Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women

Jakhongir F Alidjanov,Florian M Wagenlehner,Musluhuddin Zamuddinov,Kurt G Naber,Peter Tenke,András Magyar,Abdukhamid Radzhabov,Adrian Pilatz

doi:10.1007/s00345-019-02761-3

Abstract

PurposeTo 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).MethodsThe 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.ResultsThe 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 cut-off 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.ConclusionsNot 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.

Highlights

Despite numerous publications, there is still no generally accepted strategy regarding the clinical diagnosis of acute uncomplicated cystitis (AC)
The authors noted that postmenopausal women or those who have well-controlled diabetes mellitus in the absence of urological sequelae may be considered as having uncomplicated Urinary tract infections (UTIs) by some experts, but a discussion of specific management of these groups was outside the scope of the guidelines
The definition of UTIs in a broader sense is presented in the updated German National Clinical Practice S3 Guideline [3]: UTIs may be classified as uncomplicated in the absence of relevant functional or anatomical abnormalities in the urinary tract, with no relevant renal functional impairment and any relevant concomitant disease that could aggravate the UTIs or condition, which could increase the risk of development of serious complications

Summary

Introduction

There is still no generally accepted strategy regarding the clinical diagnosis of acute uncomplicated cystitis (AC). The definition of UTIs in a broader sense is presented in the updated German National Clinical Practice S3 Guideline [3]: UTIs may be classified as uncomplicated in the absence of relevant functional or anatomical abnormalities in the urinary tract, with no relevant renal functional impairment and any relevant concomitant disease that could aggravate the UTIs or condition, which could increase the risk of development of serious complications Simple cystitis in this regard, may represent no additional health problem for the woman with stable diabetes mellitus, whereas any kind of pyelonephritis, whether earlier defined as uncomplicated or complicated, could interfere with her metabolic balance and could lead to severe complications. A more differentiated stratification of UTIs with the deeper consideration of risk factors was proposed earlier [4]

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