Introduction

We report 2-year outcomes of a randomized controlled trial (RCT) plus 1-year results of a crossover trial after treatment with convective radiofrequency (RF) water vapor thermal therapy (Rezum System) for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). RF energy generates wet thermal energy in the form of water vapor that convectively disperses through tissue interstices, remaining confined within prostate zones to achieve rapid ablation of obstructive tissue.

Methods

Men ≥ 50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤ 15 ml/s and prostate volume 30-80 cc were randomized 2:1 to RF thermal therapy with the Rezum System and control. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months, control subjects were requalified for the crossover study. The primary endpoint compared IPSS reduction at 3 months and evaluations continued to 24 months

Results

Mean IPSS was reduced by 50% after RF thermal therapy (-11.2) vs. 20% (-4.3) for control at 3 months (p<0.0001); relief of LUTS remained durable with 51% improvements at 2 years (p<0.0001). The ≥5 (moderate) or ≥8 point (marked) IPSS decreases occurred in 84% and 74% of men through 24 months, respectively; 75% of these had severe LUTS (IPSS ≥19). Qmax increased 68% (6.2 ml/s) at 3 months vs. no change in controls (p <0.0001) and remained significantly improved at 2 years. Crossover subjects (n=53) had IPSS, Qmax and quality of life markedly improved after RF thermal therapy vs. prior control procedure (p <0.024 - <0.0001). Median lobe treatments were performed in 58 of 188 (31%) subjects in both studies; those with and without median lobe ablation achieved similarly reduced IPSS and improved Qmax. Sexual function assessments with the International Index of Erectile Function and Male Sexual Health Questionnaire remained stable. No de novo erectile dysfunction was reported.

Conclusions

Convective RF thermal therapy is a minimally invasive office or outpatient procedure requiring minimal anesthesia to achieve early, clinically meaningful LUTS relief and improved flow rate that remain durable for at least 2 years. Therapy is applicable to all obstructed prostate zones including median lobe. Patients experience minimal side effects. Rezum therapy conserves sexual function and presents an attractive alternative for men exploring a nonsurgical option for moderate to severe LUTS/BPH.

Funding

NxThera, Inc.