Table 3.
Proportion of patients with absolute PVR urine volume by different thresholds, and patients initiating CIC, both overall and by maximum attained PVR urine volume during treatment cycle 1
| Number of prior ACH therapies | Reason for inadequate management | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall pooled | 1 ACH | 2 ACH | ≥ 3 ACH | Insufficient efficacy | Intolerable side effects | ||||||||
| Pbo (n = 514) | OnabotA (n = 526) | Pbo (n = 162) | OnabotA (n = 190) | Pbo (n = 140) | OnabotA (n = 144) | Pbo (n = 211) | OnabotA (n = 190) | Pbo (n = 423) | OnabotA (n = 433) | Pbo (n = 90) | OnabotA (n = 89) | ||
| Proportion of patients with absolute PVR urine volumes at week 12 by different thresholds,n (%) | |||||||||||||
| ≤ 100 ml | 492 (95.7) | 433 (82.3) | 157 (96.9) | 159 (83.7) | 131 (93.6) | 122 (84.7) | 203 (96.2) | 151 (79.5) | 406 (96.0) | 362 (83.6) | 85 (94.4) | 68 (76.4) | |
| > 100 and < 200 ml | 20 (3.9) | 76 (14.4) | 5 (3.1) | 26 (13.7) | 8 (5.7) | 18 (12.5) | 7 (3.3) | 31 (16.3) | 15 (3.5) | 57 (13.2) | 5 (5.6) | 18 (20.2) | |
| ≥ 200 and < 350 ml | 2 (0.4) | 13 (2.5) | 0 (0) | 5 (2.6) | 1 (0.7) | 3 (2.1) | 1 (0.5) | 5 (2.6) | 2 (0.5) | 12 (2.8) | 0 (0) | 1 (1.1) | |
| ≥ 350 ml | 0 (0) | 4 (0.8) | 0 (0) | 0 (0) | 0 (0) | 1 (0.7) | 0 (0) | 3 (1.6) | 0 (0) | 2 (0.5) | 0 (0) | 2 (2.2) | |
| Proportion of patients initiating CIC at any time in treatment cycle 1, n/N (%) | |||||||||||||
| Overall | 2/542 (0.4) | 36/552 (6.5) | 1/173 (0.6) | 8/199 (4.0) | 1/145 (0.7) | 10/148 (6.8) | 0/223 (0) | 17/203 (8.4) | 2/445 (0.4) | 27/454 (5.9) | 0/96 (0) | 8/94 (8.5) | |
| Proportion of patients initiating CIC by maximum attained PVR urine volume at any time in treatment cycle 1, n/N (%) | |||||||||||||
| ≤ 100 ml | 1/477 (0.2) | 1/332 (0.3) | 0/154 (0) | 0/128 (0) | 1/127 (0.8) | 0/92 (0) | 0/195 (0) | 1/113 (0.9) | 1/392 (0.3) | 1/282 (0.4) | 0/84 (0) | 0/47 (0) | |
| > 100 and < 200 ml | 0/60 (0) | 2/161 (1.2) | 0/18 (0) | 1/55 (1.8) | 0/17 (0) | 1/43 (2.3) | 0/26 (0) | 0/61 (0) | 0/49 (0) | 1/126 (0.8) | 0/11 (0) | 1/35 (2.9) | |
| ≥ 200 and < 350 ml | 0/4 (0) | 13/38 (34.2) | NA | 2/11 (18.2) | 0/1 (0) | 2/6 (33.3) | 0/2 (0) | 9/21 (42.9) | 0/3 (0) | 12/32 (37.5) | 0/1 (0) | 1/6 (16.7) | |
| ≥ 350 ml | 1/1 (100.0) | 20/21 (95.2) | 1/1 (100.0) | 5/5 (100.0) | NA | 7/7 (100.0) | NA | 7/8 (87.5) | 1/1 (100.0) | 13/14 (92.9) | NA | 6/6 (100.0) | |
ACH, anticholinergic; CIC, clean intermittent catheterisation; NA, not available; onabotA, onabotulinumtoxinA; pbo, placebo; PVR, postvoid residual.