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

NCT03458871 | Completed Results FDA Device

• 1 other identifier: HSC-MS-17-0423
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spinal Cord Injury; Neurogenic Bowel

Keywords

electric stimulation

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (7)

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

  week 0

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

  Week 2

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

  week 4

• Number of Catheterizations Per Day

  week 1, week 2, week 3, week 4

• Volume of Catheterization

  week 1, week 2, week 3, week 4

Study Arms (1)

4-week TTNS home based protocol

EXPERIMENTAL

Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.

Device: 4-week TTNS home-based protocol

Interventions

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.

4-week TTNS home based protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Neurologically stable SCI for ≥ 6 months
• Intermittent catheterization to empty bladder
• Stable bladder medications for ≥ 3 months

You may not qualify if:

• Multiple medications for the bladder
• Other diagnoses to explain incontinence (ex: UTI, bladder stones, multiple sclerosis, etc.)
• + 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Stampas A, Korupolu R, Lee KH, Salazar B, Khavari R. Reduction of Overactive Bladder Medications in Spinal Cord Injury With Self-Administered Neuromodulation: A Randomized Trial. J Urol. 2024 Dec;212(6):800-810. doi: 10.1097/JU.0000000000004189. Epub 2024 Aug 2.

  PMID: 39093916 DERIVED

MeSH Terms

Conditions

Neurogenic Bowel

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Argyrios Stampas
• Organization: The University of Texas Health Science Center at Houston

argyrios.stampas@uth.tmc.edu

713-797-5938

Study Officials

• Argyrios Stampas, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 8, 2018
• Study Start: March 13, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: October 29, 2021
• Results First Posted: March 4, 2020

Record last verified: 2021-10

Locations

US (1)