Abstract: PNFBA-01
Sources of Funding: NxThera

Introduction

To assess the impact of convective RF water vapor thermal therapy (WaVE) to treat LUTS due to BPE (LUTS/BPE) on subjective and objective voiding and sexual function parameters and to compare results between obese (BMI > 30) and non-obese subjects.

Methods

Men ≥ 50 years old with IPSS ≥ 13, peak flow rate (Qmax) between 5 and 15 mL/s, and prostate size 30 to 80cc were randomized 2:1 between WaVE and sham procedure with cystoscopy and simulated treatment sounds. Blinded comparison was done at 3 months and the treatment arm was followed for 12 months for IPSS, Qmax, and sexual function via IIEF-15 and Male Sexual Health Questionnaire for Ejaculatory Function (MSHQ-EjF). Percentage of subjects who achieved minimal clinically important difference in erectile function perceived by subjects as beneficial (MCID) was determined. Treatment outcomes for obese and non-obese subjects were compared.

Results

197 men were randomized, 136 in WaVE group, 61 in sham group. WaVE group and control group IPSS reduced by 11.2 and 4.3 at 3 months (p<0.0001). WaVE group IPSS decreased by 50% or greater at 3, 6, and 12 months (p<0.0001). Peak flow rate in WaVE group increased by 6.2 mL/s at 3 months and sustained through 12 months (p<0.0001). 42 treatment subjects had a median lobe, 30 had the median lobe treated with similar outcomes to treated subjects without median lobes. Obese subjects had similar improvement in IPSS as compared to non-obese subjects, including both storage and voiding domains. IIEF-15 and MSHQ-EjF scores were not different between WaVE or control groups at 3 months and were not different in WaVE group from baseline at 12 months. Ejaculatory bother improved 31% in WaVE group over baseline (p=0.0011). 32% of subjects in WaVE group achieved MCID at 3 months and 27% at 1 year, in all ED categories. Obese subjects were more likely to have severe ED but experienced similar rate of MCID and improvement in ejaculatory bother as non-obese subjects. Adverse effects included hematuria, irritative voiding symptoms, hematospermia, and UTI and all resolved within 3 weeks. There were no serious adverse effects. Decreased ejaculatory volume occurred in 6 men and anejaculation was reported by 4 men.

Conclusions

Convective RF water vapor thermal therapy provides a rapid and sustainable improvement in LUTS/BPE through 1 year, can be applied to all zones including the median lobe, and preserves erectile and ejaculatory function. Results are similar for both obese and non-obese subjects.

Funding

NxThera