A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00928070
• Collaborator: (none)
• Enrollment: 566
• Locations: 125
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Fesoterodine; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 566 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine	Drug: Fesoterodine; Fesoterodine 4 mg and 8 mg
Placebo Comparator: Placebo	Drug: Placebo; Placebo sham 4 mg and 8 mg

Outcome Measures

Primary Outcome Measures

1. Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [Baseline]

   UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

2. Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 [Baseline, Week 12]

   UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Secondary Outcome Measures

1. Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 [Baseline, Week 4]

   UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

2. Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

   Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).

3. Mean Number of Micturitions Per 24 Hours [Baseline]

   Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.

4. Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

   Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.

5. Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 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 (i.e., 100*(Week 4 or 12 - baseline)/baseline).

6. Mean Number of Micturition-related Urgency Episodes Per 24 Hours [Baseline]

   The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

7. Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

   The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

8. Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

   Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).

9. Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours [Baseline]

   Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

10. Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

    Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.

11. Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

    Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).

12. Frequency-Urgency Sum Rating Per 24 Hours [Baseline]

    Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.

13. Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

    Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.

14. Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12 [Baseline, Week 4, 12]

    Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.

15. Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12 [Screening, Week 4, 12]

    PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.

16. Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [Baseline]

    OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.

17. Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 [Baseline, Week 4, 12]

    OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.

18. Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) [Baseline]

    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

19. Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12 [Baseline, Week 4, 12]

    OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.

20. Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control [Week 12]

    OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.

21. Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response [Week 12]

    Participant's response to question, "overall, how satisfied are you with your OAB medication?" was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into "satisfied", and 4 and 5 were combined into "dissatisfied".

22. Mini Mental State Examination (MMSE) [Screening]

    MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.

23. Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12 [Screening, Week 12]

    MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline

24. Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12 [Baseline, Week 4, 12]

    PVR volume is defined as volume of urine remaining in the bladder immediately after urination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• male or female subjects 65 years of age or older

• OAB symptoms for at least 3 months

• score 3 or greater on Vulnerable Elderly Survey (VES-13)

• adequate mobility for independent toileting

• mean number of at least 2 UUI episodes per 24 hours

• mean urinary frequency of 8 or more micturitions per 24 hours

• able to independently complete the bladder diaries

Exclusion Criteria:

• PVR urinary volume greater than 200 ml

• MMSE score less than 20

• greater than 15 UUI episodes per 24 hours

• creatinine clearance less than 30 ml/min

• an average resting heart rate of greater than or equal to 90 beats per minute

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States	35233
2	Pfizer Investigational Site	Birmingham	Alabama	United States	35294
3	Pfizer Investigational Site	Montgomery	Alabama	United States	36117
4	Pfizer Investigational Site	Green Valley	Arizona	United States	85614
5	Pfizer Investigational Site	Mesa	Arizona	United States	85206-1734
6	Pfizer Investigational Site	Phoenix	Arizona	United States	85032
7	Pfizer Investigational Site	Tucson	Arizona	United States	85712
8	Pfizer Investigational Site	Tuscon	Arizona	United States	85710
9	Pfizer Investigational Site	Little Rock	Arkansas	United States	72204
10	Pfizer Investigational Site	Little Rock	Arkansas	United States	72223
11	Pfizer Investigational Site	Costa Mesa	California	United States	92626
12	Pfizer Investigational Site	Fairfield	California	United States	94534
13	Pfizer Investigational Site	Glendora	California	United States	91741
14	Pfizer Investigational Site	La Mesa	California	United States	91942
15	Pfizer Investigational Site	Long Beach	California	United States	90806
16	Pfizer Investigational Site	Mission Viejo	California	United States	92691
17	Pfizer Investigational Site	Murrieta	California	United States	92562
18	Pfizer Investigational Site	Norwalk	California	United States	90650
19	Pfizer Investigational Site	Paramount	California	United States	90723
20	Pfizer Investigational Site	Rancho Santa Margarita	California	United States	92688
21	Pfizer Investigational Site	San Bernardino	California	United States	92404
22	Pfizer Investigational Site	San Diego	California	United States	92108
23	Pfizer Investigational Site	Santa Ana	California	United States	92705
24	Pfizer Investigational Site	Temecula	California	United States	92591
25	Pfizer Investigational Site	Vacaville	California	United States	95688
26	Pfizer Investigational Site	Aurora	Colorado	United States	80012
27	Pfizer Investigational Site	Colorado Springs	Colorado	United States	80907
28	Pfizer Investigational Site	Colorado Springs	Colorado	United States	80909
29	Pfizer Investigational Site	Denver	Colorado	United States	80211
30	Pfizer Investigational Site	Denver	Colorado	United States	80220
31	Pfizer Investigational Site	Englewood	Colorado	United States	80110
32	Pfizer Investigational Site	Englewood	Colorado	United States	80113
33	Pfizer Investigational Site	Longmont	Colorado	United States	80501
34	Pfizer Investigational Site	Parker	Colorado	United States	80134
35	Pfizer Investigational Site	Groton	Connecticut	United States	06340
36	Pfizer Investigational Site	Milford	Connecticut	United States	06460
37	Pfizer Investigational Site	New London	Connecticut	United States	06320
38	Pfizer Investigational Site	Bonita Springs	Florida	United States	34134
39	Pfizer Investigational Site	Boynton Beach	Florida	United States	33472
40	Pfizer Investigational Site	Brooksville	Florida	United States	34601
41	Pfizer Investigational Site	Clearwater	Florida	United States	33756
42	Pfizer Investigational Site	Daytona Beach	Florida	United States	32114
43	Pfizer Investigational Site	DeLand	Florida	United States	32720
44	Pfizer Investigational Site	Ft. Lauderdale	Florida	United States	33316
45	Pfizer Investigational Site	Lake Worth	Florida	United States	33461
46	Pfizer Investigational Site	Melbourne	Florida	United States	32901
47	Pfizer Investigational Site	Naples	Florida	United States	34102
48	Pfizer Investigational Site	New Port Richey	Florida	United States	34652
49	Pfizer Investigational Site	New Port Richey	Florida	United States	34655
50	Pfizer Investigational Site	Ocala	Florida	United States	34471
51	Pfizer Investigational Site	Plant City	Florida	United States	33563
52	Pfizer Investigational Site	Sarasota	Florida	United States	34237
53	Pfizer Investigational Site	St. Petersburg	Florida	United States	33710
54	Pfizer Investigational Site	Trinity	Florida	United States	34655
55	Pfizer Investigational Site	Wellington	Florida	United States	33449
56	Pfizer Investigational Site	Winter Haven	Florida	United States	33880
57	Pfizer Investigational Site	Atlanta	Georgia	United States	30067
58	Pfizer Investigational Site	Macon	Georgia	United States	31217
59	Pfizer Investigational Site	Springfield	Illinois	United States	62702
60	Pfizer Investigational Site	Springfield	Illinois	United States	62703
61	Pfizer Investigational Site	Newburgh	Indiana	United States	47630
62	Pfizer Investigational Site	Arkansas City	Kansas	United States	67005
63	Pfizer Investigational Site	Kansas City	Kansas	United States	66160-7390
64	Pfizer Investigational Site	Wichita	Kansas	United States	67205
65	Pfizer Investigational Site	Wichita	Kansas	United States	67207
66	Pfizer Investigational Site	Lexington	Kentucky	United States	40503
67	Pfizer Investigational Site	Lexington	Kentucky	United States	40504
68	Pfizer Investigational Site	Shreveport	Louisiana	United States	71106
69	Pfizer Investigational Site	Baltimore	Maryland	United States	21211
70	Pfizer Investigational Site	Glen Burnie	Maryland	United States	21061
71	Pfizer Investigational Site	Towson	Maryland	United States	21204
72	Pfizer Investigational Site	Springfield	Massachusetts	United States	01103
73	Pfizer Investigational Site	Grand Rapids	Michigan	United States	49503
74	Pfizer Investigational Site	Kalamazoo	Michigan	United States	49009
75	Pfizer Investigational Site	Edina	Minnesota	United States	55435
76	Pfizer Investigational Site	Picayune	Mississippi	United States	39466
77	Pfizer Investigational Site	Southaven	Mississippi	United States	38671
78	Pfizer Investigational Site	St. Louis	Missouri	United States	63117
79	Pfizer Investigational Site	Lincoln	Nebraska	United States	68516
80	Pfizer Investigational Site	Omaha	Nebraska	United States	68114
81	Pfizer Investigational Site	Las Vegas	Nevada	United States	89119
82	Pfizer Investigational Site	Moorestown	New Jersey	United States	08057
83	Pfizer Investigational Site	Sewell	New Jersey	United States	08080
84	Pfizer Investigational Site	Albany	New York	United States	12208
85	Pfizer Investigational Site	Brooklyn	New York	United States	11215
86	Pfizer Investigational Site	Staten Island	New York	United States	10304
87	Pfizer Investigational Site	Williamsville	New York	United States	14221
88	Pfizer Investigational Site	Cary	North Carolina	United States	27511
89	Pfizer Investigational Site	Cary	North Carolina	United States	27518
90	Pfizer Investigational Site	Raleigh	North Carolina	United States	27612
91	Pfizer Investigational Site	Willoughby Hills	Ohio	United States	44094
92	Pfizer Investigational Site	Bethany	Oklahoma	United States	73008
93	Pfizer Investigational Site	Norman	Oklahoma	United States	73069
94	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73109
95	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73112
96	Pfizer Investigational Site	Portland	Oregon	United States	97205
97	Pfizer Investigational Site	Altoona	Pennsylvania	United States	16602
98	Pfizer Investigational Site	Erie	Pennsylvania	United States	16507
99	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15243
100	Pfizer Investigational Site	East Providence	Rhode Island	United States	02914
101	Pfizer Investigational Site	East Providence	Rhode Island	United States	02915
102	Pfizer Investigational Site	Charleston	South Carolina	United States	29425
103	Pfizer Investigational Site	Columbia	South Carolina	United States	29201
104	Pfizer Investigational Site	Myrtle Beach	South Carolina	United States	29572
105	Pfizer Investigational Site	Bristol	Tennessee	United States	37620
106	Pfizer Investigational Site	Chattanooga	Tennessee	United States	37404
107	Pfizer Investigational Site	Jackson	Tennessee	United States	38305
108	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
109	Pfizer Investigational Site	Austin	Texas	United States	78745
110	Pfizer Investigational Site	Austin	Texas	United States	78757
111	Pfizer Investigational Site	Corpus Christi	Texas	United States	78414
112	Pfizer Investigational Site	Houston	Texas	United States	77062
113	Pfizer Investigational Site	Houston	Texas	United States	77074
114	Pfizer Investigational Site	Leander	Texas	United States	78641
115	Pfizer Investigational Site	Longview	Texas	United States	75601
116	Pfizer Investigational Site	Longview	Texas	United States	75605
117	Pfizer Investigational Site	San Antonio	Texas	United States	78216
118	Pfizer Investigational Site	San Antonio	Texas	United States	78229
119	Pfizer Investigational Site	Temple	Texas	United States	76508
120	Pfizer Investigational Site	Murray	Utah	United States	84107
121	Pfizer Investigational Site	Salt Lake City	Utah	United States	84103
122	Pfizer Investigational Site	West Jordan	Utah	United States	84088
123	Pfizer Investigational Site	Richmond	Virginia	United States	23229
124	Pfizer Investigational Site	Burien	Washington	United States	98166
125	Pfizer Investigational Site	Spokane	Washington	United States	99216

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: NCT00928070
• Other Study ID Numbers: A0221049
• First Posted: Jun 25, 2009
• Last Update Posted: Jan 17, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by Pfizer: Urgency Urinary Incontinence OAB
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Period Title: Overall Study
STARTED	283	283
Treated	281	281
COMPLETED	220	226
NOT COMPLETED	63	57

Baseline Characteristics

Arm/Group Title	Placebo	Fesoterodine	Total
Arm/Group Description	Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.	Total of all reporting groups
Overall Participants	281	281	562
Age, Customized (participants) [Number]
65 to 74 years	134 47.7%	145 51.6%	279 49.6%
75 to 84 years	118 42%	106 37.7%	224 39.9%
At least 85 years	29 10.3%	30 10.7%	59 10.5%
Sex: Female, Male (Count of Participants)
Female	236 84%	225 80.1%	461 82%
Male	45 16%	56 19.9%	101 18%

Outcome Measures

1. Primary Outcome

Title	Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Description	UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	250	256
Mean (Standard Deviation) [episodes per 24 hours]	3.93 (2.16)	4.07 (2.33)

2. Primary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS population. Last observation carried forward (LOCF) method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	250	256
Least Squares Mean (Standard Error) [episodes per 24 hours]	-2.20 (0.15)	-2.84 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Analysis of covariance (ANCOVA) model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0018
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -1.05 to -0.24
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.21
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	248	255
Least Squares Mean (Standard Error) [episodes per 24 hours]	-1.54 (0.16)	-2.36 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	ANCOVA model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	Statistical testing, two-sided, was done at 5% significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.82
	Confidence Interval	(2-Sided) 95%; -1.27 to -0.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

4. Secondary Outcome

Title	Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Description	Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	250	256
Change at Week 4	-39.2 (65.7)	-57.2 (54.4)
Change at Week 12	-55.4 (63.1)	-71.2 (51.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

5. Secondary Outcome

Title	Mean Number of Micturitions Per 24 Hours
Description	Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	253	258
Mean (Standard Deviation) [micturitions per 24 hours]	12.22 (3.21)	12.11 (3.06)

6. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
Description	Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	253	258
Change at Week 4	-0.77 (0.17)	-1.64 (0.17)
Change at Week 12	-1.50 (0.16)	-2.34 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95%; -1.35 to -0.40
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.84
	Confidence Interval	(2-Sided) 95%; -1.29 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

7. Secondary Outcome

Title	Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
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 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	253	258
Change at Week 4	-5.1 (24.4)	-12.7 (19.1)
Change at Week 12	-10.4 (22.4)	-17.8 (19.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

8. Secondary Outcome

Title	Mean Number of Micturition-related Urgency Episodes Per 24 Hours
Description	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	256
Mean (Standard Deviation) [episodes per 24 hours]	10.30 (3.67)	10.02 (3.54)

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Description	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	256
Change at Week 4	-1.64 (0.24)	-2.74 (0.24)
Change at Week 12	-2.75 (0.25)	-4.15 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0014
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.10
	Confidence Interval	(2-Sided) 95%; -1.77 to -0.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.34
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.40
	Confidence Interval	(2-Sided) 95%; -2.10 to -0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.35
	Estimation Comments

10. Secondary Outcome

Title	Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Description	Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	256
Change at Week 4	-12.7 (45.0)	-26.2 (39.4)
Change at Week 12	-23.9 (46.4)	-39.7 (45.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

11. Secondary Outcome

Title	Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours
Description	Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	254
Mean (Standard Deviation) [episodes per 24 hours]	2.87 (1.51)	2.69 (1.38)

12. Secondary Outcome

Title	Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Description	Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	254
Change at Week 4	-0.44 (0.09)	-0.58 (0.09)
Change at Week 12	-0.68 (0.09)	-0.97 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2511
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.39 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0189
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.53 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments

13. Secondary Outcome

Title	Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Description	Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	254
Change at Week 4	-4.9 (68.2)	-18.0 (62.6)
Change at Week 12	-15.5 (63.6)	-31.2 (59.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0010
	Comments	Statistical testing, two-sided, was done at 5% significance level.
	Method	Ranked ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

14. Secondary Outcome

Title	Frequency-Urgency Sum Rating Per 24 Hours
Description	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	256
Mean (Standard Deviation) [units on a scale]	45.33 (13.20)	44.92 (13.45)

15. Secondary Outcome

Title	Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12
Description	Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	251	256
Change at Week 4	-6.95 (0.86)	-11.62 (0.86)
Change at Week 12	-11.53 (0.84)	-16.50 (0.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-4.67
	Confidence Interval	(2-Sided) 95%; -7.04 to -2.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.21
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-4.97
	Confidence Interval	(2-Sided) 95%; -7.27 to -2.66
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.17
	Estimation Comments

16. Secondary Outcome

Title	Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12
Description	Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'n' is signifying those participants of the population subsets who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	281	281
Baseline: =<3.5 undergarments (n=193,184)	1.41 (0.84)	1.49 (0.74)
Baseline: >3.5 undergarments (n=12,19)	4.97 (1.84)	4.81 (0.92)
Baseline: =<2.5 undergarments (n=172,169)	1.21 (0.63)	1.35 (0.62)
Baseline: >2.5 undergarments (n=35,35)	3.71 (1.42)	3.94 (1.18)
Change at Week 4: =<3.5 undergarments(n=193,184)	-0.27 (1.13)	-0.61 (1.09)
Change at Week 4: >3.5 undergarments(n=12,19)	-2.56 (3.07)	-2.11 (3.38)
Change at Week 12: =<2.5 undergarments(n=172,169)	-0.31 (1.06)	-0.72 (0.82)
Change at Week 12: >2.5 undergarments(n=35,35)	-2.14 (2.06)	-1.98 (1.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: =<3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<3.5/day and >3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0035
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 95%; -0.56 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: >3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<3.5/day and >3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7089
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 95%; -2.01 to 2.92
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.21
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: =<2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<2.5/day and >2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.61 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.10
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: >2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<2.5/day and >2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7437
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; -0.78 to 1.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.47
	Estimation Comments

17. Secondary Outcome

Title	Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12
Description	PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.
Time Frame	Screening, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	264	265
Baseline: No problems at all	0.0 0%	0.0 0%
Baseline: Some very minor problems	0.0 0%	0.0 0%
Baseline: Some minor problems	0.0 0%	0.0 0%
Baseline: Moderate problems	44.7 15.9%	44.5 15.8%
Baseline: Severe problems	43.9 15.6%	44.2 15.7%
Baseline: Many severe problems	11.4 4.1%	11.3 4%
Change at Week 4: Deterioration	12.3 4.4%	9.5 3.4%
Change at Week 4: No change	42.5 15.1%	29.8 10.6%
Change at Week 4: Minor improvement	25.3 9%	27.5 9.8%
Change at Week 4: Major improvement	19.9 7.1%	33.2 11.8%
Change at Week 12: Deterioration	12.1 4.3%	7.2 2.6%
Change at Week 12: No change	33.7 12%	27.2 9.7%
Change at Week 12: Minor improvement	25.0 8.9%	26.8 9.5%
Change at Week 12: Major improvement	29.2 10.4%	38.9 13.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for center was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12- deterioration, no change, minor improvement and major improvement: CMH test with modified ridit scoring controlling for center was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Cochran-Mantel-Haenszel
	Comments

18. Secondary Outcome

Title	Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Description	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	267	269
Mean (Standard Deviation) [units on a scale]	67.67 (18.59)	67.25 (19.04)

19. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
Description	OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	267	269
Change at Week 4	-13.81 (1.46)	-22.96 (1.46)
Change at Week 12	-20.48 (1.58)	-28.08 (1.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-9.15
	Confidence Interval	(2-Sided) 95%; -12.85 to -5.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.88
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-7.60
	Confidence Interval	(2-Sided) 95%; -11.60 to -3.61
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.03
	Estimation Comments

20. Secondary Outcome

Title	Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Description	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	267	269
Concern domain	45.89 (25.38)	46.57 (25.88)
Coping domain	44.72 (26.12)	44.74 (26.76)
Sleep domain	40.19 (26.51)	43.41 (25.76)
Social interaction domain	72.05 (25.35)	72.70 (25.45)
Total	49.61 (22.35)	50.58 (22.87)

21. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12
Description	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. LOCF method was used to impute Week 12 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	267	269
Change at Week 4: concern domain	12.35 (1.61)	20.51 (1.61)
Change at Week 4: coping domain	12.90 (1.65)	19.86 (1.66)
Change at Week 4: sleeping domain	13.33 (1.56)	17.33 (1.56)
Change at Week 4: social interaction domain	8.77 (1.19)	11.22 (1.19)
Change at Week 4: total	12.00 (1.37)	17.80 (1.38)
Change at Week 12: concern domain	17.20 (1.70)	26.24 (1.70)
Change at Week 12: coping domain	20.34 (1.72)	25.66 (1.72)
Change at Week 12: sleeping domain	19.05 (1.63)	23.10 (1.63)
Change at Week 12: social interaction domain	12.12 (1.26)	14.47 (1.26)
Change at Week 12: total	17.55 (1.46)	23.08 (1.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	8.17
	Confidence Interval	(2-Sided) 95%; 4.09 to 12.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.08
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	6.96
	Confidence Interval	(2-Sided) 95%; 2.77 to 11.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.13
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0472
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.00
	Confidence Interval	(2-Sided) 95%; 0.05 to 7.95
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.01
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1087
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	2.46
	Confidence Interval	(2-Sided) 95%; -0.55 to 5.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.53
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	5.79
	Confidence Interval	(2-Sided) 95%; 2.31 to 9.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.77
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	9.04
	Confidence Interval	(2-Sided) 95%; 4.75 to 13.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.19
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0169
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	5.32
	Confidence Interval	(2-Sided) 95%; 0.96 to 9.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.22
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0546
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.05
	Confidence Interval	(2-Sided) 95%; -0.08 to 8.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.10
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1497
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	2.35
	Confidence Interval	(2-Sided) 95%; -0.85 to 5.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.63
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0034
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	5.53
	Confidence Interval	(2-Sided) 95%; 1.84 to 9.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.88
	Estimation Comments

22. Secondary Outcome

Title	Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control
Description	OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	224	228
Mean (Standard Deviation) [units on a scale]	52.98 (33.82)	68.89 (28.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	ANOVA model with treatment and center as factors was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% significance level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	16.25
	Confidence Interval	(2-Sided) 95%; 10.43 to 22.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.96
	Estimation Comments

23. Secondary Outcome

Title	Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response
Description	Participant's response to question, "overall, how satisfied are you with your OAB medication?" was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into "satisfied", and 4 and 5 were combined into "dissatisfied".
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	224	227
Not satisfied	37.5 13.3%	18.9 6.7%
Neither dissatisfied nor satisfied	15.2 5.4%	9.3 3.3%
Satisfied	47.3 16.8%	71.8 25.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Not satisfied, neither dissatisfied nor satisfied, satisfied: CMH test with modified ridit scoring controlling for center was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Cochran-Mantel-Haenszel
	Comments

24. Secondary Outcome

Title	Mini Mental State Examination (MMSE)
Description	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.
Time Frame	Screening

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	220	223
Mean (Standard Deviation) [units on a scale]	28.04 (2.05)	28.16 (1.80)

25. Secondary Outcome

Title	Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12
Description	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline
Time Frame	Screening, Week 12

Outcome Measure Data

Analysis Population Description

FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	220	223
Least Squares Mean (Standard Error) [units on a scale]	0.33 (0.12)	0.15 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	ANCOVA model with terms for treatment, center, centered baseline value, and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2788
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.51 to 0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

26. Secondary Outcome

Title	Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12
Description	PVR volume is defined as volume of urine remaining in the bladder immediately after urination.
Time Frame	Baseline, Week 4, 12

Outcome Measure Data

Analysis Population Description

FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.

Arm/Group Title	Placebo	Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.	Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
Measure Participants	266	271
Baseline	26.51 (35.36)	25.69 (34.28)
Change at Week 4	1.83 (41.30)	13.43 (57.70)
Change at Week 12	-2.98 (35.95)	13.58 (60.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 4: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Van Elteren's test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	4.00
	Confidence Interval	(2-Sided) 95%; 0.00 to 8.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine
	Comments	Change at Week 12: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing, two-sided, was done at 5% alpha level.
	Method	Van Elteren's test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	7.00
	Confidence Interval	(2-Sided) 95%; 3.00 to 11.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Placebo		Fesoterodine
Arm/Group Description	Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.		Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator's discretion for remaining 8 weeks.
All Cause Mortality
	Placebo		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/281 (2.1%)		8/281 (2.8%)
Cardiac disorders
Cardiac failure congestive	1/281 (0.4%)		0/281 (0%)
Coronary artery occlusion	0/281 (0%)		1/281 (0.4%)
Gastrointestinal disorders
Rectal haemorrhage	1/281 (0.4%)		0/281 (0%)
Infections and infestations
Influenza	0/281 (0%)		1/281 (0.4%)
Urosepsis	0/281 (0%)		1/281 (0.4%)
Injury, poisoning and procedural complications
Fall	0/281 (0%)		1/281 (0.4%)
Femur fracture	0/281 (0%)		1/281 (0.4%)
Hip fracture	1/281 (0.4%)		1/281 (0.4%)
Joint dislocation	1/281 (0.4%)		0/281 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	1/281 (0.4%)		0/281 (0%)
Haemarthrosis	0/281 (0%)		1/281 (0.4%)
Muscular weakness	0/281 (0%)		1/281 (0.4%)
Osteoarthritis	0/281 (0%)		1/281 (0.4%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/281 (0.4%)		0/281 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Fesoterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	120/281 (42.7%)		155/281 (55.2%)
Cardiac disorders
Atrial fibrillation	1/281 (0.4%)		1/281 (0.4%)
Bradycardia	0/281 (0%)		1/281 (0.4%)
Cardiac failure congestive	0/281 (0%)		1/281 (0.4%)
Left atrial dilatation	1/281 (0.4%)		0/281 (0%)
Palpitations	2/281 (0.7%)		0/281 (0%)
Ventricular extrasystoles	0/281 (0%)		1/281 (0.4%)
Eye disorders
Asthenopia	1/281 (0.4%)		0/281 (0%)
Cataract	1/281 (0.4%)		0/281 (0%)
Dry eye	3/281 (1.1%)		4/281 (1.4%)
Eye discharge	0/281 (0%)		1/281 (0.4%)
Eye haemorrhage	0/281 (0%)		1/281 (0.4%)
Eye oedema	0/281 (0%)		1/281 (0.4%)
Eye swelling	0/281 (0%)		1/281 (0.4%)
Glaucoma	1/281 (0.4%)		1/281 (0.4%)
Iridocyclitis	1/281 (0.4%)		0/281 (0%)
Ocular hyperaemia	1/281 (0.4%)		0/281 (0%)
Retinal tear	1/281 (0.4%)		0/281 (0%)
Vision blurred	5/281 (1.8%)		0/281 (0%)
Vitreous floaters	0/281 (0%)		1/281 (0.4%)
Gastrointestinal disorders
Abdominal discomfort	0/281 (0%)		1/281 (0.4%)
Abdominal distension	1/281 (0.4%)		2/281 (0.7%)
Abdominal pain	1/281 (0.4%)		0/281 (0%)
Abdominal pain upper	3/281 (1.1%)		1/281 (0.4%)
Abdominal tenderness	1/281 (0.4%)		0/281 (0%)
Anorectal discomfort	1/281 (0.4%)		0/281 (0%)
Colonic polyp	2/281 (0.7%)		0/281 (0%)
Constipation	12/281 (4.3%)		31/281 (11%)
Diarrhoea	7/281 (2.5%)		8/281 (2.8%)
Diverticulum	1/281 (0.4%)		0/281 (0%)
Dry mouth	17/281 (6%)		66/281 (23.5%)
Dyspepsia	1/281 (0.4%)		7/281 (2.5%)
Faecal incontinence	0/281 (0%)		1/281 (0.4%)
Faeces hard	1/281 (0.4%)		0/281 (0%)
Flatulence	1/281 (0.4%)		2/281 (0.7%)
Gastrooesophageal reflux disease	1/281 (0.4%)		3/281 (1.1%)
Haemorrhoids	0/281 (0%)		1/281 (0.4%)
Hiatus hernia	0/281 (0%)		1/281 (0.4%)
Lip swelling	1/281 (0.4%)		0/281 (0%)
Nausea	4/281 (1.4%)		5/281 (1.8%)
Rectal haemorrhage	1/281 (0.4%)		0/281 (0%)
Tongue dry	0/281 (0%)		1/281 (0.4%)
Vomiting	1/281 (0.4%)		1/281 (0.4%)
General disorders
Asthenia	1/281 (0.4%)		0/281 (0%)
Chest pain	1/281 (0.4%)		0/281 (0%)
Chills	2/281 (0.7%)		0/281 (0%)
Fatigue	3/281 (1.1%)		8/281 (2.8%)
Gait disturbance	1/281 (0.4%)		0/281 (0%)
Generalised oedema	1/281 (0.4%)		0/281 (0%)
Irritability	1/281 (0.4%)		0/281 (0%)
Local swelling	0/281 (0%)		1/281 (0.4%)
Oedema	0/281 (0%)		1/281 (0.4%)
Oedema peripheral	6/281 (2.1%)		6/281 (2.1%)
Pain	2/281 (0.7%)		0/281 (0%)
Pyrexia	2/281 (0.7%)		0/281 (0%)
Therapeutic response unexpected	0/281 (0%)		1/281 (0.4%)
Hepatobiliary disorders
Hepatic cyst	1/281 (0.4%)		0/281 (0%)
Immune system disorders
Allergy to chemicals	1/281 (0.4%)		0/281 (0%)
Seasonal allergy	1/281 (0.4%)		1/281 (0.4%)
Infections and infestations
Abdominal infection	1/281 (0.4%)		0/281 (0%)
Abscess limb	1/281 (0.4%)		0/281 (0%)
Bacterial infection	1/281 (0.4%)		0/281 (0%)
Bronchitis	5/281 (1.8%)		1/281 (0.4%)
Candidiasis	0/281 (0%)		1/281 (0.4%)
Cellulitis	1/281 (0.4%)		1/281 (0.4%)
Diverticulitis	0/281 (0%)		1/281 (0.4%)
Escherichia infection	1/281 (0.4%)		0/281 (0%)
Gastroenteritis	2/281 (0.7%)		0/281 (0%)
Gastroenteritis viral	1/281 (0.4%)		0/281 (0%)
Herpes simplex	0/281 (0%)		1/281 (0.4%)
Herpes zoster	1/281 (0.4%)		1/281 (0.4%)
Herpes zoster ophthalmic	0/281 (0%)		1/281 (0.4%)
Influenza	4/281 (1.4%)		2/281 (0.7%)
Nasopharyngitis	5/281 (1.8%)		5/281 (1.8%)
Oral herpes	0/281 (0%)		1/281 (0.4%)
Pneumonia	2/281 (0.7%)		1/281 (0.4%)
Pneumonia viral	0/281 (0%)		1/281 (0.4%)
Sinusitis	0/281 (0%)		5/281 (1.8%)
Staphylococcal infection	1/281 (0.4%)		0/281 (0%)
Tinea pedis	0/281 (0%)		1/281 (0.4%)
Tooth abscess	0/281 (0%)		1/281 (0.4%)
Tooth infection	1/281 (0.4%)		1/281 (0.4%)
Upper respiratory tract infection	8/281 (2.8%)		3/281 (1.1%)
Urinary tract infection	10/281 (3.6%)		6/281 (2.1%)
Vulvovaginal candidiasis	0/281 (0%)		1/281 (0.4%)
Injury, poisoning and procedural complications
Arthropod bite	0/281 (0%)		1/281 (0.4%)
Contusion	2/281 (0.7%)		3/281 (1.1%)
Excoriation	1/281 (0.4%)		0/281 (0%)
Facial bones fracture	1/281 (0.4%)		0/281 (0%)
Fall	8/281 (2.8%)		7/281 (2.5%)
Foot fracture	1/281 (0.4%)		0/281 (0%)
Laceration	0/281 (0%)		1/281 (0.4%)
Post procedural haematoma	0/281 (0%)		1/281 (0.4%)
Skeletal injury	0/281 (0%)		2/281 (0.7%)
Wound	1/281 (0.4%)		0/281 (0%)
Wrist fracture	1/281 (0.4%)		0/281 (0%)
Investigations
Blood glucose increased	0/281 (0%)		1/281 (0.4%)
Blood pressure increased	0/281 (0%)		2/281 (0.7%)
Blood uric acid increased	0/281 (0%)		1/281 (0.4%)
Blood urine present	1/281 (0.4%)		0/281 (0%)
International normalised ratio increased	0/281 (0%)		1/281 (0.4%)
Nitrite urine present	1/281 (0.4%)		0/281 (0%)
Residual urine volume increased	0/281 (0%)		1/281 (0.4%)
Vitamin D decreased	1/281 (0.4%)		0/281 (0%)
Weight increased	0/281 (0%)		1/281 (0.4%)
Metabolism and nutrition disorders
Diabetes mellitus	1/281 (0.4%)		0/281 (0%)
Gout	0/281 (0%)		2/281 (0.7%)
Hyperphagia	1/281 (0.4%)		0/281 (0%)
Type 2 diabetes mellitus	0/281 (0%)		1/281 (0.4%)
Vitamin B12 deficiency	1/281 (0.4%)		1/281 (0.4%)
Vitamin D deficiency	1/281 (0.4%)		0/281 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/281 (1.1%)		3/281 (1.1%)
Arthritis	1/281 (0.4%)		0/281 (0%)
Back pain	0/281 (0%)		4/281 (1.4%)
Bursitis	0/281 (0%)		1/281 (0.4%)
Intervertebral disc degeneration	0/281 (0%)		1/281 (0.4%)
Joint swelling	2/281 (0.7%)		0/281 (0%)
Muscle spasms	4/281 (1.4%)		0/281 (0%)
Musculoskeletal chest pain	0/281 (0%)		1/281 (0.4%)
Musculoskeletal pain	0/281 (0%)		2/281 (0.7%)
Musculoskeletal stiffness	1/281 (0.4%)		0/281 (0%)
Neck pain	1/281 (0.4%)		1/281 (0.4%)
Osteoarthritis	2/281 (0.7%)		0/281 (0%)
Osteoporosis	0/281 (0%)		1/281 (0.4%)
Pain in extremity	2/281 (0.7%)		1/281 (0.4%)
Rheumatoid arthritis	1/281 (0.4%)		0/281 (0%)
Tendonitis	1/281 (0.4%)		1/281 (0.4%)
Trigger finger	0/281 (0%)		1/281 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/281 (0.4%)		0/281 (0%)
Skin cancer	0/281 (0%)		1/281 (0.4%)
Squamous cell carcinoma	1/281 (0.4%)		0/281 (0%)
Nervous system disorders
Diabetic neuropathy	0/281 (0%)		1/281 (0.4%)
Dizziness	2/281 (0.7%)		3/281 (1.1%)
Headache	5/281 (1.8%)		7/281 (2.5%)
Hypersomnia	0/281 (0%)		1/281 (0.4%)
Lethargy	1/281 (0.4%)		0/281 (0%)
Memory impairment	0/281 (0%)		2/281 (0.7%)
Migraine	0/281 (0%)		1/281 (0.4%)
Neuropathy peripheral	1/281 (0.4%)		0/281 (0%)
Radiculopathy	1/281 (0.4%)		0/281 (0%)
Sinus headache	0/281 (0%)		1/281 (0.4%)
Somnolence	2/281 (0.7%)		0/281 (0%)
Tremor	0/281 (0%)		1/281 (0.4%)
Psychiatric disorders
Confusional state	0/281 (0%)		1/281 (0.4%)
Depression	0/281 (0%)		1/281 (0.4%)
Insomnia	3/281 (1.1%)		3/281 (1.1%)
Sleep disorder	0/281 (0%)		1/281 (0.4%)
Renal and urinary disorders
Bladder mass	1/281 (0.4%)		0/281 (0%)
Bladder pain	1/281 (0.4%)		0/281 (0%)
Cystitis haemorrhagic	1/281 (0.4%)		0/281 (0%)
Dysuria	3/281 (1.1%)		4/281 (1.4%)
Haematuria	1/281 (0.4%)		1/281 (0.4%)
Hypertonic bladder	1/281 (0.4%)		0/281 (0%)
Nephrolithiasis	0/281 (0%)		1/281 (0.4%)
Pollakiuria	1/281 (0.4%)		1/281 (0.4%)
Urinary hesitation	0/281 (0%)		1/281 (0.4%)
Urinary incontinence	2/281 (0.7%)		0/281 (0%)
Urinary retention	0/281 (0%)		9/281 (3.2%)
Urine flow decreased	1/281 (0.4%)		1/281 (0.4%)
Urine odour abnormal	0/281 (0%)		1/281 (0.4%)
Reproductive system and breast disorders
Vaginal haemorrhage	0/281 (0%)		1/281 (0.4%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/281 (0%)		1/281 (0.4%)
Bronchospasm	0/281 (0%)		1/281 (0.4%)
Chronic obstructive pulmonary disease	1/281 (0.4%)		2/281 (0.7%)
Cough	2/281 (0.7%)		7/281 (2.5%)
Dry throat	0/281 (0%)		5/281 (1.8%)
Dysphonia	0/281 (0%)		1/281 (0.4%)
Dyspnoea	2/281 (0.7%)		0/281 (0%)
Dyspnoea exertional	0/281 (0%)		1/281 (0.4%)
Epistaxis	0/281 (0%)		1/281 (0.4%)
Nasal congestion	1/281 (0.4%)		1/281 (0.4%)
Nasal dryness	0/281 (0%)		1/281 (0.4%)
Oropharyngeal pain	0/281 (0%)		2/281 (0.7%)
Pleural effusion	1/281 (0.4%)		0/281 (0%)
Rhinitis allergic	0/281 (0%)		1/281 (0.4%)
Sinus congestion	1/281 (0.4%)		2/281 (0.7%)
Sleep apnoea syndrome	1/281 (0.4%)		0/281 (0%)
Skin and subcutaneous tissue disorders
Alopecia	1/281 (0.4%)		0/281 (0%)
Blister	0/281 (0%)		1/281 (0.4%)
Dermatitis atopic	1/281 (0.4%)		0/281 (0%)
Dermatitis contact	1/281 (0.4%)		0/281 (0%)
Ecchymosis	1/281 (0.4%)		0/281 (0%)
Eczema	1/281 (0.4%)		0/281 (0%)
Ingrowing nail	0/281 (0%)		1/281 (0.4%)
Night sweats	1/281 (0.4%)		0/281 (0%)
Onychoclasis	0/281 (0%)		1/281 (0.4%)
Photosensitivity reaction	1/281 (0.4%)		0/281 (0%)
Pruritus	0/281 (0%)		2/281 (0.7%)
Pruritus generalised	0/281 (0%)		1/281 (0.4%)
Rash	3/281 (1.1%)		0/281 (0%)
Urticaria	0/281 (0%)		1/281 (0.4%)
Surgical and medical procedures
Skin neoplasm excision	1/281 (0.4%)		0/281 (0%)
Vascular disorders
Flushing	0/281 (0%)		1/281 (0.4%)
Haematoma	2/281 (0.7%)		0/281 (0%)
Haemorrhage	1/281 (0.4%)		0/281 (0%)
Hypertension	3/281 (1.1%)		1/281 (0.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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