Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial

Table 3 A clinical risk analysis associated with the IRE device and procedure

Potential risks of IRE ablation and procedure	Side effect/Adverse event
General Anaesthesia	Aspiration, urinary retention, extended muscle blockage, anaesthetic drug toxicity, pain, coma, death
Electric current of IRE	Cardiac arrhythmias, severe muscle contraction, electrical shock, death
Multiple Prostate Biopsies	Bleeding, infection, pain, urinary retention, pain
IRE needle placement and ablation	Damage to urethra/bowel/bladder/nerve with consequent side effects^a, bleeding, infection, pain
Insufficient IRE treatment	Residual or recurrent tumour
Insufficient Muscle Blockade	Muscle strains or damage, electrodes displaced, trauma

^ahaematuria, hematoma, infection, abscess formation, fistula, sepsis, death, urinary retention, urinary or faecal incontinence, urethra stricture, erectile dysfunction, necrosis of affected tissue

ISSN: 1471-2407