One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia.

ABSTRACT:

Background

This is the first report of the 1-year outcomes of the EVEREST-I study evaluating the safety and efficacy of the Optilume^® BPH Catheter System, a prostatic paclitaxel-coated balloon catheter system, for the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH).

Methods

Subjects were men >50 years old with moderate-to-severe LUTS secondary to BPH, peak urinary flow rate of 5-15 ml/s, prostatic urethra length 30-55 mm, and prostate volume 20-80 g. All were treated with the Optilume BPH Catheter System and followed at Foley removal, 2 weeks, 30 days, 3, 6, and 12 months after treatment. The primary endpoint was the proportion of subjects with ≥40% improvement in International Prostate Symptom Score (IPSS). The rate

SUBMITTER: Kaplan SA 

PROVIDER: S-EPMC8616755 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature