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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00928070
Other study ID # A0221049
Secondary ID
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


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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