Introduction

Older men commonly complain of needing to urinate frequently during the night (nocturia) leading to a lack of sleep and not feeling rested in the morning. We assessed, within the context of REDUCE, a randomized controlled trial of dutasteride use, whether treating lower urinary tract symptoms (LUTS) with dutasteride altered either nocturia or sleep complaints.

Methods

REDUCE was a randomized trial comparing dutasteride 0.5mg/day vs. placebo for chemoprevention of prostate cancer. At baseline, 2-years and 4-years, men completed the International Prostate Symptom Score (IPSS) survey and the MOSSS-6 questionnaire, a 6-item scale that assesses sleep and is scored 1-100. To test the differences in IPSS (and specifically nocturia) and MOSSS over the study, we used linear mixed models with predictors of treatment, visit, and the interaction between treatment and visit. Models were adjusted for baseline age, digital rectal exam findings, PSA, body mass index, race, smoking status, prostate volume, diabetes, and geographical region. Linear contrasts were used to summarize the effect of treatment on each outcome at each study visit. Subanalyses were conducted in men who were symptomatic (IPSS ≥8) and men with ≥2 nocturia episodes a night at baseline.

Results

There were 6915 patients with complete baseline data. Baseline characteristics were balanced between treatment arms. Dutasteride resulted in significant improvements in IPSS at 2-years (p<0.001) and 4-years (p<0.001) as well as specifically nocturia episodes at 2-years and (p=0.005) 4-years (p<0.001). In contrast, treatment with dutasteride had no effect on overall sleep function nor any specific domain of sleep including feeling rested in the morning or getting enough sleep (p>0.1 at all visits). When analyses were limited to symptomatic men (IPSS ≥8) or men with ≥2 nocturia episodes per night, results were unchanged in that dutasteride improved LUTS including nocturia but had no effect on sleep function including feeling rested in the morning or getting enough sleep.

Conclusions

In men who complain of nocturia resulting in not getting enough sleep, treatment of LUTS with dutasteride significantly improves LUTS but has no effect on sleep including feeling rested in the morning or getting enough sleep. These results suggest in men with nocturia who complain of poor sleep, the poor sleep is not likely to be due to LUTS but rather likely represents a primary sleep problem. Consideration should be given to referring these men to sleep experts to evaluate for sleep problems like sleep apnea or insomnia.

Funding

none