# Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder

> **NIH NIH R44** · SPINEX, INC. · 2022 · $924,935

## Abstract

Summary
 Spinal cord injury invariably leads to severe dysfunction of the lower urinary tract; patients develop urinary
incontinence, recurrent urinary tract infections, incomplete bladder emptying and high bladder pressures.
Reliance on catheters to empty the bladder is virtually universal. Established therapies for lower urinary tract
dysfunction due to spinal cord injury focus on preventing and managing complications rather than on restoring
function. Relying on our years of experience in rehabilitation of motor function after paralysis, we are confident
that we can change the paradigm of bladder care in individuals with spinal cord injuries as well. Transcutaneous
Electrical Spinal Cord Neuromodulation (TESCoN) offers a diametrically different approach to classic therapies
for neurogenic bladder: by delivering low-intensity sub-motor threshold electrical pulses to the spinal cord,
TESCoN activates lumbar neural networks rendered dysfunctional by the spinal cord injury and restores some
communication between the lower urinary tract and higher neural centers responsible for micturition control.
Results from our preliminary studies indicate that TESCoN-mediated neuromodulation improves bladder
capacity, diminishes urinary incontinence and, remarkably, restores bladder sensation even in individuals, whose
spinal cord injury is considered clinically complete.
 In this Phase II application, we propose to build a commercial version of the TESCoN prototype under
design controls and use the device in a clinical validation study. We propose a multicenter randomized control
trial to demonstrate the beneficial effects of TESCoN on the paralyzed lower urinary tract. By recruiting sixty
individuals with spinal cord injury and comparing the effects of sham and true stimulation on their lower urinary
tract, we aim to show that TESCoN has a significant role in managing and rehabilitating urinary function in the
clinical setting (primary outcome). The academic roots of our company and the team we have assembled
(engineers, entrepreneurs and clinicians) ensure that our study design, implementation and analysis will be both
impactful and rigorous. Successful completion of this study will provide evidence for a FDA 510(k) submission.
Finally, if TESCoN is successful in the case of a neurological impairment as devastating as a spinal cord injury,
we are confident that we will be able to bring this technology to a much larger population of patients suffering
from lower urinary tract dysfunction due to both neurological and non-neurological conditions, such as stroke,
multiple sclerosis, Parkinson’s disease and idiopathic overactive bladder.

## Key facts

- **NIH application ID:** 10469494
- **Project number:** 5R44DK129164-02
- **Recipient organization:** SPINEX, INC.
- **Principal Investigator:** Parag Gad
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $924,935
- **Award type:** 5
- **Project period:** 2021-08-15 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10469494

## Citation

> US National Institutes of Health, RePORTER application 10469494, Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder (5R44DK129164-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10469494. Licensed CC0.

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