To assess clinical safety (primary) and efficacy (secondary) of histotripsy for treatment of symptomatic benign prostatic enlargement (BPE) in a first-in human study.
Twenty-five male subjects with moderate to severe lower urinary tract symptoms (LUTS), prostate size between 30 and 80 grams and no evidence of prostate cancer were enrolled at two sites in a prospective, single-arm study. Treatment consisted of acoustic energy delivery through the perineum with integrated real-time TRUS monitoring using the Vortx RX system. Follow-up evaluations were performed on post-operative day 1 and 1, 3 and 6-months.
Twenty-five men underwent histotripsy treatment with no serious intra-operative adverse events. Post-operatively, three cases of transient urinary retention (<3 days), one case of urinary retention (8 days in duration, defined as serious), a minor anal abrasion and microscopic hematuria were considered device-related adverse events. Debulking of targeted prostate tissue was not observed with TRUS imaging or with endoscopic visualization and clinically meaningful improvement in uroflow or PVR did not occur. However, IPSS improvement at one month was 12.5 (52.4%) ± 6.6 points (n=25), at three months 11.9 (50.8%) ± 7.6 points (n=24), and at six months 10.4 (44.0%) ± 7.6 points (n=24) (p<0.001).
Prostate histotripsy was safe and well tolerated in this pilot human trial with improvement in LUTS.
Urology. 2018 Jan 09 [Epub ahead of print]
T G Schuster, J T Wei, K Hendlin, R Jahnke, W W Roberts
ProMedica., University of Michigan., HistoSonics., University of Michigan. Electronic address: .