Table 3.
Secondary efficacy variables-frequency volume chart parameters (full analysis set; full analysis set-incontinence)
| Varible | Placebo (N = 72; 35)c) | DA-8010 2.5 mg (N = 70; 32)c) | DA-8010 5 mg (N = 71; 36)c) | Solifenacin 5 mg (N = 72; 32)c) | |
|---|---|---|---|---|---|
| Overall incontinence episodes/24 hr (N) | |||||
| Baseline | 2.84 ± 2.98 (2.00) | 1.90 ± 2.61 (1.00) | 2.12 ± 2.50 (1.50) | 2.24 ± 1.71 (1.67) | |
| Change from baseline at week 4 | -0.44 ± 2.01 (-0.67) | -0.63 ± 2.06 (-0.33) | -0.84 ± 2.37 (-0.67) | -1.17 ± 1.66 (-0.67) | |
| P-valuea) | 0.8574 | 0.7562 | |||
| Change from baseline at week 8 | -0.67 ± 1.87 (-1.00) | -0.96 ± 2.19 (-0.67) | -0.87 ± 2.59 (-0.5) | -1.07 ± 1.69 (-1.00) | |
| P-valuea) | 0.6138 | 0.766 | |||
| Change from baseline at week 12 | -1.29 ± 2.26 (-1.00) | -0.93 ± 2.25 (-0.67) | -1.20 ± 2.75 (-1.00) | -1.31 ± 1.65 (-1.17) | |
| P-valuea) | 0.7657 | 0.6524 | |||
| Urgency urinary incontinence episodes/24 hr (N) | |||||
| Baseline | 2.84 ± 2.98 (2.00) | 1.90 ± 2.61 (1.00) | 2.05 ± 2.54 (1.33) | 2.17 ± 1.71 (1.33) | |
| Change from baseline at week 4 | -0.47 ± 2.03 (-0.67) | -0.63 ± 2.06 (-0.33) | -0.85 ± 2.36 (-0.67) | -1.09 ± 1.68 (-0.67) | |
| P-valuea) | 0.8448 | 0.7698 | |||
| Change from baseline at week 8 | -0.67 ± 1.87 (-1.00) | -0.97 ± 2.19 (-0.67) | -0.97 ± 2.52 (-0.67) | -1.00 ± 1.70 (-0.83) | |
| P-valuea) | 0.5499 | 0.8965 | |||
| Change from baseline at week 12 | -1.29 ± 2.26 (-1.00) | -0.94 ± 2.24 (-0.67) | -1.21 ± 2.74 (-0.83) | -1.24 ± 1.62 (-1.00) | |
| P-valuea) | 0.7805 | 0.7194 | |||
| Urgency episodes /24 hr (N) | |||||
| Baseline | 8.81 ± 3.80 (8.33) | 7.57 ± 3.61 (7.67) | 8.75 ± 2.83 (9.00) | 8.20 ± 3.33 (8.33) | |
| Change from baseline at week 4 | -0.58 ± 3.26 (-0.33) | -1.08 ± 3.45 (-1.33) | -2.04 ± 3.63 (-1.00) | -1.39 ± 3.25 (-1.00) | |
| P-valuea) | 0.1370 | 0.0278 | |||
| Change from baseline at week 8 | -1.21 ± 3.25 (-1.00) | -1.81 ± 3.50 (-2.00) | -2.66 ± 3.99 (-2.33) | -1.44 ± 3.72 (-1.00) | |
| LS mean (SE) | -1.17 (0.41) | -2.23 (0.42) | -2.67 (0.42) | ||
| P-valueb) | 0.0684 | 0.0092 | |||
| Change from baseline at week 12 | -1.85 ± 4.02 (-1.67) | -2.01 ± 3.91 (-2.17) | -2.74 ± 3.99 (-2.33) | -1.96 ± 3.94 (-1.83) | |
| LS mean (SE) | -1.72 (0.46) | -2.38 (0.47) | -2.65 (0.46) | ||
| P-valueb) | 0.3107 | 0.1430 | |||
| Nocturia episode /24 hr (N) | |||||
| Baseline | 1.40 ± 1.04 (1.33) | 1.64 ± 1.21 (1.67) | 1.34 ± 0.94 (1.33) | 1.56 ± 1.14 (1.33) | |
| Change from baseline at week 4 | 0.02 ± 1.03 (0.00) | -0.35 ± 0.85 (-0.33) | -0.19 ± 0.99 (0.00) | -0.25 ± 1.13 (0.00) | |
| P-valuea) | 0.0976 | 0.2130 | |||
| Change from baseline at week 8 | -0.05 ± 1.11 (0.00) | -0.44 ± 1.07 (-0.33) | -0.34 ± 0.93 (0.00) | -0.16 ± 1.12 (-0.17) | |
| P-valuea) | 0.0952 | 0.0779 | |||
| Change from baseline at week 12 | -0.05 ± 1.33 (0.00) | -0.37 ± 0.99 (-0.33) | -0.30 ± 1.05 (-0.33) | -0.26 ± 1.33 (-0.33) | |
| P-valuea) | 0.1198 | 0.1201 | |||
| Average voided volume (mL) | |||||
| Baseline | 152.97 ± 51.76 (152.53) | 161.73 ± 51.86 (162.63) | 155.32 ± 50.02 (160.74) | 158.29 ± 51.67 (161.38) | |
| Change from baseline at week 4 | 5.53 ± 30.63 (3.15) | 8.31 ± 35.08 (3.36) | 12.41 ± 35.46 (9.63) | 19.12 ± 49.52 (12.81) | |
| P-valuea) | 0.4795 | 0.0524 | |||
| Change from baseline at week 8 | 9.30 ± 36.32 (4.36) | 12.08 ± 44.12 (6.26) | 9.59 ± 39.43 (6.93) | 23.10 ± 47.13 (18.46) | |
| P-valuea) | 0.4480 | 0.4430 | |||
| Change from baseline at week 12 | 11.88 ± 46.97 (4.47) | 14.34 ± 51.49 (13.17) | 8.71 ± 40.68 (10.03) | 29.16 ± 52.04 (21.53) | |
| P-valuea) | 0.1141 | 0.5993 | |||
| Maximum voided volume (mL) | |||||
| Baseline | 296.81 ± 89.41 (300.00) | 335.79 ± 105.27 (320.00) | 312.23 ± 90.86 (300.00) | 316.88 ± 129.18 (300.00) | |
| Change from baseline at week 4 | 0.56 ± 77.33 (0.00) | 1.36 ± 101.89 (0.00) | 4.82 ± 84.01 (0.00) | 12.15 ± 126.71 (0.00) | |
| P-valuea) | 0.3678 | 0.4715 | |||
| Change from baseline at week 8 | 6.78 ± 72.38 (0.00) | -6.07 ± 151.58 (-10.00) | -11.24 ± 77.63 (0.00) | 4.51 ± 114.29 (0.00) | |
| P-valuea) | 0.2107 | 0.4874 | |||
| Change from baseline at week 12 | 0.07 ± 82.05 (0.00) | -20.79 ± 127.27 (-10.00) | -18.92 ± 85.41 (0.00) | 2.94 ± 128.53 (0.00) | |
| P-valuea) | 0.8193 | 0.9332 | |||
Values are presented as mean±standard deviation (median) or LS means (SE). The results of the solifenacin 5 mg group were added for exploratory analysis.
LS mean, least square mean; SE, standard error; ANCOVA, analysis of covariance.
a)
Rank-ANCOVA model with adjustment for the baseline value and gender for the comparison of DA-8010 2.5 mg, 5 mg vs. Placebo.
b)
ANCOVA model with adjustment for the baseline value and gender for the comparison of DA-8010 2.5 mg, 5 mg vs. Placebo.
c)
Patient number: (full analysis set; full analysis set-incontinence).