A Clinical Study in Patients With Overactive Bladder With... | NCT01302054

A Clinical Study in Patients With Overactive Bladder With... | NCT01302054 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Fesoterodine	Experimental		Drug: Fesoterodine 8 mg
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fesoterodine 8 mg	Drug	Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.	Fesoterodine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours	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.	Baseline, Week 12
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at 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.	Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Mean Number of Micturitions Per 24 Hours at 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.	Baseline, Week 12

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Radiant Research, Inc.		Birmingham	Alabama	35209	United States
Alabama Internal Medicine, PC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37160401	Derived	Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
35881009	Derived	Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tolterodine	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Lack of Efficacy		FG0004 subjects FG0010 subjects FG0020 subjects
Lost to Follow-up		FG00017 subjects FG0010 subjects FG0020 subjects
Withdrawal by Subject		FG00016 subjects FG0010 subjects FG0020 subjects
Protocol Violation		FG0008 subjects FG0010 subjects FG0020 subjects
Adverse Event		FG00013 subjects FG0010 subjects FG0020 subjects
Did Not Meet Entrance Criteria		FG000314 subjects FG0010 subjects FG0020 subjects
Other		FG0007 subjects FG0010 subjects FG0020 subjects

Between Open-Label and Double Blind

Type	Comment	Milestone Data
STARTED		FG000611 subjects FG0010 subjects FG0020 subjects
COMPLETED		FG000609 subjects FG0010 subjects FG0020 subjects
NOT COMPLETED		FG0002 subjects FG0010 subjects FG0020 subjects

Type	Comment	Reasons
Did Not Enter Double-Blind Phase		FG0002 subjects FG0010 subjects FG0020 subjects

Double-Blind Treatment Phase

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG001308 subjects FG002301 subjects
COMPLETED		FG0000 subjects FG001281 subjects FG002255 subjects
NOT COMPLETED		FG0000 subjects FG00127 subjects FG00246 subjects

Type	Comment	Reasons
Lack of Efficacy		FG0000 subjects FG0012 subjects FG0024 subjects
Lost to Follow-up		FG000

Arm/Group Information

ID	Title	Description
BG000	Entire Study Population	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.1± 13.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000810
Male	BG000180

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

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.

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).

Posted

Mean

Standard Deviation

episodes per 24 hours

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine: Double-Blind Baseline	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.
OG001	Fesoterodine: Double-Blind Week 12	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.

Units	Counts
Participants	OG000292 OG001292

Title

Denominators

Categories

Title	Measurements
	OG0003.93± 2.53 OG0011.60± 2.56

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 1 sided		<0.0001	Statistical testing: one-sided, at alpha = 0.025.	Least Squares Mean Difference	-2.37	Standard Error of the Mean	0.17	2-Sided	95	-2.63	-2.02					Superiority or Other

Primary

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

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).

Posted

Mean

Standard Deviation

episodes per 24 hours

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Units	Counts

Secondary

Change From Baseline in Mean Number of Micturitions Per 24 Hours at 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.

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).

Posted

Mean

Standard Deviation

micturitions per 24 hours

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Units	Counts

Secondary

Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at 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.

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).

Posted

Mean

Standard Deviation

episodes per 24 hours

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Secondary

Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at 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).

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.

Posted

Number

participants

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Secondary

Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at 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).

Posted

Number

participants

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Secondary

Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at 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.

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Secondary

Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at 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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Secondary

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

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).

Posted

Number

percentage of participants

Week -2, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Units	Counts

Secondary

Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline

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).

Posted

Number

percentage of participants

Baseline, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Units	Counts

Secondary

Percentage of Participants With No UUI Episodes (Diary Dry Rate)

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).

Posted

Number

percentage of participants

Week 4, Week 12

ID	Title	Description
OG000	Fesoterodine	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.
OG001	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tolterodine	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.	3	990	90	990
EG001	Fesoterodine	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.	5	308	76	308
EG002	Placebo	Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.	7	301	48	301

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0011 affected308 at risk EG0020 affected301 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0011 affected308 at risk EG0020 affected301 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Chest pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected990 at risk EG0010 affected308 at risk EG0020 affected301 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected990 at risk EG0010 affected308 at risk EG0020 affected301 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0011 affected308 at risk EG0020 affected301 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0011 affected308 at risk EG0020 affected301 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0021 affected301 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected990 at risk EG0010 affected308 at risk EG0020 affected301 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0011 affected308 at risk EG0020 affected301 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected990 at risk EG0013 affected308 at risk EG0020 affected301 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00011 affected990 at risk EG00112 affected308 at risk EG0024 affected301 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 affected990 at risk EG0012 affected308 at risk EG0024 affected301 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00061 affected990 at risk EG00151 affected308 at risk EG00212 affected301 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected990 at risk EG0016 affected308 at risk EG0020 affected301 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 affected990 at risk EG0011 affected308 at risk EG0023 affected301 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0010 affected308 at risk EG0024 affected301 at risk
Influenza	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected990 at risk EG0011 affected308 at risk EG0023 affected301 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0006 affected990 at risk EG0013 affected308 at risk EG0024 affected301 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0003 affected990 at risk EG0012 affected308 at risk EG0023 affected301 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0003 affected990 at risk EG0014 affected308 at risk EG0024 affected301 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 affected990 at risk EG0011 affected308 at risk EG0023 affected301 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected990 at risk EG0011 affected308 at risk EG0024 affected301 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 affected990 at risk EG0013 affected308 at risk EG0024 affected301 at risk

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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).	ANCOVA		0.0079	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.	Least Squares Mean Difference	-0.50	Standard Error of the Mean	0.19	2-Sided	95	-0.87	-0.13					Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA		0.0931	Statistical testing: one-sided, at alpha = 0.025.	Least Squares Mean Difference	-0.40	Standard Error of the Mean	0.24	2-Sided	95	-0.86	0.07					Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA		0.0438	Statistical testing: one-sided, at alpha = 0.025.	Least Squares Mean Difference	-0.70	Standard Error of the Mean	0.34	2-Sided	95	-1.37	-0.02					Superiority or Other

Title

Denominators

Categories

Baseline: No Problems at all

Title	Measurements
	OG0000 OG0010

Baseline: Some Very Minor Problems

Title	Measurements
	OG0004 OG0016

Baseline: Some Minor Problems

Title	Measurements
	OG00015 OG0019

Baseline: Some Moderate Problems

Title	Measurements
	OG00060 OG00175

Baseline: Severe Problems

Title	Measurements
	OG000147 OG001141

Baseline: Many Severe Problems

Title	Measurements
	OG00065 OG00136

Change at Week 12: Deterioration

Title	Measurements
	OG00017 OG00132

Change at Week 12: No Change

Title	Measurements
	OG00080 OG00195

Change at Week 12: Minor Improvement

Title	Measurements
	OG00084 OG00183

Change at Week 12: Major Improvement

Title	Measurements
	OG000110 OG00157

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		<0.0001	Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.					2-Sided								Superiority or Other

Title

Denominators

Categories

Baseline: Not able to hold urine

Title	Measurements
	OG000126 OG00199

Baseline:Able to hold urine until I reach a toilet

Title	Measurements
	OG000158 OG001157

Baseline:Able to finish what I am doing

Title	Measurements
	OG0007 OG00111

Change at Week 12: Deterioration

Title	Measurements
	OG00017 OG00131

Change at Week 12: No Change

Title	Measurements
	OG000167 OG001158

Change at Week 12: Improvement

Title	Measurements
	OG000107 OG00178

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.0095	Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.					2-Sided								Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA		0.0001	Statistical testing: one-sided, at alpha = 0.025.	Least Squares Mean Difference	-7.34	Standard Error of the Mean	1.91	2-Sided	95	-11.10	-3.58					Superiority or Other

Title

Denominators

Categories

Concern Subscale: Baseline

Title	Measurements
	OG00043.63± 26.00 OG00144.25± 25.58

Concern Subscale: Change at Week 12

Title	Measurements
	OG00023.11± 27.77 OG00113.83± 25.03

Coping Subscale: Baseline

Title	Measurements
	OG00038.74± 26.24 OG00141.15± 26.04

Coping Subscale: Change at Week 12

Title	Measurements
	OG00023.70± 26.69 OG00115.07± 24.20

Sleep Subscale: Baseline

Title	Measurements
	OG00041.38± 25.66 OG00140.69± 26.28

Sleep Subscale: Change at Week 12

Title	Measurements
	OG00020.85± 27.42 OG00114.79± 25.74

Social Interaction Subscale: Baseline

Title	Measurements
	OG00065.03± 28.34 OG00168.40± 26.29

Social Interaction Subscale: Change at Week 12

Title	Measurements
	OG00014.47± 24.26 OG0018.85± 21.12

Total HRQL Score: Baseline

Title	Measurements
	OG00045.90± 23.72 OG00147.38± 22.70

Total HRQL Score: Change at Week 12

Title	Measurements
	OG00021.12± 24.62 OG00113.42± 21.92

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA	<0.0001	Statistical testing: one-sided, at alpha = 0.025.	Least Squares (LS) Mean Difference	9.01	Standard Error of the Mean	1.98	2-Sided	95	5.12	12.91	Superiority or Other
OG000 OG001	Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA	<0.0001	Statistical testing: one-sided, at alpha = 0.025.	LS Mean Difference	7.75	Standard Error of the Mean	1.97	2-Sided	95	3.87	11.62	Superiority or Other
OG000 OG001	Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA	0.0012	Statistical testing: one-sided, at alpha = 0.025.	LS Mean Difference	6.52	Standard Error of the Mean	2.00	2-Sided	95	2.60	10.45	Superiority or Other
OG000 OG001	Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA	0.0123	Statistical testing: one-sided, at alpha = 0.025.	LS Mean Difference	4.13	Standard Error of the Mean	1.64	2-Sided	95	0.90	7.36	Superiority or Other
OG000 OG001	Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.	ANCOVA	<0.0001	Statistical testing: one-sided, at alpha = 0.025.	LS Mean Difference	7.10	Standard Error of the Mean	1.77	2-Sided	95	3.63	10.57	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.0023	The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.					2-Sided								Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.0027	The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.					2-Sided								Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.0427	Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.					2-Sided								Superiority or Other
OG000 OG001		Cochran-Mantel-Haenszel		0.1461	Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.					2-Sided								Superiority or Other