This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
SYNERGY
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder
3 other identifiers
interventional
3,527
40 countries
424
Brief Summary
The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2013
424 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
October 31, 2013
CompletedStudy Start
First participant enrolled
November 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2015
CompletedResults Posted
Study results publicly available
June 12, 2018
CompletedOctober 31, 2024
October 1, 2024
2 years
October 25, 2013
May 9, 2018
October 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Baseline and EoT (up to 12 weeks)
Secondary Outcomes (68)
Change From Baseline to EoT in Mean Volume Voided Per Micturition
Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
Baseline and EoT (up to 12 weeks)
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT
Weeks 4, 8, 12 and EoT (up to 12 weeks)
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes
Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
- +63 more secondary outcomes
Study Arms (6)
1: Solifenacin 5 mg + Mirabegron 25 mg
EXPERIMENTALParticipants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.
2: Solifenacin 5 mg + Mirabegron 50 mg
EXPERIMENTALParticipants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.
3: Placebo
PLACEBO COMPARATORParticipants who received matching placebo once a day for 12 weeks.
4: Solifenacin 5 mg
ACTIVE COMPARATORParticipants who received solifenacin 5 mg once a day for 12 weeks.
5:Mirabegron 25 mg
ACTIVE COMPARATORParticipants who received mirabegron 25 mg once a day for 12 weeks.
6: Mirabegron 50 mg
ACTIVE COMPARATORParticipants who received mirabegron 50 mg once a day for 12 weeks.
Interventions
Oral tablet
Oral tablet
Oral tablet
Oral tablet
Eligibility Criteria
You may qualify if:
- Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
- Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;
You may not qualify if:
- Subject had significant PVR volume (\> 150 mL);
- Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
- Subject had an indwelling catheter or practices intermittent self catheterization.
- Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
- Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
- Subject had moderate to severe hepatic impairment
- Subject had severe renal impairment
- Subject had a clinically significant abnormal ECG
- Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
- Subject had an average QTcF interval \> 450 ms for males or \> 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
- Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (435)
Site US10049 Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Site US10112 TFI, LLC
Mobile, Alabama, 36608, United States
Site US10104 Clinical Research Advantage, Inc.
Chandler, Arizona, 85224, United States
Site US10021 Beach Clinical Studies
Phoenix, Arizona, 85051, United States
Site US10122 Orange County Research Institute
Anaheim, California, 92801, United States
Site US10098 Skyline Research
Cerritos, California, 90703, United States
Site US10539 Citrus Valley Medical Research
Glendora, California, 91741, United States
Site US10082 American Clinical Trials
Hawaiian Gardens, California, 90716, United States
Site US10132 Axis Clinical Trials
Los Angeles, California, 90017, United States
Site US10133 Axis Clinical Trials
Los Angeles, California, 90036, United States
Site US10536 Stanford School of Medicine
Palo Alto, California, 93404, United States
Site US10149 Bayview Research Group
Paramount, California, 90723, United States
Site US10559 UC Davis Medical Center
Sacramento, California, 95817, United States
Site US10003 San Diego Clinical Trials
San Diego, California, 92120, United States
Site US10545 San Diego Institute for Sexual Medicine
San Diego, California, 92120, United States
Site US10106 West Coast Clinical Research
Tarzana, California, 91356, United States
Site US10595 Bayview Research Group
Valley Village, California, 91607, United States
Site US10034 Urology Center of Colorado
Denver, Colorado, 80211, United States
Site US10070 Physicians' Research Options/Red Rocks OB/GYN
Lakewood, Colorado, 80228, United States
Site US10053 Western Clinical Research, Inc.
Wheat Ridge, Colorado, 80033, United States
Site US10128 Clinical Research Center of CT
Danbury, Connecticut, 06810, United States
Site US10018 Grove Hill Clinical Research
New Britain, Connecticut, 06052, United States
Site US10170 Yale - New Haven Hospital West Haven VAMC
New Haven, Connecticut, 06510, United States
Site US10123 Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Site US10060 Meridien Research
Bradenton, Florida, 34208, United States
Site US10097 A.G.A. Clinical Trials DBA Neostart Group
Hialeah, Florida, 33012, United States
Site US10148 Best Quality Research, Inc.
Hialeah, Florida, 33016, United States
Site US10153 Palmetto Professional Research
Hialeah, Florida, 33016, United States
Site US10159 Urological Research Network
Hialeah, Florida, 33016, United States
Site US10534 South Florida Medical Research
Hialeah, Florida, 33016, United States
Site US10535 South Florida Medical Research
Homestead, Florida, 33030, United States
Site US10165 East Coast Institute for Research
Jacksonville, Florida, 32216, United States
Site US10091 Health Awareness
Jupiter, Florida, 33458, United States
Site US10150 Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Site US10158 Renstar Medical Research
Ocala, Florida, 34471, United States
Site US10124 Winter Park Urology Associates
Orlando, Florida, 32803, United States
Site US10134 Compass Research, LLC
Orlando, Florida, 32806, United States
Site US10009 South Broward Research
Pembroke Pines, Florida, 33027, United States
Site US10540 Demaur Clinical Research, INC
Pembroke Pines, Florida, 33028, United States
Site US10554 Private Practice
Plantation, Florida, 33317, United States
Site US10095 Florida Urology Specialists
Sarasota, Florida, 34237, United States
Site US10010 Southeastern Research Group, Inc
Tallahassee, Florida, 32308, United States
Site US10014 Private Practice
Wellington, Florida, 33449, United States
Site US10037 Atlanta Medical Research Institute
Alpharetta, Georgia, 30005, United States
Site US10127 Perimeter North Medical Research, Inc.
Roswell, Georgia, 30076, United States
Site US10120 WR-Mount Vernon Clinical Research
Sandy Springs, Georgia, 30328, United States
Site US10024 GTC Research
Shawnee Mission, Kansas, 66218, United States
Site US10078 Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Site US10088 Centex Studies, Inc.
Lake Charles, Louisiana, 70601, United States
Site US10074 Medpharmics, LLC
Metairie, Louisiana, 70006, United States
Site US10025 Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Site US10558 Chesapeake Urology Research Associates
Glen Burnie, Maryland, 21061, United States
Site US10560 Chesapeake Urology Research Associates
Owings Mills, Maryland, 21117, United States
Site US10282 Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Site US10114 Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472, United States
Site US10152 Female Pelvic Medicine & Urogynecology Institute
Grand Rapids, Michigan, 49503, United States
Site US10542 Adult & Pediatric Urology Group
Sartell, Minnesota, 56377, United States
Site US10110 Montana Health Research Institute, Inc.
Billings, Montana, 59102, United States
Site US10154 Montana Medical Research Inc
Missoula, Montana, 59801, United States
Site US10553 Women's Clinic of Lincoln
Lincoln, Nebraska, 68510, United States
Site US10140 IVCTLV
Las Vegas, Nevada, 89106, United States
Site US10002 Urology Center Research Institute
Englewood, New Jersey, 07631, United States
Site US10051 AdvancedMed Research
Lawrenceville, New Jersey, 08648, United States
Site US10047 Lawrence OBGYN Associates
Lawrenceville, New Jersey, 86480, United States
Site US10162 Phoenix OB-GYN Associates, LLC
Moorestown, New Jersey, 08057, United States
Site US10011 Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Site US10015 Urology Group of New Mexico
Albuquerque, New Mexico, 87109, United States
Site US10077 Northeast Urogynecology
Albany, New York, 12205, United States
Site US10089 Maimonides Medical Center
Brooklyn, New York, 11220, United States
Site US10026 AccuMed Research Associates
Garden City, New York, 11530, United States
Site US10040 Premier Medical Group Of The Hudson Valley
Kingston, New York, 12401, United States
Site US10073 Manhattan Medical Research Practice, PLLC
New York, New York, 10016, United States
Site US10249 New York Clinical Trials
New York, New York, 10018, United States
Site US10168 Weill Cornell Medical College
New York, New York, 10065, United States
Site US10126 Premier Medical Group
Newburgh, New York, 12550, United States
Site US10028 Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Site US10593 Upstate Clinical Research Associates LLC
Williamsville, New York, 14221, United States
Site US10076 Carolina Clinical Trials
Concord, North Carolina, 28025, United States
Site US10129 PMG Research of Raleigh
Raleigh, North Carolina, 27609, United States
Site US10549 Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Site US10062 Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Site US10050 Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Site US10033 Ohio Clinical Research
Lyndhurst, Ohio, 44124, United States
Site US10067 Family Practice Center of Wadsworth
Wadsworth, Ohio, 44281, United States
Site US10551 The Christ Hospital
West Chester, Ohio, 45069, United States
Site US10109 Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Site US10541 Sunstone Medical Research
Medford, Oregon, 97504, United States
Site US10008 Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
Site US10045 Lancaster Urology
Lancaster, Pennsylvania, 17604, United States
Site US10017 Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114, United States
Site US10167 University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Site US10250 Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, 15236, United States
Site US10248 Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15243, United States
Site US10063 Preferred Primary Care Physician Research
Uniontown, Pennsylvania, 15401, United States
Site US10012 Advanced Clinical Concepts
West Reading, Pennsylvania, 19611, United States
Site US10166 Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Site US10094 University Medical Group
Greer, South Carolina, 29650, United States
Site US10046 Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Site US10079 PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464, United States
Site US10117 Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Site US10023 Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681, United States
Site US10101 Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Site US10006 Holston Medical Group
Kingsport, Tennessee, 37660, United States
Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc
Austin, Texas, 78745, United States
Site US10066 Texas Urology PA
Carrollton, Texas, 75010, United States
Site US10065 Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Site US10085 Centex Studies, Inc.
Houston, Texas, 77062, United States
Site US10108 Clinical Trial Network
Houston, Texas, 77074, United States
Site US10219 Methodist Urology Associates
Houston, Texas, 77094, United States
Site US10093 Pioneer Research Solutions, Inc.
Houston, Texas, 77098, United States
Site US10090 Protenium Clinical Research, LLC
Hurst, Texas, 76054, United States
Site US10105 Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Site US10111 Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Site US10092 Physicians' Research Options/Salt Lake Women's Center
Sandy City, Utah, 84070, United States
Site US10032 National Clinical Research Inc.
Richmond, Virginia, 23294, United States
Site US10064 The Group for Women
Virginia Beach, Virginia, 23456, United States
Site US10083 Urology of Virginia, PLLC.
Virginia Beach, Virginia, 23462, United States
Site US10013 Seattle Urology Research Center
Burien, Washington, 98166, United States
Site US10004 Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
Site US10155 Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105, United States
Site US10135 Walla Walla Clinic
Walla Walla, Washington, 99362, United States
Site AR54005 IUBA - Instituto Urologico de Buenos Aires
Buenos Aires, 1419, Argentina
Site AR54003 Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
Site AR54006 Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
Site AR54001 CDU - Centro de Urología
Ciudad Autónoma Buenos Aires, C1120AAT, Argentina
Site AR54004 Instituto de Investigaciones Clnicas Rosario
Rosario Provincia de Santa Fe, 2000, Argentina
Site AU61026 Ballarat Urology
Ballarat, 3350, Australia
Site AU61022 Brisbane South Clinical Research Centre
Brisbane, 4152, Australia
Site AU61005 Hunter Clinical Research
Broadmeadow, 2292, Australia
Site AU61015 Repatriation General Hospital
Daw Park, 5041, Australia
Site AU61025 Western Health
Footscray, 3011, Australia
Site AU61012 Cabrini Hospital
Malvern, 3144, Australia
Site AU61010 Nambour General Hospital
Nambour, 4560, Australia
Site AU61002 The Royal Womens Hospital
Parkville, 3052, Australia
Site AU61004 Keogh Institute for Medical Research
Perth, 6009, Australia
Site AU61007 Prince of Wales Hospital
Randwick, 2031, Australia
Site AU61008 Epworth Healthcare
Richmond, 3121, Australia
Site AU61019 AusTrialsSherwood
Sherwood, 4075, Australia
Site AU61017 Healthpac Medical Centre
Sydney, 2000, Australia
Site AU61021 Royal Hospital for Women
Sydney, 2031, Australia
Site AU61011 Illawarra Health and Medical Research Institute
Wollongong, 2522, Australia
Site BE32004 Gent University Hospital
Ghent, 9000, Belgium
Site BE32011 Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Site BE32014 Hart Ziekenhuis
Roeselare, 8800, Belgium
Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna
Sint-Truiden, 3800, Belgium
Site BG35904 University Hospital (UMHAT) - George Stranski
Pleven, 5800, Bulgaria
Site BG35908 MHAT Plovdiv AD
Plovdiv, 4003, Bulgaria
Site BG35902 MHAT Ruse
Rousse, 7002, Bulgaria
Site BG35905 MHAT Alexandrovska Hospital
Sofia, 1431, Bulgaria
Site BG35903 MHATEM Pirogov
Sofia, 1606, Bulgaria
Site BG35906 UMHAT Varna
Varna, 9000, Bulgaria
Site BG35910 MHAT
Veliko Tarnovo, 5000, Bulgaria
Site CA15029 Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Site CA15035 Glenrose Rehabilitation Hospital
Edmonton, Alberta, T6G 2P4, Canada
Site CA15033 Prohealth
Vancouver, British Columbia, V5Z 4E1, Canada
Site CA15008 Private Practice
Saint John, New Brunswick, E2L 3J8, Canada
Site CA15001 The Male/Female Health & Research Centre
Barrie, Ontario, L4M 7G1, Canada
Site CA15006 Bramalea Medical Centre
Brampton, Ontario, L6T 4S5, Canada
Site CA15003 Brantford Urology Research
Brantford, Ontario, N3R 4N3, Canada
Site CA15042 G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2, Canada
Site CA15044 McMaster Institute of Urology
Hamilton, Ontario, L8N 4A6, Canada
Site CA15031 Centre for Applied Urology Research (CAUR)
Kingston, Ontario, K7L 3J7, Canada
Site CA15007 Eunoia2 Incorporated
Kitchener, Ontario, N2N 2B9, Canada
Site CA15034 Oxford/Richmond Medical
London, Ontario, N6A 5R9, Canada
Site CA15032 Stanley Flax Medical Prof Corp
North York, Ontario, M2J 1V1, Canada
Site CA15013 Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Site CA15004 Primehealth Clinical Research
Toronto, Ontario, M4S 1Y2, Canada
Site CA15002 Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Site CA15026 Rhodin Recherche Clinique
Drummondville, Quebec, J2B 7T1, Canada
Site CA15015 Recherches Cliniques Theradev, Inc.
Granby, Quebec, Canada
Site CA15021 Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3, Canada
Site CA15030 UroLaval
Laval, Quebec, H7G 2E6, Canada
Site CA15040 RechercheGCP Research
Montreal, Quebec, H2R1V6, Canada
Site CA15020 Diex Research Montreal
Montreal, Quebec, H4N 3C5, Canada
Site CA15010 Ultra Med Research, Inc.
Point-Claire, Quebec, H9R 4S3, Canada
Site CA15025 Clinique RSF Inc.
Québec, Quebec, G1S 2L6, Canada
Site CA15039 Pro-recherche
Saint Romuald, Quebec, G6W 5M6, Canada
Site CA15027 Diex Research Sherbrooke Inc
Sherbrooke, Quebec, J1H 1Z1, Canada
Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.
Fuzhou, Fujian, 350001, China
Site CN86025 Beijing Friendship Hospital
Beijing, 100050, China
Site CN86009 Peking University 3rd Hospital
Beijing, 100191, China
Site CN86013 Beijing Hospital
Beijing, 100730, China
Site CN86014 The First Hospital Bethune of Jilin University
Changchun, 130021, China
Site CN86002 Changsha Central Hospital
Changsha, 410008, China
Site CN86028 General Hospital of Chengdu Military Region of PLA
Chengdu, China
Site CN86029 Southwest Hospital (Chongqing)
Chongqing, 400038, China
Site CN86016 Guangzhou First People's Hospital
Guangzhou, 510180, China
Site CN86027 Second Hospital of Lanzhou University
Lanzhou, 730030, China
Site CN86030 Lanzhou University First Hospital
Lanzhou, China
Site CN86020 The First Affiliated Hospital of NanChang Univers
Nanchang, 330006, China
Site CN86023 Nanjing First Hospital
Nanjing, 210006, China
Site CN86021 HuaDong Hosipital Affiliated to Fudan University
Shanghai, 200040, China
Site CN86003 Shanghai Renji Hospital
Shanghai, 200127, China
Site CN86012 The Fifth People's Hospital of Shanghai
Shanghai, 200240, China
Site CN86011 The Second Affiliated Hospital of Soochow Universi
Suzhou, 215004, China
Site CN86010 1st Affiliated Hosptital of Suchow University
Suzhou, 215006, China
Site CN86026 The First Affiliated Hospital of Wenzhou Medical C
Wenzhou, 325000, China
Site CN86022 Tongji Hospital, Tongji Medical College of Hust
Wuhan, 430030, China
Site CN86015 Zhongnan Hospital of Wuhan University
Wuhan, 430071, China
Site CN86018 Wuxi People's Hospital
Wuxi, 214023, China
Site CO57003 Hospital Pablo Tobón Uribe
Medellín, Antioquia, Colombia
Site CO57004 Instituto de Coloproctologia ICO SAS
Medellín, Colombia
Site CZ42015 Centrum ambulantni gynekologie a primarni pece
Brno, 602 00, Czechia
Site CZ42003 SANUS
Hradec Králové, 500 02, Czechia
Site CZ42001 Fakultni Nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Site CZ42002 Hospital Jihlava
Jihlava, 586 33, Czechia
Site CZ42011 Hospital Novy Jicin
Nový Jičín, 741 01, Czechia
Site CZ42010 G-centrum Olomouc S.R.O.
Olomouc, 772 00, Czechia
Site CZ42014 Private Practice
Ostrava, 700 30, Czechia
Site CZ42005 Research Site s.r.o.
Pilsen, 301 00, Czechia
Site CZ42007 Uro-Santé/Nová Brumlovka
Prague, 140 00, Czechia
Site CZ42013 Urology Clinic
Sternberk, 78501, Czechia
Site CZ42009 Hospital Uherské Hradiště a.s.
Uherské Hradiště, 686 08, Czechia
Site CZ42006 Private Practice
Ústí nad Labem, 40001, Czechia
Site DK45012 Aalborg Sygehus Nord
Aalborg, 9000, Denmark
Site DK45013 University Hospital of Aarhus, Skejby
Aarhus, 8200, Denmark
Site EE37201 Parnu Hospital
Pärnu, 80010, Estonia
Site EE37205 West Tallinn Central Hospital
Tallinn, 10617, Estonia
Site EE37202 Tartu University Hospital
Tartu, 51014, Estonia
Site FI35801 Kouvolan Lääkäriasema
Kouvola, 45200, Finland
Site FI35803 Oulu University Hospital
Oulu, 90029, Finland
Site FI35802 Meilahti Hospital
Vantaa, 01400, Finland
Site FR33007 Centre Hospitalier Louis Pasteur
Colmar, 68024, France
Site FR33010 CHU Hopital du Bocage
Dijon, 21079, France
Site FR33008 CHU Nantes
Nantes, 44035, France
Site FR33002 CHU Carémeau
Nîmes, 30029, France
Site FR33013 Hopital Saint Louis
Paris, 75475, France
Site FR33001 Hopital Tenon
Paris, 75970, France
Site FR33024 Hopital Tenon
Paris, 75970, France
Site FR33011 Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Site FR33012 Hopital Foch
Suresnes, 92151, France
Site FR33005 Hopital Bretonneau
Tours, 37044, France
Site DE49008 Private Practice
Bad Ems, 56130, Germany
Site DE49031 Urologisches Zentrum Refrath
Bergisch Gladbach, 51427, Germany
Site DE49033 Universitsy Clinic Bonn
Bonn, 53217, Germany
Site DE49002 Private Practice
Duisburg, 47051, Germany
Site DE49032 Urologicum Duisburg
Duisburg, 47179, Germany
Site DE49003 Private Practice
Eisleben Lutherstadt, 6295, Germany
Site DE49010 Private Practice
Ganderkesee, 27777, Germany
Site DE49011 Private Practice
Halle, 06132, Germany
Site DE49013 Private Practice
Leipzig, 04105, Germany
Site DE49034 LMU Muenchen
Munich, 81377, Germany
Site DE49001 Private Practice
Neustadt in Sachsen, 1844, Germany
Site DE49026 Zentrum fuer Onkologie und Urologie Rostock
Rostock, 18107, Germany
Site DE49014 Private Practice
Sangerhausen, 6526, Germany
Site GR30009 Aretaieio/Maginio
Athens, 115 28, Greece
Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital
Hong Kong, Hong Kong
Site HK85201 Kwong Wah Hospital
Kowloon, Hong Kong
Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital
Shatin, 30-32, Hong Kong
Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft
Csongrád, 6640, Hungary
Site HU36007 Mediroyal Prevention Center
Kecskemét, 6000, Hungary
Site HU36005 Uro-clin Ltd
Pécs, 7621, Hungary
Site HU36013 Sopron Erzsébet Hospital
Sopron, H-9400, Hungary
Site HU36001 Donatella 99BT
Szentes, 6600, Hungary
Site HU36012 Veszprém County Cholnoky Ferenc Hospital
Veszprém, 8200, Hungary
Site IT39022 Azienda Ospedale Umberto I (Ancona)
Ancona, 60126, Italy
Site IT39007 Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100, Italy
Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza
Latina, 4100, Italy
Site IT39003 Ospedale San Raffaele
Milan, 20132, Italy
Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia
Milan, 20132, Italy
Site LV37102 Private Practice
Liepāja, LV-3401, Latvia
Site LV37103 Health Centre "Olaine"
Olaine, LV-2114, Latvia
Site LV37105 P.Stradins Clinical University Hospital
Riga, 1002, Latvia
Site LT37008 Kaunas 2nd Clinical Hospital
Kaunas, 47144, Lithuania
Site LT37004 KHospital of Lithuanian University of Health Science
Kaunas, 50009, Lithuania
Site LT37011 Saules Family Medicine Centre
Kaunas, Lithuania
Site LT37012 Klaipeda University Hospital
Klaipėda, LT-92288, Lithuania
Site LT37005 Public Institution Vilnius City University Hospital
Vilnius, 10207, Lithuania
Site LT37010 Public Institution Vilnius City University Hospital
Vilnius, 10207, Lithuania
Site LT37003 Family Medical Centre Seimos gydytojas
Vilnius, LT-01118, Lithuania
Site LT37007 Vilnius University Hospital Santariskiu Klinikos
Vilnius, LT-08661, Lithuania
Site LT37009 Clinics Privatus gydytojas
Vilnius, LT-09108, Lithuania
Site MY60006 Hospital Pulau Pinang
George Town, 10990, Malaysia
Site MY60001 Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Site MY60004 University Malaya Medical Centre
Kuala Lumpur, 50603, Malaysia
Site MY60005 Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, 56000, Malaysia
Site MY60003 Hospital Ummum Sarawak
Kuching, 93586, Malaysia
Site MY60002 Sime Darby Medical Centre
Petaling Jaya, 47500, Malaysia
Site MX52004 Consultorio de Especialidad en Urologia
Durango, 34000, Mexico
Site MX52001 Centro de Investigacin Basica y Clnica
Guadalajara, 45040, Mexico
Site MX52003 Clinstile, Sociedad Anonima de Capital Variable
Mexico City, 6700, Mexico
Site MX52002 Accelerium Clinical Research/ Hospital San Jorge
Monterrey, 64000, Mexico
Site NL31002 Academic Medical Center (AMC)
Amsterdam, 1105 AZ, Netherlands
Site NL31006 Medisch Spectrum Twente
Enschede, 7513ER, Netherlands
Site NL31005 Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ, Netherlands
Site NL31010 Antonius Ziekenhuis Sneek
Sneek, 8601 ZK, Netherlands
Site NL31001 University Medical Centre Utrecht
Utrecht, 3584 CX, Netherlands
Site NZ64004 John A Tuckey Ltd Ascot Central
Auckland, 1541, New Zealand
Site NZ64001 Canterbury Urology Research Trust
Christchurch, 8014, New Zealand
Site NZ64005 Waikato Urology Research Limited
Hamilton, 3204, New Zealand
Site NZ64002 Roundhay Medical Centre
Nelson, 7010, New Zealand
Site NZ64003 Tauranga Urology Research Ltd
Tauranga, 3140, New Zealand
Site NZ64006 Cardinal Point Specialist Centre
Whangarei, New Zealand
Site NO47007 Medi3 Clinic AS, Ålesund
Ålesund, 6003, Norway
Site NO47006 M3 Helse AS
Hamar, 2317, Norway
Site NO47008 Norsk Helseklinikk (Heiaklinikken)
Lierskogen, 3420, Norway
Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud
La Victoria, Lima region, 13, Peru
Site PE51007 Clínica Anglo Americana
San Isidro, Lima region, 27, Peru
Site PE51001 Instituto de Ginecologia y Reproduccion
Lima, 33, Peru
Site PE51002 Clinica San Borja
Lima, 41, Peru
Site PE51004 Clinica San Pablo
Lima, Peru
Site PE51005 Hospital Nacional Hipolito Unanue
Lima, Peru
Site PH63008 Dr. Pablo O. Torre Memorial Hospital
Bacolod City, 6100, Philippines
Site PH63005 Davao Doctor's Hospital
Davao City, 8000, Philippines
Site PH63010 Davao Doctor's Hospital
Davao City, 8000, Philippines
Site PH63003 University of Santo Tomas Hospital (USTH)
Manila, 1008, Philippines
Site PH63009 Chinese General Hospital and Medical Center
Manila, 1008, Philippines
Site PH63004 East Avenue Medical Center
Quezon City, 1101, Philippines
Site PL48018 Gastromed
Bialystok, 15-351, Poland
Site PL48013 Urovita Ltd.
Chorzów, 41-500, Poland
Site PL48014 Synexus Polska
Gdynia, 81-384, Poland
Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne
Lodz, 90-302, Poland
Site PL48010 Nzoz Novita
Lublin, 20-632, Poland
Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.
Mysłowice, 41-400, Poland
Site PL48016 Prywatny Gabinet Urologiczny
Opole, 45-086, Poland
Site PL48005 HEUREKA Hanna Szalecka
Piaseczno, 05-500, Poland
Site PL48012 Military Institute of Medicine
Warsaw, 00-909, Poland
Site PL48003 CSKMSW
Warsaw, 02-507, Poland
Site PL48001 Specjalistyczny Gabinet Lekarski
Warsaw, 02-929, Poland
Site PL48019 Synexus Polska sp. z o. o.
Wroclaw, 50-088, Poland
Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov
Brasov, 500152, Romania
Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan
Bucharest, 42122, Romania
Site RO40001 Spiatlul Clinic Th. Burghele
Bucharest, 50659, Romania
Site RO40005 Spiatlul Clinic Th. Burghele
Bucharest, 50659, Romania
Site RO40014 E-URO Cabinet
Cluj-Napoca, 400046, Romania
Site RO40007 Spital Clinic
Iași, 700503, Romania
Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu
Sibiu, 550245, Romania
Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara
Timișoara, 300736, Romania
Site RU70015 LLC Clinical Research Medical Complex
Kazan', 420097, Russia
Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko
Penza, 440026, Russia
Site RU70019 City Multidisciplinary Hospital No. 2
Saint Petersburg, 194354, Russia
Site RU70002 Pavlov St. Petersburg State Medical University
Saint Petersburg, 197089, Russia
Site RU70022 St. Petersburg State Public Health Institution
Saint Petersburg, 198103, Russia
Site RU70014 OOO Hospital Orkli
Saint Petersburg, 199178, Russia
Site RU70018 Bashkirsky State Medical University of Roszdrav
Ufa, 450096, Russia
Site SG65001 National University Hospital
Singapore, 119074, Singapore
Site SG65002 Singapore General Hospital
Singapore, 169608, Singapore
Site SG65003 KK Women's and Children's Hospital
Singapore, 229899, Singapore
Site SK42105 Ruzinovska poliklinika a.s.
Bratislava, 82101, Slovakia
Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.
Košice, 4001, Slovakia
Site SK42101 Andrologicka a Urologicka Ambulancia
Košice, 4013, Slovakia
Site SK42103 UroExam s.r.o.
Nitra, 949 01, Slovakia
Site SK42108 BrenCare, s. r. o.
Poprad, 058 01, Slovakia
Site SK42104 Urology Outpatient Department
Prešov, 8001, Slovakia
Site SK42106 Private Urological Care Center
Trenčín, 911 01, Slovakia
Site SK42102 CeGys, s.r.o.
Trenčín, 91101, Slovakia
Site SI38604 General Hospital Murska Sobota
Murska Sobota, 9000, Slovenia
Site SI38602 General Hospital Novo Mesto
Novo Mesto, 8000, Slovenia
Site ZA27005 Grootte Schuur Hospital
Cape Town, 7925, South Africa
Site ZA27001 Private Practice
Centurion, 0157, South Africa
Site ZA27006 Parklands Hospital
Durban, 4001, South Africa
Site ZA27013 Synexus Clinical Research SA (Pty) Ltd
Meyerspark, 184, South Africa
Site ZA27007 Paarl Medical Centre
Paarl, 7646, South Africa
Site ZA27002 Mayo Clinic
Roodepoort, 1709, South Africa
Site KR82014 Soon Chun Hyang University Hospital
Bucheon-si, 420-767, South Korea
Site KR82006 Dong-A University Medical Center
Busan, 602-715, South Korea
Site KR82016 Pusan National University Hospital
Busan, 602-739, South Korea
Site KR82024 Chungbuk National University Hospital
Cheongju-si, 361-711, South Korea
Site KR82032 Kyungpook National University Hospital
Daegu, 700-421, South Korea
Site KR82005 Yeungnam University Hospital
Daegu, 705-717, South Korea
Site KR82029 Daegu Catholic Univ. Medical Center
Daegu, 705-718, South Korea
Site KR82019 Chungnam National University Hospital
Daejeon, 301-721, South Korea
Site KR82011 Eulji University Hospital
Daejeon, 302-799, South Korea
Site KR82031 Chonnam National University Hospital
Gwangju, 501757, South Korea
Site KR82009 Wonkwang University Hospital
Iksan -Si, 570-711, South Korea
Site KR82023 Gachon University Gil Hospital
Incheon, 405760, South Korea
Site KR82010 Chonbuk National University Hospital
Jeonju, 561-712, South Korea
Site KR82025 Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Site KR82021 Cheil General Hospital & Women's Healthcare Center
Seoul, 100-380, South Korea
Site KR82020 Seoul National University Hospital
Seoul, 110-744, South Korea
Site KR82030 Severance Hospital
Seoul, 120-752, South Korea
Site KR82013 Hallym University Kangdong Sacred Heart Hospital
Seoul, 134-701, South Korea
Site KR82017 Kyung Hee University Medical Center
Seoul, 134-872, South Korea
Site KR82002 Samsung Medical Center
Seoul, 135-710, South Korea
Site KR82008 Gangnam Severance Hospital
Seoul, 135-720, South Korea
Site KR82015 Korea University Medical Center
Seoul, 136-075, South Korea
Site KR82001 Seoul Saint Mary's Hospital
Seoul, 137-040, South Korea
Site KR82003 Asan Medical Center
Seoul, 138-736, South Korea
Site KR82012 Konkuk University Medical Center
Seoul, 143-729, South Korea
Site KR82004 Ajou University Hospital
Suwon, 443-721, South Korea
Site ES34010 Hospital del Henares
Coslada, 28822, Spain
Site ES34024 Hospital San Juan de Dios
Esplugues de Llobregat-Barcelo, 08950, Spain
Site ES34001 Hospital Universitario de Getafe
Getafe (Madrid), 28905, Spain
Site ES34006 Hospital San Rafael
Madrid, 28016, Spain
Site ES34004 Hospital Infanta Leonor
Madrid, 28031, Spain
Site ES34015 Hospital 12 de Octubre
Madrid, 28044, Spain
Site ES34009 Hospital Universitario La Paz
Madrid, 28046, Spain
Site ES34005 Hospital de Fuenlabrada
Madrid, 28942, Spain
Site ES34003 Hospital Universitario Nuestra Señora de Valme
Seville, 41001, Spain
Site ES34007 Hospital Virgen del Rocio
Seville, 41013, Spain
Site ES34002 H. U. Politecnico La Fe
Valencia, 46026, Spain
Site SE46007 Ladulaas Clinical Studies
Borås, 506 30, Sweden
Site SE46025 Pharmasite
Helsingborg, 252 20, Sweden
Site SE46005 Center för Läkemedelsstudier
Malmo, 211 52, Sweden
Site SE46016 Citydiabetes - Stockholm
Stockholm, 111 57, Sweden
Site SE46008 Bragée Medect AB
Stockholm, 115 22, Sweden
Site SE46012 Karolinska University Hospital Huddinge
Stockholm, 141 86, Sweden
Site SE46003 Danderyds Hospital
Stockholm, 182 88, Sweden
Site SE46009 Encia AB, Uppsala Hälsomottagning
Uppsala, 753 35, Sweden
Site SE46017 S3 Clinical Research Centers
Vällingby, 162 68, Sweden
Site TW88605 Taichung Veteran General Hospital
Taichung, 40705, Taiwan
Site TW88611 Chung Shan Medical University Hospital
Taichung, 407, Taiwan
Site TW88612 Chi Mei Medical Center, Yong Kang
Tainan, 710, Taiwan
Site TW88614 Tri-Service General Hospital
Taipei, 114, Taiwan
Site TH66002 Chulalongkorn Hospital
Bangkok, 10330, Thailand
Site TH66008 Phramongkutklao Hospital
Bangkok, 10400, Thailand
Site TH66005 Siriraj Hospital
Bangkok, 10700, Thailand
Site TH66010 Maharaj Nakorm Chiangmai Hosp
Chiang Mai, 50200, Thailand
Site TH66006 Songklanagarind Hospital, Prince of Songkla University
Hat Yai, 90110, Thailand
Site TH66009 Srinagarind Hospital
Khon Kaen, 40002, Thailand
Site TH66007 Thammasat University Hospital
Pathum Thani, 12120, Thailand
Site TH66011 Ramathibodi Hospital
Ratchathewi, 10400, Thailand
Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital
Ankara, 06100, Turkey (Türkiye)
Site TR90013 Uludag University Faculty of Medicine
Bursa, 16059, Turkey (Türkiye)
Site TR90001 Pamukkale University Faculty of Medicine
Denizli, 20070, Turkey (Türkiye)
Site TR90017 Bilim University Sisli Florence Nightingale Hospital
Istanbul, 34381, Turkey (Türkiye)
Site UA38002 City Hospital No 2
Chernihiv, 14034, Ukraine
Site UA38015 Regional Municipal Institution, Urology Department
Chernivtsi, 58000, Ukraine
Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov
Dnipropetrovsk, 49005, Ukraine
Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology
Kharkiv, 61037, Ukraine
Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric
Kiev, 02232, Ukraine
Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3
Kyiv, 02660, Ukraine
Site UA38010 Academy of Medical Sciences of Ukraine
Kyiv, 04053, Ukraine
Site UA38014 Uzhgorod City Polyclinic
Uzhhorod, 88000, Ukraine
Site UA38004 Vinnitsa Endocrinology Dispens
Vinnytsia, 21010, Ukraine
Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic
Zaporizhzhya, 69600, Ukraine
Site GB44009 Sheepcot Medical Centre
Garston, Watfort, WD25 0EA, United Kingdom
Site GB44003 Leighton Hospital
Crewe, CW1 4QJ, United Kingdom
Site GB44021 Medway Hospital
Gillingham, ME7 5WY, United Kingdom
Site GB44005 North West London Hosp Menopause Clinic
Harrow, HA1 3UJ, United Kingdom
Site GB44024 St James's University Hospital
Leeds, LS7 9TF, United Kingdom
Site GB44025 Kings College Hospital
London, SE5 9RS, United Kingdom
Site GB44006 Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Site GB44022 The Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Site GB44001 Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Related Publications (1)
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to lack of data integrity, one site's data was not included in the efficacy and safety analysis.
Results Point of Contact
- Title
- Medical Director
- Organization
- Astellas Pharma Europe B.V.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2013
First Posted
October 31, 2013
Study Start
November 5, 2013
Primary Completion
October 22, 2015
Study Completion
October 22, 2015
Last Updated
October 31, 2024
Results First Posted
June 12, 2018
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.