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Optilume BPH — Prostatic Drug-Coated Balloon

Optilume BPH (Laborie / Urotronic) is a paclitaxel-coated dilation balloon advanced transurethrally and inflated within the prostatic urethra to mechanically open the bladder neck and prostatic fossa while simultaneously delivering antiproliferative paclitaxel to the urothelium and submucosa. The drug coating is the same approach used in the Optilume urethral DCB for anterior strictures, repurposed for a different anatomic problem.[1][2]

For procedural detail see Optilume BPH. For the urethral-stricture sibling device see Drug-Coated Balloon Therapy (Optilume).

Device Components​

  • Double-lobed dilation balloon sized to span the bladder neck and prostatic fossa.
  • Paclitaxel coating at therapeutic-dose density (~ 3 µg/mm²).
  • Inflation handpiece for graded balloon inflation to a target diameter under cystoscopic visualization.

Mechanism​

  • Mechanical dilation creates a longitudinal split through hyperplastic tissue (commissural separation at 12 o'clock and bilateral lateral lobes).
  • Paclitaxel diffuses into urothelium and submucosa, inhibiting fibroblast proliferation and scar contracture during the post-dilation healing window — the same scar-prevention rationale as the urethral DCB.

Indications​

  • BPH-related LUTS, prostate volume < 80 mL without obstructing median lobe (FDA-approved 2023).
  • Ejaculation-preservation prioritized (PINNACLE trial anejaculation rate < 2%).[3]
  • Office or outpatient setting under local + sedation.

Reconstructive Relevance​

  • PINNACLE pivotal trial (n = 148, RCT vs sham): IPSS reduction −11.5 vs −8.0; Qmax improvement +10.3 vs +4.5 mL/s; durable at 1 yr; 0% anejaculation among sexually active patients.[3]
  • Long-term durability data still maturing; retreatment rates and the impact of cumulative paclitaxel exposure with repeat dilations remain open questions.
  • Cross-links: UroLift, Rezūm, iTind, Aquablation.

References​

1. 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

2. Pichardo M, Kahn A, Pichardo C, et al. "Drug-coated balloons in urology: a review of the literature." Curr Urol Rep. 2023;24(11):485–93. doi:10.1007/s11934-023-01180-7

3. Kaplan SA, Pichardo M, Rijo E, et al. "One-year outcomes of the PINNACLE randomized controlled trial of Optilume BPH catheter system." Urology. 2024;186:32–40. doi:10.1016/j.urology.2024.01.022