Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

Not Applicable

Completed

• Conditions: Neurogenic Bladder; Chronic Spinal Cord Injury
• Interventions: Device: High Dose; Device: Low dose

• Registration Number: NCT04074616
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Study Start: 2019-11-19
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Results First Submitted: 2024-04-17
• Results First Submitted QC: 2024-04-17
• Results First Posted: 2024-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose	High Dose	-
Control	Low dose	Low dose TTNS

Primary Outcome Measures

Name	Time	Method
Number of Participants With Reduction in Bladder Medication	baseline, 3 months
Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline	Baseline, 3 months	The Neurogenic Bladder Symptom (NBSS) Score is a questionnaire that measures bladder symptoms, with total score ranging from 0 to 74; a higher score indicating a worse outcome.; Scores at baseline are compared to scores at 3 months, and a change is reported categorically as follows: Stable: A score change within + 5 or -5 points (not including 5); Worse: A score increase of 5 points or more from baseline; Improved: A score decrease of 5 points or more from baseline; These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change
Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary	baseline, 3 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline	baseline, 3 months	The Incontinence Quality of Life questionnaire assesses the impact of urinary incontinence on a person's quality of life. The total score ranges from 0 to 100, a lower score indicating a worse outcome. Scores at baseline are compared to scores at 3 months, and a change is reported as categorically as follows: Stable: A score change within +4 or -4 points (not including 4); Worse: A score decrease of 4 or more points from baseline; Improved: A score increase of 4 or more points from baseline; These categories are mutually exclusive and exhaustive; each participant will fit into only one category based on their score change.
Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey	baseline, 3 months
Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study	baseline, 3 months

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States