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A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

Primary Purpose

Overactive Bladder

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

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

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

Inclusion Criteria:

  • 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion Criteria:

  • Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.

Sites / Locations

  • Urology Centers of Alabama
  • Achieve Clinical Research, LLC
  • James Gordon McMurray, MD
  • Medical Affiliated Research Center, Inc.
  • Mobile Ob-Gyn, P.C.
  • Montgomery Women's Health Associates, P.C.
  • Scottsboro Quick Care Clinic
  • Dedicated Clinical Research
  • Genova Clinical Research
  • NEA Baptist Women's Clinic
  • A Clinic For Women
  • Larry S. Watkins, MD
  • Lynn Institute of the Ozarks
  • May Women's Health Clinic
  • The Office of Dr. Simon Yassear, MD
  • Citrus Valley Medical Research, Inc.
  • Grossmont Center for Clinical Research
  • Sockolov and Sockolov APC
  • Genesis Center for Clinical Research
  • San Diego Clinical Trials
  • Clinical Innovations, Inc.
  • Diablo Clinical Research, Inc.
  • Urology Associates, PC
  • Genitourinary Surgical Consultants
  • The Women's Clinic of Northern Colorado
  • Women's Health Specialty Care
  • South Florida Medical Research
  • Uromedix
  • Meridien Research
  • Florida Sleep Disorder Center of Brandon
  • PAB Clinical Research
  • Pulmonary Associates of Brandon
  • Meridien Research
  • Nature Coast Clinical Research
  • Doctors Medical Center of Walton County
  • Avail Clinical Research, LLC
  • SJS Clinical Research, Inc.
  • Fleming Island Center for Clinical Research
  • M & O Clinical Research, LLC
  • Florida Urology Physicians
  • Urological Research Network, LLC
  • Nature Coast Clinical Research
  • Jacksonville Center for Clinical Research
  • Altus Research
  • OB-GYN Associates of Mid-Florida, PA
  • New Horizon Research Center
  • Urology Health Team, PLLC
  • Broward Research Group
  • Clinical Research of Central Florida
  • Southeastern Research Group, Inc.
  • Meridien Research
  • Advanced OBGYN Associates
  • Clinical Research of Central Florida
  • North Fulton Urology, PC
  • Clinical Research Atlanta
  • North Georgia Clinical Research
  • North Georgia Internal Medicine
  • Women's Healthcare Associates dba Rosemark WomenCare Specialists
  • Advanced Clinical Research
  • Women's Health Practice
  • Center for Women's Research
  • Medical and Surgical Specialists
  • Clinical Investigation Specialists, Inc.
  • American Health Network of Indiana, LLC
  • Summit Research Institute
  • MediSphere Medical Research Center, LLC
  • American Health Network of Indiana, LLC
  • Metropolitan Urology
  • Deaconess Clinic Gateway Health Center
  • University of Iowa Healthcare
  • Health Science Research Center
  • Women's and Family Care dba GTC Research
  • Heartland Research Associates, LLC
  • Kentucky Medical Research Center
  • Commonwealth Biomedical Research
  • Central Kentucky Research Associates, Inc.
  • Mount Sterling Clinic
  • The Office of Dr. Myron I. Murdock, MD, LLC
  • Boston Clinical Trials, Inc.
  • Beacon Clinical Research, LLC
  • Clinical Research Center of Cape Cod, Inc.
  • Infinity Medical Research
  • DM Clinical Research
  • Clinical Research Institute of Michigan, LLC
  • CRC of Jackson
  • Mississippi Urology Clinic
  • Mercy Health Research
  • Midwest Pharmaceutical Research
  • Family Health Care Center
  • Women's Clinic of Lincoln, P.C.
  • Lincoln Internal Medicine Associates
  • Clinical Research Center of Nevada
  • Clinical Research Center of Nevada
  • Virtua Phoenix Ob-Gyn
  • Premier Research, Inc.
  • United Medical Associates
  • Brooklyn Urology Research Group
  • Urological Surgeons of Long Island
  • Premier Medical Group of the Hudson Valley
  • Mid Hudson Medical Research, PLLC
  • Premier Medical Group of the Hudson Valley
  • Upstate Clinical Research Associates
  • Kernodle Clinic, Inc.
  • American Health Research
  • Carolina Clinical Trials
  • Carolina Urology Partners, PLLC
  • Carolinas Research Associates
  • University Medical Associates
  • Wake Internal Medicine Consultants, Inc.
  • Wake Research Associates, LLC
  • PMG Research of Wilmington, LLC
  • Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates
  • Hawthorne Medical Research, Inc.
  • Patient Priority Clinical Sites, LLC
  • Rapid Medical Research, Inc.
  • Columbus Center for Women's Health Research
  • Columbus Clinical Research
  • Hometown Urgent Care and Research
  • HWC Women's Research Center
  • Ohio Clinical Research, LLC
  • The Office of Johnny B. Roy, MD
  • Legacy Clinical Research, LLC
  • Lynn Health Science Institute
  • Institute for Female Pelvic Medicine
  • Laurel Highlands OB/GYN
  • The Clinical Trial Center, LLC
  • Richard Kastelic and Associates
  • Clinical Trials Research Services, LLC
  • Triangle Urological Group
  • Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group
  • Pish Medical Associates
  • Advanced Clinical Concepts
  • Woman's Clinic Ltd.
  • Coastal Medical
  • Safe Harbor Clinical Research
  • Omega Medical Research
  • TLM Medical Services, LLC
  • Coastal Carolina Research Center
  • Southern Urogynecology
  • Internal Medicine and Pediatric Associates of Bristol, PC
  • PMG Research of Bristol, LLC
  • Adams Patterson Gynocology and Obstetrics, PLLC
  • Heartland Medical PC
  • Austin Center for Clinical Research
  • RJE Clinical Research
  • Memorial Clinical Associates dba MCA Research
  • ACRC Trials (Administrative/Mailing Site)
  • North Texas Family Medicine
  • Clinical Trials of Texas, Inc.
  • Institute for Women's Health
  • Seven Oaks Women's Center
  • Clinical Trials of Texas, Inc.
  • Scott and White Healthcare
  • Scott and White Healthcare
  • Charlottesville Medical Research
  • National Clinical Research - Richmond
  • Independence Family Medicine
  • Seattle Urology Research Center
  • CAMC Clinical Trials Center
  • CAMC Physicians Group
  • Charleston Internal Medicine, Inc.
  • Urologic Surgical Center
  • Clinical Investigation Specialists, Inc.
  • Dean Oregon Clinic
  • Allegiance Research Specialists
  • Instituto Urologico Buenos Aires
  • Centro de Urología (CDU)
  • Instituto Medico Especializado (IME)
  • Office of Dr. Peter Pommerville
  • Can-Med Clinical Research
  • Office of Dr. Nazmuddin Merali
  • Can-Med Clinical Research Incorporated
  • Pharos Medical Research Ltd.
  • Queen Elizabeth Health Sciences Centre
  • McMaster Institute of Urology, St Joseph's Healthcare Hamilton
  • Office of Dr. Bernard Goldfarb
  • Stanley Flax Medical Professional Corporation
  • Urotec
  • Toronto Western Hospital, University Health Network
  • Toronto Urology Clinical Study Group
  • Urology South Shore Research
  • UroLaval
  • Ultra-Med Inc.
  • Centre Hospitalier Universitaire de Sherbrooke
  • Clinica Uromed
  • Hospital Clinico Universidad de Chile
  • Fundacion Centro de Investigacion Clinica CIC
  • Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo
  • Urologicka ambulance
  • FN a LFUK Hradec Kralove/Urologicka klinika
  • Nemocnice Jablonec nad Nisou
  • Urologicka klinika
  • Fakultni nemocnice v Motole
  • Androgeos spol. s.r.o.
  • Urologicka ambulance
  • Herlev Hospital
  • Roskilde sygehus, Gynaekologisk/obstetrisk afdeling
  • Al-Azhar University hospital
  • Kouvolan Lääkäriasema
  • Lääkäriasema Cantti Oy
  • Hôpital Edouard Herriot
  • CHU de Nantes - Hôtel Dieu
  • Hôpital CAREMEAU - Service Urologie/Andrologie
  • Hôpital Tenon - Service d'Urologie
  • Arztpraxis
  • Synexus Clinical Research GmbH
  • Klinische Forschung Berlin-Buch GmbH
  • Synexus Clinical Research GmbH
  • Klinische Forschung Dresden GmbH
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Clinical Research Hamburg
  • Klinische Forschung Hannover - Mitte GmbH
  • Allgemeinmedizin Praktische Aerzte
  • Arztpraxis
  • Synexus Clinical Research GmbH
  • SMO MD GmbH
  • CRS Clinical Research Service Moenchengladbach GmbH
  • Praxisklinik Urologie Rhein-Ruhr
  • Facharzt fuer Urologie
  • Klinische Forschung Schwerin GmbH
  • University General Hospital of Larisa/ Urology Department
  • General Hospital Papageorgiou
  • Synexus Magyarorszag Kft.
  • Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika
  • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly
  • Università Magna Graecia di Catanzaro
  • Clinica Urologica Centro Trapianti di rene
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University College of Medicine, Department of Urology
  • Samsung Medical Center
  • Department of Urology, Korea University Anam Hospital
  • The Catholic University of Korea Seoul St. Mary's Hospital, Department of Urology
  • Asan Medical Center, Department of Urology
  • Saules Seimos Medicinos Centras, JSC
  • Mano Seimos Gydytojas, JSC
  • Seimos Gydytojas, JSC
  • Hospital Lomas de San Luis Internacional
  • Medi 3 Elverum AS
  • Medi 3 Innlandet
  • Norsk Helseklinikk AS, c/o Heiaklinikken
  • Forusakutten AS, Avdeling for oppdragsforskning
  • Perpetual Succour Hospital of Cebu Inc.
  • Dr. Pablo O. Torre Memorial Hospital
  • St. Paul's Hospital
  • Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku
  • NZOZ Centrum Medyczne
  • Centrum Urologiczne Sp. z o. o.
  • Nzoz "Nasz Lekarz"
  • Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD
  • Rostov State Medical University, Chair of Urology
  • Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS
  • URO CLINIC, s.r.o.
  • Ruzinovska poliklinika, a.s.
  • Nemocnica s Poliklinikou Svateho Lukasa Galanta
  • UROX s.r.o.
  • Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia
  • Fakultna nemocnica Trencin
  • UROGYN,s.r.o.
  • Fakultna nemocnica s poliklinikou Zilina
  • GYNPOR SK, s.r.o. Urogynekologicka ambulancia
  • Clinical Research Unit
  • Clinix Private Clinic
  • Mayo Centre
  • Carema Specialistvard Eslov
  • Hagakliniken
  • CTC, Sahlgrenska sjukhuset/SU
  • Probare
  • Center for Lakemedelsstudier
  • Ladulaas kliniska studier
  • Verksamhet Urologi
  • Kvinnokliniken Karolinska Universitetssjukhuset Huddinge
  • S3 Clinical Research Centers
  • Vasterviks sjukhus, Kvinnokliniken
  • Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital
  • National Taiwan University Hospital, Department of Urology
  • Taipei Veterans General Hospital/Division of Urology
  • RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology
  • City Hospital #4 of Donetsk, Woman Consultative Department
  • Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1
  • MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,
  • Uzhorod City Outpatient Clinic, Prophylaxis Department
  • Vinnitsa Regional Clinical Dispensary of Endocrinology
  • Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education
  • Fowey River Practice
  • Knowle House Surgery
  • Ormeau Health Centre
  • Cambridge University Hospital Trials NHS Trust
  • Southern General Hospital
  • Baillieston Health Centre
  • Sheepcot Medical Centre
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Fesoterodine 8mg

Fesoterodine 4mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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 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

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Change From Baseline in Mean Number of 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 rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
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 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.
Change From Baseline in Percentage of 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 rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Change From Baseline in Percentage 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 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.
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
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 From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total 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.
Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total 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.
Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total 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.
Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total 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.
Change From Baseline in Health Related Quality of Life (HRQL)-Total 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 Who Became Dry at Week 4.
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary
Percentage of Participants Who Became Dry at Week 12.
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.

Full Information

First Posted
February 18, 2011
Last Updated
February 25, 2014
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01302067
Brief Title
A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine
Official Title
A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2012 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fesoterodine 8mg
Arm Type
Experimental
Arm Title
Fesoterodine 4mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fesoterodine 8mg
Intervention Description
Oral, 1 tablet per day, 12 weeks duration, 8mg/day
Intervention Type
Drug
Intervention Name(s)
Fesoterodine 4mg
Intervention Description
Oral, 1 tablet per day, 12 weeks duration, 4mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral, 1 tablet per day, 12 weeks duration
Primary Outcome Measure Information:
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 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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.
Description
Micturitions include episodes of voluntary micturition and episodes of UUI.
Time Frame
Week 4
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 UUI.
Time Frame
Week 12
Title
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.
Description
Micturitions include episodes of voluntary micturition and episodes of UUI.
Time Frame
Week 4
Title
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.
Description
Micturitions include episodes of voluntary micturition and episodes of UUI.
Time Frame
Week 12
Title
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.
Description
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame
Week 4
Title
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.
Description
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame
Week 4
Title
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.
Description
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame
Week 12
Title
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
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 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.
Time Frame
Week 4
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 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.
Time Frame
Week 12
Title
Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
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 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.
Time Frame
Week 4
Title
Change From Baseline in Percentage 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 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.
Time Frame
Week 12
Title
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.
Description
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Time Frame
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
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.
Time Frame
Week 12
Title
Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total 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
Week 12
Title
Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total 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
Week 12
Title
Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total 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
Week 12
Title
Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total 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
Week 12
Title
Change From Baseline in Health Related Quality of Life (HRQL)-Total 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
Week 12
Title
Percentage of Participants Who Became Dry at Week 4.
Description
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary
Time Frame
Week 4
Title
Percentage of Participants Who Became Dry at Week 12.
Description
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours. Exclusion Criteria: Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
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
Urology Centers of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
James Gordon McMurray, MD
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mobile Ob-Gyn, P.C.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Montgomery Women's Health Associates, P.C.
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Scottsboro Quick Care Clinic
City
Scottsboro
State/Province
Alabama
ZIP/Postal Code
35768
Country
United States
Facility Name
Dedicated Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
NEA Baptist Women's Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
A Clinic For Women
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Larry S. Watkins, MD
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
May Women's Health Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
The Office of Dr. Simon Yassear, MD
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Citrus Valley Medical Research, Inc.
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Grossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sockolov and Sockolov APC
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Urology Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
The Women's Clinic of Northern Colorado
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Uromedix
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Florida Sleep Disorder Center of Brandon
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Pulmonary Associates of Brandon
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Nature Coast Clinical Research
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Doctors Medical Center of Walton County
City
DeFuniak Springs
State/Province
Florida
ZIP/Postal Code
32435
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
SJS Clinical Research, Inc.
City
Destin
State/Province
Florida
ZIP/Postal Code
32541
Country
United States
Facility Name
Fleming Island Center for Clinical Research
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
M & O Clinical Research, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Florida Urology Physicians
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Urological Research Network, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
OB-GYN Associates of Mid-Florida, PA
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Urology Health Team, PLLC
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Broward Research Group
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Clinical Research of Central Florida
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
Facility Name
Southeastern Research Group, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Advanced OBGYN Associates
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
North Fulton Urology, PC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Women's Healthcare Associates dba Rosemark WomenCare Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Women's Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Center for Women's Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Medical and Surgical Specialists
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Summit Research Institute
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Deaconess Clinic Gateway Health Center
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
University of Iowa Healthcare
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Health Science Research Center
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Women's and Family Care dba GTC Research
City
Shawnee
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Kentucky Medical Research Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Commonwealth Biomedical Research
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Mount Sterling Clinic
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
The Office of Dr. Myron I. Murdock, MD, LLC
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Boston Clinical Trials, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Clinical Research Center of Cape Cod, Inc.
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Infinity Medical Research
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
DM Clinical Research
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
CRC of Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Mississippi Urology Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Mercy Health Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Midwest Pharmaceutical Research
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Family Health Care Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Women's Clinic of Lincoln, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Lincoln Internal Medicine Associates
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89130
Country
United States
Facility Name
Virtua Phoenix Ob-Gyn
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Premier Research, Inc.
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
United Medical Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Brooklyn Urology Research Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Mid Hudson Medical Research, PLLC
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Kernodle Clinic, Inc.
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Carolina Clinical Trials
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Carolina Urology Partners, PLLC
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Carolinas Research Associates
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
University Medical Associates
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Wake Internal Medicine Consultants, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Patient Priority Clinical Sites, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Columbus Center for Women's Health Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
HWC Women's Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Ohio Clinical Research, LLC
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
The Office of Johnny B. Roy, MD
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Legacy Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Institute for Female Pelvic Medicine
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Laurel Highlands OB/GYN
City
Hopwood
State/Province
Pennsylvania
ZIP/Postal Code
15445
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Richard Kastelic and Associates
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15405
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Triangle Urological Group
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Pish Medical Associates
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Advanced Clinical Concepts
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Woman's Clinic Ltd.
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Coastal Medical
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Safe Harbor Clinical Research
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
TLM Medical Services, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Southern Urogynecology
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Internal Medicine and Pediatric Associates of Bristol, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
PMG Research of Bristol, LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Adams Patterson Gynocology and Obstetrics, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Heartland Medical PC
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Austin Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
RJE Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
Memorial Clinical Associates dba MCA Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
ACRC Trials (Administrative/Mailing Site)
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
North Texas Family Medicine
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Institute for Women's Health
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Seven Oaks Women's Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78299
Country
United States
Facility Name
Scott and White Healthcare
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Scott and White Healthcare
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
National Clinical Research - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Independence Family Medicine
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Seattle Urology Research Center
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
CAMC Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
CAMC Physicians Group
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Charleston Internal Medicine, Inc.
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Urologic Surgical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
Dean Oregon Clinic
City
Oregon
State/Province
Wisconsin
ZIP/Postal Code
53575
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Instituto Urologico Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1060AAA
Country
Argentina
Facility Name
Centro de Urología (CDU)
City
Buenos Aires
ZIP/Postal Code
C1120AAS
Country
Argentina
Facility Name
Instituto Medico Especializado (IME)
City
Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
Facility Name
Office of Dr. Peter Pommerville
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V6T 5G1
Country
Canada
Facility Name
Can-Med Clinical Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6T9
Country
Canada
Facility Name
Office of Dr. Nazmuddin Merali
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6T9
Country
Canada
Facility Name
Can-Med Clinical Research Incorporated
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
Pharos Medical Research Ltd.
City
Grand Falls-Windsor
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A2A 2E2
Country
Canada
Facility Name
Queen Elizabeth Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
McMaster Institute of Urology, St Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Office of Dr. Bernard Goldfarb
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 7K8
Country
Canada
Facility Name
Stanley Flax Medical Professional Corporation
City
North York
State/Province
Ontario
ZIP/Postal Code
M2J 1V1
Country
Canada
Facility Name
Urotec
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Toronto Urology Clinical Study Group
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
UroLaval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7G 2E6
Country
Canada
Facility Name
Ultra-Med Inc.
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Clinica Uromed
City
Santiago
State/Province
RM
ZIP/Postal Code
7500787
Country
Chile
Facility Name
Hospital Clinico Universidad de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Fundacion Centro de Investigacion Clinica CIC
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Urologicka ambulance
City
Benesov
ZIP/Postal Code
25601
Country
Czech Republic
Facility Name
FN a LFUK Hradec Kralove/Urologicka klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Nemocnice Jablonec nad Nisou
City
Jablonec nad Nisou
ZIP/Postal Code
466 60
Country
Czech Republic
Facility Name
Urologicka klinika
City
Praha 1 - Nove Mesto
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Androgeos spol. s.r.o.
City
Praha 6 - Hradcany
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Urologicka ambulance
City
Znojmo
ZIP/Postal Code
66902
Country
Czech Republic
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Roskilde sygehus, Gynaekologisk/obstetrisk afdeling
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Al-Azhar University hospital
City
Cairo
Country
Egypt
Facility Name
Kouvolan Lääkäriasema
City
Kouvola
ZIP/Postal Code
45200
Country
Finland
Facility Name
Lääkäriasema Cantti Oy
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Hôpital Edouard Herriot
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital CAREMEAU - Service Urologie/Andrologie
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital Tenon - Service d'Urologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Arztpraxis
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Klinische Forschung Berlin-Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Goerlitz
ZIP/Postal Code
02826
Country
Germany
Facility Name
Clinical Research Hamburg
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Klinische Forschung Hannover - Mitte GmbH
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Allgemeinmedizin Praktische Aerzte
City
Karlsruhe
ZIP/Postal Code
76199
Country
Germany
Facility Name
Arztpraxis
City
Lauenburg
ZIP/Postal Code
21481
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
SMO MD GmbH
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
CRS Clinical Research Service Moenchengladbach GmbH
City
Moenchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Praxisklinik Urologie Rhein-Ruhr
City
Muelheim a.d. Ruhr
ZIP/Postal Code
45468
Country
Germany
Facility Name
Facharzt fuer Urologie
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
University General Hospital of Larisa/ Urology Department
City
Larisa
ZIP/Postal Code
41110
Country
Greece
Facility Name
General Hospital Papageorgiou
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Synexus Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Università Magna Graecia di Catanzaro
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Clinica Urologica Centro Trapianti di rene
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University College of Medicine, Department of Urology
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Department of Urology, Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital, Department of Urology
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center, Department of Urology
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Saules Seimos Medicinos Centras, JSC
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Facility Name
Mano Seimos Gydytojas, JSC
City
Klaipeda
ZIP/Postal Code
94231
Country
Lithuania
Facility Name
Seimos Gydytojas, JSC
City
Vilnius
ZIP/Postal Code
01118
Country
Lithuania
Facility Name
Hospital Lomas de San Luis Internacional
City
San Luis Potosi
ZIP/Postal Code
78218
Country
Mexico
Facility Name
Medi 3 Elverum AS
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
Medi 3 Innlandet
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Norsk Helseklinikk AS, c/o Heiaklinikken
City
Lierskogen
ZIP/Postal Code
3420
Country
Norway
Facility Name
Forusakutten AS, Avdeling for oppdragsforskning
City
Stavanger
ZIP/Postal Code
4005
Country
Norway
Facility Name
Perpetual Succour Hospital of Cebu Inc.
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Dr. Pablo O. Torre Memorial Hospital
City
Bacolod City
ZIP/Postal Code
6100
Country
Philippines
Facility Name
St. Paul's Hospital
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
NZOZ Centrum Medyczne
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centrum Urologiczne Sp. z o. o.
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Nzoz "Nasz Lekarz"
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD
City
Barnaul
ZIP/Postal Code
656038
Country
Russian Federation
Facility Name
Rostov State Medical University, Chair of Urology
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS
City
Saint-Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
URO CLINIC, s.r.o.
City
Bratislava
ZIP/Postal Code
811 06
Country
Slovakia
Facility Name
Ruzinovska poliklinika, a.s.
City
Bratislava
ZIP/Postal Code
820 07
Country
Slovakia
Facility Name
Nemocnica s Poliklinikou Svateho Lukasa Galanta
City
Galanta
ZIP/Postal Code
924 22
Country
Slovakia
Facility Name
UROX s.r.o.
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia
City
Povazska Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Facility Name
Fakultna nemocnica Trencin
City
Trencin
ZIP/Postal Code
911 71
Country
Slovakia
Facility Name
UROGYN,s.r.o.
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Zilina
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
GYNPOR SK, s.r.o. Urogynekologicka ambulancia
City
Zvolen
ZIP/Postal Code
960 01
Country
Slovakia
Facility Name
Clinical Research Unit
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Clinix Private Clinic
City
Vosloorus
State/Province
Gauteng
ZIP/Postal Code
1475
Country
South Africa
Facility Name
Mayo Centre
City
Roodepoort
ZIP/Postal Code
1715
Country
South Africa
Facility Name
Carema Specialistvard Eslov
City
Eslov
ZIP/Postal Code
241 23
Country
Sweden
Facility Name
Hagakliniken
City
Goteborg
ZIP/Postal Code
413 28
Country
Sweden
Facility Name
CTC, Sahlgrenska sjukhuset/SU
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Probare
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
Center for Lakemedelsstudier
City
Malmo
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Ladulaas kliniska studier
City
Skene
ZIP/Postal Code
511 62
Country
Sweden
Facility Name
Verksamhet Urologi
City
Skovde
ZIP/Postal Code
541 85
Country
Sweden
Facility Name
Kvinnokliniken Karolinska Universitetssjukhuset Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
S3 Clinical Research Centers
City
Vallingby
ZIP/Postal Code
162 68
Country
Sweden
Facility Name
Vasterviks sjukhus, Kvinnokliniken
City
Vastervik
ZIP/Postal Code
593 81
Country
Sweden
Facility Name
Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
National Taiwan University Hospital, Department of Urology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital/Division of Urology
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
City Hospital #4 of Donetsk, Woman Consultative Department
City
Donetsk
ZIP/Postal Code
83002
Country
Ukraine
Facility Name
Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1
City
Donetsk
Country
Ukraine
Facility Name
MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,
City
Donetsk
Country
Ukraine
Facility Name
Uzhorod City Outpatient Clinic, Prophylaxis Department
City
Uzhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Vinnitsa Regional Clinical Dispensary of Endocrinology
City
Vinnitsa
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Fowey River Practice
City
Fowey
State/Province
Cornwall
ZIP/Postal Code
PL23 1DT
Country
United Kingdom
Facility Name
Knowle House Surgery
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Facility Name
Ormeau Health Centre
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Facility Name
Cambridge University Hospital Trials NHS Trust
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Southern General Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Baillieston Health Centre
City
Glasgow
ZIP/Postal Code
G69 7AD
Country
United Kingdom
Facility Name
Sheepcot Medical Centre
City
Hertfordshire
ZIP/Postal Code
WD2 6EB
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

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
24552358
Citation
Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221095&StudyName=A%2012%20week%20study%20to%20confirm%20the%20effectiveness%20of%208mg%20of%20fesoterodine%20compared%20to%204mg%20of%20fesoterodine
Description
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A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

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