Skip to main content
. Author manuscript; available in PMC: 2014 Sep 1.
Published in final edited form as: Am J Obstet Gynecol. 2013 May 6;209(3):244.e1–244.e9. doi: 10.1016/j.ajog.2013.05.008
Open Label

RCT
Baseline*
(n=498)
Open Label
Baseline**
(n=497)
Month 3
(n=491)
Month 6
(n=464)
Month 9
(n=454)

From 3-day voiding diaries

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) 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)

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)


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)

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)

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)

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)

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)

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)

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)

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