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

• Published in: European urology Vol. 55; no. 2; pp. 472 - 481
• Main Authors: Roehrborn, Claus G., Kaplan, Steven A., Jones, J. Stephen, Wang, Joseph T., Bavendam, Tamara, Guan, Zhonghong
• Format: Journal Article
• Language: English
• Published: Switzerland Elsevier B.V 01.02.2009
• Subjects: Adrenergic alpha-Antagonists - therapeutic use; Adult; Benign prostatic hyperplasia; Benzhydryl Compounds - administration & dosage; Benzhydryl Compounds - therapeutic use; Cresols - administration & dosage; Cresols - therapeutic use; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - therapeutic use; Diuresis - drug effects; Drug Therapy, Combination; Humans; Lower urinary tract symptoms; Male; Middle Aged; Multicenter Studies as Topic; Muscarinic Agonists - administration & dosage; Muscarinic Agonists - therapeutic use; Organ Size; Overactive bladder; Phenylpropanolamine - administration & dosage; Phenylpropanolamine - therapeutic use; Prostate - anatomy & histology; Prostate - drug effects; Prostate volume; Quality of life; Randomized Controlled Trials as Topic; Sulfonamides - therapeutic use; Tamsulosin; Tolterodine extended release; Tolterodine Tartrate; Urinary Bladder, Overactive - drug therapy; Urinary Retention - epidemiology; Urology; Tamsulosin; Prostate volume; Benign prostatic hyperplasia; Overactive bladder; Tolterodine extended release; Lower urinary tract symptoms; Quality of life
• DOI: 10.1016/j.eururo.2008.06.032
• ISSN: 0302-2838; 1873-7560

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. 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. Subjects 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). Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables. 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 Qmax or PVR; incidence of acute urinary retention (AUR) was low in all groups (≤2%). 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. Tolterodine extended release was effective and well tolerated in men meeting symptom-entry criteria for benign prostatic hyperplasia and overactive bladder with prostate volumes <29mL. Therapy with tolterodine extended release and tamsulosin was effective and well tolerated, regardless of prostate size.