Table 2.
Change from baseline in the efficacy measures evaluated by the diary up to post‐treatment week 12 (FAS population)
| Adjusted mean change from baseline ± SE | Difference vs placebo (95% CI) | P‐value | ||
|---|---|---|---|---|
| Placebo, n = 124 | BoNTA 100 U, n = 124 | |||
| No. daily UI episodes† | ||||
| Week 2 | −1.18 ± 0.372 | −3.24 ± 0.379 | −2.06 (−3.03, −1.09) | <0.001 |
| Week 6 | −1.20 ± 0.374 | −3.64 ± 0.382 | −2.44 (−3.41, −1.46) | <0.001 |
| Week 12 | −1.25 ± 0.375 | −3.42 ± 0.381 | −2.16 (−3.14, −1.18) | <0.001 |
| No. daily UUI episodes† | ||||
| Week 2 | −0.99 ± 0.353 | −3.17 ± 0.360 | −2.18 (−3.10, −1.26) | <0.001 |
| Week 6 | −1.02 ± 0.362 | −3.46 ± 0.369 | −2.44 (−3.39, −1.49) | <0.001 |
| Week 12 | −1.02 ± 0.363 | −3.13 ± 0.370 | −2.12 (−3.07, −1.17) | <0.001 |
| No. daily micturitions‡ | ||||
| Week 2 | −0.44 ± 0.307 | −0.58 ± 0.312 | −0.14 (−0.94, 0.65) | 0.723 |
| Week 6 | −0.29 ± 0.297 | −1.78 ± 0.303 | −1.49 (−2.25, −0.72) | <0.001 |
| Week 12 | −0.42 ± 0.306 | −1.87 ± 0.311 | −1.45 (−2.24, −0.66) | <0.001 |
| No. daily urgency episodes‡ | ||||
| Week 2 | −1.20 ± 0.432 | −2.10 ± 0.442 | −0.90 (−2.02, 0.21) | 0.112 |
| Week 6 | −1.47 ± 0.429 | −3.32 ± 0.440 | −1.85 (−2.96, −0.74) | 0.001 |
| Week 12 | −1.17 ± 0.419 | −3.40 ± 0.429 | −2.23 (−3.31, −1.16) | <0.001 |
| No. daily nocturia episodes‡ | ||||
| Week 2 | −0.05 ± 0.111 | −0.10 ± 0.113 | −0.05 (−0.33, 0.24) | 0.751 |
| Week 6 | −0.08 ± 0.115 | −0.28 ± 0.118 | −0.19 (−0.49, 0.11) | 0.209 |
| Week 12 | 0.03 ± 0.125 | −0.30 ± 0.127 | −0.33 (−0.66, 0.00) | 0.048 |
| Volume voided per micturition (mL)‡ | ||||
| Week 2 | 5.40 ± 4.105 | 15.17 ± 4.175 | 9.78 (−0.77, 20.33) | 0.069 |
| Week 6 | 2.31 ± 4.535 | 30.26 ± 4.624 | 27.96 (16.08, 39.84) | <0.001 |
| Week 12 | −0.22 ± 4.329 | 29.47 ± 4.390 | 29.69 (18.47, 40.91) | <0.001 |
†
MMRM with treatment, site, visit, treatment‐by‐visit interaction, baseline value and baseline‐by‐visit interaction as fixed effects.
‡
MMRM with treatment, site, visit, baseline UUI episodes over the 3‐day diary (≤9 or ≥10), treatment‐by‐visit interaction, baseline value and baseline‐by‐visit interaction as fixed effects.