Tamsulosin deprescribing for LUTS: N-of-1 trial

A RANDOMISED clinical trial has found that approximately one-third of older men receiving long-term tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) may derive little or no symptomatic benefit, suggesting they could be suitable candidates for a supervised deprescribing approach.

Researchers conducted a double-blind, placebo-controlled N-of-1 crossover trial to evaluate whether individualised treatment assessments could identify patients who no longer benefit from chronic tamsulosin therapy. Although tamsulosin is one of the most widely prescribed medications for LUTS attributed to BPH, its long-term effectiveness may vary substantially between individuals.

The study enrolled 31 men aged 55–80 years who had been taking tamsulosin continuously for at least 12 months. Following a 1-week placebo run-in, participants underwent two blocks of alternating 2-week treatment periods with tamsulosin (0.4 mg or 0.8 mg) and matching placebo, separated by 1-week washout intervals. Urinary symptoms were assessed daily using the American Urological Association Symptom Index (AUASI), adapted to a 24-hour recall period.

One-Third Showed Minimal Benefit

Of the 30 participants who attempted the full protocol, 11 (36.7%) demonstrated minimal or no benefit from tamsulosin compared with placebo, while another 11 (36.7%) experienced a moderate treatment effect. Four participants (13.3%) showed a strong symptomatic response to tamsulosin, whereas four (13.3%) were unable to tolerate the placebo run-in because of worsening urinary symptoms.

Across participants, responses to treatment varied considerably. Individual differences in AUASI scores ranged from a substantial improvement with tamsulosin to slightly worse symptom scores than placebo. At the group level, tamsulosin reduced daily AUASI scores by a mean of 2.96 points compared with placebo, highlighting an overall benefit but also marked heterogeneity in treatment response.

Implications For Deprescribing Tamsulosin

The authors suggest that N-of-1 deprescribing trials could offer a practical strategy for personalising long-term management of LUTS by distinguishing patients who continue to benefit from tamsulosin from those who may be able to discontinue treatment without symptom worsening. Given the potential adverse effects associated with long-term α-blocker use in older adults, including dizziness and falls, identifying patients who no longer require therapy may help reduce medication burden while maintaining symptom control.

As a proof-of-concept study conducted at a single academic centre with a small sample size, the findings require validation in larger and more diverse populations before routine implementation in clinical practice. Nevertheless, the results highlight the potential of individualised deprescribing strategies to optimise treatment for men with BPH-associated LUTS.

Reference

Bauer SR et al. Tamsulosin deprescribing for lower urinary tract symptoms in older men: a randomized clinical trial. JAMA Netw Open. 2026;9;(7):e2621639.

Featured image: Maria Vitkovska