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MP71-10 THE DIAGNOSTIC VALUES OF SYMPTOMS FOR ACUTE UNCOMPLICATED CYSTITIS – EVALUATION OF THE PROPOSED UPDATED FDA GUIDELINES

INTRODUCTION AND OBJECTIVES: Recently, US Food and Drug Administration (FDA) has proposed to use at least two of the four following symptoms for diagnosis of acute uncomplicated cystitis (AC) in women: dysuria, urinary frequency, urinary urgency, and suprapubic pain. We aimed to reevaluate the diagnostic values of symptoms for AC, using the Acute Cystitis Symptom Score (ACSS), having been validated in several languages. METHODS: The data derived from the ACSS database were analyzed and used for validating the updated FDA guidelines. Different diagnostic values of the signs, symptoms and their severity were assessed. «Model fit» analysis of the linear models and 2x2 contingency tables were used for basic statistical analysis. RESULTS: Of the 911 respondents from 7 different countries, 872 (median for age [IQR] 33[25-46]) were selected for the analysis. Respondents were allocated to groups of Patients (n=453) and Controls (n=418) according to the diagnosis of a physician concerning the presence or absence of AC, based on physical and laboratory findings. The accuracy of the diagnosis increased significantly for all symptoms when the severity of a symptom was included in the analysis. Highest diagnostic values were shown by dysuria in the «model fit» and odds ratio analyses, both for the presence and severity of this symptom. Urinary frequency and visible blood in the urine had no significant association with the diagnosis of AC when the analysis was based only on the presence or absence of signs. Inclusion the severity of urinary frequency into the analysis increased the strength of its association with AC up to significant values. The diagnostic values of suprapubic pain and sense of incomplete bladder emptying were about the same and had a significant positive association with AC. The inclusion of the severity into the analysis decreased the association of suprapubic pain with AC to insignificant values. CONCLUSIONS: The severity of the symptoms rather than their presence itself is essential for an accurate diagnosis of AC. Dysuria has the highest diagnostic value of the typical symptoms. In addition to the four symptoms proposed by the FDA, we propose also to include a sense of incomplete bladder emptying into the list of additional symptoms for the diagnosis of AC. It is, however, necessary to consider the severity of a symptom rather than its presence alone. The ACSS could be a useful tool in this regard. Source of Funding: none