DETROL LA Capsules 2 mg were evaluated in 29 patients in a Phase 2 dose-effect study.
DETROL LA 4 mg was evaluated for the treatment of overactive bladder with symptoms
of urge urinary incontinence and frequency in a randomized, placebo-controlled,
multicenter, double-blind, Phase 3, 12-week study.
A total of 507 patients received DETROL LA 4 mg once daily in the morning and 508
received placebo. The majority of patients were Caucasian (95%) and female (81%),
with a mean age of 61 years (range, 20 to 93 years). In the study, 642 patients
(42%) were 65 to 93 years of age. The study included patients known to be responsive
to tolterodine immediate release and other anticholinergic medications, however,
47% of patients never received prior pharmacotherapy for overactive bladder. At
study entry, 97% of patients had at least 5 urge incontinence episodes per week
and 91% of patients had 8 or more micturitions per day. The primary efficacy endpoint
was change in mean number of incontinence episodes per week at week 12 from baseline.
Secondary efficacy endpoints included change in mean number of micturitions per
day and mean volume voided per micturition at week 12 from baseline.
Table 3. 95% Confidence Intervals (CI) for the Difference between DETROL LA (4 mg
daily) and Placebo for Mean Change at Week 12 from Baseline*
