A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder (SYNERGY II)
August 16, 2018 updated by: Astellas Pharma Europe B.V.
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder
The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1829
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Broadmeadow, New South Wales, Australia, 2292
- Site AU61005
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Randwick, New South Wales, Australia, 2031
- Site AU61007
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Randwick, New South Wales, Australia, 2031
- Site AU61021
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Wollongong, New South Wales, Australia, 2522
- Site AU61011
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Queensland
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Brisbane, Queensland, Australia, 4152
- Site AU61022
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Nambour, Queensland, Australia, 4560
- Site AU61010
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Sherwood, Queensland, Australia, 4075
- Site AU61019
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South Australia
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Daw Park, South Australia, Australia, 5041
- Site AU61015
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Victoria
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Footscray, Victoria, Australia, 3011
- Site AU61025
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Parkville, Victoria, Australia, 3052
- Site AU61002
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Western Australia
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Perth, Western Australia, Australia, 6009
- Site AU61004
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Gent, Belgium, 9000
- Site BE32004
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Roeselare, Belgium, 8800
- Site BE32014
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Sint-Truiden, Belgium, 3800
- Site BE32012
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Plovdiv, Bulgaria, 4003
- Site BG35908
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Ruse, Bulgaria, 7000
- Site BG35902
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Sofia, Bulgaria, 1431
- Site BG35905
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Sofia, Bulgaria, 1606
- Site BG35903
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Montreal, Canada, H2R 1V6
- Site CA15040
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Quebec, Canada, G1S 2L6
- Site CA15025
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Alberta
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Edmonton, Alberta, Canada, T5G 0B7
- Site CA15035
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E1
- Site CA15033
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 3J8
- Site CA15008
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Site CA15001
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Brampton, Ontario, Canada, L6T 4S5
- Site CA15006
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Brantford, Ontario, Canada, N3S 6T6
- Site CA15003
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Kitchener, Ontario, Canada, N2N 2B9
- Site CA15007
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Toronto, Ontario, Canada, M4N 3M5
- Site CA15013
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Toronto, Ontario, Canada, M4S 1Y2
- Site CA15004
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Quebec
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Drummondville, Quebec, Canada, J2B 7T1
- Site CA15026
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Levis, Quebec, Canada, G6W 5M6
- Site CA15039
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Montreal, Quebec, Canada, H4N 3C5
- Site CA15020
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Sherbrooke, Quebec, Canada, J1H 1Z1
- Site CA15027
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Brno, Czechia, 602 00
- Site CZ42015
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Hradec Kralove, Czechia, 500 02
- Site CZ42003
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Hradec Kralove, Czechia, 50005
- Site CZ42001
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Olomouc, Czechia, 772 00
- Site CZ42010
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Ostrava, Czechia, 700 30
- Site CZ42014
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Plzen, Czechia, 32600
- Site CZ42005
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Praha 2, Czechia, 12808
- Site CZ42008
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Praha 4, Czechia, 140 00
- Site CZ42007
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Sternberk, Czechia, 78501
- Site CZ42013
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Uherske Hradiste, Czechia, 686 08
- Site CZ42009
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Usti nad Labem, Czechia, 40001
- Site CZ42006
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Aarhus, Denmark, 8200
- Site DK45013
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Parnu, Estonia, 80010
- Site EE37201
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Kouvola, Finland, 45200
- Site FI35801
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Bad Ems, Germany, 56130
- Site DE49008
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Duisburg, Germany, 47051
- Site DE49002
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Ganderkesee, Germany, 27777
- Site DE49010
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Halle (Saale), Germany, 06132
- Site DE49011
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Neustadt I. Sachsen, Germany, 01844
- Site DE49001
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Rostock, Germany, 18107
- Site DE49026
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Sangerhausen, Germany, 06526
- Site DE49014
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Bavaria
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Munich, Bavaria, Germany, 81377
- Site DE49034
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NRW
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Duisburg, NRW, Germany, 47179
- Site DE49032
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Northwest
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Bergisch Gladbach, Northwest, Germany, 51427
- Site DE49031
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Sachsen
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Leipzig, Sachsen, Germany, 04105
- Site DE49013
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Sachsen Anhalt
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Lutherstadt Eisleben, Sachsen Anhalt, Germany, 06295
- Site DE49003
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Bacs-Kiskun Megye
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Kecskemet, Bacs-Kiskun Megye, Hungary, 6000
- Site HU36007
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Baranya Megye
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Pecs, Baranya Megye, Hungary, 7621
- Site HU36005
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Csongrad Megye
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Csongrad, Csongrad Megye, Hungary, 6640
- Site HU36003
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Szentes, Csongrad Megye, Hungary, 6600
- Site HU36001
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Gyor-Moson Sopron
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Sopron, Gyor-Moson Sopron, Hungary, 9400
- Site HU36013
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Veszprem Megye
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Veszprem, Veszprem Megye, Hungary, 8200
- Site HU36012
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Ancona, Italy, 60126
- Site IT39022
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Avellino, Italy, 83100
- Site IT39007
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Latina, Italy, 04100
- SIte IT39001
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Milano, Italy, 20100
- Site IT39020
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Busan, Korea, Republic of, 602-715
- Site KR82006
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Busan, Korea, Republic of, 602-739
- Site KR82016
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Daegu, Korea, Republic of, 705-717
- Site KR82005
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Daegu, Korea, Republic of, 705-718
- Site KR82029
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Daejeon, Korea, Republic of, 301-721
- Site KR82019
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Incheon, Korea, Republic of, 405760
- Site KR82023
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Seoul, Korea, Republic of, 137-701
- Site KR82001
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Seoul, Korea, Republic of, 05505
- Site KR82003
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Seoul, Korea, Republic of, 100-380
- Site KR82021
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Seoul, Korea, Republic of, 110-744
- Site KR82020
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Seoul, Korea, Republic of, 120-752
- Site KR82030
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Seoul, Korea, Republic of, 134-701
- Site KR82013
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Seoul, Korea, Republic of, 134-872
- Site KR82017
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Seoul, Korea, Republic of, 135-710
- Site KR82002
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Seoul, Korea, Republic of, 135-720
- Site KR82008
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Seoul, Korea, Republic of, 136-075
- Site KR82015
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Gyeonggi-do
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Suwon-si, Gyeonggi-do, Korea, Republic of, 443-721
- Site KR82004
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Gyunggido
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Bucheon-Si, Gyunggido, Korea, Republic of, 420-767
- Site KR82014
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Seoul, Gyunggido, Korea, Republic of, 143-729
- Site KR82012
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Jeollabuk-do South Korea
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Jeonju-si, Jeollabuk-do South Korea, Korea, Republic of, 561-712
- Site KR82010
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Liepaja, Latvia, LV-3401
- Site LV37102
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Olaine, Latvia, LV-2114
- Site LV37103
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Riga, Latvia, LV-1002
- Site LV37105
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Kaunas, Lithuania, 47144
- Site LT37008
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Kaunas, Lithuania, 50009
- Site LT37004
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Kaunas, Lithuania, LT49449
- Site LT37011
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Klaipeda, Lithuania, LT-92288
- Site LT37012
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Vilnius, Lithuania, 10207
- Site LT37010
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Vilnius, Lithuania, LT-01118
- Site LT37003
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Vilnius, Lithuania, LT-08661
- Site LT37007
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Vilnius, Lithuania, LT-09108
- Site LT37009
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Petaling Jaya, Malaysia, 47500
- Site MY60002
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DF
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Mexico City, DF, Mexico, 06700
- Site MX52003
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Amsterdam, Netherlands, 1105 AZ
- Site NL31002
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Nijmegen, Netherlands, 6532 SZ
- Site NL31005
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Sneek, Netherlands, 8601 ZK
- Site NL31010
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NL
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Enschede, NL, Netherlands, 7513ER
- Site NL31006
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Nelson, New Zealand, 7010
- Site NZ64002
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Tauranga, New Zealand, 3140
- Site NZ64003
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Whangarei, New Zealand, 0112
- Site NZ64006
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Canterbury
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Christchurch, Canterbury, New Zealand, 8013
- Site NZ64001
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Alesund, Norway, 6003
- Site NO47007
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Hamar, Norway, 2317
- Site NO47006
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Lierskogen, Norway, 3420
- Site NO47008
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Bialystok, Poland, 15-351
- Site PL48018
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Chorzow, Poland, 41-500
- Site PL48013
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Gdynia, Poland, 81-384
- Site PL48014
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Lodz, Poland, 90-302
- Site PL48004
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Lublin, Poland, 20-632
- Site PL48010
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Myslowice, Poland, 41-400
- Site PL48011
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Opole, Poland, 45-086
- Site PL48016
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Piaseczno, Poland, 05-500
- Site PL48005
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Warsaw, Poland, 00-909
- Site PL48012
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Warszawa, Poland, 02-507
- Site PL48003
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Warszawa, Poland, 02-929
- Site PL48001
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Wrocław, Poland, 50-088
- Site PL48019
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Bucuresti, Romania, 042122
- Site RO40004
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Bucuresti, Romania, 50659
- Site RO40001
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Bucuresti, Romania, 50659
- Site RO40005
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Sibiu, Romania, 550245
- Site RO40010
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Timisoara, Romania, 300736
- Site RO40002
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Cluj
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Cluj-Napoca, Cluj, Romania, 400046
- Site RO40014
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Kazan, Russian Federation, 420097
- Site RU70015
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Penza, Russian Federation, 440026
- Site RU70023
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Saint Petersburg, Russian Federation, 197089
- Site RU70002
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Saint Petersburg, Russian Federation, 194354
- Site RU70019
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Saint Petersburg, Russian Federation, 198103
- Site RU70022
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St. Petersburg, Russian Federation, 199178
- Site RU70014
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Ufa, Russian Federation, 450096
- Site RU70018
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Singapore, Singapore, 169608
- Site SG65002
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Singapore, Singapore, 229899
- Site SG65003
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Bratislava, Slovakia, 82101
- Site SK42105
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Kosice, Slovakia, 04001
- Site SK42107
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Kosice, Slovakia, 04013
- Site SK42101
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Nitra, Slovakia, 949 01
- Site SK42103
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Poprad, Slovakia, 05801
- Site SK42108
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Prešov, Slovakia, 080 01
- Site SK42104
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Trencin, Slovakia, 91101
- Site SK42102
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Trencin, Slovakia, 91101
- Site SK42106
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Murska Sobota, Slovenia, 9000
- Site SI38604
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Gauteng
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Centurion, Gauteng, South Africa, 0157
- Site ZA27001
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Roodepoort, Gauteng, South Africa, 1709
- Site ZA27002
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Kwa Zulu Natal
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Durban, Kwa Zulu Natal, South Africa, 4001
- Site ZA27006
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Pretoria
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Meyerspark, Pretoria, South Africa, 0184
- Site ZA27013
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Western Cape
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Paarl, Western Cape, South Africa, 7646
- Site ZA27007
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Madrid, Spain, 28031
- Site ES34004
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Madrid, Spain, 28044
- Site ES34015
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Madrid, Spain, 28046
- Site ES34009
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Valencia, Spain, 46026
- Site ES34002
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Boras, Sweden, 506 30
- Site SE46007
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Malmo, Sweden, 211 52
- Site SE46005
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Stockholm, Sweden, 111 57
- Site SE46016
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Stockholm, Sweden, 141 86
- Site SE46012
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Stockholm, Sweden, 182 88
- Site SE46003
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Uppsala, Sweden, 753 19
- Site SE46009
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Bangkok, Thailand, 10400
- Site TH66008
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Khon Kaen, Thailand, 40002
- Site TH66009
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Cherenigiv, Ukraine, 14034
- Site UA38002
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Chernivtsi, Ukraine, 58002
- Site UA38015
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Dnepropetrovsk, Ukraine, 49005
- Site UA38013
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Kiev, Ukraine, 02232
- Site UA38007
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Kyiv, Ukraine, 02660
- Site UA38003
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Kyiv, Ukraine, 04053
- Site UA38010
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Zaporizhzhya, Ukraine, 69600
- Site UA38008
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Plymouth, United Kingdom, PL6 8DH
- Site GB44006
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Watford, United Kingdom, WD25 7NL
- Site GB44009
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S10 2JF
- Site GB44001
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Alabama
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Mobile, Alabama, United States, 36608
- Site US10049
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Mobile, Alabama, United States, 36608
- Site US10112
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Arizona
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Chandler, Arizona, United States, 85224
- Site US10104
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Phoenix, Arizona, United States, 85051
- Site US10021
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California
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Anaheim, California, United States, 92801
- Site US10122
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Hawaiian Gardens, California, United States, 90716
- Site US10082
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Los Angeles, California, United States, 90017
- Site US10132
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Los Angeles, California, United States, 90036
- Site US10133
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Paramount, California, United States, 90723
- Site US10149
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San Diego, California, United States, 92120
- Site US10003
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Tarzana, California, United States, 91356
- Site US10106
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Valley Village, California, United States, 91607
- Site US10595
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Colorado
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Wheat Ridge, Colorado, United States, 80033
- Site US10053
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Florida
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Bradenton, Florida, United States, 34208
- Site US10060
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Hialeah, Florida, United States, 33012
- Site US10097
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Hialeah, Florida, United States, 33016
- Site US10148
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Hialeah, Florida, United States, 33016
- Site US10153
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Jupiter, Florida, United States, 33458
- Site US10091
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New Port Richey, Florida, United States, 34652
- Site US10150
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Orlando, Florida, United States, 32803
- Site US10124
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Orlando, Florida, United States, 32806
- Site US10134
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Pembroke Pines, Florida, United States, 33027
- Site US10009
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Plantation, Florida, United States, 33317
- Site US10554
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Georgia
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Alpharetta, Georgia, United States, 30005
- Site US10037
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Roswell, Georgia, United States, 30076
- Site US10127
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Sandy Springs, Georgia, United States, 30328
- Site US10120
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Kansas
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Wichita, Kansas, United States, 67205
- Site US10078
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Louisiana
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Lake Charles, Louisiana, United States, 70601
- Site US10088
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Shreveport, Louisiana, United States, 71106
- Site US10025
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Maryland
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Hanover, Maryland, United States, 21076
- Site US10558
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Massachusetts
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Boston, Massachusetts, United States, 02131
- Site US10282
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Watertown, Massachusetts, United States, 02472
- Site US10114
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Montana
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Billings, Montana, United States, 59102
- Site US10110
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Missoula, Montana, United States, 59801
- Site US10154
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Site US10553
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New Jersey
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Englewood, New Jersey, United States, 07631
- Site US10002
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Lawrenceville, New Jersey, United States, 08648
- Site US10047
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Site US10011
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Albuquerque, New Mexico, United States, 87109
- Site US10015
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New York
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Garden City, New York, United States, 11530
- Site US10026
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Kingston, New York, United States, 12401
- Site US10040
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New York, New York, United States, 10065
- Site US10168
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Newburgh, New York, United States, 12550
- Site US10126
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Poughkeepsie, New York, United States, 12601
- Site US10028
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North Carolina
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Concord, North Carolina, United States, 28025
- Site US10076
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Raleigh, North Carolina, United States, 27609
- Site US10129
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Winston-Salem, North Carolina, United States, 27103
- Site US10062
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Ohio
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Cleveland, Ohio, United States, 44122
- Site US10050
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Wadsworth, Ohio, United States, 44281
- Site US10067
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Site US10109
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Oregon
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Medford, Oregon, United States, 97504
- Site US10541
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, United States, 19004
- Site US10008
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Philadelphia, Pennsylvania, United States, 19114
- Site US10017
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Pittsburgh, Pennsylvania, United States, 15213
- Site US10167
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Pittsburgh, Pennsylvania, United States, 15236
- Site US10250
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Pittsburgh, Pennsylvania, United States, 15243
- Site US10248
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Uniontown, Pennsylvania, United States, 15401
- Site US10063
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West Reading, Pennsylvania, United States, 19611
- Site US10012
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South Carolina
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Charleston, South Carolina, United States, 29425
- Site US10166
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Mount Pleasant, South Carolina, United States, 29464
- Site US10079
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Simpsonville, South Carolina, United States, 29681
- Site US10023
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Summerville, South Carolina, United States, 29485
- Site US10101
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Site US10006
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Texas
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Corpus Christi, Texas, United States, 78414
- Site US10065
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Houston, Texas, United States, 77058
- Site US10085
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Houston, Texas, United States, 77094
- Site US10219
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Houston, Texas, United States, 77099
- Site US10093
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Hurst, Texas, United States, 76054
- Site US10090
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San Antonio, Texas, United States, 78229
- Site US10105
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San Antonio, Texas, United States, 78229
- Site US10111
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Virginia
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Virginia Beach, Virginia, United States, 23462
- Site US10083
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Washington
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Burien, Washington, United States, 98166
- Site US10013
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Mountlake Terrace, Washington, United States, 98043
- Site US10004
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Seattle, Washington, United States, 98105
- Site US10155
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Walla Walla, Washington, United States, 99362
- Site US10135
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Main Inclusion at Screening (Visit 1):
- Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months);
- 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;
Main Inclusion at Randomization (Visit 2):
- Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition).
- Subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period.
- Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period.
Exclusion Criteria:
Main Exclusion at Screening (Visit 1):
- Subject had clinically significant bladder outflow obstruction at risk of urinary retention;
- Subject had significant PVR volume (> 150 mL);
- Subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor;
- Subject has an indwelling catheter or practices intermittent self-catheterization;
- Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
- Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
Main Exclusion at Randomization (Visit 2):
- Subject had evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite).
- Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Mirabegron 50 mg
Participants received mirabegron 50 mg once a day for 52 weeks.
|
Participants received mirabegron 50 mg orally once a day at the same time each day.
Other Names:
Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day.
This intervention was given to maintain the blind during the study.
|
|
ACTIVE_COMPARATOR: Solifenacin 5 mg
Participants received solifenacin 5 mg once a day for 52 weeks.
|
Participants received solifenacin 5 mg orally once a day at the same time each day.
Other Names:
Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day.
This intervention was given to maintain the blind during the study.
|
|
EXPERIMENTAL: Solifenacin 5 mg + Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
|
Participants received mirabegron 50 mg orally once a day at the same time each day.
Other Names:
Participants received solifenacin 5 mg orally once a day at the same time each day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
|
A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs).
This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion.
The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).
|
From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
|
|
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Time Frame: Baseline and Week 52
|
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 in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.
|
Baseline and Week 52
|
|
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline and Week 52
|
A micturition was defined as any voluntary urination (excluding incontinence only episodes).
The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.
|
Baseline and Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline to EoT in Mean Volume Voided Per Micturition
Time Frame: Baseline and Week 52
|
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 Week 52
|
|
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Time Frame: Baseline and Week 52
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL).
The symptom bother portion consists 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 Week 52
|
|
Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
Time Frame: Baseline and Week 52
|
The TS-VAS is a visual analogue scale which asks 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 52
|
|
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 in a micturition diary for 7 days prior to the baseline and prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Months 1, 3, 6, 9, 12
|
An incontinence episode was defined as the complaint of any involuntary leakage of urine.
The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
|
Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
An incontinence episode was defined as the complaint of any involuntary leakage of urine.
The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Months 1, 3, 6, 9, 12
|
The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.
|
Months 1, 3, 6, 9, 12
|
|
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Months 1, 3, 6, 9, 12
|
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.
|
Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency.
The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Months 1, 3, 6, 9, 12
|
An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency.
The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
|
Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
A micturition was defined as any voluntary urination (excluding incontinence only episodes).
The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
Time Frame: Months 1, 3, 6, 9, 12
|
The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.
|
Months 1, 3, 6, 9, 12
|
|
Change From Baseline to EoT in Corrected Micturition Frequency
Time Frame: Baseline and Month 12
|
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.
Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.
|
Baseline and Month 12
|
|
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
Time Frame: Baseline and Months 3, 6, 12
|
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 prior to each visit.
|
Baseline and Months 3, 6, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer.
An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake).
The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Months 1, 3, 6, 9, 12
|
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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit.
|
Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Months 1, 3, 6, 9, 12
|
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
|
Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL).
The symptom bother portion consists 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 Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6.
The total 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 Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6.
HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life.
A positive change from baseline indicated an improvement.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6.
HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life.
A positive change from baseline indicated an improvement.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6.
HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life.
A positive change from baseline indicated an improvement.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6.
HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life.
A positive change from baseline indicated an improvement.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The TS-VAS is a visual analogue scale which asks 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 Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The PPBC is 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 Months 1, 3, 6, 9, 12
|
|
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
Time Frame: Month 12
|
The PGIC is 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).
|
Month 12
|
|
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
Time Frame: Month 12
|
The PGIC is 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).
|
Month 12
|
|
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
Time Frame: Baseline and 12 Months
|
The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
|
Baseline and 12 Months
|
|
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care
Time Frame: Baseline and Month 12
|
The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
|
Baseline and Month 12
|
|
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
Time Frame: Baseline and Month 12
|
The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
|
Baseline and Month 12
|
|
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
Time Frame: Baseline and Month 12
|
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
|
Baseline and Month 12
|
|
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
Time Frame: Baseline and Month 12
|
The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
|
Baseline and Month 12
|
|
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
Time Frame: Baseline and Months 6,12
|
The WPAI:SHP is 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 are 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 Months 6,12
|
|
Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
Time Frame: Baseline and Months 6, 12
|
The WPAI:SHP is 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 are 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 Months 6, 12
|
|
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
Time Frame: Baseline and Months 6, 12
|
The WPAI:SHP is 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 arre 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 Months 6, 12
|
|
Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
Time Frame: Baseline and Months 6, 12
|
The WPAI:SHP is 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 are 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 Months 6, 12
|
|
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Months 1, 3, 6, 9, 12
|
An incontinence episode was defined as the complaint of any involuntary leakage of urine.
The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.
|
Months 1, 3, 6, 9, 12
|
|
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The symptom bother portion consists 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 Months 1, 3, 6, 9, 12
|
|
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6.
The total 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 Months 1, 3, 6, 9, 12
|
|
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 in a micturition diary for 7 days prior to each visit.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Months 1, 3, 6, 9, 12
|
An incontinence episode was defined as the complaint of any involuntary leakage of urine.
The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.
|
Months 1, 3, 6, 9, 12
|
|
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.
|
Baseline and Months 1, 3, 6, 9, 12
|
|
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The PPBC is 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 Months 1, 3, 6, 9, 12
|
|
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The PPBC is 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 Months 1, 3, 6, 9, 12
|
|
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 Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 in a micturition diary for 7 days prior to each visit.
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The symptom bother portion consists 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 Months 1, 3, 6, 9, 12
|
|
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 Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 in a micturition diary for 7 days prior to each visit.
The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL.
The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6.
The total 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 Months 1, 3, 6, 9, 12
|
|
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 Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
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 in a micturition diary for 7 days prior to each visit.
The PPBC is 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 Months 1, 3, 6, 9, 12
|
|
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
The symptom bother portion of the OAB-q consists 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.The PPBC is 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 Months 1, 3, 6, 9, 12
|
|
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6.
The total 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.The PPBC is 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 Months 1, 3, 6, 9, 12
|
|
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume
Time Frame: Baseline and Months 1, 3, 6, 9, 12
|
PVR volume was assessed by ultrasonography or a bladder scanner.
|
Baseline and Months 1, 3, 6, 9, 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 17, 2014
Primary Completion (ACTUAL)
September 8, 2016
Study Completion (ACTUAL)
September 8, 2016
Study Registration Dates
First Submitted
January 23, 2014
First Submitted That Met QC Criteria
January 23, 2014
First Posted (ESTIMATE)
January 27, 2014
Study Record Updates
Last Update Posted (ACTUAL)
September 13, 2018
Last Update Submitted That Met QC Criteria
August 16, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Urologic Diseases
- Urinary Bladder Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-3 Receptor Agonists
- Mirabegron
- Solifenacin Succinate
Other Study ID Numbers
- 178-CL-102
- 2012-005736-29 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
The research proposal is reviewed by an Independent Research Panel.
If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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