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 α-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 OAB 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_max 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.