Table 3.
Comparisons of the changes from baseline of clinical and bladder diary parameters between the daytime and nighttime dosing groups (n = 109).
| Variables | 4 weeks | 12 weeks | ||||
|---|---|---|---|---|---|---|
| Daytime (n = 52)† | Nighttime (n = 57)† | p‡ | Daytime (n = 40)† | Nighttime (n = 46)† | p‡ | |
| Systolic blood pressure (mmHg) | − 1.2 ± 23.9 | − 5.8 ± 17.0* | 0.30 | 4.6 ± 39.9 | − 10.0 ± 20.1** | 0.07 |
| Diastolic blood pressure (mmHg) | − 3.1 ± 9.7* | − 1.7 ± 10.5 | 0.51 | 6.0 ± 21.8 | − 5.2 ± 17.3 | 0.03 |
| Heart rate (beat per minutes) | 1.1 ± 10.9 | 1.4 ± 14.4 | 0.90 | 7.3 ± 28.6 | − 0.8 ± 18.6 | 0.20 |
| USS (0–4) | − 0.8 ± 1.3** | − 0.6 ± 1.2** | 0.56 | − 1.1 ± 1.2** | − 0.8 ± 1.2** | 0.33 |
| OABSS (0–15) | − 2.2 ± 3.5** | − 1.7 ± 3.2** | 0.43 | − 1.9 ± 2.9** | − 1.7 ± 2.6** | 0.76 |
| OABSS Q2 (i.e., nocturia) (0–3) | − 0.13 ± 0.71 | − 0.35 ± 0.70** | 0.12 | − 0.40 ± 1.00* | − 0.73 ± 1.28** | 0.24 |
| Voiding episodes (72 h) | ||||||
| 06:00–12:00 | − 0.9 ± 4.1 | − 1.2 ± 4.6 | 0.74 | − 0.0 ± 4.3 | − 2.0 ± 3.7** | 0.06 |
| 12:00–18:00 | − 1.7 ± 5.1 | − 0.1 ± 6.0 | 0.21 | − 1.4 ± 4.1 | − 1.8 ± 3.4** | 0.69 |
| 18:00–24:00 | − 0.0 ± 3.9 | − 0.3 ± 5.4 | 0.82 | − 1.1 ± 2.9* | − 1.1 ± 3.8 | 0.98 |
| 24:00–06:00 | − 0.1 ± 4.4 | − 0.5 ± 4.1 | 0.70 | − 0.8 ± 2.9 | − 1.4 ± 1.9** | 0.40 |
| All day | − 2.8 ± 12.0 | − 3.0 ± 11.6 | 0.95 | − 4.2 ± 7.3* | − 5.4 ± 8.7** | 0.57 |
| Urgency episodes (72 h) | ||||||
| 06:00–12:00 | 0.1 ± 2.4 | − 2.1 ± 3.7** | 0.003 | − 0.3 ± 3.6 | − 1.3 ± 3.4 | 0.32 |
| 12:00–18:00 | − 0.5 ± 3.4 | − 2.0 ± 4.1** | 0.09 | − 1.2 ± 4.4 | − 1.4 ± 3.4* | 0.88 |
| 18:00–24:00 | 0.4 ± 2.7 | − 1.4 ± 3.0** | 0.01 | − 0.6 ± 2.4 | − 0.6 ± 2.7 | 0.99 |
| 24:00–06:00 | − 0.1 ± 2.2 | − 0.6 ± 2.5 | 0.19 | − 0.8 ± 2.9 | − 1.1 ± 1.6** | 0.58 |
| All day | 0.1 ± 8.5 | − 6.4 ± 10.8** | 0.005 | − 3.1 ± 8.4 | − 4.2 ± 12.0** | 0.70 |
| Incontinence episodes (72 h) | ||||||
| 06:00–12:00 | − 0.0 ± 1.2 | − 0.0 ± 1.6 | 0.82 | − 0.1 ± 1.0 | − 0.4 ± 0.8 | 0.24 |
| 12:00–18:00 | − 0.4 ± 1.4 | − 0.1 ± 1.1 | 0.27 | − 0.2 ± 1.6 | − 0.1 ± 0.5 | 0.70 |
| 18:00–24:00 | − 0.4 ± 0.9* | − 0.2 ± 1.4 | 0.50 | − 0.3 ± 1.0 | − 0.3 ± 0.7 | 0.92 |
| 24:00–06:00 | − 0.1 ± 0.9 | 0.2 ± 0.3 | 0.35 | − 0.4 ± 1.2 | 0.0 ± 0.3 | 0.06 |
| All day | − 1.0 ± 3.2 | − 0.2 ± 3.8 | 0.38 | − 1.0 ± 2.3 | − 0.9 ± 2.5** | 0.83 |
| Nocturia episodes (72 h)§ | − 0.63 ± 3.12 | − 1.39 ± 2.64* | 0.41 | − 1.00 ± 2.53 | − 2.25 ± 3.72 | 0.36 |
| Fluid intake (mL/72 h) | ||||||
| 06:00–12:00 | − 75 ± 645 | 34 ± 965 | 0.58 | 118 ± 919 | − 95 ± 902 | 0.39 |
| 12:00–18:00 | − 75 ± 898 | − 14 ± 965 | 0.78 | 46 ± 839 | − 85 ± 926 | 0.59 |
| 18:00–24:00 | 158 ± 731 | − 227 ± 907 | 0.053 | − 7 ± 529 | − 245 ± 751 | 0.18 |
| 24:00–06:00 | − 106 ± 733 | 59 ± 559 | 0.27 | − 136 ± 618 | − 28 ± 329 | 0.42 |
| All day | − 117 ± 2107 | − 76 ± 2280 | 0.94 | − 112 ± 1717 | − 349 ± 1505 | 0.59 |
| Total voided volume (mL/72 h) | ||||||
| 06:00–12:00 | 18 ± 1087 | 2 ± 862 | 0.94 | 234 ± 976 | 37 ± 914 | 0.43 |
| 12:00–18:00 | − 183 ± 1099 | 102 ± 1138 | 0.28 | 45 ± 833 | − 46 ± 615 | 0.64 |
| 18:00–24:00 | 30 ± 812 | − 67 ± 1568 | 0.75 | − 40 ± 837 | − 1 ± 751 | 0.85 |
| 24:00–06:00 | 272 ± 959 | 95 ± 904 | 0.42 | 83 ± 804 | − 236 ± 627 | 0.10 |
| All day | 136 ± 2473 | 213 ± 3179 | 0.91 | 421 ± 2186 | − 325 ± 1928 | 0.17 |
| Voided volume per micturition (mL) | ||||||
| 06:00–12:00 | 29 ± 95 | 43 ± 87** | 0.51 | 39 ± 90 | 68 ± 70** | 0.18 |
| 12:00–18:00 | − 3 ± 109 | 16 ± 103 | 0.44 | 25 ± 132 | 26 ± 62* | 0.98 |
| 18:00–24:00 | − 23 ± 141 | 18 ± 156 | 0.25 | 8 ± 127 | 23 ± 58* | 0.57 |
| 24:00–06:00 | 56 ± 163 | 87 ± 193* | 0.48 | 87 ± 151 | 24 ± 81 | 0.09 |
OABSS, Overactive bladder symptoms score; USS, Urgency severity scale.
†By paired t test. *p < 0.05; **p < 0.01.
‡By paired t test.
Changes are calculated as the subtraction of pre-treatment values from post-treatment values, and expressed as the mean ± standard deviation.
§Only 16 women in the daytime group and 23 in the nighttime group have paired data about nocturia at 4 weeks. Only 11 women in the daytime group and 12 in the nighttime group have paired data about nocturia at 12 weeks.