Tamsulosin Deprescribing in Older Men With Lower Urinary Tract Symptoms

Key Takeaways

• Investigators categorized 36.7% as having minimal or no effect, 36.7% as having a moderate effect, 13.3% as having a strong effect, and 13.3% as not tolerating the placebo run-in.
• Daily AUASI-based symptom tracking was used in a placebo-controlled multiple crossover design among men aged 55 to 80 years who had taken tamsulosin for at least 12 months.
• Possible adverse reactions were common, daily assessment completion was high, and participants received individualized graphical results with an optional investigator review.

Daily urinary symptom scores were lower by a mean of 2.96 points with tamsulosin than with placebo, but the size of benefit varied markedly across participants.

The single-center, double-blind, placebo-controlled, multiple crossover randomized clinical trial was conducted in an academic urology setting. Participants were men aged 55 to 80 years with symptoms attributed to BPH who had used tamsulosin continuously for at least 12 months. Thirty-one men enrolled, 30 attempted the full protocol, mean age was 68.5 years, and baseline mean AUASI was 20.0. The protocol used a 1-week placebo run-in, then two 5-week cycles with alternating 2-week tamsulosin and placebo periods, 1-week washouts, and doses of 0.4 or 0.8 mg. Daily AUASI with a 24-hour recall was the primary efficacy outcome, and the design focused on each participant’s own treatment effect.

Response categories were based on the upper bound of each participant’s 95% CI for the tamsulosin-placebo AUASI difference. Minimal or no effect meant an upper bound of 0 or higher, moderate effect was greater than -6.0 but below 0, and strong effect was -6.0 or lower. Among the 30 men who attempted the protocol, 11 had minimal or no effect, 11 had a moderate effect, 4 had a strong effect, and 4 did not tolerate placebo run-in because symptoms worsened. Individual estimated treatment effects ranged from -10.9 (95% CI, -12.6 to -9.1) to 2.1 (95% CI, 0.4 to 3.9), and baseline severity was not associated with treatment effect. Some participants reported high perceived benefit from chronic therapy despite minimal measured response, highlighting wide variation in symptom benefit.

Adverse drug events were assessed daily with a 12-symptom bother scale, and the summary daily adverse-effect score ranged from 0 to 36. Among 26 protocol completers, 24 reported at least 1 day with a possible adverse drug reaction, and the mean number of such days was 34 (SD 18). Adverse effects were often similar during tamsulosin and placebo periods. Investigators cautioned that background symptoms or nocebo effects could have contributed to some reports. The monitored adverse-effect burden was common, but it was not confined to active-treatment periods.

Protocol completers submitted a mean of 53.5 daily AUASI assessments, and one participant withdrew during the first cycle for unrelated emergency knee surgery. At trial end, investigators shared a graphical summary of daily symptom responses and offered a phone review of results. Reported limitations included testing only one treatment-period length and one washout period, along with no urodynamics, uroflowmetry, prostate volume, or postvoid residual measures.

The authors also noted that the 24-hour recall AUASI lacked an established minimal clinically important difference, and generalizability beyond this small single-center cohort remained uncertain. Sensitivity analyses excluding the first 7 treatment days did not materially change the findings, and this proof-of-concept trial distinguished minimal responders from men with more substantial benefit within the study setting.