Optilume BPH: 2-Year Results from A Prospective Multicenter Randomized Clinical Trial for the Treatment of Benign Prostatic Hyperplasia (the PINNACLE Study)

Abstract Background Patient outcomes were assessed 2 years after treatment with the Optilume BPH Catheter System, a minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).Methods One-hundred forty-eight adult males with symptomatic BPH were enrolled and randomized in a 2:1 fashion to Optilume BPH or Sham (100 Optilume BPH; 48 Sham). Long-term measures include International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), Post-Void Residual Urine (PVR), quality of life measures and sexual function. Long term follow-up was limited to those treated with Optilume BPH.Results At 2 years, 67.5% (56/83 CI 56.3%, 77.4%) of participants in the Optilume BPH arm were symptomatic responders as defined by ≥ 30% improvement in IPSS without medical or surgical retreatment. IPSS significantly improved from 23.4 ± 5.5 to 11.0 ± 7.0. Qmax improved by 118.5% (8.9 ± 2.2 to 19.1 ± 16.3), while PVR showed a slight reduction (83.3 ± 70.6 to 67.2 ± 74.2). Improvement in uroflowmetry measures was consistent across all prostate volumes. BPH-II improved from 7.0 ± 2.9 to 2.3 ± 2.5 at 1 year and remained consistent at 2.3 ± 2.9 at the 2-years, representing a 53.9% improvement. IPSS QoL also improved from 4.6 ± 1.3 at baseline to 2.2 ± 1.5. The most common adverse events reported in the Optilume BPH arm were hematuria and urinary tract infection (UTI). No device and/or treatment related serious adverse events were reported occurring beyond 12 months post-procedure. There was no impact to sexual function.Conclusions In the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated continued and durable results at 2 years, affirming tolerability, safety, and the enduring effectiveness of the outcomes. The Optilume BPH Catheter System provides long-lasting results that are comparable to the more invasive therapy options, while preserving the advantages with being a minimally invasive therapy.