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

Study Overview
=================
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.

Official Title
-----------------
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation

Conditions
-----------------
Chronic Spinal Cord Injury, Neurogenic Bowel

Intervention / Treatment
-----------------
* Device: 4-week TTNS home-based protocol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-week TTNS home based protocol<br>Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol. | Device: 4-week TTNS home-based protocol<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 1 | 
| 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. | week 2 | 
| 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. | week 3 | 
| 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. | week 4 | 
| 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. | week 1 | 
| 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. | week 2 | 
| 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. | week 3 | 
| 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. | week 4 | 
| 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. | week 1 | 
| 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. | week 2 | 
| 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. | week 3 | 
| 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. | week 4 | 
| 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. | week 4 | 
| 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. | week 4 | 
| 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. | week 4 | 
| 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. | week 4 | 
| 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. | week 4 | 
| 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. | week 4 | 
| 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. | week 4 | 
| 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. | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 0 | 
| 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. | Week 2 | 
| 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. | week 4 | 
| 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. | week 1, week 2, week 3, week 4 | 
| Volume of Catheterization | The research assistant will call weekly to capture the written data and monitor progress with the protocol. | week 1, week 2, week 3, week 4 | 
| 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. | week 0 | 
| 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. | week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electric stimulation