TROSPIUM CHLORIDE VERSUS OXYBUTYNIN - A RANDOMIZED, DOUBLE-BLIND, MULTICENTER TRIAL IN THE TREATMENT OF DETRUSOR HYPER-REFLEXIA

Objective To compare trospium chloride (TCl), a quaternary ammonium de rivative with atropine-like effects and predominantly antispasmodic ac tivity, with oxybutynin (Oxy) in terms of efficacy and adverse effects . Patients and methods In a randomized, double-blind, multicentre tria l, 95 patients with spinal cord injuries and detrusor hyper-reflexia w ere studied. Treatment consisted of three doses per day over a 2 week period, with either Oxy (5 mg three times daily) or with TCl (20 mg tw ice daily) with an additional placebo at midday. The results were eval uated with regard to changes in objective (urodynamic) data and subjec tive symptoms as well as the incidence/severity of adverse effects. Re sults With both drugs there was a significant increase in maximum blad der capacity, a significant decrease in maximum voiding detrusor press ure and a significant increase in compliance and residual urine; there were no statistically significant differences between the treatment g roups. The percentage of patients who reported severe dryness of the m outh was considerably lower (4%) in those receiving TCl 2 x 20 mg/day than in those receiving Oxy (23%) 3 x 5 mg/day. Withdrawal from treatm ent was also less frequent in those receiving TCl (6%) than in those r eceiving Oxy (16%). Conclusion Trospium chloride and oxybutynin, judge d in terms of objective urodynamic parameters, are of substantially eq ual value as parasympathetic antagonists. However, assessment of toler ance in terms of adverse drug effects showed that TCl had certain adva ntages.