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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573402
• Other study ID #: HSC-MS-15-0806
• Status: Completed
• Phase: N/A
• Start date: July 12, 2016
• Est. completion date: October 27, 2017

Study information

• Verified date: August 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (5)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Baylor College of Medicine, Case Western Reserve University, The Institute for Rehabilitation and Research (TIRR), University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Infection	All infections were urinary tract infections (UTIs).	about 4 weeks
Primary	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
Primary	Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital		about 4 weeks
Primary	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	Maximum Detrusor Pressure as Evaluated by Urodynamic Study		baseline
Secondary	Maximum Detrusor Pressure as Evaluated by Urodynamic Study		2 weeks
Secondary	Maximum Bladder Capacity as Evaluated by Urodynamic Study		baseline
Secondary	Maximum Bladder Capacity as Evaluated by Urodynamic Study		2 weeks