TY  - CHAP
T1  - Proposed guidelines on the evaluation of non-antibiotic versus antibiotic agents indicated for treatment of uncomplicated acute cystitis in adult female patients
T2  - Urogenital Infections and Inflammations. Living Handbook
AU  - Naber, Kurt G.
AU  - Alidjanov, Jakhongir F.
AU  - Pilatz, Adrian
AU  - Wagenlehner, Florian M. E.
ED  - Naber, Kurt G.
ED  - Bjerklund Johansen, Truls Erik
AD  - Kurt G. Naber MD, PhD, Technical University of Munich, Karl-Bickleder-Straße 44C, 94315, Munich, Deutschland, E-mail: kurt.naber@nabers.de
N2  - 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. 
PY  - 2026
DA  - 2026/01/28
DO  - 10.5680/lhuii000074
ET  - 2026 Jan 28
LA  - en
L1  - https://books.publisso.de/de/system/getFile/32716
L1  - https://books.publisso.de/de/system/getFile/21217
UR  - https://dx.doi.org/10.5680/lhuii000074
L2  - https://dx.doi.org/10.5680/lhuii000074
PB  - German Medical Science GMS Publishing House
CY  - Düsseldorf
ER  -