High-intensity focused ultrasound: Complications and adverse events

Background: Transrectal high-intensity focused ultrasound (HIFU) is under i nvestigation as a minimally invasive therapeutic option for elderly men wit h prostatic cancer. Methods: From November 1996 to April 1999, 315 HIFU treatments with the Abl atherm(R) (EDAP/TMS) were performed. A questionnaire including 50 theoretic ally possible adverse events was developed. Every patient complaint was rec orded, including the physician's and patient's assessment, before and after therapy. Start date, end date, and period of every complaint were analyzed . Results: As major adverse events after primary HIFU, there were six cases o f stress incontinence grade 1, After repeat treatments with HIFU, rectouret hral fistulas occurred in five patients, stress incontinence grade 1 in eig ht, and, after additive transurethral resection, grade 2 in one and grade 3 in two patients. Post-HIFU rectal mucosa burn decreased from 15% in 1996 t o, 0 within the last year, In all treatments, obstruction was avoided by su prapubic urinary diversion, Urinary tract infections (UTIs) were recorded i nitially in 58% of patients but later in only 8%, Conclusion: Transrectal HIFU proved to be a secure, minimally invasive ther apeutic option for elderly men to avoid hormonal ablation or to postpone it s first use.