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 (<3 days), 1 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 transrectal ultrasound imaging or
with endoscopic visualization, and clinically meaningful improvement in uroflow or
postvoid residual urine (PVR) did not occur. However, International Prostate Symptom
Score improvement at 1 month was 12.5 (52.4%) ± 6.6 points (n = 25), at 3 months was
11.9 (50.8%) ± 7.6 points (n = 24), and at 6 months was 10.4 (44.0%) ± 7.6 points
(n = 24) (P <.001).
Conclusion
Prostate histotripsy was safe and well tolerated in this pilot human trial with improvement
in lower urinary tract symptoms.
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Article info
Publication history
Published online: January 09, 2018
Accepted:
December 28,
2017
Received:
August 30,
2017
Footnotes
Financial Disclosure: William W. Roberts has equity, royalty, and consulting interests with HistoSonics. The University of Michigan has an equity interest in HistoSonics. The remaining authors declare that they have no relevant financial interests.
Funding Support: Funding for the study was provided by HistoSonics.
Identification
Copyright
© 2018 Elsevier Inc. All rights reserved.
