NIHR funds trial of novel engineering approach to improve the lives of patients with urinary stents
A Southampton research team has been awarded over £1.3m from the National Institute for Health and Care Research (NIHR) for a new clinical trial which they hope could improve the lives of cancer patients and other people who need urinary stents.
Dr Ali Mosayyebi, a biomedical engineer, and his team in the Department of Mechanical Engineering at the University of Southampton, have designed a new type of stent which it’s hoped could dramatically reduce urinary stent failures and improve quality of life for patients.
Dr Mosayyebi is now working with the team from the NIHR Southampton Clinical Trials Unit (SCTU) to conduct a first-in-human clinical trial of this new device in the hope it can pave the way for better treatments for these patients in the future.
Tackling stent failure
The urinary system is very complex, which makes it very difficult to repair when it becomes blocked or damaged. An inability to drain urine can happen for many medical reasons, including for people with urinary tract cancerous tumours and those with kidney stones. If not addressed quickly, this can lead to severe pain and kidney failure.
Clinicians use small, temporary devices called stents to maintain urine drainage while a longer-term solution can be found. 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 leading to stent failures and urinary tract infections (UTIs) which 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, who led the development of this patented stent design during his PhD, continues: “Our technology is able 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 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
CASSETTE is a first-in-human clinical trial that will assess the safety, performance, and patient acceptability of the new stent design.
Working with the SCTU, alongside colleagues at University Hospital Southampton, University College London Hospital, and University College London, Dr Mosayyebi’s team will trial the patented design in two groups of patients; those with kidney stones who require short-term stents, and also in patients with abdominal and pelvic cancers that need a longer-term stent use.
Dr Andrew Cook, Associate Director of the NIHR Southampton Clinical Trials Unit and co-investigator for the CASSETTE trial, 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”
The trial is being funded by just over £1.3m from the National Institute for Health and Care Research’s Invention for Innovation Product Development Awards (NIHR i4i PDA) and is being run in collaboration with the University of Southampton, Sooba Medical, and I2R Medical.
The trial is currently in set-up and the team hope to open to patient recruitment in the first half of 2023.
Notes for editors
The Southampton Clinical Trials Unit (SCTU) is a National institute for Health and Care Research (NIHR) supported and Cancer Research UK (CRUK) core-funded CTU with expertise in the design, conduct and analysis of interventional, multi-centre clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. For more information, visit the SCTU website.
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About the National Institute for Health and Care Research
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
· Funding high quality, timely research that benefits the NHS, public health and social care;
· Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
· Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
· Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
· Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
· Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.