Table 1.
Demographics and baseline OAB characteristics of the full analysis set in period 1 of each sequence, and in the total treatment groups
| Period 1 | Total | |||||
|---|---|---|---|---|---|---|
| M/T (n = 154) | T/M (n = 144) | M/M (n = 30) | T/T (n = 30) | Mirabegron (n = 316a) | Tolterodine (n = 310a) | |
| Women, n (%) | 116 (75.3) | 108 (75.0) | 18 (60.0) | 20 (66.7) | 232 (73.4) | 233 (75.2) |
| Age (years), mean (SD) | 53.5 (14.8) | 52.3 (12.6) | 59.0 (13.1) | 54.9 (14.8) | 53.4 (13.9) | 53.2 (13.7) |
| Age group, n (%) | ||||||
| <65 years | 117 (76.0) | 120 (83.3) | 20 (66.7) | 21 (70.0) | 247 (78.2) | 243 (78.4) |
| ≥65 years | 37 (24.0) | 24 (16.7) | 10 (33.3) | 9 (30.0) | 69 (21.8) | 67 (21.6) |
| Race, n (%) | ||||||
| White | 123 (79.9) | 116 (80.6) | 24 (80.0) | 24 (80.0) | 253 (80.1) | 248 (80.0) |
| Black/African American | 28 (18.2) | 23 (16.0) | 4 (13.3) | 5 (16.7) | 53 (16.8) | 53 (17.1) |
| Asian | 2 (1.3) | 4 (2.8) | 1 (3.3) | 1 (3.3) | 7 (2.2) | 7 (2.3) |
| American Indian/Alaska native | 0 | 1 (0.7) | 0 | 0 | 1 (0.3) | 1 (0.3) |
| Other | 1 (0.6) | 0 | 1 (3.3) | 0 | 2 (0.6) | 1 (0.3) |
| Ethnicity, n (%) | ||||||
| Hispanic/Latino | 33 (21.4) | 24 (16.7) | 8 (26.7) | 6 (20.0) | 65 (20.6) | 61 (19.7) |
| Not Hispanic/Latino | 121 (78.6) | 120 (83.3) | 22 (73.3) | 24 (80.0) | 251 (79.4) | 249 (80.3) |
| Body mass index (kg/m2), mean (SD) | 28.75 (6.65) | 29.96 (7.10) | 31.25 (8.49) | 31.64 (10.98) | 29.56 (7.08) | 29.70 (7.45) |
| OAB characteristics | ||||||
| No. of patients | 154 | 144 | 30 | 30 | 341 | 336 |
| Duration of OAB (months), mean (SD) | 81.85 (74.34) | 75.11 (99.13) | 74.06 (84.98) | 67.16 (59.96) | 76.98 (86.66) | 77.57 (84.62) |
| Type of OAB, n (%) | ||||||
| Urgency incontinence only | 65 (42.2) | 55 (38.2) | 12 (40.0) | 14 (46.7) | 139 (40.8) | 140 (41.7) |
| Mixed stress/urgency incontinence with urgency as predominant factor | 53 (34.4) | 50 (34.7) | 10 (33.3) | 8 (26.7) | 116 (34.0) | 112 (33.3) |
| Frequency/urgency without incontinence | 36 (23.4) | 39 (27.1) | 8 (26.7) | 8 (26.7) | 86 (25.2) | 84 (25.0) |
| Number of episodes/24 h, mean (SD) | ||||||
| Incontinence | 3.15 (4.22) | 3.19 (4.62) | 3.80 (5.25) | 3.74 (5.10) | 2.71 (4.25) [n = 336] | 2.67 (4.18) [n = 334] |
| Urgency incontinence | 2.86 (4.19) | 2.77 (4.31) | 3.71 (5.28) | 3.54 (4.96) | 2.34 (4.02) [n = 336] | 2.27 (3.95) [n = 334] |
| Micturitions | 11.25 (2.64) | 11.65 (3.75) | 12.77 (2.68) | 11.81 (2.52) | 10.34 (3.37) [n = 336] | 10.08 (3.86) [n = 334] |
| Urgency (grade 3 or 4) | 5.34 (4.11) | 5.65 (4.73) | 6.26 (4.54) | 5.93 (4.34) | 4.39 (4.31) [n = 336] | 4.23 (4.46) [n = 334] |
| Nocturia | 1.64 (1.04) | 1.52 (0.97) | 2.26 (1.05) | 1.60 (1.18) | 1.62 (1.04) [n = 277] | 1.47 (1.00) [n = 280] |
| Incontinent patients at baseline of period 1, n (%) | ||||||
| Wet | 117 (76.0) | 98 (68.1) | 24 (80.0) | 22 (73.3) | 250 (73.3) | 241 (71.7) |
| Dry | 37 (24.0) | 46 (31.9) | 6 (20.0) | 8 (26.7) | 91 (26.7) | 95 (28.3) |
| Previous non-drug treatment, n (%) | ||||||
| Yes | 6 (3.9) | 6 (4.2) | 1 (3.3) | 3 (10.0) | 11 (3.2) | 17 (5.1) |
| No | 148 (96.1) | 138 (95.8) | 29 (96.7) | 27 (90.0) | 330 (96.8) | 319 (94.9) |
OAB Overactive bladder
aPatients with the same treatment in two different periods (sequences M/M and T/T) are counted once