Abstract
PURPOSE: Since symptomatic, non-antibiotic therapy has become an alternative approach to treat acute cystitis (AC) in women, suitable patient-reported outcome measures (PROM) are urgently needed. The aim of this part II of a larger non-interventional, case-control study was the additional assessment of the ACSS as a suitable PROM. METHODS: Data from 134 female patients with diagnosed acute uncomplicated cystitis were included in the current analysis with (1) a summary score of "Typical" domain of 6 and more; (2) at least one follow-up evaluation after the baseline visit; (3) no missing values in the ACSS questionnaire data. Six different predefined thresholds based on the scoring of the ACSS items were evaluated to define "clinical cure", also considering the draft FDA and EMA guidelines. RESULTS: Of the six different thresholds tested, a summary score of the five typical symptoms of 5 and lower with no symptom more than 1 (mild), without visible blood in urine, with or without including QoL issues was favoured, which partially also could be adapted to the draft FDA and EMA guidelines. The overall patient's clinical assessment ("Dynamic" domain) alone was not sensitive enough for a suitable PROM. CONCLUSIONS: Scoring of the severity of symptoms is needed not only for diagnosis, but also for PROM to define "clinical cure" of any intervention, which could be combined with QoL issues. Results of the study demonstrated that the ACSS questionnaire has the potential to be used as a suitable PROM and should further be tested in prospective clinical studies.