Objective To assess the tolerability and eBcacy of propicontrast to groups 2 and 3, only patients in group 1 showed increasing tolerability during the treatment verine and oxybutynin in patients with urgency and urge incontinence in a randomized, double-blind pla-(from V1 to V4). These tolerability results were further supported by the overall tolerability assessment ('very cebo-controlled clinical trial. Patients and methods In all, 366 patients (149 on propivgood' or 'good' tolerability in 67% of group 1, in 59% of group 2 and in 83% of group 3). The urodynamic erine, 145 oxybutynin and 72 placebo, ratio 25251) with urgency and urge incontinence were recruited in assessment of eBcacy (comparing V0 and V4) showed a statistically significant increase in the mean (sd) 32 study centres. Propiverine (group 1, 15 mg three times daily), oxybutynin (group 2, 5 mg twice daily) or maximal cystometric bladder capacity in group 1, being 222 (77) mL at V0 and 311 (125) mL at V4, an placebo (group 3) were administered for 4 weeks, using the double-dummy technique. The dosages were selecincrease of 89 (108) mL, and in group 2, at 226 (75) mL and 322 (123) mL, an increase of 96 ted specifically to compare the tolerability profile of propiverine with the commonly used therapeutic dosage (106) mL, compared with group 3, at 211 (77) mL and 263 (93) mL, an increase of only 52 (92) mL. The of oxybutynin. Tolerability was assessed by directly questioning the patients about adverse events at four cystometric bladder capacity at first desire to void also increased in group 1 (93 to 160 mL) and group 2 (89 visits (V-1 before and V0 after a 1-week 'washout' period, V1 after 1 week and V4 after 4 weeks of to 160 mL), whereas in group 3 there were only minor changes (93 to 120 mL). Changes in the residual urine treatment) during a 5-week surveillance period, and by tolerability ratings of the physicians. EBcacy was volume within and between the treatment groups were minimal and clinically irrelevant. The overall assessassessed using urodynamics at V0 and V4, evaluating the cystometric bladder capacity at maximal and first ment of eBcacy showed significant diCerences between the drugs when compared with placebo. desire to void, and postvoid residual urine, according to the criteria of the International Continence Society.Conclusion Propiverine is a safe and eCective drug in the treatment of urgency and urge incontinence; it is Additionally, a voiding protocol, overall assessment of clinical symptomatology and eBcacy ratings by the as eCective as oxybutynin, but the incidence of dry mouth and its severity is less with propiverine than physicians were documented. Results A remarkably high percentage of adverse events with oxybutynin. The availability of alternative pharmacotherapeutics such as propiverine should reduce was reported in the washout period (VO: 13%, 16% and 18% in groups 1-3, respectively). At V4, the the therapeutic failure rate and improves the success rate in the treatment of patients suCering from urgency clinically most r...