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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458871
Recruitment Status : Completed
First Posted : March 8, 2018
Results First Posted : February 19, 2020
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Argyrios Stampas, MD, 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.

Condition or disease Intervention/treatment Phase
Chronic Spinal Cord Injury Neurogenic Bowel Device: 4-week TTNS home-based protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4-week TTNS home based protocol
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458871


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Argyrios Stampas, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Argyrios Stampas, MD, The University of Texas Health Science Center, Houston:
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Responsible Party: Argyrios Stampas, MD, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03458871    
Other Study ID Numbers: HSC-MS-17-0423
First Posted: March 8, 2018    Key Record Dates
Results First Posted: February 19, 2020
Last Update Posted: March 4, 2020
Last Verified: February 2020

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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
Keywords provided by Argyrios Stampas, MD, The University of Texas Health Science Center, Houston:
electric stimulation
Additional relevant MeSH terms:
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Neurogenic Bowel
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases