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Fesoterodine "add-on" Male Overactive Bladder Study

Primary Purpose

Overactive Bladder Syndrome

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fesoterodine

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fesoterodine 4mg or 8mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at 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

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.

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

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.

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

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.

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

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.

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

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.

Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at 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.

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.

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.

Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12

Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at 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

Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at 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.

Number of Participants With Change From Baseline in PPBC Per 24 Hours at 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.

Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at 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.

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.

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.

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.

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.

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.

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.

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.

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.

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)

Full Information

NCT ID

NCT00546637

First Posted

October 18, 2007

Last Updated

February 15, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00546637

Brief Title

Fesoterodine "add-on" Male Overactive Bladder Study

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

947 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fesoterodine 4mg or 8mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fesoterodine

Intervention Description

Fesoterodine 4mg or 8mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4

Description

Time Frame

Baseline, Week 4

Title

Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12

Description

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

Time Frame

Baseline, Week 4 and 12

Title

Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12

Description

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

Time Frame

Baseline, Week 4 and 12

Title

Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12

Description

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.

Time Frame

Baseline, Week 4 and Week 12

Title

Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

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

Description

Time Frame

Baseline, Week 4 and 12

Title

Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4

Description

Time Frame

Baseline, Week 4

Title

Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4

Description

Time Frame

Baseline, Week 4

Title

Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4

Description

Time Frame

Baseline, Week 4

Title

Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12

Description

Time Frame

Baseline, Week 4 and 12

Title

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)

Description

Time Frame

Baseline, Week 4 and 12

Title

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)

Description

Time Frame

Baseline, Week 4 and Week 12

Title

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)

Description

Time Frame

Baseline, Week 4 and Week 12

Title

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)

Description

Time Frame

Baseline, Week 4 and Week 12

Title

Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12

Description

Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.

Time Frame

Baseline, Week 4, 8 and 12

Title

Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12

Description

Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.

Time Frame

Baseline, Week 12

Title

Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)

Description

Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.

Time Frame

Baseline, Week 12

Title

Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)

Description

Time Frame

Baseline, Week 12

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Pfizer Investigational Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Pfizer Investigational Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85295

Country

United States

Facility Name

Pfizer Investigational Site

City

Litchfield Park

State/Province

Arizona

ZIP/Postal Code

85340

Country

United States

Facility Name

Pfizer Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85021

Country

United States

Facility Name

Pfizer Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Pfizer Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Pfizer Investigational Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

Pfizer Investigational Site

City

San Bernardino

State/Province

California

ZIP/Postal Code

92404

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103-6204

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pfizer Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80211

Country

United States

Facility Name

Pfizer Investigational Site

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Pfizer Investigational Site

City

Dunwoody

State/Province

Georgia

ZIP/Postal Code

30338

Country

United States

Facility Name

Pfizer Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Pfizer Investigational Site

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

Facility Name

Pfizer Investigational Site

City

Newburgh

State/Province

Indiana

ZIP/Postal Code

47630

Country

United States

Facility Name

Pfizer Investigational Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

Pfizer Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Pfizer Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Pfizer Investigational Site

City

Owings Mills

State/Province

Maryland

ZIP/Postal Code

21117

Country

United States

Facility Name

Pfizer Investigational Site

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Pfizer Investigational Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48507

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Pfizer Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

Pfizer Investigational Site

City

Utica

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Pfizer Investigational Site

City

West Bloomfield

State/Province

Michigan

ZIP/Postal Code

48322

Country

United States

Facility Name

Pfizer Investigational Site

City

West Bloomfield

State/Province

Michigan

ZIP/Postal Code

48323

Country

United States

Facility Name

Pfizer Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Pfizer Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Pfizer Investigational Site

City

Sewell

State/Province

New Jersey

ZIP/Postal Code

08080

Country

United States

Facility Name

Pfizer Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Pfizer Investigational Site

City

Garden City

State/Province

New York

ZIP/Postal Code

11530

Country

United States

Facility Name

Pfizer Investigational Site

City

Kingston

State/Province

New York

ZIP/Postal Code

12401

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Pfizer Investigational Site

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

Pfizer Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Pfizer Investigational Site

City

Williamsville

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

Pfizer Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Pfizer Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

Pfizer Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Pfizer Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43220

Country

United States

Facility Name

Pfizer Investigational Site

City

Bethany

State/Province

Oklahoma

ZIP/Postal Code

73008

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Pfizer Investigational Site

City

Bala Cynwyd

State/Province

Pennsylvania

ZIP/Postal Code

19004

Country

United States

Facility Name

Pfizer Investigational Site

City

Camp Hill

State/Province

Pennsylvania

ZIP/Postal Code

17011

Country

United States

Facility Name

Pfizer Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Pfizer Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Pfizer Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Pfizer Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Pfizer Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Pfizer Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98431-1100

Country

United States

Facility Name

Pfizer Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53715

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

Pfizer Investigational Site

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Edegem

ZIP/Postal Code

B-2650

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Leuven

ZIP/Postal Code

B-3000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Salvador

State/Province

ZIP/Postal Code

40420-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Curitiba

State/Province

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

CEP 20551-030

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

São Paulo

State/Province

ZIP/Postal Code

04262-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Campos do Jordão

State/Province

São Paulo

ZIP/Postal Code

12460-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8T 5G1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

Pfizer Investigational Site

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 7K8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6A 3B5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 4A3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

0000

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

0000

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

Pfizer Investigational Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Pfizer Investigational Site

City

Goettingen

ZIP/Postal Code

37073

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hagenow

ZIP/Postal Code

19230

Country

Germany

Facility Name

Pfizer Investigational Site

City

Lauenburg

ZIP/Postal Code

21481

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

Pfizer Investigational Site

City

Oberursel

ZIP/Postal Code

61440

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wiesbaden

ZIP/Postal Code

65198

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ioannina

State/Province

Ipiros

ZIP/Postal Code

45 110

Country

Greece

Facility Name

Pfizer Investigational Site

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

Pfizer Investigational Site

City

Thessaloniki

ZIP/Postal Code

56403

Country

Greece

Facility Name

Pfizer Investigational Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141008

Country

India

Facility Name

Pfizer Investigational Site

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226003

Country

India

Facility Name

Pfizer Investigational Site

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226014

Country

India

Facility Name

Pfizer Investigational Site

City

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Pfizer Investigational Site

City

Bucheon-si

State/Province

Gyunggi-do

ZIP/Postal Code

420-717

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Kuching

State/Province

Sarawak

ZIP/Postal Code

93050

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Kuching

State/Province

Sarawak

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Roermond

ZIP/Postal Code

6043 CV

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Zutphen

ZIP/Postal Code

7207 BA

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Bodø

ZIP/Postal Code

8087

Country

Norway

Facility Name

Pfizer Investigational Site

City

Oslo

ZIP/Postal Code

NO-0257

Country

Norway

Facility Name

Pfizer Investigational Site

City

Cebu City

State/Province

Cebu

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Bacolod City

ZIP/Postal Code

6100

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Makati City

ZIP/Postal Code

1200

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1113

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Bialystok

ZIP/Postal Code

15-232

Country

Poland

Facility Name

Pfizer Investigational Site

City

Gdansk

ZIP/Postal Code

80-402

Country

Poland

Facility Name

Pfizer Investigational Site

City

Gdansk

ZIP/Postal Code

80-462

Country

Poland

Facility Name

Pfizer Investigational Site

City

Lodz

ZIP/Postal Code

93-338

Country

Poland

Facility Name

Pfizer Investigational Site

City

Myslowice

ZIP/Postal Code

41-400

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wroclaw

ZIP/Postal Code

51-124

Country

Poland

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Pfizer Investigational Site

City

Banska Bystrica

ZIP/Postal Code

974 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Piestany

ZIP/Postal Code

921 01

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Skalica

ZIP/Postal Code

909 82

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Martorell

State/Province

Barcelona

ZIP/Postal Code

08760

Country

Spain

Facility Name

Pfizer Investigational Site

City

Getafe

State/Province

Madrid

ZIP/Postal Code

28905

Country

Spain

Facility Name

Pfizer Investigational Site

City

Manacor

State/Province

Palma de Mallorca

ZIP/Postal Code

07500

Country

Spain

Facility Name

Pfizer Investigational Site

City

Boras

ZIP/Postal Code

503 32

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Jonkoping

ZIP/Postal Code

554 66

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Skovde

ZIP/Postal Code

541 30

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Stockholm

ZIP/Postal Code

117 94

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Amphoe Mueang

State/Province

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221009&StudyName=Fesoterodine%20%22add-on%22%20Male%20Overactive%20Bladder%20Study

Description

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

Learn more about this trial

Fesoterodine "add-on" Male Overactive Bladder Study

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Fesoterodine "add-on" Male Overactive Bladder Study

Overactive Bladder Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial