Objective: Development and validation of a simple and standardized self-reporting questionnaire for acute uncomplicated cystitis (AUC) assessing typical and differential symptoms, quality of life and possible changes after therapy in female patients with AUC. Materials and Methods: Literature research, development and evaluation of the Acute Cystitis Symptom Score (ACSS), an 18-item self-reporting questionnaire including (a) six questions about ‘typical' symptoms of AUC, (b) four questions regarding differential diagnoses, (c) three questions on quality of life and (d) five questions on additional conditions which may affect therapy. The ACSS was evaluated in 286 women (mean age 32.3 ± 12.3 years) in the Russian and Uzbek language. Measurements of reliability, validity, predictive ability and responsiveness were performed. Results: Cronbach's alpha for the ACSS was 0.89, split-half reliability was 0.92 and correlation between halves was 0.85. Mann-Whitney test revealed significant difference scores of the ‘typical' domain between patients and controls (10.75 vs. 2.02, p < 0.001). The optimal threshold score was 6 points, with a 94% sensitivity and 90% specificity to predict AUC. The symptom score decreased significantly when comparing before and after therapy (10.7 vs. 2.1, p < 0.001). Conclusion: The new validated ACSS is accurate enough and can be recommended for clinical studies and practice for initial diagnosis and monitoring treatment of AUC. Evaluation in other languages is in progress. © 2014 S. Karger AG, Basel

Objectives: The Acute Cystitis Symptom Score (ACSS) was developed as a self-reporting questionnaire for clinical diagnosis of acute uncomplicated cystitis (AUC) and symptomatic changes in female patients. The aim of the present study was to assess the utility of the different domains of ACSS including the ‘dynamics' domain after therapy. The applicability of these domains in assessing changes in symptoms, as a function of time, in this population was investigated. Materials and Methods: During the validation process of the ACSS in Uzbek and Russian languages, a subgroup of patients (n = 63) returned after therapy and filled in part B of ACSS. Descriptive statistics were used, where suitable. Results: The reduction of typical symptoms and quality of life (QoL) assessment between first and follow-up visit correlated significantly with answers in the ‘dynamics' domain. Success/cure and non-success/failure could be clearly differentiated by the scores obtained in ‘typical' and ‘QoL' domains. Conclusion: The ACSS has proven to be a useful instrument to clinically diagnose AUC in women. It is also a suitable instrument for patient-reported outcome assessment, with applicability in both daily practice and in clinical studies. Slight modifications in the ‘dynamics' domain will even increase the applicability.

Purpose To reassess the diagnostic values of the "draft" guidelines for the clinical diagnosis of acute uncomplicated cystitis (AC), recently proposed by US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Methods The data of 517 female respondents (patients with acute cystitis and controls) derived from the e-USQOLAT database were analyzed and used for the validation of proposed "draft" guidelines of FDA and EMA, compared to the Acute Cystitis Symptom Score (ACSS) questionnaire. The diagnostic values of the proposals concerning signs, symptoms and their severity were assessed and compared. Results The six "typical" symptoms of the ACSS were strongly associated with the diagnosis of AC. The number of positive "typical" symptoms differed significantly between patients and controls: median 5 (IQR 4-6) vs 1 (IQR 0-3) respectively. Scored severity of "typical" symptoms also differed significantly between groups of patients and controls: median (IQR) 10 (7-13) vs 1 (0-4), respectively. The best balance between sensitivity and specificity is shown by the ACSS cutoff value of 6 scores and more of the "Typical" domain, followed by an approach proposed by FDA and EMA, justifying ACSS to be used as a diagnostic criterion for the clinical diagnosis of AC. Conclusions Not only the presence but also the severity of the symptoms is important for an accurate diagnosis of AC. The ACSS, even without urinalysis is at least as favourable as the draft diagnostic proposals by FDA and EMA. The ACSS can be recommended for epidemiological and interventional studies, and allows women to establish self-diagnosis of AC, making the ACSS also cost-effective for healthcare.

The German version of the ACSS showed a high reliability and validity. Therefore, the German version of the ACSS can be reliably used in clinical practice and research for diagnosis and therapeutic monitoring of patients suffering from AC.

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 noninterventional, 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.