The most popular medication for benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms is tamsulosin. It is uncertain if N-of-1 deprescribing studies can determine who could benefit from stopping long-term tamsulosin medication. Thus, this study looked if N-of-1 deprescribing trials can identify older men who are not benefiting much from tamsulosin medication for LUTS.
A clinical study was carried out at a single university urology department between September 2021 and July 2022. After a 1-week placebo run-in, males aged 55 to 80 years who had been using tamsulosin for at least 12 months to treat BPH symptoms were randomly allocated to two blocks of two-week treatment periods alternating between tamsulosin and placebo, separated by one-week washout periods.
The effectiveness endpoint was the daily American Urological Association Symptom Index (AUASI), with a 24-hour adaptive recall time. The effect magnitude was characterized based on the upper bound of the individual 95% CI for the tamsulosin-placebo difference in daily AUASI: minimum (≥0), moderate (>−6.0 to <0), or strong (≤−6.0). Adverse medication events were monitored on a daily basis as a secondary outcome. At baseline, demographics, clinical features, and attitudes toward deprescribing were all examined.
The mean (SD) age of the 31 participants was 68.8 (5.7) years.
Of the thirty individuals who tried the entire N-of-1 regimen, eleven (36.7%) had little to no tamsulosin effect, eleven (36.7%) had a moderate impact, four (13.3%) had a strong effect, and four (13.3%) were unable to endure the one-week placebo run-in because of deteriorating symptoms.
The individual-level estimated mean difference in daily AUASI between tamsulosin and placebo varied from −10.9 (95% CI, −12.6 to −9.1) to 2.1 (95% CI, 0.4 to 3.9) based on a mean (SD) of 54 (3) daily LUTS examinations per participant.
The daily AUASI mean difference at the group level was −2.96 (95% CI, −4.37 to −1.54).
Overall, many older men with lower urinary tract symptoms can safely stop using tamsulosin, according to an N-of-1 crossover experiment, which showed extremely diverse reactions to the drug.
Reference:
Bauer, S. R., Kenfield, S. A., Oni-Orisan, A., Shlipak, M. G., Lu, K., Rios, N., Pearce, R., Harmon, J., McCulloch, C. E., Huang, L., Steinman, M. A., & Breyer, B. N. (2026). Tamsulosin deprescribing for lower urinary tract symptoms in older men: A randomized clinical trial: A randomized clinical trial. JAMA Network Open, 9(7), e2621639. https://doi.org/10.1001/jamanetworkopen.2026.21639
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