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.

[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.

[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.

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.

[Antibiotic prophylaxis in urology]. / Antibiotikaprophylaxe in der Urologie.

The aim of perioperative antibiotic prophylaxis is the prevention of surgical site infections and urinary tract infections during urological procedures. The indication for antibiotic prophylaxis comprises several risk factors such as the degree of contamination of the operative site, duration of surgery, implantation of devices and comorbidities of the individual patient. In general this involves a single antibiotic administration before the operative procedure. The antibiotic prophylaxis is part of the total antibiotic consumption and thus a factor contributing to emergence of antibiotic resistance. It is not a substitute for hygiene measures or operative precision.

[Primary and secondary prevention of urinary tract infections]. / Primär- und Sekundärprävention von Harnwegsinfektionen.

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. On the other hand rUTI are frequently found in patients with complicating urological factors, e.g. urinary catheters. Modifiable predisposing factors in uncomplicated rUTI in women are rare. 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%. 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 cranberries or probiotics. The prophylaxis of catheter-associated UTI or asymptomatic bacteriuria 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.

Macrolides for the treatment of chronic bacterial prostatitis: an effective application of their unique pharmacokinetic and pharmacodynamic profile (Review).

Chronic bacterial prostatitis (CBP) is a persistent infection of the prostate characterized by poor quality of life mainly due to frequent relapse episodes caused by incomplete eradication of causative pathogens. Aggressive antibacterial therapy is required to attenuate the severe symptoms of CBP and to achieve a permanent cure. Although fluoroquinolones are currently recommended as first-choice agents, macrolide antibiotics are emerging as a noteworthy option for the treatment of CBP. Macrolide antibiotics are characterized by an impressive array of distinct pharmacokinetic (PK) and pharmacodynamic (PD) properties. These properties include high intracellular accumulation in phagocytes and at sites of infection, including the prostate; broad antibiotic but also biofilm-inhibiting properties; immunomodulating and inflammation-resolving activities. These features offer particular advantages for the treatment of chronic infections of the prostate gland, which are not easily amenable to drug therapy. Macrolides may be exploited to counteract the unsatisfactory rates of clinical symptom improvement and pathogen eradication. The results of a number of clinical trials support this proposal.

[Practice management of chronic bacterial prostatitis with levofloxacin]. / Praxisdaten zur Behandlung der Chronischen Bakteriellen Prostatitis mit Levofloxacin.

The aim of this prospective observational study was to present relevant data on the efficacy and safety of levofloxacin in the treatment of chronic bacterial prostatitis (NIH-II) in the daily clinical routine of urologists in their practices. In total, 243 patients were treated, including 62 patients with a microbiologically confirmed diagnosis -based on expressed prostatic secretion (EPS). The current evaluation is based on these patients. Their median age was 53 years. The patients were treated with levofloxacin 500 mg / day for 29 days (median) which is in accordance to the -registered recommendation for this indication. Clinical symptoms were assessed using a standardised questionnaire. The clinical symptoms dysuria, painful ejaculation, perineal pain, urinary obstruction, increased urgency, prostate pain during palpation as well as CRP and number of leukocytes showed statistically significant improvements at the end of therapy with levofloxacin as compared to baseline. At the end of treatment 93.5 % (n = 58 / 62, 95 % confidence interval: 84.5 %-97.8 %) of the patients were cured or improved. The patients were able to resume their regular activities after 10 days (median). 93.5 % (n = 58 / 62) of the patients and 95.2 % (n = 59 / 62) of the doctors were satisfied or very satisfied with this treatment. In all 62 patients the diagnosis was microbiologically confirmed based on EPS. In 39 patients (62.9 %) E. coli was identified. At the end of therapy microbiological testing was performed in 62.9 % (n = 39 / 62) of the patients, in 29 cases including EPS. In 37 of these 39 patients (94.9 %) no pathogen was identified. In 2 cases (5.1 %) a pathogen was identified (Proteus mirabilis and Staphylococcus species). In 181 patients without microbiological confirmation -based on EPS comparable clinical results were found. In the total population of 243 patients 5 adverse drug reactions were reported in 3 patients (incidence 1.2 %, n = 3 / 243), The results of this study confirm the efficacy and safety of levofloxacin in the treatment of chronic bacterial prostatitis in daily clinical practice.

[National S3 guideline on uncomplicated urinary tract infection: recommendations for treatment and management of uncomplicated community-acquired bacterial urinary tract infections in adult patients]. / Nationale S3-Leitlinie "Unkomplizierte Harnwegsinfektionen" : Empfehlungen zu Therapie und Management unkomplizierter bakterieller ambulant erworbener Harnwegsinfektionen bei erwachsenen Patienten.

BACKGROUND: Urinary tract infections (UTI) belong to the most frequent bacterial infections in outpatients. Increasing antibiotic resistance rates and a new appreciation of the epidemiological side effects of antibiotics ("collateral damage") have warranted an update of the guidelines on uncomplicated UTI as an S3 clinical guideline. METHODS: The guideline was developed by the Deutsche Gesellschaft für Urologie (DGU) in collaboration with the Deutsche Gesellschaft für Allgemein- und Familienmedizin (DEGAM), Deutsche Gesellschaft für Gynäkologie und Geburtshilfe (DGGG), Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM), Deutsche Gesellschaft für Infektiologie (DGI), Deutsche Gesellschaft für Nephrologie (DGfN), Paul-Ehrlich-Gesellschaft für Chemotherapie (PEG) and a patient representative. The systematic review of the literature on the topics of the guideline was performed for the time period of 1 January 1998 to 30 April 2008 in the databases of the Cochrane Library and MEDLINE. International guidelines of the years 1999-2007 were included. RESULTS: Uncomplicated UTI comprise uncomplicated cystitis and uncomplicated pyelonephritis. The leading uropathogen is Escherichia coli. The choice of the antibiotic substance follows the five primary aspects: (1) individual patient risk and antibiotic pretreatment; (2) bacterial spectrum and antibiotic susceptibility; (3) effectivity of the antimicrobial substance demonstrated in clinical studies; (4) epidemiological effects ("collateral damage"); and (5) adverse effects. If antibiotics such as trimethoprim/sulfamethoxazole or fluoroquinolones have previously been given, the risk for pathogens to become resistant against these substances is increased. Because of increasing resistance rates of E. coli against trimethoprim/sulfamethoxazole also in uncomplicated UTI, trimethoprim alone or in combination with sulfamethoxazole is no longer regarded as the first-line agent in the empiric treatment of uncomplicated cystitis, unless the regional resistance rate is below 20%. The antibiotic resistance rates of fluoroquinolones in uncomplicated UTI are still below 10% in Germany, but there is a significant emergence of resistance compared to earlier years. Moreover, fluoroquinolones and group 3 cephalosporins exhibit negative epidemiological effects resulting in selection of multi-resistant pathogens. Because these antibiotic classes are needed in therapy of life-threatening infections, such effects should be taken seriously. For substances like fosfomycin, nitrofurantoin or mecillinam"collateral damage" has not been documented or only to a lesser degree. Therefore, for empiric therapy of frequent uncomplicated cystitis fosfomycin-trometamol, nitrofurantoin or pivmecillinam (not listed in Germany) are recommended as first-line antibiotics. For oral first-line treatment of uncomplicated pyelonephritis, fluoroquinolones are still recommended in sufficiently high dosage due to the resistance rates of E. coli still being below 10% and the superior effectivity compared to other antibiotics. Asymptomatic bacteriuria (ASB) should only be treated in exceptional cases such as pregnant women or prior to expected mucocutaneous traumatising interventions of the urinary tract. CONCLUSION: The S3 guideline on uncomplicated urinary tract infections is a comprehensive set of evidence- and consensus-based recommendations dealing with epidemiology, diagnosis, therapy and management of uncomplicated bacterial UTI of adult outpatients. A broad implementation in all disciplines taking care of patients with UTI is necessary in order to ensure a prudent antibiotic policy in these frequent infections and thus improve patient care.