Deployable Interstitial Cystitis Urine Diagnostic Technology Development
Abstract
This proposal directly focuses on the Topic Area of Interstitial Cystitis (IC), including the Area of Encouragement for the identification of biological markers for making a definitive diagnosis of IC. This is not a clinical trial as there is no intervention or therapy that will be tested in patients. The Problem: Diagnosing IC is difficult as there is no definitive test for IC. Instead, the diagnosis is based on urinary symptoms such as severe pain associated with the bladder or pelvic area, how often a person uses the bathroom, how urgent the feeling to use the bathroom is, as well as other urinary symptoms. Patients may have to undergo a procedure called a cystoscopy for the physician to look in their bladder, which can be painful and have side effects. Unfortunately, these symptoms are also experienced in other conditions such as a urinary tract infection, bladder cancer, or overactive bladder, making it difficult for the physician to uncover the cause of the patients’ symptoms. As a result, many patients may go years without a correct diagnosis and proper disease management by a knowledgeable clinical team, leading to unnecessary pain and suffering. Without proper symptom management and support, people suffering from IC may be unable to work, become depressed, and may even think of suicide. Our Solution: The goal of this grant is to develop a simple test for diagnosing IC based on urine and symptom scores called the Interstitial Cystitis Risk Score (IC-RS). A machine learning algorithm, similar to an internet search engine, will use this information to determine if a person has IC or not; and if they have IC, whether their IC is characterized by Hunner’s lesions. Our Plan to Transition the IC-RS to Patient Care: To make sure this is an accurate test for IC in all patients, we want to test this in as many patients with IC and without IC as possible (at least 1,000 people per group) from across the United States. This includes people that have a normal bladder as well as people that have similar symptoms but do not have IC such as people with urinary tract infection, bladder cancer, or overactive bladder. By testing it in these other conditions, we can develop a test that is specific to IC only. To do this, we will use social media such as Twitter and Facebook and work with patient advocacy organizations to have people collect urine samples from across the country, from the comfort of their own homes, to send to us for analysis (Aim 1). We will collect from people of all ages, genders, and from within the military as well. We will have online tools such as a website, YouTube videos on how to collect and ship urine samples, as well as a phone number and email address for additional questions. We will also collect 675 samples from three major hospitals throughout the United States, including a Veterans Affairs (VA) hospital, where we know for sure if a person has IC or not (Aim 2). We will determine if it is fine to do the test at home or if it works better when done at a clinic. Lastly, we want to make sure the urine collection kit is easy to use and can be shipped anywhere (Aim 3). Study participants will give us feedback on kit design in addition to testing done in our lab; we will make the best test kit possible. We will then work on making it so that this test can be done at any doctor’s office in the world using a small, tabletop machine that is fully automated so that patients can get their results quickly (Aim 3). Together, this will make the IC-RS ready to be used by physicians and patients within the next 5 years. Impact of This Work: Having a validated diagnostic test for IC is critical and would be a huge advancement. Patients could get a proper diagnosis and clinical management of their symptoms faster. This will help military personnel suffering from IC return to full service, improving military well-being and readiness. Also, drug companies developing new drugs and therapi
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910288
Entities
People
- Laura Lamb
Organizations
- United States Army