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Completed

NCT Number: 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

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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Key information

Conditions

Nocturnal Polyuria

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evidera Inc.

Seattle, Washington, 98101, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline EpiNP survey

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

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).

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

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

Other

No other intervention

Primary outcomes

  1. Prevalence of nocturia due to NP, NP with overactive bladder (OAB), NP with benign prostatic hyperplasia (BPH), and NP with BPH/OAB

    Time frame: 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.

  2. 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

    Time frame: Between July 2019 and June 2020

  3. 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

    Time frame: 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.

Secondary outcomes

  1. Prevalence of nocturia due to NP across the subgroups of respondents

    Time frame: 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.

  2. To describe and compare demographic and clinical characteristics in participants with nocturia due to NP across the subgroups of respondents

    Time frame: Between July 2019 and June 2020

  3. To describe and compare burden of illness in participants with nocturia due to NP across the subgroups of respondents

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2019
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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