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) max ) >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 ( 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 p 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.