Clinical trial aims to improve lives of patients with urinary stents
Patients in Southampton and London will take part in a first trial for a new type of urinary stent.
The device was developed by researchers at the University of Southampton.
The trial is testing whether it could improve the lives of cancer patients and other people who use stents.
It is hoped it could dramatically reduce urinary stent failures and improve these patients’ quality of life.
Developing the device
The CASSETTE trial is being funded by over £1.3m from the National Institute for Health and Care Research (NIHR). It will recruit 50 patients over the next year, including at University Hospital Southampton. It will run until December 2026.
The new stent was developed by Dr Ali Mosayyebi and his team in Southampton. He is a Biomedical Engineer and Senior MedTech Fellow.
Dr Mosayyebi is now working with the team from the Southampton Clinical Trials Unit (SCTU) on a first-in-human clinical trial of this new device.
Tackling stent failure
Urinary stents are temporary devices that can help to drain urine from the bladder.
“The urinary system is very complex, which makes it very difficult to repair when it becomes blocked or damaged,” says Dr Mosayyebi.
“An inability to drain urine can happen for many medical reasons, including for people with cancerous tumours in the bladder or urinary tract and those with kidney stones. If not addressed quickly, this can lead to severe pain and kidney failure.”
Stents provide huge advantages to people experiencing bladder and urine drainage problems. However, they are not always successful.
“These devices are prone to getting blocked due to crystalline and bacterial deposits,” continues Dr Mosayyebi.
“This can lead to stent failures and urinary tract infections (UTIs) which can require antibiotics and, in most cases, early removal of the stent.”
It is estimated that treatments for infections associated with stents and catheters cost the NHS around £2.5bn a year.
The team hopes that its novel stent design could help overcome these problems. This could improve the quality of life of patients who need stents and save the health service money.
This new, patented stent was developed by Dr Mosayyebi during his PhD. It is designed to prevent the accumulation of crystals which cause blockages and reduce bacterial build-up.
“In pre-clinical studies, we successfully showed the safety of this new design against live tissue,” says Dr Mosayyebi.
“We also demonstrated reduced particle deposition on the stent surface. This new trial will continue our research in the hope of finding a solution to the current problems many patients experience with traditional stents.”
First-in-human trial
The CASSETTE trial will assess the safety, performance, and patient acceptability of the new stent design.
Dr Mosayyebi’s team and the SCTU will test the patented design in two groups of patients. They will work alongside colleagues at UHS, University College London Hospital and the University of Oxford.
The team will recruit patients with kidney stones who need short-term stents. They will also recruit patients with abdominal and pelvic cancers that need a longer-term stent use.
They will follow the patients while they use the stent and for a short time afterwards to monitor how well the stent performs. They will also interview the participants and their doctors. This will allow them to get a better understanding of how useable and acceptable the new design is.
Professor Andrew Cook, Associate Director of the SCTU, is co-investigator for the CASSETTE trial. He says: “We hope that data analysis from this early-phase trial will lead to the development of larger randomised clinical trials in the future, which can provide evidence that this design can improve quality of life for patients, then bring it into regular use in the NHS.”
Professor Mike Lewis is NIHR's Scientific Director for Innovation. He said: "It’s exciting to see this novel device reach its first-in-human trial. This new urinary stent has the potential to significantly improve the quality of life for people with cancer and others who rely on stents while also reducing infection-related complications and lowering treatment costs for the NHS."
The trial is being run in collaboration with the University of Southampton (sponsor), UHS, University College London NHS Foundation Trust, the University of Oxford, and Sooba Medical.
Find out more on the CASSETTE website.