A Cross-Functional, Population-Representative, Web-Based, Epidemiologic Study to Estimate the Prevalence and Burden of Nocturia Due to Nocturnal Polyuria in the US

Completed

• Conditions: Nocturnal Polyuria

• Registration Number: NCT04125186
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-22
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-14
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10190

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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	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.
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	Between July 2019 and June 2020

Secondary Outcome Measures

Name	Time	Method
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
Prevalence of nocturia due to NP across the subgroups of respondents	Between July 2019 and June 2020	Before using 3-day bladder diary in main part, the responders of the baseline EpiNP survey were stratified by three subgroups: all respondents who report ≥2 voids/night, randomly selected cohort of respondents reporting 0 and 1 void/night. Prevalence will be calculated using number of participants with nocturia due to NP across the subgroups of respondents, in the numerator, with publicly-available estimates of the US population in the denominator.
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	Before using 3-day bladder diary in main part, the responders of the baseline EpiNP survey were stratified by three subgroups: all respondents who report ≥2 voids/night, randomly selected cohort of respondents reporting 0 and 1 void/night. The burden measures will be compared across the subgroups of respondents who self- report either 0 or 1 void/night with those reporting ≥2 voids/night.

Trial Locations

Locations (1)

Evidera Inc.; 🇺🇸 Seattle, Washington, United States