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Exclusive: First new urinary catheter for 80 years to be revealed

  • 4 Comments

The inventors of a new catheter claim it could solve one of “the biggest problems” in community nursing and reduce discomfort, embarrassment and complications for millions of patients.

They are nearing the final stages of developing their new Flume Catheter, which they hope will solve many of the common problems associated with current models, and are calling on nurses to help them with their ongoing research.

“It is really exciting because this is the first new urinary catheter for 80 years2

John Havard

Their design, which was also developed with input from community nurses, is less likely to block and also less of an infection risk than older models, according to the clinicians and engineers behind it.

The device, believed to be the first entirely new catheter design since the Foley catheter – in use since 1937 – will be officially unveiled at the Royal Institute of Engineers Continence Conference at the end of this month (see PDF of poster attached below).

Suffolk GP Dr John Havard – one of the brains behind the new device – said he was inspired to come up with a new-style catheter, after asking district nurses based at his surgery about the most vexing problem they encountered day to day.

“I asked ‘If there was one thing you could change about your job, what would that be?’ and blocked catheters was the resounding answer because they can block at any time and it is unscheduled work,” he told Nursing Times.

“Changing catheters and dealing with blockages is just such a massive workload around the country and around the world – to say nothing of the embarrassing bypasses that become a feature – usually when they are blocked,” he said.

“It must make a massive difference to nurses if there are less catheters going wrong all the time”

John Havard

Meanwhile, urinary tract infections linked to catheters are not only painful and unpleasant but can lead to complications such as pyelonephritis – serious kidney infection – sepsis and even death. One estimate puts the annual cost to the NHS of complications linked to catheters at £2.5bn.

Dr Havard, who practises in Saxmundham, said: “It is really exciting because this is the first new urinary catheter for 80 years.

“The biggest difference, which we have proven in the lab by putting infected urine in it, is that it doesn’t block anything like as quickly and so will last twice as long,” he said. “But the main issue is that it doesn’t get the bugs in the first place.”

Laboratory trials at the Bristol Urological Institute, which compared the Flume with two leading brands of Foley catheter by measuring the time each took to block, found the Flume performed 47% and 113% better respectively (see PDF attached below contrasting the two types of device).

In addition, the Flume’s innovative balloon design should reduce the risk of infection as it protects the sensitive bladder wall from the hard catheter drainage tube. It also allows the bladder to drain fully so urine does not hang around and fester.

Dr Havard said the goal was to try and keep the Flume at roughly the same price as Foley catheters, but added “even at twice the price there are good arguments for it”. He said he believed the device had the potential to transform nursing care.

“The difference to nurses will be far less catheter changes, far less emergency out of hours working, far less pain and incontinence for patients and far less embarrassing bypassing,” he said. “It must make a massive difference to the daily jobs of nurses if there are less catheters going wrong all the time.”

“The aim is for it to be introduced into both community and secondary care”

Kate Holmes

 

The team has already canvassed the views of more than 60 community nurses caring for over 1,500 patients.

However, Dr Havard said he was keen to hear from many more to help identify and describe issues with catheters and inform the design of the Flume Catheter going forward.

He has set up a short online survey and urged readers of Nursing Times to complete it. He said patients with catheters – often frail and elderly people – were reluctant to complain and often felt issues like leaks, which were linked to the design, were their fault.

But he noted that they were more likely to confide in nurses who also saw first-hand the misery that problems with catheters could cause.

“People who have catheters are among the most vulnerable people in society – they don’t complain and often just put up with things,” said Dr Havard.

“District nurses are well aware of the suffering, because they arrive in the morning when patients have had a bad night dealing with things,” he said.

“They are the ones who get called in when the catheter gets blocked and try and wash it out,” he said. “They know the pain and distress and that’s why we want to hear it right from the frontline.

“The Flume is innovative in its design and would reduce patient discomfort, UTIs and blocking”

Kate Holmes

He added: “The NHS needs to learn more from people on the ground. Nurses know what the problems are so this is their chance to speak out about one of the biggest nursing problems we have got.”

The catheter has been developed together with business partner Roger Holmes, former Marks and Spencer chief executive and an engineer by background.

Co-directors of the Flume Catheter Company also include Kate Holmes, a urology clinical nurse specialist, who only recently retired from practice this summer.

“The problems with the Foley have been widely documented and are borne out by my own experience. Blocking, catheter-associated urinary tract infections and bypassing being the main problems,” she said.

“The Flume is innovative in its design and would reduce patient discomfort, UTIs and blocking,” said Ms Holmes, who will now help with development, testing and marketing of the Flume.

“The aim is for it to be introduced into both community and secondary care as the benefits would help patients enormously in both settings,” she told Nursing Times.

Saxmundham Health/Flume

Exclusive: First new urinary catheter for 80 years to be revealed

John Havard

The team has already won financial support to develop the device – including a Medical Research Council-funded “Proof of Concept” award from the Elizabeth Blackwell Institute – and has worked with Arrotek Medical to create a working prototype.

They now hope to win another major grant to allow the first trial with real patients, which will involve nurse researchers.

A future trial, likely to take place in Bristol and Southampton, would be overseen by nurse and professor of continence technology Mandy Fader at the University of Southampton and lead investigator Marcus Drake, professor of physiological urology at the University of Bristol.

“About 40 people in the community will be given one of the Flumes instead of the Foley and we will look very carefully at the differences,” said Dr Havard. “Nurse researchers will be regularly checking how they are getting on and if there are any problems.” 

The team will find out in March if their bid for Research for Patient Benefit funding has been successful.

  • 4 Comments

Readers' comments (4)

  • While I applaud the Flume team I must say Poiesis Medical changed the Foley design several years ago and actually has had tremendous results in the UK.

    The unfortunate facts of the matter are the Flume team is misleading individuals as to how the bladder actually functions while a catheter is in place. For a true depiction of a catheter inside a bladder please go to Poiesismedical.com and watch REAL videos of a catheter inside the bladder. The Doctor’s example using a bowl is misleading and with all due respect this should be explained to patients. Nobody needs more “fake news” especially when patients lives are litterally in the balance.

    The amount of residual urine inside the bladder while the Duette is in place is extremely small, tests show about 2-5 CCs. The main goal of any new catheter should be to first do no harm, which the Duette does and has clinically been proven in a 396 patient trial against CR Bard’s balloon catheter, Duette demonstrates an 80% reduction in CAUTIs. However in addition drainage hole needs to be protected, shielded which the Flume does not do. Because thier single eye is exposed the bladder lining will block drainage from the suction in the drainage tubing leading to the bag (see video) The Duette placed balloons keeps bladder tissue away from the drainage eyes. We looked at a single balloon several years back and quickly realized placing holes in/near the trigone will also result in more bladder spasms due to the amount of nerves in this area.

    Additionally any traction of the urine tubing will pull the Flume catheter eye down and into more contact with bladder tissue resulting in more constant blockage. Having one eye will also diminish consistent drainage.

    So glad more people are starting to look at this issue but we all need truth in marketing.

    As a small company I do wish them luck anything that helps bring change I am for!!! However no one should mislead patients. Please forgive any typos as I am in an Uber car traveling across the State of Florida. Should anyone have questions about Poiesis’ other important findings along our journey to bring change to this extremely important market please feel free to email me.
    #hackCAUTIs...

    Sincerely
    Greg Wiita
    CEO and Founder
    Poiesis Medical
    Greg@poiesismedical.com

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  • We applaud all efforts to address the issues of the Foley, conscious that whatever progress has been made to date, the Foley remains ubiquitous in its use in patients requiring an indwelling catheter. We have had strong academic clinical support for the principles of the Flume design and will continue to progress it prudently towards adoption for the benefit of patients. Clinical trials will undoubtedly play an important role and through such endeavours we can only hope that the best possible solutions are developed for patients

    Dr John Havard

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  • The easiest ways to prevent catheter associated urinary tract infection (CAUTI) are:
    1. To minimise the use of indwelling urinary catheters, the NHS inserts a million annually and an estimated 25% could be avoided
    2. To offer those with retention the option of an intermittent catheter when ever possible.
    3. To remove urinary catheters as soon as possible when there is no longer a clinical indication.

    I fail to see how an different design of catheter will cut CAUTI rates. When a person has an indwelling urinary catheter for a certain time, typically two weeks in acute settings and four weeks in community the bladder becomes colonised with bacteria. Unfortunately medical and nursing staff are frequently frequently unable to differentiate between CAUTI and asymptomatic bacteriuria so people with indwelling urinary catheters are frequently inappropriately treated with antibiotics leading to the development of antimicrobial resistance.

    As professionals we need to think very carefully before inserting a urinary catheter as they can increase infection risks. The person with the catheter may suffer bladder spasm and this can cause pain and discomfort. Bladder capacity is reduced if catheter valves are not used and not everyone is suitable for a catheter valve. So catheterising a person necessarily can affect the person's health and well-being long term.
    Catheters have their place and can be a boon to patients when used appropriately and a bane when used inappropriately.

    I don't understand how this new design will improve matters

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  • Responding to Linda’s inputs re CAUTIs...

    So by her writing we should stop looking for solutions that may help individuals who for various health issues may require a catheter? Really sad to witness a healthcare professional toss the towel in. Perhaps a more helpful view would be to ask why something is occurring and set a course to try and fix the shortcomings. In the case of the Foley it is well documented as to the many shortcomings.

    At Poiesis we did this and have now reduced CAUTIs by 80%. Even more important these results are holding now over three years. Considering 17% of CAUTIs will become septic and 10% will not survive the event. The take away the bladder when heathy and not blocked, damage is well equipped to fend off bacteria. Like our skin the innate immune system in the bladder can and does fight bacteria BUT if a standard Foley is used it hurts and even causes death to patient. Confirmed in long term usage high rate of bladder cancer has been documented.

    One day the legal side of the equation will weigh in as to ever placing another Foley (current design) in a patient!!!

    Sincerely
    Greg

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