Title: Human Factors and Design Finalisation for a Bladder Drug Delivery Device.
Funder: Department of Health and Social Care

Abstract: Aim The project s outcome is finalisation of UroPharma s design for production of a fully functional direct-to-bladder drug-delivery system prototype (&ldquo;the dtb-device&rdquo;) for government approval. The project will include a users study (patients and carers) investigating risks and misuse, as well as the views of multiple sclerosis patients about handling the dtb-device. This data is required in order to progress to safety testing. Background Many people treat their bladder conditions with oral drugs, which are unreliable or have intolerable side effects. Direct-to-bladder drug delivery improves treatment efficacy and minimises side effects. Unfortunately, there are no licensed devices for this purpose, restricting the development of direct-to-bladder drug treatments. Therefore, patients are missing out. Market research confirms that healthcare professionals recognise the need for specially designed and approved devices for direct-to-bladder therapy. Currently, direct drug delivery to the bladder is through a catheter s (flexible plastic tube for assisted urination) urine drainage channel. This creates infection risks because after drainage the tube is contaminated by micro-organisms. Drug delivery through the drainage channel forces micro-organisms back into the bladder. The safest and most effective treatment approach is by directly targeting the affected area through a sterile channel. People suffering a variety of common conditions will benefit from direct-to-bladder technologies including those with: inflamed bladders/bladder pain, urinary tract infections, especially recurrent infections, bladder cancer, bladder overactivity (symptoms of intense urge to urinate when the bladder isn t full), or routine self-catheterisers. Across these conditions millions of people will benefit annually. The dtb-device resembles a urinary drainage-only catheter but has additional features including: a separate sterile drug delivery channel for safe and accurate drug dosing, a patented secure syringe connector to prevent drug administration errors with incompatible drugs, a urine drainage-channel closure mechanism to prevent unintended drug wastage, an adhesive patch for securing the device to the thigh, enabling two-handed drug administration. As a part of the design process, we will seek opinions from people with multiple sclerosis who self-catheterise. Design The project involves four key research stages: addition of a patented syringe adapter to the dtb-device prototype, consultation with patients, study of simulated (with dummy models) device use by identified users, production of devices for further safety testing. Patient and public involvement Patients will be actively involved in the design stages of the dtb-device s development. We will recruit a focus group of multiple sclerosis patients and nurses nationally. Many people with multiple sclerosis regularly catheterise so will gain substantial benefits. We will seek their comments and criticisms as they represent a major target user group and have the most diverse and challenging disabilities. Dissemination Information about the dtb-device is available for the public on UroPharma s website. We have planned to produce leaflets for healthcare professionals and patients.

Lay abstract: Aim The project s outcome is finalisation of UroPharma s design for production of a fully functional direct-to-bladder drug-delivery system prototype (&ldquo;the dtb-device&rdquo;) for government approval. The project will include a users study (patients and carers) investigating risks and misuse, as well as the views of multiple sclerosis patients about handling the dtb-device. This data is required in order to progress to safety testing. Background Many people treat their bladder conditions with oral drugs, which are unreliable or have intolerable side effects. Direct-to-bladder drug delivery improves treatment efficacy and minimises side effects. Unfortunately, there are no licensed devices for this purpose, restricting the development of direct-to-bladder drug treatments. Therefore, patients are missing out. Market research confirms that healthcare professionals recognise the need for specially designed and approved devices for direct-to-bladder therapy. Currently, direct drug delivery to the bladder is through a catheter s (flexible plastic tube for assisted urination) urine drainage channel. This creates infection risks because after drainage the tube is contaminated by micro-organisms. Drug delivery through the drainage channel forces micro-organisms back into the bladder. The safest and most effective treatment approach is by directly targeting the affected area through a sterile channel. People suffering a variety of common conditions will benefit from direct-to-bladder technologies including those with: inflamed bladders/bladder pain, urinary tract infections, especially recurrent infections, bladder cancer, bladder overactivity (symptoms of intense urge to urinate when the bladder isn t full), or routine self-catheterisers. Across these conditions millions of people will benefit annually. The dtb-device resembles a urinary drainage-only catheter but has additional features including: a separate sterile drug delivery channel for safe and accurate drug dosing, a patented secure syringe connector to prevent drug administration errors with incompatible drugs, a urine drainage-channel closure mechanism to prevent unintended drug wastage, an adhesive patch for securing the device to the thigh, enabling two-handed drug administration. As a part of the design process, we will seek opinions from people with multiple sclerosis who self-catheterise. Design The project involves four key research stages: addition of a patented syringe adapter to the dtb-device prototype, consultation with patients, study of simulated (with dummy models) device use by identified users, production of devices for further safety testing. Patient and public involvement Patients will be actively involved in the design stages of the dtb-device s development. We will recruit a focus group of multiple sclerosis patients and nurses nationally. Many people with multiple sclerosis regularly catheterise so will gain substantial benefits. We will seek their comments and criticisms as they represent a major target user group and have the most diverse and challenging disabilities. Dissemination Information about the dtb-device is available for the public on UroPharma s website. We have planned to produce leaflets for healthcare professionals and patients.

Research activity codes: 5.3 MEDICAL DEVICES
Health categories: RENAL AND UROGENITAL