HomeTTNS: Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03458871
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in chronic SCI provided by self or caregiver for 4 weeks.

Condition or Disease	Intervention/Treatment	Phase
Chronic Spinal Cord Injury; Neurogenic Bowel	Device: 4-week TTNS home-based protocol	N/A

Detailed Description

In Specific Aim 1, we will monitor for safety, feasibility, and compliance of a home TTNS program for bladder management. In Specific Aim 2, the efficacy of home TTNS will be compared to baseline Incontinence- Quality of Life questionnaire. A bladder diary will also capture important information such as frequency and volume of catheterization, incontinence episodes, and other related observations.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
• Actual Study Start Date: Mar 13, 2018
• Actual Primary Completion Date: Feb 6, 2019
• Actual Study Completion Date: Feb 6, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 4-week TTNS home based protocol Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.

Device: 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.

Outcome Measures

Primary Outcome Measures

1. Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary [week 1]

   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.

2. Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary [week 2]

   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.

3. Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary [week 3]

   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.

4. Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary [week 4]

   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.

5. Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary [week 1]

   The research assistant will call weekly to capture the written data and monitor progress with the protocol.

6. Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary [week 2]

   The research assistant will call weekly to capture the written data and monitor progress with the protocol.

7. Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary [week 3]

   The research assistant will call weekly to capture the written data and monitor progress with the protocol.

8. Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary [week 4]

   The research assistant will call weekly to capture the written data and monitor progress with the protocol.

9. Overall Satisfaction of Daily Use of TTNS at Home [week 1]

   The research assistant will call weekly to capture the written data and monitor progress with the protocol.

10. Overall Satisfaction of Daily Use of TTNS at Home [week 2]

    The research assistant will call weekly to capture the written data and monitor progress with the protocol.

11. Overall Satisfaction of Daily Use of TTNS at Home [week 3]

    The research assistant will call weekly to capture the written data and monitor progress with the protocol.

12. Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

13. Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

14. 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" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

15. Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

16. Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

17. Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

18. Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

19. 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" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

20. 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" [week 4]

    The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.

Secondary Outcome Measures

1. Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey [week 0]

   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.

2. Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey [Week 2]

   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.

3. Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey [week 4]

   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.

4. Number of Catheterizations Per Day [week 1, week 2, week 3, week 4]

   Frequency of catheterization after TTNS. The research assistant will call weekly to capture the written data and monitor progress with the protocol.

5. Volume of Catheterization [week 1, week 2, week 3, week 4]

   The research assistant will call weekly to capture the written data and monitor progress with the protocol.

6. Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire [week 0]

   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.

7. Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire [week 4]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18-65 years old

• Neurologically stable SCI for ≥ 6 months

• Intermittent catheterization to empty bladder

• Stable bladder medications for ≥ 3 months

Exclusion Criteria:

• Multiple medications for the bladder

• Other diagnoses to explain incontinence (ex: UTI, bladder stones, multiple sclerosis, etc.)

• 2+ pitting edema that does not resolve

• Known peripheral neuropathy or injury to the path of the tibial nerve

• Demand-type cardiac pacemaker or implanted defibrillator

• Cancer in the tibial nerve path and/or bladder

• Inability to elicit toe/plantar flexion with electric stimulation during the clinic visit.

• Inability to understand directions

• Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Argyrios Stampas, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 31, 2018

More Information

Publications

None provided.

• Responsible Party: Argyrios Stampas, MD, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03458871
• Other Study ID Numbers: HSC-MS-17-0423
• First Posted: Mar 8, 2018
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Argyrios Stampas, MD, Assistant Professor, The University of Texas Health Science Center, Houston: electric stimulation
• Additional relevant MeSH terms: Neurogenic Bowel; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Period Title: Overall Study
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.9 (11.1)
Sex: Female, Male (Count of Participants)
Female	3 18.8%
Male	13 81.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 12.5%
Black	2 12.5%
Hispanic	6 37.5%
White	6 37.5%
Region of Enrollment (Count of Participants)
United States	16 100%
Years of injury (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	8.75
Number of participants on bladder medication (Count of Participants)
Count of Participants [Participants]	14 87.5%
American Spinal Injury Association Impairment Scale Level (Count of Participants)
A	11 68.8%
B	2 12.5%
C	2 12.5%
D	1 6.3%

Outcome Measures

1. Primary Outcome

Title	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
Description	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.
Time Frame	week 1

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Number [adverse events]	0

2. Primary Outcome

Title	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
Description	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.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Number [adverse events]	0

3. Primary Outcome

Title	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
Description	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.
Time Frame	week 3

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Number [adverse events]	1

4. Primary Outcome

Title	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary
Description	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.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Number [adverse events]	1

5. Primary Outcome

Title	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 1

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Mean (Standard Deviation) [days]	6.9 (0.5)

6. Primary Outcome

Title	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Mean (Standard Deviation) [days]	7 (0)

7. Primary Outcome

Title	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 3

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Mean (Standard Deviation) [days]	7 (0)

8. Primary Outcome

Title	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
Mean (Standard Deviation) [days]	6.6 (1.3)

9. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 1

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	0

10. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	0

11. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 3

Outcome Measure Data

Analysis Population Description

This data was not collected.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	0

12. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	9.4 (1.7)

13. Secondary Outcome

Title	Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
Description	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.
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Error) [score on a scale]	55.6 (4.67)

14. Secondary Outcome

Title	Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
Description	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.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	70.2 (17.0)

15. Secondary Outcome

Title	Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey
Description	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.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Error) [score on a scale]	59.1 (3.51)

16. Secondary Outcome

Title	Number of Catheterizations Per Day
Description	Frequency of catheterization after TTNS. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 1, week 2, week 3, week 4

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
week 1	5.2 (1.7)
week 2	5.1 (1.8)
week 3	5.4 (1.8)
week 4	5.4 (2)

17. Secondary Outcome

Title	Volume of Catheterization
Description	The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time Frame	week 1, week 2, week 3, week 4

Outcome Measure Data

Analysis Population Description

Only 14 of the 16 participants used the bladder diary, which was used to collect this data.

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	14
week 1	366 (131.4)
week 2	332 (129.6)
week 3	340.1 (140.2)
week 4	342.6 (138.9)

18. Secondary Outcome

Title	Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Description	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.
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Dry Mouth	1.00 (1.15)
Constipation	0.50 (0.97)
Hard Stool	0.75 (0.77)
Sleepy	1.06 (0.93)
Decreased Cognition	0.25 (0.58)

19. Secondary Outcome

Title	Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire
Description	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.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Dry Mouth	0.38 (0.62)
Constipation	0.44 (0.81)
Hard Stool	0.38 (0.72)
Sleepy	0.56 (0.81)
Decreased Cognition	0.19 (0.54)

20. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	9.375 (2.420)

21. Primary Outcome

Title	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"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	9.875 (0.484)

22. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	9.375 (2.420)

23. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	10 (0)

24. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	5.6 (3.9)

25. Primary Outcome

Title	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	8.3 (3.5)

26. Primary Outcome

Title	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"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	8.4 (3.5)

27. Primary Outcome

Title	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"
Description	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	9.7 (1.3)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	4-week TTNS Home Based Protocol
Arm/Group Description	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.
All Cause Mortality
	4-week TTNS Home Based Protocol
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Serious Adverse Events
	4-week TTNS Home Based Protocol
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	4-week TTNS Home Based Protocol
	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)
Renal and urinary disorders
Urinary Tract Infection	2/16 (12.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.