Effects of serum PSA on efficacy of tolterodine extended release with or without tamsulosin in men with LUTS, including OAB.
OBJECTIVE
To evaluate the efficacy of tolterodine extended release (ER), tamsulosin, and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen (PSA) level.


METHODS
We performed a post hoc analysis of data from men >or=40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume <200 mL, maximal urinary flow rate >5 mL/s, International Prostate Symptom Score (IPSS) of >or=12, and quality-of-life score of >or=3. They had been randomized to placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER plus tamsulosin for 12 weeks. The men were stratified by the median baseline PSA level (>or=1.3 vs <1.3 ng/mL). Assessments included changes in bladder diary variables and IPSSs. The men rated the urgency level of each micturition, and the frequency-urgency sum was defined as the total of these ratings.


RESULTS
The PSA level correlated significantly with prostate size. Men with a PSA level of >or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency, daytime frequency, the frequency-urgency sum, total IPSS, and IPSS storage score compared with those receiving placebo. Tamsulosin significantly improved the IPSS voiding scores, but tolterodine ER was ineffective. In men with a PSA level <1.3 ng/mL, tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency, daytime frequency, frequency-urgency sum, and IPSS storage scores compared with those receiving placebo; tamsulosin alone was ineffective. No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group, and the acute urinary retention rates were low.


CONCLUSIONS
The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms, including overactive bladder, who had lower PSA levels (<1.3 ng/mL).
Roehrborn
Claus G
CG
Department of Urology, University of Texas Southwestern, Medical Center at Dallas, Texas 75390-9110, USA. claus.roehrborn@utsouthwestern.edu
Kaplan
Steven A
SA
Kraus
Stephen R
SR
Wang
Joseph T
JT
Bavendam
Tamara
T
Guan
Zhonghong
Z
D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D015331:Cohort Studies; D003408:Cresols / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000008:administration & dosage / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D017430:Prostate-Specific Antigen / Q000097:blood*; D011470:Prostatic Hyperplasia / Q000097:blood / Q000150:complications / Q000188:drug therapy; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D000077409:Tamsulosin; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000097:blood / Q000188:drug therapy / Q000209:etiology; D014555:Urination Disorders / Q000097:blood / Q000188:drug therapy* / Q000209:etiology
D000317:Adrenergic alpha-Antagonists; D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D013449:Sulfonamides; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D017430:Prostate-Specific Antigen; D000077409:Tamsulosin