Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01054222
• Collaborator: (none)
• Enrollment: 31
• Locations: 3
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is an open-label extension study intended for subjects who have previously completed study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the investigator as being suitable for the extended use of Fesoterodine. Data from this study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older subjects from Portugal.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Local, Multicentre, Open-Label, Extension Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Fesoterodine 4 mg Dose determined as per previous drug regime in A0221045 and investigator's evaluation.	Drug: Fesoterodine; Fesoterodine fumarate, sustained release (SR) tablet, 4 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier); Other Names: Toviaz
Other: Fesoterodine 8 mg Dose determined as per previous drug regime in A0221045 and investigator's evaluation.	Drug: Fesoterodine; Fesoterodine fumarate, sustained release (SR) tablet, 8 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier); Other Names: Toviaz

Outcome Measures

Primary Outcome Measures

1. Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT]) [End of Treatment (up to Week 82)]

   The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (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 total range 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. Mean Number of Micturition-Related Urgency Episodes Per 24 Hours [Baseline, Month 3, 6, 9, 12, 15, 18]

   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 total range 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. Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

   The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 4 divided by the total number of days that diary data was collected at that visit. USS total range 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. Mean Number of Micturitions Per 24 Hours [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

   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 total range 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.

4. Mean Number of Nocturnal Micturitions Per 24 Hours [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

   Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 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. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.

5. Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

   UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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.

6. Daily Sum Rating on the Urinary Sensation Scale (USS) [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

   The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS total range 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. Numerical decrease indicates improvement.

7. Percentage of Incontinent Participants at Baseline [Baseline]

   UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 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 No Urgency Urinary Incontinence (UUI) Episode [Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

   UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 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. Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

   The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.

10. Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

    PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).

11. Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

    PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.

12. Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

    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 (least symptom bother) to 6 (most symptom bother). 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.

13. Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)]

    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 (least symptom bother) to 6 (most symptom bother). 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.

14. Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b) [Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)]

    OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication's ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as 'very satisfied', 'somewhat satisfied', 'neither dissatisfied nor satisfied', 'somewhat dissatisfied', and 'very dissatisfied'. The results for Q9 to 11 are reported as "satisfied" (participants who answered 'very satisfied' or 'somewhat satisfied' for all 7 questions) or "not satisfied" (participants who answered 'neither dissatisfied nor satisfied' or 'somewhat dissatisfied' or 'very dissatisfied' for all 7 questions).

15. King's Health Questionnaire (KHQ) Domain Scores [Baseline, End of Treatment (EOT) (Week 82)]

    KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have previously completed fesoterodine study A0221045 [in Portugal]

• Subjects must be recommended for inclusion by the investigator

Exclusion Criteria:

• Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine

• Predominant stress incontinence as determined by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Avaliação Geriátrica	Lisboa		Portugal	1990-273
2	Hospital Ordem do Carmo	Porto		Portugal	4099-005
3	Hospital de São João	Porto		Portugal	4200-319

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: NCT01054222
• Other Study ID Numbers: A0221090
• First Posted: Jan 22, 2010
• Last Update Posted: May 15, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Pfizer: overactive bladder idiopathic; elderly fesoterodine SOFIA Portugal extension study
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Recruitment Details	Participants who completed treatment in study A0221045 (NCT00798434) were included in this study as per investigator's discretion.

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Period Title: Overall Study
STARTED	31
COMPLETED	20
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Overall Participants	31
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	75.4 (6.0)
Sex: Female, Male (Count of Participants)
Female	30 96.8%
Male	1 3.2%

Outcome Measures

1. Primary Outcome

Title	Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])
Description	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (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 total range 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	End of Treatment (up to Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Mean (Standard Deviation) [episodes per 24 hours]	5.48 (6.01)

2. Secondary Outcome

Title	Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
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 total range 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, Month 3, 6, 9, 12, 15, 18

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline (n= 28)	10.49 (5.28)
Month 3 (n= 25)	5.28 (7.33)
Month 6 (n= 28)	6.37 (6.74)
Month 9 (n= 28)	4.98 (6.41)
Month 12 (n= 28)	5.15 (6.62)
Month 15 (n= 27)	5.09 (6.46)
Month 18 (n= 24)	5.22 (6.18)

3. Secondary Outcome

Title	Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Description	The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 4 divided by the total number of days that diary data was collected at that visit. USS total range 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, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline (n= 28)	6.35 (6.90)
Month 3 (n= 25)	3.36 (7.14)
Month 6 (n= 28)	2.40 (6.15)
Month 9 (n= 28)	2.52 (5.84)
Month 12 (n= 28)	2.23 (5.86)
Month 15 (n= 27)	2.67 (6.08)
Month 18 (n= 24)	2.44 (6.27)
End of Treatment (n= 28)	2.29 (5.83)

4. Secondary Outcome

Title	Mean Number of Micturitions Per 24 Hours
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 total range 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, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline (n= 28)	13.44 (4.57)
Month 3 (n= 25)	10.97 (4.72)
Month 6 (n= 28)	10.98 (4.26)
Month 9 (n= 28)	10.44 (4.26)
Month 12 (n= 28)	10.51 (4.46)
Month 15 (n= 27)	10.67 (4.06)
Month 18 (n= 24)	10.60 (4.41)
End of Treatment (n= 28)	10.38 (4.19)

5. Secondary Outcome

Title	Mean Number of Nocturnal Micturitions Per 24 Hours
Description	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 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. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Time Frame	Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline (n= 28)	3.45 (1.53)
Month 3 (n= 25)	3.08 (1.92)
Month 6 (n= 28)	3.25 (1.72)
Month 9 (n= 28)	3.07 (1.91)
Month 12 (n= 28)	2.88 (1.99)
Month 15 (n= 27)	3.00 (2.00)
Month 18 (n= 24)	2.95 (2.05)
End of Treatment (n= 28)	2.95 (2.05)

6. Secondary Outcome

Title	Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline (n= 28)	2.64 (5.31)
Month 3 (n= 25)	2.27 (6.86)
Month 6 (n= 28)	1.54 (5.76)
Month 9 (n= 28)	1.36 (5.62)
Month 12 (n= 28)	1.29 (5.69)
Month 15 (n= 27)	1.83 (5.99)
Month 18 (n= 24)	1.65 (6.06)
End of Treatment (n= 28)	1.49 (5.62)

7. Secondary Outcome

Title	Daily Sum Rating on the Urinary Sensation Scale (USS)
Description	The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS total range 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. Numerical decrease indicates improvement.
Time Frame	Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline (n= 28)	45.63 (23.72)
Month 3 (n= 25)	31.60 (30.32)
Month 6 (n= 28)	31.39 (26.10)
Month 9 (n= 28)	28.29 (25.75)
Month 12 (n= 28)	27.63 (26.66)
Month 15 (n= 27)	28.67 (26.31)
Month 18 (n= 24)	29.01 (26.87)
End of Treatment (n= 28)	28.60 (25.16)

8. Secondary Outcome

Title	Percentage of Incontinent Participants at Baseline
Description	UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 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

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary.

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	31
Number [Percentage of Participants]	58.1 187.4%

9. Secondary Outcome

Title	Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
Description	UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 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	Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	18
Month 3 (n= 16)	81.3 262.3%
Month 6 (n= 18)	77.8 251%
Month 9 (n= 18)	77.8 251%
Month 12 (n= 18)	77.8 251%
Month 15 (n= 17)	64.7 208.7%
Month 18 (n= 15)	66.7 215.2%
End of Treatment (n= 18)	66.7 215.2%

10. Secondary Outcome

Title	Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Description	The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.
Time Frame	Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	18
Baseline: IP (n= 18)	3.69 (2.71)
Baseline: BC (n= 18)	0.48 (0.90)
Baseline: Powder (n= 18)	0.24 (1.02)
Month 3: IP (n= 16)	3.15 (4.63)
Month 3: BC (n= 16)	0.79 (2.07)
Month 3: Powder (n= 16)	0.19 (0.75)
Month 6: IP (n= 18)	3.02 (4.26)
Month 6: BC (n= 18)	0.43 (1.01)
Month 6: Powder (n= 18)	0.20 (0.86)
Month 9: IP (n= 18)	2.56 (2.34)
Month 9: BC (n= 18)	0.33 (1.07)
Month 9: Powder (n= 18)	0.17 (0.71)
Month 12: IP (n= 18)	2.52 (2.44)
Month 12: BC (n= 18)	0.13 (0.55)
Month 12: Powder (n= 18)	0.31 (1.34)
Month 15: IP (n= 17)	2.45 (2.32)
Month 15: BC (n= 17)	0.18 (0.53)
Month 15: Powder (n= 17)	0.00 (0.00)
Month 18: IP (n= 15)	2.49 (2.22)
Month 18: BC (n= 15)	0.18 (0.53)
Month 18: Powder (n= 15)	0.00 (0.00)
End of Treatment: IP (n= 18)	2.31 (2.11)
End of Treatment: BC (n= 18)	0.15 (0.49)
End of Treatment: Powder (n= 18)	0.00 (0.00)

11. Secondary Outcome

Title	Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment
Description	PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).
Time Frame	Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline: No Problems at all (n= 28)	0 0%
Baseline: Some Very Minor Problems (n= 28)	2 6.5%
Baseline: Some Minor Problems (n= 28)	11 35.5%
Baseline: Some Moderate Problems (n= 28)	11 35.5%
Baseline: Severe Problems (n= 28)	4 12.9%
Baseline: Many Severe Problems (n= 28)	0 0%
Change at Month 3: Deterioration (n= 27)	6 19.4%
Change at Month 3: No Change (n= 27)	9 29%
Change at Month 3: Improvement (n= 27)	12 38.7%
Change at Month 6: Deterioration (n= 28)	6 19.4%
Change at Month 6: No Change (n= 28)	12 38.7%
Change at Month 6: Improvement (n= 28)	10 32.3%
Change at Month 9: Deterioration (n= 28)	6 19.4%
Change at Month 9: No Change (n= 28)	12 38.7%
Change at Month 9: Improvement (n= 28)	10 32.3%
Change at Month 12: Deterioration (n= 28)	5 16.1%
Change at Month 12: No Change (n= 28)	12 38.7%
Change at Month 12: Improvement (n= 28)	11 35.5%
Change at Month 15: Deterioration (n= 27)	6 19.4%
Change at Month 15: No Change (n= 27)	10 32.3%
Change at Month 15: Improvement (n= 27)	11 35.5%
Change at Month 18: Deterioration (n= 24)	6 19.4%
Change at Month 18: No Change (n= 24)	6 19.4%
Change at Month 18: Improvement (n= 24)	12 38.7%
Change at EOT: Deterioration (n= 28)	6 19.4%
Change at EOT: No Change (n= 28)	9 29%
Change at EOT: Improvement (n= 28)	13 41.9%

12. Secondary Outcome

Title	Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment
Description	PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.
Time Frame	Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline: Score 0, Unable to hold urine (n= 28)	3 9.7%
Baseline: Score 1, Able to hold urine (n= 28)	12 38.7%
Baseline:Score 2,Able to finish ongoing task(n=28)	13 41.9%
Change at Month 3: Deterioration (n= 27)	5 16.1%
Change at Month 3: No Change (n= 27)	17 54.8%
Change at Month 3: Improvement (n= 27)	5 16.1%
Change at Month 6: Deterioration (n= 28)	9 29%
Change at Month 6: No Change (n= 28)	13 41.9%
Change at Month 6: Improvement (n= 28)	6 19.4%
Change at Month 9: Deterioration (n= 28)	7 22.6%
Change at Month 9: No Change (n= 28)	19 61.3%
Change at Month 9: Improvement (n= 28)	2 6.5%
Change at Month 12: Deterioration (n= 28)	7 22.6%
Change at Month 12: No Change (n= 28)	17 54.8%
Change at Month 12: Improvement (n= 28)	4 12.9%
Change at Month 15: Deterioration (n= 27)	5 16.1%
Change at Month 15: No Change (n= 27)	19 61.3%
Change at Month 15: Improvement (n= 27)	3 9.7%
Change at Month 18: Deterioration (n= 24)	6 19.4%
Change at Month 18: No Change (n= 24)	12 38.7%
Change at Month 18: Improvement (n= 24)	6 19.4%
Change at EOT: Deterioration (n= 28)	6 19.4%
Change at EOT: No Change (n= 28)	16 51.6%
Change at EOT: Improvement (n= 28)	6 19.4%

13. Secondary Outcome

Title	Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
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 (least symptom bother) to 6 (most symptom bother). 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.
Time Frame	Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline (n= 28)	35.54 (20.41)
Month 3 (n= 27)	33.29 (22.05)
Month 6 (n= 28)	32.95 (23.44)
Month 9 (n= 28)	33.93 (21.88)
Month 12 (n= 28)	29.55 (21.45)
Month 15 (n= 27)	31.30 (24.99)
Month 18 (n= 24)	31.46 (23.77)
End of Treatment (n= 28)	32.59 (23.98)

14. Secondary Outcome

Title	Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
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 (least symptom bother) to 6 (most symptom bother). 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, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Coping Domain: Baseline (n= 28)	77.77 (19.69)
Coping Domain: Month 3 (n= 27)	78.28 (21.17)
Coping Domain: Month 6 (n= 28)	77.14 (21.22)
Coping Domain: Month 9 (n= 28)	79.55 (20.67)
Coping Domain: Month 12 (n= 28)	76.70 (21.78)
Coping Domain: Month 15 (n= 27)	74.54 (23.47)
Coping Domain: Month 18 (n= 24)	79.69 (18.61)
Coping Domain: End of Treatment (n= 28)	79.29 (18.14)
Concern Domain: Baseline (n= 28)	71.04 (18.09)
Concern Domain: Month 3 (n= 27)	72.80 (23.20)
Concern Domain: Month 6 (n= 28)	70.51 (18.10)
Concern Domain: Month 9 (n= 28)	74.49 (19.53)
Concern Domain: Month 12 (n= 28)	71.33 (19.73)
Concern Domain: Month 15 (n= 27)	69.63 (23.79)
Concern Domain: Month 18 (n= 24)	72.50 (21.56)
Concern Domain: End of Treatment (n= 28)	72.35 (21.28)
Sleep Domain: Baseline (n= 28)	71.00 (19.74)
Sleep Domain: Month 3 (n= 27)	73.93 (20.04)
Sleep Domain: Month 6 (n= 28)	73.86 (16.85)
Sleep Domain: Month 9 (n= 28)	77.04 (19.93)
Sleep Domain: Month 12 (n= 28)	74.71 (19.08)
Sleep Domain: Month 15 (n= 27)	73.93 (21.89)
Sleep Domain: Month 18 (n= 24)	74.33 (21.62)
Sleep Domain: End of Treatment (n= 28)	73.57 (21.12)
Social Interaction Domain: Baseline (n= 28)	90.57 (10.45)
Social Interaction Domain: Month 3 (n= 27)	88.26 (17.25)
Social Interaction Domain: Month 6 (n= 28)	87.25 (12.21)
Social Interaction Domain: Month 9 (n= 28)	87.11 (15.59)
Social Interaction Domain: Month 12 (n= 28)	84.82 (13.42)
Social Interaction Domain: Month 15 (n= 27)	84.41 (18.19)
Social Interaction Domain: Month 18 (n= 24)	86.79 (17.26)
Social Interaction Domain: End of Treatment (n=28)	86.25 (16.69)
Total: Baseline (n= 28)	77.09 (16.08)
Total: Month 3 (n= 27)	77.87 (19.77)
Total: Month 6 (n= 28)	76.65 (16.84)
Total: Month 9 (n= 28)	79.14 (18.33)
Total: Month 12 (n= 28)	76.42 (18.23)
Total: Month 15 (n= 27)	75.01 (21.37)
Total: Month 18 (n= 24)	78.02 (18.79)
Total: End of Treatment (n= 28)	77.59 (18.32)

15. Secondary Outcome

Title	Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Description	OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication's ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as 'very satisfied', 'somewhat satisfied', 'neither dissatisfied nor satisfied', 'somewhat dissatisfied', and 'very dissatisfied'. The results for Q9 to 11 are reported as "satisfied" (participants who answered 'very satisfied' or 'somewhat satisfied' for all 7 questions) or "not satisfied" (participants who answered 'neither dissatisfied nor satisfied' or 'somewhat dissatisfied' or 'very dissatisfied' for all 7 questions).
Time Frame	Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
Baseline, Q5: Exceeding/meeting expectations(n=26)	22 71%
Baseline, Q5: Does not meet expectations (n= 26)	4 12.9%
Month 3, Q5: Exceeding/meeting expectations(n=27)	22 71%
Month 3, Q5: Does not meet expectations (n= 27)	5 16.1%
Month 6, Q5: Exceeding/meeting expectations(n=28)	25 80.6%
Month 6, Q5: Does not meet expectations (n= 28)	3 9.7%
Month 9, Q5: Exceeding/meeting expectations(n=28)	25 80.6%
Month 9, Q5: Does not meet expectations (n= 28)	3 9.7%
Month 12, Q5: Exceeding/meeting expectations(n=28)	24 77.4%
Month 12, Q5: Does not meet expectations (n= 28)	4 12.9%
Month 15, Q5: Exceeding/meeting expectations(n=27)	23 74.2%
Month 15, Q5: Does not meet expectations (n= 27)	4 12.9%
Month 18, Q5: Exceeding/meeting expectations(n=24)	19 61.3%
Month 18, Q5: Does not meet expectations (n= 24)	5 16.1%
EOT, Q5: Exceeding/meeting expectations(n=28)	23 74.2%
EOT, Q5: Does not meet expectations (n= 28)	5 16.1%
Baseline; Q9, 10a-10d, 11a-11b: Satisfied (n=27)	19 61.3%
Baseline; Q9,10a-10d,11a-11b: Not Satisfied (n=27)	8 25.8%
Month 3; Q9, 10a-10d, 11a-11b: Satisfied (n=26)	17 54.8%
Month 3; Q9,10a-10d,11a-11b: Not Satisfied (n=26)	9 29%
Month 6; Q9, 10a-10d, 11a-11b: Satisfied (n=27)	15 48.4%
Month 6; Q9,10a-10d,11a-11b: Not Satisfied (n=27)	12 38.7%
Month 9; Q9, 10a-10d, 11a-11b: Satisfied (n=27)	16 51.6%
Month 9; Q9,10a-10d,11a-11b: Not Satisfied (n=27)	11 35.5%
Month 12; Q9, 10a-10d, 11a-11b: Satisfied (n=27)	16 51.6%
Month 12; Q9,10a-10d,11a-11b: Not Satisfied (n=27)	11 35.5%
Month 15; Q9, 10a-10d, 11a-11b: Satisfied (n=26)	17 54.8%
Month 15; Q9,10a-10d,11a-11b: Not Satisfied (n=26)	9 29%
Month 18; Q9, 10a-10d, 11a-11b: Satisfied (n=24)	16 51.6%
Month 18; Q9,10a-10d,11a-11b: Not Satisfied (n=24)	8 25.8%
EOT; Q9, 10a-10d, 11a-11b: Satisfied (n=27)	18 58.1%
EOT; Q9,10a-10d,11a-11b: Not Satisfied (n=27)	9 29%

16. Secondary Outcome

Title	King's Health Questionnaire (KHQ) Domain Scores
Description	KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.
Time Frame	Baseline, End of Treatment (EOT) (Week 82)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points.

Arm/Group Title	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Measure Participants	28
General Health Perception: Baseline (n=28)	43.75 (21.11)
General Health Perception: EOT (n=20)	38.75 (23.61)
Incontinence Impact: Baseline (n=27)	50.62 (23.33)
Incontinence Impact: EOT (n=20)	41.67 (26.21)
Role Limitations: Baseline (n=27)	31.48 (27.09)
Role Limitations: EOT (n=20)	35.00 (30.06)
Physical Limitations: Baseline (n=27)	37.04 (30.43)
Physical Limitations: EOT (n=20)	34.17 (25.64)
Social Limitations: Baseline (n=27)	13.99 (24.19)
Social Limitations: EOT (n=20)	20.56 (24.52)
Personal Relationships: Baseline (n=11)	1.52 (5.03)
Personal Relationships: EOT (n=10)	11.67 (19.33)
Emotions: Baseline (n=27)	35.80 (25.66)
Emotions: EOT (n=20)	32.78 (22.65)
Sleep/Energy: Baseline (n=27)	34.57 (23.08)
Sleep/Energy: EOT (n=20)	35.00 (22.88)
Severity of Urinary Symptoms: Baseline (n=27)	44.69 (21.86)
Severity of Urinary Symptoms: EOT (n=20)	42.33 (21.44)

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	Fesoterodine
Arm/Group Description	Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
All Cause Mortality
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	1/31 (3.2%)
Nervous system disorders
Epilepsy	1/31 (3.2%)
Other (Not Including Serious) Adverse Events
	Fesoterodine
	Affected / at Risk (%)	# Events
Total	9/31 (29%)
Gastrointestinal disorders
Dry mouth	2/31 (6.5%)
Nausea	1/31 (3.2%)
General disorders
Gait disturbance	1/31 (3.2%)
Malaise	1/31 (3.2%)
Oedema peripheral	1/31 (3.2%)
Infections and infestations
Urinary tract infection	3/31 (9.7%)
Investigations
Blood glucose decreased	1/31 (3.2%)
Psychiatric disorders
Depression	1/31 (3.2%)
Reproductive system and breast disorders
Vulvovaginal discomfort	1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Cough	1/31 (3.2%)
Skin and subcutaneous tissue disorders
Cold sweat	1/31 (3.2%)

Limitations/Caveats

Due to the small sample size and that this is a single country study (Portugal) the results should be interpreted with caution.

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.