| Primary | Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 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. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Number | | adverse events | | week 1 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 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. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Number | | adverse events | | week 2 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 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. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Number | | adverse events | | week 3 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 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. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Number | | adverse events | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Mean | Standard Deviation | days | | week 1 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Mean | Standard Deviation | days | | week 2 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Mean | Standard Deviation | days | | week 3 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Mean | Standard Deviation | days | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | This data was not collected. | Posted | | | | | | week 1 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | This data was not collected. | Posted | | | | | | week 2 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | This data was not collected. | Posted | | | | | | week 3 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | Total 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. | | Posted | | Mean | Standard Error | score on a scale | | week 0 | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | Total 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 2 | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | Total 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. | | Posted | | Mean | Standard Error | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Number of Catheterizations Per Day | Frequency of catheterization after TTNS. The research assistant will call weekly to capture the written data and monitor progress with the protocol. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Mean | Standard Deviation | catherizations per day | | week 1, week 2, week 3, week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Volume of Catheterization | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | Only 14 of the 16 participants used the bladder diary, which was used to collect this data. | Posted | | Mean | Standard Deviation | milliliters | | week 1, week 2, week 3, week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Items 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. | | Posted | | Mean | Standard Deviation | score on a scale | | week 0 | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Items 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. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | 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" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | 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" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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| Primary | 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" | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | week 4 | | | | ID | Title | Description |
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| OG000 | 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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