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 of post-procedural complications was evaluated. Results Eighty subjects were treated at six sites in Latin America and 75 completed the 1-year follow-up. The percent of subjects with an improvement ≥40% in IPSS from baseline was 81% at 3 months and 1 year. IPSS improved from 22.3 at baseline to 7.9 at 1 year, Qmax improved from 10.9 to 18.4 ml/s, and IPSS QoL improved from 4.6 to 1.3. Post-procedural complications included common urologic events and the rate of complications was significantly impacted by device diameter. Conclusions Treatment with the minimally invasive Optilume BPH Catheter System is safe and showed subjective and objective improvements in LUTS. Benefits were rapid and persisted through 1 year. The initial results warrant further evaluation of this therapy as a treatment option for patients with LUTS related to BPH.

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

“…These outcomes substantiate previous experience with Optilume BPH, which reported an average Qmax of 18.4 mL/s and PVR improvement of 29.8 mL at 1 year posttreatment. 9 The symptom improvement seen with Optilume BPH is comparable to that reported for other MISTs in similar patient populations, while the improvement seen in flow and PVR represents the best improvements seen for this technology class. 12-18…”

“…These outcomes substantiate previous experience with Optilume BPH, which reported an average Qmax of 18.4 mL/s and PVR improvement of 29.8 mL at 1 year posttreatment. 9 The symptom improvement seen with Optilume BPH is comparable to that reported for other MISTs in similar patient populations, while the improvement seen in flow and PVR represents the best improvements seen for this technology class. [12][13][14][15][16][17][18] Sham procedures have been a fixture in randomized trials evaluating MIST devices; however, no prior studies included blinding and follow-up through 12 months in the sham subjects.…”

“…The mechanism of action described above is inferred from established action of paclitaxel in the prevention of smooth muscle cell growth and cystoscopic observations and functional maintenance of flow rate improvement during longterm follow-up from earlier studies; however, direct mechanistic evidence is lacking. 9,22…”

“…Early experience with Optilume BPH has shown significant and durable improvement in symptoms and flow. 9 Treatment with paclitaxel-coated balloons has also been shown to significantly reduce the rate of stricture recurrence in men with urethral strictures. 10,11 This study compares the safety and efficacy of Optilume BPH to a sham surgical procedure for the treatment of LUTS secondary to BPH with outcomes reported through 12 months of follow-up.…”

Primary bladder neck obstruction in men – what´s new in the pathophysiology of this underestimated problem?

“…Even if the in ammation models and clinical studies are urgently needed to understand the in ammatory signaling pathway mechanisms and the pathogenesis in the hypothized development of PBNO, new minimally invasive therapies (MIST) are emerging [43][44][45][46]. If the MIST treatment options will be a perfect match for men suffering from PBNO should be further evaluated.…”