Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.

Reporting Groups

	Description
Placebo	Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.

Participant Flow:   Overall Study

	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
STARTED	318	320	313
COMPLETED	285	286	281
NOT COMPLETED	33	34	32
Adverse Event	11	14	14
Lack of Efficacy	5	3	2
Lost to Follow-up	1	1	0
Withdrawal by Subject	10	9	10
Protocol Violation	4	3	4
Physician Decision	1	0	0
Pregnancy	0	1	0
Meet Withdrawal Criterion	0	1	1
Adverse Event Occured Before Treatment	1	2	1

Reporting Groups

	Description
Placebo	Subjects were treated with placebo once daily for 12 weeks.
Fesoterodine 4 mg	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Fesoterodine 8 mg	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.

Baseline Measures

	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg	Total
Number of Participants   [units: participants]	318	320	313	951
Age   [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	227	217	196	640
>=65 years	91	103	117	311
Age   [units: years] Mean ± Standard Deviation	56.7  ± 13.5	57.2  ± 14.2	58.8  ± 13.4	57.6  ± 13.7
Gender   [units: participants]
Female	251	251	255	757
Male	67	69	58	194

1.  Primary:

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

2.  Secondary:

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

3.  Secondary:

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

4.  Secondary:

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

5.  Secondary:

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

6.  Secondary:

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

7.  Secondary:

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

8.  Secondary:

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

9.  Secondary:

Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.   [ Time Frame: Baseline to Week 12 ]

10.  Secondary:

Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

11.  Secondary:

Change From Baseline in Mean Voided Volume Per Micturition at Week 12.   [ Time Frame: Baseline to Week 12 ]

12.  Secondary:

Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.   [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]

13.  Secondary:

Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).   [ Time Frame: Baseline to Week12 ]

14.  Secondary:

Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.   [ Time Frame: Baseline to Week 12 ]

15.  Secondary:

Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.   [ Time Frame: Baseline to Week 12 ]

16.  Secondary:

The Number of Patients With “Severe Problems, Score 5” or “Many Severe Problems, Score 6” in Patient Perception of Bladder Condition (PPBC) at Week 12.   [ Time Frame: Baseline to Week 12 ]