Tolterodine Extended Release With or Without Tamsulosin in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms: Effects of Prostate Size

Background: Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an alpha-adrenergic antagonist. Objectives: To evaluate the safety and efficacy of tolterodine extended release (ER), tamsulosin, or tolterodine ER+tamsulosin in men meeting symptom entry criteria for CAB and prostatic enlargement trials, stratified by prostate size. Design, setting, and participants: Subjects with an International Prostate Symptom Score (IPSS) >= 12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) <200 mL; and maximum urinary flow rate (Q(max)) >5 mL/s were randomized to receive placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER+tamsulosin for 12 wk. Data were stratified by median baseline prostate volume (<29 mL vs >= 29 mL). Measurements: Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables. Results and limitations: Among men with larger prostates, tolterodine ER+tamsulosin significantly improved frequency (p = 0.001); urgency (p = 0.006); and IPSS total (p = 0.001), storage (p < 0.001), and voiding scores (p < 0.013). Tamsulosin significantly improved IPSS voiding scores (p = 0.030). Among men with smaller prostates, tolterodine ER significantly improved frequency (p = 0.016), UUI episodes (p = 0.036), and IPSS storage scores (p = 0.005). Tolterodine ER+tamsulosin significantly improved frequency (p = 0.001) and IPSS storage scores (p = 0.018). Tamsulosin significantly improved nocturnal frequency (p = 0.038) and IPSS voiding (p = 0.036) and total scores (p = 0.044). There were no clinically or statistically significant changes in Q,a or PVR; incidence of acute urinary retention (AUR) was low in all groups (<= 2%). Conclusions: Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER. Therapy with tolterodine ER+tamsulosin was effective regardless of prostate size. Tolterodine ER, with or without tamsulosin, was well tolerated and not associated with increased incidence of AUR. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.