Clinical trial NCT02573402: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Neurogenic Bladder
Keywords: electric stimulation
urodynamic study
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The Institute for Rehabilitation and Research (TIRR)
name: Baylor College of Medicine
name: Case Western Reserve University
name: University of Houston
First posted: 2015-10-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Infection
timeFrame: about 4 weeks
measure: Number of Participants With Skin Irritation
timeFrame: about 4 weeks
measure: Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
timeFrame: about 4 weeks
measure: Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)
timeFrame: baseline, about 30 minutes
Secondary outcomes:
measure: Maximum Detrusor Pressure as Evaluated by Urodynamic Study
timeFrame: baseline
measure: Maximum Detrusor Pressure as Evaluated by Urodynamic Study
timeFrame: 2 weeks
measure: Maximum Bladder Capacity as Evaluated by Urodynamic Study
timeFrame: baseline
measure: Maximum Bladder Capacity as Evaluated by Urodynamic Study
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: University of Texas at Houston Health Science Center
name: Argyrios Stampas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.