Trial Outcomes & Findings for Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation (NCT NCT03458871)
NCT ID: NCT03458871
Last Updated: 2021-10-29
Results Overview
Noted on bladder diary will be description of observed changes including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
week 1
Results posted on
2021-10-29
Participant Flow
Participant milestones
| Measure |
4-week TTNS Home Based Protocol
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Baseline characteristics by cohort
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Age, Continuous
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38.9 years
STANDARD_DEVIATION 11.1 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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13 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic
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6 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
White
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6 Participants
n=5 Participants
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Region of Enrollment
United States
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16 Participants
n=5 Participants
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Years of injury
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8.75 years
n=5 Participants
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|
Number of participants on bladder medication
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14 Participants
n=5 Participants
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American Spinal Injury Association Impairment Scale Level
A
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11 Participants
n=5 Participants
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American Spinal Injury Association Impairment Scale Level
B
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2 Participants
n=5 Participants
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|
American Spinal Injury Association Impairment Scale Level
C
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2 Participants
n=5 Participants
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American Spinal Injury Association Impairment Scale Level
D
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: week 1Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
Noted on bladder diary will be description of observed changes including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
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0 adverse events
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PRIMARY outcome
Timeframe: week 2Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
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0 adverse events
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PRIMARY outcome
Timeframe: week 3Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
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1 adverse events
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PRIMARY outcome
Timeframe: week 4Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
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1 adverse events
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PRIMARY outcome
Timeframe: week 1Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
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6.9 days
Standard Deviation 0.5
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PRIMARY outcome
Timeframe: week 2Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
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7 days
Standard Deviation 0
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PRIMARY outcome
Timeframe: week 3Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
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7 days
Standard Deviation 0
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PRIMARY outcome
Timeframe: week 4Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
|
6.6 days
Standard Deviation 1.3
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PRIMARY outcome
Timeframe: week 1Population: This data was not collected.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: week 2Population: This data was not collected.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: week 3Population: This data was not collected.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use"
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9.4 score on a scale
Standard Deviation 1.7
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PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS"
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9.375 score on a scale
Standard Deviation 2.420
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PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Easy to Remember to Use TTNS"
|
9.875 score on a scale
Standard Deviation 0.484
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PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin"
|
9.375 score on a scale
Standard Deviation 2.420
|
PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful"
|
10 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life"
|
5.6 score on a scale
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS"
|
8.3 score on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
|
Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "If TTNS Works as Well as Medications, I Would Switch to TTNS"
|
8.4 score on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: week 4The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "Overall, I Would Recommend TTNS for Those With Neurogenic Bladder"
|
9.7 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: week 0Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
|
55.6 score on a scale
Standard Error 4.67
|
SECONDARY outcome
Timeframe: Week 2Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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.
|
|---|---|
|
Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
|
70.2 score on a scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: week 4Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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.
|
|---|---|
|
Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
|
59.1 score on a scale
Standard Error 3.51
|
SECONDARY outcome
Timeframe: week 1, week 2, week 3, week 4Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
Frequency of catheterization after TTNS. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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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|---|---|
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Number of Catheterizations Per Day
week 1
|
5.2 catherizations per day
Standard Deviation 1.7
|
|
Number of Catheterizations Per Day
week 2
|
5.1 catherizations per day
Standard Deviation 1.8
|
|
Number of Catheterizations Per Day
week 3
|
5.4 catherizations per day
Standard Deviation 1.8
|
|
Number of Catheterizations Per Day
week 4
|
5.4 catherizations per day
Standard Deviation 2
|
SECONDARY outcome
Timeframe: week 1, week 2, week 3, week 4Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=14 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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.
|
|---|---|
|
Volume of Catheterization
week 1
|
366 milliliters
Standard Deviation 131.4
|
|
Volume of Catheterization
week 2
|
332 milliliters
Standard Deviation 129.6
|
|
Volume of Catheterization
week 3
|
340.1 milliliters
Standard Deviation 140.2
|
|
Volume of Catheterization
week 4
|
342.6 milliliters
Standard Deviation 138.9
|
SECONDARY outcome
Timeframe: week 0Items on the anticholinergic side effect severity of symptom questionnaire is scored as 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe), with a higher score indicating a worse outcome.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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.
|
|---|---|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Dry Mouth
|
1.00 score on a scale
Standard Deviation 1.15
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Constipation
|
0.50 score on a scale
Standard Deviation 0.97
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Hard Stool
|
0.75 score on a scale
Standard Deviation 0.77
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Sleepy
|
1.06 score on a scale
Standard Deviation 0.93
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Decreased Cognition
|
0.25 score on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: week 4Items on the anticholinergic side effect severity of symptom questionnaire is scored as 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe), with a higher score indicating a worse outcome.
Outcome measures
| Measure |
4-week TTNS Home Based Protocol
n=16 Participants
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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.
|
|---|---|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Dry Mouth
|
0.38 score on a scale
Standard Deviation 0.62
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Constipation
|
0.44 score on a scale
Standard Deviation 0.81
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Hard Stool
|
0.38 score on a scale
Standard Deviation 0.72
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Sleepy
|
0.56 score on a scale
Standard Deviation 0.81
|
|
Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Decreased Cognition
|
0.19 score on a scale
Standard Deviation 0.54
|
Adverse Events
4-week TTNS Home Based Protocol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
4-week TTNS Home Based Protocol
n=16 participants at risk
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
4-week TTNS home-based protocol: 4-week TTNS home-based protocol. 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 there is not contraction seen, maximal tolerable intensity will be used.
In addition, 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.
|
|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
12.5%
2/16 • Number of events 2 • 4 weeks
|
Additional Information
Dr. Argyrios Stampas
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