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Histotripsy Treatment of Benign Prostatic Enlargement Using the Vortx R x System: Initial Human Safety and Efficacy Outcomes

Histotripsy Treatment of Benign Prostatic Enlargement Using the Vortx R x System: Initial Human Safety and Efficacy Outcomes

Authors :
John T. Wei
Kari Hendlin
Russell Jahnke
William W. Roberts
Timothy G. Schuster
Source :
Urology. 114:184-187
Publication Year :
2018
Publisher :
Elsevier BV, 2018.

Abstract

Objective To assess clinical safety (primary) and efficacy (secondary) of histotripsy for treatment of symptomatic benign prostatic enlargement in a first-in human study. Methods Twenty-five male subjects with moderate to severe lower urinary tract symptoms, prostate size between 30 and 80 g, and no evidence of prostate cancer were enrolled at 2 sites in a prospective, single-arm study. Treatment consisted of acoustic energy delivery through the perineum with integrated real-time transrectal ultrasound monitoring using the Vortx Rx system. Follow-up evaluations were performed on postoperative day 1 and 1, 3, and 6 months. Results Twenty-five men underwent histotripsy treatment with no serious intraoperative adverse events. Postoperatively, 3 cases of transient urinary retention ( Conclusion Prostate histotripsy was safe and well tolerated in this pilot human trial with improvement in lower urinary tract symptoms.

Details

ISSN :
00904295
Volume :
114
Database :
OpenAIRE
Journal :
Urology
Accession number :
edsair.doi...........b8382bc39a30dad7fa5acdb76e3811dc
Full Text :
https://doi.org/10.1016/j.urology.2017.12.033