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.

[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.

[EVALUATION OF THE EFFICACY OF STANDARD PERCUTANEOUS NEPHROLITHOTRIPSY IN STAGHORN AND MULTIPLE NEPHROLITHIASIS].

In staghorn and multiple nephrolithiasis, method of choice for removing kidney stones is percutaneous nephrolithotripsy (PCNL). However, it may be accompanied by the leaving off of stones or fragments in pyelocaliceal system. The study was aimed to the evaluation of possibilities of the standard PCNL in terms of complete removal of staghorn and multiple kidney stones. Percutaneous nephrolithotripsy was made by a single access using standard method in 99 patients with staghorn and multiple kidney stones. The average age of the patients ranged from 9 to 61 (34.4±3.2) years. Staghorn stones were found in 80 (80.8%) patients, staghorn stones with multiple stones - in 19 (19.2%) patients. Stone size ranged from 18 to 94 (49.6±2.3) mm. The use of standard PCNL to remove staghorn and multiple kidney stones as monotherapy has allowed complete removing of the stones in 74 (74.7%) patients. The average length of stay of patients in hospital after surgery was 5.9±0.3 bed-days (2 to 31), medium time for removal of drains after surgery - 4.3±0.7 days. Intraoperative blood loss was observed in 11 (11.1%) patients, its volume ranged from 150 to 1130 (407.2±28.8) ml. In 8 (8.1%) cases, bleeding regarded as a complication, because it required replacement therapy. Postoperative complications were observed in 19 (19.2%) patients, of which 8 (8.1%) had bleeding, and 11 (11.1%) had exacerbation of urinary tract infection. Thus, the standard PCNL as monotherapy in staghorn and multiple nephrolithiasis serves as alternative method for removing stones. The results of treatment depend on the size and stereometric configuration of staghorn stones. The most common causes of residual stones are inaccessibility of calyx by endoscope and intraoperative bleeding.

[Assessment of the specific characteristics of urethral stricture according to records of medical republican institution of Uzbekistan].

Urethral stricture in men is a common disorder, negatively affecting the health and therefore the quality of patients life. The aim of the study was to evaluate the nature of the stricture in various segments of male urethra and the incidence rate of urethral stricture in the Republic of Uzbekistan. The study presents the analysis of medical records of 195 men (mean age 40,6+/-13,1 years) who underwent urethroplasty in the Republican Specialized Centre of Urology between February 2013 and March 2015. 46.7% and 53.3% of patients had anterior and posterior urethral strictures, respectively. The most common causes of stricture were trauma (38.5%) and infections (22.6%); 18% of strictures were considered idiopathic, 19% - iatrogenic. In 13.3% of cases, stricture located within the pendulous urethra, in 42.7% - within the bulbar urethra, in 32% - within the posterior urethra. In 28.7% of patients the length of the stricture was more than 6 cm, in 25.6% - 2 cm or less.

[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.