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DETROL®Clinical Studies (tolterodine tartrate)

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 baseline23.223.3
  Mean change from baseline-10.6 (17)-6.9 (15)-3.7 (-5.7, -1.6)
Number of Micturitions per 24 Hours
  Mean baseline11.111.3
  Mean change from baseline-1.7 (3.3)-1.2 (2.9)-0.5* (-0.9, -0.1)
Volume Voided per Micturition (mL)
  Mean baseline137136
  Mean change from baseline29 (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
StudyDETROL
(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
008Number of patients9340
Mean baseline2.9  3.3
Mean change from baseline-1.3 (3.2)  -0.9 (1.5)0.5 (-1.3,0.3)
009Number of patients11655
Mean baseline  3.6  3.5
Mean change from baseline  -1.7 (2.5)  -1.3 (2.5)-0.4 (-1.0,0.2)
010Number of patients9050
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
008Number of patients11856
Mean baseline  11.511.7
Mean change from baseline  -2.7 (3.8)-1.6 (3.6)-1.2* (-2.0,-0.4)
009Number of patients12864
Mean baseline  11.211.3
Mean change from baseline  -2.3 (2.1)-1.4 (2.8)-0.9* (-1.5,-0.3)
010Number of patients10856
Mean baseline  11.611.6
Mean change from baseline  -1.7 (2.3)-1.4 (2.8)-0.38 (-1.1,0.3)
Volume Voided per Micturition (mL)
008Number of patients11856
Mean baseline166157
Mean change from baseline38 (54)6 (42)32* (18,46)
009Number of patients12964
Mean baseline155158
Mean change from baseline36 (50)10 (47)26* (14,38)
010Number of patients10856
Mean baseline155160
Mean change from baseline31 (45)13 (52)18* (4,32)
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