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

Ferring

Status: Completed

Conditions: Nocturnal Polyuria

Treatments: Diagnostic Test: Bladder diary; Diagnostic Test: Baseline EpiNP survey; Diagnostic Test: Testing of EpiNP baseline survey, bladder diary and a qualitative interview; Other: No other intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04125186

EVA-21176

Details and patient eligibility

About

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.

Enrollment: 10,190 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10,190 participants in 2 patient groups

Pilot Part

Description:

After providing consent, participants with nocturia will complete web-based baseline EpiNP survey followed by 3-day bladder diary and then a qualitative interview.

Treatment:

Other: No other intervention

Diagnostic Test: Testing of EpiNP baseline survey, bladder diary and a qualitative interview

Main Part

Description:

After providing consent, participants will complete web-based baseline EpiNP survey. All respondents who report greater than equal to (≥)2 voids/night, and a randomly selected cohort of respondents reporting 0 and 1 void/night will use the EpiNP 3-day web-based bladder diary.

Treatment:

Other: No other intervention

Diagnostic Test: Baseline EpiNP survey

Diagnostic Test: Bladder diary