Skip to main content
OpenTrials
Completed

NCT Number: NCT04074616

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Spinal Cord Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Dose

Device

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

Low dose

Device

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

Primary outcomes

  1. Number of Participants With Reduction in Bladder Medication

    Time frame: baseline, 3 months

  2. 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

  3. Number of Participants With Reduced Neurogenic Bladder Symptoms (NGB) as Measured by the Voiding Diary

    Time frame: baseline, 3 months

Secondary outcomes

  1. 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.

  2. Number of Participants With Decreased Anticholinergic Side Effects as Measured by the Anticholinergic Side Effects Survey

    Time frame: baseline, 3 months

  3. Number of Participants With Increased or Stable Bladder Capacity as Assessed by the Urodynamic Study

    Time frame: baseline, 3 months

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Acronym: TTNS-RCT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.