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 2.
Table 2 Mean baseline and change from baseline to Week 12 for urge urinary incontinence
episodes, number of micturitions, and volume voided per micturition
a 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.
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: Change in Number of Micturitions per 24 h (Study 1)
Figure 2: Change in Urge Incontinence Episodes per 24 h (Study 1)
Figure 3: Change in Number of Micturitions per 24 h (Study 2)
Figure 4: Change in Urge Incontinence Episodes per 24 h (Study 2)
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.