International clinical trial

The HIPSTER Trial

Methenamine hippurate to prevent recurrent febrile urinary tract infection (UTI). An international, randomized, double-blind, placebo-controlled trial.
About HIPSTER

Why is this study being conducted?

Febrile UTI is a common cause of hospital admission and can lead to serious illness, particularly in older adults and people with catheters. Many patients experience relapses, often requiring new courses of antibiotics and increasing the risk of antibiotic resistance.

The HIPSTER Trial

The HIPSTER trial investigates whether methenamine hippurate (Hiprex), a urinary antiseptic, can reduce the risk of new febrile UTI episodes after completed antibiotic treatment.

HIPSTER is an international clinical trial investigating whether methenamine hippurate (Hiprex) can reduce the risk of recurrent febrile urinary tract infection (UTI) after hospital care.

Potential benefits

Reducing the burden of recurrent febrile UTI

If methenamine hippurate proves effective, it could become an important alternative to long-term antibiotic prophylaxis and contribute to better outcomes for patients and healthcare.

Could it reduce UTI recurrences?

Investigate whether methenamine hippurate can reduce the risk of a new febrile UTI within 365 days.

Could it reduce hospital admissions?

Explore whether preventing recurrent febrile UTI could lead to fewer UTI-related readmissions and reduced care needs.

Could it reduce antibiotic use?

Assess whether methenamine hippurate could offer a preventive strategy that reduces the need for conventional antibiotics.

Could it reduce resistance pressure?

Explore whether reduced antibiotic use could help lower the pressure contributing to antibiotic resistance.
How the study works

A clear, structured 18-month study journey

The planned number of participants is approximately 963 people from multiple centers and countries.
1

Hospital care

The participant is being treated for a febrile UTI.
2

Recruitment

Eligible patients are recruited at the hospital discharge.
3

Random allocation

Participants are assigned to active treatment or placebo.
4

12-month treatment

Methenamine hippurate or placebo is taken during the first 12 months.
5

18-month follow-up

Telephone follow-ups and review of medical records monitor outcomes and safety.
Participating sites

HIPSTER trial sites in Sweden

The HIPSTER study is an international, multicentre clinical trial involving participants from multiple centres and countries. Participating sites collaborate throughout the study to support recruitment, follow-up, and collection of clinical data.

The following sites in Sweden are currently participating in the study. Additional sites will be added as they are confirmed.

  • Västerås
  • Helsingborg
  • Lund
  • Malmö
News & media

Latest updates from the HIPSTER Trial

Press materials
HIPSTER is an international, randomized, double-blind study investigating methenamine hippurate after hospital care.
Updates on participating centres may be published here once confirmed.
Participant recruitment
Details on recruitment progress and participant demographics.
Summaries of initial findings and efficacy assessments.
For patients, relatives & the public

Frequently asked questions

An international clinical trial investigating whether methenamine hippurate can prevent recurrent febrile UTI after hospital care.

Febrile UTI is a common cause of hospital admission and can lead to serious illness, particularly in older adults and people with catheters. Many patients experience relapses, often requiring new courses of antibiotics and increasing the risk of antibiotic resistance.

Methenamine hippurate (Hiprex) is a urinary antiseptic. The HIPSTER trial investigates whether it can reduce the risk of new febrile UTI episodes after completed antibiotic treatment.

Patients treated in hospital for a febrile UTI are recruited at discharge and randomly assigned to methenamine hippurate or placebo, which is taken during the first 12 months. Outcomes and safety are monitored through telephone follow-ups and review of medical records.

Participants are followed for 18 months.

No. Participants are recruited at hospital discharge after treatment for a febrile UTI and must meet the study’s eligibility criteria. The study team at the participating hospital assesses whether a patient can take part.

Yes, placebo is used under careful monitoring and is necessary to reliably determine whether the treatment has an effect.

Outcomes and safety are monitored throughout the study through telephone follow-ups and review of medical records.

Personal data is handled in accordance with the General Data Protection Regulation (GDPR). You can read more in our privacy policy or contact the study team.

Results will be published once the study has been completed and the data analysed. Updates will be posted in the news section.

You can read the latest news or get in touch with the study team via our contact page.

Partners & collaborators

Study collaboration

The study material identifies Lund University and Helsingborg, Sweden. Additional confirmed partner institutions can be added when provided.
Documents

HIPSTER Trial PDF

Access the available document related to the HIPSTER Trial. Additional documents can be added here later if they are provided by the study team. Download the available HIPSTER Trial document for more information about the study.