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

NCT04074616 | Completed Results DMC FDA Device

• 2 other identifiers: HSC-MS-19-0518KL2TR003168
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Spinal Cord Injury; Neurogenic Bladder

Keywords

electric stimulation

Outcome Measures

Primary Outcomes (3)

• 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

  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

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

  baseline, 3 months

Secondary Outcomes (3)

• Number of Participants With a Change in the Incontinence Quality of Life Questionnaire Score From Baseline

  baseline, 3 months

• 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

Study Arms (2)

High Dose

EXPERIMENTAL

Device: High Dose

Control

OTHER

Low dose TTNS

Device: Low dose

Interventions

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.

Also known as: TTNS stimulation

High Dose

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

Also known as: TTNS stimulation

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (27)

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• Sirls ER, Killinger KA, Boura JA, Peters KM. Percutaneous Tibial Nerve Stimulation in the Office Setting: Real-world Experience of Over 100 Patients. Urology. 2018 Mar;113:34-39. doi: 10.1016/j.urology.2017.11.026. Epub 2017 Nov 28.

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• Fougere RJ, Currie KD, Nigro MK, Stothers L, Rapoport D, Krassioukov AV. Reduction in Bladder-Related Autonomic Dysreflexia after OnabotulinumtoxinA Treatment in Spinal Cord Injury. J Neurotrauma. 2016 Sep 15;33(18):1651-7. doi: 10.1089/neu.2015.4278. Epub 2016 Apr 13.

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MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The COVID-19 pandemic imposed constraints on participants' ability to travel and communicate, leading to dropouts, as well as affecting research staffing and the ability to perform research.

Results Point of Contact

• Title: Argyrios Stampas, MD
• Organization: The University of Texas Health Science Center at Houston

argyrios.stampas@uth.tmc.edu

713-797-5938

Study Officials

• Argyos Stampas, MD

  UTHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized sham-control trial

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: November 19, 2019
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: October 15, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)