N/A Completed N=19 Randomized Single-blind Treatment

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

Spinal Cord Injury · Neurogenic Bladder

Source: ClinicalTrials.gov NCT02573402 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcomePrimary: Number of Participants With Infection — 4; 3 Participants

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Infection	4; 3	—
PRIMARY Number of Participants With Skin Irritation	0; 1	—
PRIMARY Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital	0; 0	—
PRIMARY Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)	-0.01; -0.06	—
SECONDARY Maximum Detrusor Pressure as Evaluated by Urodynamic Study	38.1; 44.4	—
SECONDARY Maximum Bladder Capacity as Evaluated by Urodynamic Study	552.6; 459.6	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02573402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.