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DETROL® (tolterodine tartrate) Clinical Studies

CLINICAL STUDIES

DETROL Tablets were evaluated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in four randomized, double-blind, placebo-controlled, 12-week studies. A total of 853 patients received DETROL 2 mg twice daily and 685 patients received placebo. The majority of patients were Caucasian (95%) and female (78%), with a mean age of 60 years (range, 19 to 93 years). At study entry, nearly all patients perceived they had urgency and most patients had increased frequency of micturitions and urge incontinence. These characteristics were well balanced across treatment groups for the studies.

The efficacy endpoints for study 007 (see Table 3) included the change from baseline for:

  • Number of incontinence episodes per week
  • Number of micturitions per 24 hours (averaged over 7 days)
  • Volume of urine voided per micturition (averaged over 2 days)

The efficacy endpoints for studies 008, 009, and 010 (see Table 4) were identical to the above endpoints with the exception that the number of incontinence episodes was per 24 hours (averaged over 7 days).

Table 3. 95% Confidence Intervals (CI) for the Difference between DETROL (2 mg bid) and Placebo for the Mean Change at Week 12 from Baseline in Study 007
DETROL
(SD)
N=514
Placebo
(SD)
N=508
Difference
(95% CI)
SD = Standard Deviation.
*
The difference between DETROL and placebo was statistically significant.
Number of Incontinence Episodes per Week
  Mean baseline 23.2 23.3
  Mean change from baseline -10.6 (17) -6.9 (15) -3.7 (-5.7, -1.6)
Number of Micturitions per 24 Hours
  Mean baseline 11.1 11.3
  Mean change from baseline -1.7 (3.3) -1.2 (2.9) -0.5* (-0.9, -0.1)
Volume Voided per Micturition (mL)
  Mean baseline 137 136
  Mean change from baseline 29 (47) 14 (41) 15* (9, 21)
Table 4. 95% Confidence Intervals (CI) for the Difference between DETROL (2 mg bid) and Placebo for the Mean Change at Week 12 from Baseline in Studies 008, 009, 010
Study DETROL
(SD)
Placebo
(SD)
Difference
(95% CI)
SD = Standard Deviation.
*
The difference between DETROL and placebo was statistically significant.
Number of Incontinence Episodes per 24 Hours
008 Number of patients 93 40
Mean baseline 2.9   3.3
Mean change from baseline -1.3 (3.2)   -0.9 (1.5) 0.5 (-1.3,0.3)
009 Number of patients 116 55
Mean baseline   3.6   3.5
Mean change from baseline   -1.7 (2.5)   -1.3 (2.5) -0.4 (-1.0,0.2)
010 Number of patients 90 50
Mean baseline   3.7   3.5
Mean change from baseline -1.6 (2.4) -1.1 (2.1)   -0.5 (-1.1,0.1)
Number of Micturitions per 24 Hours
008 Number of patients 118 56
Mean baseline   11.5 11.7
Mean change from baseline   -2.7 (3.8) -1.6 (3.6) -1.2* (-2.0,-0.4)
009 Number of patients 128 64
Mean baseline   11.2 11.3
Mean change from baseline   -2.3 (2.1) -1.4 (2.8) -0.9* (-1.5,-0.3)
010 Number of patients 108 56
Mean baseline   11.6 11.6
Mean change from baseline   -1.7 (2.3) -1.4 (2.8) -0.38 (-1.1,0.3)
Volume Voided per Micturition (mL)
008 Number of patients 118 56
Mean baseline 166 157
Mean change from baseline 38 (54) 6 (42) 32* (18,46)
009 Number of patients 129 64
Mean baseline 155 158
Mean change from baseline 36 (50) 10 (47) 26* (14,38)
010 Number of patients 108 56
Mean baseline 155 160
Mean change from baseline 31 (45) 13 (52) 18* (4,32)

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