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

Not Applicable

Completed

Conditions: Neurogenic Bowel
Chronic Spinal Cord Injury

Interventions: Device: 4-week TTNS home-based protocol

Registration Number: NCT03458871

Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4-week TTNS home based protocol	4-week TTNS home-based protocol	Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.