[Can one be a urologist without being familiar with the methodology of therapeutic trials?]

To define the principles of the methodology applied to therapeutic trials in medicine and surgery. To define methodological aspects related to therapeutic trials in urology. To exhaustively study three urology journals in order to analyse the methodological quality of the articles published.

The basic principles of therapeutic trials are described: the randomized double-blind placebo-controlled trial is the most valid trial to demonstrate the efficacy of a treatment. In surgery, and especially in urology, these therapeutic trials comparing two surgical techniques must be conducted by teams accepting the ambivalence of comparison after randomization. Ideally, treatment is evaluated by observers blinded to the technique used. The assessment criteria must be as clinical as possible and must be based on universally accepted standardized measurements. The quality of a therapeutic trial is assessed in terms of its protocol, but also on the quality of practical conduct of the trial, the precision and accuracy of its statistical analysis and the presentation of the results. The first 1995 issue of the "Journal of Urology", the "British Journal of Urology" and "Progrès en Urologie" were studied exhaustively, looking for articles dealing with a therapeutic evaluation. The comparative or non-comparative nature of the study, the presence or absence of randomization, double-blind, and a predetermined sample size were noted for each study.

Ten non-comparative retrospective studies, one non-comparative prospective study and five trials with a control group, including two open randomized trials were reported in the "Journal of Urology". Nine retrospective non-controlled studies were reported in the "British Journal of Urology". Seven retrospective studies, including one open, non-randomized study with a control group, were reported in "Progrès en Urologie".

The principles of the methodology of therapeutic trials can be applied to the evaluation of a treatment or a surgical technique, especially in urology. Compliance with the rules of methodology impose additional constraints, sometimes difficult to implement, but essential to ensure the quality of the results obtained. Randomized trials are rare in urological publications, which still largely consist of retrospective non-comparative series.