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.

Prostate cancer screening.

Prostate cancer incurs a substantial incidence and mortality burden, similarly to breast cancer, and it ranks among the top ten specific causes of death in the United States. It is inherent as we maximize the detection of early prostate cancer that we increase the detection of both nonaggressive (slow growing) and aggressive (faster growing) prostate cancers. The evidence clearly supports the use of PSA screening in conjunction with DRE as a means of early detection of prostate cancer. Widespread implementation of prostate cancer screening in the United States has led to the phenomenon of stage migration with more cancers being detected at a lower stage. Such a trend has decreased the incidence of metastatic disease at diagnosis and paralleled the decrease of the mortality rate from prostate cancer. Our understanding of the natural history of prostate cancer is progressing over time, but the question of its length is unanswerable. The relatively long doubling time (on average) of early prostate cancer of 3 to 4 years or more indicates a relatively good prognosis for many men with this disease, even without early detection and treatment. Unfortunately, the poor specificity of the PSA test in men with benign prostatic hyperplasia (BPH) leads to high rates of prostate biopsy and attendant illnesses and costs. Early detection is more apt to detect a slow-growing prostate cancer than a faster growing cancer that is associated with a more rapid course of progression to metastatic disease. Hence, the launching of mass screening programs for the early detection of prostate cancer is premature. However, in the absence of solid evidence of benefit, one reasonable approach to screening at the individual level is to involve the patient in decisions about whether or not to perform a PSA test. Thus, "offering" PSA testing must be accompanied by informed discussion within the context of an ongoing patient-physician relationship. This is to be distinguished from the use of PSA testing for the purpose of "mass screening." Concepts that must be explored with the patient include: 1. The long-term ramifications of screening 2. The relatively high probability of further evaluation and biopsy with positive results 3. Potentially difficult decisions that may arise about using treatments that are associated with considerable morbidity and uncertain benefits (at the time) if cancer is discovered We should identify a future path that is evidence-based, focused on the issues that make a difference to patients, and results in better and longer lives of those with the disease and those who are at risk of getting it. If that path leads to treating fewer patients in the future, even if sometimes more aggressively, we should pursue it definitely and consequently.

The role of biofilm infection in urology.

In the process of endourological development a great variety of foreign bodies have been invented besides urinary catheters on which biofilm can be formed. Bacteria in the biofilm are less sensible to antibiotics. An additional problem of medical biomaterials in the urinary tract environment is the development of encrustation and consecutive obstruction. In this review, we tried to sum up the conditions where biofilm formation has a great impact on the development or maintenance of urological infections and on treatment success. Modification of the biomaterial surface seems to be the most promising prevention strategy for bacterial biofilms. Easier methods for diagnosing and quantifying biofilm infection, to develop more specific antimicrobial agents and ideal device surfaces would surely help the fight against biofilm formation.

Results of salvage retroperitoneal lymphadenectomy (RLA) in the treatment of patients with nonseminomatous germ cell tumours remaining marker positive after inductive chemotherapy.

The authors describe the evidence and results obtained in 21 out of 100 patients who underwent salvage retroperitoneal lymphadenectomy for advanced testicular cancer (UICC stage II/B bulky and stage III) in the period 1982-1993, and in whom inductive chemotherapy was not followed by marker conversion. It is stated that if AFP positivity is low (titres below 100 ng/ml) salvage retroperitoneal lymphadenectomy (RLA) is of high therapeutic value, whereas in all cases with HCG positivity or AFP titres higher than 500 ng/ml tumorous death ensued without exception. In our cases viable tumour residues occurred in 81%. Salvage resection was feasible in 76%, but every incomplete resection (19%) was followed by death due to tumour. In all but one of the cases marker positivity, an indicator of therapy-resistant viable tumour residues, persisted after having used more than four PVB combinations or changes in the chemotherapeutic regimen.

Follow-up of the effect of BCG vaccine treatment in bladder tumour patients.

The effect of intravesical BCG vaccine treatment in 38 patients with superficial bladder tumour after TUR (Transurethral Resection) was followed by the lymphocyte transformation test (LTT) and the staphylococcus phagocytosis test of in vitro washed leukocytes. The results have confirmed the immunostimulating and hence anti-tumour effect of intravesical BCG vaccine. Monitoring of the cellular immune response is suitable for the continuous follow-up of the BCG effect. Comparing the tolerable side-effects with their favourable therapeutic results, BCG vaccine is considered to be effective for the prevention of recurrences in treating superficial bladder tumours.

Follow-up of the effect of BCG in bladder tumour patients.

The intravesical BCG effect in 38 patients with superficial bladder tumour after TUR was followed by the lymphocyte transformation test (LTT) and the staphylococcus phagocytosis test of in vitro washed leukocytes. The results have confirmed the immunostimulating and hence anti-tumour effect of intravesical BCG. The beginning and the duration of the stimulation effect were defined and the necessity of maintenance treatment was verified. Authors consider monitoring of the cellular immune response suitable for the continuous follow-up of the BCG effect. Comparing the tolerable side-effects with their favourable therapeutic results, BCG is considered to be suitable for the prevention of recurrences in treating superficial bladder tumours.