Prostatic Diseases and Male Voiding Dysfunction| Volume 114, P184-187, April 2018

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

Published:January 09, 2018DOI:


      To assess clinical safety (primary) and efficacy (secondary) of histotripsy for treatment of symptomatic benign prostatic enlargement in a first-in human study.


      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.


      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).


      Prostate histotripsy was safe and well tolerated in this pilot human trial with improvement in lower urinary tract symptoms.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Urology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Mayer E.K.
        • Kroeze S.G.C.
        • Chopra S.
        • et al.
        Examining the “gold standard”: a comparative critical analysis of three consecutive decades of monopolar transurethral resection of the prostate (TURP) outcomes.
        BJU Int. 2012; 110: 1595-1601
        • Wang L.
        • Yu Q.Y.
        • Liu Y.
        • et al.
        Efficacy and safety of laser surgery and transurethral resection of the prostate for treating benign hyperplasia: a network meta-analysis.
        Asian Pac J Cancer Prev. 2016; 17: 4281-4288
        • Kang D.H.
        • Cho K.S.
        • Ham W.S.
        • et al.
        A systematic review and meta-analysis of functional outcomes and complications following the photoselective vaporization of the prostate and monopolar transurethral resection of the prostate.
        World J Mens Health. 2016; 34: 110-122
        • Zhang X.
        • Shen P.
        • He Q.
        • et al.
        Different lasers in the treatment of benign prostatic hyperplasia: a network meta-analysis.
        Sci Rep. 2016; 6: 23503
        • Rosario D.J.
        • Phillips J.T.
        • Chapple C.R.
        Durability and cost-effectiveness of transurethral needle ablation of the prostate as an alternative to transurethral resection of the prostate when alpha-adrenergic antagonist therapy fails.
        J Urol. 2007; 177: 1047-1051
        • Roberts W.W.
        New technologies in benign prostatic hyperplasia management.
        Curr Opin Urol. 2016; 26: 254-258
        • Roberts W.W.
        • Teofilovic D.
        • Jahnke R.C.
        • et al.
        Histotripsy of the prostate using a commercial system in a canine model.
        J Urol. 2014; 191: 860-865
        • Schade G.R.
        • Styn N.R.
        • Hall T.L.
        • Roberts W.W.
        Endoscopic assessment and prediction of prostate urethral disintegration after histotripsy treatment in a canine model.
        J Endourol. 2012; 26: 183-189
        • Lake A.M.
        • Xu Z.
        • Cain C.A.
        • et al.
        Renal ablation by histotripsy—does it spare the collecting system?.
        J Urol. 2008; 179: 1150-1154
        • Welliver C.
        • Kottwitz M.
        • Feustel P.
        • McVary K.
        Clinically and statistically significant changes seen in sham surgery arms of randomized, controlled benign prostatic hyperplasia surgery trials.
        J Urol. 2015; 194: 1682-1687
        • Eredics K.
        • Madersbacher S.
        • Schauer I.
        A relevant midterm (12 months) placebo effect on lower urinary tract symptoms and maximum flow rate in male lower urinary tract symptom and benign prostatic hyperplasia—a meta-analysis.
        Urology. 2017; 106: 160-166