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TOVIAZ®Clinical Studies (fesoterodine fumarate)

14 CLINICAL STUDIES

Toviaz extended-release tablets were evaluated in two, Phase 3, randomized, double-blind, placebo-controlled, 12-week studies for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Entry criteria required that patients have symptoms of overactive bladder for ≥6-months duration, at least 8 micturitions per day, and at least 6 urinary urgency episodes or 3 urge incontinence episodes per 3-day diary period. Patients were randomized to a fixed dose of Toviaz 4 or 8 mg/day or placebo. In one of these studies, 290 patients were randomized to an active control arm (an oral antimuscarinic agent). For the combined studies, a total of 554 patients received placebo, 554 patients received Toviaz 4 mg/day, and 566 patients received Toviaz 8 mg/day. The majority of patients were Caucasian (91%) and female (79%) with a mean age of 58 years (range 19–91 years).

The primary efficacy endpoints were the mean change in the number of urge urinary incontinence episodes per 24 hours and the mean change in the number of micturitions (frequency) per 24 hours. An important secondary endpoint was the mean change in the voided volume per micturition.

Results for the primary endpoints and for mean change in voided volume per micturition from the two 12-week clinical studies of Toviaz are reported in Table 3.

Table 3: Mean baseline and change from baseline to Week 12 for urge urinary incontinence episodes, number of micturitions, and volume voided per micturition
Study 1Study 2
ParameterPlacebo
N=279
Toviaz
4mg/day
N=265
Toviaz
8mg/day
N=276
Placebo
N=266
Toviaz
4mg/day
N=267
Toviaz
8mg/day
N=267
vs. = versus
*
Only those patients who were urge incontinent at baseline were included for the analysis of number of urge incontinence episodes per 24 hours: In Study 1, the number of these patients was 211, 199, and 223 in the placebo, Toviaz 4 mg/day and Toviaz 8 mg/day groups, respectively. In Study 2, the number of these patients was 205, 228, and 218, respectively.
Number of urge incontinence episodes per 24 hours*
  Baseline3.73.83.73.73.93.9
  Change from baseline-1.20-2.06-2.27-1.00-1.77-2.42
  p-value vs. placebo-0.001<0.001-<0.003<0.001
Number of micturitions per 24 hours
  Baseline12.011.611.912.212.912.0
  Change from baseline-1.02-1.74-1.94-1.02-1.86-1.94
  p-value vs. placebo-<0.001<0.001-0.032<0.001
Voided volume per micturition (mL)
  Baseline150160154159152156
  Change from baseline10273381733
  p-value vs. placebo-<0.001<0.001-0.150<0.001

Figures 1–4: The following figures show change from baseline over time in number of micturitions and urge urinary incontinence episodes per 24 h in the two studies.

Figure 1

Figure 2

Figure 3

Figure 4

A reduction in number of urge urinary incontinence episodes per 24 hours was observed for both doses as compared to placebo as early as two weeks after starting Toviaz therapy.

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