Table 1.
Baseline characteristics, by population (FAS)
| UUI population | MUI population | |||
|---|---|---|---|---|
| Placebo (n = 204) | Mirabegron 50 mg (n = 214) | Placebo (n = 122) | Mirabegron 50 mg (n = 139) | |
| Mean age, years (SD) | 58.3 (13.4) | 57.9 (14.0) | 59.4 (11.3) | 58.8 (12.3) |
| Median | 60.0 | 59.5 | 61.0 | 60.0 |
| Q1–Q3 | 47.0–68.5 | 48.0–69.0 | 51.0–67.0 | 48.0–69.0 |
| Age group, n (%) | ||||
| <65 years | 122 (59.8) | 133 (62.1) | 78 (63.9) | 92 (66.2) |
| ≥65 years | 82 (40.2) | 81 (37.9) | 44 (36.1) | 47 (33.8) |
| Mean weight, kg (SD) | 53.51 (7.88) | 53.74 (8.85) | 55.28 (9.27) | 56.17 (10.19) |
| Median | 53.00 | 52.40 | 54.45 | 54.80 |
| Q1–Q3 | 48.95–57.0 | 47.90–58.0 | 49.00–59.50 | 49.00–61.50 |
| Mean height, cm (SD) | 155.25 (6.40) | 155.22 (6.17) | 154.11 (6.30) | 153.96 (5.78) |
| Median | 155.40 | 155.00 | 154.00 | 154.00 |
| Q1–Q3 | 151.0–159.75 | 151.0–159.40 | 150.0–158.0 | 150.0–158.0 |
| Mean duration of illness, months† (SD) | 81.9 (95.6) | 74.7 (69.5) | 68.9 (53.0) | 83.2 (75.4) |
| Median | 55.0 | 55.0 | 52.5 | 57.0 |
| Q1–Q3 | 33.0–93.0 | 33.0–93.0 | 32.5–95.0 | 34.0–104.0 |
| OAB severity (mean no. micturitions/24 h), n (%) | ||||
| <10 | 65 (31.9) | 64 (29.9) | 39 (32.0) | 46 (33.1) |
| ≥10 to <15 | 127 (62.3) | 134 (62.6) | 78 (63.9) | 75 (54.0) |
| ≥15 | 12 (5.9) | 16 (7.5) | 5 (4.1) | 18 (12.9) |
| Mean PVR urine volume, mL (SD) | 9.68 (13.54) | 8.20 (14.01) | 7.05 (14.22) | 10.14 (13.85) |
| Median | 4.80 | 2.55 | 0.65 | 4.70 |
| Q1–Q3 | 0–14.00 | 0–10.20 | 0–8.40 | 0–14.50 |
| Medical history, n (%) | ||||
| No | 177 (86.8) | 180 (84.1) | 101 (82.8) | 116 (83.5) |
| Yes | 27 (13.2) | 34 (15.9) | 21 (17.2) | 23 (16.5) |
| Complications, n (%) | ||||
| No | 52 (25.5) | 60 (28.0) | 27 (22.1) | 31 (22.3) |
| Yes | 152 (74.5) | 154 (72.0) | 95 (77.9) | 108 (77.7) |
| Previous medications, n (%) | ||||
| No | 76 (37.3) | 78 (36.4) | 49 (40.2) | 60 (43.2) |
| Yes | 128 (62.7) | 136 (63.6) | 73 (59.8) | 79 (56.8) |
| Concomitant medications, n (%) | ||||
| No | 61 (29.9) | 62 (29.0) | 31 (25.4) | 38 (27.3) |
| Yes | 143 (70.1) | 152 (71.0) | 91 (74.6) | 101 (72.7) |
| Mean no. micturitions/24 h (SD) | 11.21 (2.47) | 11.48 (2.67) | 11.10 (2.16) | 11.49 (2.76) |
| Min–max | 8.0–21.3 | 7.7–23.3 | 8.0–18.0 | 8.0–21.3 |
| Median | 11.00 | 11.00 | 10.67 | 10.67 |
| Q1–Q3 | 9.33–12.50 | 9.33–13.00 | 9.67–12.33 | 9.33–13.00 |
| Mean no. urgency episodes/24 h (SD) | 4.85 (2.80) | 5.11 (3.09) | 4.38 (2.67) | 4.89 (3.10) |
| Min–max | 1.0–14.3 | 1.0–15.7 | 1.0–13.7 | 1.0–16.0 |
| Median | 4.33 | 4.33 | 3.67 | 4.33 |
| Q1–Q3 | 2.67–6.67 | 2.67–6.33 | 2.67–5.67 | 2.67–6.33 |
| Mean no. incontinence episodes/24 h (SD) | 1.88 (1.71) | 2.07 (1.86) | 1.86 (1.79) | 2.24 (2.64) |
| Min–max | 0.3–9.7 | 0.3–12.7 | 0.3–12.0 | 0.3–21.0 |
| Median | 1.33 | 1.67 | 1.67 | 1.33 |
| Q1–Q3 | 0.67–2.33 | 1.00–2.67 | 0.67–2.33 | 0.67–3.00 |
| Mean no. urge incontinence episodes/24 h (SD [n]) | 1.67 (1.37) [196] | 1.85 (1.70) [204] | 1.54 (1.39) [118] | 2.02 (2.29) [135] |
| Min–max | 0.3–7.7 | 0.3–12.7 | 0.3–6.7 | 0.3–15.7 |
| Median | 1.33 | 1.33 | 1.17 | 1.33 |
| Q1–Q3 | 0.67–2.33 | 0.67–2.33 | 0.67–2.00 | 0.67–2.67 |
| Mean voided volume/micturition, mL (SD [n]) | 149.4 (43.9) [203] | 148.3 (45.0) [214] | 148.5 (43.1) [121] | 153.6 (51.1) [138] |
| Min–max | 56.46–282.80 | 50.00–276.00 | 60.43–275.00 | 45.67–332.08 |
| Median | 143.261 | 141.584 | 140.769 | 148.267 |
| Q1–Q3 | 117.742–176.875 | 114.211–180.789 | 117.000–179.531 | 120.962–185.000 |
| Mean no. nocturia episodes (SD [n]) | 1.76 (1.19) [175] | 1.71 (0.97) [197] | 1.76 (1.12) [108] | 1.61 (1.03) [119] |
| Min–max | 0.5–6.5 | 0.5–5.0 | 0.5–5.5 | 0.5–5.0 |
| Median | 1.50 | 1.50 | 1.50 | 1.50 |
| Q1–Q3 | 1.00–2.00 | 1.00–2.50 | 1.0–2.50 | 1.0–2.00 |
| QOL analysis set, mean (SD) of KHQ domain score | n = 201 | n = 211 | n = 121 | n = 136 |
| D1: general health perception | 32.8 (18.6) | 31.2 (19.3) | 33.5 (19.2) | 32.5 (17.0) |
| D2: incontinence impact | 52.9 (28.2) | 51.8 (26.6) | 44.9 (24.6) | 46.8 (29.4) |
| D3: role limitations | 39.4 (26.1) | 36.2 (26.0) | 37.5 (23.6) | 38.5 (26.2) |
| D4: physical limitations | 40.2 (27.5) | 38.1 (27.8) | 42.7 (25.4) | 41.7 (29.4) |
| D5: social limitations | 21.1 (23.5) | 20.8 (23.6) | 20.4 (22.2) | 21.2 (23.8) |
| D6: personal relationships [n] | 9.4 (17.9) [153] | 11.7 (20.4) [157] | 6.9 (13.3) [92] | 10.5 (21.4) [106] |
| D7: emotions | 42.7 (28.3) | 39.7 (25.6) | 41.2 (26.2) | 37.2 (26.4) |
| D8: sleep/energy | 31.8 (26.2) | 30.9 (23.4) | 31.5 (25.7) | 27.5 (24.8) |
| D9: severity measures | 36.4 (19.9) | 36.7 (18.2) | 36.3 (18.2) | 37.6 (21.9) |
†
For the UUI population, n = 203 for placebo, n = 209 for mirabegron 50 mg. For the MUI population, n = 120 for placebo, n = 134 for mirabegron 50 mg.