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

Primary Purpose

Chronic Spinal Cord Injury, Neurogenic Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Dose
Low dose
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spinal Cord Injury focused on measuring electric stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High Dose

Control

Arm Description

Low dose TTNS

Outcomes

Primary Outcome Measures

Number of participants with reduction in bladder medication
Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the neurogenic bladder symptom score (NBSS)scale.
The NBSS scale consists of 24 questions each with a score ranging form 0-4.Higher the score indicates a worse outcome.
Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the voiding dairy

Secondary Outcome Measures

Number of participants with improved quality of life as assessed by the I-QOL questionnaire
Number of participants with decreased anticholinergic side effects as measured by the anticholinergic side effects survey
Number of participants with stable or improved bladder capacity as assessed by the urodynamic study
urodynamic study

Full Information

First Posted
August 28, 2019
Last Updated
June 21, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT04074616
Brief Title
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Acronym
TTNS-RCT
Official Title
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spinal Cord Injury, Neurogenic Bladder
Keywords
electric stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized sham-control trial
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Arm Description
Low dose TTNS
Intervention Type
Device
Intervention Name(s)
High Dose
Other Intervention Name(s)
TTNS stimulation
Intervention Description
Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks,with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
Intervention Type
Device
Intervention Name(s)
Low dose
Other Intervention Name(s)
TTNS stimulation
Intervention Description
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
Primary Outcome Measure Information:
Title
Number of participants with reduction in bladder medication
Time Frame
3 months after subject enrollment
Title
Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the neurogenic bladder symptom score (NBSS)scale.
Description
The NBSS scale consists of 24 questions each with a score ranging form 0-4.Higher the score indicates a worse outcome.
Time Frame
3 months after subject enrollment
Title
Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the voiding dairy
Time Frame
3 months after subject enrollment
Secondary Outcome Measure Information:
Title
Number of participants with improved quality of life as assessed by the I-QOL questionnaire
Time Frame
3 months after subject enrollment
Title
Number of participants with decreased anticholinergic side effects as measured by the anticholinergic side effects survey
Time Frame
3 months after subject enrollment
Title
Number of participants with stable or improved bladder capacity as assessed by the urodynamic study
Description
urodynamic study
Time Frame
At baseline and 3 month after subject enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argyos Stampas, MD
Organizational Affiliation
UTHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

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