BackgroundSome men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-adrenergic antagonist. ObjectivesTo 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 participantsSubjects with an International Prostate Symptom Score (IPSS) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) <200mL; and maximum urinary flow rate (Qmax) >5mL/s were randomized to receive placebo, tolterodine ER (4mg), tamsulosin (0.4mg), or tolterodine ER+tamsulosin for 12 wk. Data were stratified by median baseline prostate volume (<29mL vs ≥29mL). MeasurementsEndpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables. Results and limitationsAmong 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 Qmax or PVR; incidence of acute urinary retention (AUR) was low in all groups (≤2%). ConclusionsMen 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.
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