Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00611026

Collaborator

(none)

2,417

Enrollment

227

Locations

Arms

Duration (Months)

10.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Tolterodine ER Drug: Placebo Drug: Fesoterodine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

2417 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Tolterodine ER The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
Placebo Comparator: 2	Drug: Placebo Placebo treatment will be once daily(QD) for 12 weeks.
Experimental: 3	Drug: Fesoterodine The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

Arm

Intervention/Treatment

Active Comparator: 1

Drug: Tolterodine ER

The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.

Placebo Comparator: 2

Drug: Placebo

Placebo treatment will be once daily(QD) for 12 weeks.

Experimental: 3

Drug: Fesoterodine

The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

Outcome Measures

Primary Outcome Measures

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 [Baseline, Week 12]
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Secondary Outcome Measures

Change From Baseline in Mean Voided Volume Per Micturition [Baseline, Week 1, Week 4, Week 12]
Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Change From Baseline in Mean Number of Micturitions Per 24 Hours [Baseline, Week 1, Week 4, Week 12]
The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Percent Change From Baseline of Micturitions Per 24 Hours [Baseline, Week 1, Week 4, Week 12]
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours [Baseline, Week 1, Week 4, Week 12]
Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours [Baseline, Week 1, Week 4, Week 12]
Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 [Baseline, Week 1, Week 4]
UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Percent Change From Baseline of UUI Episodes Per 24 Hours [Baseline, Week 1, Week 4, Week 12]
UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [Baseline, Week 1, Week 4, Week 12]
Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [Baseline, Week 1, Week 4, Week 12]
Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours [Baseline, Week 1, Week 4, Week 12]
Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours [Baseline, Week 1, Week 4, Week 12]
Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours. [Baseline, Week 1, Week 4, Week 12]
Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol) [Baseline, Week 1, Week 4, Week 12]
Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary [Week 1, Week 4, Week 12]
Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Change From Baseline in Patient Perception of Bladder Condition (PPBC) [Baseline, Week 1, Week, 4, Week 12]
Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol. [Baseline, Week 1, Week, 4, Week 12]
Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 [Baseline, Week 12]
Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12 [Baseline, Week 12]
HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Enterprise	Alabama	United States	36330
2	Pfizer Investigational Site	Mobile	Alabama	United States	36608
3	Pfizer Investigational Site	Montgomery	Alabama	United States	36117
4	Pfizer Investigational Site	Chandler	Arizona	United States	85225
5	Pfizer Investigational Site	Peoria	Arizona	United States	85381
6	Pfizer Investigational Site	Tucson	Arizona	United States	85741
7	Pfizer Investigational Site	Little Rock	Arkansas	United States	72205
8	Pfizer Investigational Site	Anaheim	California	United States	92801
9	Pfizer Investigational Site	Clovis	California	United States	93611
10	Pfizer Investigational Site	Fresno	California	United States	93710
11	Pfizer Investigational Site	Fresno	California	United States	93720
12	Pfizer Investigational Site	San Diego	California	United States	92103
13	Pfizer Investigational Site	Torrance	California	United States	90505
14	Pfizer Investigational Site	Upland	California	United States	91786
15	Pfizer Investigational Site	Vista	California	United States	92083
16	Pfizer Investigational Site	Westlake Village	California	United States	91361
17	Pfizer Investigational Site	Englewood	Colorado	United States	80112
18	Pfizer Investigational Site	New London	Connecticut	United States	06320
19	Pfizer Investigational Site	Bonita Spring	Florida	United States	34134
20	Pfizer Investigational Site	Hollywood	Florida	United States	33021
21	Pfizer Investigational Site	Jacksonville	Florida	United States	32205
22	Pfizer Investigational Site	Jacksonville	Florida	United States	32216
23	Pfizer Investigational Site	Lake Worth	Florida	United States	33461
24	Pfizer Investigational Site	Leesburg	Florida	United States	34748
25	Pfizer Investigational Site	Longwood	Florida	United States	32779
26	Pfizer Investigational Site	Loxahatchee	Florida	United States	33470
27	Pfizer Investigational Site	Miami	Florida	United States	33143
28	Pfizer Investigational Site	Miami	Florida	United States	33186
29	Pfizer Investigational Site	Naples	Florida	United States	34102
30	Pfizer Investigational Site	Pembroke Pines	Florida	United States	33024
31	Pfizer Investigational Site	Stuart	Florida	United States	34996
32	Pfizer Investigational Site	Tallahassee	Florida	United States	32308
33	Pfizer Investigational Site	West Palm Beach	Florida	United States	33409
34	Pfizer Investigational Site	Atlanta	Georgia	United States	30308
35	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
36	Pfizer Investigational Site	Meridian	Idaho	United States	83642
37	Pfizer Investigational Site	Chicago	Illinois	United States	60654
38	Pfizer Investigational Site	Peoria	Illinois	United States	61614
39	Pfizer Investigational Site	Avon	Indiana	United States	46123
40	Pfizer Investigational Site	Evansville	Indiana	United States	47714
41	Pfizer Investigational Site	Noblesville	Indiana	United States	46158
42	Pfizer Investigational Site	Overland Park	Kansas	United States	66210
43	Pfizer Investigational Site	Overland Park	Kansas	United States	66215
44	Pfizer Investigational Site	Lexington	Kentucky	United States	40504
45	Pfizer Investigational Site	Lexington	Kentucky	United States	40509
46	Pfizer Investigational Site	Louisville	Kentucky	United States	40207
47	Pfizer Investigational Site	Louisville	Kentucky	United States	40291
48	Pfizer Investigational Site	Metairie	Louisiana	United States	70002
49	Pfizer Investigational Site	Baltimore	Maryland	United States	21211
50	Pfizer Investigational Site	Bel Air	Maryland	United States	21014
51	Pfizer Investigational Site	North Dartmouth	Massachusetts	United States	02747
52	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48103
53	Pfizer Investigational Site	Royal Oak	Michigan	United States	48073
54	Pfizer Investigational Site	Troy	Michigan	United States	48098
55	Pfizer Investigational Site	Edina	Minnesota	United States	55435
56	Pfizer Investigational Site	Sartell	Minnesota	United States	56377
57	Pfizer Investigational Site	Olive Branch	Mississippi	United States	38654
58	Pfizer Investigational Site	Picayune	Mississippi	United States	39466
59	Pfizer Investigational Site	Kansas City	Missouri	United States	64114
60	Pfizer Investigational Site	St. Louis	Missouri	United States	63117
61	Pfizer Investigational Site	Lincoln	Nebraska	United States	68506
62	Pfizer Investigational Site	Lincoln	Nebraska	United States	68510
63	Pfizer Investigational Site	Omaha	Nebraska	United States	68134
64	Pfizer Investigational Site	Las Vegas	Nevada	United States	89148
65	Pfizer Investigational Site	Hamilton	New Jersey	United States	08690
66	Pfizer Investigational Site	Williamsville	New York	United States	14221
67	Pfizer Investigational Site	Cary	North Carolina	United States	27518
68	Pfizer Investigational Site	Raleigh	North Carolina	United States	27609
69	Pfizer Investigational Site	Raleigh	North Carolina	United States	27612
70	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27103
71	Pfizer Investigational Site	Cincinnati	Ohio	United States	45212
72	Pfizer Investigational Site	Cincinnati	Ohio	United States	45249
73	Pfizer Investigational Site	Bensalem	Pennsylvania	United States	19020
74	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19114
75	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15243
76	Pfizer Investigational Site	Uniontown	Pennsylvania	United States	15401
77	Pfizer Investigational Site	Cumberland	Rhode Island	United States	02864
78	Pfizer Investigational Site	Pawtucket	Rhode Island	United States	02860
79	Pfizer Investigational Site	Anderson	South Carolina	United States	29621
80	Pfizer Investigational Site	Greer	South Carolina	United States	29651
81	Pfizer Investigational Site	Summerville	South Carolina	United States	29485
82	Pfizer Investigational Site	Johnson City	Tennessee	United States	37601
83	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
84	Pfizer Investigational Site	New Tazewell	Tennessee	United States	37825
85	Pfizer Investigational Site	Beaumont	Texas	United States	77701
86	Pfizer Investigational Site	Beaumont	Texas	United States	77706
87	Pfizer Investigational Site	Bryan	Texas	United States	77802
88	Pfizer Investigational Site	Plano	Texas	United States	75024
89	Pfizer Investigational Site	Plano	Texas	United States	75093
90	Pfizer Investigational Site	San Antonio	Texas	United States	78229
91	Pfizer Investigational Site	Sugar Land	Texas	United States	77479
92	Pfizer Investigational Site	Midvale	Utah	United States	84047
93	Pfizer Investigational Site	West Jordan	Utah	United States	84088
94	Pfizer Investigational Site	Arlington	Virginia	United States	22205
95	Pfizer Investigational Site	Charlottesville	Virginia	United States	22911
96	Pfizer Investigational Site	Richmond	Virginia	United States	23294
97	Pfizer Investigational Site	Virginia Beach	Virginia	United States	23455
98	Pfizer Investigational Site	Virginia Beach	Virginia	United States	23464
99	Pfizer Investigational Site	Weber City	Virginia	United States	24290
100	Pfizer Investigational Site	Seattle	Washington	United States	98104
101	Pfizer Investigational Site	Seattle	Washington	United States	98166
102	Pfizer Investigational Site	Spokane	Washington	United States	99207
103	Pfizer Investigational Site	Salvador	BA	Brazil	40420-000
104	Pfizer Investigational Site	Goiania	GO	Brazil	74175-080
105	Pfizer Investigational Site	Curitiba	PR	Brazil	80030-220
106	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	CEP 20551-030
107	Pfizer Investigational Site	Porto Alegre	RS	Brazil	90470-340
108	Pfizer Investigational Site	Sao Paulo	SP	Brazil	04025-001
109	Pfizer Investigational Site	Pernik		Bulgaria	2300
110	Pfizer Investigational Site	Pleven		Bulgaria	5800
111	Pfizer Investigational Site	Plovdiv		Bulgaria	4002
112	Pfizer Investigational Site	Plovdiv		Bulgaria	4003
113	Pfizer Investigational Site	Sofia		Bulgaria	1606
114	Pfizer Investigational Site	Veliko Tarnovo		Bulgaria	5000
115	Pfizer Investigational Site	Surrey	British Columbia	Canada	V3V 1N1
116	Pfizer Investigational Site	Winnipeg	Manitoba	Canada	R3C 0N2
117	Pfizer Investigational Site	Halifax	Nova Scotia	Canada	B3H 3A7
118	Pfizer Investigational Site	Oshawa	Ontario	Canada	L1H 7K4
119	Pfizer Investigational Site	Chicoutimi	Quebec	Canada	G7H 4A3
120	Pfizer Investigational Site	Montreal	Quebec	Canada	H1T 2M4
121	Pfizer Investigational Site	Montreal	Quebec	Canada	H2X 1N8
122	Pfizer Investigational Site	Montreal	Quebec	Canada	H2X 3J4
123	Pfizer Investigational Site	Trois-Rivieres	Quebec	Canada	G9A 3V7
124	Pfizer Investigational Site	Saskatoon	Saskatchewan	Canada	S7K 1N8
125	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia	0
126	Pfizer Investigational Site	Bogota		Colombia
127	Pfizer Investigational Site	Alajuela		Costa Rica
128	Pfizer Investigational Site	Cartago		Costa Rica
129	Pfizer Investigational Site	San Jose		Costa Rica
130	Pfizer Investigational Site	Tallinn		Estonia	10138
131	Pfizer Investigational Site	Tallinn		Estonia	10611
132	Pfizer Investigational Site	Tartu		Estonia	51014
133	Pfizer Investigational Site	Berlin		Germany	10629
134	Pfizer Investigational Site	Berlin		Germany	10787
135	Pfizer Investigational Site	Gruenstadt		Germany	67269
136	Pfizer Investigational Site	Hamburg		Germany	20253
137	Pfizer Investigational Site	Krumbach		Germany	86381
138	Pfizer Investigational Site	Leipzig		Germany	04103
139	Pfizer Investigational Site	Marburg		Germany	35039
140	Pfizer Investigational Site	Muelheim a.d. Ruhr		Germany	45468
141	Pfizer Investigational Site	Muenchen		Germany	81241
142	Pfizer Investigational Site	Muenchen		Germany	81925
143	Pfizer Investigational Site	Heraklion/Voutes	Crete	Greece	71001
144	Pfizer Investigational Site	Alexandroupolis		Greece	68100
145	Pfizer Investigational Site	Athens, Maroussi		Greece	14126
146	Pfizer Investigational Site	Larisa		Greece	41110
147	Pfizer Investigational Site	Thessaloniki		Greece	546 35
148	Pfizer Investigational Site	Debrecen		Hungary	4043
149	Pfizer Investigational Site	Gyor		Hungary	9023
150	Pfizer Investigational Site	Nyiregyhaza		Hungary	4400
151	Pfizer Investigational Site	Salgotarjan		Hungary	3100
152	Pfizer Investigational Site	Szentes		Hungary	6600
153	Pfizer Investigational Site	Hyderabad	Andhra Pradesh	India	500 001
154	Pfizer Investigational Site	Ahmedabad	Gujarat	India	380 009
155	Pfizer Investigational Site	Nadiad	Gujarat	India	387 001
156	Pfizer Investigational Site	Bengaluru	Karnataka	India	560 010
157	Pfizer Investigational Site	Pune	Maharashtra	India	411 053
158	Pfizer Investigational Site	New Delhi		India	110001
159	Pfizer Investigational Site	Beaumont	Dublin	Ireland	9
160	Pfizer Investigational Site	Dublin		Ireland	9
161	Pfizer Investigational Site	Chonju	Chonbuk	Korea, Republic of	561-712
162	Pfizer Investigational Site	Busan		Korea, Republic of	602-715
163	Pfizer Investigational Site	Daegu		Korea, Republic of	700-721
164	Pfizer Investigational Site	Incheon		Korea, Republic of	405-760
165	Pfizer Investigational Site	Seoul		Korea, Republic of	134-791
166	Pfizer Investigational Site	Suwon		Korea, Republic of	443-721
167	Pfizer Investigational Site	Riga		Latvia	LV 1002
168	Pfizer Investigational Site	Kaunas		Lithuania	49476
169	Pfizer Investigational Site	Kaunas		Lithuania	50425
170	Pfizer Investigational Site	Klaipeda		Lithuania	94231
171	Pfizer Investigational Site	Vilnius		Lithuania	01118
172	Pfizer Investigational Site	Vilnius		Lithuania	10207
173	Pfizer Investigational Site	Kuala Lumpur		Malaysia	50586
174	Pfizer Investigational Site	Kuala Lumpur		Malaysia	59100
175	Pfizer Investigational Site	Bialystok		Poland	15-276
176	Pfizer Investigational Site	Bydgoszcz		Poland	85-094
177	Pfizer Investigational Site	Gdynia		Poland	81-366
178	Pfizer Investigational Site	Krakow		Poland	30-017
179	Pfizer Investigational Site	Lublin		Poland	20-954
180	Pfizer Investigational Site	Poznan		Poland	61-251
181	Pfizer Investigational Site	Slupsk		Poland	76-200
182	Pfizer Investigational Site	Bucuresti	Sector 5,	Romania	050653
183	Pfizer Investigational Site	Arad		Romania	310175
184	Pfizer Investigational Site	Bucuresti		Romania	041345
185	Pfizer Investigational Site	Sibiu		Romania	550245
186	Pfizer Investigational Site	Moscow		Russian Federation	101000
187	Pfizer Investigational Site	Moscow		Russian Federation	105425
188	Pfizer Investigational Site	Moscow		Russian Federation	109388
189	Pfizer Investigational Site	Moscow		Russian Federation	115516
190	Pfizer Investigational Site	Moscow		Russian Federation	117997
191	Pfizer Investigational Site	Moscow		Russian Federation	119991
192	Pfizer Investigational Site	Rostov-on-Don		Russian Federation	344022
193	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	196247
194	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	197022
195	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	199106
196	Pfizer Investigational Site	St. Petersburg		Russian Federation	190013
197	Pfizer Investigational Site	Singapore		Singapore	229899
198	Pfizer Investigational Site	Nitra		Slovakia	949 01
199	Pfizer Investigational Site	Povazska Bystrica		Slovakia	017 01
200	Pfizer Investigational Site	Presov		Slovakia	080 01
201	Pfizer Investigational Site	Trencin		Slovakia	911 01
202	Pfizer Investigational Site	Zvolen		Slovakia	960 01
203	Pfizer Investigational Site	Claremont	Cape Town	South Africa	8001
204	Pfizer Investigational Site	Bloemfontein	Free State	South Africa	9301
205	Pfizer Investigational Site	Vosloorus	Gauteng	South Africa	1475
206	Pfizer Investigational Site	Durban	Kwa Zulu Natal	South Africa	4001
207	Pfizer Investigational Site	Durban	Kwa Zulu Natal	South Africa
208	Pfizer Investigational Site	Pietermaritzburg	Kwa Zulu Natal	South Africa	3201
209	Pfizer Investigational Site	Pretoria		South Africa	0083
210	Pfizer Investigational Site	Roodepoort		South Africa	1715
211	Pfizer Investigational Site	Santander	Cantabria	Spain	39008
212	Pfizer Investigational Site	La Laguna	Santa Cruz de Tenerife	Spain	38320
213	Pfizer Investigational Site	Las Palmas de Gran Canaria		Spain	35010
214	Pfizer Investigational Site	Madrid		Spain	28040
215	Pfizer Investigational Site	Valencia		Spain	46009
216	Pfizer Investigational Site	Valencia		Spain	46017
217	Pfizer Investigational Site	Karlskoga		Sweden	691 81
218	Pfizer Investigational Site	Malmo		Sweden	211 52
219	Pfizer Investigational Site	Norrkoping		Sweden	601 82
220	Pfizer Investigational Site	Orebro		Sweden	701 46
221	Pfizer Investigational Site	Skovde		Sweden	541 85
222	Pfizer Investigational Site	Stockholm		Sweden
223	Pfizer Investigational Site	Chernivtsi		Ukraine	58002
224	Pfizer Investigational Site	Dnipropetrovsk		Ukraine	49005
225	Pfizer Investigational Site	Kyiv		Ukraine	04053
226	Pfizer Investigational Site	Uzhorod		Ukraine	88000
227	Pfizer Investigational Site	Zaporizhzhia		Ukraine	69000

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00611026

Other Study ID Numbers:

A0221046

First Posted:

Feb 8, 2008

Last Update Posted:

Feb 2, 2011

Last Verified:

Jan 1, 2011

Keywords provided by , ,

Treatment of overactive bladder

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Tolterodine Tartrate

Fesoterodine

Study Results

Participant Flow

Recruitment Details	Participants with urgency incontinence Overactive Bladder (OAB) symptoms who met all entrance criteria were randomized to the double-blind treatment period.
Pre-assignment Detail	3867 participants entered the single-blind placebo run-in period; 2417 participants completed single-blind placebo run-in and progressed to randomization in the double-blind treatment period.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Period Title: Randomized to Double-blind Treatment
STARTED	480	974	963
COMPLETED	478	973	960
NOT COMPLETED	2	1	3
Period Title: Randomized to Double-blind Treatment
STARTED	478	973	960
COMPLETED	431	885	862
NOT COMPLETED	47	88	98

Baseline Characteristics

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine	Total
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.	Total of all reporting groups
Overall Participants	478	973	960	2411
Age, Customized (participants) [Number]
Between 18 and 44 years	70 14.6%	157 16.1%	156 16.3%	383 15.9%
Between 45 and 64 years	214 44.8%	462 47.5%	474 49.4%	1150 47.7%
≥65 years	194 40.6%	354 36.4%	330 34.4%	878 36.4%
Sex: Female, Male (Count of Participants)
Female	410 85.8%	818 84.1%	816 85%	2044 84.8%
Male	68 14.2%	155 15.9%	144 15%	367 15.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Description	UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was blinded.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	448	926	908
Mean (Standard Error) [episodes per 24 hours]	-1.62 (0.07)	-1.74 (0.06)	-1.95 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively). If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0228
	Comments	Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0072
	Comments	Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.
	Method	Van Elteren's test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

2. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Micturition
Description	Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [Last Observation Carried Forward (LOCF)], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	452	930	912
Week 1 (n=447, 917, 895)	9.80 (1.92)	15.65 (1.43)	18.63 (1.55)
Week 4 [LOCF] (n=452, 927, 909)	14.27 (2.28)	26.43 (1.76)	32.26 (1.94)
Week 12 [LOCF] (n=452, 930, 912)	17.34 (2.40)	28.43 (1.82)	34.47 (2.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively). If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0020
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0519
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1503
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0130
	Comments
	Method	Van Elteren's
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0021
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0525
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.

3. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours
Description	The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	454	935	916
Week 1 (n=448, 921, 908)	-0.8 (0.1)	-1.0 (0.1)	-1.0 (0.1)
Week 4 [LOCF] (n=454, 931, 916)	-1.5 (0.1)	-1.8 (0.1)	-2.1 (0.1)
Week 12 [LOCF] (n=454, 935, 916)	-2.0 (0.1)	-2.3 (0.1)	-2.6 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0161
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95% -0.5 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0944
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95% -0.4 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3613
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.3 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95% -0.9 to -0.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0043
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95% -0.6 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0186
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95% -0.5 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95% -0.9 to -0.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0407
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95% -0.6 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95% -0.6 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

4. Secondary Outcome

Title	Percent Change From Baseline of Micturitions Per 24 Hours
Description	Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	454	935	916
Week 1 (n=448, 921, 908)	-7.1	-9.4	-9.0
Week 4 [LOCF] (n=454, 931, 916)	-13.4	-16.7	-18.9
Week 12 [LOCF] (n=454, 935, 916)	-18.2	-20.8	-23.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0217
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0020
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0217
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0421
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0023
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.

5. Secondary Outcome

Title	Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours
Description	Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	445	899	892
Week 1 (n=432, 879, 871)	-0.2 (0.1)	-0.3 (0.0)	-0.3 (0.0)
Week 4 [LOCF] (n=437, 888, 879)	-0.4 (0.1)	-0.5 (0.0)	-0.5 (0.0)
Week 12 [LOCF] (n=437, 892, 879)	-0.5 (0.1)	-0.6 (0.0)	-0.7 (0.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3823
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 95% -0.1 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4802
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95% -0.1 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8355
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95% -0.1 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0286
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95% -0.12 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0794
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95% -0.2 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5906
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95% -0.1 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0134
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95% -0.3 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1759
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 95% -0.2 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1661
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95% -0.2 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

6. Secondary Outcome

Title	Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours
Description	Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	445	899	892
Week 1 (n=432, 879, 871)	-7.7	-14.3	-12.5
Week 4 [LOCF] (n=437, 888, 879)	-20.0	-25.0	-25.0
Week 12 [LOCF] (n=437, 892, 879)	-27.3	-33.3	-33.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0021
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0200
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

7. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4
Description	UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Baseline, Week 1, Week 4

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [LOCF] for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	456	932	920
Week 1 (n=442, 911, 899)	-0.80 (0.06)	-0.95 (0.05)	-1.03 (0.05)
Week 4 [LOCF] (n=448, 922, 908)	-1.31 (0.07)	-1.52 (0.05)	-1.68 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively). If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0202
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2126
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0019
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0148
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.

8. Secondary Outcome

Title	Percent Change From Baseline of UUI Episodes Per 24 Hours
Description	UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	456	932	920
Week 1 (n=442, 911, 899)	-40.8	-50.0	-50.0
Week 4 [LOCF] (n=448, 922, 908)	-75.0	-88.9	-100.0
Week 12 [LOCF] (n=448, 926, 908)	-100.0	-100.0	-100.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0012
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0205
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0038
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0219
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0805
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0093
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
Description	Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	461	940	928
Week 1 (n=447, 918, 906)	-0.8 (0.2)	-1.0 (0.1)	-1.2 (0.2)
Week 4 [LOCF] (n=453, 929, 915)	-1.9 (0.2)	-2.5 (0.2)	-3.1 (0.2)
Week 12 [LOCF] (n=453, 933, 915)	-3.2 (0.2)	-3.5 (0.2)	-4.2 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0374
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95% -0.7 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3161
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95% -0.5 to 0.2
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1817
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95% -0.5 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95% -1.6 to -0.8
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0054
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95% -1.0 to -0.2
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0005
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95% -0.9 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95% -1.5 to -0.6
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1467
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95% -0.7 to 0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95% -1.1 to -0.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

10. Secondary Outcome

Title	Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
Description	Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	461	940	928
Week 1 (n=447, 918, 906)	-9.4	-12.0	-11.8
Week 4 [LOCF] (n=453, 929, 915)	-17.2	-26.3	-32.1
Week 12 [LOCF] (n=453, 933, 915)	-31.0	-37.5	-45.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0828
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0008
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0022
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0008
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

11. Secondary Outcome

Title	Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours
Description	Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	460	937	924
Week 1 (n=446, 915, 902)	-1.14 (0.13)	-1.34 (0.10)	-1.58 (0.11)
Week 4 [LOCF] (n=452, 926, 911)	-2.14 (0.16)	-2.71 (0.12)	-3.21 (0.12)
Week 12 [LOCF] (n=452, 930, 911)	-3.01 (0.17)	-3.39 (0.13)	-4.08 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively). If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0576
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2230
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3555
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0009
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0071
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1764
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.

12. Secondary Outcome

Title	Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours
Description	Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	460	937	924
Week 1 (n=446, 915, 902)	-19.7	-24.1	-25.0
Week 4 [LOCF] (n=452, 926, 911)	-41.7	-55.6	-61.1
Week 12 [LOCF] (n=452, 930, 911)	-61.0	-69.2	-79.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0302
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0007
	Comments	Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
	Method	ANCOVA
	Comments	Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.

13. Secondary Outcome

Title	Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.
Description	Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	453	933	915
Week 1 (n=447, 918, 906)	-0.2 (0.0)	-0.2 (0.0)	-0.2 (0.0)
Week 4 [LOCF] (n=453, 929, 915)	-0.3 (0.0)	-0.4 (0.0)	-0.5 (0.0)
Week 12 [LOCF] (n=453, 933, 915)	-0.6 (0.0)	-0.6 (0.0)	-0.7 (0.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0701
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.1 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4823
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95% -0.1 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1702
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95% -0.1 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95% -0.3 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0059
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.2 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0014
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.2 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95% -0.3 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3110
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95% -0.1 to 0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95% -0.2 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

14. Secondary Outcome

Title	Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)
Description	Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	453	933	915
Week 1 (n=447, 918, 906)	-4.0 (0.6)	-4.8 (0.5)	-5.5 (0.5)
Week 4 [LOCF] (n=453, 929, 915)	-8.1 (0.7)	-10.1 (0.6)	-12.0 (0.6)
Week 12 [LOCF] (n=453, 933, 915)	-12.0 (0.7)	-13.2 (0.6)	-15.6 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0136
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95% -2.7 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.6
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1918
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95% -2.0 to 0.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.6
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1505
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95% -1.7 to 0.3
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.5
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.9
	Confidence Interval	(2-Sided) 95% -5.2 to -2.6
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0034
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95% -3.3 to -0.7
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 95% -3.0 to -0.8
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.5
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.7
	Confidence Interval	(2-Sided) 95% -5.0 to -2.3
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0859
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95% -2.5 to 0.2
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.7
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95% -3.6 to -1.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.6
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

15. Secondary Outcome

Title	Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary
Description	Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame	Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing baseline and respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	448	926	908
Week 1 (n=422, 911, 899)	17.6 3.7%	24.5 2.5%	25.1 2.6%
Week 4 [LOCF] (n=448, 922, 908)	39.5 8.3%	46.7 4.8%	51.1 5.3%
Week 12 [LOCF] (n=448, 926, 908)	53.8 11.3%	58.1 6%	63.2 6.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference in continent rate for fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0024
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6514
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference in continent rate for fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0063
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0494
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference in continent rate for fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0991
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0169
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.

16. Secondary Outcome

Title	Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Description	Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Time Frame	Baseline, Week 1, Week, 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	455	937	918
Week 1 (n=452, 931, 913) ≥2 points improvement	43 9%	138 14.2%	144 15%
Week 1: 1-point improvement	144 30.1%	278 28.6%	280 29.2%
Week 1: no change	210 43.9%	434 44.6%	428 44.6%
Week 1: deterioration	55 11.5%	81 8.3%	61 6.4%
Week 4 (n=455, 937, 918) ≥2 points improvement	111 23.2%	290 29.8%	334 34.8%
Week 4: 1-point improvement	124 25.9%	298 30.6%	280 29.2%
Week 4: no change	172 36%	285 29.3%	250 26%
Week 4: deterioration	48 10%	64 6.6%	54 5.6%
Week 12 (n=455, 937, 918) ≥2 points improvement	166 34.7%	379 39%	440 45.8%
Week 12: 1-point improvement	106 22.2%	250 25.7%	236 24.6%
Week 12: no change	133 27.8%	249 25.6%	189 19.7%
Week 12: deterioration	50 10.5%	59 6.1%	53 5.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0009
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0279
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2817
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0177
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0107
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0005
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

17. Secondary Outcome

Title	Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.
Description	Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Time Frame	Baseline, Week 1, Week, 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	455	938	918
Week 1 (n=452, 932, 913) improvement	97 20.3%	264 27.1%	267 27.8%
Week 1: no change	326 68.2%	619 63.6%	609 63.4%
Week 1: deterioration	29 6.1%	49 5%	37 3.9%
Week 4 (n=455, 938, 918) improvement	161 33.7%	376 38.6%	421 43.9%
Week 4: no change	271 56.7%	511 52.5%	467 48.6%
Week 4: deterioration	23 4.8%	51 5.2%	30 3.1%
Week 12 (n=455, 938, 918) improvement	183 38.3%	440 45.2%	495 51.6%
Week 12: no change	239 50%	455 46.8%	393 40.9%
Week 12: deterioration	33 6.9%	43 4.4%	30 3.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0011
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0072
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3713
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1485
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0040
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0060
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference fesoterodine vs Tolterodine ER at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.

18. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12
Description	Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	436	897	876
Least Squares Mean (Standard Error) [scores on a scale]	-21.8 (1.3)	-24.3 (1.0)	-28.9 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment difference fesoterodine vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.1
	Confidence Interval	(2-Sided) 95% -9.5 to -4.7
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment difference Tolterodine ER vs placebo at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0458
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95% -4.8 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.6
	Confidence Interval	(2-Sided) 95% -6.6 to -2.7
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

19. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12
Description	HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.

Arm/Group Title	Placebo	Tolterodine ER	Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	435	894	875
HRQL scale score total (n=431, 892, 873)	17.2 (1.2)	19.5 (1.0)	22.9 (1.0)
HRQL concern domain (n=434, 894, 875)	20.2 (1.4)	22.5 (1.1)	26.8 (1.1)
HRQL coping domain (n=433, 892, 875)	19.0 (1.4)	22.0 (1.1)	25.9 (1.2)
HRQL sleep domain (n=433, 894, 875)	16.6 (1.3)	18.7 (1.1)	21.0 (1.1)
HRQL social interaction domain (n=435, 894, 873)	10.8 (1.0)	12.0 (0.8)	13.9 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo: HRQL scale score total.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.6
	Confidence Interval	(2-Sided) 95% 3.4 to 7.9
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs Placebo: HRQL scale score total.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0429
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95% 0.1 to 4.6
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs Tolterodine ER: HRQL scale score total.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 95% 1.5 to 5.2
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.9
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo: HRQL concern domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.6
	Confidence Interval	(2-Sided) 95% 4.0 to 9.2
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Placebo vs Tolterodine ER: HRQL concern domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0795
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95% -0.3 to 4.9
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs Tolterodine ER: HRQL concern domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 95% 2.1 to 6.3
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo: HRQL coping domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95% 4.3 to 9.6
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.4
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo: HRQL coping domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0229
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95% 0.4 to 5.7
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.3
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs Tolterodine ER: HRQL coping domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95% 1.7 to 6.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.5
	Confidence Interval	(2-Sided) 95% 2.0 to 6.9
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo: HRQL sleep domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0923
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95% -0.3 to 4.5
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.2
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment Difference Tolterodine ER vs Fesoterodine: HRQL sleep domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0180
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95% 0.4 to 4.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0011
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 95% 1.3 to 5.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo: HRQL social interaction domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2208
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95% -0.7 to 3.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Tolterodine ER, Fesoterodine
	Comments	Treatment Difference Tolterodine ER vs Fesoterodine: HRQL social interaction domain.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0117
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 95% 0.4 to 3.5
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.8
	Estimation Comments	Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.

20. Post-Hoc Outcome

Title	Post-hoc Adverse Events (AEs)
Description	An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description
Safety population included all participants who were randomized and received at least 1 dose of study treatment. N=number of participants with AEs noted in other unreviewed medical chart records as performed at other departments during the clinical trial but were not included as AEs in Case Report Forms; reported post-hoc.

Arm/Group Title	Tolterodine ER	Fesoterodine
Arm/Group Description	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
Measure Participants	1	1
Constipation	1	0
Fingers tingling	0	1
Finger numbness	0	1
Hypertension	0	2
Diabetes mellitus	0	2
Abdominal distension and discomfort	0	1
Tina pedis	0	1
Tingling sensation/decreased sensation of fingers	0	1
Dyspepsia	0	1
Abdominal bloating	0	1

Adverse Events

	Placebo		Tolterodine ER		Fesoterodine
Time Frame
Adverse Event Reporting Description	An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.

Arm/Group Title	Placebo		Tolterodine ER		Fesoterodine
Arm/Group Description	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.		Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).		Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Tolterodine ER		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/478 (1.7%)		6/973 (0.6%)		13/960 (1.4%)
Cardiac disorders
Angina unstable	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Atrial fibrillation	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Atrial tachycardia	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Cardiac failure chronic	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Cardiac failure congestive	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Mitral valve stenosis	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Large intestine perforation	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Peritonitis	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
General disorders
Chest pain	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Hepatobiliary disorders
Hepatitis acute	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Infections and infestations
Bronchopneumonia	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Cellulitis	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Pneumonia	1/478 (0.2%)		0/973 (0%)		1/960 (0.1%)
Pyelonephritis	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Pyelonephritis acute	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Sepsis	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Fibula fracture	0/478 (0%)		1/973 (0.1%)		0/960 (0%)
Lower limb fracture	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Spinal compression fracture	0/478 (0%)		1/973 (0.1%)		0/960 (0%)
Therapeutic agent toxicity	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Musculoskeletal and connective tissue disorders
Osteoporotic fracture	0/478 (0%)		1/973 (0.1%)		0/960 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/478 (0%)		1/973 (0.1%)		0/960 (0%)
Colon cancer	0/478 (0%)		1/973 (0.1%)		1/960 (0.1%)
Gastric cancer	0/478 (0%)		1/973 (0.1%)		0/960 (0%)
Hepatic neoplasm	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Nervous system disorders
Balance disorder	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Dizziness	0/478 (0%)		0/973 (0%)		2/960 (0.2%)
Ischaemic stroke	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Psychiatric disorders
Bipolar disorder	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Mania	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Renal and urinary disorders
Renal failure acute	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Urinary retention	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Reproductive system and breast disorders
Postmenopausal haemorrhage	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Respiratory, thoracic and mediastinal disorders
Allergic respiratory disease	0/478 (0%)		1/973 (0.1%)		0/960 (0%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Surgical and medical procedures
Cholecystectomy	0/478 (0%)		0/973 (0%)		1/960 (0.1%)
Vascular disorders
Deep vein thrombosis	1/478 (0.2%)		0/973 (0%)		0/960 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Tolterodine ER		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	83/478 (17.4%)		261/973 (26.8%)		375/960 (39.1%)
Gastrointestinal disorders
Constipation	7/478 (1.5%)		30/973 (3.1%)		42/960 (4.4%)
Diarrhoea	3/478 (0.6%)		11/973 (1.1%)		11/960 (1.1%)
Dry mouth	26/478 (5.4%)		130/973 (13.4%)		265/960 (27.6%)
Dyspepsia	2/478 (0.4%)		10/973 (1%)		21/960 (2.2%)
Nausea	3/478 (0.6%)		13/973 (1.3%)		11/960 (1.1%)
General disorders
Oedema peripheral	5/478 (1%)		14/973 (1.4%)		4/960 (0.4%)
Infections and infestations
Bronchitis	6/478 (1.3%)		10/973 (1%)		3/960 (0.3%)
Influenza	1/478 (0.2%)		12/973 (1.2%)		5/960 (0.5%)
Nasopharyngitis	6/478 (1.3%)		9/973 (0.9%)		8/960 (0.8%)
Sinusitis	2/478 (0.4%)		11/973 (1.1%)		4/960 (0.4%)
Urinary tract infection	5/478 (1%)		12/973 (1.2%)		14/960 (1.5%)
Musculoskeletal and connective tissue disorders
Back pain	6/478 (1.3%)		9/973 (0.9%)		8/960 (0.8%)
Nervous system disorders
Headache	6/478 (1.3%)		20/973 (2.1%)		27/960 (2.8%)
Renal and urinary disorders
Dysuria	2/478 (0.4%)		8/973 (0.8%)		10/960 (1%)
Polyuria	10/478 (2.1%)		24/973 (2.5%)		29/960 (3%)
Respiratory, thoracic and mediastinal disorders
Cough	3/478 (0.6%)		4/973 (0.4%)		12/960 (1.3%)
Dry throat	0/478 (0%)		2/973 (0.2%)		11/960 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00611026

Other Study ID Numbers:

A0221046

First Posted:

Feb 8, 2008

Last Update Posted:

Feb 2, 2011

Last Verified:

Jan 1, 2011