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In an RCT, dutasteride significantly reduced total International Prostate Symptom Score in men with lower urinary tract symptoms over 24 months.

In an RCT, dutasteride significantly reduced total International Prostate Symptom Score in men with …
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Key Takeaway
Consider dutasteride for LUTS; significantly improved total IPSS and voiding at 24 months, but safety data not reported.

This randomized controlled trial evaluated the efficacy of dutasteride versus placebo in men with lower urinary tract symptoms. The study included a sample size of 8122 participants and maintained a follow-up duration of 24.0 months. The primary outcome assessed was the International Prostate Symptom Score and its subscores.

At the 24-month mark, dutasteride resulted in a significantly reduced total International Prostate Symptom Score compared to placebo, with a p-value of < 0.001. Similarly, the voiding subscore was significantly reduced (p < 0.001). However, storage symptoms showed no significant reduction (p = 0.09), and nocturia was not significantly reduced (p = 0.2) at this time point.

Longer-term analysis at 4 years indicated improvement in storage symptoms by 0.62 points (p < 0.001) and improvement in nocturia (p = 0.003). The study did not report adverse events, serious adverse events, discontinuations, or tolerability data. No limitations were explicitly listed in the provided data, and funding or conflicts of interest were not reported.

The practice relevance suggests that timely, comprehensive management of lower urinary tract symptoms may require additional therapy. Clinicians should interpret these findings with caution given the lack of reported safety data and the specific timing of symptom improvements.

Study Details

Study typeRct
EvidenceLevel 2
Follow-up24.0 mo
PublishedDec 2026
View Original Abstract ↓
BACKGROUND: Dutasteride is used to treat voiding symptoms; its impact on storage symptoms is unclear. METHODS: We reviewed 8122 men in the placebo and dutasteride arms from the REDUCE trial. Lower urinary tract symptoms outcomes were measured with international prostate symptom score and subscores. RESULTS: At 2-year follow-up, dutasteride significantly reduced the total International Prostate Symptom Score and voiding subscore versus placebo (both < 0.001), but not storage symptoms (= 0.09) or nocturia (= 0.2). By 4 years, improvements in the total score and voiding subscores remained, but now extended to storage symptoms (< 0.001) and nocturia (= 0.003), though the impact on storage symptoms was modest (0.62 points improvement). CONCLUSION: While dutasteride reduces storage symptoms, it takes several years, and the overall effect is modest and unlikely to be clinically meaningful. Timely, comprehensive lower urinary tract symptoms management may require additional therapy.
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