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

Abstract

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.

Acute Cystitis Symptom Score questionnaire for measuring patient-reported outcomes in women with acute uncomplicated cystitis: Clinical validation as part of a phase III trial comparing antibiotic and nonantibiotic therapy

“…For the diagnosis and treatment of uUTI in women, the UTI Symptom Assessment (UTISA) questionnaire was described by Clayson et al [29], which also uses a scoring system of UTI symptoms and QoL assessment but does not include questions for differential diagnosis concerning py elonephritis, fluor vaginalis, or sexual transmitted diseases, which can imitate socalled typical urinary symptoms, or questions concerning additional conditions like pregnancy, menopause, and diabetes mellitus. Since the ACSS questionnaire was used in this double blind, controlled, doubledummy, parallelgroup, randomized, multicenter, multinational phase III noninferiority trial in the treatment of AC, comparing a phytodrug (BNO 1045) with an antibacterial agent (FT) [5], its suitability as a pa tientreported outcome measure could be validated and com pared with the results of an earlier noninterventional study [20] in which the same clinical thresholds defining clinical cure could be tested.…”

“…The ACSS is now available, translated, and validated in several languages ( www.acss.world ). In two smaller and one larger noninterventional study, the ACSS was evaluated as a measure of patient-reported outcomes [ 18 19 20 ]. The ACSS has now been used in a larger prospective phase III trial comparing the outcome of an antibacterial agent (a single oral dose of fosfomycin trometamol [FT]) with that of a herbal treatment (Canephron®N [BNO 1045]; 2 dragées three times daily for 7 days) in women with AC [ 5 ].…”

“…The clinical efficacy of BNO 1045 has been proven in several studies [ 22 ]. With the data of this recent clinical trial [ 5 ], additional assessment of the ACSS as a patient-reported outcome measure can be performed and compared with results obtained by the earlier noninterventional studies [ 18 19 20 ].…”

Effect of a Herbal Therapy on Clinical Symptoms of Acute Lower Uncomplicated Urinary Tract Infections in Women: Secondary Analysis from a Randomized Controlled Trial

“…This means that the following patients were excluded from microPP: patients whose bacterial count was less than 10 4 CFU/mL at the time of inclusion patients whose urine cultures were contaminated and, therefore, not evaluable patients who took concomitant medication that could influence the results of the urine cultures. For this secondary analysis, we defined a new patient-relevant clinical endpoint (i.e., clinical improvement of symptoms) based on the Acute Cystitis Symptom Score (ACSS) (Table S3), a validated, standardized self-reporting questionnaire used to evaluate the symptoms of acute uncomplicated cystitis in women [22][23][24][25][26]. In addition, we analyzed whether the herbal combination reduced the rate of antibiotic use.…”

“…To this end, new symptomatic endpoints based on the Acute Cystitis Symptom Score (ACSS) were defined. The ACSS is a validated, standardized self-reporting questionnaire used to evaluate the symptoms of acute uncomplicated cystitis in women, which can be used for clinical diagnostics and patient-reported outcome assessment [22][23][24][25]. In addition, the proportion of patients who required additional antibiotic therapy to treat their acute lower uUTIs was analyzed more closely.…”