Table 2.
Adverse events (AEs) reported according to Clavien-Dindo classification [12]
| Adverse event | Value |
|---|---|
| Intraoperative AEs | 0 (0) |
| Preactivation AEs | |
| Grade I | 7/70 (10.0) |
| AUR | 4 (5.7) |
| Local pain | 2 (2.9) |
| Hematoma | 1 (1.4) |
| Grade II | 6/70 (8.6) |
| Wound infection | 4 (5.7) |
| UTI | 2 (2.9) |
| Grade IIIb (causes of revision) | 5/70 (7.1) |
| Urethral erosion | 2 (2.9) |
| Mechanical dysfunctiona) | 2 (2.9) |
| Device infection | 1 (1.4) |
| Postactivation AEs | |
| Grade I | 3/64 (4.7) |
| AUR | 3 (4.7) |
| Grade II | 1/64 (1.6) |
| UTI | 1 (1.6) |
| Grade IIIb (causes of revision) | 17/64 (26.6) |
| Mechanical dysfunctionb) | 9 (14.0) |
| Urethral erosion | 4 (6.3) |
| Urethral atrophy | 3 (4.7) |
| Device infection | 1 (1.6) |
Values are presented as number (%).
AUR, acute urinary retention; UTI, urinary tract infection.
a)
Pressure-regulating balloon migration/malposition.
b)
Pressure-regulating balloon migration/malposition (n=2), pump malposition (n=3), rupture of pressure-regulating balloon (n=1), other malfunctions not specified (n=3).