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Introduction: Recurrent urinary tract infections (rUTIs) are a significant burden for both affected women and the healthcare system. With the urinary antiseptic drug methenamine hippurate (Cystohipp^®), a non-antibiotic, guideline recommended treatment option (AWMF 2024; EAU 2024) for long-term prophylaxis of rUTIs will become available in Germany from mid-2026. The purpose of this NIS is to expand the existing international evidence from clinical trials (Harding et al. 2022; Heltveit-Olsen et al. 2025) by collecting prospective real-world data in the context of everyday urological practice in Germany. In addition to evaluating the therapy’s effectiveness and safety, the study will focus on the role of risk factors and the potential for reducing antibiotic use.

Method: This prospective, open-label, multicentre NIS is planned to include approximately 500 female patients across about 50 urological centres in Germany. Women aged ≥18 years who at the physician’s discretion will be prescribed methenamine hippurate for rUTI prophylaxis following completion of acute treatment and appropriate differential diagnostics are eligible for inclusion. The planned observation period is 6 months from starting the prophylaxis with methenamine hippurate. Data collection will be integrated into routine care and will take place at several visits (baseline, month 3, month 6, additional visits in case of recurrences). Among other tools, validated patient-reported outcome measurements will be used to capture patient-relevant data.

Results: The main objective of the NIS is to assess the number of symptomatic UTI episodes during the observation period. Additional parameters include the proportion of patients who remain UTI free, time to first recurrence, symptom severity and duration, tolerability, quality of life, antibiotic conservation, treatment adherence, and satisfaction among both physicians and patients. Furthermore, several subgroup analyses and evaluations of health economic parameters are planned.

A preceding feasibility survey among office-based urologists revealed considerable interest and a high willingness to participate, underscoring the clinical relevance of this therapeutic option.

Schlussfolgerung: The planned NIS will generate up-to-date, prospective real-world evidence on the use of methenamine hippurate in Germany. Expected insights include data on effectiveness, safety, reduction of antibiotic use, as well as a detailed picture of real-world care and treatment adherence. The study will provide a robust scientific foundation for urological practice and support a rational prophylactic strategy within the broader framework of antibiotic stewardship.