Data from 12-week , r and omised , double-blind , placebo-controlled trials of tolterodine extended release ( ER ) , oxybutynin and solifenacin show that combined antimuscarinic+α-blocker treatment is generally more effective than monotherapy or placebo in men with OAB symptoms .
The efficacy and safety  of tolterodine ER+α-blocker treatment was not affected by prostate size or prostate-specific antigen ( PSA ) level .
In men meeting entry criteria for OAB and benign prostatic obstruction trials  , tolterodine ER alone was effective selectively in men with prostate size or PSA level below study medians .
Post hoc analyses from double-blind , placebo-controlled trials and prospect i ve studies of fesoterodine , oxybutynin , propiverine , solifenacin and tolterodine also suggest that antimuscarinics are generally safe and efficacious in men .
A retrospective data base study found that risk of AUR in men was the highest in the first month of treatment and decreased considerably thereafter .
Antimuscarinics , alone or with an α-blocker , appear to be efficacious and safe in many men with predominant OAB symptoms or persistent OAB symptoms despite α-blocker or 5-α-reductase inhibitor treatment .
Despite potential benefits , primary care clinicians may avoid using antimuscarinics in men with overactive bladder ( OAB ) symptoms because of safety concerns .
Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial.
CONTEXT Men with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or alpha-receptor antagonists . OBJECTIVE To evaluate the efficacy and safety of tolterodine extended release ( ER ) , tamsulosin , or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and , an International Prostate Symptom Score quality -of-life ( QOL ) item score of 3 or higher , a self-rated bladder condition of at least moderate bother , and a bladder diary documenting micturition frequency ( > or=8 micturitions per 24 hours ) and urgency ( > or=3 episodes per 24 hours ) , with or without urgency urinary incontinence . Patients were recruited between November 2004 and February 2006 , and the study was completed May 2006 . INTERVENTIONS Patients were r and omly assigned to receive placebo ( n = 222 ) , 4 mg of tolterodine ER ( n = 217 ) , 0.4 mg of tamsulosin ( n = 215 ) , or both tolterodine ER plus tamsulosin ( n = 225 ) for 12 weeks . MAIN OUTCOME MEASURES Patient perception of treatment benefit , bladder diary variables , International Prostate Symptom Scores , and safety and tolerability were assessed . RESULTS A total of 172 men ( 80 % ) receiving tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients ( 62 % ) receiving placebo ( P<.001 ) , 146 ( 71 % ) receiving tamsulosin ( P=.06 vs placebo ) , or 135 ( 65 % ) receiving tolterodine ER ( P=.48 vs placebo ) . Patients receiving tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence ( -0.88 vs -0.31 , P=.005 ) , urgency episodes without incontinence ( -3.33 vs -2.54 , P=.03 ) , micturitions per 24 hours ( -2.54 vs -1.41 , P<.001 ) , and micturitions per night ( -0.59 vs -0.39 , P.02 ) . Patients receiving tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score ( -8.02 vs placebo , -6.19 , P=.003 ) and QOL item ( -1.61 vs -1.17 , P=.003 ) . All interventions were well tolerated . The incidence of acute urinary retention requiring catheterization was low ( tolterodine ER plus tamsulosin , 0.4 % ; tolterodine ER , 0.5 % ; tamsulosin , 0 % ; and placebo , 0 % ) . CONCLUSIONS These results suggest that treatment with tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder . Clinical Trials Registration clinical trials.gov Identifier : NCT00147654
Data from 12-week , r and omised , double-blind , placebo-controlled trials of tolterodine extended release ( ER ) , oxybutynin and solifenacin show that combined antimuscarinic+α-blocker treatment is generally more effective than monotherapy or placebo in men with OAB symptoms .
The efficacy and safety  of tolterodine ER+α-blocker treatment was not affected by prostate size or prostate-specific antigen ( PSA ) level .
In men meeting entry criteria for OAB and benign prostatic obstruction trials  , tolterodine ER alone was effective selectively in men with prostate size or PSA level below study medians .
Post hoc analyses from double-blind , placebo-controlled trials and prospect i ve studies of fesoterodine , oxybutynin , propiverine , solifenacin and tolterodine also suggest that antimuscarinics are generally safe and efficacious in men .
A retrospective data base study found that risk of AUR in men was the highest in the first month of treatment and decreased considerably thereafter .
Antimuscarinics , alone or with an α-blocker , appear to be efficacious and safe in many men with predominant OAB symptoms or persistent OAB symptoms despite α-blocker or 5-α-reductase inhibitor treatment .
Despite potential benefits , primary care clinicians may avoid using antimuscarinics in men with overactive bladder ( OAB ) symptoms because of safety concerns .