Clinical trial NCT04074616: Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Official title: Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Spinal Cord Injury
Neurogenic Bladder
Keywords: electric stimulation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized sham-control trial
Primary purpose: TREATMENT

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 home


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Reduction in Bladder Medication
timeFrame: baseline, 3 months
measure: Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline
timeFrame: Baseline, 3 months
measure: Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline
timeFrame: baseline, 3 months
measure: Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey
timeFrame: baseline, 3 months
measure: Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UTHealth
name: Argyos Stampas, MD
role: PRINCIPAL_INVESTIGATOR
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