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

Neurogenic Bowel Clinical Trial

— HomeTTNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458871
• Other study ID #: HSC-MS-17-0423
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: February 6, 2019

Study information

• Verified date: October 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Spinal Cord Injury
• Neurogenic Bowel
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	Noted on bladder diary will be description of observed changes including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 1
Primary	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 2
Primary	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 3
Primary	Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary	Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 4
Primary	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 1
Primary	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 2
Primary	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 3
Primary	Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary	The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home	The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 1
Primary	Overall Satisfaction of Daily Use of TTNS at Home	The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 2
Primary	Overall Satisfaction of Daily Use of TTNS at Home	The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 3
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Easy to Remember to Use TTNS"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "If TTNS Works as Well as Medications, I Would Switch to TTNS"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Primary	Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "Overall, I Would Recommend TTNS for Those With Neurogenic Bladder"	The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.	week 4
Secondary	Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey	Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.	week 0
Secondary	Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey	Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.	Week 2
Secondary	Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey	Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.	week 4
Secondary	Number of Catheterizations Per Day	Frequency of catheterization after TTNS. The research assistant will call weekly to capture the written data and monitor progress with the protocol.	week 1, week 2, week 3, week 4
Secondary	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
Secondary	Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire	Items on the anticholinergic side effect severity of symptom questionnaire is scored as 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe), with a higher score indicating a worse outcome.	week 0
Secondary	Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire	Items on the anticholinergic side effect severity of symptom questionnaire is scored as 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe), with a higher score indicating a worse outcome.	week 4