Abstract

BackgroundInterstitial cystitis/bladder pain syndrome (IC) is a multifactorial syndrome of severe pelvic and genitalia pain and compromised urinary function; a subset of IC patients present with Hunner’s lesions or ulcers on their bladder walls (UIC). UIC is diagnosed by cystoscopy, which may be quite painful. The objective of this study was to determine if a calculated Bladder Permeability Defect Risk Score (BP-RS) based on non-invasive urinary cytokines could discriminate UIC patients from controls and IC patients without Hunner’s ulcers.MethodsA national crowdsourcing effort targeted IC patients and age-matched controls to provide urine samples. Urinary cytokine levels for GRO, IL-6, and IL-8 were determined using a Luminex assay.ResultsWe collected 448 urine samples from 46 states consisting of 153 IC patients (147 female, 6 male), of which 54 UIC patients (50 females, 4 male), 159 female controls, and 136 male controls. A defined BP-RS was calculated to classify UIC, or a bladder permeability defect etiology, with 89% validity.ConclusionsThe BP-RS Score quantifies UIC risk, indicative of a bladder permeability defect etiology in a subset of IC patients. The Bladder Permeability Defect Risk Score is the first validated urine biomarker assay for interstitial cystitis/bladder pain syndrome.

Highlights

  • Interstitial cystitis/bladder pain syndrome (IC) is a chronic, severely debilitating disease of the bladder characterized by urinary frequency and urgency, and severe suprapubic, external genitalia, and/or pelvic pain [1]

  • The objective of this study was to determine if a calculated Bladder Permeability Defect Risk Score (BP-RS) based on non-invasive urinary cytokines could discriminate UIC patients from controls and IC patients without Hunner’s ulcers

  • The Bladder Permeability Defect Risk Score is the first validated urine biomarker assay for interstitial cystitis/bladder pain syndrome

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Summary

Introduction

Interstitial cystitis/bladder pain syndrome (IC) is a chronic, severely debilitating disease of the bladder characterized by urinary frequency and urgency, and severe suprapubic, external genitalia, and/or pelvic pain [1]. 10% of IC patients present with Hunner’s lesions or ulcers (UIC), distinct areas of inflammation on the bladder wall. Some patients may experience painful urination, hematuria, urinary tract infection, and rare risk of bladder wall perforation. In an effort to limit invasive testing and to meaningfully classify IC patients, we sought to determine if a urine based test could be developed to distinguish UIC from IC without Hunner’s lesions (NUIC). Interstitial cystitis/bladder pain syndrome (IC) is a multifactorial syndrome of severe pelvic and genitalia pain and compromised urinary function; a subset of IC patients present with Hunner’s lesions or ulcers on their bladder walls (UIC). The objective of this study was to determine if a calculated Bladder Permeability Defect Risk Score (BP-RS) based on non-invasive urinary cytokines could discriminate UIC patients from controls and IC patients without Hunner’s ulcers

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