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. 2017 Apr 27:10:71-80.
doi: 10.2147/MDER.S135378. eCollection 2017.

Perspective on the Rezūm® System: a minimally invasive treatment strategy for benign prostatic hyperplasia using convective radiofrequency water vapor thermal therapy

Affiliations

Perspective on the Rezūm® System: a minimally invasive treatment strategy for benign prostatic hyperplasia using convective radiofrequency water vapor thermal therapy

Henry H Woo et al. Med Devices (Auckl). .

Abstract

Convective radiofrequency (RF) water vapor thermal therapy is a minimally invasive office or outpatient procedure for the treatment of bothersome moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). It provides an option for patients seeking rapid and durable relief of urinary symptoms, improved quality of life, and preservation of sexual function as an alternative to long-term use of drugs and avoidance of the potential side effects of pharmaceuticals or invasive BPH surgery. The procedure is also applicable for the treatment of the median lobe or elevated bladder neck from central zone hyperplasia. This perspective presents a comprehensive overview of the Rezūm® System convective RF thermal therapy device, the principles upon which it is based, the operative procedure, and the clinical evidence accrued to this point in time.

Keywords: lower urinary tract symptoms; minimally invasive procedure; prostate; prostatic hyperplasia; thermal therapy.

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Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Rezūm® System delivery device and vapor needle. Note: The vapor needle resides within the insulated lumen of the delivery device until it is deployed into the prostate tissue.
Figure 2
Figure 2
Prostate zonal anatomy. Notes: (A) Young male with minimal TZ hypertrophy. The preprostatic sphincter and periejaculatory duct zone (CZ) are defined. (B) Older male with TZ hypertrophy, which effaces the preprostatic sphincter and compresses the periejaculatory duct zone. Reprinted from Int J Radiat Oncol Biol Phys, 63(2), McLaughlin PW, Troyer S, Berri S, et al, Functional anatomy of the prostate: implications for treatment planning, 479–491, Copyright (2005), with permission from Elsevier. Abbreviations: CZ, central zone; SV, seminal vesicle; TZ, transition zone; AFS, anterior fibromuscular stroma; PZ, peripheral zone.
Figure 3
Figure 3
IPSS changes throughout 24 months after convective RF thermal therapy in the RCT and pilot study and 12 months in the crossover study, showing similarity and durability of improvements in the three studies. Notes: Values are the means, and errors bars represent the 95% CI. With the exception of the sham/control arm of the RCT, improvements relative to baseline are significant at all time points, p < 0.001. Abbreviations: CI, confidence interval; FIM, first-in-man; IPSS, International Prostate Symptom Score; RF, radiofrequency; RCT, randomized controlled trial.
Figure 4
Figure 4
Improvements in IPSS after convective RF thermal therapy compared to baseline at (A) 3 months and (B) 2 years in patients with moderate and severe LUTS. Abbreviations: IPSS, International Prostate Symptom Score; RF, radiofrequency; LUTS, lower urinary tract symptoms.

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