Division of Urology, Southern Illinois University School of Medicine, Springfield, Illinois, USA.
Can J Urol. 2020 Feb;27(1):10106-10117.
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.
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.
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.
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.
有组织的睡眠在整体健康和生活质量（QoL）中起着至关重要的作用。夜尿症必然会打乱正常的睡眠周期，对健康、工作效率和生活质量产生负面影响。我们首次在探索性试点研究中调查了米拉贝隆在改善睡眠障碍和夜尿症方面的有效性。
这是一项前瞻性、开放标签的 12 周试验，评估米拉贝隆对 34 名睡眠障碍和下尿路症状（LUTS）男性和女性的疗效。受试者接受米拉贝隆 25mg 每日一次，持续 4 周，然后增加至 50mg。受试者完成了患者报告的结局测量信息系统睡眠障碍简短表格（PROMIS-SDSF）、詹金斯睡眠量表（JSS）、国际前列腺症状评分（IPSS）、排尿日记和生活质量问卷。
PROMIS-SDSF 评分从 26.5 分降至 19.3 分，代表睡眠障碍从临床“轻度”到“无至轻度”的分类改善（p < 0.001）。JSS 评分也从 14.1 分降至 8.3 分（p < 0.001）。IPSS 从 21.0 分降至 12.4 分，表示 LUTS 从“严重”到“中度”的分类改善（p < 0.001）。排尿日记显示每天排尿次数减少 1.9 次（p < 0.01），夜间排尿次数减少 0.8 次（p < 0.05）。生活质量从选择“大多满意”、“高兴”或“欣喜”的受试者的 0%提高到随访时的 29.6%。
米拉贝隆的使用可改善夜尿症，并迅速、持久、显著改善与睡眠障碍相关的男性和女性的尿路症状引起的睡眠障碍和 LUTS。
