Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation (HomeTTNS)
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About
Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in chronic SCI provided by self or caregiver for 4 weeks.
Full 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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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