Abstract: |
OBJECTIVE: To present final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezum water vapor therapy for treatment of moderate-to-severe LUTS due to BPH. MATERIALS AND METHODS: Total of 197 subjects 50 years of age, with IPSS =13, maximum flow rate (Qmax) =15 mL/s and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the 61 subject control arm, a subset of 53 subjects requalified and after 3 months, received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. RESULTS: Significant improvement of LUTS was observed at 3 months post thermal therapy, remaining durable through 5 years in the treatment group (IPSS reduced 48%, QOL increased 45%, Qmax improved 44%, BPHII decreased 48%. Surgical retreatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years. CONCLUSION: Minimally invasive treatment with Rezum water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical retreatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes. |