Table 1 Patient demographics, OAB characteristics, and baseline PROs
| Â | Period 1 | Total | ||||
|---|---|---|---|---|---|---|
|  | M/T (n = 154) | T/M (n = 144) | M/M (n = 30) | T/T (n = 30) | Mirabegrona (n = 316) | Tolterodinea (n = 310) |
Women, n (%) | 116 (75.3) | 108 (75.0) | 18 (60.0) | 20 (66.7) | 232 (73.4) | 233 (75.2) |
Mean (SD) age, years | 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) |
Mean (SD) BMI (kg/m2) | 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 | N = 154 | N = 144 | N = 30 | N = 30 | N = 341 | N = 336 |
Mean duration of OAB, months (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) |
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) |
Baseline PROs | N = 154 | N = 144 | N = 30 | N = 30 | N = 337 | N = 336 |
Premedication OAB-S scales, mean (SE) | ||||||
 Impact on Daily Living with OAB | 44.71 (2.37) | 48.36 (2.38) [n = 143] | 40.50 (5.50) | 47.33 (5.15) | 51.49 (1.67) | 53.78 (1.60) [n = 335] |
 Overall Assessment of Interruption of Day-to-Day Life Due to OAB | 1.69 (0.07) | 1.67 (0.07) [n = 143] | 1.57 (0.14) | 1.77 (0.19) | 1.95 (0.06) | 2.01 (0.06) [n = 335] |
OAB-q scales and PPBC, mean (SE) | ||||||
 Symptom Bother (0–100; higher score indicates greater bother) | 61.20 (1.65) | 60.83 (1.62) | 66.83 (3.79) | 59.83 (3.94) | 52.67 (1.28) | 51.14 (1.28) |
 Coping (0–100; higher score indicates improvement) | 48.04 (2.25) | 51.89 (2.23) | 47.50 (6.01) | 53.58 (4.58) | 56.98 (1.59) | 59.96 (1.52) |
 Concern (0–100; higher score indicates improvement) | 51.54 (1.97) | 51.57 (2.04) | 50.86 (4.74) | 56.67 (4.30) | 59.86 (1.42) | 61.60 (1.41) |
 Sleep (0–100; higher score indicates improvement) | 40.99 (2.13) | 44.53 (2.23) | 37.20 (4.63) | 48.53 (5.27) | 51.09 (1.59) | 52.44 (1.54) |
 Social Interaction (0–100; higher score indicates improvement) | 75.45 (2.05) | 77.44 (2.00) | 70.00 (4.71) | 76.53 (4.41) | 78.86 (1.33) | 80.54 (1.28) |
 HRQL total (0–100; higher score indicates better QoL) | 53.09 (1.83) | 55.44 (1.88) | 50.88 (4.69) | 58.03 (4.15) | 60.99 (1.34) | 63.03 (1.31) |
 PPBC (1–6; higher score indicates deterioration in bladder condition) | 4.51 (0.08) | 4.54 (0.09) [n = 143] | 4.47 (0.21) | 4.40 (0.15) | 4.20 (0.06) | 4.16 (0.06) [n = 335] |