Table 2.
Adverse Event (AE) Reporting Following Injection With The Non-Particulate Bulking Agent Bulkamid®
| AE | Lose et al 200618 (n=21) 12 Months |
Lose et al 201033 (n=135) 12 Months |
Leone Roberti Maggiore et al 201334 (n=82) 12 Months |
Sokol et al 201435 (n=136) 12 Months |
Zivanovic et al 201736 | Krhut et al 201637 12 Months |
|||
|---|---|---|---|---|---|---|---|---|---|
| 1 Month (n=60) |
6 months (n=60) |
12 Months (n=55) |
Previous Rx (n =24) |
No Previous Rx (n=22) |
|||||
| UTI | 10 (47.6%) | 10 (7.4) | 8 (9.8%) | 8 (3.5%) | 3 (5.0%) | 7 (11.7%) | 2 (3.6%) | 2 (8.3%) | 2 (9.1%) |
| Dysuria | 2 (0.9%) | ||||||||
| Urgency | 2 (9.5%) | 2 (0.9%) | |||||||
| de novo urgency | 1 (1.7%) | 2 (3.3%) | 2 (3.6%) | 3 (12.5%) | 3 (13.6%) | ||||
| Post-void residual > 100 mL | 2 (1.5%) | ||||||||
| Urinary retention | 5 (23.8) | 2 (1.5%) | 13 (5.7%) | ||||||
| Voiding dysfunction | 2 (1.5%) | 8 (13.3%) | 5 (8.3%) | 1 (1.8%) | |||||
| Persistent urge incontinence | 12 (20%) | 10 (16.7%) | 11 (20%) | ||||||
| Urge incontinence aggravated | 2 (1.5%) | ||||||||
| de novo urge incontinence | 2 (9.5%) | 2 (1.5%) | 4 (4.8%) | 2 (0.9%) | |||||
| Incomplete bladder emptying | 1 (4.5%) | ||||||||
| Hematuria | 2 (1.5%) | 2 (2.4%) | 3 (1.3%) | 1 (1.7%) | 0 | 0 | 1 (4.2%) | ||
| Injection site pain | 5 (3.7%) | 5 (6.1%) | |||||||
| Implantation site pain | 28 (12.2%) | ||||||||
| Injection site laceration | 1 (0.7%) | 1 (1.7%) | 0 | 0 | |||||
| Vaginal infection/irritation/lichen sclerosis | 1 (0.4%) | ||||||||
| Worsening urinary incontinence | 1 (0.4%) | ||||||||
| Nocturia | 1 (4.8%) | ||||||||
| Other (including headaches, nausea) | 4 (3.0%) | 6 (2.6%) | |||||||
| Implant leakage | 4 (19.0%) | ||||||||
| Hematoma | 1 (1.7%) | 0 | 0 | ||||||
Abbreviations: Rx, radiotherapy; UTI, urinary tract infection.