Abstract

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• INTRODUCTION:

  The role of organized sleep in overall health and quality-of-life (QoL) is critical. Nocturia necessarily disrupts the normal sleep cycle and negatively impacts one’s health, work productivity, and QoL. We investigated, for the first time in an exploratory pilot, the effectiveness of mirabegron for improving sleep disturbance and nocturia.

  MATERIALS AND METHODS:

  This was a prospective, open-label 12-week trial evaluating the efficacy of mirabegron in 34 men and women with disordered sleep and lower urinary tract symptoms (LUTS). Subjects received mirabegron 25 mg daily for 4 weeks, then increased to 50 mg. Subjects completed the Patient-Reported Outcome Measurement Information System Sleep Disturbance Short Form (PROMIS-SDSF), Jenkins Sleep Scale (JSS), International Prostate Symptom Score (IPSS), voiding diaries, and QoL questionnaires.

  RESULTS:

  PROMIS-SDSF scores decreased from 26.5 points to 19.3, representing a categorical improvement from clinically 'mild' to 'none to slight' sleep disturbance (p < 0.001). JSS scores also decreased from 14.1 to 8.3 (p < 0.001). IPSS decreased from 21.0 to 12.4, denoting a categorical improvement from 'severe' to 'moderate' LUTS (p < 0.001). Voiding diaries revealed 1.9 fewer voids per day (p < 0.01) and 0.8 fewer nighttime voids (p < 0.05). QoL improved from 0% in subjects who selected 'mostly satisfied,' 'pleased,' or 'delighted' to 29.6% at follow up.

  CONCLUSIONS:

  Mirabegron use improves nocturia and produces rapid, durable, and clinically significant improvement in sleep disturbance and LUTS in males and females with urinary symptoms associated with disordered sleep.