Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8522, Japan.
BMC Urol. 2020 Jul 11;20(1):96. doi: 10.1186/s12894-020-00668-5.
Nocturia is one of the most bothersome lower urinary tract symptoms and often impairs sleep quality in the elderly. Although previous studies on nocturia have indicated that the successful treatment of nocturia improves sleep quality, most used questionnaires and activity devices to analyze sleep/wake patterns. Therefore, there is little information about the treatment effects of desmopressin on objective sleep quality. The aim of the DISTINCT study is to investigate the change in subjective and objective sleep quality using electroencephalography (EEG) and the Pittsburgh Sleep Quality Index (PSQI) after the administration of desmopressin in patients with nocturia due to nocturnal polyuria.
A total of 20 male patients, ≥65 years old, with nocturnal polyuria, defined as a nocturnal polyuria index (NPi) (nocturnal urine volume / 24 h urine volume) value ≥0.33, will participate in this study. The participants must have a nocturnal frequency of ≥2 and the first uninterrupted sleep period (FUSP) must occur within < 2.5 h. Desmopressin 50 μg per day will be orally administered before going to bed for 4 weeks. Urinary frequency volume charts (FVC) and EEG will be recorded prior to treatment and at 1 week and 4 weeks after the initiation of treatment. The PSQI will be completed before and 4 weeks after treatment. The primary endpoint is the change from baseline in the mean time of slow-wave sleep (sleep stages N3 and N4) at 4 weeks. The secondary endpoints include the change in the mean value of each sleep variable, the mean delta power during the FUSP, the correlation between nocturnal urinary frequency and slow-wave sleep time, and the change in PSQI score before and after treatment.
The DISTINCT study will provide valuable evidence to indicate that oral desmopressin treatment for nocturnal polyuria prolongs the FUSP, resulting in the extension of slow-wave sleep time associated with sleep quality.
The Japan Registry of Clinical Trials ( jRCTs051190080 ). Registered 9 December, 2019.
夜尿症是最恼人的下尿路症状之一，常导致老年人睡眠质量下降。尽管先前关于夜尿症的研究表明，成功治疗夜尿症可以改善睡眠质量，但大多数研究使用问卷和活动设备来分析睡眠/觉醒模式。因此，关于去氨加压素治疗对客观睡眠质量的影响的信息很少。DISTINCT 研究的目的是使用脑电图（EEG）和匹兹堡睡眠质量指数（PSQI）调查由于夜间多尿引起的夜尿症患者在服用去氨加压素后主观和客观睡眠质量的变化。
共有 20 名年龄≥65 岁的男性患者，有夜间多尿症，定义为夜间多尿指数（NPi）（夜间尿量/24 小时尿量）值≥0.33，将参与本研究。参与者必须有≥2 次夜间排尿频率，并且第一个不间断的睡眠期（FUSP）必须在<2.5 小时内发生。在睡前每天口服 50μg 去氨加压素，持续 4 周。在治疗前、治疗后 1 周和 4 周记录排尿频率体积图（FVC）和 EEG。在治疗前和治疗后 4 周完成 PSQI。主要终点是治疗 4 周时慢波睡眠（睡眠阶段 N3 和 N4）的平均时间的基线变化。次要终点包括每个睡眠变量的平均值变化、FUSP 期间平均 delta 功率、夜间排尿频率与慢波睡眠时间的相关性以及治疗前后 PSQI 评分的变化。
DISTINCT 研究将提供有价值的证据表明，口服去氨加压素治疗夜间多尿症可延长 FUSP，从而延长与睡眠质量相关的慢波睡眠时间。
日本临床试验注册处（jRCTs051190080）。注册于 2019 年 12 月 9 日。
