Linguistic validation and cognitive assessment of the French version of the Acute Cystitis Symptom Score questionnaire.

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.

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

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 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.

[Urogenital tuberculosis and schistosomiasis (bilharzia) : Urological challenges in displaced persons]. / Urogenitaltuberkulose und Schistosomiasis (Bilharziose) : Urologische Herausforderungen durch Flucht und Vertreibung.

We are observing the largest worldwide wave of migration ever. Displaced persons usually do not have access to general health care and are faced with a lack of hygienic conditions and infection control while fleeing, which leads to an accumulation of "exotic" infectious diseases. The number of patients with tuberculosis (TB) had declined for many years in Germany; however, increasing numbers of cases have recently been observed. For urologists, of course, the manifestations of urogenital TB (UGTB) are of particular interest. Therefore, the basics regarding diagnosis and therapy of UGTB are discussed in this article and explained using case studies. The second important "exotic" infectious disease that urologists are increasingly facing is schistosomiasis. The larvae (found mostly in stagnant water) penetrate through intact human skin, mature and migrate into the liver, from where they immigrate into the venous capillaries of the intestine, the small pelvis, the bladder wall and the distal ureter, and there cause chronic inflammation. All urologists should be familiar with the diagnosis, therapy and prophylaxis of urogenital schistosomiasis and the oncogenesis of schistosomiasis-associated bladder carcinoma.

Explorative Randomized Phase II Clinical Study of the Efficacy and Safety of Finafloxacin versus Ciprofloxacin for Treatment of Complicated Urinary Tract Infections.

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 group, 42.7% in the FINA10 group, and 54.2% in the CIPRO10 group experienced mostly mild and treatment-emergent but unrelated adverse events. A short-course regimen of 5 days of finafloxacin resulted in high eradication and improved clinical outcome rates compared to those for treatment with ciprofloxacin for 10 days. In contrast to those of ciprofloxacin, the clinical effects of finafloxacin were not reduced by acidic urine pH. Hospitalized adults were randomized 1:1:1 to finafloxacin treatment (800 mg q.d.) for either 5 or 10 days or to ciprofloxacin treatment (400 mg/500 mg b.i.d.) for 10 days with an optional switch from intravenous (i.v.) to oral administration at day 3. The primary endpoint was the combined microbiological and clinical response at the TOC visit in the microbiological intent-to-treat population. (This study has been registered at ClinicalTrials.gov under identifier NCT01928433.).

[Epidemiology, diagnostics, therapy, prevention and management of uncomplicated bacterial outpatient acquired urinary tract infections in adult patients : Update 2017 of the interdisciplinary AWMF S3 guideline]. / Epidemiologie, Diagnostik, Therapie, Prävention und Management unkomplizierter, bakterieller, ambulant erworbener Harnwegsinfektionen bei erwachsenen Patienten : Aktualisierung 2017 der interdisziplinären AWMF S3­Leitlinie.

BACKGROUND: Update of the 2010 published evidence-based S3 guideline on epidemiology, diagnostics, therapy and management of uncomplicated, bacterial, outpatient-acquired urinary tract infections in adult patients. The guideline contains current evidence for the rational use of antimicrobial substances, avoidance of inappropriate use of certain antibiotic classes and development of resistance. METHODOLOGY: The update was created under the leadership of the German Association of Urology (DGU). A systematic literature search was conducted for the period 01 January 2008 to 31 December 2015. International guidelines have also been taken into account. Evidence level and risk of bias were used for quality review. RESULTS: Updated information on bacterial susceptibility, success, collateral damage and safety of first- and second-line antibiotics was given. For the treatment of uncomplicated cystitis the first line antibiotics are fosfomycin trometamol, nitrofurantoin, nitroxoline, pivmecillinam, trimethoprim (with consideration of the local resistance rates). Fluoroquinolones and cephalosporins should not be used as first choice antibiotics. In the case of uncomplicated pyelonephritis of mild to moderate forms, preferably cefpodoxime, ceftibuten, ciprofloxacin or levofloxacin should be used as oral antibiotics. CONCLUSION: The updated German S3 guideline provides comprehensive evidence- and consensus-based recommendations on epidemiology, diagnostics, therapy, prevention and management of uncomplicated bacterial outpatient acquired urinary tract infections in adult patients. Antibiotic stewardship aspects have significantly influenced the therapeutic recommendations. A broad implementation in all clinical practice settings is necessary to ensure a foresighted antibiotic policy and thus t improve clinical care.

[Bacteriuria after Radical Prostatectomy: Importance of Bacterial Count]. / Bakteriurie nach radikaler Prostatektomie - Stellenwert der Keimzahl.

MATERIAL AND METHODS: 100 consecutive cases after radical prostatectomy with a bacterial count of 10(4) CFU/ml in midstream urine were followed during urological inpatient rehabilitation without antibiotic treatment. Before discharge, a follow-up examination with a urine dipstick and a second urine culture were performed. RESULTS: No symptomatic urinary tract infections (UTI) occurred during the average follow-up period of 15.2 days. Patients with unremarkable urine dipstick findings at follow-up (no leukocyturia and no haematuria and no nitrituria) had no relevant bacteriuria (≥10(5) CFU/ml).54 of urine culture controls before discharge were negative, 31 showed insignificant bacterial growth (≤10(4) CFU/ml) and 15 had a bacterial count≥10(5) CFU/ml. 4 patients (27%) with > 10(5) CFU/ml were successfully treated with antibiotics for clear signs of infection (fever, chills, leukocytosis); the other 11 patients were just followed further. CONCLUSIONS: Even though almost all patients after radical prostatectomy continue to suffer from some discomfort that might be due to UTI, patients with 10(4) CFU/ml in midstream urine samples should not receive antibiotic treatment unless they have clear systemic symptoms of an infection, e. g. fever, chills or leukocytosis. Unremarkable urine dipstick findings during the follow-up period (no leukocyturia and no erythrocyturia and no nitrituria) rule out a relevant bacteriuria (≥10(5) CFU/ml). Clear systemic signs of infection during follow-up only occurred in 4 patients, who were successfully treated with test-adapted antibiotics.

[Are there alternatives to antimicrobial therapy and prophylaxis of uncomplicated urinary tract infections?]

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.

[German validation of the Acute Cystitis Symptom Score]. / Deutsche Validierung des "Acute Cystitis Symptom Score".

BACKGROUND: The Uzbek version of the Acute Cystitis Symptom Score (ACSS) was developed as a simple self-reporting questionnaire to improve diagnosis and therapy of women with acute cystitis (AC). The purpose of this work was to validate the ACSS in the German language. MATERIALS AND METHODS: The ACSS consists of 18 questions in four subscales: (1) typical symptoms, (2) differential diagnosis, (3) quality of life, and (4) additional circumstances. Translation of the ACSS into German was performed according to international guidelines. For the validation process 36 German-speaking women (age: 18-90 years), with and without symptoms of AC, were included in the study. Classification of participants into two groups (patients or controls) was based on the presence or absence of typical symptoms and significant bacteriuria (≥ 10(3) CFU/ml). Statistical evaluations of reliability, validity, and predictive ability were performed. ROC curve analysis was performed to assess sensitivity and specificity of ACSS and its subscales. The Mann-Whitney's U test and t-test were used to compare the scores of the groups. RESULTS: Of the 36 German-speaking women (age: 40 ± 19 years), 19 were diagnosed with AC (patient group), while 17 women served as controls. Cronbach's α for the German ACSS total scale was 0.87. A threshold score of ≥ 6 points in category 1 (typical symptoms) significantly predicted AC (sensitivity 94.7%, specificity 82.4%). There were no significant differences in ACSS scores in patients and controls compared to the original Uzbek version of the ACSS. CONCLUSION: The German version of the ACSS showed a high reliability and validity. Therefore, the German version of the ACSS can be reliably used in clinical practice and research for diagnosis and therapeutic monitoring of patients suffering from AC.

[New aspects on diagnostics and therapy of uncomplicated cystitis]. / Neue Aspekte zur Diagnose und Therapie der unkomplizierten Zystitis.

BACKGROUND: Acute uncomplicated cystitis in women is one of the most frequently diagnosed bacterial infections. A clinically symptomatic urinary tract infection must be differentiated from asymptomatic bacteriuria, which is not considered an infection but more a colonization which as a rule should not be treated. Acute cystitis can also be caused by a low number of uropathogenic bacteria, especially Escherichia coli, which is often overlooked during routine bacteriological diagnostics. ANTIBIOTIC THERAPY: According to the guidelines the old oral antibiotics (e.g. fosfomycin tromethamine, nitrofurantoin and pivmecillinam) should be prescribed for antimicrobial therapy which are still effective against Escherichia coli in over 90% of cases. ALTERNATIVE THERAPY: With new therapeutic concepts the elimination of bacteria is no longer the main aim but treatment of the inflammatory (over) reaction of the host. 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 measurement parameters for diagnostics and outcome are needed. The acute cystitis symptom score (ACSS) has now also been developed and validated in the German language. 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 acute uncomplicated cystitis in women.

[Urinary tract infections]. / Harnwegsinfektionen.

Urinary tract infections (UTI) are amongst the most frequent bacterial infections and therefore responsible for a great amount of antibiotic administration. UTI may present as benign, uncomplicated cystitis or severe, life-threatening urosepsis. Due to the heterogeneity of UTI the European Section of Infections in Urology (ESIU) has introduced a phenotypical classification, based upon the clinical presentation, the risk factors and the antibiotic susceptibility of the causative pathogens. Antibiotic treatment of the UTI varies accordingly. In uncomplicated cystitis antibiotics with low potential for collateral damage are recommended, which are mainly indicated for these infections. In uncomplicated pyelonephritis fluoroquinolones and 3rd generation cephalosporines are recommended. Antibiotic treatment regimens of complicated UTI depend very much on the antibiotic susceptibility according to regional resistance statistics. In urosepsis an early diagnosis and therapy is mandatory. In this regard a procalcitonin level > 0.25 µg/l has a good sensitivity and acceptable specificity in predicting bacteremia. Apart from the early antibiotic therapy successful decompression of the obstructed urinary tract is a predictor of survival. In children UTI are also amongst the most important bacterial infections, although symptoms are frequently not characteristic. The correct sampling of urine for microbiological investigations is critical. Due to the increasing fluoroquinolone resistance, infectious complications after transrectal prostate biopsy are becoming more frequent. Strategies to decrease complications encompass, amongst others, microbiological screening of the faecal flora for fluoroquinolone resistance, administration of alternative antibiotics for prophylaxis and alternative techniques for biopsy, such as perineal prostate biopsy.

[Are there alternatives to antimicrobial therapy and prophylaxis of uncomplicated urinary tract infections?].

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 infectionbut 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.

[Development and clinical testing of the Russian version of the Acute Cystitis Symptom Score - ACSS].

The Acute Cystitis Symptom Score - ACSS was originally developed in the Uzbek language and has demonstrated high reliability and validity. The study was aimed to develop a Russian version of the ACSS questionnaire and evaluate its psychometric properties. Translation and adaptation of the ACSS questionnaire containing 18 questions, 6 of them - for the typical symptoms of acute cystitis (AC), 4 - for the differential diagnosis; 3 - for the quality of life, and 5 - for the conditions that may affect the choice of treatment, were performed according to the recommendations developed by the Mapi Research Institute. Study involved 83 Russian-speaking women (mean age, 35.6 ±13.7 years); 38 (45.8%) patients were in the main group (patients with AC), and 45 (54.2%) - in the control group (without AC). Medical examination and appropriate treatment of the respondents were conducted in accordance with approved standards. After completing the course of therapy, 19 (50%) patients of the main group came for the control examination. There was statistically significant difference in the scores obtained in the two groups. Score profiles positively correlated with the results of laboratory tests (rho = 0.26-0.48). Cronbach's alpha for the Russian version of the questionnaire was 0.86 (95% CI, 0.81-0.91), area under the curve in the ROC analysis was 0.96. The results of testing the Russian version correspond to those of the original version. The Russian version of the ACSS questionnaire has high. reliability and validity, and can be recommended for clinical research and diagnosis of primary AC, and dynamic monitoring of the effectiveness of the treatment of the Russian-speaking population of patients.

[Prostatitis - diagnostics and therapy]. / Prostatitis: Diagnostik und Therapie.

The prostatitis syndrome is a frequent and complex disease. During the last 40 years the scientific perception has shifted between sometimes success and sometimes disappointment. Whereas acute prostatitis is most frequently considered an infectious disease, in only about 10% of cases with a chronic prostatitis syndrome can pathogens be identified. The bacterial spectrum is similar to that of complicated urinary tract infections with mainly Gram-negative pathogens. In some studies atypical pathogens, such as Chlamydia trachomatis and mycoplasmas, can be found in a considerable proportion. In most cases, however, a multifactorial aetiology is discussed. This has lead to a phenotyping directed multimodal treatment approach, considering the main symptoms. In prostatitis of microbial origin antibiotics, particulary fluorquinolones, are still the therapy of first choice. In the other cases multimodal treatment strategies are used considering evidence-based monotherapeutic studies. The evidence for multimodal combination treatment is still sparse.

Prevention of recurrent urinary tract infections.

Urinary tract infections (UTI) are among the most frequent bacterial infections in the community and health care setting. Mostly young and, to some extent, postmenopausal women are affected by recurrent UTI (rUTI) defined as ≥3 UTI/year or ≥2 UTI/half year. In contrast, rUTI is rare in healthy men. On the other hand, rUTI are frequently found in female and male patients with complicating urological factors, e.g. urinary catheters, infection stones. Remediable predisposing factors in uncomplicated rUTI in women are rare. In complicated rUTI the success depends mainly on the possibility to eliminate or at leastimprove the complicating risk factors. Continuous antibiotic prophylaxis or postcoital prophylaxis, if there is close correlation with sexual intercourse, are most effective to prevent rUTI. Nitrofurantoin, trimethoprim (or cotrimoxazole), and fosfomycin trometamol are available as first-line drugs. Oral cephalosporins and quinolones should be restricted to specific indications. Antibiotic prophylaxis reduces the number of uropathogens in the gut and/or vaginal flora and reduces bacterial "fitness". Given the correct indication, the recurrence rate of rUTI can be reduced by about 90%. Due to possible adverse events and the concern of selecting resistant pathogens, according to the guidelines of the European Association of Urology antimicrobial prophylaxis should be considered only after counselling, behavioural modification and non-antimicrobial measures have been attempted. In postmenopausal patients vaginal substitution of oestriol should be started first. Oral or parenteral immunoprophylaxis is another option in patients with rUTI. Other possibilities with varying scientific evidence are prophylaxis with cranberry products, specific plant combinations or probiotics. The prophylaxis of catheter-associated UTI should employ strategies which result in a reduction of frequency and duration of catheter drainage of the urinary tract. The currently available catheter materials have only little influence on reducing catheter-associated rUTI.

Improved diagnostics of chronic inflammatory prostatitis.

AIM: Prostatitis is a prevalent condition that encompasses a large array of clinical symptoms with significant impacts on men's life. The diagnosis and treatment of this disorder presents numerous challenges for urologists, most notably, a lack of specific and effective diagnostic methods. METHODS: To improve the diagnostics the comparison of classic 4-glass test Meares and Stamey, 2-glass tests and 3-glass test was conducted in 177 men suspicious for chronic prostatitis. RESULTS: Four-glass test is uncomfortable both for patients and doctors, and leads to contamination of urine with prostatic secretion. Two-glass test is insufficiently effective too. Three-glass test (three urine specimens obtained from one continuous micturition stream) gives more adequate results and may be used for screening. CONCLUSION: Three-glass test as screening test with the option of an additional EPS investigation in those patients the final diagnosis of chronic prostatitis has to be confirmed is more convenient for patients and doctors than the standard M&S 4-glass test and "false-positive" (contaminated with EPS) midstream urine results are avoided thus improving discrimination of urethritis, cystitis and prostatitis. Therefore, we recommend the KE 3-glass test as a new standard for screening patients with signs and symptoms of chronic inflammatory prostatitis.