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Completed

NCT Number: NCT03458871

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

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

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Key information

Conditions

Chronic Spinal Cord Injury Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurogenic Bowel

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4-week TTNS home-based protocol

Device

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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: week 4

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: HomeTTNS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2018
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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