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Optilume BPH — Prostatic Drug-Coated Balloon System

Optilume BPH combines mechanical opening of the prostatic outlet with local paclitaxel delivery. It uses an uncoated predilation catheter followed by a separate drug-coated balloon, rather than a single interchangeable urethral-stricture balloon. The BPH balloon has a paclitaxel coating density of 2.4 µg/mm².[1]

For operative selection and technique, see Optilume BPH. For the distinct anterior-urethral-stricture product and its drug evidence, see Drug-Coated Balloon Therapy.

Label and Safety​

The US PMA indication is obstructive urinary symptoms associated with BPH in men aged 50 years or older. The pivotal trial enrolled men with 20–80 g prostates; this study population is separate from the wording of the labeled indication. Balloon sizing, anatomy and eligibility must follow the BPH-specific instructions.[1]

  • Contraindications include active UTI, paclitaxel-related hypersensitivity, an artificial urinary sphincter or a penile prosthesis.
  • Use barrier protection during sex for 30 days after treatment. Men with partners of childbearing potential should use highly effective contraception and avoid fathering a child for at least 12 months; paclitaxel has been detected in semen during follow-up, and effects on sperm and spermatogenesis are uncertain. Do not substitute the shorter counseling interval from another Optilume product.
  • Hematuria, infection, dysuria and retention can occur. An office or outpatient setting does not eliminate the need for a complication and catheter plan.
  • Avoid damaging or prematurely wetting the drug coating. Device preparation, hydration, inflation limits and handling after a failed inflation are governed by the full BPH instructions.[1]

PINNACLE Evidence​

PINNACLE randomized 148 men: 100 to Optilume BPH and 48 to sham. Its primary comparison used the active group's one-year IPSS improvement versus the sham group's three-month improvement. The reported 11.5 versus 8.0-point change must not be presented as a contemporaneous one-year sham comparison.[2]

At two years, follow-up was limited to treated participants: 56 of 83 evaluable participants met the symptom-response definition without medical or surgical retreatment. Missing follow-up and the lack of a long-term concurrent control limit comparisons with other procedures. Favorable sexual-function findings do not establish zero ejaculatory risk or equivalence to more invasive surgery.[3]

References​

1. Urotronic/FDA. Optilume BPH Catheter System: Instructions for Use. PMA P220029, physician labeling. FDA-posted label.

2. Kaplan SA, Moss J, Freedman S, et al. "The PINNACLE study: a double-blind, randomized, sham-controlled study evaluating the Optilume BPH catheter system for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia." J Urol. 2023;210(3):500–9. doi:10.1097/JU.0000000000003568

3. Kaplan SA, et al. Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study). Prostate Cancer Prostatic Dis. 2024. doi:10.1038/s41391-024-00833-z.