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Men with benign prostatic hyperplasia (BPH) may benefit from a combination of tamsulosin and mirabegron, according to new research presented at the American Urological Association (AUA) 2026 Annual Meeting.

In the multicenter, randomized, double-blind, phase 3 clinical trial, men who took the combination treatment reported urinating less frequently and experienced significant improvement in other symptoms of BPH than those on monotherapy, the researchers reported.

Although the size of improvement was small, Donald Neff, MD, the director of benign prostatic disease at the University of Kansas Medical Center in Kansas City, Kansas, who was not involved with the research, said he was happy with the findings.

“These are the types of patients I see all the time, and this provides more data to support this medication combination,” Neff said. “This trial gives me better evidence to start combination therapy earlier in men who present with mixed symptoms, rather than making them fail tamsulosin alone for 3-6 months first.”

Tamsulosin, an alpha-1 adrenoceptor antagonist, is approved for the treatment of BPH, and mirabegron, a beta-3 adrenergic agonist, is approved for the treatment of overactive bladder.

The study — from Tae Hyo Kim, MD, of the Department of Urology at Dong A University School of Medical in Busan, Korea, and colleagues — also was published in The World Journal of Men’s Health.

The researchers analyzed data from 795 men aged 40 years or older with a confirmed diagnosis of BPH, an International Prostate Symptom Score (IPSS) ≥ 13, and a voiding frequency of at least eight times per day. Of those, 397 received 0.4 mg of tamsulosin and 398 received 50 mg of mirabegron and 0.4 mg of tamsulosin daily.

The main endpoints were change in the IPSS and lower urinary tract symptoms (LUTS).

Men who took the combination treatment experienced better total urinary frequency and the IPSS than those who received tamsulosin alone (P < .0001 and P = .0325, respectively). Those on the combination regimen also reported significant improvement in daytime frequency, urgency, and incontinence compared with those on monotherapy.

“Compared to tamsulosin monotherapy, combination therapy with mirabegron 50 mg and tamsulosin 0.4 mg significantly improves LUTS in patients with BPH, particularly storage symptoms, without increasing adverse events. This combination therapy represents a promising treatment option,” the researchers wrote.

Treatment-emergent adverse events were similar between the groups (13.10% vs 16.58%; P =.1943), with no serious complications reported.

The findings reinforce the understanding that BPH symptoms can fall into two groups, said Tal Cohen, MD, a clinical assistant professor at the Stony Brook University in Stony Brook, New York.

“The way people are thinking about it now is [there are] different categories to these symptoms in men: [There are] more emptying-related issues, which could be related to the prostate, and then [there are] people that are experiencing more storage-related symptoms and that can be more of an overactive bladder,” said Cohen, who was not involved in the research. Emptying symptoms include weak urine stream, starting and stopping urination, or taking time to start urinating, he said, while storage symptoms include frequent urination.

Current guidelines from the AUA and other recent research support the use of mirabegron in certain symptomatic patients with BPH, according to Sender Herschorn, MDCM, chair of functional urology and a professor of surgery and urology at the University of Toronto in Toronto, Ontario, Canada. The new study “confirms previous research,” said Herschorn, who was not involved in the work but who helped conduct a phase 4 trial which added mirabegron to tamsulosin treatment of BPH. “The difference from previous research is the administration of a combination up front rather than adding in mirabegron. The study shows that an up-front combination may be of benefit. However, some patients may improve with tamsulosin alone and not need a second drug.”

Herschorn said he would like to see more long-term outcomes, the effect of prostate size on the results, and information about treatment failure. “My main challenge is treating failures of therapy, especially with persistent overactive bladder or storage symptoms,” he said.

But overall, the research supports a combination that can help. “If a patient has persistent urgency, we haven’t failed to treat the BPH, we haven’t addressed the bladder problem,” Neff said. “That is where mirabegron and other treatments directed at the bladder come in, and where this study helps guide us.”

Cohen, Herschorn, and Neff reported having no relevant financial disclosures. The study was funded by KyungDong Pharmaceutical Co., Ltd. 

Meaghan Lee Callaghan is a science journalist based outside of New York City. Her work has appeared in Audubon, Infectious Disease Special Edition, Popular Science, and Scientific American, among other places.