Table 2. Efficacy and Safety Outcomes in Patients Undergoing High-Frequency Irreversible Electroporation.
| Outcomes | No. | % (95% CI) |
|---|---|---|
| 6-mo Biopsy (n = 100) | ||
| Median No. of cores | 14 | NA |
| Clinically significant prostate cancer | 6 | 6 (2.2 to 12.6) |
| Any cancer | 14 | 14 (7.9 to 22.4) |
| Gleason score | ||
| 3 + 3 | 12 | 12 (6.4 to 20.0) |
| 4 + 3 | 2 | 2 (0.2 to 7.0) |
| Complications (n = 109) | ||
| No. of patients | 29 | 26.6 (18.6 to 35.9) |
| No. of events | 41 | 37.6 (28.5 to 47.4) |
| Clavien-Dindo gradea | ||
| I | 33 | 30.3 (21.8 to 39.8) |
| II | 7 | 6.4 (2.6 to 12.8) |
| III | 1 | 0.9 (0 to 5.0) |
| Type | ||
| Abnormal white blood cell in urine | 26 | 23.9 (16.2 to 33.0) |
| Epididymitis | 5 | 4.6 (1.5 to 10.4) |
| Prolonged gross hematuria | 4 | 3.7 (1.0 to 9.1) |
| Urinary retention | 3 | 2.8 (0.6 to 7.8) |
| Urinary tract infection | 2 | 1.8 (0.2 to 6.5) |
| Bladder stone | 1 | 0.9 (0 to 5.0) |
| Other 6-mo assessments (n = 100) | ||
| PSA, ng/mL | 1.08 (0.4 to 3.2)b | –6.4 (–7.7 to –5.1)c |
| IPSS | 4.50 (2.0 to 7.0)b | –4.0 (–6.1 to –1.9)c |
| IIEF-5 | 2.00 (0.5 to 12.5)b | 0 (–0.2 to 0.2)c |
Abbreviations: IIEF-5, International Index of Erectile Function 5; IPSS, International Prostate Symptom Score; NA, not applicable; PSA, prostate-specific antigen.
SI conversion factor: To convert prostate-specific antigen to μg/L, multiply by 1.
a
Clavien-Dindo grades are as follows: I, any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions; II, requiring pharmacologic treatment with drugs other than those allowed for grade I complications; III, requiring surgical, endoscopic, or radiologic intervention.
b
Median (IQR).
c
Change from baseline.