Table 2.
Adverse events (AEs) associated with MRgFUS procedure. All data shown as frequency (%).
| Adverse Event | N = 101 | |
|---|---|---|
| Grade 1–2 | Grade 3 | |
| Anal/rectal pain | 2 (2.0) | — |
| Bladder spasm | 3 (3.0) | — |
| Bullous dermatitis | 1 (1.0) | — |
| Constipation/bloating | 3 (3.0) | — |
| Deep vein thrombosis | 1 (1.0) | — |
| Diarrhea | 1 (1.0) | — |
| Edema limbs | 2 (2.0) | — |
| Ejaculation disorder | 9 (8.9) | — |
| Erectile dysfunction | 20 (20) | — |
| Fatigue | 8 (7.9) | — |
| Groin/pelvic/suprapubic pain | 3 (3.0) | — |
| Hematospermia | 13 (13) | — |
| Hematuria | 24 (24) | — |
| Hemorrhoidal hemorrhage | 1 (1.0) | — |
| Orchitis | 1 (1.0) | — |
| Paresthesia | 1 (1.0) | — |
| Penile/testicular pain | 13 (13) | — |
| Positional pain | 1 (1.0) | — |
| Proctitis | 1 (1.0) | — |
| Prostatic cyst | 1 (1.0) | — |
| Prostatic pain | 1 (1.0) | — |
| Testicular infection | 1 (1.0) | — |
| Urethral stricture | 1 (1.0) | — |
| Urinary frequency | 9 (8.9) | — |
| Urinary hesitancy | 6 (5.9) | — |
| Urinary incontinence | 18 (18) | — |
| Urinary retention | 15 (15) | — |
| Urinary tract infection | 1 (1.0) | 1 (1.0) |
| Urinary tract pain | 6 (5.9) | — |
| Urinary urgency | 6 (5.9) | — |
| Vertigo | 1 (1.0) | — |
No grade 4 or 5 events occurred in the study population.