The full analysis set (FAS) consisted of 231 patients that were randomized (116 and 115 patients in the TAS-303 and placebo groups, respectively). The mean age of the TAS-303 and placebo groups were 53.9 and 54.1 years, respectively. A total of 106 (91.4 %) patients in the TAS-303 group and 107 (93.0 %) in the placebo group were diagnosed with SUI. The mean SUIEF per 24 hours at baseline was 2.009 and 2.126 in the TAS-303 and placebo groups, respectively. The percent change in mean SUIEF per 24 hours at week 12 in the FAS were -58.48 % and -46.70 % in the TAS-303 and placebo groups, respectively (P value=0.022, Student's t-test) (Figure 1). The percent change in mean SUIEF per 24 hours at week 12 from the mean SUIEF ≥ 2 per 24 hours at baseline were -59.28 % and -40.53 % in the TAS-303 and placebo groups, respectively (Figure 2). In the subgroup with the higher baseline SUIEF, the percent change of SUIEF in the TAS-303 group was similar to that of the overall population, but smaller in the placebo group.
The percent change in mean SUIEF per 24 hours at week 12 in per mean SUIEF (1–1.5, 1.5–2, 2–3, 3–4, 4–5, 5 ≤ ) were -59.40 %, -53.19 %, -59.86 %, -59.93 %, -45.87 %, and -73.90 % in the TAS-303 group, respectively, and -47.37 %, -62.64 %, -47.81 %, -46.25 %, -17.93 %, and -7.52 % in the placebo group, respectively. The percent change in mean SUIEF per 24 hours at week 12 in the 24-hour pad test severity (none: 0–4.4 g, mild: 4.4–20 g, moderate: > 20–75 g, severe: > 75 g) were -63.77 %, -55.21 %, -56.08 %, and -81.51 % in the TAS-303 group, and -49.04 %, -49.87 %, -37.02 %, and -20.76 % in the placebo group. A more detailed analysis of SUI severity showed that the TAS-303 group was as effective as the overall population, regardless of severity of SUI. Whereas, the placebo group showed a smaller effect in the severe population.
The percent change in mean SUIEF per 24 hours at week 12 in patients aged ≥ 60 years were -67.46 % and -49.36 % in the TAS-303 and placebo groups, respectively. Compared to the overall population, the difference between the TAS-303 and placebo groups widened in the elderly population.