"The next-generation Optilume BPH Catheter System offers a safe and effective new, minimally invasive treatment for BPH, reducing urinary obstruction with a low rate of sexual or other adverse effects," says Steven A. Kaplan, MD.
The Optilume BPH Catheter System showed improvements in obstructive symptoms and flow rate while preserving sexual function among patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), according to 12-month follow-up data from the PINNACLE study (NCT04131907).1,2
Key findings from the study were presented at the American Urological Association 2023 Annual Meeting in May, and the data were recently fully published in the Journal of Urology.1
"The next-generation Optilume BPH Catheter System offers a safe and effective new, minimally invasive treatment for BPH, reducing urinary obstruction with a low rate of sexual or other adverse effects, in a simple outpatient procedure," said lead author Steven A. Kaplan, MD, in a news release on the findings.2 Kaplan is director of the Men’s Wellness Program at Mount Sinai Health System and a professor at Icahn School of Medicine at Mount Sinai in New York, New York.
The Optilume BPH System is a minimally invasive surgical therapy (MIST) that consists of a drug-coated balloon system. The treatment was granted FDA approval in July 2023.
In total, 148 men aged 50 and older were enrolled in the prospective PINNACLE study. The average age of patients in the study was 65 years. All participants had symptomatic BPH and a prostate size between 20 g and 80 g. Patients were randomly assigned to treatment with Optilume (n = 100) or a sham surgical procedure (n = 48) across 18 centers in the United States and Canada.
Data showed that patients who underwent treatment with Optilume saw an average reduction of 11.5 ± 7.8 points in International Prostate Symptom Score (IPSS) at 1 year following treatment, compared with an average reduction of 4.8 points in the sham arm. The 1-year Optilume IPSS was found to be greater than the 3-month reported data from the sham arm, in which patients experienced a reduction of 8.0 ± 8.3 (95% CI 0.6 to 6.2, P = .008).
The change in peak urinary flow rate (Qmax) was also greater at 12 months among patients in the Optilume arm compared with the 3-month Qmax among patients in the sham arm (+9.7 ± 10.1 vs +5.5 ± 7.4 mL/s, P = .009). Postvoid residual urine volume also showed improvement for patients in the Optilume cohort, decreasing from 82 mL at baseline to 58 mL at 1-year follow-up (P = .004).
The authors noted, “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.”
Improvements were also observed in urinary health-related quality of life scores, as measured by the IPSS-Quality of Life (−2.4, −51%) and BPH Impact Index (−4.5, −63%) questionnaires.
Further, patients in both treatment arms showed mild improvement in average scores across all subdomains of the International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Dysfunction, indicating no significant effect of treatment on sexual function. In total, 4 patients in the Optilume cohort reported ejaculatory dysfunction, compared with 1 patient in the sham arm (P > .9).
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. Published online August 9, 2023. Accessed August 14, 2023. doi:10.1097/JU.0000000000003568
2. Next-generation treatment reduces symptoms, preserves sexual function in men with enlarged prostate. News release. Wolters Kluwer Health: Lippincott. August 10, 2023. Accessed August 14, 2023. https://www.newswise.com/articles/next-generation-treatment-reduces-symptoms-preserves-sexual-function-in-men-with-enlarged-prostate?sc=mwhr&xy=10016681