Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00561951
• Collaborator: (none)
• Enrollment: 951
• Locations: 65
• Arms: 3
• Duration (Months): 14
• Patients Per Site: 14.6
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: fesoterodine fumarate; Drug: Placebo; Drug: fesoterodine fumarate	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 951 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, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine fumarate 4 mg (Double-Blind)	Drug: fesoterodine fumarate; 4mg tablets OD for 12 weeks
Placebo Comparator: Placebo (Double-Blind)	Drug: Placebo; Corresponding placebo tablets OD for 12 weeks
Experimental: Fesoterodine fumarate 8 mg (Double-Blind)	Drug: fesoterodine fumarate; 8mg tablets OD for 12 weeks

Outcome Measures

Primary Outcome Measures

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

   Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.

Secondary Outcome Measures

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

   Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.

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

   Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.

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

   Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.

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

   Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.

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

   Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.

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

   Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline.

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

   Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline.

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

   Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.

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

   Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.

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

    Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline.

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

    Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.

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

    King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline.

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

    The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline.

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

    Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems Change: mean at Week 12 minus mean at Baseline.

15. 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. [Baseline to Week 12]

    Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.

Exclusion Criteria:

• Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.

• Patient has a known neurological disease influencing bladder function.

• Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Kowloon		Hong Kong
2	Pfizer Investigational Site	Shatin		Hong Kong
3	Pfizer Investigational Site	Nagoya	Aichi	Japan
4	Pfizer Investigational Site	Chuo-ku, Chiba-shi	Chiba-ken	Japan
5	Pfizer Investigational Site	Eiheiji-cyo,yoshida-gun,	Fukui-ken	Japan
6	Pfizer Investigational Site	Fukuoka-Shi	Fukuoka-Ken	Japan
7	Pfizer Investigational Site	Koga-shi	Fukuoka-ken	Japan
8	Pfizer Investigational Site	Minami-ku, Fukuoka-shi	Fukuoka-ken	Japan
9	Pfizer Investigational Site	Nishi-ku	Fukuoka	Japan
10	Pfizer Investigational Site	Sawara-ku	Fukuoka	Japan
11	Pfizer Investigational Site	Amagasaki-shi	Hyogo	Japan
12	Pfizer Investigational Site	Suma-ku, Kobe-shi	Hyogo	Japan
13	Pfizer Investigational Site	Higashinada	Hyougo	Japan
14	Pfizer Investigational Site	Nada-ku, Kobe-shi	Hyougo	Japan
15	Pfizer Investigational Site	Takaraduka-city	Hyougo	Japan
16	Pfizer Investigational Site	Aira-gun, Aira-chou,	Kagosima	Japan
17	Pfizer Investigational Site	Kawasakishi	Kanagawaken	Japan
18	Pfizer Investigational Site	Isogo-ku, Yokohama-shi	Kanagawa	Japan
19	Pfizer Investigational Site	Sagamihara-shi	Kanagawa	Japan
20	Pfizer Investigational Site	Tama-ku, Kawasaki-shi	Kanagawa	Japan
21	Pfizer Investigational Site	Kouchi-shi	Kouchi	Japan
22	Pfizer Investigational Site	Tamana-shi	Kumamoto-ken	Japan
23	Pfizer Investigational Site	Matumoto-Shi	Nagano-Ken	Japan
24	Pfizer Investigational Site	Matsumoto-shi	Nagano	Japan
25	Pfizer Investigational Site	Hunaki-cho, Ibaraki-shi	Osaka	Japan
26	Pfizer Investigational Site	Kita-ku, Osaka-shi	Osaka	Japan
27	Pfizer Investigational Site	Kosobe-cho, Takatsuki-shi	Osaka	Japan
28	Pfizer Investigational Site	Minami-ku, Sakai-shi	Osaka	Japan
29	Pfizer Investigational Site	Nishinari-ku	Osaka	Japan
30	Pfizer Investigational Site	Osaka-shi	Osaka	Japan
31	Pfizer Investigational Site	Suita-shi,	Osaka	Japan
32	Pfizer Investigational Site	Suita-shi	Osaka	Japan
33	Pfizer Investigational Site	Toyonaka-city	Osaka	Japan
34	Pfizer Investigational Site	Yodogawa-Ku	Osaka	Japan
35	Pfizer Investigational Site	Saitama-shi	Saitama-ken	Japan
36	Pfizer Investigational Site	Satte-shi	Saitama	Japan
37	Pfizer Investigational Site	Wakou-shi	Saitama	Japan
38	Pfizer Investigational Site	Gotenbashi	Shizuokaken	Japan
39	Pfizer Investigational Site	Susono	Shizuokaken	Japan
40	Pfizer Investigational Site	Bunkyo-ku	Tokyo	Japan
41	Pfizer Investigational Site	Chofu-shi	Tokyo	Japan
42	Pfizer Investigational Site	Chuo-ku	Tokyo	Japan
43	Pfizer Investigational Site	Fucyushi	Tokyo	Japan
44	Pfizer Investigational Site	Koto-ku	Tokyo	Japan
45	Pfizer Investigational Site	Nakano-ku	Tokyo	Japan
46	Pfizer Investigational Site	Nishitokyo-shi	Tokyo	Japan
47	Pfizer Investigational Site	Setagaya-ku	Tokyo	Japan
48	Pfizer Investigational Site	Setgaya-ku	Tokyo	Japan
49	Pfizer Investigational Site	Shibuya-ku	Tokyo	Japan
50	Pfizer Investigational Site	Shinjuku-ku	Tokyo	Japan
51	Pfizer Investigational Site	Suginami-ku	Tokyo	Japan
52	Pfizer Investigational Site	Sumida-ku	Tokyo	Japan
53	Pfizer Investigational Site	Chuou-shi	Yamanashi	Japan
54	Pfizer Investigational Site	Kumamoto		Japan
55	Pfizer Investigational Site	Cheonan-si	Chungcheongnam-do	Korea, Republic of	330-715
56	Pfizer Investigational Site	Pusan		Korea, Republic of	602-739
57	Pfizer Investigational Site	Seoul		Korea, Republic of	100-380
58	Pfizer Investigational Site	Seoul		Korea, Republic of	136-705
59	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
60	Pfizer Investigational Site	Chiayi Country		Taiwan	613
61	Pfizer Investigational Site	Hualien		Taiwan	970
62	Pfizer Investigational Site	Koahsiung		Taiwan	833
63	Pfizer Investigational Site	Taichung		Taiwan	402
64	Pfizer Investigational Site	Taipei		Taiwan	100
65	Pfizer Investigational Site	Taipei		Taiwan	112

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.

• ClinicalTrials.gov Identifier: NCT00561951
• Other Study ID Numbers: A0221005
• First Posted: Nov 21, 2007
• Last Update Posted: Jul 14, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Period Title: Overall Study
STARTED	318	320	313
COMPLETED	285	286	281
NOT COMPLETED	33	34	32

Baseline Characteristics

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg	Total
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.	Total of all reporting groups
Overall Participants	318	320	313	951
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	227 71.4%	217 67.8%	196 62.6%	640 67.3%
>=65 years	91 28.6%	103 32.2%	117 37.4%	311 32.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.7 (13.5)	57.2 (14.2)	58.8 (13.4)	57.6 (13.7)
Sex: Female, Male (Count of Participants)
Female	251 78.9%	251 78.4%	255 81.5%	757 79.6%
Male	67 21.1%	69 21.6%	58 18.5%	194 20.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Description	Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Least Squares Mean (95% Confidence Interval) [UUI Episodes]	-1.01	-1.35	-1.40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	The closed testing procedure was used in order to control the probability of a type 1 error.
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.34
	Confidence Interval	() 95%; -0.56 to -0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The closed testing procedure was used in order to control the probability of a type 1 error.
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.39
	Confidence Interval	() 95%; -0.60 to -0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Week 2 (n=308, 314, 305)	-0.79 (1.465)	-1.10 (1.681)	-1.12 (1.736)
Week 4 (n=301, 303, 296)	-1.15 (1.532)	-1.48 (1.688)	-1.49 (1.643)
Week 8 (n=289, 289, 287)	-1.45 (1.518)	-1.61 (1.680)	-1.65 (1.690)
Week 12 (n=284, 284, 281)	-1.49 (1.717)	-1.76 (1.618)	-1.87 (1.814)

3. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Description	Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Least Squares Mean (95% Confidence Interval) [Micturitions]	-0.59	-1.15	-1.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.56
	Confidence Interval	() 95%; -0.91 to -0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.66
	Confidence Interval	() 95%; -1.01 to -0.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Week 2 (n=308, 314, 305)	-0.47 (1.786)	-0.94 (1.987)	-1.06 (2.076)
Week 4 (n=301, 303, 296)	-0.85 (1.960)	-1.33 (2.146)	-1.60 (2.246)
Week 8 (n=289, 289, 287)	-1.36 (2.215)	-1.81 (2.277)	-2.15 (2.402)
Week 12 (n=284, 284, 281)	-1.36 (2.415)	-2.13 (2.214)	-2.17 (2.515)

5. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
Description	Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Least Squares Mean (95% Confidence Interval) [Urgency Episodes]	-1.00	-1.65	-1.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.65
	Confidence Interval	() 95%; -1.07 to -0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.66
	Confidence Interval	() 95%; -1.09 to -0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Week 2 (n=308, 314, 305)	-0.79 (2.640)	-1.37 (2.722)	-1.59 (2.816)
Week 4 (n=301, 303, 296)	-1.60 (2.780)	-2.16 (2.906)	-2.16 (3.065)
Week 8 (n=289, 289, 287)	-2.34 (2.835)	-2.50 (3.080)	-2.71 (3.139)
Week 12 (n=284, 284, 281)	-2.37 (2.975)	-2.89 (2.838)	-3.05 (3.462)

7. Secondary Outcome

Title	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
Description	Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Least Squares Mean (95% Confidence Interval) [Incontinence Episodes]	-0.88	-1.27	-1.15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.39
	Confidence Interval	() 95%; -0.63 to -0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.27
	Confidence Interval	() 95%; -0.52 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Week 2 (n=308, 314, 305)	-0.80 (1.573)	-1.11 (1.725)	-1.06 (1.887)
Week 4 (n=301, 303, 296)	-1.22 (1.598)	-1.61 (1.755)	-1.50 (1.707)
Week 8 (n=289, 289, 287)	-1.56 (1.727)	-1.76 (1.795)	-1.73 (1.760)
Week 12 (n=284, 284, 281)	-1.59 (1.869)	-1.97 (1.843)	-1.86 (2.000)

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
Description	Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline . Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	243	256	257
Least Squares Mean (95% Confidence Interval) [Night-Time Micturitions]	-0.18	-0.21	-0.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.624
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	() 95%; -0.18 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.129
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	() 95%; -0.26 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	243	256	257
Week 2 (n=242, 256, 256)	-0.25 (0.696)	-0.24 (0.796)	-0.34 (0.809)
Week 4 (n=236, 246, 248)	-0.30 (0.835)	-0.30 (0.830)	-0.46 (0.780)
Week 8 (n=224, 232, 241)	-0.41 (0.820)	-0.45 (0.815)	-0.58 (0.903)
Week 12 (n=220, 229, 236)	-0.44 (0.945)	-0.48 (0.882)	-0.63 (0.945)

11. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
Description	Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Mean (Standard Deviation) [mL]	13.07 (46.207)	22.80 (47.590)	32.77 (52.893)

12. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Description	Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	309	314	306
Week 2 (n=308, 314, 304)	5.06 (37.875)	13.63 (35.350)	21.52 (42.946)
Week 4 (n=301, 303, 296)	9.23 (43.639)	21.62 (44.623)	27.41 (45.803)
Week 8 (n=289, 289, 287)	10.75 (45.628)	22.05 (44.949)	30.94 (51.258)
Week 12 (n=284, 284, 281)	13.28 (46.317)	24.52 (48.620)	33.40 (53.379)

13. Secondary Outcome

Title	Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Description	King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	285	283	283
General Health Perceptions (n=285, 283, 283)	-7.02 (22.573)	-9.36 (25.190)	-6.10 (25.272)
Impact on Life (n=285, 283, 283)	-22.46 (28.018)	-27.33 (29.960)	-25.09 (32.172)
Role Limitations (n=285, 283, 283)	-20.47 (27.730)	-27.92 (26.373)	-25.97 (28.590)
Physical Limitations (n=285, 283, 283)	-18.65 (28.250)	-23.50 (28.807)	-25.97 (28.278)
Social Limitations (n=285, 283, 283)	-14.44 (25.541)	-17.92 (24.029)	-18.53 (25.765)
Personal Relationships (n=214, 210, 202)	-8.33 (21.773)	-16.11 (25.798)	-9.98 (24.335)
Emotions (n=285, 283, 283)	-18.01 (26.365)	-24.70 (27.192)	-24.89 (27.310)
Sleep/Energy (n=285, 283, 283)	-12.51 (24.967)	-19.08 (23.800)	-18.02 (25.287)
Incontinence Severity Measures (n=285, 283, 283)	-13.75 (20.763)	-17.67 (21.038)	-18.59 (21.814)

14. Secondary Outcome

Title	Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description	The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	285	283	283
Symptom Bother Score	-18.25 (23.618)	-26.61 (22.592)	-26.35 (23.849)
Total Score of HRQL domain	12.88 (18.868)	17.84 (17.880)	17.29 (19.670)
Coping Score of HRQL domain	16.54 (23.633)	21.01 (22.109)	21.48 (25.336)
Concern Score of HRQL domain	13.25 (21.182)	20.05 (20.526)	19.10 (21.868)
Sleep Score of HRQL domain	12.03 (22.215)	16.16 (21.886)	15.35 (24.654)
Social Score of HRQL domain	7.37 (17.211)	11.35 (16.504)	9.98 (16.706)

15. Secondary Outcome

Title	Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
Description	Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	285	283	283
Mean (Standard Deviation) [score on scale]	-1.57 (1.236)	-1.83 (1.157)	-1.76 (1.182)

16. Secondary Outcome

Title	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.
Description	Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all Some very minor problems Some minor problems Some moderate problems Severe problems Many severe problems
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Measure Participants	285	283	283
Baseline	82 25.8%	97 30.3%	83 26.5%
Week 12	28 8.8%	12 3.8%	19 6.1%

Adverse Events

Arm/Group Title	Placebo		Fesoterodine 4 mg		Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.		Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.		Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
All Cause Mortality
	Placebo		Fesoterodine 4 mg		Fesoterodine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Fesoterodine 4 mg		Fesoterodine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/318 (1.6%)		3/320 (0.9%)		0/313 (0%)
Gastrointestinal disorders
Abdominal pain	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
Diarrhoea	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
Vomiting	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
General disorders
Pyrexia	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
Infections and infestations
Abscess	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
Cellulitis	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
Urinary tract infection	0/318 (0%)		1/320 (0.3%)		0/313 (0%)
Injury, poisoning and procedural complications
Pelvic fracture	0/318 (0%)		1/320 (0.3%)		0/313 (0%)
Road traffic accident	0/318 (0%)		1/320 (0.3%)		0/313 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
Nervous system disorders
Cerebral infarction	1/318 (0.3%)		0/320 (0%)		0/313 (0%)
Reproductive system and breast disorders
Pelvic pain	0/318 (0%)		1/320 (0.3%)		0/313 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Fesoterodine 4 mg		Fesoterodine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/318 (21.4%)		138/320 (43.1%)		185/313 (59.1%)
Gastrointestinal disorders
Constipation	15/318 (4.7%)		17/320 (5.3%)		33/313 (10.5%)
Diarrhoea	2/318 (0.6%)		7/320 (2.2%)		3/313 (1%)
Dry mouth	31/318 (9.7%)		93/320 (29.1%)		158/313 (50.5%)
Infections and infestations
Cystitis	4/318 (1.3%)		12/320 (3.8%)		7/313 (2.2%)
Nasopharyngitis	21/318 (6.6%)		19/320 (5.9%)		22/313 (7%)
Nervous system disorders
Dizziness	1/318 (0.3%)		7/320 (2.2%)		2/313 (0.6%)
Headache	5/318 (1.6%)		10/320 (3.1%)		4/313 (1.3%)
Renal and urinary disorders
Dysuria	0/318 (0%)		2/320 (0.6%)		14/313 (4.5%)
Residual urine	5/318 (1.6%)		7/320 (2.2%)		2/313 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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