Status:
COMPLETED
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Chronic Spinal Cord Injury
Neurogenic Bladder
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04074616
Start Date
November 19 2019
End Date
April 20 2023
Last Update
October 15 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030