Overactive Bladder Clinical Trial
— SYNERGYOfficial 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
| Verified date | October 2018 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| 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 | |
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| 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 | |
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| Czechia | Site CZ42003 SANUS | Hradec Kralove | |
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| Czechia | Site CZ42013 Urology Clinic | Sternberk | |
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| Germany | Site DE49031 Urologisches Zentrum Refrath | Bergisch Gladbach | |
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| Germany | Site DE49032 Urologicum Duisburg | Duisburg | |
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| Germany | Site DE49026 Zentrum fuer Onkologie und Urologie Rostock | Rostock | |
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| 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 | |
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| 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 | |
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| 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 | |
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| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Europe B.V. |
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,
| 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) |
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