The primary objective of the trial is to evaluate the effect of tolterodine ER plus
tamsulosin versus placebo on patient perception of overall treatment benefit in men who have
frequency and urgency, with or without urinary urge incontinence (UUI), with or without
bladder outlet obstruction (BOO).
Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.
Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline
Change in number of OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline
Change in number of daytime OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline
Change in number of nighttime OAB micturition episodes per 24 hours. (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
Change in number of severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
Change in number of daytime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
Change in number of nighttime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
International Prostate Symptom Score (I-PSS):
Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline
Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline
Patient perception of urgency:
Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline
Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline
Patient Perception of Treatment benefit at week 1 and week 6
Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6
Change in International Continence Society Male (ICSmaleLF) Questionnaire (long form modified) individual item scores at Week 1, Week 6 and Week 12 relative to baseline
Change in the total score of Overactive Bladder Questionnaire (OABq) and change in total scores for each domain of OABq at week 6 and week 12 relative to baseline
Change in the total score of International Index of Erectile Function (IIEF) and change in total scores for each domain of IIEF Questionnaire at week 6 and week 12 relative to baseline
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Male.
Pfizer Investigational Site, Birmingham, Alabama, United States
Pfizer Investigational Site, Homewood, Alabama, United States
Pfizer Investigational Site, Tucson, Arizona, United States
Pfizer Investigational Site, Anaheim, California, United States
Pfizer Investigational Site, Culver City, California, United States
Pfizer Investigational Site, Fresno, California, United States
Pfizer Investigational Site, La Mesa, California, United States
Pfizer Investigational Site, Long Beach, California, United States
Pfizer Investigational Site, Los Angeles, California, United States
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Pfizer Investigational Site, Denver, Colorado, United States
Pfizer Investigational Site, New Britain, Connecticut, United States
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Pfizer Investigational Site, Melbourne, Florida, United States
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Pfizer Investigational Site, Tallahassee, Florida, United States
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Pfizer Investigational Site, Atlanta, Georgia, United States
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Pfizer Investigational Site, Shreveport, Louisiana, United States
Pfizer Investigational Site, Boston, Massachusetts, United States
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Pfizer Investigational Site, Watertown, Massachusetts, United States
Pfizer Investigational Site, Columbia, Missouri, United States
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Pfizer Investigational Site, Missoula, Montana, United States
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Pfizer Investigational Site, Cherry Hill, New Jersey, United States
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Pfizer Investigational Site, Westhampton, New Jersey, United States
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Pfizer Investigational Site, Albany, New York, United States
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Pfizer Investigational Site, Cincinnati, Ohio, United States
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Pfizer Investigational Site, Philadelphia, Pennsylvania, United States
Pfizer Investigational Site, State College, Pennsylvania, United States
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Pfizer Investigational Site, Providence, Rhode Island, United States
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Pfizer Investigational Site, Greer, South Carolina, United States
Pfizer Investigational Site, Prosperity, South Carolina, United States
Pfizer Investigational Site, Saluda, South Carolina, United States
Pfizer Investigational Site, Germantown, Tennessee, United States
Pfizer Investigational Site, Milan, Tennessee, United States
Pfizer Investigational Site, Arlington, Texas, United States
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Pfizer Investigational Site, Provo, Utah, United States
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