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

October 9, 2024 updated by: Argyrios Stampas, MD, The University of Texas Health Science Center, Houston
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose
Device: High Dose
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.
Other Names:
  • TTNS stimulation
Other: Control
Low dose TTNS
Device: Low dose
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
Other Names:
  • TTNS stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Reduction in Bladder Medication
Time Frame: baseline, 3 months
baseline, 3 months
Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary
Time Frame: baseline, 3 months
baseline, 3 months
Number of Participants With a Change in Neurogenic Bladder Symptom Score (NBSS) Scale From Baseline
Time Frame: 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
Baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey
Time Frame: baseline, 3 months
baseline, 3 months
Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study
Time Frame: baseline, 3 months
baseline, 3 months
Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline
Time Frame: 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.
baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Argyos Stampas, MD, UTHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-19-0518
  • KL2TR003168 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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