A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01302054
• Collaborator: (none)
• Enrollment: 990
• Locations: 176
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder, Overactive	Drug: Fesoterodine 8 mg; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 990 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine	Drug: Fesoterodine 8 mg; Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.; Other Names: Toviaz
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [Baseline, Week 12]

   UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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 urinary sensation scale (USS) rating of 5 in the diary. USS range from 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 Micturitions Per 24 Hours at Week 12 [Baseline, Week 12]

   Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (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.

2. Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 [Baseline, Week 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 range from 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.

3. Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 [Baseline, Week 12]

   PPBC: single-item, self-administered validated questionnaire. Participant answered: "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2).

4. Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 [Baseline, Week 12]

   UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).

5. Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 [Baseline, Week 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 (not at all) to 6 (a very great deal). 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. Change=observation minus baseline.

6. Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 [Baseline, Week 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 (not at all) to 6 (a very great deal). 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.

7. Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2 [Week -2, Week 12]

   UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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. Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline [Baseline, Week 12]

   UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.

9. Percentage of Participants With No UUI Episodes (Diary Dry Rate) [Week 4, Week 12]

   UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of overactive bladder with symptoms for at least 6 months.

• Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine

• Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception

Exclusion Criteria:

• Conditions or prior treatment that may also affect bladder function

• Clinically significant urinary tract infection (UTI)

• Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research, Inc.	Birmingham	Alabama	United States	35209
2	Alabama Internal Medicine, PC	Birmingham	Alabama	United States	35235
3	Brown and McCool Gynecology	Fairhope	Alabama	United States	36532
4	Radiant Research, Inc.	Chandler	Arizona	United States	85225
5	Eclipse Clinical Research	Green Valley	Arizona	United States	85614
6	Radiant Research, Inc.	Tucson	Arizona	United States	85710
7	Urological Associates of Southern Arizona, PC	Tucson	Arizona	United States	85715
8	American Institute of Research	Los Angeles	California	United States	90017
9	Moaz Khorsandi, DO	Los Angeles	California	United States	90017
10	Urology Group of Southern California	Los Angeles	California	United States	90017
11	Institute for Advanced Urology	Los Angeles	California	United States	90048
12	Center for Clinical Trials, LLC	Paramount	California	United States	90723
13	Sierra Clinical Research	Roseville	California	United States	95661
14	Superior Research LLC	Sacramento	California	United States	95825
15	California Research Foundation	San Diego	California	United States	92103
16	Medical Center for Clinical Research	San Diego	California	United States	92108
17	Advanced Urology, PC	Parker	Colorado	United States	80134
18	Thameside Obstetrics/Gynecological Center	Groton	Connecticut	United States	06340
19	S.H.E. Medical Associates	Hartford	Connecticut	United States	06105
20	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
21	Manatee Medical Research Institute, LLC	Bradenton	Florida	United States	34205
22	Atlantic Institute of Clinical Research	Daytona Beach	Florida	United States	32114
23	SJS Clinical Research	Destin	Florida	United States	32541
24	Ocala Urology Specialists	Ocala	Florida	United States	34471
25	Renstar Medical Research, Inc.	Ocala	Florida	United States	34471
26	Accord Clinical Research, LLC	Port Orange	Florida	United States	32129
27	Pinellas Urology, Inc.	Saint Petersburg	Florida	United States	33710
28	Florida Urology Partners	Tampa	Florida	United States	33607
29	The Office of Georgis Patsias, MD, PA	Wellington	Florida	United States	33449
30	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
31	Atlanta Medical Research Institute, LLC	Alpharetta	Georgia	United States	30005
32	Radiant Research, Inc.	Atlanta	Georgia	United States	30342
33	In-Quest Medical Research, LLC	Duluth	Georgia	United States	30096
34	Prism Research Group	Rome	Georgia	United States	30165
35	Valley Health Care	Rome	Georgia	United States	30165
36	Fox Valley Clinical Research Center, LLC	Aurora	Illinois	United States	60504
37	Radiant Research, Inc.	Chicago	Illinois	United States	60654
38	Urology of Indiana, LLC	Noblesville	Indiana	United States	46062
39	Radiant Research, Inc.	Overland Park	Kansas	United States	66202
40	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
41	New England Center for Clinical Research Fall River, LLC	Fall River	Massachusetts	United States	02720
42	New England Center for Clinical Research of Massachusetts, LLC	New Bedford	Massachusetts	United States	02740
43	Bay State Clinical Trials, Inc.	Watertown	Massachusetts	United States	02472
44	Beyer Research	Kalamazoo	Michigan	United States	49009
45	Medical Research Associates, Inc.	Traverse City	Michigan	United States	49684
46	Radiant Research, Inc.	Edina	Minnesota	United States	55435
47	Adult and Pediatric Urology	Sartell	Minnesota	United States	56377
48	CRC of Jackson	Jackson	Mississippi	United States	39202
49	Women's Specialty Center	Jackson	Mississippi	United States	39202
50	The Urology Group	Southaven	Mississippi	United States	38671
51	Radiant Research, Inc.	Saint Louis	Missouri	United States	63141
52	Quality Clinical Research, Inc.	Omaha	Nebraska	United States	68114
53	Francis Jimenez, MD	Las Vegas	Nevada	United States	89102
54	Impact Clinical Trials	Las Vegas	Nevada	United States	89106
55	Richard M. Groom, MD	Las Vegas	Nevada	United States	89106
56	Northeast Urogynecology	Albany	New York	United States	12205
57	The Urologic Institute of Northeastern New York - Community Care Physicians, PC	Albany	New York	United States	12208
58	University Urology Associates	New York	New York	United States	10016
59	Associated Medical Professionals of New York, PLLC	Oneida	New York	United States	13421
60	Associated Medical Professionals of NY	Syracuse	New York	United States	13210
61	PMG Research of Raleigh, LLC d/b/a PMG Research of Cary	Cary	North Carolina	United States	27518
62	PMG Research of Charlotte	Charlotte	North Carolina	United States	28209
63	Urology Specialists of the Carolinas	Charlotte	North Carolina	United States	28210
64	PMG Research of Raleigh, LLC	Raleigh	North Carolina	United States	27609
65	PMG Research of Salisbury, LLC	Salisbury	North Carolina	United States	28144
66	Salibury Urological Clinic	Salisbury	North Carolina	United States	28144
67	Carolina Urological Associates	Winston-Salem	North Carolina	United States	27103
68	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
69	Lillestol Research LLC	Fargo	North Dakota	United States	58103
70	Radiant Research, Inc.	Akron	Ohio	United States	44311
71	Radiant Research, Inc.	Cincinnati	Ohio	United States	45249
72	Radiant Research, Inc.	Columbus	Ohio	United States	43212
73	Providence Health Partners - Center for Clinical Research	Dayton	Ohio	United States	45439
74	Central Sooner Research	Norman	Oklahoma	United States	73071
75	Pacific Women's Center, LLC	Eugene	Oregon	United States	97401
76	Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania	United States	19004
77	OB/GYN Associates of Erie	Erie	Pennsylvania	United States	16507
78	Research Protocol Management Specialists	Pittsburgh	Pennsylvania	United States	15243
79	Gilbert Teixeira, DO	East Providence	Rhode Island	United States	02914
80	Pharma Resource	East Providence	Rhode Island	United States	02915
81	Memorial Hospital of Rhode Island - Clinical Studies Center	Pawtucket	Rhode Island	United States	02860
82	Radiant Research, Inc.	Anderson	South Carolina	United States	29621
83	Columbia Women's Healthcare, LLC	Columbia	South Carolina	United States	29201
84	SC Clinical Research Center, LLC	Columbia	South Carolina	United States	29201
85	Radiant Research, Inc.	Greer	South Carolina	United States	29651
86	PMG Research of Charleston, LLC	Mount Pleasant	South Carolina	United States	29464
87	Chattanooga Medical Research, LLC	Chattanooga	Tennessee	United States	37404
88	OB-GYN Centre of Excellence	Chattanooga	Tennessee	United States	37404
89	Advanced Therapeutics, Inc.	Johnson City	Tennessee	United States	37601
90	Johnson City Internal Medicine	Johnson City	Tennessee	United States	37604
91	Adult Care of Austin	Austin	Texas	United States	78745
92	Senior Adults Specialty Research	Austin	Texas	United States	78757
93	DiscoveResearch, Inc.	Beaumont	Texas	United States	77701
94	Beaumont Internal Medicine & Geriatric Associates	Beaumont	Texas	United States	77702
95	DiscoveResearch, Inc.	Bryan	Texas	United States	77802
96	DiscoveResearch, Incorporated	Bryan	Texas	United States	77802
97	Radiant Research, Inc.	Dallas	Texas	United States	75231
98	Advances In Health, Inc.	Houston	Texas	United States	77030
99	Centex Research, Inc. - Pineloch Medical Clinic	Houston	Texas	United States	77062
100	The Office of Dr. Steven Maislos, MD	Houston	Texas	United States	77074
101	Village Health Partners	Plano	Texas	United States	75024
102	Paragon Research Center, LLC	San Antonio	Texas	United States	78205
103	Radiant Research, Inc.	Murray	Utah	United States	84123
104	Advanced Clinical Research	West Jordan	Utah	United States	84088
105	Integra Trials, LLC	Arlington	Virginia	United States	22205
106	Washington Urology	Arlington	Virginia	United States	22205
107	Integrity Medical Research, LLC	Mountlake Terrace	Washington	United States	98043
108	Urology Northwest, PA	Mountlake Terrace	Washington	United States	98043
109	North Spokane Women's Clinic	Spokane	Washington	United States	99207
110	MBAL Trimontsium OOD	Plovdiv		Bulgaria	4000
111	MBAL Ruse AD, Urologichno otdelenie,	Ruse		Bulgaria	7002
112	UMBAL Aleksandrovska EAD	Sofia		Bulgaria	1431
113	MBALSM N.I.Pirogov EAD	Sofia		Bulgaria	1606
114	MBAL Doverie AD, Otdelenie po urologia	Sofia		Bulgaria	1632
115	The Prostate Cancer Centre	Calgary	Alberta	Canada	T2V 1P9
116	Lois Hole Hospital for Women, Royal Alexandra Hospital	Edmonton	Alberta	Canada	T5H 3V9
117	Maritime Research Center	Bathurst	New Brunswick	Canada	E2A 4X7
118	Maritime Research Center	Bathurst	New Brunswick	Canada	E2A 4Z9
119	The Male/Female Health and Research Centre, Royal Court Medical Centre	Barrie	Ontario	Canada	L4M 7G1
120	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
121	Centre for Applied Urological Research, Queen's University, Kingston General Hospital	Kingston	Ontario	Canada	K7L 3J7
122	URLX Corporation	Ottawa	Ontario	Canada	K1H 1A2
123	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
124	Diex Research Montreal Inc.	Montreal	Quebec	Canada	H4N 3C5
125	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec	Canada	J1H 1Z1
126	Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS	Hradec Kralove		Czechia	500 02
127	Nemocnice Jindrichuv Hradec	Jindrichuv Hradec		Czechia	377 38
128	Oblastni nemocnice Kolin, a.s.	Kolin III		Czechia	28000
129	Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.	Usti nad Labem		Czechia	401 13
130	Ain Shams University Hospital	Cairo		Egypt
131	Suomen Terveystalo Turku	Turku		Finland	20100
132	Klinische Forschung Berlin-Mitte GmbH	Berlin		Germany	10117
133	Klinische Forschung Berlin	Berlin		Germany	10787
134	Praxis fuer Urologie	Berlin		Germany	14052
135	Duisburger Fachaerztegemeinschaft	Duisburg		Germany	47179
136	ZKS Suedbrandenburg GmbH	Elsterwerda		Germany	04910
137	Facharzt für Frauenheilkunde und Geburtshilfe	Frankfurt am Main		Germany	60322
138	Urologische Praxis	Hagenow		Germany	19230
139	Klinische Forschung Hamburg GmbH	Hamburg		Germany	20253
140	Arztpraxis Dr. von Keitz	Marburg		Germany	35039
141	Pharmakologisches Studienzentrum Chemnitz GmbH	Mittweida		Germany	09648
142	Frauenarzt Praxis	Muenchen		Germany	81241
143	Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika	Budapest		Hungary	1082
144	Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly	Sopron		Hungary	9400
145	Donatella 99 Bt.	Szentes		Hungary	6600
146	MAV Korhaz es Rendelointezet, Urologia	Szolnok		Hungary	5000
147	Department of Urology, Pusan National University Hospital	Pusan		Korea, Republic of	602-739
148	Department of Urology, Konkuk University Medical Center	Seoul		Korea, Republic of	143-729
149	Department of Urology, Ajou University Hospital	Suwon		Korea, Republic of	443-721
150	Phylasis Clinicas Research S de RL de CV	Cuautitlan Izcalli	Estado De Mexico	Mexico	54740
151	Unidad de Diagnostico Integral	Colima		Mexico	28000
152	NZOZ VIP - MED, Poradnia Urologiczna	Gdynia		Poland	81-366
153	SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka	Slupsk		Poland	76-200
154	Specjalistyczny Gabinet Lekarski	Warszawa		Poland	02-926
155	Kemerovо Regional Perinatal Center	Kemerovo		Russian Federation	650066
156	Moscow State Healthcare Institution City Clinical Hospital #12	Moscow		Russian Federation	115516
157	Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26	Saint-Petersburg		Russian Federation	196247
158	Saint-Petersburg State Medical University I.P.Pavlov	Saint-Petersburg		Russian Federation	197022
159	Saint-Petersburg State Healthcare Institution City Hospital # 15	Saint-Petersburg		Russian Federation	198205
160	St. Petersburg State Healthcare Institution	St. Petersburg		Russian Federation	199106
161	Siberian State Medical University	Tomsk		Russian Federation	634050
162	Parklands Hospital	Durban	Kwa Zulu Natal	South Africa
163	Kvinnohalsan Soder	Bandhagen		Sweden	124 54
164	Specialistmottagningen i urologi	Goteborg		Sweden	405 45
165	Partus Kvinnohalsa	Goteborg		Sweden	412 54
166	Me3plus Clinical Trials	Goteborg		Sweden	41263
167	Tudorkliniken, Specialistmottagningen i Urologi	Halmstad		Sweden	302 46
168	Vrinnevisjukhuset	Norrkoping		Sweden	601 82
169	Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy	Dnipropetrovsk		Ukraine	49005
170	Regional Clinical Center of Urology and Nephrology	Kharkiv		Ukraine	61037
171	Institute of Urology of AMS of Ukraine	Kyiv		Ukraine	04053
172	Lugansk City Multi-Discipline Hospital #2, department of Urology	Lugansk		Ukraine
173	5Th City Clinical Hospital, Urology Department	Lviv		Ukraine	79059
174	LTD Out-patient clinic of General practice and Family medicine	Odesa		Ukraine	65009
175	Poltava Regional Clinical Hospital, Department of Urology	Poltava		Ukraine
176	Municipal Institution of Ternopil Regional Council, Ternopil University Hospital	Ternopil		Ukraine	46002

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: NCT01302054
• Other Study ID Numbers: A0221094
• First Posted: Feb 23, 2011
• Last Update Posted: Dec 4, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Pfizer: Bladder Overactive; Overactive urinary bladder; Overactive Bladder
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Arm/Group Title	Tolterodine	Fesoterodine	Placebo
Arm/Group Description	Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Period Title: Tolterodine Open-Label Run-In Phase
STARTED	990	0	0
COMPLETED	611	0	0
NOT COMPLETED	379	0	0
Period Title: Tolterodine Open-Label Run-In Phase
STARTED	611	0	0
COMPLETED	609	0	0
NOT COMPLETED	2	0	0
Period Title: Tolterodine Open-Label Run-In Phase
STARTED	0	308	301
COMPLETED	0	281	255
NOT COMPLETED	0	27	46

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had <= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
Overall Participants	990
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (13.7)
Sex: Female, Male (Count of Participants)
Female	810 81.8%
Male	180 18.2%

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 range from 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

Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12(LOCF).

Arm/Group Title	Fesoterodine: Double-Blind Baseline	Fesoterodine: Double-Blind Week 12
Arm/Group Description	Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Measure Participants	292	292
Mean (Standard Deviation) [episodes per 24 hours]	3.93 (2.53)	1.60 (2.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.37
	Confidence Interval	(2-Sided) 95%; -2.63 to -2.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

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 urinary sensation scale (USS) rating of 5 in the diary. USS range from 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

Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	292	279
Baseline	3.93 (2.53)	3.83 (2.52)
Change at Week 12	-2.32 (2.67)	-1.76 (2.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance [ANCOVA]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0079
	Comments	Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.50
	Confidence Interval	(2-Sided) 95%; -0.87 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Description	Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (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 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here 'N' (number of participants analyzed): participants with baseline micturitions >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	292	279
Baseline	12.44 (3.57)	12.48 (3.75)
Change at Week 12	-1.94 (3.15)	-1.57 (3.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0931
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -0.86 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 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 range from 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: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here 'N' (number of participants analyzed): participants with baseline urgency episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	292	279
Baseline	11.38 (3.98)	11.26 (4.01)
Change at Week 12	-3.33 (4.47)	-2.52 (4.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0438
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.37 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.34
	Estimation Comments

5. Secondary Outcome

Title	Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Description	PPBC: single-item, self-administered validated questionnaire. Participant answered: "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	291	267
Baseline: No Problems at all	0 0%	0 NaN
Baseline: Some Very Minor Problems	4 0.4%	6 NaN
Baseline: Some Minor Problems	15 1.5%	9 NaN
Baseline: Some Moderate Problems	60 6.1%	75 NaN
Baseline: Severe Problems	147 14.8%	141 NaN
Baseline: Many Severe Problems	65 6.6%	36 NaN
Change at Week 12: Deterioration	17 1.7%	32 NaN
Change at Week 12: No Change	80 8.1%	95 NaN
Change at Week 12: Minor Improvement	84 8.5%	83 NaN
Change at Week 12: Major Improvement	110 11.1%	57 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.
	Method	Cochran-Mantel-Haenszel
	Comments

6. Secondary Outcome

Title	Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Description	UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	291	267
Baseline: Not able to hold urine	126 12.7%	99 NaN
Baseline:Able to hold urine until I reach a toilet	158 16%	157 NaN
Baseline:Able to finish what I am doing	7 0.7%	11 NaN
Change at Week 12: Deterioration	17 1.7%	31 NaN
Change at Week 12: No Change	167 16.9%	158 NaN
Change at Week 12: Improvement	107 10.8%	78 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0095
	Comments	Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.
	Method	Cochran-Mantel-Haenszel
	Comments

7. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 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 (not at all) to 6 (a very great deal). 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. Change=observation minus baseline.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	286	267
Baseline	66.67 (20.28)	64.74 (19.69)
Change at Week 12	-24.61 (25.57)	-15.99 (24.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.34
	Confidence Interval	(2-Sided) 95%; -11.10 to -3.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.91
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 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 (not at all) to 6 (a very great deal). 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 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	286	267
Concern Subscale: Baseline	43.63 (26.00)	44.25 (25.58)
Concern Subscale: Change at Week 12	23.11 (27.77)	13.83 (25.03)
Coping Subscale: Baseline	38.74 (26.24)	41.15 (26.04)
Coping Subscale: Change at Week 12	23.70 (26.69)	15.07 (24.20)
Sleep Subscale: Baseline	41.38 (25.66)	40.69 (26.28)
Sleep Subscale: Change at Week 12	20.85 (27.42)	14.79 (25.74)
Social Interaction Subscale: Baseline	65.03 (28.34)	68.40 (26.29)
Social Interaction Subscale: Change at Week 12	14.47 (24.26)	8.85 (21.12)
Total HRQL Score: Baseline	45.90 (23.72)	47.38 (22.70)
Total HRQL Score: Change at Week 12	21.12 (24.62)	13.42 (21.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares (LS) Mean Difference
	Estimated Value	9.01
	Confidence Interval	(2-Sided) 95%; 5.12 to 12.91
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.98
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	7.75
	Confidence Interval	(2-Sided) 95%; 3.87 to 11.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.97
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	6.52
	Confidence Interval	(2-Sided) 95%; 2.60 to 10.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.00
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0123
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	4.13
	Confidence Interval	(2-Sided) 95%; 0.90 to 7.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.64
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments	Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing: one-sided, at alpha = 0.025.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	7.10
	Confidence Interval	(2-Sided) 95%; 3.63 to 10.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.77
	Estimation Comments

9. Secondary Outcome

Title	Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2
Description	UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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	Week -2, Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	279	275
Number [percentage of participants]	72.8 7.4%	59.6 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0023
	Comments	The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
	Method	Cochran-Mantel-Haenszel
	Comments

10. Secondary Outcome

Title	Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline
Description	UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	292	279
Number [percentage of participants]	69.9 7.1%	57.0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0027
	Comments	The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
	Method	Cochran-Mantel-Haenszel
	Comments

11. Secondary Outcome

Title	Percentage of Participants With No UUI Episodes (Diary Dry Rate)
Description	UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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	Week 4, Week 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).

Arm/Group Title	Fesoterodine	Placebo
Arm/Group Description	Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Measure Participants	292	279
Week 4	25.4 2.6%	17.7 NaN
Week 12	39.0 3.9%	32.3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0427
	Comments	Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1461
	Comments	Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
	Method	Cochran-Mantel-Haenszel
	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	Tolterodine		Fesoterodine		Placebo
Arm/Group Description	Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.		Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.		Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
All Cause Mortality
	Tolterodine		Fesoterodine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Tolterodine		Fesoterodine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/990 (0.3%)		5/308 (1.6%)		7/301 (2.3%)
Cardiac disorders
Angina pectoris	0/990 (0%)		1/308 (0.3%)		0/301 (0%)
Atrial fibrillation	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Myocardial infarction	0/990 (0%)		1/308 (0.3%)		0/301 (0%)
Gastrointestinal disorders
Dysphagia	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Hiatus hernia	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
General disorders
Chest pain	1/990 (0.1%)		0/308 (0%)		0/301 (0%)
Non-cardiac chest pain	1/990 (0.1%)		0/308 (0%)		0/301 (0%)
Hepatobiliary disorders
Cholecystitis acute	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Injury, poisoning and procedural complications
Femur fracture	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Prostate cancer	0/990 (0%)		1/308 (0.3%)		0/301 (0%)
Psychiatric disorders
Adjustment disorder	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Reproductive system and breast disorders
Uterine haemorrhage	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/990 (0%)		1/308 (0.3%)		0/301 (0%)
Pneumonia aspiration	0/990 (0%)		0/308 (0%)		1/301 (0.3%)
Vascular disorders
Arterial occlusive disease	1/990 (0.1%)		0/308 (0%)		0/301 (0%)
Hypertension	0/990 (0%)		1/308 (0.3%)		0/301 (0%)
Other (Not Including Serious) Adverse Events
	Tolterodine		Fesoterodine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	90/990 (9.1%)		76/308 (24.7%)		48/301 (15.9%)
Eye disorders
Vision blurred	1/990 (0.1%)		3/308 (1%)		0/301 (0%)
Gastrointestinal disorders
Constipation	11/990 (1.1%)		12/308 (3.9%)		4/301 (1.3%)
Diarrhoea	4/990 (0.4%)		2/308 (0.6%)		4/301 (1.3%)
Dry mouth	61/990 (6.2%)		51/308 (16.6%)		12/301 (4%)
Dyspepsia	2/990 (0.2%)		6/308 (1.9%)		0/301 (0%)
Nausea	7/990 (0.7%)		1/308 (0.3%)		3/301 (1%)
Infections and infestations
Bronchitis	0/990 (0%)		0/308 (0%)		4/301 (1.3%)
Influenza	0/990 (0%)		1/308 (0.3%)		3/301 (1%)
Nasopharyngitis	6/990 (0.6%)		3/308 (1%)		4/301 (1.3%)
Upper respiratory tract infection	3/990 (0.3%)		2/308 (0.6%)		3/301 (1%)
Urinary tract infection	3/990 (0.3%)		4/308 (1.3%)		4/301 (1.3%)
Musculoskeletal and connective tissue disorders
Back pain	3/990 (0.3%)		1/308 (0.3%)		3/301 (1%)
Nervous system disorders
Dizziness	1/990 (0.1%)		1/308 (0.3%)		4/301 (1.3%)
Headache	4/990 (0.4%)		3/308 (1%)		4/301 (1.3%)

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.