# Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Based Bladder Permeability Assay

> **NIH NIH R44** · LIPELLA PHARMACEUTICALS, INC. · 2022 · $673,049

## Abstract

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic, debilitating condition that affects more than 2
million individuals within the US. Recently, the chronic pelvic pain working group of the ICS has classified
IC/BPS into either hypersensitive bladder with no identifiable pathology explaining the symptoms of IC/BPS,
IC/BPS with Hunner lesion (HIC) or IC/BPS with no lesions on cystoscopy (NHIC). Though the etiology of
IC/BPS is multifactorial, a large body of evidence supports the impairment of bladder mucosal permeability as
a major pathophysiological cause in HIC. Yet, there remains variability (5-57%) in the true identification of
IC/BPS that is bladder-centric on the basis on cystoscopy. Therefore, a minimally invasive, assay that reliably
measures bladder permeability without evoking pain or exposing ionizing radiation to subjects may be able to
meet the FDA regulatory criteria for a diagnostic test. With the past funding support, we developed a radiation
free, minimally invasive assay of bladder mucosal permeability, and we demonstrated the validity of
intravesical contrast enhanced magnetic resonance imaging (ICE-MRI) to measure permeability of thin mouse
and rat bladder at high field scanners of 7T and 9.4T (PMC7509285; PMC6028942; PMC8484474). A key
feature of our ICE-MRI assay of bladder permeability is the transurethral catheter instillation of Gadobutrol and
Ferumoxytol mixture and then MRI capitalizes on the linear relationship between the concentration of instilled
Gadobutrol diffusing passively into the mucosa to cause concentration dependent changes in T1 relaxation rate
(1/T1 relaxation time) of the mucosa. While Gadobutrol instilled into bladder lumen diffuses into mucosa down
the concentration gradient, our preliminary data demonstrates that mucosa lesion accelerates the Gadobutrol
diffusion relative to normal areas. We now seek funding support to generate clinical evidence for
demonstrating that ICE-MRI can be a diagnostic test for bladder-centric phenotype in IC/BPS patients to
complement conventional cystoscopy-based diagnosis. Following Specific Aims will test the hypothesis that
bladder mucosal permeability of instilled Gadobutrol mixture descends quantitatively from HIC >NHIC
>asymptomatic control subjects.: Aim 1: To calibrate the ICE-MRI based bladder mucosal permeability assay
on HIC, NHIC patients and asymptomatic subjects who have normal cystoscopic findings. In a cross-sectional
prospective study on previously cystoscoped 10 HIC patients, 10 NHIC patients, and 10 asymptomatic
controls, we will calibrate the ICE-MRI based bladder mucosal permeability assay. Aim 2: To manufacture
sterile clinical trial materials and complete the IND/IDE submission for the ICE-MRI based bladder permeability
assay kit. A radiation-free, objective diagnostic test of bladder permeability can objectively phenotype IC/BPS
IC/BPS that is bladder-centric, thereby identifying patients who would be most likely to benefit from anti-...

## Key facts

- **NIH application ID:** 10545115
- **Project number:** 2R44DK108397-04
- **Recipient organization:** LIPELLA PHARMACEUTICALS, INC.
- **Principal Investigator:** JONATHAN H KAUFMAN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $673,049
- **Award type:** 2
- **Project period:** 2015-09-20 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10545115

## Citation

> US National Institutes of Health, RePORTER application 10545115, Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Based Bladder Permeability Assay (2R44DK108397-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10545115. Licensed CC0.

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