Status:
COMPLETED
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Chronic Spinal Cord Injury
Neurogenic Bowel
Eligibility:
All Genders
18-65 years
Phase:
NA
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 Inco...
Eligibility Criteria
Inclusion
- 18-65 years old
- Neurologically stable SCI for ≥ 6 months
- Intermittent catheterization to empty bladder
- Stable bladder medications for ≥ 3 months
Exclusion
- 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
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03458871
Start Date
March 13 2018
End Date
February 6 2019
Last Update
October 29 2021
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030