Research Summary

One-Third of Older Men on Chronic Tamsulosin May Be Candidates for Deprescribing

Edited by:
Ashton L. Stahl

Key Highlights

  • Approximately one-third of participants had minimal or no symptomatic benefit from tamsulosin compared with placebo.
  • Individual treatment effects ranged from a 10.9-point improvement to a 2.1-point worsening on the daily AUASI.
  • Four participants could not tolerate the placebo run-in period due to worsening urinary symptoms.

Treatment response to chronic tamsulosin varied substantially among older men with lower urinary tract symptoms (LUTS), according to a randomized clinical trial published in JAMA Network Open. The findings suggest that placebo-controlled N-of-1 trials may help identify patients who receive minimal symptomatic benefit and could be candidates for deprescribing.

Researchers conducted a 12-week, double-blind, placebo-controlled, multiple-crossover trial at the University of California, San Francisco, between September 2021 and July 2022. Participants were men aged 55 to 80 years who had used tamsulosin continuously for at least 12 months for symptoms attributed to benign prostatic hyperplasia. Following a 1-week placebo run-in, participants were randomly assigned to 2 cycles of alternating 2-week tamsulosin and placebo periods separated by 1-week washouts. Tamsulosin was administered at each participant’s established dose of 0.4 or 0.8 mg. The primary outcome was the daily American Urological Association Symptom Index (AUASI), modified to use a 24-hour recall period.

Study Findings

Among 31 enrolled participants, the mean age was 68.5 years, and the mean baseline AUASI score was 20. Four participants discontinued during the placebo run-in due to worsening LUTS, 1 withdrew because of an unrelated emergency surgery, and 26 completed the full N-of-1 protocol.

Of the 30 participants who attempted the protocol, 11 (36.7%) had minimal or no response to tamsulosin, 11 (36.7%) had a moderate response, and 4 (13.3%) had a strong response. The remaining 4 participants (13.3%) were unable to tolerate the placebo run-in.

The estimated individual differences in daily AUASI scores between tamsulosin and placebo ranged from −10.9 (95% CI, −12.6 to −9.1) to 2.1 (95% CI, 0.4 to 3.9). The group-level mean difference was −2.96 points (95% CI, −4.37 to −1.54). Treatment effects did not differ significantly according to treatment sequence or baseline AUASI score.

Possible adverse drug reactions were reported on at least 1 day by 24 of the 26 participants who completed the protocol. For most participants, however, the frequency of adverse effects was similar during tamsulosin and placebo treatment.

Clinical Implications

According to the study authors, approximately 1 in 3 older men receiving chronic tamsulosin may obtain minimal symptomatic benefit and could be prioritized for carefully monitored deprescribing. The findings also support individualized medication trials instead of assuming that tamsulosin should be continued indefinitely.

The study was limited by its small, predominantly White sample from a single academic urology center. The modified 24-hour AUASI also lacks an established minimal clinically important difference, and the trial was not powered to identify predictors of treatment response or assess long-term outcomes.

Expert Commentary

“This study highlights the need to counsel patients on the heterogeneity of tamsulosin treatment effects and supports the clinical use of empiric tamsulosin trials rather than lifelong therapy,” the researchers concluded.

Reference

Bauer SR, Kenfield SA, Oni-Orisan A, et al. Tamsulosin deprescribing for lower urinary tract symptoms in older men: a randomized clinical trial. JAMA Netw Open. 2026;9(7):e2621639. doi:10.1001/jamanetworkopen.2026.21639