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

CompletedOBSERVATIONAL
Enrollment

10,190

Participants

Timeline

Start Date

July 22, 2019

Primary Completion Date

June 30, 2020

Study Completion Date

June 30, 2020

Conditions
Nocturnal Polyuria
Interventions
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

Trial Locations (1)

98101

Evidera Inc., Seattle

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY