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RecruitingPhase IIInterventional

A clinical trial of extended (high) treatment dose antibiotics in combination with methenamine hippurate compared to the standard of care (either prophylactic (low) dose antibiotic treatment or methenamine hippurate) in people with chronic urinary tract infection

This study is investigating new treatments for people with chronic urinary tract infections (UTIs) – a condition where individuals experience ongoing bladder infection symptoms every day. Current treatments often don't work for chronic UTIs, which is why this research is so important. We want to see if taking a higher dose of antibiotics for longer, combined with a urinary antiseptic called methenamine hippurate, is safer and more effective than current approaches, like lower-dose antibiotics or methenamine hippurate alone. We'll also be using a special urine test that can better detect these infections. The aim is to find better ways to help people living with chronic UTIs.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
University College London Comprehensive Clinical Trials Unit
Enrolment target
192
Start
28 Feb 2026
Estimated completion
31 May 2027

What is this study about?

Imagine constantly feeling the symptoms of a bladder infection, day in and day out. That's what it's like for people with chronic urinary tract infections (UTIs). This is a newly recognised type of UTI, different from regular UTIs that come and go. Unfortunately, the usual treatments, which mostly focus on short bursts of antibiotics or very low-dose preventative antibiotics, often don't fully work for chronic UTIs.

This study, called EAT-UP, aims to find a more effective way to treat these ongoing infections. We're looking into whether a stronger, longer course of antibiotics, combined with another medicine called methenamine hippurate, can ease symptoms better than current standard treatments. Methenamine hippurate is a urinary antiseptic, meaning it helps to prevent bacteria from growing in the urine. We're also using an advanced urine test to spot infections that standard NHS tests might miss, ensuring we're really targeting the problem.

The main goal is to improve the quality of life for people with chronic UTIs by finding a treatment that truly works. If this new approach proves to be safe and effective, it could change how doctors treat this challenging condition in the future, leading to better outcomes for many individuals.

Key takeaways

  • This study explores a new approach for chronic urinary tract infections (UTIs).
  • It compares stronger, longer antibiotic courses with standard treatments.
  • Participation involves regular clinic visits for blood, urine, and swab samples.
  • There are potential benefits in finding a more effective treatment.
  • Common and rare side effects are possible with all medications used.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women aged 18 or over who have had ongoing bladder infection symptoms every day for at least the past three months. Your symptoms should include problems like needing to pee often or urgently, or feeling pain in your bladder or urethra. Crucially, your doctor should believe these symptoms are due to a chronic (long-term) bladder infection.

You also need to have passed a special urine test that shows a certain level of white blood cells, which indicates an infection, and have healthy enough kidneys. You cannot have any major structural problems with your urinary system, such as kidney stones or a prolapse that might impact bladder emptying. You also cannot be pregnant, planning to get pregnant, or breastfeeding during the study, and if you can get pregnant, you must agree to use reliable contraception throughout the study.

If you fit these descriptions and are willing to attend all study visits and follow the procedures, you might be able to take part. The study team will check all these details carefully to make sure it's the right fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you female and 18 years old or older?
  2. Have you had daily bladder infection symptoms for at least 3 months?
  3. Does your doctor think these symptoms are due to a chronic UTI?
  4. Are you not pregnant, planning pregnancy, or breastfeeding?
  5. Are you willing and able to use contraception if you can get pregnant?
  6. Do you have no major structural problems with your urinary system?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of two groups, like drawing names from a hat. You won't get to choose which group you're in. Both groups will take study medicines for 12 weeks. One group will receive a stronger dose of antibiotics plus methenamine hippurate, while the other group will receive standard treatment, which is either a low-dose antibiotic or methenamine hippurate alone. Your doctor will choose the specific antibiotic that's best for you, based on your health history.

During these 12 weeks, you'll need to visit the clinic every 4 weeks. At these visits, you'll answer questions about your health, and the team will collect blood and urine samples. They will also take a swab from the area between your vagina and anus. These tests help the researchers understand how the treatment is working and make sure you're safe. After the 12 weeks of medication, there will be further follow-up to see how you are doing.

Potential risks and benefits

Taking part in this study could potentially help find a better way to manage chronic UTIs, which could improve your symptoms and quality of life. If successful, this study might even lead to new guidelines for treating this condition. While there are potential benefits, it's important to be aware of the possible risks. All the medicines used in this study are commonly prescribed, but, like all medications, they can cause side effects. These might include upset stomach, skin rashes, headaches, or fungal infections. More rarely, some antibiotics can cause changes in blood salts or lung problems, and methenamine hippurate can cause bladder irritation. The study team will explain all possible side effects in detail and will monitor you closely through regular blood tests and by asking you to report any concerns. You'll receive a safety card with contact details for the research team, available day and night. Remember, participation is always voluntary, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (2)

  • The Whittington Hospital
    Approximate
    London, England
  • Freeman Hospital
    Approximate
    Newcastle upon Tyne, England

Common questions

What is chronic UTI?

Chronic UTI means you have ongoing bladder infection symptoms every day, rather than infections that come and go with symptom-free periods in between.

What is methenamine hippurate?

It's a medicine that acts as a urinary antiseptic, helping to prevent bacteria from growing in your urine.

How long will I take the study medication?

You will take the study medication for 12 weeks.

How often will I need to visit the clinic?

You will need to attend clinic for assessments every 4 weeks during the 12 weeks of treatment.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of two groups, and you won't know which specific treatment you are receiving until the end of the study.

How to find out more

EAT-UP Trial Team

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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