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

March 10, 2023 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Evidera INC.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be conducted in two parts: (1) Pilot part: approximately 30 participants who have a physician diagnosis of nocturia. Participants will be recruited by one clinical site in the US. (2) Main part: a sample of 10,000 participants who are representative of the general population in the US stratified by age (≥30), gender, and race. Participants will be recruited by e-mail from a web-based panel of people that have previously opted in to be contacted for research studies.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.
Other: No other intervention
No other intervention
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Between July 2019 and June 2020
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
Between July 2019 and June 2020
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.
Between July 2019 and June 2020

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Between July 2019 and June 2020
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
Between July 2019 and June 2020
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.
Between July 2019 and June 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EVA-21176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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