A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

Overactive Bladder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928070
• Other study ID #: A0221049
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2009
• Last updated: December 10, 2012
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine
Fesoterodine 4 mg and 8 mg
• Placebo
Placebo sham 4 mg and 8 mg

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Altoona	Pennsylvania
United States	Pfizer Investigational Site	Arkansas City	Kansas
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bethany	Oklahoma
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Bonita Springs	Florida
United States	Pfizer Investigational Site	Boynton Beach	Florida
United States	Pfizer Investigational Site	Bristol	Tennessee
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Brooksville	Florida
United States	Pfizer Investigational Site	Burien	Washington
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chattanooga	Tennessee
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Corpus Christi	Texas
United States	Pfizer Investigational Site	Costa Mesa	California
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Englewood	Colorado
United States	Pfizer Investigational Site	Englewood	Colorado
United States	Pfizer Investigational Site	Erie	Pennsylvania
United States	Pfizer Investigational Site	Fairfield	California
United States	Pfizer Investigational Site	Ft. Lauderdale	Florida
United States	Pfizer Investigational Site	Glen Burnie	Maryland
United States	Pfizer Investigational Site	Glendora	California
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Green Valley	Arizona
United States	Pfizer Investigational Site	Groton	Connecticut
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jackson	Tennessee
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	Lake Worth	Florida
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Leander	Texas
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Longmont	Colorado
United States	Pfizer Investigational Site	Longview	Texas
United States	Pfizer Investigational Site	Longview	Texas
United States	Pfizer Investigational Site	Macon	Georgia
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Milford	Connecticut
United States	Pfizer Investigational Site	Mission Viejo	California
United States	Pfizer Investigational Site	Montgomery	Alabama
United States	Pfizer Investigational Site	Moorestown	New Jersey
United States	Pfizer Investigational Site	Murray	Utah
United States	Pfizer Investigational Site	Murrieta	California
United States	Pfizer Investigational Site	Myrtle Beach	South Carolina
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	New London	Connecticut
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	Newburgh	Indiana
United States	Pfizer Investigational Site	Norman	Oklahoma
United States	Pfizer Investigational Site	Norwalk	California
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Paramount	California
United States	Pfizer Investigational Site	Parker	Colorado
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Picayune	Mississippi
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Plant City	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Rancho Santa Margarita	California
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Bernardino	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Santa Ana	California
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Sewell	New Jersey
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Southaven	Mississippi
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Springfield	Massachusetts
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	Staten Island	New York
United States	Pfizer Investigational Site	Temecula	California
United States	Pfizer Investigational Site	Temple	Texas
United States	Pfizer Investigational Site	Towson	Maryland
United States	Pfizer Investigational Site	Trinity	Florida
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tuscon	Arizona
United States	Pfizer Investigational Site	Vacaville	California
United States	Pfizer Investigational Site	Wellington	Florida
United States	Pfizer Investigational Site	West Jordan	Utah
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Williamsville	New York
United States	Pfizer Investigational Site	Willoughby Hills	Ohio
United States	Pfizer Investigational Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours	UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline	No
Primary	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline, Week 12	No
Secondary	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline, Week 4	No
Secondary	Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4, 12	No
Secondary	Mean Number of Micturitions Per 24 Hours	Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.	Baseline	No
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12	Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.	Baseline, Week 4, 12	No
Secondary	Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4, 12	No
Secondary	Mean Number of Micturition-related Urgency Episodes Per 24 Hours	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline	No
Secondary	Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Baseline, Week 4, 12	No
Secondary	Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4, 12	No
Secondary	Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours	Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.	Baseline	No
Secondary	Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.	Baseline, Week 4, 12	No
Secondary	Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12	Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).	Baseline, Week 4, 12	No
Secondary	Frequency-Urgency Sum Rating Per 24 Hours	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.	Baseline	No
Secondary	Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.	Baseline, Week 4, 12	No
Secondary	Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12	Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.	Baseline, Week 4, 12	No
Secondary	Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12	PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.	Screening, Week 4, 12	No
Secondary	Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.	Baseline	No
Secondary	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.	Baseline, Week 4, 12	No
Secondary	Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Baseline	No
Secondary	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	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Baseline, Week 4, 12	No
Secondary	Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control	OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.	Week 12	No
Secondary	Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response	Participant's response to question, "overall, how satisfied are you with your OAB medication?" was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into "satisfied", and 4 and 5 were combined into "dissatisfied".	Week 12	No
Secondary	Mini Mental State Examination (MMSE)	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.	Screening	Yes
Secondary	Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline	Screening, Week 12	Yes
Secondary	Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12	PVR volume is defined as volume of urine remaining in the bladder immediately after urination.	Baseline, Week 4, 12	Yes

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