Open Label | |||||
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RCT Baseline* (n=498) |
Open Label Baseline** (n=497)† |
Month 3 (n=491) |
Month 6 (n=464) |
Month 9 (n=454) |
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From 3-day voiding diaries ∞ | |||||
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Urgency incontinence episodes per day† | |||||
Adjusted means [standard errors (SE)] | 3.90 (0.11) | 1.75 (0.11) | 1.08 (0.11) | 0.97 (0.11) | 0.95 (0.11) |
Median (IQR)F̄ | 3.0 (2.0-5.0) | 1.0 (0.0-2.3) | 0.3 (0.0-1.3) | 0.3 (0.0-1.0) | 0.3 (0.0-1.0) |
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Total incontinence episodes per day | |||||
Adjusted means (SE) | 4.64 (0.12) | 2.11 (0.13) | 1.36 (0.13) | 1.22 (0.13) | 1.16 (0.13) |
Median (IQR) | 3.7 (2.3-6.0) | 1.0 (0.3-2.7) | 0.7 (0.0-1.7) | 0.3 (0.0-1.3) | 0.3 (0.0-1.3) |
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Daytime incontinence episodes per day | |||||
Adjusted means (SE) | 4.03 (0.11) | 1.84 (0.11) | 1.19 (0.11) | 1.09 (0.11) | 1.06 (0.11) |
Median (IQR) | 3.2 (2.0-5.0) | 1.0 (0.3-2.3) | 0.3 (0.0-1.7) | 0.3 (0.0-1.3) | 0.3 (0.0-1.3) |
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Daytime voiding episodes per day | |||||
Adjusted means (SE) | 8.67 (0.14) | 7.99 (0.14) | 7.59 (0.14) | 7.67 (0.14) | 7.70 (0.14) |
Median (IQR) | 8.3 (6.7-10.0) | 7.7 (6.3-9.3) | 7.3 (6.0-9.0) | 7.3 (6.0-8.7) | 7.3 (5.8-9.2) |
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Nocturnal voiding episodes per night¥ | |||||
Adjusted means (SE) | 1.24 (0.05) | 0.89 (0.05) | 0.75 (0.05) | 0.75 (0.05) | 0.74 (0.05) |
Median (IQR) | 1.0 (0.3-2.0) | 0.7 (0.0-1.3) | 0.3 (0.0-1.3) | 0.3 (0.0-1.3) | 0.3 (0.0-1.2) |
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Moderate urgency-associated voids per day‡ | |||||
Adjusted means (SE) | 7.65 (0.20) | 5.76 (0.20) | 5.07 (0.20) | 4.87 (0.20) | 4.96 (0.20) |
Median (IQR) | 6.7 (4.7-9.7) | 5.0 (2.3-8.0) | 4.7 (1.7-7.3) | 4.3 (1.7-6.7) | 4.3 (2.0-7.0) |
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Severe urgency-associated voids per day§ | |||||
Adjusted means (SE) | 3.44 (0.12) | 1.90 (0.12) | 1.29 (0.12) | 1.30 (0.13) | 1.38 (0.13) |
Median (IQR) | 2.3 (1.0-4.7) | 0.7 (0.0-2.7) | 0.7 (0.0-1.7) | 0.3 (0.0-1.7) | 0.7 (0.0-1.7) |
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Self-report Bladder-specific questionnaires | |||||
Overactive Bladder Questionnaire score¶ | |||||
Adjusted means (SE) | 36.70 (0.85) | 21.65 (0.85) | 15.39 (0.85) | 14.90 (0.86) | 14.86 (0.86) |
Median (IQR) | 33.6 (21.8-47.3) | 15.8 (6.7-31.5) | 9.7 (3.6-20.0) | 9.1 (3.6-18.8) | 8.5 (3.6-18.8) |
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Patient Perception of Bladder Condition score∥ | |||||
Adjusted means (SE) | 3.04 (0.06) | 2.12 (0.06) | 1.52 (0.06) | 1.49 (0.06) | 1.44 (0.06) |
Median (IQR) | 3.0 (2.0-4.0) | 2.0 (1.0-3.0) | 1.0 (1.0-2.0) | 1.0 (0.0-2.0) | 1.0 (0.0-2.0) |
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Patient Perception of Urgency Scale score± | |||||
Adjusted means (SE) | 1.38 (0.03) | 1.01 (0.03) | 0.86 (0.03) | 0.80 (0.03) | 0.80 (0.03) |
Median (IQR) | 1.0 (1.0-2.0) | 1.0 (1.0-1.0) | 1.0 (0.0-1.0) | 1.0 (0.0-1.0) | 1.0 (0.0-1.0) |
Randomized Control Trial (RCT): the pre-randomization visit of the 12-week RCT.
Baseline Open Label bladder diaries included data on RCT participants that had been on fesoterodine or placebo, all comparisons are significant at p<0.001 compared to the initial RCT visit.
One participant failed show for the Baseline Open Label visit, but was enrolled in open label at the subsequent visit.
Values reflect events per day based on participant completion of a 3-day voiding diary.
Self report on diary as an urgency or stress incontinence episode.
Interquartile range (IQR), Medians are unadjusted
Self report on the diary as to the time the participant went to bed for the evening and when the participant woke in the morning.
Moderate urgency-associated voids were defined as voiding episodes associated with at least a “moderate” sensation of urgency on voiding diary.
Severe urgency-associated voids were defined as voiding episodes associated with a “severe” sensation of urgency on voiding diary.
Overactive Bladder Questionnaire scores range from 0 to 100, with higher scores indicating more severe or bothersome overactive bladder symptoms.13,14
Patient Perception of Bladder Condition scores range from 1 to 6, with higher scores indicating more severe bladder-related problems.14
Patient Perception of Urgency Scale scores range from 1 to 3, with higher scores indicating greater urgency.15