Dutasteride Improves Nocturia but Does Not Lead to Better Sleep: Results from the REDUCE Clinical Trial.

PURPOSE In men, complaints of nocturia causing poor sleep are often attributed to benign prostatic hyperplasia (BPH) and treated with BPH medications. We assessed whether treating lower urinary tract symptoms (LUTS) with dutasteride altered either nocturia or sleep quality using data from REDUCE. MATERIALS AND METHODS REDUCE was a 4-year randomized, multi-center trial comparing dutasteride 0.5mg/day vs. placebo for prostate cancer chemoprevention. Study participants were men considered at increased risk of prostate cancer. Eligibility included age 50-75 years, PSA 2.5-10 ng/mL, and one negative prostate biopsy. At baseline, 2-years and 4-years, men completed the International Prostate Symptom Score (IPSS) and MOS Sleep Scale (MOSSS), a 6-item scale assessing sleep. To test differences in nocturia and MOSSS over time, we used linear mixed models adjusted for baseline confounders. Subanalyses were conducted in men symptomatic from LUTS, nocturia, poor sleep, or combinations thereof. RESULTS Of 6,914 men with complete baseline data, 80% and 59% were assessed at 2- and 4-year follow-up. Baseline characteristics were balanced between treatment arms. Dutasteride improved nocturia at 2 (-0.15, [-0.21,-0.09]) and 4 years (-0.24, [-0.31,-0.18]), but did not improve sleep. When limited to men symptomatic from LUTS, nocturia, poor sleep or combinations thereof, results mirrored findings from the full cohort. CONCLUSIONS In men with poor sleep who complain of nocturia, treatment of LUTS with dutasteride modestly improves nocturia but has no effect on sleep. These results suggest men with poor sleep who complain of nocturia may not benefit from oral BPH treatment.