5-year data sustain water vapor thermal therapy benefit in BPH-related LUTS

The benefit of Rezūm water vapor thermal therapy was sustained at 5 years in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), according to data from a phase 2 trial shared in an abstract during the 2020 European Association of Urology Virtual Congress.¹

“Preliminary results show that the minimally invasive water vapor thermal therapy offers rapid improvements in LUTS, QoL, and flow rate that remain durable to 5 years,” co-principle investigators Kevin T. McVary, MD, Loyola University Medical Center, and Claus G. Roehrborn, MD, UT Southwestern Medical Center, wrote in their abstract conclusion.

The study included patients aged ≥50 years with a prostate volume of 30 to 80 cc, an International Prostate Symptom Score (IPSS) of ≥13, and a maximum flow rate (Qmax) of ≤15 ml/s. Patients were not allowed to enroll if they had a PSA >2.5 ng/mL with a free PSA <25%, except those patients for whom biopsy had ruled out prostate cancer. Patients with an active urinary tract infection were also excluded from enrollment.

Investigators randomized patients in a 2:1 ratio to thermal therapy (Rezūm System; n = 136) or sham control (rigid cystoscopy; n = 61). The study design allowed for crossover of some patients from the control arm to active treatment.

Patients received 1 treatment and were followed for 5 years. According to the investigators, “The water vapor thermal therapy procedure can be performed under local anesthesia in an office setting and is used to ablate obstructing prostate tissue including the median lobe/enlarged central zone.”

Data for the primary study analysis showed that at 3 months, the mean IPSS reduction from baseline was 11.2 points with water vapor thermal therapy and 4.3 points with sham control (P <.0001). At 5 years, the reduction in IPSS was sustained in the water vapor thermal therapy cohort with a 10.4-point (48%) mean reduction from baseline. The change from baseline in maximum urinary flow rate was 6.4 ml/sec (69%) and 4.3 ml/sec (49%) at 3 months and 5 years, respectively.

Also of note, there was a strong correlation (Spearman’s rho = 0.72; P <.001) between improvements in IPSS and QoL scores. The investigators reported that the estimated mean change in IPSS from baseline corresponding to a 1-point QoL improvement for mild (IPSS 13-19), moderate (IPSS 20-26), and severe (IPSS 27-35) LUTS was -4.9, -7.8, and -10.0 points, respectively.

The researchers consider these data to be preliminary, as 5-year data are not yet available for the patients who crossed over from the control arm to receive active treatment. They did note, however, that the available 4-year follow-up data for the crossover cohort show similar improvements as the 5-year findings in the primary randomization.

Four-year follow-up data published in the journal Urology² previously demonstrated the durability of the benefit of Rezūm water vapor thermal therapy for BPH-related LUTS.

Over 4 years, the surgical retreatment rate was 4.4%. The mean IPSS improvement (decrease means improvement) from baseline remained consistent between the 3-month assessment (-49.9%) and the 4-year assessment (-46.7%). At 4 years, the mean IPSS reduction was 10.1 points (P <.0001). The IPSS QoL mean improvement (decrease means improvement) from baseline was -50.1% at 1 year, compared with -42.9% at 4 years, with a mean IPSS QoL score improvement of -2 points (P <.0001).

Regarding maximum flow rate, the mean improvement in Qmax from baseline was 58.5% at 1 year compared with 49.5% at 5 years. At 4 years, the mean improvement in Qmax was 4.2 mL/sec (P <.0001). The mean BPH Impact Index (BPHII) improvement (decrease means improvement) from baseline was -60.5% at 1 year and -52.2% at 4 years. At 4 years, the mean BPHII improvement was -3.5 (P <.0001).

Reference

1. Roehrborn C, McVary KT. Five-year preliminary functional urinary outcomes of the prospective, randomized controlled trial of convective water vapor thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. 2020 European Association of Urology Virtual Congress. July 17-26, 2020. Abstract 212.

2. McVary KT, Rogers T, Roehrborn CG. Rezūm water vapor thermal therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia: 4-year results from randomized controlled study. Urology. 2019;126:171-179. doi: 10.1016/j.urology.2018.12.041

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