# Clinical readiness of Uzap - the minimally invasive Overactive Bladder treatment

> **NIH NIH R44** · STELLARTECH RESEARCH CORPORATION · 2023 · $975,754

## Abstract

Abstract
 Overactive bladder (OAB) severely impacts over 12% of the adult population in the United States
– roughly 30 million people (Irwin, et al., 2006). Pressing and frequent urges to urinate, arousal
from sleep, and sometimes incontinence, result in immense psychosocial and financial costs,
leading to an estimated annual economic burden of >$70B in the US alone (Reynolds, et al.,
2016). Current OAB interventions are varied and include pharmaceuticals, neurostimulators,
botulinum toxin injections, and surgical approaches, all of which have adverse side effects and
lack widespread and enduring efficacy. In addition, drug therapies require long-term dosing and
other treatments can require repeat clinical interventions.
 Stellartech Research Corporation is developing the NewUro Uzap device for transurethral
radiofrequency mucosal partitioning. It is the only minimally-invasive, single-session, non-drug,
non-implant therapy for alleviating the symptoms of OAB without compromising voiding function.
Research has shown excessive electrical connectivity within the bladder mucosa in models of
overactivity (Kanai et al., 2007). This results in exaggerated propagation of wave-like intrinsic
electrical and mechanical activity, which is anticipated to be amenable to therapy by minimally
invasive thermal ablation of mucosal isolation lines by the Uzap. The innovations behind the Uzap
system are already covered by 7 granted patents. Preliminary studies of Uzap ablation on whole
pig bladder and tissue specimens demonstrated reduced contractile response to agonists.
Successful preclinical safety and performance tests were completed in ex vivo and preliminary in
vivo porcine models. This Fast-Track proposal seeks, in Phase 1, to demonstrate long-term in
vivo safety and durability of Uzap therapy, and, in Phase 2, to 1) perform a long-term animal
safety and efficacy study; 2) optimize system and electrode design and usability and fabricate
Verification and Validation units; 3) perform Verification and Validation tests; hold a pre-IDE
(Investigational Device Exemption) meeting and submit an IDE application for a future First-In-
Human trial of 30 female patients with refractory overactive bladder with incontinence. The
rigorous work proposed will create a firm base for advancing the Uzap to the clinical phase and
towards commercialization, in order to provide relief for millions of patients and eliminate the need
for implants or repetitive clinical interventions.

## Key facts

- **NIH application ID:** 10682650
- **Project number:** 4R44DK130724-02
- **Recipient organization:** STELLARTECH RESEARCH CORPORATION
- **Principal Investigator:** Roger Stern
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $975,754
- **Award type:** 4N
- **Project period:** 2021-09-20 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10682650

## Citation

> US National Institutes of Health, RePORTER application 10682650, Clinical readiness of Uzap - the minimally invasive Overactive Bladder treatment (4R44DK130724-02). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10682650. Licensed CC0.

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