The first ever clinical trial dedicated to improving the treatment of chronic urinary tract infections (UTI) could pave the way for more NHS clinics to offer extended courses of antibiotics.
It comes as the nation’s only chronic UTI clinic has been forced to pause most referrals after the waitlist surpassed one year, leaving patients with limited treatment options.
It is hoped that the EAT-UP trial – a randomised, multi-centre study across the UK – could embolden more NHS clinics to treat chronic UTI with an extended course of antibiotics alongside a urinary antiseptic known as methenamine hippurate (Hiprex).
This treatment protocol is used at the Lower Urinary Tract Symptoms (Luts) Service at the Whittington Hospital, in north London. However, this is one of the only NHS clinics to offer the protocol as it veers away from the standard treatment guidelines set by the National Institute for Health and Care Excellence (Nice).
If the trial proves that the treatment is safe and effective, it could encourage other NHS doctors to use the same technique at more clinics.
Patients and clinicians hope it could also contribute to a growing body of evidence that triggers a review of the Nice guidelines. Currently, there is no separate guidance on treating chronic UTI, meaning doctors must defer to the information on recurrent UTIs – but this is a separate condition.
Nice creates guidelines for GPs and hospitals by making “evidence-based recommendations” for NHS England, using “the best available evidence of clinical effectiveness and cost-effectiveness”. The criteria for deciding whether to update guidelines include new clinical areas being identified or the emergence of significant new evidence.
Chronic UTI occurs when bacteria from an acute UTI embed into the bladder lining, triggering a long-term, persistent infection that is extremely painful and difficult to diagnose and treat.
It can affect women, men, children and the elderly, and can leave them bedbound and unable to work, sleep, leave the house or socialise. In extreme cases, the illness can leave people feeling suicidal.
Referrals paused at only chronic UTI clinic
The Luts clinic at the Whittington has been forced to pause referrals from everyone outside of five London boroughs from 1 March after the waitlist grew to 56 weeks – just over a year. Only patients living in Barnet, Camden, Enfield, Haringey or Islington can continue to be referred to this service.
Rajvinder Khasriya, a consultant urogynaecologist who is the lead investigator of the EAT-UP trial and who runs the clinic, said patients who already have a referral will remain on the waitlist, and the temporary closure will be reviewed every three months.
She said the year-long waitlist is “a reflection of the demand for our service”, as the only NHS clinic dedicated to treating chronic UTI.
If this trial proves that the Whittington’s treatment protocol is “safe and effective”, Khasriya hopes it will give other NHS clinics the “courage” to follow the same regime.
“We’re hoping that the trial is going to help to expose the number of people who are suffering with this, and that this treatment can be offered in different places. It will then take the pressure off patients and clinicians, meaning that patients can be seen elsewhere.
“We just really hope that this is going to make a big difference to services and how patients are treated. This just legitimises this condition.”
Joanne McKinlay, who has suffered from chronic UTI and now campaigns on the issue, said the EAT-UP trial is “really important for the community” as it could prove the efficacy of extended courses of antibiotics and lead to more treatment centres opening.
“What we all hope for within the chronic UTI community is that the guidelines do change on the NHS,” she said. With no Nice guideline for chronic UTI, she said sufferers face flawed testing, long waits for a diagnosis, a lack of NHS treatment options and “dismissal” by medical professionals.
All you need to know about the chronic UTI trial
The EAT-UP trial, funded by the Medical Research Council, is comparing the most effective way of treating a chronic UTI in 200 patients over three months.
It will compare the treatment method used at the Whittington – an extended high dose of antibiotics and Hiprex – with the current “standard of care”, which is a low dose of an antibiotic, known as a prophylactic, or Hiprex.
The standard of care is taken from the Nice guideline for recurrent UTIs, as there is no official guidance for chronic infections.
Where is the trial taking place?
The study is aiming to recruit patients at five locations, including 100 at the Whittington Hospital and around 50 at Guy’s and St Thomas’, in London.
The remaining participants will be spread across University College London Hospital, St Mary’s Hospital in Manchester and Freeman Hospital in Newcastle upon Tyne.
When does recruitment start?
The Whittington will start recruiting over the next week, with the other centres to follow in the coming months. The study will be taking participants over the next 18 months.
It will then take around six months to gather and publish the data.
There could be evidence on how extended antibiotics, combined with Hiprex, are a safe and effective treatment for chronic UTI within two and a half years.
What happens during the trial?
Participants will be randomised and either given the Whittington’s treatment protocol or the Nice standard for a recurrent UTI over three months.
Khasriya said that no patient in the Nice group would be left to suffer if their condition gets worse. They would be given a higher dose of antibiotics to treat their infection.
All patients will be offered full treatment after the three-month trial.
How to get involved?
The trial is for women aged 18+ in the UK who have been living with symptoms for at least three months and who meet the eligibility criteria.
If you are interested, email whh-tr.researchanddevelopment@nhs.net.
Separately, patients and clinicians have agreed on the top 10 research priorities for chronic UTI, identifying long-standing gaps in knowledge related to diagnosis and treatment.
The priorities, ranging from more research into chronic UTI diagnosis to new treatment options, have been developed by AMR Action UK and the James Lind Alliance, alongside The Urology Foundation and Bladder Health UK.
Khasriya said the James Lind Alliance has a “direct impact on funding bodies” as organisations such as Nice look to them to establish where they should commission research.
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