# Toward wearable ultrasonic neurostimulation for daily at-home treatment of urinary urge incontinence

> **NIH VA I21** · LOUIS STOKES CLEVELAND VA MEDICAL CENTER · 2021 · —

## Abstract

Urinary incontinence (UI) significantly impacts approximately 30% of the world’s population. The most
prevalent condition, overactive bladder (OAB), affects 15% of adults and often manifests with other urinary
dysfunctions causing urine leakage. OAB has an enormous US economic burden of $83 billion, in part from
increased nursing home use due to UI. Incontinence profoundly impacts dignified, independent living, contributes
to urinary tract infections, pressure ulcer sepsis and fall risk, and is a leading factor in functional decline among
the elderly. As a result, UI is a major factor in clinical depression and contributes to social isolation . The risk
factors for OAB (aging, obesity, diabetes, menopause, enlarged prostate) are disproportionately experienced by
Veterans, and UI associates with military service and post-traumatic stress disorder in both male and female
Veterans. Therefore UI (and OAB in particular) will continue to affect older Veterans disproportionately.
 Of the limited treatments for refractory OAB, percutaneous tibial nerve stimulation (PTNS) is likely the
cheapest and safest. This project will demonstrate the feasibility of using ultrasonic nerve stimulation (UNS) as
a novel alternative to PTNS. The rapidly decreasing cost for ultrasonic equipment is driving investigation of UNS
to deliver targeted energy to the nerve without breaking the skin or causing discomfort from surface stimulation.
UNS has many potential rehabilitation uses, i.e. for the treatment of neuropathic or amputee pain, or for locations
that are difficult to access surgically. These treatments are all opportunities for future research. However,
beginning with OAB is an excellent option for initial translation because the tibial nerve is superficial, PTNS is an
established therapy, and because there are designated safe limits for ultrasound exposure. At this stage of
research, our first goal is to generate the needed evidence to compete for funding to translate UNS to Veterans
with OAB. Wearable tibial neurostimulation that is easy to use in the home would greatly expand access to these
rehabilitation treatments for Veterans who have limited mobility, income, or live in rural locales.
 Critically, prior studies have demonstrated that low-intensity tibial UNS modulates bladder function and that
peripheral UNS occurs with ultrasonic intensities below FDA safety limits. However, the UNS energy thresholds
to produce compound action potentials (CAP) in the tibial and sciatic nerves have not been determined in the
context of UI. Further, all prior UNS research has used bulky transducers which are not usable outside of
laboratory settings. This work will address two feasibility challenges for future funding and translation: 1)
identifying the minimum UNS intensity needed to noninvasively modulate CAPs and inhibit bladder contractions
and 2) showing that thin, flexible, beam-formed arrays can produce ultrasonic intensities up to FDA safety limits
at human anatomical...

## Key facts

- **NIH application ID:** 10363621
- **Project number:** 5I21RX003591-02
- **Recipient organization:** LOUIS STOKES CLEVELAND VA MEDICAL CENTER
- **Principal Investigator:** Steve Majerus
- **Activity code:** I21 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2021
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2020-10-01 → 2022-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10363621

## Citation

> US National Institutes of Health, RePORTER application 10363621, Toward wearable ultrasonic neurostimulation for daily at-home treatment of urinary urge incontinence (5I21RX003591-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10363621. Licensed CC0.

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