high-intensity focused ultrasound (HIFU)

Product Name: Sonablate 500
Country: United Kingdom (UK)

NETSCC, HTA – NIHR Coordinating Centre for Health Technology Assessment

Outcome Measure

a. Efficacy: Primary - symptom score, Secondary - urodynamic (peak urine flow rate, mean urine flow rate, total voided volume, residual volume, detrusor pressure), prostate size, quality of life score<br>b. Safety: Complications: intraoperative complications, co-interventions, clot retention, cardiovascular events, transurethral resection syndrome, blood transfusion, septicaemia, urinary retention, recatheterisation, urinary tract infection (including epididymitis), irritative urinary symptoms, incontinence, retrograde ejaculation, erectile dysfunction, stricture, reoperation rate, mortality (p. 24)

Body Classification

Male Reproductive System

Device Type

Therapeutic device

Device Category

Treatment of disease

Risk Classification

IIb

Indication

benign prostatic enlargement

ICD-10

N40

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