Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia
2016
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 Rezum 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 adverseevents (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 Rezum 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.
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