Project overview
Background The urinary system is complex and difficult to repair. Many factors can affect urine drainage, resulting in inability to urinate, pain, and kidney damage. Stents and catheters are tubular devices that are used as temporary solutions to maintain urine drainage while exploring patient-specific long-term treatments. These devices are prone to blockage due to the build-up of crystals and bacterial deposits (encrustation-and-biofilm-formation (E&B)), causing infection. Infections associated with stents and catheters impose a £2.5b annual burden on the NHS; they require antibiotics and possibly surgery under general anaesthetic, with negative effects on patients health and increased demand on clinical services. Aims We have identified a reason behind failure of these devices and have developed new patented stents preventing blockage by crystals and bacterial build-up. To date, we have conducted laboratory experiments and animal testing, and aim to perform human trials to assess whether they: Reduce encrustation and biofilm formation Increase stent lifetime Reduce premature removal Reduce unplanned operations Reduce pain Improve quality of life Reduce infection Design and methods used To test these new stents, we will run 'First-in-Human' trials to assess safety, performance, and patient acceptability, providing data for analysis and development of wider clinical trials. We have identified two clinical subgroups where this device may offer advantages against E&B: Short-term: Patients with kidney/renal stones who require stent insertion ( Long-term: Patients with abdominal/pelvic cancers compressing the ureters (16 weeks indwelling time). We expect the device to have similar performance and safety in both groups. If it underperforms in either group, it is likely to be the cancer group, due to disease characteristics. We therefore plan to assess the use of the device in both groups separately, and will only proceed to assessment in the cancer group if there are no safety concerns identified in the stone group. Patient and public involvement (PPI) A PPI officer and PPI members (with lived patient experience) are part of the core team and have helped developing this submission. Their involvement will include (but is not limited to): The PPI officer will help organise and deliver meetings with PPI members to advise on the design of forms and information for study participants, and will provide liaison between the project team and patients. PPI members will join meetings to contribute towards product development, design of Patient-Information-Sheet and Informed-Consent-Form (PIS-ICF), and development of the clinical trial protocol. Dissemination We will disseminate clinical protocols and findings through scientific publications and share findings with the public. The project outcome will inform final product development, manufacturing scale-up, submission for regulatory approval, early marketing, and design of larger studies to demonstrate impact for patients and the NHS.
