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A postmarketing study showed that the Optilume BPH system improved the flow of urine while leaving sexual function unchanged in men with benign prostatic hyperplasia (BPH), researchers reported at the American Urological Association 2025 Annual Meeting.

Approved by the US Food and Drug Administration in 2023, the Optilume BPH devices uses balloons to dilate the anterior commissure of the prostate, which connects the two lobes of the gland, and the roof of the prostatic urethra. A slow-release coating of paclitaxel on one of the balloons shrinks the prostatic tissue and prevents it from closing around the opening to enhance the enhanced flow of urine.

The new study, from 30 men participating in the SUMMIT study, provides encouraging 1-year data on the effectiveness of the approach, said Dean Elterman, MD, MSc, associate professor of urology at the University of Toronto, Toronto, Ontario, Canada, who presented the findings.

“We saw all the things we expected to see in this type of study, such as a good improvement in their symptoms and improvement in their flow and emptying of their bladders,” Elterman told Medscape Medical News. 

The trial found sustained improvement in maximum urinary flow and postvoid volume of residual urine after treatment with the device: Maximum urinary flow increased 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 said men reported significant improvements in quality of life a year after treatment, and none said they had experienced problems with erections or ejaculations as a result of the therapy. 

Zachary Glaser, MD, urologist at Rush University Medical Center in Chicago, called the results “very exciting. There is limited data beyond 5 years postoperatively, but the short-term data with 1-5 years of follow-up is robust and quite promising from an avoiding and sexual health standpoint,” Glaser said. “I’d be very, very curious to see if this is something that remains durable for greater than 10-15 years after treatment.”

Two main advantages of Optilume BPH over techniques such as transurethral resection or holmium laser enucleation of the prostate and aquablation are that it does not involve any incisions or cutting of tissue and that the approach preserves antegrade ejaculation, Glaser said. As a result, the treatment may be particularly appealing to younger men who want either to preserve their fertility or maintain the ability to conceive without assistance or who would be bothered by retrograde ejaculation.

However, he said, the therapy requires a catheter to be left in the urethra for several days, and in some cases, men should use a condom because the paclitaxel can pass to a female partner during sex, raising the risk for birth defects should she become pregnant. Men taking blood thinners also may experience more issues with blood in the urine, Glaser added.

Elterman is an investigator for Laborie Medical Technologies, which supplied the catheters for the study.

Howard Wolinsky is a medical journalist in Chicago.