Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia

Christopher M Dixon, Edwin Rijo Cedano, Dalibor Pacik, Vítězslav Vit, Gabriel Varga, Lennart Wagrell, Thayne R Larson, Lance A Mynderse, Christopher M Dixon, Edwin Rijo Cedano, Dalibor Pacik, Vítězslav Vit, Gabriel Varga, Lennart Wagrell, Thayne R Larson, Lance A Mynderse

Abstract

Objective: The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations.

Patients and methods: Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20-120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months.

Results: LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen.

Conclusion: The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.

Keywords: benign prostatic hyperplasia; convective RF; lower urinary tract symptoms; minimally invasive; water vapor thermal therapy.

Conflict of interest statement

Christopher M Dixon and Thayne R Larson have consulted with NxThera in the clinical trial design. Lennart Wagrell has served as a consultant to NxThera for other projects. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Schematic of contiguous ablation zones in the prostate after convective RF water vapor thermal therapy; example shows 3 treatments per side.
Figure 2
Figure 2
IPSS changes throughout 24 months after convective RF water vapor thermal therapy. Notes: Also plotted are results from a randomized, blinded, sham controlled trial showing similarity of outcomes over 12 months. Values are the mean absolute IPSS, errors bars represent 95% CI. Abbreviations: IPSS, International Prostate Symptom Score; CI, confidence interval; RCT, randomized controlled trial.
Figure 3
Figure 3
IPSS responses after convective RF water vapor thermal therapy including (A) storage and voiding categories of symptoms and (B) 7 individual question responses. Abbreviation: IPSS, International Prostate Symptom Score.
Figure 4
Figure 4
Improvements in IPSS from baseline in patients with moderate and severe LUTS. Note: *P<0.0001 vs baseline. Abbreviations: IPSS, International Prostate Symptom Score; LUTS, lower urinary tract symptoms.

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