N/A
Completed N=16
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Chronic Spinal Cord Injury · Neurogenic Bowel
Source: ClinicalTrials.gov NCT03458871 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary — 0 adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary |
1 | — |
| PRIMARY Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary |
6.6 | — |
| PRIMARY Overall Satisfaction of Daily Use of TTNS at Home |
— | — |
| PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Easy to Use" |
9.4 | — |
| 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" |
9.375 | — |
| 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" |
9.875 | — |
| PRIMARY 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 | — |
| PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "TTNS Was Not Painful" |
10 | — |
| PRIMARY 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 | — |
| PRIMARY Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item "I Enjoyed Using TTNS" |
8.3 | — |
| 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" |
8.4 | — |
| 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" |
9.7 | — |
| SECONDARY Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey |
59.1 | — |
| SECONDARY Number of Catheterizations Per Day |
5.2; 5.1; 5.4; 5.4 | — |
| SECONDARY Volume of Catheterization |
366; 332; 340.1; 342.6 | — |
| SECONDARY Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire |
0.38; 0.44; 0.38; 0.56; 0.19 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03458871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.