Treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) with the Optilume BPH Catheter System appears to preserve erectile and ejaculatory function in addition to providing relief from LUTS, according to a study presented at the 2024 American Urological Association (AUA) Annual Meeting in San Antonio, Texas.
The Optilume BPH Catheter System is a minimally invasive surgical treatment consisting of a drug-coated (paclitaxel) balloon system. Data from the randomized controlled trial were presented by Olivia Copelan, MD, a urology resident at Loyola Medicine in Chicago, Illinois. For the study, Copelan and her colleagues randomly assigned 148 subjects 2:1 to receive Optilume BPH or a sham procedure. One hundred patients received Optilume BPH and 48 patients received a sham. Patients were assessed at baseline using the International Index of Erectile Function (IIEF) and Men’s Sexual Health Questionnaire – Ejaculatory Dysfunction (MSHQ-EjD). Sexual function assessments were conducted for the entire cohort at baseline and at 3, 6, and 12 months after treatment. The International Prostate Symptom Score (IPSS) was used to evaluated symptoms. In addition, the investigators assessed semen paclitaxel concentration and semen quality parameters in the PK sub-study cohort at baseline, and at 1, 3, and 6 months post treatment.
Demographics were similar between the 2 arms, and no difference was noted in the sexually active vs non-sexually active patients. “Our results demonstrated that treatment with [the] Optilume BPH procedure resulted in significant symptom relief while still preserving erectile and ejaculatory function,” Copelan said during her presentation at the AUA Annual Meeting. The IIEF-EF and MSHQ-EjD scores for patients in the Optilume BPH group were not different from patients in the sham group at 3, 6, or 12 months. In addition, the “change in IIEF-EF remained consistent across all levels of baseline ED severity,” the investigators wrote in their poster. They also reported that there was no significant change in semen quality parameters post procedure.
Also during the AUA Annual Meeting, Steven A. Kaplan, MD, presented 2-year results from the PINNACLE trial and 5-year data from the EVEREST trial. Kaplan, professor of urology at Icahn School of Medicine at Mount Sinai and director of the Men’s Wellness Program at Mount Sinai Health System in New York City, New York, reported from PINNACLE a sustained maximum flow rate (Qmax) of 19.0 mL/sec at 2 years vs 19.0 mL/sec at 12 months, as well as a 53% decrease in IPSS. In the EVEREST study, “results show an improved Qmax of 20.6mL/sec and an IPSS decrease of 10.2 points vs baseline, with a retreatment rate of 3.8% (1.3% surgical and 2.5% medical),” according to the release.
“Optilume for BPH is an exciting therapy that offers a safe, effective, and minimally invasive procedure for men suffering from BPH. The long-term results from both trials show positive outcomes for men suffering from BPH who undergo this minimally invasive procedure,” Kaplan said in the release.
In the United States, the Optilume BPH Catheter System was approved by the FDA on June 30, 2023, for the treatment of patients with LUTS secondary to BPH. The approval was supported by data from the PINNACLE and EVEREST trials.
