Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07264868
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • iTNS — DEVICE
    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.
  • Sham iTNS — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 7, 2026
Status verified
May 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bilateral iTNS
    participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation
  • 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.
  • Sham Comparator: Sham iTNS
    participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use.

Primary Outcome Measure

Safety as assessed by the number of device-related adverse events [ Time Frame: From baseline to 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Argyrios Stampas, MD
[email protected]
713-797-5938
Danira Garcia Gutierrez
[email protected]
(713) 797-7133

Find similar trials in Houston, TX

By research site
The University of Texas Health Science Center at Houston· Houston, TX

Related Studies