Urodynamic protocol and central review of data for clinical trials in lower urinary tract dysfunction.

Schafer et al. [1] showed, in a multicentre, multinational study of men with LUTS suggestive of benign prostatic obstruction (BPO), that many urodynamic traces were dif®cult or impossible to interpret. Subsequent experience with a standardized urodynamic protocol showed a great improvement in the standard of the urodynamics carried out. A standardized urodynamic protocol is now a prerequisite in all studies investigating lower urinary tract dysfunction. In multicentre trials, a central evaluation at a quality-control centre (QCC) further contributes to the value of the trial [2]. It is therefore of paramount importance that these data are of the highest possible quality to maximize the information available for analysis. In studies which use urodynamic endpoints, the use of a standardized urodynamic protocol with quality-control analysis of the tracings has become the norm. This protocol covers studies in both BPO and in storage dysfunction, i.e. either bladder overactivity (BOA, detrusor instability) or genuine stress incontinence (GSI). Methods, de®nitions and units conform to the standards recommended by the ICS, except where speci®cally noted [3].