Official Title: “A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Without Urinary Urge Incontinence, With Or Without Bladder Outlet Obstruction”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: Tolterodine ER 4 mg QD
• Drug: Tamsulosin 0.4 mg QD

Primary Measures

• Patient Perception of Treatment Benefit at Week 12:
• Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Secondary Measures

• 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
• (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 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

Inclusion Criteria:

• Male 40 years of age
• Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
• Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

Exclusion Criteria:

• Post-void residual urine volume (PVR) of > 200 ml as measured by an ultrasound
• Maximum urinary flow rate (Qmax) of < 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
• Prescribed and administered an antimuscarinic or antispasmodic within 1 month
• Prescribed and administered an a-1-adrenergic antagonist within 2 weeks

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00147654

Study ID Number: A6121120

ClinicalTrials.gov Identifier: NCT00147654

Health Authority: United States: Food and Drug Administration

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