Objective: To determine the efficacy and safety of a diuretic agent, frusemide, combined with doxazosin in the treatment of nocturia in patients with benign prostate hyperplasia / lower urinary tract symptoms (BPH/LUTS).

Methods: Sixty-four BPH/LUTS patients with nocturia were equally randomized into two groups, one treated with doxazosin (4 mg/d), and the other with frusemide (40 mg/d) and doxazosin (4 mg/d), given 6 h before sleep, both for 4 weeks. Urine volume, IPSS, QOL, serum electrolytes, plasma osmolality were recorded and compared between the two groups before and after the treatment.

Results: Compared with the doxazosin group, the frusemide plus doxazosin group showed significantly reduced nocturia frequency (P < 0.01), increased daytime urine output (P < 0.01), decreased nocturia urine output (P < 0.01), unchanged total urine output (P > 0.05), improved IPSS and QOL (P < 0.05, P < 0.01), but with no remarkable differences in the levels of serum sodium, potassium, chlorine, and osmotic pressure (P > 0.05).

Conclusion: Four-week treatment with frusemide plus doxazosin was safe and effective for nocturia in patients with BPH/LUTS.

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