Trial Outcomes & Findings for Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder. (NCT NCT00561951)
NCT ID: NCT00561951
Last Updated: 2011-07-14
Results Overview
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
COMPLETED
PHASE2
951 participants
Baseline to Week 12
2011-07-14
Participant Flow
Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.
Participant milestones
| Measure |
Placebo
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
Fesoterodine 8 mg
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
318
|
320
|
313
|
|
Overall Study
COMPLETED
|
285
|
286
|
281
|
|
Overall Study
NOT COMPLETED
|
33
|
34
|
32
|
Reasons for withdrawal
| Measure |
Placebo
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
Fesoterodine 8 mg
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
14
|
14
|
|
Overall Study
Lack of Efficacy
|
5
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
10
|
|
Overall Study
Protocol Violation
|
4
|
3
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Meet Withdrawal Criterion
|
0
|
1
|
1
|
|
Overall Study
Adverse Event Occured Before Treatment
|
1
|
2
|
1
|
Baseline Characteristics
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Baseline characteristics by cohort
| Measure |
Placebo
n=318 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=320 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
Fesoterodine 8 mg
n=313 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Total
n=951 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
227 Participants
n=99 Participants
|
217 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
640 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
91 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
311 Participants
n=7 Participants
|
|
Age Continuous
|
56.7 years
STANDARD_DEVIATION 13.5 • n=99 Participants
|
57.2 years
STANDARD_DEVIATION 14.2 • n=107 Participants
|
58.8 years
STANDARD_DEVIATION 13.4 • n=206 Participants
|
57.6 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
251 Participants
n=99 Participants
|
251 Participants
n=107 Participants
|
255 Participants
n=206 Participants
|
757 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
194 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. Last observation carried forward.
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
|
-1.40 UUI Episodes
Interval -1.7 to -1.09
|
-1.01 UUI Episodes
Interval -1.31 to -0.71
|
-1.35 UUI Episodes
Interval -1.65 to -1.05
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8, and 12Population: Full analysis set. No imputation was used for missing data.
Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 2 (n=308, 314, 305)
|
-1.12 UUI Episodes
Standard Deviation 1.736
|
-0.79 UUI Episodes
Standard Deviation 1.465
|
-1.10 UUI Episodes
Standard Deviation 1.681
|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 4 (n=301, 303, 296)
|
-1.49 UUI Episodes
Standard Deviation 1.643
|
-1.15 UUI Episodes
Standard Deviation 1.532
|
-1.48 UUI Episodes
Standard Deviation 1.688
|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 12 (n=284, 284, 281)
|
-1.87 UUI Episodes
Standard Deviation 1.814
|
-1.49 UUI Episodes
Standard Deviation 1.717
|
-1.76 UUI Episodes
Standard Deviation 1.618
|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 8 (n=289, 289, 287)
|
-1.65 UUI Episodes
Standard Deviation 1.690
|
-1.45 UUI Episodes
Standard Deviation 1.518
|
-1.61 UUI Episodes
Standard Deviation 1.680
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. Last observation carried forward.
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
|
-1.25 Micturitions
Interval -1.75 to -0.76
|
-0.59 Micturitions
Interval -1.08 to -0.1
|
-1.15 Micturitions
Interval -1.64 to -0.67
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8, and 12Population: Full analysis set. No imputation was used for missing data.
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 2 (n=308, 314, 305)
|
-1.06 Micturitions
Standard Deviation 2.076
|
-0.47 Micturitions
Standard Deviation 1.786
|
-0.94 Micturitions
Standard Deviation 1.987
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 4 (n=301, 303, 296)
|
-1.60 Micturitions
Standard Deviation 2.246
|
-0.85 Micturitions
Standard Deviation 1.960
|
-1.33 Micturitions
Standard Deviation 2.146
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 8 (n=289, 289, 287)
|
-2.15 Micturitions
Standard Deviation 2.402
|
-1.36 Micturitions
Standard Deviation 2.215
|
-1.81 Micturitions
Standard Deviation 2.277
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 12 (n=284, 284, 281)
|
-2.17 Micturitions
Standard Deviation 2.515
|
-1.36 Micturitions
Standard Deviation 2.415
|
-2.13 Micturitions
Standard Deviation 2.214
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. Last observation carried forward.
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
|
-1.66 Urgency Episodes
Interval -2.27 to -1.05
|
-1.00 Urgency Episodes
Interval -1.6 to -0.4
|
-1.65 Urgency Episodes
Interval -2.25 to -1.05
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8, and 12Population: Full analysis set. No imputation was used for missing data.
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 2 (n=308, 314, 305)
|
-1.59 Urgency Episodes
Standard Deviation 2.816
|
-0.79 Urgency Episodes
Standard Deviation 2.640
|
-1.37 Urgency Episodes
Standard Deviation 2.722
|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 4 (n=301, 303, 296)
|
-2.16 Urgency Episodes
Standard Deviation 3.065
|
-1.60 Urgency Episodes
Standard Deviation 2.780
|
-2.16 Urgency Episodes
Standard Deviation 2.906
|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 12 (n=284, 284, 281)
|
-3.05 Urgency Episodes
Standard Deviation 3.462
|
-2.37 Urgency Episodes
Standard Deviation 2.975
|
-2.89 Urgency Episodes
Standard Deviation 2.838
|
|
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 8 (n=289, 289, 287)
|
-2.71 Urgency Episodes
Standard Deviation 3.139
|
-2.34 Urgency Episodes
Standard Deviation 2.835
|
-2.50 Urgency Episodes
Standard Deviation 3.080
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. Last observation carried forward
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
|
-1.15 Incontinence Episodes
Interval -1.5 to -0.8
|
-0.88 Incontinence Episodes
Interval -1.22 to -0.54
|
-1.27 Incontinence Episodes
Interval -1.61 to -0.93
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8, and 12Population: Full analysis set. No imputation was used for missing data.
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 2 (n=308, 314, 305)
|
-1.06 Incontinence Episodes
Standard Deviation 1.887
|
-0.80 Incontinence Episodes
Standard Deviation 1.573
|
-1.11 Incontinence Episodes
Standard Deviation 1.725
|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 4 (n=301, 303, 296)
|
-1.50 Incontinence Episodes
Standard Deviation 1.707
|
-1.22 Incontinence Episodes
Standard Deviation 1.598
|
-1.61 Incontinence Episodes
Standard Deviation 1.755
|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 8 (n=289, 289, 287)
|
-1.73 Incontinence Episodes
Standard Deviation 1.760
|
-1.56 Incontinence Episodes
Standard Deviation 1.727
|
-1.76 Incontinence Episodes
Standard Deviation 1.795
|
|
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 12 (n=284, 284, 281)
|
-1.86 Incontinence Episodes
Standard Deviation 2.000
|
-1.59 Incontinence Episodes
Standard Deviation 1.869
|
-1.97 Incontinence Episodes
Standard Deviation 1.843
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline . Last observation carried forward.
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=257 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=243 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=256 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
|
-0.29 Night-Time Micturitions
Interval -0.52 to -0.05
|
-0.18 Night-Time Micturitions
Interval -0.41 to 0.06
|
-0.21 Night-Time Micturitions
Interval -0.44 to 0.02
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8, and 12Population: Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set. No imputation was used for missing data.
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=257 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=243 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=256 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 2 (n=242, 256, 256)
|
-0.34 Night-Time Micturitions
Standard Deviation 0.809
|
-0.25 Night-Time Micturitions
Standard Deviation 0.696
|
-0.24 Night-Time Micturitions
Standard Deviation 0.796
|
|
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 4 (n=236, 246, 248)
|
-0.46 Night-Time Micturitions
Standard Deviation 0.780
|
-0.30 Night-Time Micturitions
Standard Deviation 0.835
|
-0.30 Night-Time Micturitions
Standard Deviation 0.830
|
|
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 8 (n=224, 232, 241)
|
-0.58 Night-Time Micturitions
Standard Deviation 0.903
|
-0.41 Night-Time Micturitions
Standard Deviation 0.820
|
-0.45 Night-Time Micturitions
Standard Deviation 0.815
|
|
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Week 12 (n=220, 229, 236)
|
-0.63 Night-Time Micturitions
Standard Deviation 0.945
|
-0.44 Night-Time Micturitions
Standard Deviation 0.945
|
-0.48 Night-Time Micturitions
Standard Deviation 0.882
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. Last observation carried forward.
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
|
32.77 mL
Standard Deviation 52.893
|
13.07 mL
Standard Deviation 46.207
|
22.80 mL
Standard Deviation 47.590
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 4, 8, and 12Population: Full analysis set. No imputation was used for missing data.
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=306 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=309 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=314 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Week 2 (n=308, 314, 304)
|
21.52 mL
Standard Deviation 42.946
|
5.06 mL
Standard Deviation 37.875
|
13.63 mL
Standard Deviation 35.350
|
|
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Week 4 (n=301, 303, 296)
|
27.41 mL
Standard Deviation 45.803
|
9.23 mL
Standard Deviation 43.639
|
21.62 mL
Standard Deviation 44.623
|
|
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Week 8 (n=289, 289, 287)
|
30.94 mL
Standard Deviation 51.258
|
10.75 mL
Standard Deviation 45.628
|
22.05 mL
Standard Deviation 44.949
|
|
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Week 12 (n=284, 284, 281)
|
33.40 mL
Standard Deviation 53.379
|
13.28 mL
Standard Deviation 46.317
|
24.52 mL
Standard Deviation 48.620
|
SECONDARY outcome
Timeframe: Baseline to Week12Population: Full analysis set. No imputation was used for missing data.
King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=283 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=285 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=283 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
General Health Perceptions (n=285, 283, 283)
|
-6.10 score on scale
Standard Deviation 25.272
|
-7.02 score on scale
Standard Deviation 22.573
|
-9.36 score on scale
Standard Deviation 25.190
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Physical Limitations (n=285, 283, 283)
|
-25.97 score on scale
Standard Deviation 28.278
|
-18.65 score on scale
Standard Deviation 28.250
|
-23.50 score on scale
Standard Deviation 28.807
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Social Limitations (n=285, 283, 283)
|
-18.53 score on scale
Standard Deviation 25.765
|
-14.44 score on scale
Standard Deviation 25.541
|
-17.92 score on scale
Standard Deviation 24.029
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Personal Relationships (n=214, 210, 202)
|
-9.98 score on scale
Standard Deviation 24.335
|
-8.33 score on scale
Standard Deviation 21.773
|
-16.11 score on scale
Standard Deviation 25.798
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Emotions (n=285, 283, 283)
|
-24.89 score on scale
Standard Deviation 27.310
|
-18.01 score on scale
Standard Deviation 26.365
|
-24.70 score on scale
Standard Deviation 27.192
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Sleep/Energy (n=285, 283, 283)
|
-18.02 score on scale
Standard Deviation 25.287
|
-12.51 score on scale
Standard Deviation 24.967
|
-19.08 score on scale
Standard Deviation 23.800
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Incontinence Severity Measures (n=285, 283, 283)
|
-18.59 score on scale
Standard Deviation 21.814
|
-13.75 score on scale
Standard Deviation 20.763
|
-17.67 score on scale
Standard Deviation 21.038
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Impact on Life (n=285, 283, 283)
|
-25.09 score on scale
Standard Deviation 32.172
|
-22.46 score on scale
Standard Deviation 28.018
|
-27.33 score on scale
Standard Deviation 29.960
|
|
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Role Limitations (n=285, 283, 283)
|
-25.97 score on scale
Standard Deviation 28.590
|
-20.47 score on scale
Standard Deviation 27.730
|
-27.92 score on scale
Standard Deviation 26.373
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)
The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=283 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=285 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=283 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Concern Score of HRQL domain
|
19.10 score on scale
Standard Deviation 21.868
|
13.25 score on scale
Standard Deviation 21.182
|
20.05 score on scale
Standard Deviation 20.526
|
|
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Symptom Bother Score
|
-26.35 score on scale
Standard Deviation 23.849
|
-18.25 score on scale
Standard Deviation 23.618
|
-26.61 score on scale
Standard Deviation 22.592
|
|
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Total Score of HRQL domain
|
17.29 score on scale
Standard Deviation 19.670
|
12.88 score on scale
Standard Deviation 18.868
|
17.84 score on scale
Standard Deviation 17.880
|
|
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Coping Score of HRQL domain
|
21.48 score on scale
Standard Deviation 25.336
|
16.54 score on scale
Standard Deviation 23.633
|
21.01 score on scale
Standard Deviation 22.109
|
|
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Sleep Score of HRQL domain
|
15.35 score on scale
Standard Deviation 24.654
|
12.03 score on scale
Standard Deviation 22.215
|
16.16 score on scale
Standard Deviation 21.886
|
|
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Social Score of HRQL domain
|
9.98 score on scale
Standard Deviation 16.706
|
7.37 score on scale
Standard Deviation 17.211
|
11.35 score on scale
Standard Deviation 16.504
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. No imputation was used for missing data.
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: 1. No problems at all 2. Some very minor problems 3. Some minor problems 4. Some moderate problems 5. Severe problems 6. Many severe problems Change: mean at Week 12 minus mean at Baseline.
Outcome measures
| Measure |
Fesoterodine 8 mg
n=283 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=285 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=283 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
|
-1.76 score on scale
Standard Deviation 1.182
|
-1.57 score on scale
Standard Deviation 1.236
|
-1.83 score on scale
Standard Deviation 1.157
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full analysis set. No imputation was used for missing data
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: 1. No problems at all 2. Some very minor problems 3. Some minor problems 4. Some moderate problems 5. Severe problems 6. Many severe problems
Outcome measures
| Measure |
Fesoterodine 8 mg
n=283 Participants
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
Placebo
n=285 Participants
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=283 Participants
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
|---|---|---|---|
|
The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.
Baseline
|
83 participants
|
82 participants
|
97 participants
|
|
The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.
Week 12
|
19 participants
|
28 participants
|
12 participants
|
Adverse Events
Placebo
Fesoterodine 4 mg
Fesoterodine 8 mg
Serious adverse events
| Measure |
Placebo
n=318 participants at risk
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=320 participants at risk
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
Fesoterodine 8 mg
n=313 participants at risk
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
|
Infections and infestations
Abscess
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
|
Infections and infestations
Cellulitis
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
|
Nervous system disorders
Cerebral infarction
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
|
Gastrointestinal disorders
Diarrhoea
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/318
|
0.31%
1/320
|
0.00%
0/313
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/318
|
0.31%
1/320
|
0.00%
0/313
|
|
General disorders
Pyrexia
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/318
|
0.31%
1/320
|
0.00%
0/313
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/318
|
0.31%
1/320
|
0.00%
0/313
|
|
Gastrointestinal disorders
Vomiting
|
0.31%
1/318
|
0.00%
0/320
|
0.00%
0/313
|
Other adverse events
| Measure |
Placebo
n=318 participants at risk
Subjects were treated with placebo once daily for 12 weeks.
|
Fesoterodine 4 mg
n=320 participants at risk
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
|
Fesoterodine 8 mg
n=313 participants at risk
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.7%
15/318
|
5.3%
17/320
|
10.5%
33/313
|
|
Infections and infestations
Cystitis
|
1.3%
4/318
|
3.8%
12/320
|
2.2%
7/313
|
|
Gastrointestinal disorders
Diarrhoea
|
0.63%
2/318
|
2.2%
7/320
|
0.96%
3/313
|
|
Nervous system disorders
Dizziness
|
0.31%
1/318
|
2.2%
7/320
|
0.64%
2/313
|
|
Gastrointestinal disorders
Dry mouth
|
9.7%
31/318
|
29.1%
93/320
|
50.5%
158/313
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/318
|
0.62%
2/320
|
4.5%
14/313
|
|
Nervous system disorders
Headache
|
1.6%
5/318
|
3.1%
10/320
|
1.3%
4/313
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
21/318
|
5.9%
19/320
|
7.0%
22/313
|
|
Renal and urinary disorders
Residual urine
|
1.6%
5/318
|
2.2%
7/320
|
0.64%
2/313
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER