ABSTRACT
Objective
To report 1-year safety and efficacy outcomes after either Aquablation or transurethral
resection of the prostate (TURP) for the treatment of lower urinary tract symptoms
related to benign prostatic hyperplasia (BPH)
Methods
This double-blinded, multicenter prospective randomized controlled trial assigned
181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to either
electrocautery-based prostate resection (TURP) or Aquablation. Efficacy endpoints
included reduction in International Prostate Symptom Score and improvement in uroflow
parameters. The primary safety endpoint was the occurrence of Clavien-Dindo persistent
grade 1 or grade 2 or higher complications.
Results
BPH symptom score improvements were similar across groups with 12-month reduction
of 15.1 points after TURP or Aquablation. In both groups, mean maximum urinary flow
rates increased markedly postoperatively, with mean improvements of 10.3 cc/s for
Aquablation versus 10.6 cc/s for TURP (P = .8632). At 1 year, Prostate-specific antigen (PSA) was reduced significantly (P < .01) in both groups by 1 point; the reduction was similar across groups (P = .9125). Surgical retreatment for BPH rates for TURP were 1.5% and Aquablation 2.6%
within 1 year from the study procedure (P = not significant (NS)). The rate of late complications was low, with no procedure-related
adverse events after month 6.
Conclusion
The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related
complications was low. (ClinicalTrials.gov number, NCT02505919).
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Article Info
Publication History
Published online: December 12, 2018
Accepted:
December 3,
2018
Received:
August 31,
2018
Footnotes
Conflict of Interest: Mohamed Bidair and Eugene Kramolowsky are consultants for PROCEPT BioRobotics. No other author has a conflict of interest with PROCEPT BioRobotics.
Financial Disclosure: The study was funded by PROCEPT BioRobotics.
Identification
Copyright
© 2018 Elsevier Inc. All rights reserved.
