Proposed guidelines on the evaluation of non-antibiotic versus antibiotic agents indicated for treatment of uncomplicated acute cystitis in adult female patients.

Since several current clinical guidelines also recommend non-antibiotic therapy of uncomplicated acute cystitis (uAC) in women, research guidelines are needed on conducting clinical trials to demonstrate their efficacy compared to e.g. standard antibiotic therapy. As the mechanism of action of antibiotic and non-antibiotic therapy is different, clinical outcome in such comparative trials must be the main criteria, although the effect of microbiological outcomes on clinical outcome may also be considered. The research guidelines proposed here are adjusted to the current guidelines recommended by the European Medicines Agency (EMA, 2022) and the U.S. Food and Drug Administration (FDA, 2019), using in addition a patient self-reporting questionnaire already clinically validated in many languages for diagnostics of uAC and as a patient-reported outcome measure (PROM) with well-defined thresholds for successful and non-successful clinical outcome. These adapted guidelines could be used in prospective clinical studies comparing e.g. antibacterial and non-antibacterial products for the treatment of women suffering from uAC.