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.
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Drug: Placebo
- Registration Number
- NCT01302054
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 990
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fesoterodine Fesoterodine 8 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Baseline, 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.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 Baseline, 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
Name Time Method Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 Baseline, 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.
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 Baseline, 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 Week -2, 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.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 Baseline, 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.
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 Baseline, 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 Baseline, 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 Baseline, 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.
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline Baseline, 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.
Percentage of Participants With No UUI Episodes (Diary Dry Rate) Week 4, 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.
Trial Locations
- Locations (160)
Women's Specialty Center
🇺🇸Jackson, Mississippi, United States
CRC of Jackson
🇺🇸Jackson, Mississippi, United States
Advances In Health, Inc.
🇺🇸Houston, Texas, United States
Brown and McCool Gynecology
🇺🇸Fairhope, Alabama, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
Urology Group of Southern California
🇺🇸Los Angeles, California, United States
Moaz Khorsandi, DO
🇺🇸Los Angeles, California, United States
Superior Research LLC
🇺🇸Sacramento, California, United States
Institute for Advanced Urology
🇺🇸Los Angeles, California, United States
Sierra Clinical Research
🇺🇸Roseville, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
In-Quest Medical Research, LLC
🇺🇸Duluth, Georgia, United States
Atlanta Medical Research Institute, LLC
🇺🇸Alpharetta, Georgia, United States
Prism Research Group
🇺🇸Rome, Georgia, United States
Fox Valley Clinical Research Center, LLC
🇺🇸Aurora, Illinois, United States
Valley Health Care
🇺🇸Rome, Georgia, United States
Urology of Indiana, LLC
🇺🇸Noblesville, Indiana, United States
Medical Research Associates, Inc.
🇺🇸Traverse City, Michigan, United States
Adult and Pediatric Urology
🇺🇸Sartell, Minnesota, United States
Northeast Urogynecology
🇺🇸Albany, New York, United States
Associated Medical Professionals of New York, PLLC
🇺🇸Oneida, New York, United States
University Urology Associates
🇺🇸New York, New York, United States
The Urologic Institute of Northeastern New York - Community Care Physicians, PC
🇺🇸Albany, New York, United States
Associated Medical Professionals of NY
🇺🇸Syracuse, New York, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
🇺🇸Cary, North Carolina, United States
PMG Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
Urology Specialists of the Carolinas
🇺🇸Charlotte, North Carolina, United States
PMG Research of Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
Salibury Urological Clinic
🇺🇸Salisbury, North Carolina, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Carolina Urological Associates
🇺🇸Winston-Salem, North Carolina, United States
Providence Health Partners - Center for Clinical Research
🇺🇸Dayton, Ohio, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Urologic Consultants of Southeastern Pennsylvania
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Research Protocol Management Specialists
🇺🇸Pittsburgh, Pennsylvania, United States
Gilbert Teixeira, DO
🇺🇸East Providence, Rhode Island, United States
OB/GYN Associates of Erie
🇺🇸Erie, Pennsylvania, United States
Pharma Resource
🇺🇸East Providence, Rhode Island, United States
Memorial Hospital of Rhode Island - Clinical Studies Center
🇺🇸Pawtucket, Rhode Island, United States
Senior Adults Specialty Research
🇺🇸Austin, Texas, United States
Adult Care of Austin
🇺🇸Austin, Texas, United States
DiscoveResearch, Inc.
🇺🇸Bryan, Texas, United States
Centex Research, Inc. - Pineloch Medical Clinic
🇺🇸Houston, Texas, United States
Beaumont Internal Medicine & Geriatric Associates
🇺🇸Beaumont, Texas, United States
DiscoveResearch, Incorporated
🇺🇸Bryan, Texas, United States
Village Health Partners
🇺🇸Plano, Texas, United States
The Office of Dr. Steven Maislos, MD
🇺🇸Houston, Texas, United States
Integra Trials, LLC
🇺🇸Arlington, Virginia, United States
Washington Urology
🇺🇸Arlington, Virginia, United States
Integrity Medical Research, LLC
🇺🇸Mountlake Terrace, Washington, United States
Urology Northwest, PA
🇺🇸Mountlake Terrace, Washington, United States
North Spokane Women's Clinic
🇺🇸Spokane, Washington, United States
Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS
🇨🇿Hradec Kralove, Czechia
Nemocnice Jindrichuv Hradec
🇨🇿Jindrichuv Hradec, Czechia
Oblastni nemocnice Kolin, a.s.
🇨🇿Kolin III, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
🇨🇿Usti nad Labem, Czechia
Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly
🇭🇺Sopron, Hungary
Department of Urology, Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Department of Urology, Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
NZOZ VIP - MED, Poradnia Urologiczna
🇵🇱Gdynia, Poland
SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka
🇵🇱Slupsk, Poland
Me3plus Clinical Trials
🇸🇪Goteborg, Sweden
Parklands Hospital
🇿🇦Durban, Kwa Zulu Natal, South Africa
Specialistmottagningen i urologi
🇸🇪Goteborg, Sweden
Tudorkliniken, Specialistmottagningen i Urologi
🇸🇪Halmstad, Sweden
Kvinnohalsan Soder
🇸🇪Bandhagen, Sweden
Partus Kvinnohalsa
🇸🇪Goteborg, Sweden
Vrinnevisjukhuset
🇸🇪Norrkoping, Sweden
Francis Jimenez, MD
🇺🇸Las Vegas, Nevada, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Richard M. Groom, MD
🇺🇸Las Vegas, Nevada, United States
Eclipse Clinical Research
🇺🇸Green Valley, Arizona, United States
Radiant Research, Inc.
🇺🇸Murray, Utah, United States
Thameside Obstetrics/Gynecological Center
🇺🇸Groton, Connecticut, United States
Urological Associates of Southern Arizona, PC
🇺🇸Tucson, Arizona, United States
S.H.E. Medical Associates
🇺🇸Hartford, Connecticut, United States
Atlantic Institute of Clinical Research
🇺🇸Daytona Beach, Florida, United States
Manatee Medical Research Institute, LLC
🇺🇸Bradenton, Florida, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
SJS Clinical Research
🇺🇸Destin, Florida, United States
Ocala Urology Specialists
🇺🇸Ocala, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
New England Center for Clinical Research Fall River, LLC
🇺🇸Fall River, Massachusetts, United States
Pinellas Urology, Inc.
🇺🇸Saint Petersburg, Florida, United States
Renstar Medical Research, Inc.
🇺🇸Ocala, Florida, United States
The Office of Georgis Patsias, MD, PA
🇺🇸Wellington, Florida, United States
New England Center for Clinical Research of Massachusetts, LLC
🇺🇸New Bedford, Massachusetts, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
The Urology Group
🇺🇸Southaven, Mississippi, United States
SC Clinical Research Center, LLC
🇺🇸Columbia, South Carolina, United States
Pacific Women's Center, LLC
🇺🇸Eugene, Oregon, United States
Johnson City Internal Medicine
🇺🇸Johnson City, Tennessee, United States
Columbia Women's Healthcare, LLC
🇺🇸Columbia, South Carolina, United States
PMG Research of Charleston, LLC
🇺🇸Mount Pleasant, South Carolina, United States
Chattanooga Medical Research, LLC
🇺🇸Chattanooga, Tennessee, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Advanced Therapeutics, Inc.
🇺🇸Johnson City, Tennessee, United States
MBAL Trimontsium OOD
🇧🇬Plovdiv, Bulgaria
MBAL Ruse AD, Urologichno otdelenie,
🇧🇬Ruse, Bulgaria
OB-GYN Centre of Excellence
🇺🇸Chattanooga, Tennessee, United States
Ain Shams University Hospital
🇪🇬Cairo, Egypt
MBAL Doverie AD, Otdelenie po urologia
🇧🇬Sofia, Bulgaria
UMBAL Aleksandrovska EAD
🇧🇬Sofia, Bulgaria
Lois Hole Hospital for Women, Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
URLX Corporation
🇨🇦Ottawa, Ontario, Canada
MBALSM N.I.Pirogov EAD
🇧🇬Sofia, Bulgaria
Diex Research Montreal Inc.
🇨🇦Montreal, Quebec, Canada
The Prostate Cancer Centre
🇨🇦Calgary, Alberta, Canada
Suomen Terveystalo Turku
🇫🇮Turku, Finland
The Male/Female Health and Research Centre, Royal Court Medical Centre
🇨🇦Barrie, Ontario, Canada
Maritime Research Center
🇨🇦Bathurst, New Brunswick, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Centre for Applied Urological Research, Queen's University, Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Klinische Forschung Berlin
🇩🇪Berlin, Germany
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Praxis fuer Urologie
🇩🇪Berlin, Germany
Urologische Praxis
🇩🇪Hagenow, Germany
Frauenarzt Praxis
🇩🇪Muenchen, Germany
Duisburger Fachaerztegemeinschaft
🇩🇪Duisburg, Germany
Facharzt für Frauenheilkunde und Geburtshilfe
🇩🇪Frankfurt am Main, Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika
🇭🇺Budapest, Hungary
ZKS Suedbrandenburg GmbH
🇩🇪Elsterwerda, Germany
MAV Korhaz es Rendelointezet, Urologia
🇭🇺Szolnok, Hungary
Arztpraxis Dr. von Keitz
🇩🇪Marburg, Germany
Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
🇩🇪Mittweida, Germany
Department of Urology, Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Donatella 99 Bt.
🇭🇺Szentes, Hungary
Saint-Petersburg State Medical University I.P.Pavlov
🇷🇺Saint-Petersburg, Russian Federation
St. Petersburg State Healthcare Institution
🇷🇺St. Petersburg, Russian Federation
Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy
🇺🇦Dnipropetrovsk, Ukraine
Institute of Urology of AMS of Ukraine
🇺🇦Kyiv, Ukraine
Phylasis Clinicas Research S de RL de CV
🇲🇽Cuautitlan Izcalli, Estado De Mexico, Mexico
Unidad de Diagnostico Integral
🇲🇽Colima, Mexico
Specjalistyczny Gabinet Lekarski
🇵🇱Warszawa, Poland
Kemerovо Regional Perinatal Center
🇷🇺Kemerovo, Russian Federation
Moscow State Healthcare Institution City Clinical Hospital #12
🇷🇺Moscow, Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26
🇷🇺Saint-Petersburg, Russian Federation
Siberian State Medical University
🇷🇺Tomsk, Russian Federation
Saint-Petersburg State Healthcare Institution City Hospital # 15
🇷🇺Saint-Petersburg, Russian Federation
Regional Clinical Center of Urology and Nephrology
🇺🇦Kharkiv, Ukraine
Lugansk City Multi-Discipline Hospital #2, department of Urology
🇺🇦Lugansk, Ukraine
Municipal Institution of Ternopil Regional Council, Ternopil University Hospital
🇺🇦Ternopil, Ukraine
5Th City Clinical Hospital, Urology Department
🇺🇦Lviv, Ukraine
LTD Out-patient clinic of General practice and Family medicine
🇺🇦Odesa, Ukraine
Poltava Regional Clinical Hospital, Department of Urology
🇺🇦Poltava, Ukraine
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Advanced Urology, PC
🇺🇸Parker, Colorado, United States
California Research Foundation
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Paragon Research Center, LLC
🇺🇸San Antonio, Texas, United States
Alabama Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
Florida Urology Partners
🇺🇸Tampa, Florida, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States