Tamsulosin Deprescribing for Lower Urinary Tract Symptoms in Older Men

Importance: Tamsulosin is the most common treatment for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). The ability of N-of-1 deprescribing trials to identify who may benefit from discontinuing chronic tamsulosin therapy is unknown. Objective: To determine if N-of-1 deprescribing trials can identify older men who are receiving minimal benefit from tamsulosin therapy for LUTS. Design, Setting, and Participants: Double-blind, placebo-controlled, multiple crossover (N-of-1) randomized clinical trial conducted at a single academic urology department between September 2021 and July 2022. After a 1-week placebo run-in, men aged 55 to 80 years who were continuous users of tamsulosin for at least 12 months to treat symptoms of BPH were randomly assigned to 2 blocks of 2-week treatment periods alternating tamsulosin and placebo, separated by 1-week washout periods. Data were analyzed from November 2022 to October 2024. Intervention: Tamsulosin, dosed at either 0.4 mg or 0.8 mg, vs matching placebo. Main Outcomess and Measures: The efficacy outcome was daily American Urological Association Symptom Index (AUASI) with an adapted recall period of 24 hours. Effect size was categorized based on the upper bound of the individual 95% CI for the tamsulosin-placebo difference in daily AUASI: minimal or no (≥0), moderate (>-6.0 to