Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
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
1 other identifier
interventional
830
1 country
95
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2004
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedJanuary 27, 2021
January 1, 2021
September 2, 2005
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Patient Perception of Treatment Benefit at Week 12:
Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12
Secondary Outcomes (27)
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
- +22 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Homewood, Alabama, United States
Pfizer Investigational Site
Tucson, Arizona, United States
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Anaheim, California, United States
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Culver City, California, United States
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Fresno, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Murrieta, California, United States
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Poway, California, United States
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San Bernardino, California, United States
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Santa Monica, California, United States
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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New Britain, Connecticut, United States
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Waterbury, Connecticut, United States
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Melbourne, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Tallahassee, Florida, United States
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Wellington, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Roswell, Georgia, United States
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Melrose Park, Illinois, United States
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Evansville, Indiana, United States
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Jeffersonville, Indiana, United States
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Iowa City, Iowa, United States
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Overland Park, Kansas, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Brighton, Massachusetts, United States
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Watertown, Massachusetts, United States
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Columbia, Missouri, United States
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O'Fallon, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Edison, New Jersey, United States
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Hamilton, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Marlton, New Jersey, United States
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Mount Laurel, New Jersey, United States
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Sewell, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Westhampton, New Jersey, United States
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Woodbury, New Jersey, United States
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Albuquerque, New Mexico, United States
Pfizer Investigational Site
Albany, New York, United States
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Bay Shore, New York, United States
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Carmel, New York, United States
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Cortlandt Manor, New York, United States
Pfizer Investigational Site
Garden City, New York, United States
Pfizer Investigational Site
Manhasset, New York, United States
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New York, New York, United States
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Orchard Park, New York, United States
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Poughkeepsie, New York, United States
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Staten Island, New York, United States
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Syracuse, New York, United States
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Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Columbus, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Allentown, Pennsylvania, United States
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania, United States
Pfizer Investigational Site
Bryn Mawr, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
State College, Pennsylvania, United States
Pfizer Investigational Site
Wynnewood, Pennsylvania, United States
Pfizer Investigational Site
Providence, Rhode Island, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Greenwood, South Carolina, United States
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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Austin, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Provo, Utah, United States
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Alexandria, Virginia, United States
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Arlington, Virginia, United States
Pfizer Investigational Site
Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
Pfizer Investigational Site
Virginia Beach, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
Pfizer Investigational Site
Cheyenne, Wyoming, United States
Related Publications (1)
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.
PMID: 17105794DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
November 1, 2004
Study Completion
May 1, 2006
Last Updated
January 27, 2021
Record last verified: 2021-01