4.0%
1/25 • 3 months
|
0.00%
0/25 • 3 months
|
|
General disorders
COVID
|
4.0%
1/25 • 3 months
|
4.0%
1/25 • 3 months
|
Additional Information
Argyrios Stampas, MD
The University of Texas Health Science Center at Houston
Phone: 713-797-5938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place