Table 4.
Adverse Events Reported for Unique Cohorts of Men Treated with Transurethral Ultrasound Ablation
| Cancer indication | Primary prostate cancer | Recurrent prostate cancer | Locally advanced PCa | ||||
|---|---|---|---|---|---|---|---|
| Study (N) | Chin11 (30) (N = 30)a | Klotz8 (N = 115)a | Anttinen14 (N = 6)b | Lumiani10 (N = 47)b(subgroup) | Lumiani10 (N = 5)b(subgroup) | Anttinen15 (N = 11)b | Anttinen16 (N = 10)b |
| Urinary tract infection | 10 (33%) G2 | 40 (25%) G2 3 (3%) G3 |
1 (2.1%) C-D I | 1 (20%) C-D I | 4 (36%) | 3 (30%) C-D I 2 (20%) C-D II |
|
| Epididymitis | 1 (3.3%) G3 | 6 (5%) G2 2 (1%) G3 |
1 (2.1%) C-D I | ||||
| Urethral stricture/bladder outlet obstruction | 1 (3.3%) G1 1 (3.3%) G2 |
1 (1%) G1 2 (2%) G3 |
1 (2.1%) C-D IIIa, TURP for BOO from persistent BPH | ||||
| Urinary retention | 3 (10%) G1 5 (17%) G2 |
9 (7%) G2 2 (2%) G3 |
6 (13%) C-D I | 2 (18%) C-D II 1 (9.1%) C-D III, SPC and Double-J stents |
|||
| Urinary incontinence | 1 (3.3%) G1 3 (10%) G2 At 12 months: 1/30 (3.3%) G1 (no pads) |
21 (17%) G1 7 (6.0%) G2 At 12 months: 3 (2.6%) G2 |
|||||
| Hematuria | 13 (43%) G1 2 (6.7%) G2 |
43 (35%) G1 2 (2%) G2 |
1 (2.1%) C-D I | ||||
| Nocturia | 1 (2.1%) C-D IIIa, cystoscopy to evaluate residual prostate tissue, self-resolved after 3 months | ||||||
| Pain/discomfort (bladder, urinary tract) | 4 (3%) G1 4 (3%) G2 1 (1%) G3 |
||||||
| Urethral calculus | 1 (1%) G3 | ||||||
| Urinoma | 1 (1%) G3 | ||||||
| Rectal injury or fistula | 0 | 0 | 0 | 0 | 0 | 0 | |
| Classification | G3: 1 (3.3%) G4: 0 |
G3: 9 men (7.8%) G4: 0 |
Nil. | C-D IIIa: 2 (4.2%) C-D IIIb: 0 C-D IV: 0 |
C-D III: 0 C-D IV: 0 |
C-D III: 1 (9.1%) | C-D III: 0 C-D IV: 0 |
| Length of catheterization median (IQR), and type | 2.2 (2.0–3.3) weeks, SPC | 17 (11–24) days, SPC | 2–3 days, Foley | 2 weeks, for 48/52 (88%) of men, SPC | 7 days (1–14) median (IQR). Foley: 9/11 SPC: 2/11 |
N/A | |
Complications of any grade that are reported in more than one study, and all Grade III complications are listed. The number of events is reported for all studies except Chin et al.11 2016 (no. of men). Percentages are the proportion of men incurring ≥1 adverse event relative to the number of men enrolled in the study. In the FU reports, no new serious or severe adverse events were reported up to 5 years. Adverse events for the subgroup analysis in Elterman et al.17 2021 study are included in Chin et al.11 2016, and Lumiani et al.10 2021 includes adverse events for the subgroup of men treated for PCa concurrent with LUTS.
Common Terminology Criteria for Adverse Events classification system.
Clavien–Dindo classification system.
BOO = bladder outlet obstruction; C-D = Clavien–Dindo; G = grade; GA = general anesthesia; SPC = suprapubic catheter; TURP = transurethral resection of the prostate.