Tolterodine Extended Release Attenuates Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia

Abstract

In this open label, prospective study we determined the efficacy and tolerability of tolterodine extended release (ER) in men with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) in whom previous alpha-blocker therapy had failed. A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events (11) or a lack of efficacy (32) received tolterodine ER (4 mg daily) for 6 months. Primary efficacy end points were American Urological Association symptom score, and mean daytime and nighttime micturition frequency. Secondary end points were the peak urinary flow rate, post-void residual volume, the incidence of urinary retention, total score on the erectile function domain of the International Index of Erectile Function and adverse events. A total of 39 men (91%) with a mean age of 61 years completed the 6-month trial. Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly. Significant changes in mean American Urological Association symptom scores (-6.1), the peak urinary flow rate (1.9 ml per second) and post-void residual volume (-22 ml) were also observed. Of the men 27 (63%) were potent at baseline and 29 (67%) were potent after 6 months of tolterodine ER treatment. Mean International Index of Erectile Function erectile function domain scores increased (6.9). Four men (9%) discontinued therapy because of intolerable dry mouth. There were no reports of urinary retention. Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers.