Clinical trial NCT00928070: A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Urgency Urinary Incontinence OAB
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 566
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).


Eligibility criteria: Inclusion Criteria:

* male or female subjects 65 years of age or older
* OAB symptoms for at least 3 months
* score 3 or greater on Vulnerable Elderly Survey (VES-13)
* adequate mobility for independent toileting
* mean number of at least 2 UUI episodes per 24 hours
* mean urinary frequency of 8 or more micturitions per 24 hours
* able to independently complete the bladder diaries

Exclusion Criteria:

* PVR urinary volume greater than 200 ml
* MMSE score less than 20
* greater than 15 UUI episodes per 24 hours
* creatinine clearance less than 30 ml/min
* an average resting heart rate of greater than or equal to 90 beats per minute

Primary outcomes:
measure: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4
timeFrame: Baseline, Week 4
measure: Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Mean Number of Micturition-related Urgency Episodes Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Frequency-Urgency Sum Rating Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12
timeFrame: Screening, Week 4, 12
measure: Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
timeFrame: Baseline
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
timeFrame: Baseline
measure: Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12
timeFrame: Baseline, Week 4, 12
measure: Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control
timeFrame: Week 12
measure: Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response
timeFrame: Week 12
measure: Mini Mental State Examination (MMSE)
timeFrame: Screening
measure: Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12
timeFrame: Screening, Week 12
measure: Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12
timeFrame: Baseline, Week 4, 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Green Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tuscon
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Costa Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Fairfield
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendora
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Murrieta
country: United States
facility: Pfizer Investigational Site
state: California
city: Norwalk
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Santa Margarita
country: United States
facility: Pfizer Investigational Site
state: California
city: San Bernardino
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Temecula
country: United States
facility: Pfizer Investigational Site
state: California
city: Vacaville
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Englewood
country: United States
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state: Colorado
city: Longmont
country: United States
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state: Colorado
city: Parker
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state: Colorado
city: Groton
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New London
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Bonita Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boynton Beach
country: United States
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state: Florida
city: Brooksville
country: United States
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city: Clearwater
country: United States
facility: Pfizer Investigational Site
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city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
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city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
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state: Florida
city: Melbourne
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facility: Pfizer Investigational Site
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city: Naples
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facility: Pfizer Investigational Site
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city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plant City
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facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
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state: Florida
city: Trinity
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city: Wellington
country: United States
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city: Winter Haven
country: United States
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state: Florida
city: Atlanta
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facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Springfield
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state: Illinois
city: Springfield
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state: Illinois
city: Newburgh
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state: Indiana
city: Arkansas City
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facility: Pfizer Investigational Site
state: Kansas
city: Kansas City
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facility: Pfizer Investigational Site
state: Kansas
city: Wichita
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facility: Pfizer Investigational Site
state: Kansas
city: Wichita
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state: Kansas
city: Lexington
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facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
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state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Glen Burnie
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Towson
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Picayune
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Southaven
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
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facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
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facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
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facility: Pfizer Investigational Site
state: Nevada
city: Moorestown
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facility: Pfizer Investigational Site
state: New Jersey
city: Sewell
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city: Albany
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facility: Pfizer Investigational Site
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city: Brooklyn
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facility: Pfizer Investigational Site
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city: Staten Island
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city: Williamsville
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state: New York
city: Cary
country: United States
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state: North Carolina
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Willoughby Hills
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Leander
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Murray
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Burien
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Dubeau CE, Kraus SR, Griebling TL, Newman DK, Wyman JF, Johnson TM 2nd, Ouslander JG, Sun F, Gong J, Bavendam T. Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial. J Urol. 2014 Feb;191(2):395-404. doi: 10.1016/j.juro.2013.08.027. Epub 2013 Aug 21.