# Novel treatment for urinary incontinence and overactive bladder symptoms in the elderly

> **NIH NIH R43** · DIGNIFY THERAPEUTICS, LLC · 2024 · $389,852

## Abstract

Abstract
 Urinary incontinence (UI) and symptoms of overactive bladder (OAB) become more prevalent with age.
The impact on elderly and their caregivers makes it difficult to continue at-home care, and UI is a top reason
for institutionalizing the elderly. More than half of nursing home residents have UI and over ¾ of those with
dementia have UI. The current application proposes to develop new formulations of drugs that are instilled into
the bladder and produce long-term relief of symptoms (> 3 months) in patients who are refractory to current
therapies.
 This project dovetails nicely with the PI’s basic science doctoral and post-doctoral studies of “somatic
nociception” and pain. Our drugs block nociceptor terminals in bladder that are responsible for causing UI and
OAB symptoms, i.e. “visceral nociception”. Thus, Dignify and the PI provide valuable complementary
perspectives and insight into control of nociceptors. As described in the Research Approach, the scientific
rationale for our drugs’ ability to block nociceptors, and for the formulation proposed to deliver drugs directly to
the drug target inside the bladder (i.e. intravesical), are strongly supported by both basic science and clinical
literature. Intravesical delivery should maximize efficacy at the target and minimize plasma concentrations of
the drugs, keeping side-effects, metabolism issues, and drug-drug interactions to a minimum.
 Aim 1 creates novel formulations for the drugs tested in Aims 2 and 3. Aim 2 provides rapid screening of
new formulations of the drugs in acute, in vivo, proof-of-concept, dose-ranging studies in anesthetized rats.
Drug formulations that produce positive results in Aim 2 are then studied across 4 weeks in Aim 3 to determine
duration of therapeutic effects after a single pre-treatment with drug formulations. Protocols for determining
blockade of visceral nociceptors in the bladder are standard cystometrogram methods used in Dignify’s
laboratory for decades, and the results are straight-forward changes in bladder pressures that are induced by
nociceptive stimuli, and the blockade of those changes by our novel therapy. Rigorous analyses, inclusion of
positive and negative internal controls, and other techniques are part of Dignify’s routine for ensuring
reproducible results and confident conclusions. Mastering these in vivo methods and analyses of bladder
nociception will allow the PI to expand into various other bladder, bowel, and sexual conditions that present
symptoms of visceral nociception, as well as an opportunity to become an expert in general CNS and
peripheral neuronal control of sacral pelvic viscera in the elderly under supervision of Dignify mentors.
 Assuming positive results, an SBIR Phase 2 application will be submitted to select a lead candidate and
refine the formulation to maximize efficacy and minimize systemic absorption (if any). Subsequently, IND-
enabling studies will begin with the lead candidate to allow clinical study, in which ...

## Key facts

- **NIH application ID:** 10975087
- **Project number:** 1R43AG088838-01
- **Recipient organization:** DIGNIFY THERAPEUTICS, LLC
- **Principal Investigator:** Qiaojuan ZHANG
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $389,852
- **Award type:** 1
- **Project period:** 2024-09-05 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10975087

## Citation

> US National Institutes of Health, RePORTER application 10975087, Novel treatment for urinary incontinence and overactive bladder symptoms in the elderly (1R43AG088838-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10975087. Licensed CC0.

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