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<strong><em>Objective:</em></strong> Development and validation of a simple and standardized self-reporting questionnaire for acute uncomplicated cystitis (AUC) assessing typical and differential symptoms, quality... more
<strong><em>Objective:</em></strong> Development and validation of a simple and standardized self-reporting questionnaire for acute uncomplicated cystitis (AUC) assessing typical and differential symptoms, quality of life and possible changes after therapy in female patients with AUC. <b><i>Materials and Methods:</i></b> Literature research, development and evaluation of the Acute Cystitis Symptom Score (ACSS), an 18-item self-reporting questionnaire including (a) six questions about 'typical' symptoms of AUC, (b) four questions regarding differential diagnoses, (c) three questions on quality of life and (d) five questions on additional conditions which may affect therapy. The ACSS was evaluated in 286 women (mean age 32.3 ± 12.3 years) in the Russian and Uzbek language. Measurements of reliability, validity, predictive ability and responsiveness were performed. <b><i>Results:</i></b> Cronbach's alpha for the ACSS was 0.89, split-half reliability was 0.92 and correlation between halves was 0.85. Mann-Whitney test revealed significant difference scores of the 'typical' domain between patients and controls (10.75 vs. 2.02, p &lt; 0.001). The optimal threshold score was 6 points, with a 94% sensitivity and 90% specificity to predict AUC. The symptom score decreased significantly when comparing before and after therapy (10.7 vs. 2.1, p &lt; 0.001). <b><i>Conclusion:</i></b> The new validated ACSS is accurate enough and can be recommended for clinical studies and practice for initial diagnosis and monitoring treatment of AUC. Evaluation in other languages is in progress.
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The acute uncomplicated cystitis in women is one of the most frequently diagnosed bacterial infection. A clinically symptomatic urinary tract infection must be differentiated from the asymptomatic bacteriuria, which is not considered an... more
The acute uncomplicated cystitis in women is one of the most frequently diagnosed bacterial infection. A clinically symptomatic urinary tract infection must be differentiated from the asymptomatic bacteriuria, which is not considered an infection but rather a colonization which should not be treated. For the antimicrobial therapy according to the European guidelines the old oral antibiotics (fosfomycin trometamol, nitrofurantoin, pivmecillinam) should be prescribed, against which E. coli is still susceptible in over 90%. With new therapeutic concepts not mainly the elimination of bacteria but rather the treatment of the inflammatory (over)reaction of the host is highlighted. To establish the significance of these therapeutic options as compared to the standard antibiotic therapy, the results of the ongoing and planned phase 3 studies need to be awaited. Thus reliable clinical measuring parameters for diagnostics and outcome are needed. The acute cystitis symptom score (ACSS) was developed and validated in Russian and Uzbec languages. Because of its high reliability, validity and predictive value it can be used not only in daily practice but also for clinical studies for the diagnosis of an acute uncomplicated cystitis in women.
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Background and Objectives: Acute uncomplicated cystitis (AC) is common among women. Acute onset of specific typical symptoms may serve as reliable criteria for developing a cost-effective strategy to make an accurate diagnosis of AC. We... more
Background and Objectives: Acute uncomplicated cystitis (AC) is common among women. Acute onset of specific typical symptoms may serve as reliable criteria for developing a cost-effective strategy to make an accurate diagnosis of AC. We aimed to evaluate the diagnostic values of most common symptoms and signs of AC depending on their presence and severity. Methods: The current trial was designed as a case-control study. Data derived from the Acute Cystitis Symptom Score (ACSS) database were analyzed. Diagnostic values of the symptoms and their severity were assessed via the calculations of the sensitivity and specificity, odds ratio, positive and negative likelihood ratios. The strength of associations was estimated by the coefficient of correlation (Pearson’s R). Results: Data from 819 female subjects (423 Patients, 396 controls) with the mean age of 37.1 ± 15.3 were analyzed. Highest diagnostic values for AC in this study belonged to dysuria, urgency, and frequency. Interestingly, complaints of vaginal discharge was not found to decrease the odds for having AC in the study population. Conclusions: The severity of the symptom is even more essential than just its presence for an accurate diagnosis. The ACSS is an accurate tool and may be recommended for clinical practice and studies for diagnosis of AC in women. Further studies and unification of terms are need.
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Real-world data were collected to examine antimicrobial resistance (AMR) prevalence, treatment patterns, and clinical outcomes among female patients with uncomplicated urinary tract infection (uUTI) in Germany. Data were from a... more
Real-world data were collected to examine antimicrobial resistance (AMR) prevalence, treatment patterns, and clinical outcomes among female patients with uncomplicated urinary tract infection (uUTI) in Germany. Data were from a retrospective physician-based chart review completed by physicians treating patients with uUTI. Non-pregnant women aged ≥ 12 years, with a uUTI diagnosis, an E. coli-positive urine culture between January 2017–December 2019, and susceptibility test results for ≥ 4 drug classes were eligible. Patients were stratified into three cohorts by drug class susceptibility: susceptible to all (SUS), resistant to one or two drug classes (DR1/2), and resistant to ≥ 3 (MDR) drug classes tested. Among 386 eligible patients [SUS (67.1%); DR1/2 (29.0%); MDR (3.9%)], AMR prevalence was highest for FMIs (18.3%) and lowest for fluoroquinolones (5.2%). The most prescribed drugs were fosfomycin in SUS (44.0%), DR1/2 (41.4%), and fluoroquinolones in MDR (40.0%). Treatment for uUTI...
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Background: the nature of alpha-D-mannose - natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing urinary tract infections - in the interaction with E. coli is addressed in order to drive the issue of its... more
Background: the nature of alpha-D-mannose - natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing urinary tract infections - in the interaction with E. coli is addressed in order to drive the issue of its regulatory classification as a medicinal product or medical device. Methods: PRISMA systematic review approach was applied; Delphi Panel method used to target consensus on statements retrieved from evidence. Results: Based of regulatory definitions and research evidences, the mechanism of D-mannose does not involve a metabolic or immunological action while there is an uncertainty regarding the pharmacological action. Specific interaction between the product and the bacteria within the body occurs, but its nature is inert: it does not induce a direct response activating or inhibiting body processes. Moreover, the action of D-mannose takes place, even if inside the bladder, outside the epithelium on bacteria that have not yet invaded the urothelial tissue...
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Background: A catheter allowing a release of antibacterial substances such as antiseptics into the bladder could be a new way of preventing biofilm formation and subsequent catheter-associated urinary tract infections. Methods: Minimal... more
Background: A catheter allowing a release of antibacterial substances such as antiseptics into the bladder could be a new way of preventing biofilm formation and subsequent catheter-associated urinary tract infections. Methods: Minimal inhibitory and bactericidal concentration (MIC/MBC) determinations in cation-adjusted Mueller-Hinton broth and artificial urine were performed for 4 antiseptics against 3 uropathogenic biofilm producers, Escherichia coli, Pseudomonas aeruginosa, and Proteus mirabilis. Furthermore, effects of octenidine and polyhexanide against catheter biofilm formation were determined by quantification of biofilm-producing bacteria. Results: Sodium hypochlorite showed MIC/MBC values between 200 and 800 mg/L for all strains tested. Triclosan was efficient against E. coli and P. mirabilis (MIC ≤2.98 mg/L) but ineffective against P. aeruginosa. Octenidine and polyhexanide showed antibacterial activity against all 3 species tested (MIC 1.95–7.8 and 3.9–31.25 mg/L). Both ...
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Background Health care-associated urinary tract infection (HAUTI) consists of unique conditions (cystitis, pyelonephritis and urosepsis). These conditions could have different pathogen diversity and antibiotic resistance impacting on the... more
Background Health care-associated urinary tract infection (HAUTI) consists of unique conditions (cystitis, pyelonephritis and urosepsis). These conditions could have different pathogen diversity and antibiotic resistance impacting on the empirical antibiotic choices. The aim of this study is to compare the estimated chances of coverage of empirical antibiotics between conditions (cystitis, pyelonephritis and urosepsis) in urology departments from Europe. Methods A mathematical modelling based on antibiotic susceptibility data from a point prevalence study was carried. Data were obtained for HAUTI patients from multiple urology departments in Europe from 2006 to 2017. The primary outcome of the study is the Bayesian weighted incidence syndromic antibiogram (WISCA) and Bayesian factor. Bayesian WISCA is the estimated chance of an antibiotic to cover the causative pathogens when used for first-line empirical treatment. Bayesian factor is used to compare if HAUTI conditions did or did n...
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The broad-spectrum C-8-cyano-fluoroquinolone finafloxacin displays enhanced activity under acidic conditions. This phase II clinical study compared the efficacies and safeties of finafloxacin and ciprofloxacin in patients with complicated... more
The broad-spectrum C-8-cyano-fluoroquinolone finafloxacin displays enhanced activity under acidic conditions. This phase II clinical study compared the efficacies and safeties of finafloxacin and ciprofloxacin in patients with complicated urinary tract infection and/or pyelonephritis. A 5-day regimen with 800 mg finafloxacin once a day (q.d.) (FINA05) had results similar to those of a 10-day regimen with 800 mg finafloxacin q.d. (FINA10). Combined microbiological and clinical responses at the test-of-cure (TOC) visit were 70% for FINA05, 68% for FINA10, and 57% for a 10-day ciprofloxacin regimen (CIPRO10) in 193 patients (64 for FINA05, 68 for FINA10, and 61 for CIPRO10) of the microbiological intent-to-treat (mITT) population. Additionally, the clinical effects of ciprofloxacin on patients with an acidic urine pH (80% of patients) were reduced, whereas the effects of finafloxacin were unchanged. Finafloxacin was safe and well tolerated. Overall, 43.4% of the patients in the FINA05 ...
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Aim. The aim of this observational study was to evaluate the effectiveness of a phytotherapic drug (Canephron N) in preventing urinary tract infection (UTI) in high-risk women undergoing urodynamic studies (UDS). Methods. The study... more
Aim. The aim of this observational study was to evaluate the effectiveness of a phytotherapic drug (Canephron N) in preventing urinary tract infection (UTI) in high-risk women undergoing urodynamic studies (UDS). Methods. The study protocol was approved by the local institutional ethical committee. Adult women with at least one risk factor for acquiring UTI (defined as: age over 70, elevated postvoid residual urine>100 ml, recurrent UTI, pelvic organ prolapse (POP) ≥II in POP-Q scale, and neurogenic bladder) had received after UDS either a single oral dose of fosfomycin trometamol (FT) (3 grams) or a phytodrug containing centaury herb, lovage root, and rosemary leaves (5 ml taken orally three times daily for one week). All patients included in the study had no pyuria according to urine dipstick (nitrite and/or blood and/or leukocyte esterase) and negative urine culture (CFU < 103/ml) before UDS. Urine samples were also tested 7 days after UDS. Results. Seventy-two high-risk pa...
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The Acute Cystitis Symptom Score (ACSS) was developed as a self-reporting questionnaire for clinical diagnosis of acute uncomplicated cystitis (AUC) and symptomatic changes in female patients. The aim of the present study was to assess... more
The Acute Cystitis Symptom Score (ACSS) was developed as a self-reporting questionnaire for clinical diagnosis of acute uncomplicated cystitis (AUC) and symptomatic changes in female patients. The aim of the present study was to assess the utility of the different domains of ACSS including the &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;dynamics&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; domain after therapy. The applicability of these domains in assessing changes in symptoms, as a function of time, in this population was investigated. During the validation process of the ACSS in Uzbek and Russian languages, a subgroup of patients (n = 63) returned after therapy and filled in part B of ACSS. Descriptive statistics were used, where suitable. The reduction of typical symptoms and quality of life (QoL) assessment between first and follow-up visit correlated significantly with answers in the &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;dynamics&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; domain. Success/cure and non-success/failure could be clearly differentiated by the scores obtained in &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;typical&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;QoL&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; domains. The ACSS has proven to be a useful instrument to clinically diagnose AUC in women. It is also a suitable instrument for patient-reported outcome assessment, with applicability in both daily practice and in clinical studies. Slight modifications in the &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;dynamics&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; domain will even increase the applicability.
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Objective: Development and validation of a simple and standardized self-reporting questionnaire for acute uncomplicated cystitis (AUC) assessing typical and differential symptoms, quality of life and possible changes after therapy in... more
Objective: Development and validation of a simple and standardized self-reporting questionnaire for acute uncomplicated cystitis (AUC) assessing typical and differential symptoms, quality of life and possible changes after therapy in female patients with AUC. Materials and Methods: Literature research, development and evaluation of the Acute Cystitis Symptom Score (ACSS), an 18-item self-reporting questionnaire including (a) six questions about ‘typical' symptoms of AUC, (b) four questions regarding differential diagnoses, (c) three questions on quality of life and (d) five questions on additional conditions which may affect therapy. The ACSS was evaluated in 286 women (mean age 32.3 ± 12.3 years) in the Russian and Uzbek language. Measurements of reliability, validity, predictive ability and responsiveness were performed. Results: Cronbach's alpha for the ACSS was 0.89, split-half reliability was 0.92 and correlation between halves was 0.85. Mann-Whitney test revealed significant difference scores of the ‘typical' domain between patients and controls (10.75 vs. 2.02, p &lt; 0.001). The optimal threshold score was 6 points, with a 94% sensitivity and 90% specificity to predict AUC. The symptom score decreased significantly when comparing before and after therapy (10.7 vs. 2.1, p &lt; 0.001). Conclusion: The new validated ACSS is accurate enough and can be recommended for clinical studies and practice for initial diagnosis and monitoring treatment of AUC. Evaluation in other languages is in progress. © 2014 S. Karger AG, Basel
Research Interests: Quality of life, Adolescent, Medicine, Humans, Internal Medicine, and 15 moreFemale, Young Adult, Urinary Tract Infections, Differential Diagnosis, Middle Aged, Questionnaires, Adult, Urinary System, Reproducibility of Results, Sensitivity and Specificity, Self report, Severity of Illness Index, Acute Disease, Symptom assessment, and cystitis
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Introduction: The Acute Cystitis Symptom Score (ACSS) is a new self-reporting tool to evaluate the symptoms of uncomplicated acute cystitis (AC) in women. The linguistic and clinical validation process of the Hungarian version used in... more
Introduction: The Acute Cystitis Symptom Score (ACSS) is a new self-reporting tool to evaluate the symptoms of uncomplicated acute cystitis (AC) in women. The linguistic and clinical validation process of the Hungarian version used in this study may serve as a guide for the validation of the ACSS in other languages. Material and methods: In this prospective cohort study, women with AC (Patients) and those without (Controls) filled in the Hungarian ACSS version, during their visits to physician's office. Statistical analysis included ordinary descriptive values, calculation of reliability, validity, discriminative ability, responsiveness (sensitivity, specificity) and comparative analysis. Results: Thirty-one patients were recruited for validation along with 37 controls. Statistical analyses resulted in excellent values of internal consistency, discriminative ability and validity for diagnosis of AC. At the cut-off at a score of 6 in the 'typical' domain, positive and negative predictive values were 97% and 92%, sensitivity and specificity were 90% and 97%, respectively. Conclusions: The ACSS has demonstrated benefits for diagnosis and patient-reported outcome assessment. It is objective, fast, and cost-effective, and may help to easily confirm the accurate diagnosis of AC. Therefore, it may be especially important for clinical and epidemiological studies on AC in women.
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Introduction and ObjectivesThe Acute Cystitis Symptom Score (ACSS) is a patient self‐reporting questionnaire for clinical diagnostics and patient‐reported outcome (PRO), which may assess the symptoms and the effect on the quality of life... more
Introduction and ObjectivesThe Acute Cystitis Symptom Score (ACSS) is a patient self‐reporting questionnaire for clinical diagnostics and patient‐reported outcome (PRO), which may assess the symptoms and the effect on the quality of life in women with acute cystitis (AC). The current study aimed to create a validated Spanish version of the ACSS questionnaire.Material and MethodsThe process of linguistic validation of the Spanish version of the ACSS consisted of the independent forward and backward translations, revision and reconciliation, and cognitive assessment. Clinical evaluation of the study version of the ACSS was carried out in clinics in Spain and Latin America. Statistical tests included the calculation of Cronbach's α, split‐half reliability, specificity, sensitivity, diagnostic odds ratio, positive and negative likelihood ratio, and area under the receiver‐operating characteristic curve (AUC).ResultsThe study was performed on 132 patients [age (mean;SD) 45.0;17.8 yea...
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INTRODUCTION The Acute Cystitis Symptom Score (ACSS) questionnaire first developed in Russian and Uzbek languages and now available in many other languages can be used for clinical diagnostics and patient-reported outcome (PRO) in female... more
INTRODUCTION The Acute Cystitis Symptom Score (ACSS) questionnaire first developed in Russian and Uzbek languages and now available in many other languages can be used for clinical diagnostics and patient-reported outcome (PRO) in female patients with acute uncomplicated cystitis (AUC). The aim of the current study was the linguistic validation and cognitive assessment of the French version of the ACSS questionnaire according to internationally accepted guidelines. METHODS After two forward translations from Russian into the French language and backward translation into Russian and Uzbek, the two original languages, the scientific committee (SC) performed a slightly adapted French version, which finally was cognitively assessed by female subjects with different ages and educational levels and medical professionals, such as nurses, physicians, and pharmacists. RESULTS All comments of the female subjects and professionals were discussed within the SC and after slight, but necessary adaptations, the SC agreed on the final study version of the French ACSS. CONCLUSION Now, the linguistically validated and cognitively assessed French version of the ACSS can be used for clinical studies and practice.
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Background Urinary tract infections (UTIs) are among the most common infections that require antibiotic therapy. In December 2015, new guidelines for UTI management were published in France with the aim of reducing antibiotic misuse and... more
Background Urinary tract infections (UTIs) are among the most common infections that require antibiotic therapy. In December 2015, new guidelines for UTI management were published in France with the aim of reducing antibiotic misuse and the risk of antimicrobial resistance. Objectives To analyze changes in antibiotic prescribing behavior for acute uncomplicated UTI in women in France from 2014 to 2019. Methods Retrospective study using data extracted from the medico-administrative database ‘OpenMedic’ that is linked to the French National Health Data System and collects data on the reimbursement of prescribed drugs. The analyses focused on the number of boxes of antibiotics delivered by community pharmacies, the molecule class, and the prescriber’s specialty. Results Overall, antibiotic dispensing by community pharmacies increased by 2% between 2014 and 2019, but with differences in function of the antibiotic class. The use of antibiotics recommended as first-line and second-line tr...
Research Interests: Medicine, Antibiotic Resistance, Library and Information Studies, Urinary tract infection, Antimicrobial resistance, and 9 moreAntibiotics, Public health systems and services research, Educational Intervention, Ciprofloxacin, Nitrofurantoin, Lomefloxacin, Guideline Adherence, Fosfomycin, and Medical prescription
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Introduction and hypothesis The Global Prevalence Study of Infections in Urinary tract in Community Setting (GPIU.COM) includes epidemiological aspects of acute cystitis (AC) in women in Germany and Switzerland. The primary study relates... more
Introduction and hypothesis The Global Prevalence Study of Infections in Urinary tract in Community Setting (GPIU.COM) includes epidemiological aspects of acute cystitis (AC) in women in Germany and Switzerland. The primary study relates to the German version of the Acute Cystitis Symptom Score (ACSS), a self-reporting questionnaire for self-diagnosis and monitoring the symptomatic course of AC in women. The current study aimed to analyze the validity and reliability of the German ACSS in German-speaking female patients with AC in Switzerland. Methods Anonymized patient data were collected and analyzed from women with AC at the first visit (diagnosis) and follow-up visits as baseline and controls, respectively. Data from 97 patients with a median age of 41 years underwent analysis. Psychometric and diagnostic characteristics of the ACSS were measured and statistically analyzed. Results Average internal consistency of the ACSS resulted in a Cronbach’s alpha (95% CI) of 0.86 (0.83; 0....
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Purpose To evaluate and report the complications, and to analyse antimicrobial stewardship aspects following prostate biopsies (P-Bx) based on the data from a 9-year global study. Methods The primary outcome was to compare complications... more
Purpose To evaluate and report the complications, and to analyse antimicrobial stewardship aspects following prostate biopsies (P-Bx) based on the data from a 9-year global study. Methods The primary outcome was to compare complications after P-Bx between patients of two cohorts: 2010–2014 and 2016–2019. Primary outcomes included symptoms of lower and severe/systemic urinary tract infection (LUTIS and SUTIS, respectively), and positive urine culture. Readmission to hospital after P-Bx, need for additional antimicrobial therapy, consumption of different antimicrobial agents for prophylaxis and therapy were evaluated. Students t test and chi-square test were used for comparative analyses. Results Outcome data were available for 1615 men. Fluoroquinolones-based prophylaxis rate increased from 72.0% in 2010–2014 to 78.6% in 2015–2019. Overall rates of complications increased from 6 to 11.7% including an increase in symptomatic complications from 4.7 to 10.2%, mainly due to an increase i...
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Background: Reports suggest an increase of life-threatening infectious complications following prostate biopsies (P-Bx). Methods: Risk factors and time trends in rates of infectious complications were evaluated in the multicentre,... more
Background: Reports suggest an increase of life-threatening infectious complications following prostate biopsies (P-Bx). Methods: Risk factors and time trends in rates of infectious complications were evaluated in the multicentre, worldwide, prospective Global Prevalence of Infections in Urology (GPIU) study 2010-2018. The primary outcome was infectious complications after P-Bx. Uni- and multivariate statistical analysis, two-sample t and chi-square tests were used. Findings: Outcome data were available for 1556 men. Rates of symptomatic complications increased from 6.1% in 2010 to 10.2% in 2018. Prevalence of symptoms of urinary tract infections (UTI) justifying antibiotic treatment was 6.5%. Fluoroquinolone-based prophylaxis was administered in 79.7%. Transperineal P-Bx, repeated P-Bx, aminoglycosides as prophylaxis and histopathologic signs of inflammation in the prostate were risk factors to develop symptoms of UTI. Inflammation of the prostatic tissue was associated with a higher number of post-P-Bx symptoms. Of 88 urine cultures post-P-Bx, 33 were positive (37.5%). Escherichia coli was the most common causative uropathogen (75.8%). Resistance rate to fluoroquinolones was 60.0%. Following transrectal P-Bx, 3.9% of patients required hospitalization and 2.7% developed febrile infections. Two men (0.13%) died after transrectal P-Bx due to sepsis. Interpretation: Symptoms of UTI after P-Bx increased during study period. Inflammation of the prostatic tissue is associated with a higher number of post-P-Bx symptoms. Transrectal P-Bx was a risk factor for severe complications, such as febrile UTIs and mortality. Funding: European Section of Infections in Urology (ESIU), European Association of Urology (EAU), EAU Research Foundation (EAU RF), Technische Hochschule Mittelhessen (THM), Germany, Merian Iselin Foundation, Switzerland. Declaration of Interests: Authors have no potential conflict of personal interest to disclose that could give the appearance of potentially influencing the submitted work. Ethics Approval Statement: The GPIU study was approved by the Ethical Committee of the Justus Liebig University, Giessen, Germany (ethical vote: AZ:116/07). Due to the multicentric and multinational nature, obtaining regulatory approval was the responsibility of each study centre.
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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... more
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 non-interventional, 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 includi...
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The Acute Cystitis Symptom Score (ACSS) was developed as a self-reporting questionnaire for clinical diagnosis of acute uncomplicated cystitis (AUC) and symptomatic changes in female patients. The aim of the present study was to assess... more
The Acute Cystitis Symptom Score (ACSS) was developed as a self-reporting questionnaire for clinical diagnosis of acute uncomplicated cystitis (AUC) and symptomatic changes in female patients. The aim of the present study was to assess the utility of the different domains of ACSS including the 'dynamics' domain after therapy. The applicability of these domains in assessing changes in symptoms, as a function of time, in this population was investigated. During the validation process of the ACSS in Uzbek and Russian languages, a subgroup of patients (n = 63) returned after therapy and filled in part B of ACSS. Descriptive statistics were used, where suitable. The reduction of typical symptoms and quality of life (QoL) assessment between first and follow-up visit correlated significantly with answers in the 'dynamics' domain. Success/cure and non-success/failure could be clearly differentiated by the scores obtained in 'typical' and 'QoL' domains. The AC...
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Background and Objectives: Acute Cystitis Symptom Score (ACSS) is a self-reporting questionnaire for clinical diagnosis and follow-up of acute uncomplicated cystitis (AC) in women. The ACSS, originally developed in Uzbek and Russian, both... more
Background and Objectives: Acute Cystitis Symptom Score (ACSS) is a self-reporting questionnaire for clinical diagnosis and follow-up of acute uncomplicated cystitis (AC) in women. The ACSS, originally developed in Uzbek and Russian, both considered original languages, is now available in several other languages. This study aimed to translate and validate the ACSS in the Tajik language. Material and Methods: Linguistic validation was carried out according to the Linguistic Validation Manual for Patient-Reported Outcomes Instruments guidelines. Clinical validation was performed by enrolling fifty-four Tajik-speaking women. All women included in this study were first interviewed about the understandability of all questions and statements in the final Tajik ACSS and were asked to fill in form A at the first visit (diagnostics) and form B at any follow-up visit (patient-reported outcome). Results: Thirty-three women, median (range) age of 35 (18–77), were diagnosed with AC (patient grou...
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Zusammenfassung Hintergrund Nitroxolin zählt entsprechend der AWMF-S3-Leitlinie zu den Antibiotika der ersten Wahl für die Behandlung der unkomplizierten Zystitis (UZ) bei Frauen. Unter Real-world-Bedingungen sollte die klinische... more
Zusammenfassung Hintergrund Nitroxolin zählt entsprechend der AWMF-S3-Leitlinie zu den Antibiotika der ersten Wahl für die Behandlung der unkomplizierten Zystitis (UZ) bei Frauen. Unter Real-world-Bedingungen sollte die klinische Effektivität von Nitroxolin in einer prospektiven, multizentrischen, nicht-interventionellen Studie (NIS) und die Resistenz von Escherichia coli gegenüber Nitroxolin überprüft werden. Material und Methoden Patientinnen mit UZ und einer Therapie mit Nitroxolin (empfohlene Dosierung 3 × täglich 250 mg über 5 Tage) wurden von Urologen, Allgemeinmedizinern und hausärztlich tätigen Internisten deutschlandweit von April bis Dezember 2022 rekrutiert und über einen Zeitraum von 21–28 Tagen nachverfolgt. Die Diagnosestellung und der Therapieverlauf wurden mit Hilfe des ACSS-Fragebogens und anhand von Laboruntersuchungen (Leukozyturie etc.) beurteilt. Unabhängig von der NIS wurden im Rahmen einer bundesweiten Resistenz-Surveillance im Zeitraum 2019–20 in 23 Laborator...