AuthorisedTherapeutic use (Phase IV)Interventional

Randomized, multicenter, open-label clinical trial to evaluate the clinical and microbiological impact of methenamine hippurate as an alternative prophylaxis to antibiotics in the management of recurrent urinary tract infections in women

This study is for women who keep getting urine infections (UTIs). It wants to find out if a medicine called methenamine hippurate, which is not an antibiotic, can be a good alternative to antibiotics for preventing these infections. Researchers will compare methenamine hippurate with commonly used antibiotics to see which is more effective at stopping UTIs over six months. They will also check if using a non-antibiotic helps reduce the problem of antibiotic resistance, where germs become too strong for antibiotics to work. The aim is to find safer and more sustainable ways to manage repeat UTIs in women.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Consorci Mar Parc De Salut De Barcelona

Enrolment target

204

Start

25 Mar 2026

recurrent urine infections

What is this study about?

Many women suffer from recurrent urine infections, which can be painful and disruptive to daily life. Often, these infections are treated with or prevented by antibiotics. However, using antibiotics a lot can lead to germs becoming resistant to them, meaning the antibiotics might not work as well when you really need them. This study aims to find a different approach.

The main idea is to see if a medicine called methenamine hippurate, which works in a different way to antibiotics, can help prevent these infections just as well as standard antibiotics. Methenamine hippurate helps make urine more acidic, which makes it harder for bacteria to grow. By looking at how many infections women get and if the bacteria become resistant, the study hopes to find a safer long-term way to manage recurrent UTIs.

This research is important because it could offer women another option beyond continuous antibiotic use, potentially reducing the risk of antibiotic resistance and improving their quality of life. It builds on what we already know about these treatments to give doctors and patients more clear information.

Key takeaways

This study compares a non-antibiotic treatment with standard antibiotics for repeat urine infections.
It aims to find out which treatment is better at preventing infections in women.
Researchers will also check if the new treatment helps reduce antibiotic resistance.
The study lasts for 6 months of treatment, plus 6 months of follow-up.
It's an open-label study, so you'll know what medication you're on.

Who may be eligible?

This study is specifically looking for women who are 18 years old or older. You would need to be someone who experiences urine infections often.

It's important that you fit these basic criteria because the study wants to understand how the treatments work for adults who commonly get UTIs.

There might be other specific health requirements or conditions that mean you can or cannot join, and these would be discussed in detail by the study team.

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.

Are you a woman?
Are you 18 years old or older?
Do you get urine infections often (recurrent UTIs)?
Are you willing to take study medication for 6 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either methenamine hippurate or one of the standard antibiotics (such as Cefalexin, Septrin, or Fosfomycin) to prevent your urine infections. The main treatment part of the study would last for six months. During this time, the study team would keep track of how many urine infections you have and collect samples to see if the bacteria become resistant to antibiotics.

After the six-month treatment period, there would be another six months of follow-up. This means the researchers would continue to monitor your health and how you're feeling, even if you are no longer taking the study medication. You would likely have a number of visits to the clinic for check-ups, to provide urine samples, and to complete questionnaires about your health and how satisfied you are with your treatment. The study team would explain the exact schedule of visits and assessments to you.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you might find a more effective or suitable treatment for your recurrent urine infections. You might also contribute to important research that helps other women in the future. However, there's no guarantee that the treatment you receive will work for you, or that it will be better than your current treatment. As with any medication, there's a risk of side effects. The study team will explain all known side effects of the medicines used. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a recurrent urine infection?

This means you get urine infections often, usually three or more in a year, or two or more in six months.

What is methenamine hippurate?

It's a medicine that makes your urine more acidic, which helps stop bacteria from growing and causing infections. It's not an antibiotic.

Why is reducing antibiotic resistance important?

If bacteria become resistant to antibiotics, these medicines might not work when you really need them for serious infections.

Will I know which treatment I'm getting?

This is an 'open-label' study, which means both you and the doctors will know which treatment you are receiving.

How long will I be involved in the study?

You'll be on the study treatment for 6 months, followed by another 6 months where researchers will keep track of your health.