THURSDAY July 9, 2026 (HealthDay News) -- For men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) who are continuous users of tamsulosin, about one-third have minimal or no tamsulosin effect, according to a study published online July 6 in JAMA Network Open.
Scott R. Bauer, M.D., from the University of California in San Francisco, and colleagues conducted a double-blind, placebo-controlled, multiple crossover (N-of-1) randomized clinical trial involving men aged 55 to 80 years who were continuous users of tamsulosin for at least 12 months to treat symptoms of BPH. After a one-week placebo run-in, participants were randomly assigned to two blocks of two-week treatment periods alternating tamsulosin and placebo, separated by one-week washout periods.
The researchers found that of the 30 participants who attempted the full N-of-1 protocol, 11, 11, four, and four (36.7, 36.7, 13.3, and 13.3 percent, respectively) had minimal or no tamsulosin effect, had a moderate effect, had a strong effect, and did not tolerate the one-week run-in due to worsening symptoms, respectively. The individual-level estimated mean difference in daily American Urological Association Symptom Index (AUASI) between tamsulosin and placebo ranged from −10.9 to 2.1 based on a mean of 54 daily LUTS assessments per participant. In daily AUASI, the group-level mean difference was −2.96.
"We found that tamsulosin treatment response varied substantially from person to person and that an N-of-1 deprescribing trial can precisely measure how much benefit an individual is receiving from continued treatment," Bauer said in a statement. "The results of this small clinical trial suggest that we should reconsider the assumption that long-standing BPH medications should automatically be continued. For many older men, especially those taking several medications, periodically reassessing whether tamsulosin is still providing meaningful benefit is an important part of age-friendly, personalized BPH care."
One author disclosed ties to Fellow Health; a second author disclosed ties to the pharmaceutical industry.
