RESUMEN
PURPOSE: To evaluate the efficacy and safety of adding a low-dose oral desmopressin to tamsulosin therapy for treatment of nocturia in patients with benign prostatic hyperplasia (BPH). METHODS: Eligible patients with BPH and nocturia ≥2/night were randomly allocated to two treatment groups; the first of which received 3-month treatment scheme of daily oral dose of tamsulosin OCAS 0.4 mg and desmopressin MELT 60 mcg (D/T group), while the second one received tamsulosin OCAS 0.4 mg only (T group). Patients were followed on monthly basis and changes in the parameters from baseline to 3 months after treatment were assessed on I-PSS/QoL questionnaire, 7-day voiding diary, urinalysis, serum sodium, abdominal ultrasonography and uroflowmetry. RESULTS: A total of 248 patients were included within the study; 123 patients in the combined D/T group and 125 patients in T group. The frequencies of night voids decreased by 64.3% in D/T group compared to 44.6% in T group. The first sleep period, significantly increased from 82.1 to 160.0 min and from 83.2 to 123.8 min in D/T and T group, respectively; and significant differences between both groups were observed at the end of study (p < 0.001). I-PSS, QoL score, post-void residual urine volume and Q max were significantly improved with no statistical difference between both groups. No serious adverse effects were reported in both groups. CONCLUSION: The addition of low-dose oral desmopressin therapy to an α-blocker tamsulosin provides effective treatment for nocturia in patients with LUTS/BPH.