Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Purpose
The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home
Conditions
- Chronic Spinal Cord Injury
- Neurogenic Bladder
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Traumatic and non-traumatic SCI performing IC - Up to 2 anticholinergic overactive bladder (OAB) medications - No changes in OAB medications - Neurologic level of injury above T10 - English and Spanish speaking
Exclusion Criteria
- Past history of genitourinary diagnoses or surgeries - History of central nervous system (CNS) disorders and/or peripheral neuropathy - Pregnancy - Lower motor neuron bladder - Concern for tibial nerve pathway injury - Absence of toe flexion or AD with electric stimulation - Bladder chemodenervation in past 6 months - Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- randomized sham-control trial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- The Study is designed to look at the difference in "high dose" group, which will be submotor amperage, compared to "low dose" which will be set to 1 mA. Both groups will need to stimulate the tibial nerve and visualize toe movement, and then decrease to the amperage of either "high dose" or "low dose." Both groups will use the device for 30 minutes, 5 days per week. A urodynamic study will be performed to measure bladder capacity, sensations while filling, and detrusor pressures before starting using the device and one last time at the end of the study. We are also conducting surveys to describe differences in preferences with using bladder medications versus devices.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental High Dose |
|
|
Other Control |
Low dose TTNS |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston