Conclusion
The concept of a second urine specimen obtained by optimal methods in in cases of bacteriuria is a good compromise between the routine clinical procedures for screening and the need for valid data in clinical studies with scientific claims. The additional expenses are minor compared to the total cost of such a study. The risk of excluding some patients from the per protocol analysis after therapy has already been started is also justified, because antibacterial agents are usually well tolerated.
The alternative would have been either to use time-consuming or invasive methods of urine sampling as a routine, or to treat an unsuitable patient with a full course of antibiotics which is even less justifiable, or to add an additional pretreatment visit which is impossible in most cases.
During the follow-up period this concept of confirming or disproving each positive bacteriuria by an optimal urine sampling method, which might be necessary in a small but sometimes statistically relevant proportion of patients, is also useful to distinguish between contamination and incomplete elimination during the follow-up period.
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Naber, K.G. Urine sampling method and significance of bacteriuria in men. Infection 22 (Suppl 1), S44–S46 (1994). https://doi.org/10.1007/BF01716043
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DOI: https://doi.org/10.1007/BF01716043