Fesoterodine "add-on" Male Overactive Bladder Study

A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.

To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 947
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • Pfizer Investigational Site
  • Edegem, Belgium, B-2650
    • Pfizer Investigational Site
  • Leuven, Belgium, B-3000
    • Pfizer Investigational Site
• Brazil
  • BA
    • Salvador, BA, Brazil, 40420-000
      • Pfizer Investigational Site
  • PR
    • Curitiba, PR, Brazil, 80060-900
      • Pfizer Investigational Site
  • RJ
    • Rio de Janeiro, RJ, Brazil, CEP 20551-030
      • Pfizer Investigational Site
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Pfizer Investigational Site
  • SP
    • São Paulo, SP, Brazil, 04262-000
      • Pfizer Investigational Site
  • São Paulo
    • Campos do Jordão, São Paulo, Brazil, 12460-000
      • Pfizer Investigational Site
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8T 5G1
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Pfizer Investigational Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Pfizer Investigational Site
    • North Bay, Ontario, Canada, P1B 7K8
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M6A 3B5
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Pfizer Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 4A3
      • Pfizer Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Pfizer Investigational Site
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 0000
      • Pfizer Investigational Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0000
      • Pfizer Investigational Site
• Germany
  • Berlin, Germany, 12627
    • Pfizer Investigational Site
  • Frankfurt, Germany, 60596
    • Pfizer Investigational Site
  • Goettingen, Germany, 37073
    • Pfizer Investigational Site
  • Hagenow, Germany, 19230
    • Pfizer Investigational Site
  • Lauenburg, Germany, 21481
    • Pfizer Investigational Site
  • Leipzig, Germany, 04109
    • Pfizer Investigational Site
  • Oberursel, Germany, 61440
    • Pfizer Investigational Site
  • Wiesbaden, Germany, 65198
    • Pfizer Investigational Site
• Greece
  • Patras, Greece, 26500
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 56403
    • Pfizer Investigational Site
  • Ipiros
    • Ioannina, Ipiros, Greece, 45 110
      • Pfizer Investigational Site
• India
  • New Delhi, India, 110029
    • Pfizer Investigational Site
  • Punjab
    • Ludhiana, Punjab, India, 141008
      • Pfizer Investigational Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Pfizer Investigational Site
    • Lucknow, Uttar Pradesh, India, 226014
      • Pfizer Investigational Site
• Korea, Republic of
  • Pusan, Korea, Republic of, 602-739
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-720
    • Pfizer Investigational Site
  • Gyunggi-do
    • Bucheon-si, Gyunggi-do, Korea, Republic of, 420-717
      • Pfizer Investigational Site
• Malaysia
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Pfizer Investigational Site
    • Kuching, Sarawak, Malaysia, 93050
      • Pfizer Investigational Site
• Netherlands
  • Roermond, Netherlands, 6043 CV
    • Pfizer Investigational Site
  • Tilburg, Netherlands, 5022 GC
    • Pfizer Investigational Site
  • Zutphen, Netherlands, 7207 BA
    • Pfizer Investigational Site
• Norway
  • Bodø, Norway, 8087
    • Pfizer Investigational Site
  • Oslo, Norway, NO-0257
    • Pfizer Investigational Site
• Philippines
  • Bacolod City, Philippines, 6100
    • Pfizer Investigational Site
  • Makati City, Philippines, 1200
    • Pfizer Investigational Site
  • Manila, Philippines, 1000
    • Pfizer Investigational Site
  • Manila, Philippines, 1008
    • Pfizer Investigational Site
  • Quezon City, Philippines, 1113
    • Pfizer Investigational Site
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Pfizer Investigational Site
• Poland
  • Bialystok, Poland, 15-232
    • Pfizer Investigational Site
  • Gdansk, Poland, 80-462
    • Pfizer Investigational Site
  • Gdansk, Poland, 80-402
    • Pfizer Investigational Site
  • Lodz, Poland, 93-338
    • Pfizer Investigational Site
  • Myslowice, Poland, 41-400
    • Pfizer Investigational Site
  • Wroclaw, Poland, 51-124
    • Pfizer Investigational Site
• Singapore
  • Singapore, Singapore, 169608
    • Pfizer Investigational Site
  • Singapore, Singapore, 308433
    • Pfizer Investigational Site
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • Pfizer Investigational Site
  • Bratislava, Slovakia, 833 05
    • Pfizer Investigational Site
  • Martin, Slovakia, 036 59
    • Pfizer Investigational Site
  • Piestany, Slovakia, 921 01
    • Pfizer Investigational Site
  • Skalica, Slovakia, 909 82
    • Pfizer Investigational Site
• Spain
  • Barcelona
    • Martorell, Barcelona, Spain, 08760
      • Pfizer Investigational Site
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Pfizer Investigational Site
  • Palma de Mallorca
    • Manacor, Palma de Mallorca, Spain, 07500
      • Pfizer Investigational Site
• Sweden
  • Boras, Sweden, 503 32
    • Pfizer Investigational Site
  • Jonkoping, Sweden, 554 66
    • Pfizer Investigational Site
  • Skovde, Sweden, 541 30
    • Pfizer Investigational Site
  • Stockholm, Sweden, 141 86
    • Pfizer Investigational Site
  • Stockholm, Sweden, 117 94
    • Pfizer Investigational Site
• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Pfizer Investigational Site
  • Chiang Mai
    • Amphoe Mueang, Chiang Mai, Thailand, 50200
      • Pfizer Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Pfizer Investigational Site
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Pfizer Investigational Site
    • Gilbert, Arizona, United States, 85295
      • Pfizer Investigational Site
    • Litchfield Park, Arizona, United States, 85340
      • Pfizer Investigational Site
    • Mesa, Arizona, United States, 85210
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85021
      • Pfizer Investigational Site
    • Tucson, Arizona, United States, 85712
      • Pfizer Investigational Site
  • California
    • La Mesa, California, United States, 91942
      • Pfizer Investigational Site
    • Newport Beach, California, United States, 92660
      • Pfizer Investigational Site
    • San Bernardino, California, United States, 92404
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103-6204
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80211
      • Pfizer Investigational Site
  • Florida
    • Jupiter, Florida, United States, 33458
      • Pfizer Investigational Site
    • Orange City, Florida, United States, 32763
      • Pfizer Investigational Site
    • West Palm Beach, Florida, United States, 33401
      • Pfizer Investigational Site
  • Georgia
    • Dunwoody, Georgia, United States, 30338
      • 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
    • Des Moines, Iowa, United States, 50309
      • Pfizer Investigational Site
    • Iowa City, Iowa, United States, 52242
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Pfizer Investigational Site
    • Owings Mills, Maryland, United States, 21117
      • Pfizer Investigational Site
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Pfizer Investigational Site
  • Michigan
    • Flint, Michigan, United States, 48507
      • Pfizer Investigational Site
    • St. Clair Shores, Michigan, United States, 48081
      • Pfizer Investigational Site
    • Troy, Michigan, United States, 48084
      • Pfizer Investigational Site
    • Utica, Michigan, United States, 48081
      • Pfizer Investigational Site
    • West Bloomfield, Michigan, United States, 48322
      • Pfizer Investigational Site
    • West Bloomfield, Michigan, United States, 48323
      • Pfizer Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Pfizer Investigational Site
  • New Jersey
    • Sewell, New Jersey, United States, 08080
      • Pfizer Investigational Site
  • New York
    • Albany, New York, United States, 12208
      • Pfizer Investigational Site
    • Garden City, New York, United States, 11530
      • Pfizer Investigational Site
    • Kingston, New York, United States, 12401
      • Pfizer Investigational Site
    • New York, New York, United States, 10016
      • Pfizer Investigational Site
    • Poughkeepsie, New York, United States, 12601
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
    • Williamsville, New York, United States, 14221
      • Pfizer Investigational Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Pfizer Investigational Site
    • Greensboro, North Carolina, United States, 27403
      • Pfizer Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Pfizer Investigational Site
    • Fargo, North Dakota, United States, 58104
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43214
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43220
      • Pfizer Investigational Site
  • Oklahoma
    • Bethany, Oklahoma, United States, 73008
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Pfizer Investigational Site
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States, 19004
      • Pfizer Investigational Site
    • Camp Hill, Pennsylvania, United States, 17011
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Pfizer Investigational Site
    • Greer, South Carolina, United States, 29650
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78759
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77024
      • Pfizer Investigational Site
  • Washington
    • Tacoma, Washington, United States, 98431-1100
      • Pfizer Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Pfizer Investigational Site
    • Milwaukee, Wisconsin, United States, 53209
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Men aged 40 years and above.
• On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
• Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria:

• Contraindication to fesoterodine (antimuscarinics).
• 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	Drug: Placebo; Placebo
Experimental: Fesoterodine 4mg or 8mg	Drug: Fesoterodine; Fesoterodine 4mg or 8mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 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 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 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
Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition 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. The percentage change at Week 4 or 12 was calculated as: 100* (Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12
Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	All micturitions with USS rating 1 to 5. USS rating: 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. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline.	Baseline, Week 4 and 12
Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	All micturitions with USS rating 1 to 5. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Micturitions at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12
Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.	Baseline, Week 4 and 12
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal micturitions at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12
Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine.	Baseline, Week 4 and Week 12
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12	UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (UUI Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12
Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Severe micturition related urgency episodes were defined as those micturitions with USS rating >=4 marked for the corresponding micturition in the diary. USS: 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 and 12
Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12
Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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 and 12
Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12
Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12	The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. USS rating: 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. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit.	Baseline, Week 4 and 12
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.	Baseline, Week 4 and 12
Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points.	Baseline, Week 4 and 12
Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points.	Baseline, Week 4 and 12
Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points.	Baseline, Week 4 and 12
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.	Baseline, Week 4
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.	Baseline, Week 12
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4	PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2.	Baseline, Week 4
Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12	PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2.	Baseline, Week 12
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4	Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.	Baseline, Week 4
Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.	Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.	Baseline, Week 12
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12	OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome.	Baseline, Week 4 and 12
Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12	HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.	Baseline, Week 4 and 12
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)	The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and 12
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)	The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and Week 12
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)	The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and Week 12
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)	The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and Week 12
Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12	Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.	Baseline, Week 4, 8 and 12
Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12	Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.	Baseline, Week 12
Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)	Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.	Baseline, Week 12
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)	Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation)	Baseline, 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: November 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: October 18, 2007
• First Submitted That Met QC Criteria: October 18, 2007
• First Posted (Estimate): October 19, 2007

Study Record Updates

• Last Update Posted (Estimate): February 18, 2011
• Last Update Submitted That Met QC Criteria: February 15, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• 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: A0221009