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.


OBJECTIVE
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.


METHODS
Subjects with an International Prostate Symptom Score (IPSS) >or=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 >or=29 mL).


METHODS
Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables.


CONCLUSIONS
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 (<or=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.
Roehrborn
Claus G
CG
Department of Urology, University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390-9110, USA. claus.roehrborn@utsouthwestern.edu
Kaplan
Steven A
SA
Jones
J Stephen
JS
Wang
Joseph T
JT
Bavendam
Tamara
T
Guan
Zhonghong
Z
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D003408:Cresols / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D004231:Diuresis / Q000187:drug effects; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D018721:Muscarinic Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D009929:Organ Size; D010665:Phenylpropanolamine / Q000008:administration & dosage / Q000627:therapeutic use*; D011467:Prostate / Q000033:anatomy & histology* / Q000187:drug effects; D016032:Randomized Controlled Trials as Topic; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D000068737:Tolterodine Tartrate; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D016055:Urinary Retention / Q000453:epidemiology
D000317:Adrenergic alpha-Antagonists; D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018721:Muscarinic Agonists; D013449:Sulfonamides; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D000077409:Tamsulosin