Epidemiology and Burden of Nocturia Due to Nocturnal Polyuria in the United States: The EpiNP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,190
- 试验地点
- 1
- 主要终点
- To describe and compare demographic and clinical characteristics in participants with nocturia due to NP, NP with OAB, NP with BPH, and NP with BPH/OAB
研究概览
简要总结
To estimate the prevalence of nocturia due to nocturnal polyuria (NP) in the US and describe the demographic and clinical characteristics as well as the burden of illness in participants with nocturia due to NP.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 30 years of age;
- •Willing to provide informed consent;
- •Able to read US-English or Spanish
- •Able to use a computer and access the internet.
排除标准
- •Symptomatic acute urinary tract infection (UTI) (experiencing symptoms such as pain or burning when you urinate, strong and frequent urge to urinate, or cloudy, bloody, or strong-smelling urine);
- •Currently pregnant or ≤12 months postpartum;
- •Recent surgery in the last <6 months;
- •Current lifestyle that leads to irregular or atypical circadian patterns (e.g. employed in overnight shift work)
- •Prior YouGov survey participation in past two weeks
结局指标
主要结局
To describe and compare demographic and clinical characteristics in participants with nocturia due to NP, NP with OAB, NP with BPH, and NP with BPH/OAB
时间窗: Between July 2019 and June 2020
To describe and compare burden of illness in participants with nocturia due to NP, NP with OAB, NP with BPH, and NP with BPH/OAB
时间窗: Between July 2019 and June 2020
The burden measures (including health-related quality of life \[HRQL\], work productivity, fatigue, sleep, and depression as assessed through EpiNP survey and bladder diary) in participants with nocturia due to NP, NP with OAB, NP with BPH, and NP with BPH/OAB (overall and by relevant strata \[e.g., by age/race/gender categories\]) will be presented.
Prevalence of nocturia due to NP, NP with overactive bladder (OAB), NP with benign prostatic hyperplasia (BPH), and NP with BPH/OAB
时间窗: Between July 2019 and June 2020
Nocturia due to NP will be derived using data of participants who completed the 3-day bladder diaries. Nocturnal polyuria was defined when nocturnal urine production proportional to daytime urine production was greater than threshold 0.33 (Nocturnal Polyuria index \[NPi\]). Prevalence will be calculated using number of participants with nocturia due to NP, in the numerator (overall and by relevant strata \[e.g., by age/race/gender categories\]), with publicly-available estimates of the US population in the denominator (overall and for relevant strata). In addition, the prevalence of NP with OAB, NP with BPH, and NP with BPH/OAB will also be estimated.
次要结局
- Prevalence of nocturia due to NP across the subgroups of respondents(Between July 2019 and June 2020)
- To describe and compare demographic and clinical characteristics in participants with nocturia due to NP across the subgroups of respondents(Between July 2019 and June 2020)
- To describe and compare burden of illness in participants with nocturia due to NP across the subgroups of respondents(Between July 2019 and June 2020)