NCT04125186

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

Epidemiology and Burden of Nocturia Due to Nocturnal Polyuria in the United States: The EpiNP Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,190 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: —

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.

Conditions

• Nocturnal Polyuria

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Baseline EpiNP survey	The survey takes approximately 20 to 30 minutes to complete, and consists of the following: Short Form Health Survey version 2.0 (SF-12v2.0); Lower Urinary Tract Symptoms (LUTS) Tool; Patient Perception of Bladder Condition (PPBC); Self-report Medical History and Current Medication Form; Nocturia Impact Diary (NID); Disease-Specific Healthcare-Seeking Behavior and Treatment; Epworth Sleepiness Questionnaire (ESS); Patient Reported Outcome Measurement Information System Fatigue-Short Form version 1.0 (PROMIS F-SFv1.0); Patient Health Questionnaire (PHQ-8); Work Productivity and Activity Index (WPAI-SHP); Sexual health questions; lifestyle and sociodemographic questions; additionally, only men will complete the International Prostate Symptom Score (IPSS).
DIAGNOSTIC_TEST	Bladder diary	It consists of four components: measurement of waist and neck circumference, daily voiding diary (to assess voiding patterns, including frequency, volume, associated urgency, and incontinence episodes over a 24-hour period), NID (to assess nocturia impact), and assessment of morning sleepiness for 3 consecutive days and nights (including the morning of the fourth day).
DIAGNOSTIC_TEST	Testing of EpiNP baseline survey, bladder diary and a qualitative interview	This part briefly reviews the usability of the EpiNP survey and bladder diary. The feedback obtained after qualitative interview will be used to refine and finalize the instructions sent to the participants in the main part.
OTHER	No other intervention	No other intervention

Timeline

• Start date: 2019-07-22
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-10-14
• Last updated: 2023-03-13

Locations

1 site across 1 country: United States