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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolterodine ER 4 mg QD | Drug | |||
| Tamsulosin 0.4 mg QD | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perception of Treatment Benefit at Week 12: | ||
| Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | United States | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17105794 | Derived | Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
| Homewood |
| Alabama |
| United States |
| Pfizer Investigational Site | Tucson | Arizona | United States |
| Pfizer Investigational Site | Anaheim | California | United States |
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| Pfizer Investigational Site | Cheyenne | Wyoming | United States |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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