Chronic Spinal Cord Injury, Neurogenic Bowel
Conditions
Keywords
electric stimulation
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.
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.
Interventions
DEVICE4-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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Was Not Painful | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Improved my Quality of Life | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item I Enjoyed Using TTNS | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| 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 | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary | 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. |
| Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary | week 1 | The research assistant will call weekly to capture the written data and monitor progress with the protocol. |
| Overall Satisfaction of Daily Use of TTNS at Home | week 1 | The research assistant will call weekly to capture the written data and monitor progress with the protocol. |
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Was Easy to Use | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item It Was Not Embarrassing to Use TTNS | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| 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 | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
| Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Did Not Irritate my Skin | week 4 | The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Catheterizations Per Day | 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. |
| Volume of Catheterization | 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. |
| Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | 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. |
| Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4-week TTNS Home Based Protocol Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 4-week protocol.
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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | 4-week TTNS Home Based Protocol |
|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 11.1 |
| American Spinal Injury Association Impairment Scale Level A | 11 Participants |
| American Spinal Injury Association Impairment Scale Level B | 2 Participants |
| American Spinal Injury Association Impairment Scale Level C | 2 Participants |
| American Spinal Injury Association Impairment Scale Level D | 1 Participants |
| Number of participants on bladder medication | 14 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
| Years of injury | 8.75 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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.
Time frame: week 4
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 days | Standard Deviation 1.3 |
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.
Time frame: week 1
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 days | Standard Deviation 0.5 |
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.
Time frame: week 2
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 days | Standard Deviation 0 |
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.
Time frame: week 3
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 days | Standard Deviation 0 |
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.
Time frame: week 1
Population: This data was not collected.
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.
Time frame: week 3
Population: This data was not collected.
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.
Time frame: week 2
Population: This data was not collected.
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 3.5 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 3.5 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 0.484 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 2.42 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 1.3 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 2.42 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 3.9 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 1.7 |
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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 score on a scale | Standard Deviation 0 |
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.
Time frame: week 1
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 adverse events |
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.
Time frame: week 2
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 adverse events |
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.
Time frame: week 3
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 adverse events |
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.
Time frame: week 4
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 adverse events |
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.
Time frame: week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Dry Mouth | 0.38 score on a scale | Standard Deviation 0.62 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Constipation | 0.44 score on a scale | Standard Deviation 0.81 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Hard Stool | 0.38 score on a scale | Standard Deviation 0.72 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Sleepy | 0.56 score on a scale | Standard Deviation 0.81 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Decreased Cognition | 0.19 score on a scale | Standard Deviation 0.54 |
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.
Time frame: week 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Dry Mouth | 1.00 score on a scale | Standard Deviation 1.15 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Constipation | 0.50 score on a scale | Standard Deviation 0.97 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Hard Stool | 0.75 score on a scale | Standard Deviation 0.77 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Sleepy | 1.06 score on a scale | Standard Deviation 0.93 |
| 4-week TTNS Home Based Protocol | Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire | Decreased Cognition | 0.25 score on a scale | Standard Deviation 0.58 |
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.
Time frame: week 1, week 2, week 3, week 4
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4-week TTNS Home Based Protocol | Number of Catheterizations Per Day | week 1 | 5.2 catherizations per day | Standard Deviation 1.7 |
| 4-week TTNS Home Based Protocol | Number of Catheterizations Per Day | week 2 | 5.1 catherizations per day | Standard Deviation 1.8 |
| 4-week TTNS Home Based Protocol | Number of Catheterizations Per Day | week 3 | 5.4 catherizations per day | Standard Deviation 1.8 |
| 4-week TTNS Home Based Protocol | Number of Catheterizations Per Day | week 4 | 5.4 catherizations per day | Standard Deviation 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.
Time frame: week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week TTNS Home Based Protocol | Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | 59.1 score on a scale | Standard Error 3.51 |
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.
Time frame: Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week TTNS Home Based Protocol | Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | 70.2 score on a scale | Standard Deviation 17 |
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.
Time frame: week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week TTNS Home Based Protocol | Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey | 55.6 score on a scale | Standard Error 4.67 |
Secondary
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
Population: Only 14 of the 16 participants used the bladder diary, which was used to collect this data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 4-week TTNS Home Based Protocol | Volume of Catheterization | week 1 | 366 milliliters | Standard Deviation 131.4 |
| 4-week TTNS Home Based Protocol | Volume of Catheterization | week 2 | 332 milliliters | Standard Deviation 129.6 |
| 4-week TTNS Home Based Protocol | Volume of Catheterization | week 3 | 340.1 milliliters | Standard Deviation 140.2 |
| 4-week TTNS Home Based Protocol | Volume of Catheterization | week 4 | 342.6 milliliters | Standard Deviation 138.9 |