‘Petty rules on nurses’ stations seem absurd and dangerous’

A new urinary catheter designed to reduce nursing workload and patient discomfort by minimising the chance of blockages and infections, is progressing through the initial stages of its first patient trial in the UK.

Research nurses involved in the project have told Nursing Times about their hopes for the pioneering Flume catheter – which is understood to be the first entirely new catheter design for more 80 years.

The device, which was created by Suffolk GP Dr John Havard and business partner Roger Holmes, and exclusively revealed by Nursing Times in 2017, was recently placed into patients within a trial for the first time.

Dr Havard had been inspired to come up with the new style of catheter after speaking with district nurses based at his practice in Saxmundham about the challenges of blocked catheters and the workload this caused.

Professor Mandy Fader, professor of continence technology at the University of Southampton and a nurse by background, has been involved in the Flume project for the past eight or nine years ago.

In the most recent stages, she has been working as part of the research team, alongside colleagues in Bristol, in testing its safety and efficacy.

The “very essential but basic” difference in the design of the Flume catheter was that it has no protruding tip, she explained to Nursing Times.

She said: “There is no tip to which can irritate or cause inflammation in the bladder.

“We expect that this will fundamentally change the way the catheter will work in the bladder, causing there to be potentially less infection and inflammation and pain and discomfort and blockage – all the things that come about from having essentially a foreign body in the bladder.

“So, it’s making it a more physiological design for a presence in the bladder,” she told Nursing Times.

In March, the first Flume catheter was placed into patients in Bristol, marking the start of its first human trial, which was funded by the National Institute for Health and Care Research and that had been delayed by the coronavirus pandemic.

Stage one of this trial was placing the device into a patient before removing it in two days’ time.

“We anticipate that [the flume catheter] will cause less blockage, less infection, less inflammation, and so the nursing workload will reduce”

The second stage – of which the trial is currently at – will see 15 patients keep the catheter in for one month. A third stage will then see 40 patients given the catheter for up to three months.

Although starting in Bristol, the later phase of the trial will include patients in the Southampton area, with Professor Fader directly involved.

To fully prove its effectiveness, Professor Fader said a randomised control trial would be required in future, working with around 250 to 300 patients.

A benefit of the Flume catheter was that it otherwise appears like a typical catheter, meaning there is “no difference in the normal process in putting the catheter in” and no additional staff training required.

“That is a very good thing – it makes it easy to adopt when it becomes available,” added Professor Fader.

When considering the benefits to nurses, she highlighted that problems with catheters, such as blockages and infections, caused “the most intensive work” for community nurses.

If a catheter blocked, this could require an emergency call-out for a nurse, or the patient may have to go to accident and emergency for it to be replaced, she noted.

“Frequent re-catheterisation and replacement of catheters is a problem because that requires nursing time and effort to do that, and is obviously uncomfortable and undesirable for the patient,” said Professor Fader.

“Ideally”, a catheter should stay in for a long period of time, usually 90 days, she noted.

She added: “We anticipate that [the Flume catheter] will cause less blockage, less infection, less inflammation, and so the nursing workload will reduce.

“And for the patient’s perspective, they'll have less distress, pain and discomfort, and also be less troubled by any emergency situations with their catheter or having to deal with going to A&E.”

Although some people with catheters have no problems, those who do have a “very miserable time”, said Professor Fader.

“So, we know that what we can do to help will be very important,” she added.

Marta Cobos-Arrivabene and Vikki Garner

Marta Cobos-Arrivabene, a urology research nurse at North Bristol NHS Trust, was involved in the initial placements of the Flume catheter in patients.

She shares her role with Vikki Garner, and told Nursing Times they were both grateful for “the opportunity to take part in researching and testing the performance of this new type of catheter”.

“​It is always exciting as a research nurse to be a part of a first in human trial, and we have had the pleasure to work with some absolutely lovely participants,” added Ms Cobos-Arrivabene.

“As research nurses, we have the privilege of being the members of the team who conduct research right alongside our participants.”

She added: “Urology research often puts us in contact with patients who struggle to discuss their problems due to embarrassment or the intimate nature of the problems they are facing.

“The more we can work to develop tools or equipment to ease this difficulty for our patients, the better.”

The Flume catheter was this month launched at the American Urological Association’s 2022 annual meeting in New Orleans, which Dr Havard attended.

Speaking to Nursing Times, Dr Havard reiterated how the idea of the new catheter had been born through conversations with nurses at his GP surgery more than 20 years ago.

By working in what he described as a “rural” practice, which was far away from a local hospital, his team would be dealing with a considerable number of catheter problems – many of which would usually be dealt with in A&E.

Dr Havard said he felt the latest developments of the patient trial were “really important” because these issues “affect so many people in the world”.

Interesting. Seen similar before across several device areas that came to nothing due to cost. As always with these stories (clinician comes up with great product solution) I keep my fingers crossed but always worry that due diligence on the actual cost of bringing to market has been done properly. We shall see. Reminds me of the fantastic disposable tourniquet (the Saint) designed by a junior doctor that was a brilliant design and loved by all. Problem was it cost 45p (nearly as much as the IV cannula) and the alternative was 1p. Procurement just laughed…… Will keep an eye on this though as the concept has been proven previously, just has never made it to market. Would shake up the incumbents (Bard et al) and would love to know the patent cover they have

Interesting. Seen similar before across several device areas that came to nothing due to cost. As always with these stories (clinician comes up with great product solution) I keep my fingers crossed but always worry that due diligence on the actual cost of bringing to market has been done properly. We shall see. Reminds me of the fantastic disposable tourniquet (the Saint) designed by a junior doctor that was a brilliant design and loved by all. Problem was it cost 45p (nearly as much as the IV cannula) and the alternative was 1p. Procurement just laughed…… Will keep an eye on this though as the concept has been proven previously, just has never made it to market. Would shake up the incumbents (Bard et al) and would love to know the patent cover they have

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