Clinical Trial

Tibial Nerve Stimulation for Neurogenic Bladder at UT Houston

We are collaborating with UT Health TIRR Spinal Cord Injury Clinic, Baylor Urology Clinic, Houston Methodist Hospital, the Michael E. DeBakey Department of Veterans Affairs Medical Center Urology Clinic, and Neuronoff, Inc. to conduct a clinical pilot study. This study will utilize the Injectrode to provide bilateral tibial nerve stimulation and evaluate its therapeutic impact on neurogenic bladder symptoms.

Fig. 1 (right): Video showing the placement of the Injecrode on the Tibial Nerve and stimulation with the External Pulse Generator to activate sensory input to sacral spinal circuitry to study impact on Neurogenic Bladder.

To enable this randomized sham-controlled clinical trial (RCT), we plan to enroll 21 individuals, starting in Q4/2025, with chronic non-progressive SCI (men and women) meeting the inclusion/exclusion (I/E) criteria. Study participants will be will be recruited from the UT Health TIRR SCI clinic, Baylor Urology clinic, Houston Methodist Hospital, and the Michael E. DeBakey Dept. of Veterans Affairs Medical Center Urology Clinic (VA Urology); and randomized to the active bilateral (n=7), active unilateral (n=7) or sham-control group (n=7) using a 1:1:1 randomization process (Fig. 2).

We plan to have Injectrodes implanted bilaterally on the left leg and right leg tibial nerve during this 2-month study. The age range (>18 years) for this study was selected because age-related changes (prostate and bladder) that may alter the urodynamic studies in adults increase over the age of 75. Neurologic level T9 and above and severity of injury A-D on the International Standards for Neurological Classification of SCI (ISNCSCI) will be included. Given the challenges that people with SCI face regarding access to health care, we plan to reimburse all travel expenses and time for each study component.

Fig 2. Study Design