Fesoterodine Flexible Dose Study

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Fesoterodine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 896
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Pfizer Investigational Site
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Pfizer Investigational Site
    • Peoria, Arizona, United States, 85381
      • Pfizer Investigational Site
    • Tucson, Arizona, United States, 85741
      • Pfizer Investigational Site
  • California
    • Rancho Cordova, California, United States, 95670
      • Pfizer Investigational Site
    • Sacramento, California, United States, 95825
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80210
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80211
      • Pfizer Investigational Site
    • Englewood, Colorado, United States, 80112
      • Pfizer Investigational Site
  • Connecticut
    • New Britain, Connecticut, United States, 06052
      • Pfizer Investigational Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Pfizer Investigational Site
    • Bonita Springs, Florida, United States, 34134
      • Pfizer Investigational Site
    • Hollywood, Florida, United States, 33021
      • Pfizer Investigational Site
    • Lake Worth, Florida, United States, 33461
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33176
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33143
      • Pfizer Investigational Site
    • Naples, Florida, United States, 34102
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33024
      • Pfizer Investigational Site
    • St. Petersburg, Florida, United States, 33709
      • Pfizer Investigational Site
    • Stuart, Florida, United States, 34996
      • Pfizer Investigational Site
    • Tallahassee, Florida, United States, 32308
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Pfizer Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Pfizer Investigational Site
    • Jeffersonville, Indiana, United States, 47130
      • Pfizer Investigational Site
    • Newburgh, Indiana, United States, 47630
      • Pfizer Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States, 66210
      • Pfizer Investigational Site
    • Pratt, Kansas, United States, 67124
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40207
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40291
      • Pfizer Investigational Site
    • Madisonville, Kentucky, United States, 42431
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Pfizer Investigational Site
    • Bel Air, Maryland, United States, 21014
      • Pfizer Investigational Site
  • Massachusetts
    • Milford, Massachusetts, United States, 01757
      • Pfizer Investigational Site
    • Springfield, Massachusetts, United States, 01103
      • Pfizer Investigational Site
    • West Yarmouth, Massachusetts, United States, 02673
      • Pfizer Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Pfizer Investigational Site
    • Paw Paw, Michigan, United States, 49079
      • Pfizer Investigational Site
    • Royal Oak, Michigan, United States, 48073
      • Pfizer Investigational Site
    • Troy, Michigan, United States, 48098
      • Pfizer Investigational Site
  • Mississippi
    • Picayune, Mississippi, United States, 39466
      • Pfizer Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63117
      • Pfizer Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Pfizer Investigational Site
    • Lincoln, Nebraska, United States, 68510
      • Pfizer Investigational Site
    • Omaha, Nebraska, United States, 68114
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89130
      • Pfizer Investigational Site
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Pfizer Investigational Site
  • New York
    • Garden City, New York, United States, 11530
      • Pfizer Investigational Site
    • Kingston, New York, United States, 12401
      • Pfizer Investigational Site
    • Manlius, New York, United States, 13104
      • Pfizer Investigational Site
    • New York, New York, United States, 10016
      • Pfizer Investigational Site
    • Poughkeepsie, New York, United States, 12601
      • Pfizer Investigational Site
    • Rochester, New York, United States, 14609
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
    • Williamsville, New York, United States, 14221
      • Pfizer Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Pfizer Investigational Site
    • Charlotte, North Carolina, United States, 28204
      • Pfizer Investigational Site
    • Charlotte, North Carolina, United States, 28207
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • Pfizer Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45249
      • Pfizer Investigational Site
  • Oklahoma
    • Bethany, Oklahoma, United States, 73008
      • Pfizer Investigational Site
    • Norman, Oklahoma, United States, 73071
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Pfizer Investigational Site
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19114
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19115
      • Pfizer Investigational Site
    • Sellersville, Pennsylvania, United States, 18960
      • Pfizer Investigational Site
    • State College, Pennsylvania, United States, 16801
      • Pfizer Investigational Site
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Pfizer Investigational Site
    • Cumberland, Rhode Island, United States, 02864
      • Pfizer Investigational Site
    • Warwick, Rhode Island, United States, 02886
      • Pfizer Investigational Site
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Pfizer Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Pfizer Investigational Site
    • Johnson City, Tennessee, United States, 37601
      • Pfizer Investigational Site
    • Johnson City, Tennessee, United States, 36701
      • Pfizer Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Pfizer Investigational Site
    • New Tazewell, Tennessee, United States, 37825
      • Pfizer Investigational Site
  • Texas
    • Bryan, Texas, United States, 77802
      • Pfizer Investigational Site
    • Corpus Christi, Texas, United States, 78414
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75231
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77079
      • Pfizer Investigational Site
    • Longview, Texas, United States, 75605
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Pfizer Investigational Site
    • Norfolk, Virginia, United States, 23502
      • Pfizer Investigational Site
    • Richmond, Virginia, United States, 23294
      • Pfizer Investigational Site
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99207
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overactive bladder symptoms for greater than or equal to 3 months.
• Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
• Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

• Contraindication to fesoterodine (antimuscarinics).
• Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
• Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
• Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Double-Blind)	Drug: Placebo; Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
Experimental: Fesoterodine (Double-Blind)	Drug: Fesoterodine; 4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.	The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline	The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at observation minus mean at baseline	Baseline, Week 2 and Week 6
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline	Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.	Baseline, Week 2, Week 6 and Week 12
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline	Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.	Baseline, Week 2, Week 6 and Week 12
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline	Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine	Baseline, Week 2, Week 6 and Week 12
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline	Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.	Baseline, Week 2, Week 6 and Week 12
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline	Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit	Baseline, Week 2, Week 6 and Week 12
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline	Change in frequency urgency sum is total urinary sensation scale (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 2, Week 6 and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale	Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement. Change: mean at Week 12 minus mean at baseline	Baseline and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales	Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement. Change: mean at Week 12 minus mean at baseline.	Baseline and Week 12
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline	PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline	Baseline, Week 2, Week 6 and Week 12
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline	UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet [without leaking]"). Improvement: positive score change; No change: score change=0; Deterioration: negative score change	Baseline, Week 2, Week 6 and Week 12
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline	The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement. Change: mean at observation minus mean at baseline.	Baseline, Week 2, Week 6 and Week 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: September 25, 2007
• First Submitted That Met QC Criteria: September 25, 2007
• First Posted (Estimate): September 27, 2007

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 10, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Overactive Bladder
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Fesoterodine
• Other Study ID Numbers: A0221014