A postmarketing examine confirmed that the Optilume BPH system improved the circulation of urine whereas leaving sexual operate unchanged in males with benign prostatic hyperplasia (BPH), researchers reported on the American Urological Affiliation 2025 Annual Assembly.
Accepted by the US Meals and Drug Administration in 2023, the Optilume BPH units makes use of balloons to dilate the anterior commissure of the prostate, which connects the 2 lobes of the gland, and the roof of the prostatic urethra. A slow-release coating of paclitaxel on one of many balloons shrinks the prostatic tissue and prevents it from closing across the opening to reinforce the improved circulation of urine.
The brand new examine, from 30 males collaborating within the SUMMIT examine, supplies encouraging 1-year knowledge on the effectiveness of the method, mentioned Dean Elterman, MD, MSc, affiliate professor of urology on the College of Toronto, Toronto, Ontario, Canada, who introduced the findings.
“We noticed all of the issues we anticipated to see in such a examine, corresponding to enchancment of their signs and enchancment of their circulation and emptying of their bladders,” Elterman informed Medscape Medical Information.
The trial discovered sustained enchancment in most urinary circulation and postvoid quantity of residual urine after therapy with the machine: Most urinary circulation elevated from 7.9 mL/s at baseline to 16.4 mL/s at 12 months, and postvoid residual urine declined from a baseline of 77.5 to 68.1 mL at 12 months (P < .05).
Elterman mentioned males reported important enhancements in high quality of life a yr after therapy, and none mentioned they’d skilled issues with erections or ejaculations because of the remedy.
Zachary Glaser, MD, urologist at Rush College Medical Middle in Chicago, referred to as the outcomes “very thrilling. There’s restricted knowledge past 5 years postoperatively, however the short-term knowledge with 1-5 years of follow-up is strong and fairly promising from an avoiding and sexual well being standpoint,” Glaser mentioned. “I’d be very, very curious to see if that is one thing that is still sturdy for larger than 10-15 years after therapy.”
Two principal benefits of Optilume BPH over methods corresponding to transurethral resection or holmium laser enucleation of the prostate and aquablation are that it doesn’t contain any incisions or slicing of tissue and that the method preserves antegrade ejaculation, Glaser mentioned. In consequence, the therapy could also be notably interesting to youthful males who need both to protect their fertility or preserve the flexibility to conceive with out help or who can be bothered by retrograde ejaculation.
Nevertheless, he mentioned, the remedy requires a catheter to be left within the urethra for a number of days, and in some instances, males ought to use a condom as a result of the paclitaxel can go to a feminine companion throughout intercourse, elevating the danger for beginning defects ought to she change into pregnant. Males taking blood thinners additionally might expertise extra points with blood within the urine, Glaser added.
Elterman is an investigator for Laborie Medical Applied sciences, which equipped the catheters for the examine.
Howard Wolinsky is a medical journalist in Chicago.
