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

Overactive Bladder Clinical Trial

— SYNERGY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972841
• Other study ID #: 178-CL-101
• Secondary ID: 2012-005735-91U1
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2013
• Est. completion date: October 22, 2015

Study information

• Verified date: October 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3527
• Est. completion date: October 22, 2015
• Est. primary completion date: October 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urgency Incontinence
• Urinary Bladder Diseases
• Urinary Bladder Diseases\Urologic Diseases
• Urinary Bladder Overactive
• Urinary Bladder, Overactive
• Urologic Diseases

Intervention

Drug:
• Solifenacin succinate
Oral tablet
• Mirabegron
Oral tablet
• Placebo to match solifenacin succinate
Oral tablet
• Placebo to match mirabegron
Oral tablet

Locations

Country	Name	City	State
Argentina	Site AR54003 Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Site AR54005 IUBA - Instituto Urologico de Buenos Aires	Buenos Aires
Argentina	Site AR54006 Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Site AR54001 CDU - Centro de Urología	Ciudad Autónoma Buenos Aires
Argentina	Site AR54004 Instituto de Investigaciones Clnicas Rosario	Rosario Provincia De Santa Fe
Australia	Site AU61026 Ballarat Urology	Ballarat
Australia	Site AU61022 Brisbane South Clinical Research Centre	Brisbane
Australia	Site AU61005 Hunter Clinical Research	Broadmeadow
Australia	Site AU61015 Repatriation General Hospital	Daw Park
Australia	Site AU61025 Western Health	Footscray
Australia	Site AU61012 Cabrini Hospital	Malvern
Australia	Site AU61010 Nambour General Hospital	Nambour
Australia	Site AU61002 The Royal Womens Hospital	Parkville
Australia	Site AU61004 Keogh Institute for Medical Research	Perth
Australia	Site AU61007 Prince of Wales Hospital	Randwick
Australia	Site AU61008 Epworth Healthcare	Richmond
Australia	Site AU61019 AusTrialsSherwood	Sherwood
Australia	Site AU61017 Healthpac Medical Centre	Sydney
Australia	Site AU61021 Royal Hospital for Women	Sydney
Australia	Site AU61011 Illawarra Health and Medical Research Institute	Wollongong
Belgium	Site BE32004 Gent University Hospital	Gent
Belgium	Site BE32011 Universitaire Ziekenhuizen Leuven	Leuven
Belgium	Site BE32014 Hart Ziekenhuis	Roeselare
Belgium	Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna	Sint-Truiden
Bulgaria	Site BG35904 University Hospital (UMHAT) - George Stranski	Pleven
Bulgaria	Site BG35908 MHAT Plovdiv AD	Plovdiv
Bulgaria	Site BG35902 MHAT Ruse	Ruse
Bulgaria	Site BG35903 MHATEM Pirogov	Sofia
Bulgaria	Site BG35905 MHAT Alexandrovska Hospital	Sofia
Bulgaria	Site BG35906 UMHAT Varna	Varna
Bulgaria	Site BG35910 MHAT	Veliko Tarnovo
Canada	Site CA15001 The Male/Female Health & Research Centre	Barrie	Ontario
Canada	Site CA15006 Bramalea Medical Centre	Brampton	Ontario
Canada	Site CA15003 Brantford Urology Research	Brantford	Ontario
Canada	Site CA15042 G. Kenneth Jansz Medicine Professional Corporation	Burlington	Ontario
Canada	Site CA15026 Rhodin Recherche Clinique	Drummondville	Quebec
Canada	Site CA15029 Royal Alexandra Hospital	Edmonton	Alberta
Canada	Site CA15035 Glenrose Rehabilitation Hospital	Edmonton	Alberta
Canada	Site CA15015 Recherches Cliniques Theradev, Inc.	Granby	Quebec
Canada	Site CA15021 Urology South Shore Research	Greenfield Park	Quebec
Canada	Site CA15044 McMaster Institute of Urology	Hamilton	Ontario
Canada	Site CA15031 Centre for Applied Urology Research (CAUR)	Kingston	Ontario
Canada	Site CA15007 Eunoia2 Incorporated	Kitchener	Ontario
Canada	Site CA15030 UroLaval	Laval	Quebec
Canada	Site CA15034 Oxford/Richmond Medical	London	Ontario
Canada	Site CA15020 Diex Research Montreal	Montreal	Quebec
Canada	Site CA15040 RechercheGCP Research	Montreal	Quebec
Canada	Site CA15032 Stanley Flax Medical Prof Corp	North York	Ontario
Canada	Site CA15010 Ultra Med Research, Inc.	Point-Claire	Quebec
Canada	Site CA15025 Clinique RSF Inc.	Quebec
Canada	Site CA15008 Private Practice	Saint John	New Brunswick
Canada	Site CA15027 Diex Research Sherbrooke Inc	Sherbrooke	Quebec
Canada	Site CA15039 Pro-recherche	St-Romuald	Quebec
Canada	Site CA15002 Toronto Western Hospital	Toronto	Ontario
Canada	Site CA15004 Primehealth Clinical Research	Toronto	Ontario
Canada	Site CA15013 Sunnybrook Health Sciences Center	Toronto	Ontario
Canada	Site CA15033 Prohealth	Vancouver	British Columbia
China	Site CN86009 Peking University 3rd Hospital	Beijing
China	Site CN86013 Beijing Hospital	Beijing
China	Site CN86025 Beijing Friendship Hospital	Beijing
China	Site CN86014 The First Hospital Bethune of Jilin University	Changchun
China	Site CN86002 Changsha Central Hospital	Changsha
China	Site CN86028 General Hospital of Chengdu Military Region of PLA	Chengdu
China	Site CN86029 Southwest Hospital (Chongqing)	Chongqing
China	Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.	Fuzhou	Fujian
China	Site CN86016 Guangzhou First People's Hospital	Guangzhou
China	Site CN86027 Second Hospital of Lanzhou University	Lan Zhou
China	Site CN86030 Lanzhou University First Hospital	Lanzhou
China	Site CN86020 The First Affiliated Hospital of NanChang Univers	Nanchang
China	Site CN86023 Nanjing First Hospital	Nanjing
China	Site CN86003 Shanghai Renji Hospital	Shanghai
China	Site CN86012 The Fifth People's Hospital of Shanghai	Shanghai
China	Site CN86021 HuaDong Hosipital Affiliated to Fudan University	Shanghai
China	Site CN86010 1st Affiliated Hosptital of Suchow University	Suzhou
China	Site CN86011 The Second Affiliated Hospital of Soochow Universi	Suzhou
China	Site CN86026 The First Affiliated Hospital of Wenzhou Medical C	Wenzhou
China	Site CN86015 Zhongnan Hospital of Wuhan University	Wuhan
China	Site CN86022 Tongji Hospital, Tongji Medical College of Hust	Wuhan
China	Site CN86018 Wuxi People's Hospital	Wuxi
Colombia	Site CO57003 Hospital Pablo Tobón Uribe	Medellin	Antioquia
Colombia	Site CO57004 Instituto de Coloproctologia ICO SAS	Medellin
Czechia	Site CZ42015 Centrum ambulantni gynekologie a primarni pece	Brno
Czechia	Site CZ42001 Fakultni Nemocnice Hradec Kralove	Hradec Kralove
Czechia	Site CZ42003 SANUS	Hradec Kralove
Czechia	Site CZ42002 Hospital Jihlava	Jihlava
Czechia	Site CZ42011 Hospital Novy Jicin	Novy Jicin
Czechia	Site CZ42010 G-centrum Olomouc S.R.O.	Olomouc
Czechia	Site CZ42014 Private Practice	Ostrava
Czechia	Site CZ42005 Research Site s.r.o.	Plzen
Czechia	Site CZ42007 Uro-Santé/Nová Brumlovka	Praha 4
Czechia	Site CZ42013 Urology Clinic	Sternberk
Czechia	Site CZ42009 Hospital Uherské Hradište a.s.	Uherske Hradiste
Czechia	Site CZ42006 Private Practice	Usti nad Labem
Denmark	Site DK45012 Aalborg Sygehus Nord	Aalborg
Denmark	Site DK45013 University Hospital of Aarhus, Skejby	Aarhus
Estonia	Site EE37201 Parnu Hospital	Parnu
Estonia	Site EE37205 West Tallinn Central Hospital	Tallinn
Estonia	Site EE37202 Tartu University Hospital	Tartu
Finland	Site FI35801 Kouvolan Lääkäriasema	Kouvola
Finland	Site FI35803 Oulu University Hospital	Oulu
Finland	Site FI35802 Meilahti Hospital	Vantaa
France	Site FR33007 Centre Hospitalier Louis Pasteur	Colmar Cedex
France	Site FR33010 CHU Hopital du Bocage	Dijon
France	Site FR33008 CHU Nantes	Nantes Cedex 1
France	Site FR33002 CHU Carémeau	Nimes Cedex
France	Site FR33013 Hopital Saint Louis	Paris
France	Site FR33001 Hopital Tenon	Paris Cedex 20
France	Site FR33024 Hopital Tenon	Paris Cedex 20
France	Site FR33011 Centre Hospitalier Lyon Sud	Pierre Benite Cedex
France	Site FR33012 Hopital Foch	Suresnes
France	Site FR33005 Hopital Bretonneau	Tours Cedex 9
Germany	Site DE49008 Private Practice	Bad Ems
Germany	Site DE49031 Urologisches Zentrum Refrath	Bergisch Gladbach
Germany	Site DE49033 Universitsy Clinic Bonn	Bonn
Germany	Site DE49002 Private Practice	Duisburg
Germany	Site DE49032 Urologicum Duisburg	Duisburg
Germany	Site DE49010 Private Practice	Ganderkesee
Germany	Site DE49011 Private Practice	Halle (Saale)
Germany	Site DE49013 Private Practice	Leipzig
Germany	Site DE49003 Private Practice	Lutherstadt Eisleben
Germany	Site DE49034 LMU Muenchen	Munich
Germany	Site DE49001 Private Practice	Neustadt I. Sachsen
Germany	Site DE49026 Zentrum fuer Onkologie und Urologie Rostock	Rostock
Germany	Site DE49014 Private Practice	Sangerhausen
Greece	Site GR30009 Aretaieio/Maginio	Athens
Hong Kong	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
Hungary	Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft	Csongrád
Hungary	Site HU36007 Mediroyal Prevention Center	Kecskemet
Hungary	Site HU36005 Uro-clin Ltd	Pecs
Hungary	Site HU36013 Sopron Erzsébet Hospital	Sopron
Hungary	Site HU36001 Donatella 99BT	Szentes
Hungary	Site HU36012 Veszprém County Cholnoky Ferenc Hospital	Veszprém
Italy	Site IT39022 Azienda Ospedale Umberto I (Ancona)	Ancona
Italy	Site IT39007 Azienda Ospedaliera San Giuseppe Moscati	Avellino
Italy	Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza	Latina
Italy	Site IT39003 Ospedale San Raffaele	Milan
Italy	Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia	Milano
Korea, Republic of	Site KR82014 Soon Chun Hyang University Hospital	Bucheon-Si
Korea, Republic of	Site KR82006 Dong-A University Medical Center	Busan
Korea, Republic of	Site KR82016 Pusan National University Hospital	Busan
Korea, Republic of	Site KR82024 Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Site KR82005 Yeungnam University Hospital	Daegu
Korea, Republic of	Site KR82029 Daegu Catholic Univ. Medical Center	Daegu
Korea, Republic of	Site KR82032 Kyungpook National University Hospital	Daegu
Korea, Republic of	Site KR82011 Eulji University Hospital	Daejeon
Korea, Republic of	Site KR82019 Chungnam National University Hospital	Daejeon
Korea, Republic of	Site KR82031 Chonnam National University Hospital	Gwangju
Korea, Republic of	Site KR82009 Wonkwang University Hospital	Iksan -Si
Korea, Republic of	Site KR82023 Gachon University Gil Hospital	Incheon
Korea, Republic of	Site KR82010 Chonbuk National University Hospital	Jeonju-si
Korea, Republic of	Site KR82025 Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Site KR82001 Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	Site KR82002 Samsung Medical Center	Seoul
Korea, Republic of	Site KR82003 Asan Medical Center	Seoul
Korea, Republic of	Site KR82008 Gangnam Severance Hospital	Seoul
Korea, Republic of	Site KR82012 Konkuk University Medical Center	Seoul
Korea, Republic of	Site KR82013 Hallym University Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Site KR82015 Korea University Medical Center	Seoul
Korea, Republic of	Site KR82017 Kyung Hee University Medical Center	Seoul
Korea, Republic of	Site KR82020 Seoul National University Hospital	Seoul
Korea, Republic of	Site KR82021 Cheil General Hospital & Women's Healthcare Center	Seoul
Korea, Republic of	Site KR82030 Severance Hospital	Seoul
Korea, Republic of	Site KR82004 Ajou University Hospital	Suwon-si
Latvia	Site LV37102 Private Practice	Liepaja
Latvia	Site LV37103 Health Centre "Olaine"	Olaine
Latvia	Site LV37105 P.Stradins Clinical University Hospital	Riga
Lithuania	Site LT37004 KHospital of Lithuanian University of Health Science	Kaunas
Lithuania	Site LT37008 Kaunas 2nd Clinical Hospital	Kaunas
Lithuania	Site LT37011 Saules Family Medicine Centre	Kaunas
Lithuania	Site LT37012 Klaipeda University Hospital	Klaipeda
Lithuania	Site LT37003 Family Medical Centre Seimos gydytojas	Vilnius
Lithuania	Site LT37005 Public Institution Vilnius City University Hospital	Vilnius
Lithuania	Site LT37007 Vilnius University Hospital Santariskiu Klinikos	Vilnius
Lithuania	Site LT37009 Clinics Privatus gydytojas	Vilnius
Lithuania	Site LT37010 Public Institution Vilnius City University Hospital	Vilnius
Malaysia	Site MY60006 Hospital Pulau Pinang	Georgetown
Malaysia	Site MY60001 Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	Site MY60004 University Malaya Medical Centre	Kuala Lumpur
Malaysia	Site MY60005 Universiti Kebangsaan Malaysia Medical Centre	Kuala Lumpur
Malaysia	Site MY60003 Hospital Ummum Sarawak	Kuching
Malaysia	Site MY60002 Sime Darby Medical Centre	Petaling Jaya
Mexico	Site MX52004 Consultorio de Especialidad en Urologia	Durango
Mexico	Site MX52001 Centro de Investigacin Basica y Clnica	Guadalajara
Mexico	Site MX52003 Clinstile, Sociedad Anonima de Capital Variable	Mexico City
Mexico	Site MX52002 Accelerium Clinical Research/ Hospital San Jorge	Monterrey
Netherlands	Site NL31002 Academic Medical Center (AMC)	Amsterdam
Netherlands	Site NL31006 Medisch Spectrum Twente	Enschede
Netherlands	Site NL31005 Canisius-Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Site NL31010 Antonius Ziekenhuis Sneek	Sneek
Netherlands	Site NL31001 University Medical Centre Utrecht	Utrecht
New Zealand	Site NZ64004 John A Tuckey Ltd Ascot Central	Auckland
New Zealand	Site NZ64001 Canterbury Urology Research Trust	Christchurch
New Zealand	Site NZ64005 Waikato Urology Research Limited	Hamilton
New Zealand	Site NZ64002 Roundhay Medical Centre	Nelson
New Zealand	Site NZ64003 Tauranga Urology Research Ltd	Tauranga
New Zealand	Site NZ64006 Cardinal Point Specialist Centre	Whangarei
Norway	Site NO47007 Medi3 Clinic AS, Ålesund	Ålesund
Norway	Site NO47006 M3 Helse AS	Hamar
Norway	Site NO47008 Norsk Helseklinikk (Heiaklinikken)	Lierskogen
Peru	Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud	La Victoria	Lima
Peru	Site PE51001 Instituto de Ginecologia y Reproduccion	Lima
Peru	Site PE51002 Clinica San Borja	Lima
Peru	Site PE51004 Clinica San Pablo	Lima
Peru	Site PE51005 Hospital Nacional Hipolito Unanue	Lima
Peru	Site PE51007 Clínica Anglo Americana	San Isidro	Lima
Philippines	Site PH63008 Dr. Pablo O. Torre Memorial Hospital	Bacolod City
Philippines	Site PH63005 Davao Doctor's Hospital	Davao City
Philippines	Site PH63010 Davao Doctor's Hospital	Davao City
Philippines	Site PH63003 University of Santo Tomas Hospital (USTH)	Manila
Philippines	Site PH63009 Chinese General Hospital and Medical Center	Manila
Philippines	Site PH63004 East Avenue Medical Center	Quezon City
Poland	Site PL48018 Gastromed	Bialystok
Poland	Site PL48013 Urovita Ltd.	Chorzow
Poland	Site PL48014 Synexus Polska	Gdynia
Poland	Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne	Lodz
Poland	Site PL48010 Nzoz Novita	Lublin
Poland	Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.	Myslowice
Poland	Site PL48016 Prywatny Gabinet Urologiczny	Opole
Poland	Site PL48005 HEUREKA Hanna Szalecka	Piaseczno
Poland	Site PL48003 CSKMSW	Warsaw
Poland	Site PL48012 Military Institute of Medicine	Warsaw
Poland	Site PL48001 Specjalistyczny Gabinet Lekarski	Warszawa
Poland	Site PL48019 Synexus Polska sp. z o. o.	Wroclaw
Romania	Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov	Brasov
Romania	Site RO40001 Spiatlul Clinic Th. Burghele	Bucuresti
Romania	Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan	Bucuresti
Romania	Site RO40005 Spiatlul Clinic Th. Burghele	Bucuresti
Romania	Site RO40014 E-URO Cabinet	Cluj-Napoca
Romania	Site RO40007 Spital Clinic	Iasi
Romania	Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu	Sibiu
Romania	Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara	Timisoara
Russian Federation	Site RU70015 LLC Clinical Research Medical Complex	Kazan
Russian Federation	Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko	Penza
Russian Federation	Site RU70002 Pavlov St. Petersburg State Medical University	Saint Petersburg
Russian Federation	Site RU70019 City Multidisciplinary Hospital No. 2	Saint Petersburg
Russian Federation	Site RU70022 St. Petersburg State Public Health Institution	Saint Petersburg
Russian Federation	Site RU70014 OOO Hospital Orkli	St. Petersburg
Russian Federation	Site RU70018 Bashkirsky State Medical University of Roszdrav	Ufa
Singapore	Site SG65001 National University Hospital	Singapore
Singapore	Site SG65002 Singapore General Hospital	Singapore
Singapore	Site SG65003 KK Women's and Children's Hospital	Singapore
Slovakia	Site SK42105 Ruzinovska poliklinika a.s.	Bratislava
Slovakia	Site SK42101 Andrologicka a Urologicka Ambulancia	Kosice
Slovakia	Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.	Kosice
Slovakia	Site SK42103 UroExam s.r.o.	Nitra
Slovakia	Site SK42108 BrenCare, s. r. o.	Poprad
Slovakia	Site SK42104 Urology Outpatient Department	Presov
Slovakia	Site SK42102 CeGys, s.r.o.	Trencin
Slovakia	Site SK42106 Private Urological Care Center	Trencin
Slovenia	Site SI38604 General Hospital Murska Sobota	Murska Sobota
Slovenia	Site SI38602 General Hospital Novo Mesto	Novo Mesto
South Africa	Site ZA27005 Grootte Schuur Hospital	Cape Town
South Africa	Site ZA27001 Private Practice	Centurion
South Africa	Site ZA27006 Parklands Hospital	Durban
South Africa	Site ZA27013 Synexus Clinical Research SA (Pty) Ltd	Meyerspark
South Africa	Site ZA27007 Paarl Medical Centre	Paarl
South Africa	Site ZA27002 Mayo Clinic	Roodepoort
Spain	Site ES34010 Hospital del Henares	Coslada
Spain	Site ES34024 Hospital San Juan de Dios	Esplugues De Llobregat-Barcelo
Spain	Site ES34001 Hospital Universitario de Getafe	Getafe (Madrid)
Spain	Site ES34004 Hospital Infanta Leonor	Madrid
Spain	Site ES34005 Hospital de Fuenlabrada	Madrid
Spain	Site ES34006 Hospital San Rafael	Madrid
Spain	Site ES34009 Hospital Universitario La Paz	Madrid
Spain	Site ES34015 Hospital 12 de Octubre	Madrid
Spain	Site ES34003 Hospital Universitario Nuestra Señora de Valme	Sevilla
Spain	Site ES34007 Hospital Virgen del Rocio	Sevilla
Spain	Site ES34002 H. U. Politecnico La Fe	Valencia
Sweden	Site SE46007 Ladulaas Clinical Studies	Boras
Sweden	Site SE46025 Pharmasite	Helsingborg
Sweden	Site SE46005 Center för Läkemedelsstudier	Malmö
Sweden	Site SE46003 Danderyds Hospital	Stockholm
Sweden	Site SE46008 Bragée Medect AB	Stockholm
Sweden	Site SE46012 Karolinska University Hospital Huddinge	Stockholm
Sweden	Site SE46016 Citydiabetes - Stockholm	Stockholm
Sweden	Site SE46009 Encia AB, Uppsala Hälsomottagning	Uppsala
Sweden	Site SE46017 S3 Clinical Research Centers	Vällingby
Taiwan	Site TW88605 Taichung Veteran General Hospital	Taichung
Taiwan	Site TW88611 Chung Shan Medical University Hospital	Taichung
Taiwan	Site TW88612 Chi Mei Medical Center, Yong Kang	Tainan
Taiwan	Site TW88614 Tri-Service General Hospital	Taipei
Thailand	Site TH66002 Chulalongkorn Hospital	Bangkok
Thailand	Site TH66005 Siriraj Hospital	Bangkok
Thailand	Site TH66008 Phramongkutklao Hospital	Bangkok
Thailand	Site TH66010 Maharaj Nakorm Chiangmai Hosp	Chiang Mai
Thailand	Site TH66006 Songklanagarind Hospital, Prince of Songkla University	Hat Yai
Thailand	Site TH66009 Srinagarind Hospital	Khon Kaen
Thailand	Site TH66007 Thammasat University Hospital	Pathum Thani
Thailand	Site TH66011 Ramathibodi Hospital	Ratchathewi
Turkey	Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital	Ankara
Turkey	Site TR90013 Uludag University Faculty of Medicine	Bursa
Turkey	Site TR90001 Pamukkale University Faculty of Medicine	Denizli
Turkey	Site TR90017 Bilim University Sisli Florence Nightingale Hospital	Istanbul
Ukraine	Site UA38002 City Hospital No 2	Chernigov
Ukraine	Site UA38015 Regional Municipal Institution, Urology Department	Chernivtsi
Ukraine	Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov	Dnipropetrovsk
Ukraine	Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology	Kharkiv
Ukraine	Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric	Kiev
Ukraine	Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3	Kyiv
Ukraine	Site UA38010 Academy of Medical Sciences of Ukraine	Kyiv
Ukraine	Site UA38014 Uzhgorod City Polyclinic	Uzhorod
Ukraine	Site UA38004 Vinnitsa Endocrinology Dispens	Vinnytsya
Ukraine	Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic	Zaporizhzhya
United Kingdom	Site GB44003 Leighton Hospital	Crewe
United Kingdom	Site GB44009 Sheepcot Medical Centre	Garston	Watfort
United Kingdom	Site GB44021 Medway Hospital	Gillingham
United Kingdom	Site GB44005 North West London Hosp Menopause Clinic	Harrow
United Kingdom	Site GB44024 St James's University Hospital	Leeds
United Kingdom	Site GB44025 Kings College Hospital	London
United Kingdom	Site GB44006 Derriford Hospital	Plymouth
United Kingdom	Site GB44022 The Royal Berkshire Hospital	Reading
United Kingdom	Site GB44001 Royal Hallamshire Hospital	Sheffield
United States	Site US10077 Northeast Urogynecology	Albany	New York
United States	Site US10011 Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Site US10015 Urology Group of New Mexico	Albuquerque	New Mexico
United States	Site US10037 Atlanta Medical Research Institute	Alpharetta	Georgia
United States	Site US10122 Orange County Research Institute	Anaheim	California
United States	Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc	Austin	Texas
United States	Site US10008 Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Site US10110 Montana Health Research Institute, Inc.	Billings	Montana
United States	Site US10282 Boston Clinical Trials	Boston	Massachusetts
United States	Site US10060 Meridien Research	Bradenton	Florida
United States	Site US10089 Maimonides Medical Center	Brooklyn	New York
United States	Site US10013 Seattle Urology Research Center	Burien	Washington
United States	Site US10066 Texas Urology PA	Carrollton	Texas
United States	Site US10098 Skyline Research	Cerritos	California
United States	Site US10104 Clinical Research Advantage, Inc.	Chandler	Arizona
United States	Site US10166 Medical University of South Carolina	Charleston	South Carolina
United States	Site US10050 Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Site US10076 Carolina Clinical Trials	Concord	North Carolina
United States	Site US10065 Advanced Research Associates	Corpus Christi	Texas
United States	Site US10128 Clinical Research Center of CT	Danbury	Connecticut
United States	Site US10034 Urology Center of Colorado	Denver	Colorado
United States	Site US10002 Urology Center Research Institute	Englewood	New Jersey
United States	Site US10026 AccuMed Research Associates	Garden City	New York
United States	Site US10558 Chesapeake Urology Research Associates	Glen Burnie	Maryland
United States	Site US10539 Citrus Valley Medical Research	Glendora	California
United States	Site US10152 Female Pelvic Medicine & Urogynecology Institute	Grand Rapids	Michigan
United States	Site US10094 University Medical Group	Greer	South Carolina
United States	Site US10082 American Clinical Trials	Hawaiian Gardens	California
United States	Site US10097 A.G.A. Clinical Trials DBA Neostart Group	Hialeah	Florida
United States	Site US10148 Best Quality Research, Inc.	Hialeah	Florida
United States	Site US10153 Palmetto Professional Research	Hialeah	Florida
United States	Site US10159 Urological Research Network	Hialeah	Florida
United States	Site US10534 South Florida Medical Research	Hialeah	Florida
United States	Site US10535 South Florida Medical Research	Homestead	Florida
United States	Site US10085 Centex Studies, Inc.	Houston	Texas
United States	Site US10093 Pioneer Research Solutions, Inc.	Houston	Texas
United States	Site US10108 Clinical Trial Network	Houston	Texas
United States	Site US10219 Methodist Urology Associates	Houston	Texas
United States	Site US10090 Protenium Clinical Research, LLC	Hurst	Texas
United States	Site US10165 East Coast Institute for Research	Jacksonville	Florida
United States	Site US10091 Health Awareness	Jupiter	Florida
United States	Site US10006 Holston Medical Group	Kingsport	Tennessee
United States	Site US10040 Premier Medical Group Of The Hudson Valley	Kingston	New York
United States	Site US10088 Centex Studies, Inc.	Lake Charles	Louisiana
United States	Site US10070 Physicians' Research Options/Red Rocks OB/GYN	Lakewood	Colorado
United States	Site US10045 Lancaster Urology	Lancaster	Pennsylvania
United States	Site US10140 IVCTLV	Las Vegas	Nevada
United States	Site US10047 Lawrence OBGYN Associates	Lawrenceville	New Jersey
United States	Site US10051 AdvancedMed Research	Lawrenceville	New Jersey
United States	Site US10553 Women's Clinic of Lincoln	Lincoln	Nebraska
United States	Site US10132 Axis Clinical Trials	Los Angeles	California
United States	Site US10133 Axis Clinical Trials	Los Angeles	California
United States	Site US10033 Ohio Clinical Research	Lyndhurst	Ohio
United States	Site US10541 Sunstone Medical Research	Medford	Oregon
United States	Site US10074 Medpharmics, LLC	Metairie	Louisiana
United States	Site US10154 Montana Medical Research Inc	Missoula	Montana
United States	Site US10049 Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Site US10112 TFI, LLC	Mobile	Alabama
United States	Site US10162 Phoenix OB-GYN Associates, LLC	Moorestown	New Jersey
United States	Site US10046 Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Site US10079 PMG Research of Charleston, LLC	Mount Pleasant	South Carolina
United States	Site US10004 Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	Site US10117 Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Site US10018 Grove Hill Clinical Research	New Britain	Connecticut
United States	Site US10170 Yale - New Haven Hospital West Haven VAMC	New Haven	Connecticut
United States	Site US10150 Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Site US10073 Manhattan Medical Research Practice, PLLC	New York	New York
United States	Site US10168 Weill Cornell Medical College	New York	New York
United States	Site US10249 New York Clinical Trials	New York	New York
United States	Site US10126 Premier Medical Group	Newburgh	New York
United States	Site US10158 Renstar Medical Research	Ocala	Florida
United States	Site US10109 Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Site US10124 Winter Park Urology Associates	Orlando	Florida
United States	Site US10134 Compass Research, LLC	Orlando	Florida
United States	Site US10560 Chesapeake Urology Research Associates	Owings Mills	Maryland
United States	Site US10536 Stanford School of Medicine	Palo Alto	California
United States	Site US10149 Bayview Research Group	Paramount	California
United States	Site US10009 South Broward Research	Pembroke Pines	Florida
United States	Site US10540 Demaur Clinical Research, INC	Pembroke Pines	Florida
United States	Site US10017 Philadelphia Clinical Research, LLC	Philadelphia	Pennsylvania
United States	Site US10021 Beach Clinical Studies	Phoenix	Arizona
United States	Site US10167 University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Site US10248 Preferred Primary Care Physicians, Inc	Pittsburgh	Pennsylvania
United States	Site US10250 Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Site US10554 Private Practice	Plantation	Florida
United States	Site US10028 Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Site US10129 PMG Research of Raleigh	Raleigh	North Carolina
United States	Site US10549 Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Site US10032 National Clinical Research Inc.	Richmond	Virginia
United States	Site US10127 Perimeter North Medical Research, Inc.	Roswell	Georgia
United States	Site US10559 UC Davis Medical Center	Sacramento	California
United States	Site US10105 Clinical Trials of Texas	San Antonio	Texas
United States	Site US10111 Clinical Trials of Texas	San Antonio	Texas
United States	Site US10003 San Diego Clinical Trials	San Diego	California
United States	Site US10545 San Diego Institute for Sexual Medicine	San Diego	California
United States	Site US10092 Physicians' Research Options/Salt Lake Women's Center	Sandy	Utah
United States	Site US10120 WR-Mount Vernon Clinical Research	Sandy Springs	Georgia
United States	Site US10095 Florida Urology Specialists	Sarasota	Florida
United States	Site US10542 Adult & Pediatric Urology Group	Sartell	Minnesota
United States	Site US10155 Seattle Women's Health, Research, Gynecology	Seattle	Washington
United States	Site US10024 GTC Research	Shawnee Mission	Kansas
United States	Site US10025 Regional Urology, LLC	Shreveport	Louisiana
United States	Site US10023 Hillcrest Clinical Research, LLC	Simpsonville	South Carolina
United States	Site US10101 Palmetto Clinical Research	Summerville	South Carolina
United States	Site US10010 Southeastern Research Group, Inc	Tallahassee	Florida
United States	Site US10106 West Coast Clinical Research	Tarzana	California
United States	Site US10063 Preferred Primary Care Physician Research	Uniontown	Pennsylvania
United States	Site US10595 Bayview Research Group	Valley Village	California
United States	Site US10064 The Group for Women	Virginia Beach	Virginia
United States	Site US10083 Urology of Virginia, PLLC.	Virginia Beach	Virginia
United States	Site US10067 Family Practice Center of Wadsworth	Wadsworth	Ohio
United States	Site US10135 Walla Walla Clinic	Walla Walla	Washington
United States	Site US10123 Chase Medical Research, LLC	Waterbury	Connecticut
United States	Site US10114 Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Site US10014 Private Practice	Wellington	Florida
United States	Site US10551 The Christ Hospital	West Chester	Ohio
United States	Site US10012 Advanced Clinical Concepts	West Reading	Pennsylvania
United States	Site US10053 Western Clinical Research, Inc.	Wheat Ridge	Colorado
United States	Site US10078 Heartland Research Associates, LLC	Wichita	Kansas
United States	Site US10593 Upstate Clinical Research Associates LLC	Williamsville	New York
United States	Site US10062 Piedmont Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Colombia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change From Baseline to EoT in Mean Volume Voided Per Micturition	The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.	Baseline and EoT (up to 12 weeks)
Secondary	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	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)
Secondary	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours		Baseline and weeks 4, 8 and 12
Secondary	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours		Baseline and weeks 4, 8 and 12
Secondary	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition		Baseline and weeks 4, 8 and 12
Secondary	Change From Baseline to EoT in Corrected Micturition Frequency	Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.	Baseline and Week 12
Secondary	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes		Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	The mean number of urgency 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 prior to each visit.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency 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 prior to each visit.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes		Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Number of Pads Used at Weeks 4, 8, 12 and EoT	The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.	Weeks 4, 8 and 12 (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used		Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.	Baseline and weeks 4, 8 and 12 (up to 12 weeks)
Secondary	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.	Weeks 4, 8,12 and EoT (up to 12 weeks)
Secondary	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.	Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.	Baseline and weeks 4, 8 and 12
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).	Week 12 and EoT (up to 12 weeks)
Secondary	PGIC Scale: Impression in General Health at Week 12 and EoT	The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).	Week 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).	Baseline and EoT (up to 12 weeks)
Secondary	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.	Baseline and week 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working		Baseline and week 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment		Baseline and week 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment		Baseline and week 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.	Baseline and week 4, 8 and 12
Secondary	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants With = 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	The percentage of participants with = 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants With = 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	The percentage of participants with = 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	The percentage of participants with = 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	The percentage of participants with micturition frequency normalization was defined as any participant who had = 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.	Weeks 4, 8 , 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants With = 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	The percentage of participants with = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants With Major (= 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	The percentage of participants with a major (= 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by = 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by = 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by = 10 points) on the OAB-q Symptom Bother score, and = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by = 10 points) on the HRQL total score, and = 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.	Weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.	From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)
Secondary	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	PVR volume was assessed by ultrasonography or a bladder scanner.	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)
Secondary	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.	Baseline and weeks 4, 12 and EoT (up to 12 weeks)

External Links

•   Link to results on the Astellas Clinical Study Results website