New £1.3m trial to improve lives of patients with urinary stents
A Southampton research team has been awarded over £1.3m for a clinical trial of a new type of stent that could improve patients' quality of life.
Dr Ali Mosayyebi, a biomedical engineer at the University of Southampton, is leading the team. They've designed a new stent that could dramatically reduce urinary stent failures.
He is now working with the NIHR Southampton Clinical Trials Unit (SCTU) to conduct a first-in-human clinical trial of this new device. The hope is this will pave the way for better treatments for these patients in the future.
The funding has been awarded by the National Institute for Health and Care Research (NIHR).
Developing better stents
The urinary system is very complex, which makes it difficult to repair when it becomes blocked or damaged. This can happen due to a variety of medical reasons, including urinary tract tumours and kidney stones. This results in an inability to drain urine, and if not addressed quickly, can lead to severe pain and kidney failure.
Doctors use small, temporary devices called stents to ensure urine can still drain out while they find a longer-term solution. But despite the great advantages they offer, stents are not always successful.
“These devices are prone to getting blocked due to crystalline and bacterial deposits. This leads to stent failures and urinary tract infections (UTIs). These can require antibiotics and, in most cases early removal of the stent,” says Dr Mosayyebi. “In fact, treatments for infections associated with stents and catheters cost the NHS an estimated £2.5bn a year.”
Dr Mosayyebi led the development of a new, patented stent design during his PhD.
“Our technology is able to prevent the accumulation of crystals which cause blockages, and reduce bacterial build-up," he explains.
"In pre-clinical studies, we successfully showed the safety of this new design against live tissue, and demonstrated an indication of 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 researchers plan to do a first-in-human clinical trial, known as CASSETTE. This will assess the safety, performance, and patient acceptability of the new stent design.
The team will trial the design in two groups of patients. The first, with kidney stones, will need short-term stents. The second, with abdominal and pelvic cancers, will need longer-term stents.
They will work with colleagues at the SCTU, University Hospital Southampton, University College London Hospital and University College London.
Dr Andrew Cook, Associate Director of the SCTU and co-investigator for the CASSETTE trial, says: “We hope data analysis from this early-phase trial will lead to the development of larger randomised clinical trials in the future. If these provide evidence this design can improve quality of life for patients, we can then bring it into regular use in the NHS.”
The NIHR is funding the trial, with just over £1.3m from their Invention for Innovation Product Development Awards. It is being run in collaboration with the University of Southampton, Sooba Medical and I2R Medical.
The trial is currently in set-up. The team hope to open to patient recruitment in the first half of 2023.