Abstract
BACKGROUND: Uncomplicated urinary tract infections (UTIs) affect ∼50%-60% of women. Treatment failure can have adverse effects on antibiotic resistance, healthcare utilization and quality of life. The lack of consistently applied definitions of treatment failure prevents comparisons between studies of UTI treatments. OBJECTIVES: We conducted a systematic literature review to investigate definitions of treatment failure in UTI and the corresponding failure rates. METHODS: MEDLINE, Embase and CENTRAL databases were searched from 2011 to 2024 and relevant conference proceedings from 2021 to 2024 for English language studies reporting rates of treatment failure in females aged ≥12 years with uncomplicated UTI. RESULTS: Publications included reported 14 clinical trials, 11 non-interventional observational studies with chart review and 10 healthcare database studies. Treatment failure definitions were classified as microbiological, clinical, antibiotic prescription based or a composite of these. Evaluation timepoints typically ranged from 1 to 30 days post-treatment. In clinical trials, failure rates varied from 0.8% to 83%, often with marked differences between microbiological, clinical and prescription definitions within the same trial. Rates of treatment failure using combined endpoints, including prescription failure with a healthcare encounter in database studies, were generally more consistent (6.87%-16.7%). Few studies assessed time to symptom resolution. Prescription failure or additional healthcare visits frequently occurred after a median 2-4 weeks. CONCLUSIONS: Treatment failure definitions have been variably defined in the literature. Symptom scores in clinical trials and the need for additional antibiotics or healthcare visits are meaningful outcomes that could underly treatment failure definitions in future studies. The optimal time for each outcome assessment needs further evaluation.