Table 2.
Complications of BoNT-A and placebo
| Adverse event | BoNT-A | Placebo | P-valuea) |
|---|---|---|---|
| Symptomatic UTI | 432/861 (50.17) | 160/425 (37.65) | 0.00002 |
| Urinary retention | 150/732 (20.49) | 15/409 (3.67) | 0.00000 |
| Hematuria | 57/861 (6.62) | 15/425 (3.53) | 0.02334 |
| Diarrhea | 41/732 (5.60) | 19/409 (4.65) | 0.48799 |
| Nausea | 40/732 (5.46) | 8/409 (1.96) | 0.00464 |
| Constipation | 38/732 (5.19) | 18/409 (4.40) | 0.55348 |
| Pyrexia | 38/761 (4.99) | 16/396 (4.04) | 0.34073 |
| Fatigue | 35/704 (4.97) | 13/380 (3.42) | 0.23639 |
| Headache | 34/732 (4.64) | 15/409 (3.67) | 0.43487 |
| Autonomic dysreflexia | 29/776 (3.74) | 2/380 (0.53) | 0.00150 |
Values are presented as number (%).
BoNT-A, onabotulinumtoxinA; UTI, urinary tract infection.
a)
P-values were the outcomes of the chi-square tests for independence of each adverse event between the 2 groups.