Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation (TTNS-RCT)

The University of Texas System (UT)

Status: Completed

Conditions: Chronic Spinal Cord Injury; Neurogenic Bladder

Treatments: Device: High Dose; Device: Low dose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04074616

HSC-MS-19-0518

KL2TR003168 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

High Dose

Experimental group

Treatment:

Device: High Dose

Control

Other group

Description:

Low dose TTNS

Treatment:

Device: Low dose