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

Primary Purpose

Spinal Cord Injury, Neurogenic Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Tibial Nerve Stimulation
Control
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 Spinal Cord Injury focused on measuring electric stimulation, urodynamic study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcutaneous Tibial Nerve Stimulation

Control

Arm Description

Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.

Sham stimulation.

Outcomes

Primary Outcome Measures

Number of Participants With Infection
All infections were urinary tract infections (UTIs).
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.
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
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.

Secondary Outcome Measures

Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Maximum Bladder Capacity as Evaluated by Urodynamic Study
Maximum Bladder Capacity as Evaluated by Urodynamic Study

Full Information

First Posted
October 5, 2015
Last Updated
August 9, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
The Institute for Rehabilitation and Research (TIRR), Baylor College of Medicine, Case Western Reserve University, University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02573402
Brief Title
The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
Official Title
The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 12, 2016 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
The Institute for Rehabilitation and Research (TIRR), Baylor College of Medicine, Case Western Reserve University, University of Houston

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

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Tibial Nerve Stimulation
Arm Type
Experimental
Arm Description
Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham stimulation.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Tibial Nerve Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Infection
Description
All infections were urinary tract infections (UTIs).
Time Frame
about 4 weeks
Title
Number of Participants With Skin Irritation
Description
Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.
Time Frame
about 4 weeks
Title
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
Time Frame
about 4 weeks
Title
Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)
Description
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.
Time Frame
baseline, about 30 minutes
Secondary Outcome Measure Information:
Title
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Time Frame
baseline
Title
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Time Frame
2 weeks
Title
Maximum Bladder Capacity as Evaluated by Urodynamic Study
Time Frame
baseline
Title
Maximum Bladder Capacity as Evaluated by Urodynamic Study
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argyrios Stampas, MD
Organizational Affiliation
University of Texas at Houston Health Science Center
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

Citations:
PubMed Identifier
30837835
Citation
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.
Results Reference
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The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury

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