Trial Outcomes & Findings for Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder (NCT NCT01054222)
NCT ID: NCT01054222
Last Updated: 2013-05-15
Results Overview
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.
COMPLETED
PHASE4
31 participants
End of Treatment (up to Week 82)
2013-05-15
Participant Flow
Participants who completed treatment in study A0221045 (NCT00798434) were included in this study as per investigator's discretion.
Participant milestones
| Measure |
Fesoterodine
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Fesoterodine
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
Baseline characteristics by cohort
| Measure |
Fesoterodine
n=31 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Age Continuous
|
75.4 Years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (up to Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])
|
5.48 episodes per 24 hours
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
Baseline (n= 28)
|
10.49 episodes per 24 hours
Standard Deviation 5.28
|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
Month 3 (n= 25)
|
5.28 episodes per 24 hours
Standard Deviation 7.33
|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
Month 9 (n= 28)
|
4.98 episodes per 24 hours
Standard Deviation 6.41
|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
Month 12 (n= 28)
|
5.15 episodes per 24 hours
Standard Deviation 6.62
|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
Month 15 (n= 27)
|
5.09 episodes per 24 hours
Standard Deviation 6.46
|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
Month 18 (n= 24)
|
5.22 episodes per 24 hours
Standard Deviation 6.18
|
|
Mean Number of Micturition-Related Urgency Episodes Per 24 Hours
Month 6 (n= 28)
|
6.37 episodes per 24 hours
Standard Deviation 6.74
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Month 12 (n= 28)
|
2.23 episodes per 24 hours
Standard Deviation 5.86
|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Month 15 (n= 27)
|
2.67 episodes per 24 hours
Standard Deviation 6.08
|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Month 18 (n= 24)
|
2.44 episodes per 24 hours
Standard Deviation 6.27
|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
End of Treatment (n= 28)
|
2.29 episodes per 24 hours
Standard Deviation 5.83
|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Baseline (n= 28)
|
6.35 episodes per 24 hours
Standard Deviation 6.90
|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Month 3 (n= 25)
|
3.36 episodes per 24 hours
Standard Deviation 7.14
|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Month 6 (n= 28)
|
2.40 episodes per 24 hours
Standard Deviation 6.15
|
|
Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours
Month 9 (n= 28)
|
2.52 episodes per 24 hours
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Mean Number of Micturitions Per 24 Hours
End of Treatment (n= 28)
|
10.38 micturitions per 24 hours
Standard Deviation 4.19
|
|
Mean Number of Micturitions Per 24 Hours
Baseline (n= 28)
|
13.44 micturitions per 24 hours
Standard Deviation 4.57
|
|
Mean Number of Micturitions Per 24 Hours
Month 3 (n= 25)
|
10.97 micturitions per 24 hours
Standard Deviation 4.72
|
|
Mean Number of Micturitions Per 24 Hours
Month 6 (n= 28)
|
10.98 micturitions per 24 hours
Standard Deviation 4.26
|
|
Mean Number of Micturitions Per 24 Hours
Month 9 (n= 28)
|
10.44 micturitions per 24 hours
Standard Deviation 4.26
|
|
Mean Number of Micturitions Per 24 Hours
Month 12 (n= 28)
|
10.51 micturitions per 24 hours
Standard Deviation 4.46
|
|
Mean Number of Micturitions Per 24 Hours
Month 15 (n= 27)
|
10.67 micturitions per 24 hours
Standard Deviation 4.06
|
|
Mean Number of Micturitions Per 24 Hours
Month 18 (n= 24)
|
10.60 micturitions per 24 hours
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
Baseline (n= 28)
|
3.45 micturitions per 24 hours
Standard Deviation 1.53
|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
Month 9 (n= 28)
|
3.07 micturitions per 24 hours
Standard Deviation 1.91
|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
Month 3 (n= 25)
|
3.08 micturitions per 24 hours
Standard Deviation 1.92
|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
Month 6 (n= 28)
|
3.25 micturitions per 24 hours
Standard Deviation 1.72
|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
Month 12 (n= 28)
|
2.88 micturitions per 24 hours
Standard Deviation 1.99
|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
Month 15 (n= 27)
|
3.00 micturitions per 24 hours
Standard Deviation 2.00
|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
Month 18 (n= 24)
|
2.95 micturitions per 24 hours
Standard Deviation 2.05
|
|
Mean Number of Nocturnal Micturitions Per 24 Hours
End of Treatment (n= 28)
|
2.95 micturitions per 24 hours
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Month 6 (n= 28)
|
1.54 episodes per 24 hours
Standard Deviation 5.76
|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Month 9 (n= 28)
|
1.36 episodes per 24 hours
Standard Deviation 5.62
|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Month 12 (n= 28)
|
1.29 episodes per 24 hours
Standard Deviation 5.69
|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Baseline (n= 28)
|
2.64 episodes per 24 hours
Standard Deviation 5.31
|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Month 3 (n= 25)
|
2.27 episodes per 24 hours
Standard Deviation 6.86
|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Month 15 (n= 27)
|
1.83 episodes per 24 hours
Standard Deviation 5.99
|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Month 18 (n= 24)
|
1.65 episodes per 24 hours
Standard Deviation 6.06
|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
End of Treatment (n= 28)
|
1.49 episodes per 24 hours
Standard Deviation 5.62
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
Month 3 (n= 25)
|
31.60 Units on a Scale
Standard Deviation 30.32
|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
Baseline (n= 28)
|
45.63 Units on a Scale
Standard Deviation 23.72
|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
Month 6 (n= 28)
|
31.39 Units on a Scale
Standard Deviation 26.10
|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
Month 9 (n= 28)
|
28.29 Units on a Scale
Standard Deviation 25.75
|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
Month 12 (n= 28)
|
27.63 Units on a Scale
Standard Deviation 26.66
|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
Month 15 (n= 27)
|
28.67 Units on a Scale
Standard Deviation 26.31
|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
Month 18 (n= 24)
|
29.01 Units on a Scale
Standard Deviation 26.87
|
|
Daily Sum Rating on the Urinary Sensation Scale (USS)
End of Treatment (n= 28)
|
28.60 Units on a Scale
Standard Deviation 25.16
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Fesoterodine
n=31 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Percentage of Incontinent Participants at Baseline
|
58.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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.
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.
Outcome measures
| Measure |
Fesoterodine
n=18 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
Month 18 (n= 15)
|
66.7 Percentage of Participants
|
|
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
End of Treatment (n= 18)
|
66.7 Percentage of Participants
|
|
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
Month 3 (n= 16)
|
81.3 Percentage of Participants
|
|
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
Month 6 (n= 18)
|
77.8 Percentage of Participants
|
|
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
Month 9 (n= 18)
|
77.8 Percentage of Participants
|
|
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
Month 12 (n= 18)
|
77.8 Percentage of Participants
|
|
Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode
Month 15 (n= 17)
|
64.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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.
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.
Outcome measures
| Measure |
Fesoterodine
n=18 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Baseline: IP (n= 18)
|
3.69 Units per 24 hours
Standard Deviation 2.71
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 6: Powder (n= 18)
|
0.20 Units per 24 hours
Standard Deviation 0.86
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 9: IP (n= 18)
|
2.56 Units per 24 hours
Standard Deviation 2.34
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 18: IP (n= 15)
|
2.49 Units per 24 hours
Standard Deviation 2.22
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 18: BC (n= 15)
|
0.18 Units per 24 hours
Standard Deviation 0.53
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 18: Powder (n= 15)
|
0.00 Units per 24 hours
Standard Deviation 0.00
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
End of Treatment: IP (n= 18)
|
2.31 Units per 24 hours
Standard Deviation 2.11
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Baseline: BC (n= 18)
|
0.48 Units per 24 hours
Standard Deviation 0.90
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Baseline: Powder (n= 18)
|
0.24 Units per 24 hours
Standard Deviation 1.02
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 3: IP (n= 16)
|
3.15 Units per 24 hours
Standard Deviation 4.63
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 3: BC (n= 16)
|
0.79 Units per 24 hours
Standard Deviation 2.07
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 3: Powder (n= 16)
|
0.19 Units per 24 hours
Standard Deviation 0.75
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 6: IP (n= 18)
|
3.02 Units per 24 hours
Standard Deviation 4.26
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 6: BC (n= 18)
|
0.43 Units per 24 hours
Standard Deviation 1.01
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 9: BC (n= 18)
|
0.33 Units per 24 hours
Standard Deviation 1.07
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 9: Powder (n= 18)
|
0.17 Units per 24 hours
Standard Deviation 0.71
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 12: IP (n= 18)
|
2.52 Units per 24 hours
Standard Deviation 2.44
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 12: BC (n= 18)
|
0.13 Units per 24 hours
Standard Deviation 0.55
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 12: Powder (n= 18)
|
0.31 Units per 24 hours
Standard Deviation 1.34
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 15: IP (n= 17)
|
2.45 Units per 24 hours
Standard Deviation 2.32
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 15: BC (n= 17)
|
0.18 Units per 24 hours
Standard Deviation 0.53
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
Month 15: Powder (n= 17)
|
0.00 Units per 24 hours
Standard Deviation 0.00
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
End of Treatment: BC (n= 18)
|
0.15 Units per 24 hours
Standard Deviation 0.49
|
|
Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours
End of Treatment: Powder (n= 18)
|
0.00 Units per 24 hours
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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).
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
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: Some Minor Problems (n= 28)
|
11 Participants
|
|
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: Some Moderate Problems (n= 28)
|
11 Participants
|
|
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
Change at Month 3: No Change (n= 27)
|
9 Participants
|
|
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
Change at Month 3: Improvement (n= 27)
|
12 Participants
|
|
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
Change at Month 15: Improvement (n= 27)
|
11 Participants
|
|
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
Change at Month 18: Deterioration (n= 24)
|
6 Participants
|
|
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: No Problems at all (n= 28)
|
0 Participants
|
|
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: Some Very Minor Problems (n= 28)
|
2 Participants
|
|
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: Severe Problems (n= 28)
|
4 Participants
|
|
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: Many Severe Problems (n= 28)
|
0 Participants
|
|
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
Change at Month 3: Deterioration (n= 27)
|
6 Participants
|
|
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
Change at Month 6: Deterioration (n= 28)
|
6 Participants
|
|
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
Change at Month 6: No Change (n= 28)
|
12 Participants
|
|
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
Change at Month 6: Improvement (n= 28)
|
10 Participants
|
|
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
Change at Month 9: Deterioration (n= 28)
|
6 Participants
|
|
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
Change at Month 9: No Change (n= 28)
|
12 Participants
|
|
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
Change at Month 9: Improvement (n= 28)
|
10 Participants
|
|
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
Change at Month 12: Deterioration (n= 28)
|
5 Participants
|
|
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
Change at Month 12: No Change (n= 28)
|
12 Participants
|
|
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
Change at Month 12: Improvement (n= 28)
|
11 Participants
|
|
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
Change at Month 15: Deterioration (n= 27)
|
6 Participants
|
|
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
Change at Month 15: No Change (n= 27)
|
10 Participants
|
|
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
Change at Month 18: No Change (n= 24)
|
6 Participants
|
|
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
Change at Month 18: Improvement (n= 24)
|
12 Participants
|
|
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
Change at EOT: Deterioration (n= 28)
|
6 Participants
|
|
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
Change at EOT: No Change (n= 28)
|
9 Participants
|
|
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
Change at EOT: Improvement (n= 28)
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
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
Change at Month 3: No Change (n= 27)
|
17 Participants
|
|
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
Change at Month 9: Improvement (n= 28)
|
2 Participants
|
|
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
Change at Month 15: No Change (n= 27)
|
19 Participants
|
|
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
Change at Month 15: Improvement (n= 27)
|
3 Participants
|
|
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
Change at Month 18: Deterioration (n= 24)
|
6 Participants
|
|
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
Change at Month 18: No Change (n= 24)
|
12 Participants
|
|
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: Score 0, Unable to hold urine (n= 28)
|
3 Participants
|
|
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: Score 1, Able to hold urine (n= 28)
|
12 Participants
|
|
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:Score 2,Able to finish ongoing task(n=28)
|
13 Participants
|
|
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
Change at Month 3: Deterioration (n= 27)
|
5 Participants
|
|
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
Change at Month 3: Improvement (n= 27)
|
5 Participants
|
|
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
Change at Month 6: Deterioration (n= 28)
|
9 Participants
|
|
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
Change at Month 6: No Change (n= 28)
|
13 Participants
|
|
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
Change at Month 6: Improvement (n= 28)
|
6 Participants
|
|
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
Change at Month 9: Deterioration (n= 28)
|
7 Participants
|
|
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
Change at Month 9: No Change (n= 28)
|
19 Participants
|
|
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
Change at Month 12: Deterioration (n= 28)
|
7 Participants
|
|
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
Change at Month 12: No Change (n= 28)
|
17 Participants
|
|
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
Change at Month 12: Improvement (n= 28)
|
4 Participants
|
|
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
Change at Month 15: Deterioration (n= 27)
|
5 Participants
|
|
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
Change at Month 18: Improvement (n= 24)
|
6 Participants
|
|
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
Change at EOT: Deterioration (n= 28)
|
6 Participants
|
|
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
Change at EOT: No Change (n= 28)
|
16 Participants
|
|
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
Change at EOT: Improvement (n= 28)
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
End of Treatment (n= 28)
|
32.59 units on a scale
Standard Deviation 23.98
|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Baseline (n= 28)
|
35.54 units on a scale
Standard Deviation 20.41
|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Month 3 (n= 27)
|
33.29 units on a scale
Standard Deviation 22.05
|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Month 6 (n= 28)
|
32.95 units on a scale
Standard Deviation 23.44
|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Month 9 (n= 28)
|
33.93 units on a scale
Standard Deviation 21.88
|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Month 12 (n= 28)
|
29.55 units on a scale
Standard Deviation 21.45
|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Month 15 (n= 27)
|
31.30 units on a scale
Standard Deviation 24.99
|
|
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Month 18 (n= 24)
|
31.46 units on a scale
Standard Deviation 23.77
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)Population: 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).
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: End of Treatment (n= 28)
|
77.59 units on a scale
Standard Deviation 18.32
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: Month 12 (n= 28)
|
76.70 units on a scale
Standard Deviation 21.78
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: Month 3 (n= 27)
|
72.80 units on a scale
Standard Deviation 23.20
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: Month 15 (n= 27)
|
69.63 units on a scale
Standard Deviation 23.79
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: Month 9 (n= 28)
|
77.04 units on a scale
Standard Deviation 19.93
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: Month 12 (n= 28)
|
74.71 units on a scale
Standard Deviation 19.08
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: Month 15 (n= 27)
|
73.93 units on a scale
Standard Deviation 21.89
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: Month 3 (n= 27)
|
88.26 units on a scale
Standard Deviation 17.25
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: Month 9 (n= 28)
|
79.14 units on a scale
Standard Deviation 18.33
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: Month 12 (n= 28)
|
76.42 units on a scale
Standard Deviation 18.23
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: Baseline (n= 28)
|
77.77 units on a scale
Standard Deviation 19.69
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: Month 3 (n= 27)
|
78.28 units on a scale
Standard Deviation 21.17
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: Month 6 (n= 28)
|
77.14 units on a scale
Standard Deviation 21.22
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: Month 9 (n= 28)
|
79.55 units on a scale
Standard Deviation 20.67
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: Month 15 (n= 27)
|
74.54 units on a scale
Standard Deviation 23.47
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: Month 18 (n= 24)
|
79.69 units on a scale
Standard Deviation 18.61
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Coping Domain: End of Treatment (n= 28)
|
79.29 units on a scale
Standard Deviation 18.14
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: Baseline (n= 28)
|
71.04 units on a scale
Standard Deviation 18.09
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: Month 6 (n= 28)
|
70.51 units on a scale
Standard Deviation 18.10
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: Month 9 (n= 28)
|
74.49 units on a scale
Standard Deviation 19.53
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: Month 12 (n= 28)
|
71.33 units on a scale
Standard Deviation 19.73
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: Month 18 (n= 24)
|
72.50 units on a scale
Standard Deviation 21.56
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Concern Domain: End of Treatment (n= 28)
|
72.35 units on a scale
Standard Deviation 21.28
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: Baseline (n= 28)
|
71.00 units on a scale
Standard Deviation 19.74
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: Month 3 (n= 27)
|
73.93 units on a scale
Standard Deviation 20.04
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: Month 6 (n= 28)
|
73.86 units on a scale
Standard Deviation 16.85
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: Month 18 (n= 24)
|
74.33 units on a scale
Standard Deviation 21.62
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Sleep Domain: End of Treatment (n= 28)
|
73.57 units on a scale
Standard Deviation 21.12
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: Baseline (n= 28)
|
90.57 units on a scale
Standard Deviation 10.45
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: Month 6 (n= 28)
|
87.25 units on a scale
Standard Deviation 12.21
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: Month 9 (n= 28)
|
87.11 units on a scale
Standard Deviation 15.59
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: Month 12 (n= 28)
|
84.82 units on a scale
Standard Deviation 13.42
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: Month 15 (n= 27)
|
84.41 units on a scale
Standard Deviation 18.19
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: Month 18 (n= 24)
|
86.79 units on a scale
Standard Deviation 17.26
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Social Interaction Domain: End of Treatment (n=28)
|
86.25 units on a scale
Standard Deviation 16.69
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: Baseline (n= 28)
|
77.09 units on a scale
Standard Deviation 16.08
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: Month 3 (n= 27)
|
77.87 units on a scale
Standard Deviation 19.77
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: Month 6 (n= 28)
|
76.65 units on a scale
Standard Deviation 16.84
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: Month 15 (n= 27)
|
75.01 units on a scale
Standard Deviation 21.37
|
|
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Total: Month 18 (n= 24)
|
78.02 units on a scale
Standard Deviation 18.79
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)Population: 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).
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).
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Baseline, Q5: Exceeding/meeting expectations(n=26)
|
22 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 9, Q5: Does not meet expectations (n= 28)
|
3 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 6; Q9,10a-10d,11a-11b: Not Satisfied (n=27)
|
12 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 3, Q5: Exceeding/meeting expectations(n=27)
|
22 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Baseline, Q5: Does not meet expectations (n= 26)
|
4 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 3, Q5: Does not meet expectations (n= 27)
|
5 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 6, Q5: Exceeding/meeting expectations(n=28)
|
25 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 6, Q5: Does not meet expectations (n= 28)
|
3 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 9, Q5: Exceeding/meeting expectations(n=28)
|
25 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 12, Q5: Exceeding/meeting expectations(n=28)
|
24 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 12, Q5: Does not meet expectations (n= 28)
|
4 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 15, Q5: Exceeding/meeting expectations(n=27)
|
23 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 15, Q5: Does not meet expectations (n= 27)
|
4 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 18, Q5: Exceeding/meeting expectations(n=24)
|
19 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 18, Q5: Does not meet expectations (n= 24)
|
5 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
EOT, Q5: Exceeding/meeting expectations(n=28)
|
23 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
EOT, Q5: Does not meet expectations (n= 28)
|
5 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Baseline; Q9, 10a-10d, 11a-11b: Satisfied (n=27)
|
19 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Baseline; Q9,10a-10d,11a-11b: Not Satisfied (n=27)
|
8 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 3; Q9, 10a-10d, 11a-11b: Satisfied (n=26)
|
17 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 3; Q9,10a-10d,11a-11b: Not Satisfied (n=26)
|
9 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 6; Q9, 10a-10d, 11a-11b: Satisfied (n=27)
|
15 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 9; Q9, 10a-10d, 11a-11b: Satisfied (n=27)
|
16 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 9; Q9,10a-10d,11a-11b: Not Satisfied (n=27)
|
11 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 12; Q9, 10a-10d, 11a-11b: Satisfied (n=27)
|
16 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 12; Q9,10a-10d,11a-11b: Not Satisfied (n=27)
|
11 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 15; Q9, 10a-10d, 11a-11b: Satisfied (n=26)
|
17 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 15; Q9,10a-10d,11a-11b: Not Satisfied (n=26)
|
9 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 18; Q9, 10a-10d, 11a-11b: Satisfied (n=24)
|
16 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
Month 18; Q9,10a-10d,11a-11b: Not Satisfied (n=24)
|
8 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
EOT; Q9, 10a-10d, 11a-11b: Satisfied (n=27)
|
18 participants
|
|
Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)
EOT; Q9,10a-10d,11a-11b: Not Satisfied (n=27)
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (EOT) (Week 82)Population: 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.
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.
Outcome measures
| Measure |
Fesoterodine
n=28 Participants
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
King's Health Questionnaire (KHQ) Domain Scores
General Health Perception: Baseline (n=28)
|
43.75 units on a scale
Standard Deviation 21.11
|
|
King's Health Questionnaire (KHQ) Domain Scores
General Health Perception: EOT (n=20)
|
38.75 units on a scale
Standard Deviation 23.61
|
|
King's Health Questionnaire (KHQ) Domain Scores
Incontinence Impact: Baseline (n=27)
|
50.62 units on a scale
Standard Deviation 23.33
|
|
King's Health Questionnaire (KHQ) Domain Scores
Incontinence Impact: EOT (n=20)
|
41.67 units on a scale
Standard Deviation 26.21
|
|
King's Health Questionnaire (KHQ) Domain Scores
Role Limitations: Baseline (n=27)
|
31.48 units on a scale
Standard Deviation 27.09
|
|
King's Health Questionnaire (KHQ) Domain Scores
Role Limitations: EOT (n=20)
|
35.00 units on a scale
Standard Deviation 30.06
|
|
King's Health Questionnaire (KHQ) Domain Scores
Physical Limitations: Baseline (n=27)
|
37.04 units on a scale
Standard Deviation 30.43
|
|
King's Health Questionnaire (KHQ) Domain Scores
Physical Limitations: EOT (n=20)
|
34.17 units on a scale
Standard Deviation 25.64
|
|
King's Health Questionnaire (KHQ) Domain Scores
Social Limitations: Baseline (n=27)
|
13.99 units on a scale
Standard Deviation 24.19
|
|
King's Health Questionnaire (KHQ) Domain Scores
Social Limitations: EOT (n=20)
|
20.56 units on a scale
Standard Deviation 24.52
|
|
King's Health Questionnaire (KHQ) Domain Scores
Personal Relationships: Baseline (n=11)
|
1.52 units on a scale
Standard Deviation 5.03
|
|
King's Health Questionnaire (KHQ) Domain Scores
Personal Relationships: EOT (n=10)
|
11.67 units on a scale
Standard Deviation 19.33
|
|
King's Health Questionnaire (KHQ) Domain Scores
Emotions: Baseline (n=27)
|
35.80 units on a scale
Standard Deviation 25.66
|
|
King's Health Questionnaire (KHQ) Domain Scores
Emotions: EOT (n=20)
|
32.78 units on a scale
Standard Deviation 22.65
|
|
King's Health Questionnaire (KHQ) Domain Scores
Sleep/Energy: Baseline (n=27)
|
34.57 units on a scale
Standard Deviation 23.08
|
|
King's Health Questionnaire (KHQ) Domain Scores
Sleep/Energy: EOT (n=20)
|
35.00 units on a scale
Standard Deviation 22.88
|
|
King's Health Questionnaire (KHQ) Domain Scores
Severity of Urinary Symptoms: Baseline (n=27)
|
44.69 units on a scale
Standard Deviation 21.86
|
|
King's Health Questionnaire (KHQ) Domain Scores
Severity of Urinary Symptoms: EOT (n=20)
|
42.33 units on a scale
Standard Deviation 21.44
|
Adverse Events
Fesoterodine
Serious adverse events
| Measure |
Fesoterodine
n=31 participants at risk
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Nervous system disorders
Epilepsy
|
3.2%
1/31
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.
|
Other adverse events
| Measure |
Fesoterodine
n=31 participants at risk
Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31
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.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31
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.
|
|
General disorders
Gait disturbance
|
3.2%
1/31
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.
|
|
General disorders
Malaise
|
3.2%
1/31
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.
|
|
General disorders
Oedema peripheral
|
3.2%
1/31
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.
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31
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.
|
|
Investigations
Blood glucose decreased
|
3.2%
1/31
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.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31
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.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
3.2%
1/31
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31
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.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
3.2%
1/31
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER