One in 3 older men may not benefit from tamsulosin

Clinical takeaway: For older men on chronic tamsulosin whose LUTS are stable or whose benefit is uncertain, consider a monitored deprescribing trial with symptom tracking rather than assuming lifelong therapy.

Tamsulosin is commonly continued long term for LUTS/BPH, but this trial suggests some older men may be taking it with minimal symptom benefit while still facing potential adverse effects.

In a double-blind, placebo-controlled N-of-1 randomized trial, 31 men aged 55 to 80 years who had used tamsulosin for at least 12 months underwent alternating 2-week periods of tamsulosin and placebo, separated by 1-week washouts. Participants completed about 54 daily LUTS assessments each using a 24-hour version of the American Urological Association Symptom Index (AUASI).

Among 30 men who attempted the protocol, responses varied markedly: 11 men (36.7%) had minimal or no symptomatic benefit from tamsulosin, 11 (36.7%) had a moderate benefit, 4 (13.3%) had a strong benefit, and 4 (13.3%) could not tolerate the placebo run-in because symptoms worsened. Individual changes in daily AUASI ranged from a 10.9-point improvement on tamsulosin to a 2.1-point worsening, while the average benefit across the group was a 3-point improvement.

Adverse-effect reporting was common: 24 of 26 protocol completers (92.3%) reported at least 1 day with a possible adverse drug reaction, though symptoms were often similar on placebo and tamsulosin. Notably, many men who ultimately had little or no measured benefit still reported baseline satisfaction with tamsulosin, highlighting the challenge of judging benefit without structured testing.

“The findings suggest that 1 in 3 older men” may be high-priority candidates for deprescribing, the authors wrote. An accompanying commentary highlighted the study as an important example of how personalized N-of-1 trials can help guide individual treatment decisions rather than relying solely on average trial results.

Source: Bauer SR, et al. (2026 July 6) JAMA Netw Open. Tamsulosin Deprescribing for Lower Urinary Tract Symptoms in Older Men: A Randomized Clinical Trial