An interventional study of 4-week TTNS home-based protocol in Chronic Spinal Cord Injury and Neurogenic Bowel, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
Among 18 studies in Neurogenic Bowel with a site in United States — 6 open to participants now, 7 under way, 1 of them phase 3. Neurogenic Bowel · United States.
Among the 18 studies in Neurogenic Bowel with a site in United States, this one is the 7th largest by enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2018, is one of 10 with no phase, and was the 7th registered.
35 studies on the registry are indexed under Neurogenic Bowel; 13 are open to participants now.
Browse Neurogenic Bowel studies →6 of the 18 studies in Neurogenic Bowel with a site in United States are open now. Recruiting first, the newest first:
Casa Colina Hospital and Centers for Healthcare · Sites in United States
David Chu · Sites in United States
Craig Hospital · Sites in United States
MetroHealth Medical Center · Sites in United States
VA Office of Research and Development · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Neurogenic Bowel studies recruiting now, 7 (70%) set no upper age limit and 3 (30%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 20 across 32 interventional studies indexed under Neurogenic Bowel.
Median enrollment 13 across the 17 interventional studies, 943 across the 1 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 18 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
The University of Texas Health Science Center, Houston has 1 study filed under Neurogenic Bowel — fewer than ten, so there is no comparison to draw.
3 of the studies in Neurogenic Bowel with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06078176VA Office of Research and DevelopmentStimulation for Bowel Emptying | 2026-12-31 |
| NCT07817199Casa Colina Hospital and Centers for HealthcareTime Comparison of Interventions on Bowel Programs in Spinal Cord Injury | 2027-07-01 |
| NCT06836739MetroHealth Medical CenterAt-Home Genital Nerve Stimulation for SCI Bowel | 2027-09-30 |
Among the 18 studies in Neurogenic Bowel with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in chronic SCI provided by self or caregiver for 4 weeks.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 4
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.
Time frame: week 0
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.
Time frame: Week 2
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.
Time frame: week 4
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.
Time frame: week 1, week 2, week 3, week 4
Volume of Catheterization
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
Time frame: week 1, week 2, week 3, week 4
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.
Time frame: week 0
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.
Time frame: week 4
| Milestone | 4-week TTNS Home Based Protocol |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
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.
| adverse events | 4-week TTNS Home Based Protocol |
|---|---|
| Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 0 |
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.
| adverse events | 4-week TTNS Home Based Protocol |
|---|---|
| Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 0 |
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.
| adverse events | 4-week TTNS Home Based Protocol |
|---|---|
| Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 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.
| adverse events | 4-week TTNS Home Based Protocol |
|---|---|
| Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 1 |
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
| days | 4-week TTNS Home Based Protocol |
|---|---|
| Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | 6.9 ± 0.5 |
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
| days | 4-week TTNS Home Based Protocol |
|---|---|
| Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | 7 ± 0 |
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
| days | 4-week TTNS Home Based Protocol |
|---|---|
| Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | 7 ± 0 |
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
| days | 4-week TTNS Home Based Protocol |
|---|---|
| Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | 6.6 ± 1.3 |
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
No measurements were reported for this outcome.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
No measurements were reported for this outcome.
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
No measurements were reported for this outcome.
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use" | 9.4 ± 1.7 |
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.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | 55.6 ± 4.67 |
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.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | 70.2 ± 17.0 |
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.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | 59.1 ± 3.51 |
Frequency of catheterization after TTNS. The research assistant will call weekly to capture the written data and monitor progress with the protocol.
| catherizations per day | 4-week TTNS Home Based Protocol |
|---|---|
| week 1 | 5.2 ± 1.7 |
| week 2 | 5.1 ± 1.8 |
| week 3 | 5.4 ± 1.8 |
| week 4 | 5.4 ± 2 |
The research assistant will call weekly to capture the written data and monitor progress with the protocol.
| milliliters | 4-week TTNS Home Based Protocol |
|---|---|
| week 1 | 366 ± 131.4 |
| week 2 | 332 ± 129.6 |
| week 3 | 340.1 ± 140.2 |
| week 4 | 342.6 ± 138.9 |
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.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Dry Mouth | 1.00 ± 1.15 |
| Constipation | 0.50 ± 0.97 |
| Hard Stool | 0.75 ± 0.77 |
| Sleepy | 1.06 ± 0.93 |
| Decreased Cognition | 0.25 ± 0.58 |
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.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Dry Mouth | 0.38 ± 0.62 |
| Constipation | 0.44 ± 0.81 |
| Hard Stool | 0.38 ± 0.72 |
| Sleepy | 0.56 ± 0.81 |
| Decreased Cognition | 0.19 ± 0.54 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "It Was Not Embarrassing to Use TTNS" | 9.375 ± 2.420 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| 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" | 9.875 ± 0.484 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Did Not Irritate my Skin" | 9.375 ± 2.420 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful" | 10 ± 0 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Improved my Quality of Life" | 5.6 ± 3.9 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS" | 8.3 ± 3.5 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based Protocol |
|---|---|
| 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" | 8.4 ± 3.5 |
The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.
| score on a scale | 4-week TTNS Home Based 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" | 9.7 ± 1.3 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4-week TTNS Home Based Protocol | 0/16 (0%) | 0/16 (0%) | 2/16 (12.5%) |
| Event | 4-week TTNS Home Based Protocol |
|---|---|
| Urinary Tract InfectionRenal and urinary disorders | 2/16 |
| Age, Continuous(years) | 4-week TTNS Home Based Protocol |
|---|---|
| Mean | 38.9 ± 11.1 |
| Sex: Female, Male(Participants) | 4-week TTNS Home Based Protocol |
|---|---|
| Female | 3 |
| Male | 13 |
| Race/Ethnicity, Customized(Participants) | 4-week TTNS Home Based Protocol |
|---|---|
| Asian | 2 |
| Black | 2 |
| Hispanic | 6 |
| White | 6 |
| Region of Enrollment(Participants) | 4-week TTNS Home Based Protocol |
|---|---|
| United States | 16 |
| Years of injury(years) | 4-week TTNS Home Based Protocol |
|---|---|
| Median | 8.75 (3.1 to 19.4) |
| Number of participants on bladder medication(Participants) | 4-week TTNS Home Based Protocol |
|---|---|
| Count of participants | 14 |
| American Spinal Injury Association Impairment Scale Level(Participants) | 4-week TTNS Home Based Protocol |
|---|---|
| A | 11 |
| B | 2 |
| C | 2 |
| D | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Feb 2019, 10 months.
Results were first posted in Mar 2020, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Health Science Center, Houston →