Study suggests tamsulosin deprescribing may be appropriate for select men with BPH

A proof-of-concept randomized clinical trial found that one-third of older men receiving long-term tamsulosin (Flomax) for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) had minimal ongoing symptomatic benefit, raising the possibility that individualized deprescribing strategies could help reduce unnecessary medication exposure in selected patients.¹

Published in JAMA Network Open, the results highlight how much response varies from patient to patient once treatment has continued for years, and they offer a potential framework for deciding, on an individual basis, whether continued therapy is warranted.

“Tamsulosin is widely prescribed, but clinicians have little evidence to support whether it is providing meaningful benefit to an individual patient several years after treatment begins,” said lead author Scott R. Bauer, MD, ScM, associate professor of medicine, urology, epidemiology and biostatistics at the University of California, San Francisco (UCSF), in a news release on the results.² “Our findings suggest that long-term tamsulosin therapy should be periodically reassessed because the balance between benefit and harm may change over time.”

Trial evaluated individualized treatment response

Investigators from the UCSF conducted a single-center, randomized, double-blind, placebo-controlled multiple-crossover (N-of-1) clinical trial (NCT05415748) between September 2021 and July 2022. Men aged 55 to 80 years who had received continuous tamsulosin therapy for at least 12 months for LUTS attributed to BPH were eligible for enrollment.

The study used an N-of-1 methodology, in which each participant serves as his own control through repeated randomized treatment periods. Following a 1-week placebo run-in period, participants were randomly assigned to 2 blocks of alternating 2-week treatment periods with either tamsulosin (0.4 mg or 0.8 mg) or matching placebo, separated by 1-week washout intervals. The primary efficacy outcome was daily symptom assessment using an adapted 24-hour recall version of the American Urological Association Symptom Index (AUASI).

Among 31 enrolled participants, the mean age was 68.8 (SD, 5.7) years. At baseline, the mean AUASI score was 20.0 (SD, 5.9) and the mean bother score was 3.0 (SD, 1.5). Thirty participants attempted the full N-of-1 protocol. There were 4 participants (13.3%) who were unable to tolerate the 1-week placebo run-in because of symptom worsening, and thus 26 participants ultimately completed the full protocol.

Based on individualized treatment effects, the authors reported that 36.7% of patients experienced minimal or no effect of treatment, 36.7% experienced a moderate effect, and 13.3% of patients experienced a strong effect.

According to the authors, “Individual-level treatment effects did not vary by treatment sequence (F3 = 1.52; P = .21) or by baseline AUASI score (t24 = −0.79; P = .43).”

Individual mean differences in AUASI scores between tamsulosin and placebo ranged from −10.9 points (95% CI, −12.6 to −9.1) to 2.1 points (95% CI, 0.4 to 3.9). Across the study population, the mean difference was -2.96 AUASI points (95% CI, −4.37 to −1.54).

Adverse events were common, with 92.3% of participants reporting at least 1 day with an adverse event. The mean number of days with a possible adverse event was 34 days (SD, 18).

Personalized deprescribing may identify appropriate candidates

The investigators suggest that the marked heterogeneity in treatment response supports a more individualized approach to chronic alpha-blocker therapy rather than assuming continued benefit after years of treatment.

“We found that tamsulosin treatment response varied substantially from person to person and that an N-of-1 deprescribing trial can precisely measure how much benefit an individual is receiving from continued treatment,” said Bauer.² “The results of this small clinical trial suggest that we should reconsider the assumption that long-standing BPH medications should automatically be continued. For many older men, especially those taking several medications, periodically reassessing whether tamsulosin is still providing meaningful benefit is an important part of age-friendly, personalized BPH care.”

Findings should be interpreted cautiously

Although the results suggest that some patients may be appropriate candidates for discontinuation, the authors acknowledge several limitations. Notably, the trial included a small sample size and evaluated only 1 treatment schedule, consisting of 2-week treatment periods separated by 1-week washout intervals, although the authors noted that these durations were supported by a pharmacokinetic substudy and sensitivity analyses. The investigators also focused on patient-reported LUTS severity and did not collect objective measures such as urodynamics, uroflowmetry, prostate volume, or postvoid residual volume.

They emphasize that larger studies are needed to confirm these findings, identify predictors of sustained benefit, and determine whether N-of-1-guided deprescribing improves clinical outcomes.

REFERENCES
1. Bauer SR, Kenfield SA, Oni-Orisan A, et al. Tamsulosin deprescribing for lower urinary tract symptoms in older men: A randomized clinical trial. JAMA Netw Open. 2026;9(7):e2621639. doi:10.1001/jamanetworkopen.2026.21639

2. Should older men reassess their long-term prostate medications? News release. University of California, San Francisco. July 7, 2026. Accessed July 8, 2026. https://urology.ucsf.edu/news/all/202607/should-older-men-reassess-their-long-term-prostate-medications