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A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Fesoterodine 8 mg
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Bladder Overactive, Overactive urinary bladder, Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of overactive bladder with symptoms for at least 6 months.
  • Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
  • Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception

Exclusion Criteria:

  • Conditions or prior treatment that may also affect bladder function
  • Clinically significant urinary tract infection (UTI)
  • Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).

Sites / Locations

  • Radiant Research, Inc.
  • Alabama Internal Medicine, PC
  • Brown and McCool Gynecology
  • Radiant Research, Inc.
  • Eclipse Clinical Research
  • Radiant Research, Inc.
  • Urological Associates of Southern Arizona, PC
  • American Institute of Research
  • Moaz Khorsandi, DO
  • Urology Group of Southern California
  • Institute for Advanced Urology
  • Center for Clinical Trials, LLC
  • Sierra Clinical Research
  • Superior Research LLC
  • California Research Foundation
  • Medical Center for Clinical Research
  • Advanced Urology, PC
  • Thameside Obstetrics/Gynecological Center
  • S.H.E. Medical Associates
  • Chase Medical Research, LLC
  • Manatee Medical Research Institute, LLC
  • Atlantic Institute of Clinical Research
  • SJS Clinical Research
  • Ocala Urology Specialists
  • Renstar Medical Research, Inc.
  • Accord Clinical Research, LLC
  • Pinellas Urology, Inc.
  • Florida Urology Partners
  • The Office of Georgis Patsias, MD, PA
  • Palm Beach Research Center
  • Atlanta Medical Research Institute, LLC
  • Radiant Research, Inc.
  • In-Quest Medical Research, LLC
  • Prism Research Group
  • Valley Health Care
  • Fox Valley Clinical Research Center, LLC
  • Radiant Research, Inc.
  • Urology of Indiana, LLC
  • Radiant Research, Inc.
  • Regional Urology, LLC
  • New England Center for Clinical Research Fall River, LLC
  • New England Center for Clinical Research of Massachusetts, LLC
  • Bay State Clinical Trials, Inc.
  • Beyer Research
  • Medical Research Associates, Inc.
  • Radiant Research, Inc.
  • Adult and Pediatric Urology
  • CRC of Jackson
  • Women's Specialty Center
  • The Urology Group
  • Radiant Research, Inc.
  • Quality Clinical Research, Inc.
  • Francis Jimenez, MD
  • Impact Clinical Trials
  • Richard M. Groom, MD
  • Northeast Urogynecology
  • The Urologic Institute of Northeastern New York - Community Care Physicians, PC
  • University Urology Associates
  • Associated Medical Professionals of New York, PLLC
  • Associated Medical Professionals of NY
  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
  • PMG Research of Charlotte
  • Urology Specialists of the Carolinas
  • PMG Research of Raleigh, LLC
  • PMG Research of Salisbury, LLC
  • Salibury Urological Clinic
  • Carolina Urological Associates
  • PMG Research of Winston-Salem, LLC
  • Lillestol Research LLC
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Providence Health Partners - Center for Clinical Research
  • Central Sooner Research
  • Pacific Women's Center, LLC
  • Urologic Consultants of Southeastern Pennsylvania
  • OB/GYN Associates of Erie
  • Research Protocol Management Specialists
  • Gilbert Teixeira, DO
  • Pharma Resource
  • Memorial Hospital of Rhode Island - Clinical Studies Center
  • Radiant Research, Inc.
  • Columbia Women's Healthcare, LLC
  • SC Clinical Research Center, LLC
  • Radiant Research, Inc.
  • PMG Research of Charleston, LLC
  • Chattanooga Medical Research, LLC
  • OB-GYN Centre of Excellence
  • Advanced Therapeutics, Inc.
  • Johnson City Internal Medicine
  • Adult Care of Austin
  • Senior Adults Specialty Research
  • DiscoveResearch, Inc.
  • Beaumont Internal Medicine & Geriatric Associates
  • DiscoveResearch, Inc.
  • DiscoveResearch, Incorporated
  • Radiant Research, Inc.
  • Advances In Health, Inc.
  • Centex Research, Inc. - Pineloch Medical Clinic
  • The Office of Dr. Steven Maislos, MD
  • Village Health Partners
  • Paragon Research Center, LLC
  • Radiant Research, Inc.
  • Advanced Clinical Research
  • Integra Trials, LLC
  • Washington Urology
  • Integrity Medical Research, LLC
  • Urology Northwest, PA
  • North Spokane Women's Clinic
  • MBAL Trimontsium OOD
  • MBAL Ruse AD, Urologichno otdelenie,
  • UMBAL Aleksandrovska EAD
  • MBALSM N.I.Pirogov EAD
  • MBAL Doverie AD, Otdelenie po urologia
  • The Prostate Cancer Centre
  • Lois Hole Hospital for Women, Royal Alexandra Hospital
  • Maritime Research Center
  • Maritime Research Center
  • The Male/Female Health and Research Centre, Royal Court Medical Centre
  • Kingston General Hospital
  • Centre for Applied Urological Research, Queen's University, Kingston General Hospital
  • URLX Corporation
  • Sunnybrook Health Sciences Centre
  • Diex Research Montreal Inc.
  • Diex Research Sherbrooke Inc.
  • Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS
  • Nemocnice Jindrichuv Hradec
  • Oblastni nemocnice Kolin, a.s.
  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
  • Ain Shams University Hospital
  • Suomen Terveystalo Turku
  • Klinische Forschung Berlin-Mitte GmbH
  • Klinische Forschung Berlin
  • Praxis fuer Urologie
  • Duisburger Fachaerztegemeinschaft
  • ZKS Suedbrandenburg GmbH
  • Facharzt für Frauenheilkunde und Geburtshilfe
  • Urologische Praxis
  • Klinische Forschung Hamburg GmbH
  • Arztpraxis Dr. von Keitz
  • Pharmakologisches Studienzentrum Chemnitz GmbH
  • Frauenarzt Praxis
  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika
  • Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly
  • Donatella 99 Bt.
  • MAV Korhaz es Rendelointezet, Urologia
  • Department of Urology, Pusan National University Hospital
  • Department of Urology, Konkuk University Medical Center
  • Department of Urology, Ajou University Hospital
  • Phylasis Clinicas Research S de RL de CV
  • Unidad de Diagnostico Integral
  • NZOZ VIP - MED, Poradnia Urologiczna
  • SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka
  • Specjalistyczny Gabinet Lekarski
  • Kemerovо Regional Perinatal Center
  • Moscow State Healthcare Institution City Clinical Hospital #12
  • Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26
  • Saint-Petersburg State Medical University I.P.Pavlov
  • Saint-Petersburg State Healthcare Institution City Hospital # 15
  • St. Petersburg State Healthcare Institution
  • Siberian State Medical University
  • Parklands Hospital
  • Kvinnohalsan Soder
  • Specialistmottagningen i urologi
  • Partus Kvinnohalsa
  • Me3plus Clinical Trials
  • Tudorkliniken, Specialistmottagningen i Urologi
  • Vrinnevisjukhuset
  • Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy
  • Regional Clinical Center of Urology and Nephrology
  • Institute of Urology of AMS of Ukraine
  • Lugansk City Multi-Discipline Hospital #2, department of Urology
  • 5Th City Clinical Hospital, Urology Department
  • LTD Out-patient clinic of General practice and Family medicine
  • Poltava Regional Clinical Hospital, Department of Urology
  • Municipal Institution of Ternopil Regional Council, Ternopil University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fesoterodine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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 range from 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.
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 urinary sensation scale (USS) rating of 5 in the diary. USS range from 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

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (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.
Change From Baseline in Mean Number of 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 rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 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.
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
PPBC: single-item, self-administered validated questionnaire. Participant answered: "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 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. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2).
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 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 (not at all) to 6 (a very great deal). 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. Change=observation minus baseline.
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 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 (not at all) to 6 (a very great deal). 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.
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Percentage of Participants With No UUI Episodes (Diary Dry Rate)
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.

Full Information

First Posted
February 18, 2011
Last Updated
November 7, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01302054
Brief Title
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Official Title
A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Bladder Overactive, Overactive urinary bladder, Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
990 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fesoterodine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fesoterodine 8 mg
Other Intervention Name(s)
Toviaz
Intervention Description
Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.
Primary Outcome Measure Information:
Title
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Description
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Description
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Description
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
Description
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 range from 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.
Time Frame
Baseline, Week 12
Title
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Description
PPBC: single-item, self-administered validated questionnaire. Participant answered: "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 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. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2).
Time Frame
Baseline, Week 12
Title
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Description
UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Time Frame
Baseline, Week 12
Title
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
Description
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 (not at all) to 6 (a very great deal). 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. Change=observation minus baseline.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Description
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 (not at all) to 6 (a very great deal). 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.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2
Description
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Time Frame
Week -2, Week 12
Title
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline
Description
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With No UUI Episodes (Diary Dry Rate)
Description
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Time Frame
Week 4, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of overactive bladder with symptoms for at least 6 months. Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception Exclusion Criteria: Conditions or prior treatment that may also affect bladder function Clinically significant urinary tract infection (UTI) Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
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
Radiant Research, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alabama Internal Medicine, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Brown and McCool Gynecology
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Eclipse Clinical Research
City
Green Valley
State/Province
Arizona
ZIP/Postal Code
85614
Country
United States
Facility Name
Radiant Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Urological Associates of Southern Arizona, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Moaz Khorsandi, DO
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Urology Group of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Institute for Advanced Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Center for Clinical Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Sierra Clinical Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Superior Research LLC
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Advanced Urology, PC
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Thameside Obstetrics/Gynecological Center
City
Groton
State/Province
Connecticut
ZIP/Postal Code
06340
Country
United States
Facility Name
S.H.E. Medical Associates
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Manatee Medical Research Institute, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Atlantic Institute of Clinical Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
SJS Clinical Research
City
Destin
State/Province
Florida
ZIP/Postal Code
32541
Country
United States
Facility Name
Ocala Urology Specialists
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Renstar Medical Research, Inc.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Pinellas Urology, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
The Office of Georgis Patsias, MD, PA
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Medical Research Institute, LLC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Radiant Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
In-Quest Medical Research, LLC
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Prism Research Group
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Valley Health Care
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Fox Valley Clinical Research Center, LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Radiant Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Urology of Indiana, LLC
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
Radiant Research, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
New England Center for Clinical Research Fall River, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
New England Center for Clinical Research of Massachusetts, LLC
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Medical Research Associates, Inc.
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Radiant Research, Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Adult and Pediatric Urology
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
CRC of Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Women's Specialty Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
The Urology Group
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Radiant Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Francis Jimenez, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Richard M. Groom, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Northeast Urogynecology
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
The Urologic Institute of Northeastern New York - Community Care Physicians, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Associated Medical Professionals of New York, PLLC
City
Oneida
State/Province
New York
ZIP/Postal Code
13421
Country
United States
Facility Name
Associated Medical Professionals of NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Urology Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Salibury Urological Clinic
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Carolina Urological Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Radiant Research, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Providence Health Partners - Center for Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Pacific Women's Center, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
OB/GYN Associates of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Research Protocol Management Specialists
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Gilbert Teixeira, DO
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Pharma Resource
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Memorial Hospital of Rhode Island - Clinical Studies Center
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Radiant Research, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Columbia Women's Healthcare, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
SC Clinical Research Center, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Radiant Research, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
PMG Research of Charleston, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
OB-GYN Centre of Excellence
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Advanced Therapeutics, Inc.
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Johnson City Internal Medicine
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Adult Care of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Beaumont Internal Medicine & Geriatric Associates
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
DiscoveResearch, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
DiscoveResearch, Incorporated
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Radiant Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Advances In Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centex Research, Inc. - Pineloch Medical Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
The Office of Dr. Steven Maislos, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Village Health Partners
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Paragon Research Center, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Radiant Research, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Integra Trials, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Washington Urology
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Urology Northwest, PA
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
North Spokane Women's Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
MBAL Trimontsium OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MBAL Ruse AD, Urologichno otdelenie,
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
UMBAL Aleksandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MBALSM N.I.Pirogov EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MBAL Doverie AD, Otdelenie po urologia
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Facility Name
The Prostate Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Lois Hole Hospital for Women, Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Maritime Research Center
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
Maritime Research Center
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4Z9
Country
Canada
Facility Name
The Male/Female Health and Research Centre, Royal Court Medical Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Centre for Applied Urological Research, Queen's University, Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
URLX Corporation
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Diex Research Montreal Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
Nemocnice Jindrichuv Hradec
City
Jindrichuv Hradec
ZIP/Postal Code
377 38
Country
Czechia
Facility Name
Oblastni nemocnice Kolin, a.s.
City
Kolin III
ZIP/Postal Code
28000
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
Facility Name
Suomen Terveystalo Turku
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Berlin
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Praxis fuer Urologie
City
Berlin
ZIP/Postal Code
14052
Country
Germany
Facility Name
Duisburger Fachaerztegemeinschaft
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
ZKS Suedbrandenburg GmbH
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Facility Name
Facharzt für Frauenheilkunde und Geburtshilfe
City
Frankfurt am Main
ZIP/Postal Code
60322
Country
Germany
Facility Name
Urologische Praxis
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Arztpraxis Dr. von Keitz
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz GmbH
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Frauenarzt Praxis
City
Muenchen
ZIP/Postal Code
81241
Country
Germany
Facility Name
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Donatella 99 Bt.
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
MAV Korhaz es Rendelointezet, Urologia
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Department of Urology, Pusan National University Hospital
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Department of Urology, Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Department of Urology, Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Phylasis Clinicas Research S de RL de CV
City
Cuautitlan Izcalli
State/Province
Estado De Mexico
ZIP/Postal Code
54740
Country
Mexico
Facility Name
Unidad de Diagnostico Integral
City
Colima
ZIP/Postal Code
28000
Country
Mexico
Facility Name
NZOZ VIP - MED, Poradnia Urologiczna
City
Gdynia
ZIP/Postal Code
81-366
Country
Poland
Facility Name
SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Specjalistyczny Gabinet Lekarski
City
Warszawa
ZIP/Postal Code
02-926
Country
Poland
Facility Name
Kemerovо Regional Perinatal Center
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Moscow State Healthcare Institution City Clinical Hospital #12
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Saint-Petersburg State Medical University I.P.Pavlov
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Saint-Petersburg State Healthcare Institution City Hospital # 15
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution
City
St. Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Siberian State Medical University
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Parklands Hospital
City
Durban
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Kvinnohalsan Soder
City
Bandhagen
ZIP/Postal Code
124 54
Country
Sweden
Facility Name
Specialistmottagningen i urologi
City
Goteborg
ZIP/Postal Code
405 45
Country
Sweden
Facility Name
Partus Kvinnohalsa
City
Goteborg
ZIP/Postal Code
412 54
Country
Sweden
Facility Name
Me3plus Clinical Trials
City
Goteborg
ZIP/Postal Code
41263
Country
Sweden
Facility Name
Tudorkliniken, Specialistmottagningen i Urologi
City
Halmstad
ZIP/Postal Code
302 46
Country
Sweden
Facility Name
Vrinnevisjukhuset
City
Norrkoping
ZIP/Postal Code
601 82
Country
Sweden
Facility Name
Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Regional Clinical Center of Urology and Nephrology
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Institute of Urology of AMS of Ukraine
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Lugansk City Multi-Discipline Hospital #2, department of Urology
City
Lugansk
Country
Ukraine
Facility Name
5Th City Clinical Hospital, Urology Department
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
LTD Out-patient clinic of General practice and Family medicine
City
Odesa
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital, Department of Urology
City
Poltava
Country
Ukraine
Facility Name
Municipal Institution of Ternopil Regional Council, Ternopil University Hospital
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
35881009
Citation
Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
Results Reference
derived
PubMed Identifier
24898471
Citation
Kaplan SA, Cardozo L, Herschorn S, Grenabo L, Carlsson M, Arumi D, Crook TJ, Whelan L, Scholfield D, Ntanios F; Assessment of Fesoterodine after Tolterodine ER (AFTER) Study Group. Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER. Int J Clin Pract. 2014 Sep;68(9):1065-73. doi: 10.1111/ijcp.12464. Epub 2014 Jun 4.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221094
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

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