Efficacy and Cardiac Safety of Propiverine in Elderly Patients – A Double–Blind, Placebo–Controlled Clinical Study

Abstract

The study investigated the efficacy and cardiac safety of propiverine in the elderly, because the induction of life–threatening ventricular arrhythmia has been reported for some drugs prescribed in the therapy of urinary incontinence. Ninety–eight patients (21 male, 77 female; 67.7±6.3 years of age) suffering from urgency, urge incontinence or mixed urge–stress incontinence were included in the double–blind, multicentre, placebo–controlled, randomized study. After a 2–week placebo run–in period, the patients received propiverine (15 mg t.i.d.) or placebo (t.i.d.) for 4 weeks. Before (V1, V2) and during the treatment period (V3, V4), standard ECGs and 24–hour long–term ECGs were recorded. Propiverine caused a significant reduction of the micturition frequency (V2: 8.7±4.2, V4: 6.5±3.2 ml; p≤0.01), reflected in a significant increase in the average micturition volume (V2: 163.5±65.9, V4: 216.3±101.5 ml; p≤0.01) and a significant decrease in episodes of incontinence (–54%; p = 0.048). These findings were confirmed by the overall assessment at V4, in which approximately 90% of patients under propiverine either had no urge incontinence or urge symptoms, or showed improvement. Resting and ambulatory electrocardiograms indicated no significant changes. Neither the frequency–corrected Q–T interval nor other cardiac parameters were relevantly altered. The frequency of cardiac events (Lown classes IVa/b) was random, revealing no difference between placebo and propiverine. The incidence of adverse events was very low (2% dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires. A favourable benefit–risk ratio without the induction of any cardiac arrhythmia in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge–stress incontinence is therefore proven for propiverine.