The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury

The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury; Neurogenic Bladder
• Intervention / Treatment: Device: Transcutaneous Tibial Nerve Stimulation; Device: Control

Detailed Description

In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrollment within 6 weeks of injury
• Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord.
• Location and transportation available for follow-up appointments

Exclusion Criteria:

• History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy
• Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.)
• History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
• Pregnancy
• History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
• Morbid obesity
• Ventilator dependent respiration
• Significant autonomic dysreflexia during baseline urodynamic study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Tibial Nerve Stimulation; Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.	Device: Transcutaneous Tibial Nerve Stimulation; 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch 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. Current intensity may vary from patient to patient and will be documented and used in the analysis.
Sham Comparator: Control; Sham stimulation.	Device: Control; 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Infection	All infections were urinary tract infections (UTIs).	about 4 weeks
Number of Participants With Skin Irritation	Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.	about 4 weeks
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital		about 4 weeks
Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)	Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's "mean change in pain score": [Average of the post-stimulation measurements for all 10 time points] minus [Average of baseline measurements for all 10 time points time point] = [mean change in pain score]. The value reported is the mean of all participants' "mean change in pain score." The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain.	baseline, about 30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Detrusor Pressure as Evaluated by Urodynamic Study	baseline
Maximum Detrusor Pressure as Evaluated by Urodynamic Study	2 weeks
Maximum Bladder Capacity as Evaluated by Urodynamic Study	baseline
Maximum Bladder Capacity as Evaluated by Urodynamic Study	2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Baylor College of Medicine; University of Houston; Case Western Reserve University; The Institute for Rehabilitation and Research (TIRR)
• Investigators: Principal Investigator: Argyrios Stampas, MD, University of Texas at Houston Health Science Center

Publications and helpful links

General Publications

• Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2016
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: electric stimulation; urodynamic study
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: HSC-MS-15-0806

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