Table 2.
UUI population | MUI population | |||
---|---|---|---|---|
Placebo (n = 204) | Mirabegron 50 mg (n = 214) | Placebo (n = 122) | Mirabegron 50 mg (n = 139) | |
Urgency episodes/24 h | ||||
Median value at baseline (Q1–Q3) | 4.33 (2.67–6.67) | 4.33 (2.67–6.33) | 3.67 (2.67–5.67) | 4.33 (2.67–6.33) |
Estimate of the median change (95% two‐sided CI)† | −1.83 (−2.17, −1.5) | −2.50 (−2.83, −2.17) | −1.67 (−2.17, −1.17) | −2.17 (−2.50, −1.83) |
Difference in median change versus placebo (95% two‐sided CI)† | −0.67 (−1.00, −0.33) | −0.50 (−1.00, −0.00) | ||
Two‐sided P‐value‡ | 0.002 | 0.266 | ||
Incontinence episodes/24 h | ||||
Median value at baseline (Q1–Q3) | 1.33 (0.67–2.33) | 1.67 (1.00–2.67) | 1.67 (0.67–2.33) | 1.33 (0.67–3.00) |
Estimate of the median change (95% two‐sided CI)† | −0.67 (−0.83, −0.50) | −1.00 (−1.17, −1.00) | −0.67 (−0.83, −0.50) | −1.17 (−1.33, −1.00) |
Difference in median change versus placebo (95% two‐sided CI)† | −0.33 (−0.67, 0.00) | −0.50 (−0.67, −0.33) | ||
Two‐sided P‐value‡ | 0.002 | <0.001 | ||
Mean voided volume/micturition | ||||
Median value at baseline (Q1–Q3) | 143.261 (117.742–176.875) | 141.584 (114.211–180.789) | 140.769 (117.000–179.531) | 148.267 (120.962–185.000) |
Estimate of the median change (95% two‐sided CI)† | 6.303 (2.244–10.439) | 25.619 (21.144–30.070) | 14.578 (8.301–20.685) | 24.839 (19.476–30.837) |
Difference in median change versus placebo (95% two‐sided CI)† | 19.203 (13.121–25.285) | 10.973 (3.363–18.583) | ||
Two‐sided P‐value‡ | <0.001 | 0.005 | ||
Nocturia episodes/night | ||||
Median value at baseline (Q1–Q3) | 1.50 (1.00–2.00) | 1.50 (1.00–2.50) | 1.50 (1.00–2.50) | 1.50 (1.00–2.00) |
Estimate of the median change (95% two‐sided CI)† | −0.25 (−0.50, −0.25) | −0.50 (−0.50, −0.25) | −0.25 (−0.50, 0.00) | −0.50 (−0.50, −0.25) |
Difference in median change versus placebo (95% two‐sided CI)† | 0.00 (0.00, 0.00) | −0.25 (−0.50, 0.00) | ||
Two‐sided P‐value‡ | 0.588 | 0.030 |
The Hodges–Lehmann method was used to obtain an estimate in the median (and 95% CI) change.
Ranked ancova (vs placebo).