Desmopressin in the Treatment of Mixed Nocturia With Nocturnal Polyuria and Low Nocturnal Bladder Capacity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 6
- 主要终点
- Proportion of patients with a 50% or greater reduction in the mean number of nocturnal voids compared with baseline levels.
研究概览
简要总结
Nocturia is defined as waking one or more times to void during the period between going to bed with the intention of sleeping and waking with the intention of arising.The pathophysiology of nocturia is multifactorial and can be complex. Therefore it is important to adopt a systematic approach to identify the possible causal factors of nocturia and to treat them accordingly. Patients with nocturia can be categorized as having one of the following three disorders: (1) nocturnal polyuria (NP) in which the voided urine volume during the hours of sleep exceeds 35% of the 24-hr output, (2) low nocturnal bladder capacity (NBC) causing a nocturnal urinary volume greater than the bladder capacity, (3) or mixed nocturia, a combination of the preceding two categories.
Desmopressin, a synthetic analogue of the antidiuretic hormone (ADH), has been used for many years to treat diabetes insipidus and primary nocturnal enuresis.More recently, it is also known to be effective against nocturia with NP by decreasing night-time urine production.However, it may be associated with an increased risk of developing hyponatremia due to water retention, especially in elderly patients.In the present study, we investigated the safety and efficacy of oral desmopressin for the treatment of mixed nocturia in patients with both NP and a low NBC.
详细描述
- Open label, prospective, multicenter study
- Study design
- screening (1-week), dose titration (1-3 weeks) and 4-weeks of treatment period
- open-label dose-titration periods of up to 3 wk; the patients' optimum oral desmopressin dose (0.1, 0.2 and 0.4 mg) was determined as the dose that decreased the number of nocturnal voids by ≥50% and NUV decreased by ≥20% without hyponatremia.
- If the patients did not meet the above criteria during dose titration period, they received the maximum tolerable dose instead of the optimum dose. -- 4-weeks of treatment period; Eligible patients were treated with the determined optimum desmopressin dose for 4-weeks.
- Measurements
- 3-day frequency-volume charts
- sleep questionnaire
- body weight, blood and urine analysis,serum sodium monitoring
- adverse event
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥18 yr
- •nocturia ≥2 voids/night
- •nocturnal polyuria index (NPi) >33%
- •nocturnal bladder capacity index (NBCi) >1
排除标准
- •nocturia due to other defined causes of increased urinary frequency
- •primary polydipsia (>40mL/kg/24 h)
- •neurogenic bladder dysfunction
- •significant bladder outlet obstruction
- •urge incontinence
- •continued post-voiding residual urine >150mL
- •serum sodium levels <135mmol/L
- •uncontrolled hypertension characterized by fluid and/or electrolyte imbalance
- •use of diuretics
- •actual or planned pregnancy
研究组 & 干预措施
Desmopressin
干预措施: Desmopressin (Drug)
结局指标
主要结局
Proportion of patients with a 50% or greater reduction in the mean number of nocturnal voids compared with baseline levels.
时间窗: after 4-weeks of treatment phase
次要结局
- Change in the proportion of patients that felt they had a good sleep experience.(after 4-weeks of treatment phase)
- Body weight gain.(after 4-weeks of treatment phase)
- Change in the mean number of nocturnal voids.(after 4-weeks of treatment phase)
- Change in the mean duration of the period from bedtime to the first nocturnal void.(after 4-weeks of treatment phase)