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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-22

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Nocturnal Polyuria

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pilot Part

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

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

Intervention Type DIAGNOSTIC_TEST

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.

No other intervention

Intervention Type OTHER

No other intervention

Main Part

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.

Baseline EpiNP survey

Intervention Type DIAGNOSTIC_TEST

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).

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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).

No other intervention

Intervention Type OTHER

No other intervention

Interventions

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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).

Intervention Type 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).

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

No other intervention

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No