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Completed

NCT Number: NCT02573402

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

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).

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Tibial Nerve Stimulation

Device

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

Device

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 outcomes

  1. Number of Participants With Infection

    Time frame: about 4 weeks

    All infections were urinary tract infections (UTIs).

  2. Number of Participants With Skin Irritation

    Time frame: about 4 weeks

    Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.

  3. Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital

    Time frame: about 4 weeks

  4. Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)

    Time frame: baseline, about 30 minutes

    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 outcomes

  1. Maximum Detrusor Pressure as Evaluated by Urodynamic Study

    Time frame: baseline

  2. Maximum Detrusor Pressure as Evaluated by Urodynamic Study

    Time frame: 2 weeks

  3. Maximum Bladder Capacity as Evaluated by Urodynamic Study

    Time frame: baseline

  4. Maximum Bladder Capacity as Evaluated by Urodynamic Study

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Baylor College of Medicine
  • Case Western Reserve University
  • The Institute for Rehabilitation and Research (TIRR)
  • University of Houston

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2015
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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