Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with urgency incontinence Overactive Bladder (OAB) symptoms who met all entrance criteria were randomized to the double-blind treatment period.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3867 participants entered the single-blind placebo run-in period; 2417 participants completed single-blind placebo run-in and progressed to randomization in the double-blind treatment period.

Reporting Groups

	Description
Placebo	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Participant Flow for 2 periods

Period 1:   Randomized to Double-blind Treatment

	Placebo	Tolterodine ER	Fesoterodine
STARTED	480	974	963
COMPLETED	478	973	960
NOT COMPLETED	2	1	3
Not treated	2	1	3

Period 2:   Double-blind Treatment Period

	Placebo	Tolterodine ER	Fesoterodine
STARTED	478	973	960
COMPLETED	431	885	862
NOT COMPLETED	47	88	98
Death	1	0	0
Adverse Event	9	28	46
Lack of Efficacy	11	10	4
Lost to Follow-up	6	11	14
Withdrawal by Subject	7	19	16
Unspecified	13	20	18

Reporting Groups

	Description
Placebo	Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
Tolterodine ER	Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
Fesoterodine	Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.

Baseline Measures

	Placebo	Tolterodine ER	Fesoterodine	Total
Number of Participants   [units: participants]	478	973	960	2411
Age, Customized   [units: participants]
Between 18 and 44 years	70	157	156	383
Between 45 and 64 years	214	462	474	1150
≥65 years	194	354	330	878
Gender   [units: participants]
Female	410	818	816	2044
Male	68	155	144	367

1.  Primary:

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

2.  Secondary:

Change From Baseline in Mean Voided Volume Per Micturition   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

3.  Secondary:

Change From Baseline in Mean Number of Micturitions Per 24 Hours   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

4.  Secondary:

Percent Change From Baseline of Micturitions Per 24 Hours   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

5.  Secondary:

Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

6.  Secondary:

Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

7.  Secondary:

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

8.  Secondary:

Percent Change From Baseline of UUI Episodes Per 24 Hours   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

9.  Secondary:

Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

10.  Secondary:

Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

11.  Secondary:

Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

12.  Secondary:

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

13.  Secondary:

Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

14.  Secondary:

Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)   [ Time Frame: Baseline, Week 1, Week 4, Week 12 ]

15.  Secondary:

Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary   [ Time Frame: Week 1, Week 4, Week 12 ]

16.  Secondary:

Change From Baseline in Patient Perception of Bladder Condition (PPBC)   [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ]

17.  Secondary:

Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.   [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ]

18.  Secondary:

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12   [ Time Frame: Baseline, Week 12 ]

19.  Secondary:

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12   [ Time Frame: Baseline, Week 12 ]

20.  Post-Hoc:

Post-hoc Adverse Events (AEs)   [ Time Frame: Baseline up to Week 12 ]