Aim: To determine the efficacy of toterodine extended release (ER) treatment for 1 year in older men with benign prostatic hyperplasia (BPH) and storage symptoms treated with alpha-blockers and/or 5-alpha-reductase inhibitors (5ARI).
Methods: Men aged over 70 years with BPH/bladder outlet obstruction (BOO) and clinical storage symptoms were randomly treated with or without tolterodine ER in combination with alpha-blockers and/or 5ARI for 12 months. Among them, 50 patients (group 1) received additive tolterodine extended release (ER) 4 mg q.d., another 87 patients (group 2) did not. All patients had a baseline and 12th month post-treatment evaluation, which comprised of uroflowmetry, post-void residual (PVR) volume, International Prostate Symptom Score (IPSS), and quality of life index (QoL-I), transrectal ultrasound of the prostate and serum prostate specific antigen.
Results: One hundred thirty-seven of 153 enrolled patients with a mean age of 74.9 years completed the study. Treatment benefit demonstrated in both groups included deceased total, voiding and storage IPSS scores, increased peak urinary flow rate and deceased QoL-I. Inter-group difference was only observed on the storage domain of IPSS score (P = 0.012). The mean PVR after treatment did not significantly differ between two groups. Two patients of group 1 and three of group 2 developed acute urinary retention. Among group 1, six patients discontinued tolterodine ER for intolerable dry mouth; among group 2, three patients reported dizziness.
Conclusions: This longer comparative study indicated that additive treatment with tolterodine ER in older men with BPH/BOO and significant storage symptoms is a beneficial and safe therapeutic option.
Copyright © 2011 Wiley-Liss, Inc.