Additional assessment of Acute Cystitis Symptom Score questionnaire for patient-reported outcome measure in female patients with acute uncomplicated cystitis: part II

M. Zamuddinov,F. M. Wagenlehner,J. F. Alidjanov,P. Tenke,A. Radzhabov,K. G. Naber,A. Pilatz,A. Magyar

doi:10.1007/s00345-019-02948-8

M. Zamuddinov, F. M. Wagenlehner + Show 6 more

Open Access

https://doi.org/10.1007/s00345-019-02948-8

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Abstract

PurposeSince 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.MethodsData 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.ResultsOf 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.ConclusionsScoring 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.

Highlights

Current guidelines recommend the use of antibiotics (ABs) as the first choice of treatment for the acute phase of uncomplicated urinary tract infections [1, 2], several prospective randomized, controlled studies have been performed already comparing antibiotic therapy with symptomatic therapy of uncomplicated acute cystitis (AC) in women [3,4,5,6]
Taking into account the possible protective abilities of asymptomatic bacteriuria against recurrent UTI, it has become obvious that the elimination of bacteriuria cannot be considered anymore the main aim of studies focused on the assessment of the efficacy of non-antibiotic modalities in the treatment of AC [7, 8]
Two-by-two contingency tables were used for the statistical analysis of the bivariate variables, where the thresholds in different times of the evaluation were considered as the test variable, and efficacy of the therapy was taken as an outcome

Summary

Introduction

Current guidelines recommend the use of antibiotics (ABs) as the first choice of treatment for the acute phase of uncomplicated urinary tract infections (uUTI) [1, 2], several prospective randomized, controlled studies have been performed already comparing antibiotic therapy with symptomatic therapy of uncomplicated acute cystitis (AC) in women [3,4,5,6] These results were compelling enough for the updated German Clinical Guidelines [2] to encourage the use of non-AB symptomatic treatment in selected cases of acute lower uUTIs with mild-to-moderate symptoms. A PROM can be used to measure the effect of a medical intervention on one or more concepts (i.e., the thing being measured, such as a symptom or group of symptoms, effects on a particular function or group of functions, or a group of symptoms or functions shown to measure the severity of a health condition)” [9]

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