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July 02, 2020

An assessment of draft guidelines for the clinical diagnosis of acute uncomplicated cystitis in women 1


At present there is no generally accepted strategy for the clinical diagnosis of acute uncomplicated cystitis. Recently, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) proposed draft guidelines for the clinical diagnosis of this condition for further discussion. The authors of this paper assessed the diagnostic value of these draft guidelines using the previously validated Acute Cystitis Symptom Score (ACSS).


  • Non-interventional, case-control study that mined data for females with (patients) and without (controls) acute uncomplicated cystitis contained in the e-USQOLAT database that was used for the clinical validation of the ACSS.
  • Only cases with sufficient symptom data and urinalysis were included for analysis.
  • The diagnosis of acute uncomplicated cystitis made by the treating physician was taken as reference.
  • The presence/absence of six “typical” symptoms of the ACSS (dysuria, urinary frequency, urinary urgency, suprapubic pain, incomplete bladder emptying and visible blood in urine), symptom severity (mild, moderate, severe), and the proposed diagnostic approaches (EMA, FDA, ACSS) were assessed for their diagnostic values.
    • Draft FDA approach: Adult and, if appropriate, adolescent females with pyuria
      (WBC ≥10/μL) and ≥2 signs or symptoms of dysuria, urinary frequency, urinary urgency and suprapubic pain.
    • Draft EMA approach: Females with pyuria (WBC ≥10/μL) and a minimum number of symptoms such as frequency, urgency and dysuria.

Key Results

Female Group
  • Median and mean age of the study population (n=517) was 30.5 and 34.4 years, respectively; median number of positive symptoms was one (interquartile range 0-3) for controls and five (interquartile range 4-6) for (p<0.001).
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  • All six symptoms had a significant positive association with the diagnosis of acute uncomplicated cystitis and their severity was also important.
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  • Average sensitivity and specificity for the different diagnostic approaches were 0.84 and 0.83 for the draft EMA approach, 0.83 and 0.88 for the draft FDA approach and 0.87 and 0.88 for the cut-off value (≥6 scores) of the ACSS, respectively.
    • ACSS cut-off value combined with positive pyuria had an average specificity of 0.96 and sensitivity of 0.73.



The presence and also the severity of symptoms are important for an accurate diagnosis of acute uncomplicated cystitis. The ACSS is at least as favourable as the draft diagnostic proposals by the FDA and EMA and therefore can be recommended for epidemiological and interventional studies. It also allows women to self-diagnose acute uncomplicated cystitis.



  1. Alidjanov JF, Naber KG, Pilatz A, et al. Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women. World J Urol. 2020;38(1):63–-72.

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