The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI

Summary

Recurrent urinary tract infection (UTI) in elderly women is a major driver of antibiotic prescription. Hence, the question of feasible and appropriate preventive measures are important issues in this field. Methenamine hippurate is frequently prescribed in Norway and Sweden as prophylaxis for recurrent UTI. Methenamine hippurate acts via the production of formaldehyde from hexamine, which in turn acts as a bacteriostatic agent, therefore methenamine hippurate is not defined as an antibiotic. According to a Cochrane review 2012 the rates of adverse events for preventing UTI was low. Although this review showed methenamine hippurate might be effective in preventing UTI in the short term, there is a need for large well-conducted randomised controlled trial (RCT) to clarify both the safety and effectivity of preventive methenamine hippurate for longer term use. This is particularly important for longer term use for people without neuropathic bladder disorders. A Norwegian longitudinal observational study including women aged 50-80 years with recurrent UTI indicated a significant and large reduction of more than 50% in antibiotic prescriptions for UTI after start of prophylactic methenamine hippurate. This further strengthens the need for an RCT of methenamine hippurate as prophylaxis for recurrent UTI.

Conditions

• Recurrent Urinary Tract Infection

Interventions

DRUG

Methenamine Hippurate 1000 MG

Methenamine and placebo is taken 1 tablet morning and evening for 180 days

Sponsors & Collaborators

• Amsterdam UMC, location VUmc

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Medical University of Lodz

  collaborator OTHER

• University of Oslo

  lead OTHER

Principal Investigators

• Cees Hertogh, prof.MD · Amsterdam UMC, location VUmc

• Theo Verheij, prof. MD · UMC Utrecht

• Maciek Godycki.Cwirko, prof MD · Medical University of Lodz

• Per-Daniel Sundvall, MD PhD · Vastra Gotaland Region

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2023-06-30

Completion

2023-06-30

Countries

• Netherlands
• Norway
• Poland
• Sweden

Study Locations