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abstract

abstract

634

Convective radiofrequency thermal therapy (Rezum®) effectively treats lower urinary tract symptoms due to benign prostatic hyperplasia regardless of obesity while preserving erectile and ejaculatory function

Helo, S1; Tadros, N1; Gupta, N2; Kohler, TS3McVary, KT1

1: Southern Illinois University School of Medicine, United States; 2: Rutgers Robert Wood Johnson Medical School, United States; 3: Mayo Clinic, United States

Objective: Obesity is a component of metabolic syndrome, which influences erectile dysfunction, lower urinary tract symptoms (LUTS), and response to benign prostatic hyperplasia (BPH) treatment. We assessed the effect of obesity on voiding and sexual function parameters in men treated with convective radiofrequency thermal therapy, Rezum (REZ), for LUTS/BPH and compared results between obese (BMI > 30) and non-obese subjects.

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

Results: 197 men were randomized, 136 in REZ group, 61 in sham group. IPSS improved by 11.2 and 4.3 points at 3 months for REZ and control groups, respectively (p<0.0001). The treatment arm experienced 50% or greater IPSS reduction at 3, 6, and 12 months (p<0.0001). Improvements in IPSS were similar in both obese versus non-obese subjects for storage and voiding domains. Qmax in treatment arm improved by 6.2 mL/s at 3 months and was sustained through 12 months (p<0.0001). 42 subjects in the treatment arm had a median lobe, those treated with REZ had similar outcomes to subjects without a median lobe. IIEF-15 and MSHQ-EjF scores were similar in both arms at 3 months and unchanged in the treatment arm from baseline at 12 months. Obesity was associated with more moderate/severe ED at baseline but MCID rates regardless of obesity status or ED severity. 32% of subjects in the treatment arm achieved MCID at 3 months and 27% at 1 year, in all ED categories. Ejaculatory bother improved 31% in the treatment arm over baseline (p=0.0011). Decreased ejaculatory volume occurred in 6 men and anejaculation in 4 men.

Conclusion: Convective radiofrequency thermal therapy provides a rapid and sustainable improvement in LUTS/BPH in both obese and non-obese subjects through 1 year. Unlike other BPH treatments, REZ can be applied to all zones including a median lobe, while preserving erectile and ejaculatory function.

Disclosure:

Work supported by industry: yes, by NxTHERA (industry funding only - investigator initiated and executed study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

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