Tamsulosin Deprescribing for Lower Urinary Tract Symptoms in Older Men: A Randomized Clinical Trial

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.

To determine if N-of-1 deprescribing trials can identify older men who are receiving minimal benefit from tamsulosin therapy for LUTS.

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.

Tamsulosin, dosed at either 0.4 mg or 0.8 mg, vs matching placebo.

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 <0), or strong (≤-6.0) effect. Adverse drug events were assessed daily as a secondary outcome. Demographics, clinical characteristics, and attitudes toward deprescribing were assessed at baseline.

Among the 31 participants enrolled, the mean (SD) age was 68.8 (5.7) years. Of 30 participants who attempted the full N-of-1 protocol, 11 (36.7%) had minimal or no tamsulosin effect, 11 (36.7%) had moderate effect, 4 (13.3%) had strong effect, and 4 (13.3%) did not tolerate the 1-week placebo run-in due to worsening symptoms. Based on a mean (SD) of 54 (3) daily LUTS assessments per participant, individual-level estimated mean difference in daily AUASI 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 in daily AUASI was -2.96 (95% CI, -4.37 to -1.54).

In this randomized N-of-1 clinical trial of tamsulosin deprescribing, treatment response was heterogeneous. The findings suggest that 1 in 3 older men who had minimal symptomatic benefit from tamsulosin may be high-priority candidates for deprescribing.

ClinicalTrials.gov Identifier: NCT05415748.