N/A
N=19
The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
Spinal Cord Injury · Neurogenic Bladder
Bottom Line
View on ClinicalTrials.gov: NCT02573402 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Infection — 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous Tibial Nerve Stimulation (Device); Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Oct 2017
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 Detrusor Pressure as Evaluated by Urodynamic Study |
38.1; 44.4 | — |
| SECONDARY Maximum Bladder Capacity as Evaluated by Urodynamic Study |
552.6; 459.6 | — |
| SECONDARY Maximum Bladder Capacity as Evaluated by Urodynamic Study |
552.6; 459.6 | — |
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).
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.
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.