Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Purpose

The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.

Conditions

  • Spinal Cord Injury (SCI)
  • Neurogenic Bladder (NB)

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Non-progressive chronic (>1 year) SCI - Neurologic level of injury T9 and above - Stable over active bladder (OAB) medications (≥3 months) - No contraindication to MRI (per MRI Safety Questionnaire) - English or Spanish speaking - Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted) - Pass the tTNS competency checklist to perform or direct performance of tTNS.

Exclusion Criteria

  • Ongoing/active genitourinary oncologic diagnoses - History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy - Pregnancy or planning to become pregnant. - Lower Motor Neuron bladder - Restorative bladder surgery such as augmentation cystoplasty - Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed) - Anticoagulation treatment or prophylaxis - Advanced peripheral vascular disease (gangrene, amputation, etc.) - History of intolerance to electrical stimulation, particularly of the leg

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bilateral iTNS 		participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation
  • Device: iTNS
    The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.
Active Comparator
Unilateral iTNS 		participants will receive one active and one sham tibial nerve stimulation (TNS) device. The treatment will only be delivered to the leg with the active device.
  • Device: iTNS
    The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.
  • Device: Sham iTNS
    The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.
Sham Comparator
Sham iTNS 		participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use.
  • Device: Sham iTNS
    The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Argyrios Stampas, MD
713-797-5938
argyrios.stampas@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Argyrios Stampas, MD
(713) 797-5938
argyrios.stampas@uth.tmc.edu