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Objective:To evaluate the performance of a new 30-cm-long, telescoping male intermittent catheter (SpeediCath Compact Male; Coloplast A/S, Humlebæk, Denmark) in urinary bladder emptying, safety and subject acceptance vs a standard-length male intermittent catheter (SpeediCath).Materials and methods:In a prospective, randomized, multicenter, crossover non-inferiority study, 37 male intermittent catheter users self-catheterized three times with the test catheter on one test day and three times with the standard-length male (reference) catheter on another test day. Residual urine (RU) volume in the bladder after catheterization was measured by ultrasound. Safety was assessed in the entire study period in terms of adverse events (AEs) and adverse device events (ADEs). Subjects evaluated their experience, sensation, disposal, bleeding and discomfort with the test and reference catheters and final catheter preference.Results:SpeediCath Compact Male did not differ from the reference catheter in terms of performance (bladder emptying). The upper confidence limit of the mean difference between absolute RU volumes for the test and reference catheter groups did not exceed a pre-established non-inferiority limit of 20 ml, thereby showing the test catheter's non-inferiority to the reference catheter (that is, no worse at bladder emptying). The only AE/ADE reported was one instance of mild urethral burning for 30 min after catheterization, which was judged possibly related to the test catheter but resolved quickly.Conclusions:The SpeediCath Compact Male catheter is as efficient as a conventional intermittent catheter (SpeediCath) at emptying the bladder with the additional benefit of being more discreet and easier to use. [ABSTRACT FROM AUTHOR]

The purpose of this analysis of health economic studies in the field of oncology was to investigate among sponsored studies whether any relationship could be established between the type of sponsorship and (1) type of economic analysis, (2) health technology assessed, (3) sensitivity analysis performed, (4) publication status, and (5) qualitative conclusions about costs. The Health Economic Evaluations Database (HEED, version 1995-2000) was searched on the basis of oncological ICD-9 codes, sponsorship, and comparative studies. This search yielded a total of 150 eligible articles. Their evaluations were prepared independently by two investigators, on the basis of specific criteria. When evaluators disagreed, a third investigator provided a deciding evaluation. There was no statistically significant relationship between the type of sponsorship and sensitivity analysis performed (P=0.29) or publication status (P=0.08). However, we found a significant relationship between the types of sponsorship and of economic analysis (P=0.004), the health technology assessed (P<0.0001), and qualitative cost assessment (P=0.002). Studies with industrial sponsorship were 2.56 (99% lower confidence interval (CI)=1.28) times more likely to involve cost-minimisation analyses, were 0.04 (99% higher CI=0.39) times less likely to investigate diagnostic screening methods, and were 1.86 (99% lower CI=1.21) times more likely to reach positive qualitative conclusions about costs than studies supported by nonprofit organisations. In conclusion, our results suggest that there is a greater probability that industry-sponsored economic studies in the field of oncology tend to be cost-minimisation analyses, to investigate less likely diagnostic screening methods, and to draw positive qualitative conclusions about costs, as compared to studies supported by nonprofit organisations. [ABSTRACT FROM AUTHOR]