Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation (HomeTTNS)
Primary Purpose
Chronic Spinal Cord Injury, Neurogenic Bowel
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4-week TTNS home-based protocol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spinal Cord Injury focused on measuring electric stimulation
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
4-week TTNS home based protocol
Arm Description
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Volume of Catheterization
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
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.
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.
Full Information
NCT ID
NCT03458871
First Posted
February 26, 2018
Last Updated
October 15, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03458871
Brief Title
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Acronym
HomeTTNS
Official Title
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spinal Cord Injury, Neurogenic Bowel
Keywords
electric stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4-week TTNS home based protocol
Arm Type
Experimental
Arm Description
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
Intervention Type
Device
Intervention Name(s)
4-week TTNS home-based protocol
Intervention Description
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.
Primary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argyrios Stampas, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
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