Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00444925

Collaborator

(none)

1,712

Enrollment

178

Locations

Arms

Duration (Months)

9.6

Patients Per Site

0.6

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: fesoterodine fumarate Drug: placebo Drug: tolterodine tartrate	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1712 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 (OAB)

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine Tablets	Drug: fesoterodine fumarate 4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
Placebo Comparator: Placebo Tablets and capsules	Drug: placebo once daily (OD)for 12 weeks
Active Comparator: Tolterodine Capsules	Drug: tolterodine tartrate 4 mg once daily (OD) for 12 weeks

Arm

Intervention/Treatment

Experimental: Fesoterodine

Tablets

Drug: fesoterodine fumarate

4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks

Placebo Comparator: Placebo

Tablets and capsules

Drug: placebo

once daily (OD)for 12 weeks

Active Comparator: Tolterodine

Capsules

Drug: tolterodine tartrate

4 mg once daily (OD) for 12 weeks

Outcome Measures

Primary Outcome Measures

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment). [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). Change: mean at observation minus mean at baseline.

Secondary Outcome Measures

Change From Baseline in Mean Number of 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). Change calculated as mean at observation minus mean at baseline.
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 Voided Volume Per Micturition. [Baseline, Week 1, Week 4, Week 12]
Mean voided volume 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 sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.
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 12 or 4 - 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 sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject 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 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. [Baseline, Week 1, Week 4, Week 12]
Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Percent Change From Baseline of Urgency Episodes Per 24 Hours. [Baseline, Week 1, Week 4, Week 12]
Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. 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 Mean Number of Severe Urgency Episodes Per 24 Hours. [Baseline, Week 1, Week 4, Week 12]
Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions 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). Change calculated as mean at observation minus mean at baseline.
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 >= to 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 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 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). Change calculated as mean at observation minus mean at baseline.
Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours. [Baseline, Week 1, Week 4, Week 12]
Frequency-Urgency Sum rating 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). Change calculated as mean at observation minus mean at baseline.
Change From Baseline in Patient Perception of Bladder Condition (PPBC). [Baseline, Week 1, Week, 4, Week 12]
Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, 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 Equals Patient Perception of Urgency Scale (PPUS) in Protocol. [Baseline, Week 1, Week 4, Week 12]
Number of subjects 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 (End of Treatment). [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)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). [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]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Homewood	Alabama	United States	35209
2	Pfizer Investigational Site	Huntsville	Alabama	United States	35801
3	Pfizer Investigational Site	Mobile	Alabama	United States	36608
4	Pfizer Investigational Site	Carmichael	California	United States	95608
5	Pfizer Investigational Site	Orangevale	California	United States	95662
6	Pfizer Investigational Site	San Diego	California	United States	92103-6204
7	Pfizer Investigational Site	Aurora	Colorado	United States	80012
8	Pfizer Investigational Site	Waterbury	Connecticut	United States	06708
9	Pfizer Investigational Site	Miami	Florida	United States	33186
10	Pfizer Investigational Site	Wellington	Florida	United States	33414
11	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
12	Pfizer Investigational Site	Coeur D Alene	Idaho	United States	83814
13	Pfizer Investigational Site	Sandpoint	Idaho	United States	83864
14	Pfizer Investigational Site	Aurora	Illinois	United States	60504
15	Pfizer Investigational Site	West Des Moines	Iowa	United States	50266
16	Pfizer Investigational Site	Newton	Kansas	United States	67114
17	Pfizer Investigational Site	Shrevport	Louisiana	United States	71106
18	Pfizer Investigational Site	Watertown	Massachusetts	United States	02472
19	Pfizer Investigational Site	Chaska	Minnesota	United States	55318
20	Pfizer Investigational Site	Lawrenceville	New Jersey	United States	08648
21	Pfizer Investigational Site	Albuquerque	New Mexico	United States	87109
22	Pfizer Investigational Site	Garden City	New York	United States	11530
23	Pfizer Investigational Site	Mineola	New York	United States	11501
24	Pfizer Investigational Site	Burlington	North Carolina	United States	27215
25	Pfizer Investigational Site	Concord	North Carolina	United States	28025
26	Pfizer Investigational Site	Huntersville	North Carolina	United States	28078
27	Pfizer Investigational Site	Dayton	Ohio	United States	45439
28	Pfizer Investigational Site	Allentown	Pennsylvania	United States	18103
29	Pfizer Investigational Site	Allentown	Pennsylvania	United States	18106
30	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15212
31	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15213-3180
32	Pfizer Investigational Site	East Providence	Rhode Island	United States	02914
33	Pfizer Investigational Site	Charleston	South Carolina	United States	29425
34	Pfizer Investigational Site	Columbia	South Carolina	United States	29201
35	Pfizer Investigational Site	Kingsport	Tennessee	United States	37660
36	Pfizer Investigational Site	Milan	Tennessee	United States	38358
37	Pfizer Investigational Site	Houston	Texas	United States	77024
38	Pfizer Investigational Site	Provo	Utah	United States	84604
39	Pfizer Investigational Site	Chesapeake	Virginia	United States	23320
40	Pfizer Investigational Site	Seattle	Washington	United States	98104
41	Pfizer Investigational Site	Menomonee Falls	Wisconsin	United States	53051
42	Pfizer Investigational Site	Antwerpen		Belgium	2020
43	Pfizer Investigational Site	Bruxelles		Belgium	1070
44	Pfizer Investigational Site	Kortrijk		Belgium	8500
45	Pfizer Investigational Site	Tessenderlo		Belgium	3980
46	Pfizer Investigational Site	Salvador	BA	Brazil	40420-000
47	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	CEP 20551-030
48	Pfizer Investigational Site	Porto Alegre	RS	Brazil	90020-090
49	Pfizer Investigational Site	Porto Alegre	RS	Brazil	90470-340
50	Pfizer Investigational Site	Campinas	SP	Brazil	13084-882
51	Pfizer Investigational Site	São Paulo	SP	Brazil	04039-901
52	Pfizer Investigational Site	São Paulo	SP	Brazil	04262-000
53	Pfizer Investigational Site	Calgary	Alberta	Canada	T2V 4R6
54	Pfizer Investigational Site	Edmonton	Alberta	Canada	T5H 3V9
55	Pfizer Investigational Site	Victoria	British Columbia	Canada	V8V 3N1
56	Pfizer Investigational Site	Saint John	New Brunswick	Canada	E2L 3J8
57	Pfizer Investigational Site	Kitchener	Ontario	Canada	N2N 2B9
58	Pfizer Investigational Site	Toronto	Ontario	Canada	M4N 3M5
59	Pfizer Investigational Site	Toronto	Ontario	Canada	M6A 3B5
60	Pfizer Investigational Site	Montreal	Quebec	Canada	H2X 1N8
61	Pfizer Investigational Site	Montreal	Quebec	Canada	H3S 1Z1
62	Pfizer Investigational Site	Montréal	Quebec	Canada	H2X 3J4
63	Pfizer Investigational Site	Sherbrooke	Quebec	Canada	J1H 5N4
64	Pfizer Investigational Site	Rancagua	VI Región	Chile	2820945
65	Pfizer Investigational Site	Puerto Montt		Chile	5480000
66	Pfizer Investigational Site	Santiago		Chile
67	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	0
68	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
69	Pfizer Investigational Site	Alajuela		Costa Rica
70	Pfizer Investigational Site	Cartago		Costa Rica
71	Pfizer Investigational Site	San Jose		Costa Rica
72	Pfizer Investigational Site	Hradec Kralove		Czech Republic	500 02
73	Pfizer Investigational Site	Jablonec nad Nisou		Czech Republic	466 60
74	Pfizer Investigational Site	Jindrichuv Hradec		Czech Republic	377 38
75	Pfizer Investigational Site	Ostrava		Czech Republic	708 52
76	Pfizer Investigational Site	Praha 8		Czech Republic	180 00
77	Pfizer Investigational Site	Aalborg		Denmark	9100
78	Pfizer Investigational Site	Aarhus N		Denmark	8200
79	Pfizer Investigational Site	Glostrup		Denmark	2600
80	Pfizer Investigational Site	Herlev		Denmark	2730
81	Pfizer Investigational Site	Kolding		Denmark	6000
82	Pfizer Investigational Site	Nykoebing Falster		Denmark	4800
83	Pfizer Investigational Site	Roskilde		Denmark	4000
84	Pfizer Investigational Site	Ahaus		Germany	41683
85	Pfizer Investigational Site	Alzey		Germany	55232
86	Pfizer Investigational Site	Berlin		Germany	10787
87	Pfizer Investigational Site	Berlin		Germany	13125
88	Pfizer Investigational Site	Berlin		Germany	13347
89	Pfizer Investigational Site	Karlsruhe		Germany	76199
90	Pfizer Investigational Site	Krumbach		Germany	86381
91	Pfizer Investigational Site	Leipzig		Germany	04105
92	Pfizer Investigational Site	Leipzig		Germany	04109
93	Pfizer Investigational Site	Marburg		Germany	35039
94	Pfizer Investigational Site	Muelheim a.d. Ruhr		Germany	45468
95	Pfizer Investigational Site	Muenchen		Germany	81241
96	Pfizer Investigational Site	Muenchen		Germany	81925
97	Pfizer Investigational Site	Rosenheim		Germany	83022
98	Pfizer Investigational Site	Athens	Attiki	Greece	10552
99	Pfizer Investigational Site	Ioannina	Ipiros	Greece	45001
100	Pfizer Investigational Site	Rio, Patras		Greece	26500
101	Pfizer Investigational Site	Thessaloniki		Greece	56403
102	Pfizer Investigational Site	Hong Kong		Hong Kong
103	Pfizer Investigational Site	Shatin		Hong Kong
104	Pfizer Investigational Site	Debrecen		Hungary	4026
105	Pfizer Investigational Site	Nyiregyhaza		Hungary	4400
106	Pfizer Investigational Site	Szeged		Hungary	6725
107	Pfizer Investigational Site	Szentes		Hungary	6600
108	Pfizer Investigational Site	Hyderabad	Andhra Pradesh	India	500 001
109	Pfizer Investigational Site	Hyderabad	Andhra Pradesh	India	500 082
110	Pfizer Investigational Site	Bangalore	Karnataka	India	560 034
111	Pfizer Investigational Site	Jaipur	Rajasthan	India	302 004
112	Pfizer Investigational Site	Vellore	Tamil Nadu	India	632 004
113	Pfizer Investigational Site	Lucknow	Uttar Pradesh	India	226003
114	Pfizer Investigational Site	Latina		Italy	04100
115	Pfizer Investigational Site	Padova		Italy	35128
116	Pfizer Investigational Site	Siena		Italy	53100
117	Pfizer Investigational Site	Seoul	Korea	Korea, Republic of	110-744
118	Pfizer Investigational Site	Daegu		Korea, Republic of	705-718
119	Pfizer Investigational Site	Seoul		Korea, Republic of	100-380
120	Pfizer Investigational Site	Seoul		Korea, Republic of	120-752
121	Pfizer Investigational Site	Seoul		Korea, Republic of	136-705
122	Pfizer Investigational Site	Seoul		Korea, Republic of	137-040
123	Pfizer Investigational Site	Batu Caves	Selangor	Malaysia	68100
124	Pfizer Investigational Site	Kuala Lumpur		Malaysia	59100
125	Pfizer Investigational Site	Bergen		Norway	5005
126	Pfizer Investigational Site	Hamar		Norway	2317
127	Pfizer Investigational Site	Lysaker		Norway	1366
128	Pfizer Investigational Site	Oslo		Norway	0264
129	Pfizer Investigational Site	Oslo		Norway	NO-0257
130	Pfizer Investigational Site	Sandnes		Norway	4313
131	Pfizer Investigational Site	Surco	Lima	Peru	L33
132	Pfizer Investigational Site	Lima		Peru	L27
133	Pfizer Investigational Site	Bialystok		Poland	15-950
134	Pfizer Investigational Site	Bydgoszcz		Poland	85-168
135	Pfizer Investigational Site	Lodz		Poland	91-463
136	Pfizer Investigational Site	Szczecin		Poland	70-11
137	Pfizer Investigational Site	Warszawa		Poland	02-507
138	Pfizer Investigational Site	Arad		Romania	310175
139	Pfizer Investigational Site	Bucuresti		Romania	041345
140	Pfizer Investigational Site	Bucuresti		Romania	050653
141	Pfizer Investigational Site	Sibiu		Romania	550245
142	Pfizer Investigational Site	Timisoara		Romania	300736
143	Pfizer Investigational Site	Moscow	Russia	Russian Federation	105425
144	Pfizer Investigational Site	St. Petersburg	Russia	Russian Federation
145	Pfizer Investigational Site	Moscow		Russian Federation	101000
146	Pfizer Investigational Site	Moscow		Russian Federation	115516
147	Pfizer Investigational Site	Moscow		Russian Federation	117815
148	Pfizer Investigational Site	Rostov-on-Don		Russian Federation	344022
149	Pfizer Investigational Site	Singapore		Singapore	119074
150	Pfizer Investigational Site	Singapore		Singapore	229899
151	Pfizer Investigational Site	Bloemfontein	Free State	South Africa	9300
152	Pfizer Investigational Site	Parktown	Gauteng Province	South Africa	2193
153	Pfizer Investigational Site	Vosloorus	Gauteng	South Africa	1475
154	Pfizer Investigational Site	Durban	Kwa Zulu Natal	South Africa	4001
155	Pfizer Investigational Site	Pietermaritzburg	Kwa Zulu Natal	South Africa	3201
156	Pfizer Investigational Site	Cape Town		South Africa	8001
157	Pfizer Investigational Site	Pretoria		South Africa	0083
158	Pfizer Investigational Site	Getafe	Madrid	Spain	28905
159	Pfizer Investigational Site	Bilbao	Vizcaya	Spain	48013
160	Pfizer Investigational Site	Madrid		Spain	28046
161	Pfizer Investigational Site	Valencia		Spain	46010
162	Pfizer Investigational Site	Huskvarna		Sweden	561 36
163	Pfizer Investigational Site	Lulea		Sweden	97180
164	Pfizer Investigational Site	Malmo		Sweden	205 02
165	Pfizer Investigational Site	Skovde		Sweden	541 30
166	Pfizer Investigational Site	Stockholm		Sweden
167	Pfizer Investigational Site	Frauenfeld		Switzerland	CH-8500
168	Pfizer Investigational Site	Luzern 16		Switzerland	CH-6000
169	Pfizer Investigational Site	Niao-Sung Hsiang	Kaohsiung	Taiwan	833
170	Pfizer Investigational Site	Hualien		Taiwan	970
171	Pfizer Investigational Site	Taichung City		Taiwan	40705
172	Pfizer Investigational Site	Taipei		Taiwan	100
173	Pfizer Investigational Site	Taipei		Taiwan
174	Pfizer Investigational Site	Chernivtsi		Ukraine	58002
175	Pfizer Investigational Site	Kharkiv		Ukraine	61037
176	Pfizer Investigational Site	Kyiv		Ukraine	04053
177	Pfizer Investigational Site	Odessa		Ukraine	65000
178	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:

Pfizer

ClinicalTrials.gov Identifier:

NCT00444925

Other Study ID Numbers:

A0221008

First Posted:

Mar 8, 2007

Last Update Posted:

Mar 24, 2015

Last Verified:

Mar 1, 2015

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

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	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: Single-blind Placebo Run-In Period
STARTED	2446	0	0
COMPLETED	1712	0	0
NOT COMPLETED	734	0	0
Period Title: Single-blind Placebo Run-In Period
STARTED	337	690	685
COMPLETED	334	684	679
NOT COMPLETED	3	6	6
Period Title: Single-blind Placebo Run-In Period
STARTED	334	684	679
COMPLETED	304	628	598
NOT COMPLETED	30	56	81

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	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	334	684	679	1697
Age, Customized (participants) [Number]
18 - 44 years	55 16.5%	103 15.1%	96 14.1%	254 15%
45 - 64 years	167 50%	349 51%	367 54.1%	883 52%
>= 65 years	112 33.5%	232 33.9%	216 31.8%	560 33%
Sex: Female, Male (Count of Participants)
Female	269 80.5%	564 82.5%	558 82.2%	1391 82%
Male	65 19.5%	120 17.5%	121 17.8%	306 18%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
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). Change: mean at observation minus mean at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS): took at least 1 dose of assigned treatment, contributed data to at least 1 baseline or post-baseline efficacy assessment, and excluded 107 subjects from two study sites with significant Good Clinical Practices (GCP) deviations. The decision to exclude that data was made while the study was still 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	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	307	626	619
Mean (Standard Error) [number of episodes per 24 hours]	-1.46 (0.10)	-1.61 (0.06)	-1.72 (0.06)

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).
	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	0.0107
	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	0.0172
	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 Number of 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). Change calculated as mean at observation minus mean at baseline.
Time Frame	Baseline, Week 1, Week 4

Outcome Measure Data

Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [Last Observation Carried Forward (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	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	334	684	679
Week 1 (n=302, 614, 612)	-0.54 (0.09)	-0.92 (0.06)	-0.95 (0.06)
Week 4 [LOCF] (n=307, 626, 618)	-1.06 (0.10)	-1.40 (0.06)	-1.52 (0.06)

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).
	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 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	<0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's 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	0.8460
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's 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 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	<0.0001
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's 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	0.1937
	Comments
	Method	Van Elteren's Test
	Comments	P-value based on Van Elteren's Test adjusted by baseline UUI quartile.

3. 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; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, 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	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	334	684	679
Week 1 (n=302, 614, 612)	-28.6	-55.1	-53.6
Week 4 [LOCF] (n=307, 626, 618)	-60.0	-85.7	-93.2
Week 12 [LOCF] (n=307, 626, 619)	-82.1	-100.0	-100.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	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 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	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, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 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	<0.0001
	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 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	0.0220
	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.

4. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Micturition.
Description	Mean voided volume 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 subjects 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	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	334	684	679
Week 1 (n=306, 622, 623)	11.0 (3.2)	19.2 (2.5)	18.7 (2.5)
Week 4 [LOCF] (n=313, 633, 625)	14.0 (3.8)	25.7 (3.0)	30.5 (3.0)
Week 12 [LOCF] (n=313, 633, 626)	16.8 (3.9)	23.5 (3.0)	32.9 (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	0.0214
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.8
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.4
	Estimation Comments	Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (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	0.0149
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.2
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.4
	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	0.8659
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.5
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.7
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.5
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.0
	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	0.0036
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.7
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.0
	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 Fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1484
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.7
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.3
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.1
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.1
	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	0.1029
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.7
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.1
	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	0.0048
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.4
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.3
	Estimation Comments	Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of subjects 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	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	334	684	679
Week 1 (n=307, 622, 623)	-0.5 (0.1)	-1.0 (0.1)	-1.0 (0.1)
Week 4 [LOCF] (n= 313, 634, 627)	-1.2 (0.2)	-1.8 (0.1)	-1.9 (0.1)
Week 12 [LOCF] (n= 313, 634, 628)	-1.5 (0.2)	-2.1 (0.1)	-2.2 (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	0.0002
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	() % to
	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	0.0006
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.5
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7395
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0
	Confidence Interval	() % to
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	() % to
	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	0.0007
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4185
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	() % to
	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	0.0005
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3798
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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.

6. 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 12 or 4 - baseline)/baseline).
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of subjects 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	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	334	684	679
Week 1 (n=307, 622, 623)	-2.7	-7.7	-7.9
Week 4 [LOCF] (n=313, 634, 627)	-10.3	-15.0	-14.8
Week 12 [LOCF] (n=313, 634, 628)	-12.1	-16.2	-18.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	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 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	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, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
	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. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
	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 country and treatment as factors, and ranked baseline value as a covariate.

7. 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 sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject 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; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, 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	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	334	684	679
Week 1 (n=288, 584, 596)	-0.1 (0.1)	-0.3 (0.0)	-0.2 (0.0)
Week 4 [LOCF] (n=293, 596, 600)	-0.4 (0.1)	-0.5 (0.0)	-0.5 (0.1)
Week 12 [LOCF] (n=293, 596, 601)	-0.5 (0.1)	-0.6 (0.1)	-0.6 (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	0.2730
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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	0.0652
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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	0.3503
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.0
	Confidence Interval	() % to
	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	0.2667
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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	0.1643
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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	0.7264
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.0
	Confidence Interval	() % to
	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	0.3269
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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	0.5059
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0
	Confidence Interval	() % to
	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	0.6990
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0
	Confidence Interval	() % to
	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.

8. 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 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject 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; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, 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	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	334	684	679
Week 1 (n=288, 584, 596)	-10.0	-12.5	0.0
Week 4 [LOCF] (n=293, 596, 600)	-22.2	-25.0	-20.0
Week 12 [LOCF] (n=293, 596, 601)	-25.0	-27.9	-28.6

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
Description	Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, 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	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	334	684	679
Week 1 (n=306, 619, 621)	-0.4 (0.2)	-1.3 (0.2)	-1.1 (0.2)
Week 4 [LOCF] (n=311, 631, 627)	-1.2 (0.2)	-2.4 (0.2)	-2.6 (0.2)
Week 12 [LOCF] (n=311, 631, 628)	-2.0 (0.3)	-3.1 (0.2)	-3.5 (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	0.0008
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	() % to
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.9
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3820
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	() % to
	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 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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.4
	Confidence Interval	() % to
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.2
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3498
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() % to
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.5
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.1
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3
	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 at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0542
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.4
	Confidence Interval	() % to
	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 of Urgency Episodes Per 24 Hours.
Description	Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 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; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, 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	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	334	684	679
Week 1 (n=306, 619, 621)	-5.6	-12.5	-9.7
Week 4 [LOCF] (n=311,631, 627)	-11.4	-23.1	-26.9
Week 12 [LOCF] (n=311, 631, 628)	-17.6	-30.8	-37.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	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, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	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, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
	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. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
	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.

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 >= to 4 in diary ) per 24 hours: sum of all micturitions 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). Change calculated as mean at observation minus mean at baseline.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, 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	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	334	684	679
Week 1 (n=306, 618, 618)	-0.4 (0.2)	-1.3 (0.2)	-1.2 (0.2)
Week 4 [LOCF] (n=311, 630, 624)	-1.2 (0.2)	-2.2 (0.2)	-2.4 (0.2)
Week 12 [LOCF] (n=311, 630, 625)	-1.9 (0.2)	-2.8 (0.2)	-3.0 (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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.9
	Confidence Interval	() % to
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.0
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5581
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	() % to
	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 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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.2
	Confidence Interval	() % to
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.0
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1510
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	() % to
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.1
	Confidence Interval	() % to
	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	0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.9
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 12.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1391
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	() % to
	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.

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 >= to 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; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, 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	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	334	684	679
Week 1 (n=306, 618, 618)	-9.4	-25.0	-25.0
Week 4 [LOCF] (n=311, 630, 624)	-25.0	-45.8	-54.5
Week 12 [LOCF] (n=311, 630, 625)	-48.0	-63.4	-71.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	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 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
	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, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Tolterodine ER
	Comments	Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
	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 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
	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. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
	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.

13. Secondary Outcome

Title	Change From Baseline in Mean 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 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). Change calculated as mean at observation minus mean at baseline.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of subjects 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	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	334	684	679
Week 1 (n=306, 619, 621)	-0.1 (0.0)	-0.2 (0.0)	-0.2 (0.0)
Week 4 [LOCF] (n=311, 631, 627)	-0.2 (0.0)	-0.4 (0.0)	-0.5 (0.0)
Week 12 [LOCF] (n=311, 631, 628)	-0.4 (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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() % to
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 1.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5972
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.0
	Confidence Interval	() % to
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	() % to
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() % to
	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 Fesoterodine vs Tolterodine ER at Week 4.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.1267
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.3
	Confidence Interval	() % to
	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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	() % to
	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	0.0289
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.1
	Confidence Interval	() % to
	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 (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
Description	Frequency-Urgency Sum rating 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). Change calculated as mean at observation minus mean at baseline.
Time Frame	Baseline, Week 1, Week 4, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of subjects 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	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	334	684	679
Week 1 (n=306, 619, 621)	-2.4 (0.7)	-5.7 (0.5)	-5.5 (0.5)
Week 4 [LOCF] (n=311,631, 627)	-5.7 (0.8)	-9.7 (0.6)	-10.5 (0.6)
Week 12 [LOCF] (n=311, 631, 628)	-8.2 (0.8)	-12.1 (0.6)	-13.2 (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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.1
	Confidence Interval	() % to
	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 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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.3
	Confidence Interval	() % to
	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 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	0.7288
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	() % to
	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 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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.7
	Confidence Interval	() % to
	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.

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	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.0
	Confidence Interval	() % to
	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.

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	0.2473
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.7
	Confidence Interval	() % to
	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 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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.9
	Confidence Interval	() % to
	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.

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	<0.0001
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.8
	Confidence Interval	() % to
	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.

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	0.1047
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.1
	Confidence Interval	() % to
	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.

15. Secondary Outcome

Title	Change From Baseline in Patient Perception of Bladder Condition (PPBC).
Description	Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, 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 subjects 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	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	334	684	679
Week 1 (n=309, 625, 623), >=2 points improvement	32 9.6%	79 11.5%	102 15%
Week 1, 1-point improvement	94 28.1%	181 26.5%	186 27.4%
Week 1, no change	147 44%	306 44.7%	286 42.1%
Week 1, deterioration	36 10.8%	59 8.6%	49 7.2%
Week 4 (n=313, 632, 629), >=2 points improvement	57 17.1%	169 24.7%	196 28.9%
Week 4, 1-point improvement	95 28.4%	201 29.4%	224 33%
Week 4, no change	127 38%	203 29.7%	176 25.9%
Week 4, deterioration	34 10.2%	59 8.6%	33 4.9%
Week 12 (n=313, 632, 630), >=2 points improvement	67 20.1%	210 30.7%	254 37.4%
Week 12, 1-point improvement	102 30.5%	189 27.6%	198 29.2%
Week 12, no change	111 33.2%	171 25%	148 21.8%
Week 12, deterioration	33 9.9%	62 9.1%	30 4.4%

Statistical Analysis 1

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

Statistical Test of Hypothesis	p-Value	0.0143
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	With modified ridit scoring and stratified by country.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	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	With modified ridit scoring and stratified by country.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	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	With modified ridit scoring and stratified by country.

16. Secondary Outcome

Title	Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
Description	Number of subjects 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 subjects 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	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	334	684	679
Week 1 (n=309, 627, 624), improvement	68 20.4%	162 23.7%	171 25.2%
Week 1, no change	218 65.3%	438 64%	413 60.8%
Week 1, deterioration	23 6.9%	27 3.9%	40 5.9%
Week 4 (n=313, 633, 629), improvement	98 29.3%	238 34.8%	256 37.7%
Week 4, no change	194 58.1%	362 52.9%	348 51.3%
Week 4, deterioration	21 6.3%	33 4.8%	25 3.7%
Week 12 (n=313, 633, 630), improvement	112 33.5%	254 37.1%	291 42.9%
Week 12, no change	181 54.2%	344 50.3%	314 46.2%
Week 12, deterioration	20 6%	35 5.1%	25 3.7%

Statistical Analysis 1

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

Statistical Test of Hypothesis	p-Value	0.0773
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	With modified ridit scoring and stratified by country.

Statistical Analysis 2

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

Statistical Test of Hypothesis	p-Value	0.0017
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	With modified ridit scoring and stratified by country.

Statistical Analysis 3

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

Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	With modified ridit scoring and stratified by country.

17. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
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)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo n=289; Tolterodine ER n=589; Fesoterodine n=571.

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	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	334	684	679
Least Squares Mean (Standard Error) [score on scale]	-16.3 (1.4)	-22.5 (1.1)	-27.1 (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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-10.8
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.5
	Estimation Comments	Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.

18. Secondary Outcome

Title	Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
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]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 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	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	334	684	679
HRQL concern domain (n=289, 589, 572)	13.4 (1.5)	19.3 (1.1)	22.6 (1.2)
HRQL coping domain (n=289, 589, 572)	14.0 (1.5)	18.5 (1.2)	22.6 (1.2)
HRQL sleep domain (n=289, 589, 572)	12.2 (1.4)	15.1 (1.1)	17.3 (1.1)
HRQL social interaction domain (n=289, 588, 572)	6.8 (1.1)	9.4 (0.9)	11.6 (0.9)
HRQL scale score total (n=289, 588, 572)	12.0 (1.3)	16.3 (1.0)	19.3 (1.0)

Statistical Analysis 1

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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.2
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.6
	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, 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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.6
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.6
	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	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	0.0008
	Comments
	Method	ANCOVA
	Comments	Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.0
	Confidence Interval	() % to
	Parameter Dispersion	Type: Standard Deviation Value: 1.5
	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: HRQL social interaction 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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.8
	Confidence Interval	() % to
	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 5

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 country and treatment as factors, and centered baseline value as a covariate.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.3
	Confidence Interval	() % to
	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.

19. Post-Hoc Outcome

Title	Diary Dry Rates
Description	Diary dry rate: number of subjects 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; only subjects with baseline urgency urinary incontinence >0 per 24 hours are included; n=number of subjects in the respective category at observation (Week 1, Week 4, Week 12).

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	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	334	684	679
Week 1	54 16.2%	153 22.4%	159 23.4%
Week 4	97 29%	290 42.4%	306 45.1%
Week 12	138 41.3%	358 52.3%	396 58.3%

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	0.0072
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by baseline urgency urinary incontinence quartile.

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	0.0116
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by baseline urgency urinary incontinence quartile.

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	0.7828
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by baseline urgency urinary incontinence quartile.

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	Stratified by baseline urgency urinary incontinence quartile.

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	Stratified by baseline urgency urinary incontinence quartile.

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	0.3104
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by baseline urgency urinary incontinence quartile.

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	Stratified by baseline urgency urinary incontinence quartile.

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	0.0004
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by baseline urgency urinary incontinence quartile.

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	0.0153
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by baseline urgency urinary incontinence quartile.

Adverse Events

	Placebo		Tolterodine ER		Fesoterodine
Time Frame
Adverse Event Reporting Description

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		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/ (NaN)		9/ (NaN)		15/ (NaN)
Blood and lymphatic system disorders
Iron deficiency anaemia	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Cardiac disorders
Hypertensive heart disease	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Myocardial ischaemia	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Gastrointestinal disorders
Abdominal pain	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Appendicitis perforated	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Nausea	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Rectal haemorrhage	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Vomiting	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
General disorders
Chest pain	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Hepatobiliary disorders
Biliary colic	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Infections and infestations
Abdominal wall abscess	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Bronchiectasis	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Cystitis	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Herpes zoster	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Injury, poisoning and procedural complications
Hand fracture	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Head injury	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Seroma	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Traumatic brain injury	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Upper limb fracture	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Intervertebral disc protrusion	0/334 (0%)		1/684 (0.1%)		1/679 (0.1%)
Musculoskeletal pain	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Pain in extremity	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Spinal column stenosis	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Hepatic neoplasm malignant	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Lung cancer metastatic	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Lymphoma	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Neoplasm malignant	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Prostate cancer	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Skin cancer	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Nervous system disorders
Dizziness	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Haemorrhage intracranial	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Vertebrobasilar insufficiency	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Psychiatric disorders
Mental status changes	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Suicidal behaviour	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Renal and urinary disorders
Urinary incontinence	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Reproductive system and breast disorders
Breast mass	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Uterine haemorrhage	0/334 (0%)		0/684 (0%)		1/679 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Dyspnoea exertional	0/334 (0%)		1/684 (0.1%)		0/679 (0%)
Vascular disorders
Arteriosclerosis	1/334 (0.3%)		0/684 (0%)		0/679 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Tolterodine ER		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	76/ (NaN)		213/ (NaN)		290/ (NaN)
Eye disorders
Dry eye	6/334 (1.8%)		8/684 (1.2%)		9/679 (1.3%)
Vision blurred	1/334 (0.3%)		8/684 (1.2%)		12/679 (1.8%)
Gastrointestinal disorders
Abdominal pain	4/334 (1.2%)		4/684 (0.6%)		10/679 (1.5%)
Abdominal pain upper	3/334 (0.9%)		6/684 (0.9%)		9/679 (1.3%)
Constipation	10/334 (3%)		28/684 (4.1%)		37/679 (5.4%)
Diarrhoea	4/334 (1.2%)		15/684 (2.2%)		14/679 (2.1%)
Dry mouth	20/334 (6%)		112/684 (16.4%)		189/679 (27.8%)
Dyspepsia	1/334 (0.3%)		8/684 (1.2%)		12/679 (1.8%)
Nausea	6/334 (1.8%)		7/684 (1%)		12/679 (1.8%)
Vomiting	2/334 (0.6%)		2/684 (0.3%)		7/679 (1%)
General disorders
Fatigue	0/334 (0%)		4/684 (0.6%)		12/679 (1.8%)
Infections and infestations
Influenza	4/334 (1.2%)		8/684 (1.2%)		7/679 (1%)
Nasopharyngitis	10/334 (3%)		13/684 (1.9%)		13/679 (1.9%)
Sinusitis	3/334 (0.9%)		8/684 (1.2%)		3/679 (0.4%)
Upper respiratory tract infection	4/334 (1.2%)		9/684 (1.3%)		2/679 (0.3%)
Urinary tract infection	2/334 (0.6%)		10/684 (1.5%)		15/679 (2.2%)
Musculoskeletal and connective tissue disorders
Back pain	10/334 (3%)		7/684 (1%)		10/679 (1.5%)
Nervous system disorders
Dizziness	3/334 (0.9%)		10/684 (1.5%)		8/679 (1.2%)
Headache	8/334 (2.4%)		23/684 (3.4%)		38/679 (5.6%)
Renal and urinary disorders
Dysuria	1/334 (0.3%)		7/684 (1%)		4/679 (0.6%)
Respiratory, thoracic and mediastinal disorders
Cough	1/334 (0.3%)		4/684 (0.6%)		8/679 (1.2%)
Vascular disorders
Hypertension	3/334 (0.9%)		3/684 (0.4%)		8/679 (1.2%)

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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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.govCallCenter@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00444925

Other Study ID Numbers:

A0221008

First Posted:

Mar 8, 2007

Last Update Posted:

Mar 24, 2015

Last Verified:

Mar 1, 2015