Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.
Christopher M. Dixon,Edwin Rijo Cedano,Dalibor Pacík,Vítězslav Vít,Gabriel Varga,Lennart Wagrell,Thayne R. Larson,Lance A. Mynderse +7 more
TLDR
The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.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 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.read more
Citations
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Journal ArticleDOI
Three-Year Outcomes of the Prospective, Randomized Controlled Rezūm System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
TL;DR: The minimally invasive convective RF thermal therapy is an office or ambulatory outpatient procedure with minimal transient perioperative side effects that provides early effective and durable relief of BPH symptoms with preservation of sexual function in subjects followed up for 3 years.
Journal ArticleDOI
Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rezūm system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.
Micheal F Darson,Erik E Alexander,Zvi J Schiffman,Michael Lewitton,Robert A Light,Mark A Sutton,Carlos Delgado-Rodriguez,Ricardo Gonzalez +7 more
TL;DR: Convective radiofrequency thermal therapy with the Rezūm system warrants consideration as a first-line treatment for LUTS/BPH as an alternative to the use of pharmaceutical agents.
Journal ArticleDOI
Convective radiofrequency water vapor thermal therapy for benign prostatic hyperplasia: a single office experience
TL;DR: Rezūm radiofrequency water vapor thermal therapy offers a minimally invasive option for BPH management with moderate improvement in symptoms and flow rate and has now been replicated in a single office setting.
Journal ArticleDOI
Rezum: a new transurethral water vapour therapy for benign prostatic hyperplasia.
TL;DR: Rezum is a minimally invasive transurethral water vapour therapy for benign prostatic enlargement which uses thermal energy for treatment and has good outcomes with a potential for outpatient-based treatment preserving sexual function.
Journal ArticleDOI
Minimizing Sexual Dysfunction in BPH Surgery
TL;DR: The prevalence and risks of sexual dysfunction associated with current treatment options for benign prostatic hyperplasia are reviewed, and techniques and methods to manage postoperative sexual dysfunction-related side effects are characterized.
References
More filters
Journal ArticleDOI
Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7).
Raymond C. Rosen,Jens Altwein,Peter Boyle,Roger Kirby,Bertrand Lukacs,Eric J.H. Meuleman,Michael P. O'Leary,Paolo Puppo,Chris Robertson,François Giuliano +9 more
TL;DR: A large-scale, multinational survey was conducted in the US and six European countries to systematically investigate the relationship between lower urinary tract symptoms (LUTS) and sexual dysfunction in older men.
Journal Article
[Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging.male (MSAM-7)].
Raymond C. Rosen,Jens Altwein,Peter Boyle,Roger Kirby,Bertrand Lukacs,Eric J.H. Meuleman,Michael P. O'Leary,Paolo Puppo,Robertson Chris,François Giuliano +9 more
TL;DR: The results highlight the clinical importance of evaluating LUTS in patients with sexual dysfunction, and the need to consider sexual issues in the management of patients with benign prostatic hypertrophy.
Management of non-neurogenic male lower urinary tract symptoms (LUTS), incl. benign prostatic obstruction (BPO)
Stavros Gravas,Jean-Nicolas Cornu,Mauro Gacci,Christian Gratzke,Thomas R. W. Herrmann,Charalampos Mamoulakis,Malte Rieken,M.J. Speakman,Kari A.O. Tikkinen +8 more
Journal ArticleDOI
Silodosin Therapy for Lower Urinary Tract Symptoms in Men with Suspected Benign Prostatic Hyperplasia: Results of an International, Randomized, Double-Blind, Placebo- and Active-Controlled Clinical Trial Performed in Europe
Christopher R. Chapple,Francesco Montorsi,Teuvo L.J. Tammela,Manfred P. Wirth,Evert L. Koldewijn,Eldiberto Fernández Fernández +5 more
TL;DR: A multicenter double-blind, placebo- and active-controlled parallel group study to test silodosin's superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound.
Journal ArticleDOI
Quality-of-life impact of lower urinary tract symptom severity: results from the Health Professionals Follow-up Study.
TL;DR: Men with high-moderate and severe LUTS identified in a large U.S. cohort have a poorer health status in several important quality-of-life dimensions and the detection and effective treatment of LUTs may substantially improve the health status for these men in these dimensions.
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