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

Abstract

ObjectiveThe 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 methodsMen 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.ResultsLUTS, 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.ConclusionThe 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.

Blasenentleerungsstörung auf dem Boden einer gutartigen Prostatavergrößerung (BPO)

“…Im Falle einer intravesikalen Protrusion der Prostata beginnt die Behandlung 1 cm distal der proximalen Kante der Protrusion. Die PEEK-Dampfnadel wird in das Prostatagewebe (Gesamtlänge 10,25 mm) eingebracht und appliziert Wasserdampf mit einer feuchten Energie von 208 cal für 9 Sekunden [17]. Die Dampfnadel wird nach jeder Injektion zurückgezogen und circa 1 cm distal vom vorherigen Behandlungspunkt repositioniert bis zum proximalen Rand des Samenhügels.…”

“…Die besten Ergebnisse wurden 3 Monate postoperativ nachgewiesen (IPSS-Reduktion um ≥ 50 % bei 72,6 % der Patienten; IPSS-Reduktion durchschnittlich um 12,6 Punkte, mittlerer Qmax-Anstieg um 4,6 ml/s, jeweils p < 0.001) und blieben über einen Zeitraum von 24 Monaten signifikant (IPSS-Reduktion um ≥ 50 % bei 60,5 % der Patienten) [17]. Sowohl die Speichersymptome (Urge, Pollakisurie, Nykturie) als auch die Entleerungssymptome zeigten in IPSS signifikante Verbesserungen.…”

“…Es zeigten sich keine Einschränkungen für die Behandlung des Mittellappens. Die Ergebnisse waren bei Patienten mit oder ohne Mittellappen absolut vergleichbar [17,18]. 75 % der perioperativen unerwünschten Ereignissen (UE) traten innerhalb der ersten 30 Tage nach dem Eingriff auf und waren leichte bis mittelschwere Ereignisse (Clavien-Dindo Grad I oder II: Harnverhalt, Dysurie, Urge, Hämatospermie und Harnwegsinfekte), die innerhalb von wenigen Tagen bis 4 Wochen behoben werden konnten.…”

<div>Perspective on the Rezūm^&reg; System: a minimally invasive treatment strategy for benign prostatic hyperplasia using convective radiofrequency water vapor thermal therapy</div>

“…IPSS changes throughout 24 months after convective RF thermal therapy in the RCT11 and pilot study14 and 12 months in the crossover study,11 showing similarity and durability of improvements in the three studies.…”

“…Little attention has been paid to understanding the prevalence of PZ/CZ or median zone hypertrophy and contribution to LUTS. In Rezūm clinical trials, 28% of all 253 patients presenting for treatment had a median lobe 11,14. Information on the prevalence of a median lobe in benign hypertrophic prostates was not found but will likely vary as does the individual expressions of LUTS in patients with BPH.…”