SCORPIO: Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00689104

Collaborator

(none)

2,336

Enrollment

219

Locations

Arms

10.8

Actual Duration (Months)

10.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder, Overactive	Drug: Mirabegron Drug: Tolterodine Drug: Placebo to Mirabegron Drug: Placebo to Tolterodine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

2336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder

Actual Study Start Date :

Apr 28, 2008

Actual Primary Completion Date :

Mar 24, 2009

Actual Study Completion Date :

Mar 24, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Drug: Placebo to Mirabegron Matching mirabegron placebo tablets. Drug: Placebo to Tolterodine Matching tolterodine placebo capsules.
Experimental: Mirabegron 50 mg Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Drug: Mirabegron Tablets Other Names: Myrbetriq YM178 Drug: Placebo to Tolterodine Matching tolterodine placebo capsules.
Experimental: Mirabegron 100 mg Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Drug: Mirabegron Tablets Other Names: Myrbetriq YM178 Drug: Placebo to Tolterodine Matching tolterodine placebo capsules.
Active Comparator: Tolterodine SR 4 mg Participants received tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.	Drug: Tolterodine Capsules Drug: Placebo to Mirabegron Matching mirabegron placebo tablets.

Outcome Measures

Primary Outcome Measures

Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours [Baseline and Week 12 (final visit)]
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours [Baseline and Week 12]
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Secondary Outcome Measures

Change From Baseline to Final Visit in Mean Volume Voided Per Micturition [Baseline and Week 12]
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours [Baseline and Week 4]
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours [Baseline and Week 4]
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours [Baseline and Weeks 8 and 12]
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours [Baseline and Weeks 8 and 12]
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition [Baseline and Weeks 4, 8 and 12]
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours [Baseline and Weeks 4, 8 and 12]
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours [Baseline and Weeks 4, 8 and 12]
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency [Baseline and Weeks 4, 8 and 12]
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours [Baseline and Weeks 4, 8 and 12]
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours [Baseline and Weeks 4, 8 and 12]
The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit [Weeks 4, 8 and 12]
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit [Baseline and Weeks 4, 8 and 12]
The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score [Baseline and Weeks 4, 8 and 12]
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score [Baseline and Weeks 4, 8 and 12]
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed [Baseline and Week 12]
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working [Baseline and Week 12]
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment [Baseline and Week 12]
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment [Baseline and Week 12]
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score [Baseline and Week 12]
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score [Baseline and Week 12]
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score [Baseline and Week 12]
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score [Baseline and Week 12]
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score [Baseline and Week 12]
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) [Baseline and Weeks 4, 8 and 12]
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) [Baseline and Week 12]
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) [Baseline and Week 12]
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician [Baseline and Weeks 4, 8 and 12]
The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit [Baseline and Week 12]
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is willing and able to complete the micturition diary and questionnaires correctly
Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period

Exclusion Criteria:

Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
Subject has an indwelling catheter or practices intermittent self-catheterization
Subject has diabetic neuropathy
Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Subject receives non-drug treatment including electro-stimulation therapy
Subject has severe hypertension
Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
Subject has serum creatinine >150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) > 3x ULN
Subject has a clinically significant abnormal electrocardiogram (ECG)

Contacts and Locations

Locations

	City	Country	Postal Code
1	Auchenflower	Australia
2	Clayton	Australia
3	Kogarah	Australia
4	Randwick	Australia
5	Woolloongabba	Australia
6	Graz	Austria	8036
7	Innsbruck	Austria	6020
8	Linz	Austria	4020
9	Minsk	Belarus	220036
10	Minsk	Belarus	220119
11	Minsk	Belarus	223041
12	Antwerp	Belgium	2020
13	Antwerp	Belgium	2030
14	Brussels	Belgium	1070
15	Brussels	Belgium	1090
16	Edegem	Belgium	2650
17	Gent	Belgium	9000
18	Kortrijk	Belgium	8500
19	Leper	Belgium	8900
20	Leuven	Belgium	3000
21	Liege	Belgium	4000
22	Sint Truiden	Belgium	3800
23	Pleven	Bulgaria
24	Sofia	Bulgaria
25	Varna	Bulgaria
26	Brno	Czechia	60200
27	Melnik	Czechia	27601
28	Olomouc	Czechia	77200
29	Ostrava-Poruba	Czechia	70853
30	Plzen	Czechia	30599
31	Prague	Czechia	12851
32	Prague	Czechia	14056
33	Prague	Czechia	18081
34	Steti	Czechia	41108
35	Usti nad Labem	Czechia	40001
36	Aalborg	Denmark	9100
37	Aarhus	Denmark	8200
38	Glostrup	Denmark	2600
39	Roskilde	Denmark
40	Helsinki	Finland	00029
41	Oulu	Finland	90220
42	Tampere	Finland	33521
43	Turku	Finland	20100
44	Bordeaux	France	33076
45	Colmar	France	68024
46	Marseille Cedex 9	France	13274
47	Marseille	France	13285
48	Mulhouse	France	68070
49	Nantes	France	45035
50	Nimes Cedex 9	France	30029
51	Orleans Cedex 2	France	45067
52	Paris-Cedex 12	France	75571
53	Paris	France	75020
54	Rouen	France	76031
55	Saint Priest en Jarez	France	42055
56	Strasbourg	France	67000
57	Toulouse Cedex 9	France	31059
58	Aichach	Germany	86551
59	Bad Ems	Germany	56130
60	Bautzen	Germany	02625
61	Berlin	Germany	13347
62	Duisburg	Germany	47051
63	Frankfurt	Germany	65933
64	Ganderkesee	Germany	27777
65	Hagenow	Germany	19230
66	Halle/Saale	Germany	06132
67	Hamburg	Germany	20253
68	Henningsdorf	Germany	16761
69	Hettstedt	Germany	06333
70	Koblenz	Germany	56068
71	Leipzig	Germany	04105
72	Lutherstadt Eisleben	Germany	06295
73	Muenchen-Bogenhausen	Germany	81925
74	Neustadt I. Sachsen	Germany	01844
75	Oranienburg	Germany	16151
76	Radebeul	Germany	01445
77	Sangerhausen	Germany	06526
78	Trier	Germany	54290
79	Uetersen	Germany	25436
80	Athens	Greece
81	Nikaias-Piraeus	Greece
82	Patras	Greece
83	Thessaloniki	Greece
84	Budapest	Hungary	1047
85	Budapest	Hungary	1076
86	Budapest	Hungary	1204
87	Debrecen	Hungary	4043
88	Eger	Hungary	3300
89	Nyiregyhaza	Hungary	4400
90	Papa	Hungary
91	Sopron	Hungary
92	Szeged	Hungary	6725
93	Szekesfehervar	Hungary	8000
94	Szekszard	Hungary	7100
95	Tatabanya	Hungary	2800
96	Veszprem	Hungary	8200
97	Reykjavik	Iceland	101
98	Cork	Ireland
99	Dublin 9	Ireland
100	Dublin	Ireland
101	Mullingar	Ireland
102	Tralee	Ireland
103	Bari	Italy	70124
104	Catanzaro	Italy	88100
105	Florence	Italy	50139
106	Florence	Italy	59129
107	Genoa	Italy	16128
108	Latina	Italy	04100
109	Magenta	Italy	20013
110	Milan	Italy	20142
111	Milan	Italy	20153
112	Modena	Italy	41100
113	Naples	Italy	80131
114	Perugia	Italy	06122
115	Teramo	Italy	64100
116	Treviglio	Italy	24047
117	Varese	Italy	21100
118	Liepaja	Latvia
119	Riga	Latvia
120	Kaunas	Lithuania
121	Vilnius	Lithuania
122	Amsterdam	Netherlands	1105 AZ
123	Apeldoorn	Netherlands	7334 DZ
124	Apeldoorn	Netherlands
125	Eindhoven	Netherlands	5623 EJ
126	Enschede	Netherlands	7511 JX
127	Leiden	Netherlands	2334 CK
128	Maastricht	Netherlands	6229 HX
129	Nijmegen	Netherlands	6532 SZ
130	Sneek	Netherlands	8600 BA
131	Tilburg	Netherlands	5022 GC
132	Winterswijk	Netherlands	7101 BN
133	Bergen	Norway	5021
134	Drammen	Norway	3016
135	Hamar	Norway	2317
136	Oslo	Norway	0257
137	Tonsberg	Norway	3103
138	Bialystok	Poland	15-278
139	Chorzow	Poland	41-500
140	Lodz	Poland	93-338
141	Lodz	Poland	93-513
142	Lublin	Poland	20-954
143	Warsaw	Poland	00-846
144	Warsaw	Poland	02-005
145	Warsaw	Poland	02-507
146	Wroclaw	Poland	50-556
147	Amadora	Portugal	2700
148	Porto	Portugal	4099-005
149	Tomar	Portugal	2304-909
150	Viana do Castelo	Portugal	4900-858
151	Bucharest	Romania	22328
152	Bucharest	Romania
153	Lasi	Romania
154	Oradea	Romania
155	Timisoara	Romania
156	Moscow	Russian Federation	101000
157	Moscow	Russian Federation	105425
158	Moscow	Russian Federation	111020
159	Moscow	Russian Federation	111123
160	Moscow	Russian Federation	115516
161	Moscow	Russian Federation	117049
162	Moscow	Russian Federation	117815
163	Moscow	Russian Federation	119435
164	Moscow	Russian Federation	123836
165	Moscow	Russian Federation	125206
166	St. Petersburg	Russian Federation	197089
167	St. Petersburg	Russian Federation	198013
168	Martin	Slovakia	03659
169	Poprad	Slovakia	05801
170	Skalica	Slovakia	90982
171	Trencin	Slovakia	91101
172	Zilina	Slovakia	01207
173	Bloemfontein	South Africa
174	Hatfield	South Africa
175	Lyttelton	South Africa
176	Paarl	South Africa
177	Pietermaritzburg	South Africa
178	Barcelona	Spain	08020
179	Bilbao	Spain	48013
180	Esplugues De Llobregat-Barcelo	Spain	08950
181	Fuenlabrada	Spain	28942
182	Getafe	Spain	28905
183	Madrid	Spain	28016
184	Madrid	Spain	28046
185	Madrid	Spain
186	Mataro	Spain	8304
187	Miranda de Ebro	Spain	09200
188	Palma de Mallorca	Spain	07014
189	Sevilla	Spain	41013
190	Toledo	Spain	45071
191	Valencia	Spain	46010
192	Villareal	Spain	12540
193	Boras	Sweden	50182
194	Helsingborg	Sweden	25187
195	Orebro	Sweden	70185
196	Skovde	Sweden	54130
197	Stockholm	Sweden	11883
198	Stockholm	Sweden	14186
199	Stockholm	Sweden	17176
200	Stockholm	Sweden	18288
201	Umea	Sweden	90185
202	Uppsala	Sweden	75185
203	Frauenfeld	Switzerland	8501
204	Luzern	Switzerland	6000
205	Kiev	Ukraine	01023
206	Kiev	Ukraine	04053
207	Birmingham	United Kingdom	B15 2TG
208	Chorley	United Kingdom	PR7 7NA
209	Croydon	United Kingdom	CR7 7YE
210	Liverpool	United Kingdom	L22 OLG
211	London	United Kingdom	SE5 9RS
212	London	United Kingdom	W2 2YP
213	Manchester	United Kingdom	M15 6SX
214	Newcastle Upon Tyne	United Kingdom	NE7 7DN
215	Northwood	United Kingdom	HA6 2RN
216	Reading	United Kingdom	RG1 5AN
217	Reading	United Kingdom	RG2 7AG
218	Sheffield	United Kingdom	S10 2JF
219	Swansea	United Kingdom	SA6 6NL

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director: Central Contact, Astellas Pharma Europe B.V.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Link to results on Astellas Clinical Study Results website

Publications

Khullar V, Amarenco G, Angulo JC, Cambronero J, Høye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.

Responsible Party:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00689104

Other Study ID Numbers:

178-CL-046
2007-001451-19

First Posted:

Jun 3, 2008

Last Update Posted:

Dec 11, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Astellas Pharma Inc

Micturition

Urinary incontinence

Urinary urge incontinence

Overactive bladder (OAB)

Urgency

YM178

Frequency

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Mirabegron

Tolterodine Tartrate

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	After screening, 2336 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 1987 eligible patients were randomly assigned to receive placebo, mirabegron 50 mg, mirabegron 100 mg or tolterodine 4 mg for 12 weeks.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Period Title: Overall Study
STARTED	497	497	498	495
Safety Analysis Set (SAF)	494	493	496	495
Full Analysis Set (FAS)	480	473	478	475
Full Analysis Set Incontinence (FAS-I)	291	293	281	300
COMPLETED	453	440	453	445
NOT COMPLETED	44	57	45	50

Baseline Characteristics

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg	Total
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.	Total of all reporting groups
Overall Participants	494	493	496	495	1978
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.2 (12.30)	59.1 (12.36)	59.0 (12.71)	59.1 (12.89)	59.1 (12.56)
Sex: Female, Male (Count of Participants)
Female	356 72.1%	357 72.4%	355 71.6%	361 72.9%	1429 72.2%
Male	138 27.9%	136 27.6%	141 28.4%	134 27.1%	549 27.8%
Race/Ethnicity, Customized (participants) [Number]
White	490 99.2%	488 99%	492 99.2%	490 99%	1960 99.1%
Black or African American	2 0.4%	1 0.2%	1 0.2%	3 0.6%	7 0.4%
Asian	0 0%	2 0.4%	2 0.4%	2 0.4%	6 0.3%
Other	2 0.4%	2 0.4%	1 0.2%	0 0%	5 0.3%
Type of overactive bladder (OAB) (participants) [Number]
Urge Incontinence	204 41.3%	200 40.6%	188 37.9%	190 38.4%	782 39.5%
Mixed	106 21.5%	113 22.9%	119 24%	111 22.4%	449 22.7%
Frequency	184 37.2%	180 36.5%	189 38.1%	194 39.2%	747 37.8%
Duration of OAB symptoms (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	76.0 (91.38)	79.6 (87.14)	84.8 (94.12)	75.5 (92.20)	79.0 (91.25)
Mean number of micturitions per 24 Hours (micturitions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [micturitions]	11.72 (3.122)	11.64 (2.967)	11.49 (2.720)	11.53 (2.773)	11.59 (2.899)
Mean volume voided per micturition (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	156.8 (52.73)	160.3 (57.85)	158.9 (53.95)	157.4 (54.23)	158.3 (54.69)
Mean number of urgency episodes (grade 3 or 4) per 24 hours (urgency episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [urgency episodes]	5.72 (3.972)	5.68 (3.679)	5.95 (3.699)	5.79 (3.494)	5.79 (3.713)
Mean level of urgency (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	2.36 (0.563)	2.40 (0.547)	2.46 (0.528)	2.41 (0.561)	2.41 (0.551)
Mean number of nocturia episodes per 24 hours (nocturia episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nocturia episodes]	1.98 (1.405)	1.87 (1.294)	1.91 (1.374)	1.93 (1.417)	1.92 (1.373)
Mean number of pads used per 24 hours (pads) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pads]	1.12 (1.812)	1.12 (1.941)	1.25 (2.020)	1.04 (1.752)	1.13 (1.884)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
Description	The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Week 12 (final visit)

Outcome Measure Data

Analysis Population Description
The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	291	293	281	300
Least Squares Mean (Standard Error) [Incontinence episodes]	-1.17 (0.113)	-1.57 (0.113)	-1.46 (0.115)	-1.27 (0.112)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 50 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments	The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.
	Method	Stratified rank ANCOVA
	Comments	LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95% -0.72 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 100 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.010
	Comments	The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.
	Method	Stratified rank ANCOVA
	Comments	LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95% -0.61 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine SR 4 mg
	Comments	Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.11
	Comments	The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.
	Method	Stratified rank ANCOVA
	Comments	LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95% -0.42 to 0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
Description	The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Least Squares Mean (Standard Error) [micturitions]	-1.34 (0.110)	-1.93 (0.111)	-1.77 (0.110)	-1.59 (0.111)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 50 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.60
	Confidence Interval	(2-Sided) 95% -0.90 to -0.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 100 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 95% -0.74 to -0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine SR 4 mg
	Comments	Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.11
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95% -0.55 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
Description	The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The Full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	472	478	475
Least Squares Mean (Standard Error) [mL]	12.3 (1.99)	24.2 (2.01)	25.6 (2.00)	25.0 (2.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 50 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	11.9
	Confidence Interval	(2-Sided) 95% 6.3 to 17.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 100 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	13.2
	Confidence Interval	(2-Sided) 95% 7.7 to 18.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine SR 4 mg
	Comments	Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	12.6
	Confidence Interval	(2-Sided) 95% 7.1 to 18.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
Description	The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description
The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not utilized in this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	291	293	281	299
Least Squares Mean (Standard Error) [Incontinence episodes]	-0.65 (0.118)	-1.04 (0.118)	-1.03 (0.120)	-1.00 (0.117)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 50 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments	The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.
	Method	Stratified rank ANCOVA
	Comments	LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95% -0.71 to -0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 100 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments	The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.
	Method	Stratified rank ANCOVA
	Comments	LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95% -0.71 to -0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine SR 4 mg
	Comments	Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.019
	Comments	The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.
	Method	Stratified rank ANCOVA
	Comments	LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Method of Estimation	Estimation Parameter	LS mean Difference
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 95% -0.68 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
Description	The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description
The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	479	471	477	474
Least Squares Mean (Standard Error) [micturitions]	-0.77 (0.096)	-1.16 (0.097)	-1.29 (0.096)	-1.10 (0.096)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 50 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS mean Difference
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95% -0.66 to -0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Mirabegron 100 mg
	Comments	Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95% -0.79 to -0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine SR 4 mg
	Comments	Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.016
	Comments	LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95% -0.60 to -0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
Description	The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as "N". LOCF was not utilized.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	291	293	281	300
Week 8 [N=280; 277; 268; 292]	-1.00 (0.127)	-1.29 (0.128)	-1.40 (0.130)	-1.02 (0.125)
Week 12 [N=275; 272; 262; 276]	-1.18 (0.116)	-1.62 (0.117)	-1.45 (0.119)	-1.27 (0.116)

7. Secondary Outcome

Title	Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
Description	The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as "N". LOCF was not used in this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 8 [N=463; 450; 455; 461]	-1.15 (0.106)	-1.64 (0.107)	-1.66 (0.106)	-1.43 (0.106)
Week 12 [N=452; 437; 447; 438]	-1.33 (0.113)	-2.02 (0.115)	-1.78 (0.113)	-1.60 (0.114)

8. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
Description	The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as "N".

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=479; 470; 477; 474]	9.8 (1.73)	20.1 (1.75)	20.3 (1.74)	21.4 (1.74)
Week 8 [N=463; 449; 455; 461]	11.7 (1.97)	20.7 (2.00)	25.3 (1.99)	25.9 (1.97)
Week 12 [N=452; 437; 447; 438]	11.9 (2.07)	25.3 (2.11)	25.7 (2.08)	25.8 (2.10)

9. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Description	The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	291	293	281	300
Week 4 [N=283; 286; 276; 288]	-0.63 (0.108)	-0.98 (0.107)	-1.00 (0.109)	-1.01 (0.107)
Week 8 [N=273; 272; 263; 281]	-0.94 (0.118)	-1.27 (0.118)	-1.32 (0.120)	-0.99 (0.116)
Week 12 [N=269; 267; 257; 265]	-1.12 (0.111)	-1.52 (0.112)	-1.32 (0.114)	-1.19 (0.122)
Final Visit (LOCF) [N=283; 286; 276; 289]	-1.11 (0.110)	-1.46 (0.109)	-1.33 (0.111)	-1.18 (0.109)

10. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
Description	The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=475; 469; 471; 470]	-0.89 (0.138)	-1.39 (0.139)	-1.54 (0.138)	-1.63 (0.139)
Week 8 [N=460; 446; 450; 456]	-1.28 (0.152)	-1.90 (0.155)	-1.90 (0.154)	-1.91 (0.153)
Week 12 [N=450; 433; 441; 434]	-1.65 (0.154)	-2.35 (0.157)	-2.00 (0.155)	-2.16 (0.156)
Final Visit (LOCF) [N=479; 470; 474; 472]	-1.65 (0.151)	-2.25 (0.152)	-1.96 (0.151)	-2.07 (0.152)

11. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
Description	Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 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. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=476; 469; 472; 471]	-0.08 (0.023)	-0.19 (0.023)	-0.21 (0.023)	-0.21 (0.023)
Week 8 [N=460; 447; 451; 456]	-0.16 (0.027)	-0.26 (0.027)	-0.27 (0.027)	-0.25 (0.027)
Week 12 [N=450; 434; 442; 434]	-0.22 (0.029)	-0.33 (0.029)	-0.31 (0.029)	-0.30 (0.029)
Final Visit (LOCF) [N=480; 472; 475; 473]	-0.22 (0.028)	-0.31 (0.028)	-0.30 (0.028)	-0.29 (0.028)

12. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
Description	Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=428; 422; 422; 432]	-0.25 (0.045)	-0.27 (0.045)	-0.34 (0.045)	-0.29 (0.045)
Week 8 [N=414; 404; 403; 419]	-0.30 (0.047)	-0.41 (0.048)	-0.48 (0.048)	-0.39 (0.047)
Week 12 [N=404; 393; 395; 399]	-0.41 (0.048)	-0.57 (0.049)	-0.47 (0.049)	-0.44 (0.048)
Final Visit (LOCF) [N=428; 423; 422; 433]	-0.41 (0.047)	-0.56 (0.047)	-0.50 (0.047)	-0.45 (0.047)

13. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
Description	The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=209; 183; 195; 181]	-0.45 (0.103)	-0.73 (0.110)	-0.81 (0.107)	-0.67 (0.111)
Week 8 [N=204; 176; 183; 177]	-0.72 (0.116)	-1.02 (0.125)	-1.03 (0.122)	-0.77 (0.124)
Week 12 [N=200; 172; 181; 165]	-0.99 (0.117)	-1.26 (0.126)	-1.11 (0.123)	-0.95 (0.128)
Final Visit (LOCF) [N=209; 183; 195; 181]	-0.95 (0.115)	-1.17 (0.123)	-1.12 (0.119)	-0.95 (0.123)

14. Secondary Outcome

Title	Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit
Description	The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.
Time Frame	Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	291	293	281	300
Week 4 [N=291; 293; 281; 299]	28.9 5.9%	32.1 6.5%	32.0 6.5%	33.4 6.7%
Week 8 [N=280; 277; 268; 292]	34.3 6.9%	42.6 8.6%	45.1 9.1%	41.8 8.4%
Week 12 [N=275; 272; 262; 276]	41.1 8.3%	46.3 9.4%	43.9 8.9%	48.6 9.8%
Final Visit (LOCF) [N=291; 293; 281; 300]	40.5 8.2%	45.1 9.1%	43.8 8.8%	47.3 9.6%

15. Secondary Outcome

Title	Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
Description	The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	291	293	281	300
Week 4 [N=291; 293; 281; 299]	46.0 9.3%	57.3 11.6%	54.4 11%	56.5 11.4%
Week 8 [N=280; 277; 268; 292]	53.9 10.9%	67.9 13.8%	68.3 13.8%	64.4 13%
Week 12 [N=275; 272; 262; 276]	61.5 12.4%	73.5 14.9%	67.9 13.7%	69.6 14.1%
Final Visit (LOCF) [N=291; 293; 281; 300]	60.1 12.2%	72.2 14.6%	67.6 13.6%	68.3 13.8%

16. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
Description	Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=472; 460; 470; 467]	-9.7 (0.75)	-13.0 (0.76)	-13.8 (0.75)	-13.8 (0.76)
Week 8 [N=455; 441; 450; 451]	-13.3 (0.84)	-17.8 (0.85)	-17.6 (0.84)	-17.1 (0.84)
Week 12 [N=445; 424; 435; 433]	-15.3 (0.87)	-20.3 (0.89)	-20.0 (0.88)	-18.5 (0.88)
Final Visit (LOCF) [N=475; 465; 473; 469]	-14.9 (0.84)	-19.6 (0.85)	-19.9 (0.84)	-18.4 (0.85)

17. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
Description	Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was utilized for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as "N".

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=471; 463; 469; 467]	8.8 (0.68)	9.5 (0.68)	11.2 (0.68)	9.4 (0.68)
Week 8 [N=454; 446; 450; 453]	11.9 (0.76)	13.7 (0.76)	14.8 (0.76)	13.2 (0.76)
Week 12 [N=445; 426; 435; 432]	14.1 (0.79)	16.6 (0.80)	17.2 (0.80)	15.1 (0.80)
Final Visit (LOCF) [N=473; 468; 472; 470]	13.7 (0.76)	16.1 (0.77)	17.0 (0.77)	14.8 (0.77)

18. Secondary Outcome

Title	Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Description	The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 12 [N=111; 120; 109; 113]	-0.2 (7.31)	-1.9 (13.42)	-1.7 (18.83)	-1.2 (12.68)
Final Visit (LOCF) [N=113; 122; 110; 114]	-0.2 (7.24)	-1.8 (13.31)	-1.7 (18.74)	-1.2 (12.62)

19. Secondary Outcome

Title	Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Description	The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 12 [N=116; 128; 104; 114]	-8.3 (24.50)	-12.5 (23.24)	-10.8 (25.19)	-6.7 (28.40)
Final Visit (LOCF) [N=118; 130; 106; 115]	-8.1 (24.43)	-12.8 (23.24)	-10.8 (25.04)	-6.6 (28.28)

20. Secondary Outcome

Title	Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Description	The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 12 [N=104; 117; 98; 104]	-7.9 (23.86)	-13.2 (25.70)	-11.6 (27.09)	-5.8 (28.32)
Final Visit (LOCF) [N=106; 119; 99; 105]	-7.7 (23.79)	-13.6 (25.64)	-11.5 (26.97)	-5.8 (28.19)

21. Secondary Outcome

Title	Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Description	The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 12 [N=409; 395; 409; 400]	-11.2 (27.73)	-15.0 (27.93)	-14.5 (28.67)	-14.7 (29.50)
Final Visit (LOCF) [N=419; 400; 417; 409]	-11.0 (27.78)	-14.9 (27.84)	-14.4 (28.70)	-14.3 (29.70)

22. Secondary Outcome

Title	Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
Description	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
No problem -> No problem	334 67.6%	340 69%	334 67.3%	330 66.7%
No problem -> Some problems	27 5.5%	26 5.3%	18 3.6%	28 5.7%
No problem -> Confined to bed	0 0%	1 0.2%	0 0%	0 0%
No problem -> Missing data	2 0.4%	2 0.4%	1 0.2%	1 0.2%
Some problems -> No problems	37 7.5%	44 8.9%	40 8.1%	38 7.7%
Some problems -> Some problems	78 15.8%	59 12%	82 16.5%	73 14.7%
Some problems -> Confined to bed	0 0%	0 0%	0 0%	1 0.2%
Some problems -> Missing data	0 0%	0 0%	1 0.2%	0 0%
Confined -> No problems	0 0%	0 0%	0 0%	0 0%
Confined -> Some problems	0 0%	0 0%	0 0%	0 0%
Confined -> Confined to bed	0 0%	0 0%	0 0%	0 0%
Confined -> Missing data	0 0%	0 0%	0 0%	0 0%
Missing data -> No problem	2 0.4%	1 0.2%	2 0.4%	3 0.6%
Missing data -> Some problems	0 0%	0 0%	0 0%	1 0.2%
Missing data -> Confined to bed	0 0%	0 0%	0 0%	0 0%
Missing data -> Missing data	0 0%	0 0%	0 0%	0 0%

23. Secondary Outcome

Title	Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
Description	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
No problem -> No problem	437 88.5%	445 90.3%	439 88.5%	432 87.3%
No problem -> Some problems	7 1.4%	9 1.8%	17 3.4%	12 2.4%
No problem -> Unable to wash or dress myself	0 0%	0 0%	0 0%	1 0.2%
No problem -> Missing data	2 0.4%	2 0.4%	2 0.4%	1 0.2%
Some problems -> No problems	18 3.6%	9 1.8%	8 1.6%	9 1.8%
Some problems -> Some problems	14 2.8%	6 1.2%	10 2%	15 3%
Some problems -> Unable to wash or dress myself	0 0%	0 0%	0 0%	0 0%
Some problems -> Missing data	0 0%	0 0%	0 0%	0 0%
Unable to wash or dress myself -> No problems	1 0.2%	0 0%	0 0%	0 0%
Unable to wash or dress myself -> Some problems	0 0%	1 0.2%	1 0.2%	0 0%
Unable to wash or dress -> Unable to wash or dress	0 0%	0 0%	0 0%	0 0%
Unable to wash or dress myself -> Missing data	0 0%	0 0%	0 0%	0 0%
Missing data -> No problem	1 0.2%	1 0.2%	1 0.2%	4 0.8%
Missing data -> Some problems	0 0%	0 0%	0 0%	1 0.2%
Missing data -> Unable to wash or dress myself	0 0%	0 0%	0 0%	0 0%
Missing data -> Missing data	0 0%	0 0%	0 0%	0 0%

24. Secondary Outcome

Title	Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
Description	The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
No problem -> No problem	298 60.3%	316 64.1%	327 65.9%	283 57.2%
No problem -> Some problems	25 5.1%	18 3.7%	25 5%	39 7.9%
No problem -> Unable to perform usual activities	0 0%	2 0.4%	3 0.6%	0 0%
No problem -> Missing data	2 0.4%	1 0.2%	1 0.2%	1 0.2%
Some problems -> No problems	73 14.8%	82 16.6%	51 10.3%	68 13.7%
Some problems -> Some problems	75 15.2%	48 9.7%	63 12.7%	73 14.7%
Some problems-> Unable to perform usual activities	2 0.4%	0 0%	0 0%	0 0%
Some problems -> Missing data	0 0%	1 0.2%	1 0.2%	0 0%
Unable to perform usual activities -> No problems	0 0%	1 0.2%	1 0.2%	2 0.4%
Unable to perform usual activities-> Some problems	2 0.4%	1 0.2%	3 0.6%	3 0.6%
Unable to perform -> Unable to perform	0 0%	1 0.2%	2 0.4%	1 0.2%
Unable to perform usual activities -> Missing data	0 0%	0 0%	0 0%	0 0%
Missing data -> No problem	2 0.4%	2 0.4%	1 0.2%	4 0.8%
Missing data -> Some problems	1 0.2%	0 0%	0 0%	1 0.2%
Missing data -> Unable to perform usual activities	0 0%	0 0%	0 0%	0 0%
Missing data -> Missing data	0 0%	0 0%	0 0%	0 0%

25. Secondary Outcome

Title	Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
Description	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
No pain -> No pain	210 42.5%	211 42.8%	209 42.1%	197 39.8%
No pain -> Moderate pain	36 7.3%	32 6.5%	50 10.1%	37 7.5%
No pain -> Extreme pain	4 0.8%	2 0.4%	2 0.4%	2 0.4%
No pain -> Missing data	0 0%	2 0.4%	1 0.2%	1 0.2%
Moderate pain -> No pain	70 14.2%	71 14.4%	76 15.3%	69 13.9%
Moderate pain -> Moderate pain	129 26.1%	128 26%	114 23%	132 26.7%
Moderate pain -> Extreme pain	2 0.4%	8 1.6%	5 1%	7 1.4%
Moderate pain ->Missing data	2 0.4%	0 0%	1 0.2%	0 0%
Extreme pain -> No pain	3 0.6%	2 0.4%	1 0.2%	4 0.8%
Extreme pain -> Moderate pain	13 2.6%	12 2.4%	12 2.4%	12 2.4%
Extreme pain -> Extreme pain	10 2%	4 0.8%	5 1%	9 1.8%
Extreme pain -> Missing data	0 0%	0 0%	0 0%	0 0%
Missing data -> No pain	0 0%	1 0.2%	1 0.2%	3 0.6%
Missing data -> Moderate pain	1 0.2%	0 0%	1 0.2%	1 0.2%
Missing data -> Extreme pain	0 0%	0 0%	0 0%	1 0.2%
Missing data -> Missing data	0 0%	0 0%	0 0%	0 0%

26. Secondary Outcome

Title	Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score
Description	The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Not anxious -> Not anxious	219 44.3%	224 45.4%	232 46.8%	217 43.8%
Not anxious -> Moderately anxious	37 7.5%	30 6.1%	19 3.8%	21 4.2%
Not anxious -> Extremely anxious	2 0.4%	1 0.2%	1 0.2%	3 0.6%
Not anxious -> Missing data	1 0.2%	0 0%	2 0.4%	0 0%
Moderately anxious -> Not anxious	76 15.4%	74 15%	88 17.7%	71 14.3%
Moderately anxious -> Moderately anxious	108 21.9%	111 22.5%	105 21.2%	122 24.6%
Moderately anxious -> Extremely anxious	9 1.8%	5 1%	10 2%	12 2.4%
Moderately anxious -> Missing data	1 0.2%	1 0.2%	0 0%	1 0.2%
Extremely anxious -> Not anxious	3 0.6%	4 0.8%	1 0.2%	4 0.8%
Extremely anxious -> Moderately anxious	12 2.4%	12 2.4%	11 2.2%	18 3.6%
Extremely anxious -> Extremely anxious	9 1.8%	9 1.8%	8 1.6%	2 0.4%
Extremely anxious -> Missing data	0 0%	1 0.2%	0 0%	0 0%
Missing data -> Not anxious	2 0.4%	1 0.2%	1 0.2%	3 0.6%
Missing data -> Moderately anxious	1 0.2%	0 0%	0 0%	1 0.2%
Missing data -> Extremely anxious	0 0%	0 0%	0 0%	0 0%
Missing data -> Missing data	0 0%	0 0%	0 0%	0 0%

27. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Description	The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=466; 459; 468; 461]	3.1 (15.64)	3.3 (15.74)	4.4 (16.75)	3.2 (17.68)
Week 8 [N=451; 443; 447; 447]	4.5 (16.81)	5.5 (16.79)	6.8 (17.42)	6.0 (17.31)
Week 12 [N=443; 423; 437; 429]	6.7 (19.01)	7.1 (18.89)	8.2 (17.56)	6.9 (17.62)
Final Visit (LOCF) [N=470; 466; 472; 467]	6.4 (19.03)	6.5 (18.67)	8.1 (17.74)	6.4 (18.23)

28. Secondary Outcome

Title	Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
Description	The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 12 [N=425; 410; 421; 417]	-0.8 (0.06)	-1.1 (0.06)	-0.1 (0.06)	-1.0 (0.06)
Final Visit (LOCF) [N=433; 416; 429; 426]	-0.8 (0.05)	-1.0 (0.06)	-1.1 (0.05)	-1.0 (0.06)

29. Secondary Outcome

Title	Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
Description	The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 12 [N=421; 410; 420; 416]	1.92 (0.147)	2.57 (0.149)	2.67 (0.147)	2.44 (0.148)
Final Visit (LOCF) [N=428; 414; 427; 425]	1.89 (0.146)	2.55 (0.149)	2.66 (0.146)	2.44 (0.147)

30. Secondary Outcome

Title	Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
Description	The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Week 4 [N=477; 467; 473; 474]	-0.0 (0.20)	-0.0 (0.14)	-0.0 (0.19)	0.0 (0.23)
Week 8 [N=462; 448; 453; 460]	-0.0 (0.17)	0.0 (0.18)	-0.0 (0.21)	-0.0 (0.15)
Week 12 [N=451; 435; 443; 439]	-0.0 (0.16)	-0.0 (0.16)	-0.0 (0.18)	-0.0 (0.18)
Final Visit (LOCF) [N=478; 469; 475; 474]	-0.0 (0.19)	-0.0 (0.17)	-0.0 (0.18)	-0.0 (0.19)

31. Secondary Outcome

Title	Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
Description	The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 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' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description
The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.

Arm/Group Title	Placebo	Mirabegron 50 mg	Mirabegron 100 mg	Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.	Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
Measure Participants	480	473	478	475
Improvement: Week 12 [N=425; 410;421; 417]	56.9 11.5%	61.5 12.5%	62.7 12.6%	65.2 13.2%
Improvement: Final Visit [N=433; 416; 429; 426]	56.6 11.5%	61.3 12.4%	62.2 12.5%	65.0 13.1%
Major Improvement: Week 12 [N=425; 410; 421; 417]	28.5 5.8%	29.5 6%	34.0 6.9%	31.7 6.4%
Major Improvement: Final Visit [N=433;416;429;426]	28.2 5.7%	29.1 5.9%	33.6 6.8%	31.5 6.4%

Adverse Events

	Placebo		Mirabegron 50 mg		Mirabegron 100 mg		Tolterodine SR 4 mg
Time Frame	Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake.
Adverse Event Reporting Description

Arm/Group Title	Placebo		Mirabegron 50 mg		Mirabegron 100 mg		Tolterodine SR 4 mg
Arm/Group Description	Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.		Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.		Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.		Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Mirabegron 50 mg		Mirabegron 100 mg		Tolterodine SR 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/494 (1.6%)		14/493 (2.8%)		12/496 (2.4%)		11/495 (2.2%)
Cardiac disorders
Atrial fibrillation	0/494 (0%)		1/493 (0.2%)		1/496 (0.2%)		0/495 (0%)
Acute coronary syndrome	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Cardiac failure acute	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Arrhythmia	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Atrioventricular block first degree	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Coronary artery disease	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Myocardial infarction	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Eye disorders
Retinitis	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Gastrointestinal disorders
Abdominal pain	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Enterocele	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Pancreatitis chronic	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Reflux oesophagitis	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Gastritis	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
General disorders
Asthenia	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Chest pain	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Pyrexia	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Hepatobiliary disorders
Hepatitis	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Infections and infestations
Erysipelas	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		1/495 (0.2%)
Hepatitis A	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Postoperative infection	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Urinary tract infection	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Injury, poisoning and procedural complications
Fall	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		1/495 (0.2%)
Humerus fracture	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Limb injury	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Open wound	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Gas poisoning	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Lower limb fracture	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Investigations
Cardiovascular evaluation	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Hepatic enzyme increased	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Catheterisation cardiac	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Sympathetic posterior cervical syndrome	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Leukaemia	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Nervous system disorders
Cerebral ischaemia	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Neuralgia	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Balance disorder	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Epilepsy	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Ruptured cerebral aneurysm	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Renal and urinary disorders
Calculus urinary	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Nephrolithiasis	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Urinary retention	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Reproductive system and breast disorders
Rectocele	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Vaginal erosion	0/494 (0%)		0/493 (0%)		1/496 (0.2%)		0/495 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Surgical and medical procedures
Bunion operation	0/494 (0%)		0/493 (0%)		2/496 (0.4%)		0/495 (0%)
Papilloma excision	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Polypectomy	1/494 (0.2%)		0/493 (0%)		0/496 (0%)		0/495 (0%)
Vascular disorders
Hypertensive crisis	0/494 (0%)		1/493 (0.2%)		0/496 (0%)		0/495 (0%)
Hypertension	0/494 (0%)		0/493 (0%)		0/496 (0%)		1/495 (0.2%)
Other (Not Including Serious) Adverse Events
	Placebo		Mirabegron 50 mg		Mirabegron 100 mg		Tolterodine SR 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	49/494 (9.9%)		42/493 (8.5%)		41/496 (8.3%)		86/495 (17.4%)
Gastrointestinal disorders
Dry mouth	13/494 (2.6%)		14/493 (2.8%)		14/496 (2.8%)		50/495 (10.1%)
Vascular disorders
hypertension	38/494 (7.7%)		29/493 (5.9%)		27/496 (5.4%)		39/495 (7.9%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Institute and/or Principal Investigator may publish trial data generated at their specific study site after Primary publication of the multi-center data. Sponsor must receive a site's manuscript at least 45 days prior to planned submission to ensure that no confidential information of Sponsor is included in the document. Sponsor will respond within 30 days and may request changes or delay the publication to seek patent protection.

Results Point of Contact

Name/Title	Director Medical Science
Organization	Astellas Pharma Europe B.V.
Phone
Email	ClinicalTrials.Disclosure@us.astellas.com

Responsible Party:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00689104

Other Study ID Numbers:

178-CL-046
2007-001451-19

First Posted:

Jun 3, 2008

Last Update Posted:

Dec 11, 2017

Last Verified:

Nov 1, 2017

SCORPIO: Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Study Details

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Baseline Characteristics

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Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

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Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

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All Cause Mortality

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