NCT04125186

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,190

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 13, 2023

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

October 10, 2019

Last Update Submit

March 10, 2023

Conditions

Nocturnal Polyuria

Keywords

Bladder diary

Outcome Measures

Primary Outcomes (3)

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

    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

    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

    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 Outcomes (3)

  • Prevalence of nocturia due to NP across the subgroups of respondents

    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

    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

    Between July 2019 and June 2020

Study Arms (2)

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 interviewOther: 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.

Diagnostic Test: Baseline EpiNP surveyDiagnostic Test: Bladder diaryOther: No other intervention

Interventions

Baseline EpiNP surveyDIAGNOSTIC_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).

Main Part
Bladder diaryDIAGNOSTIC_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).

Main Part
Testing of EpiNP baseline survey, bladder diary and a qualitative interviewDIAGNOSTIC_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.

Pilot Part
No other interventionOTHER

No other intervention

Main PartPilot Part

Eligibility Criteria

Age30 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidera Inc.

Seattle, Washington, 98101, United States

Location

Related Publications (4)

  • Weiss JP, Bosch JLHR, Chapple CR, Bacci ED, Simeone JC, Rosenberg MT, Mueller ER, Andersson FL, Juul K, Chughtai B, Coyne KS. The Prevalence of Nocturnal Polyuria in the United States: Results from the Epidemiology of Nocturnal Polyuria Study. Eur Urol Focus. 2022 Sep;8(5):1415-1423. doi: 10.1016/j.euf.2021.12.016. Epub 2022 Jan 14.

    PMID: 35039242RESULT

  • Bosch JLHR, Chapple CR, Mueller ER, Rosenberg MT, Chughtai B, Juul K, Coyne KS, Andersson FL, Bacci ED, Simeone JC, Weiss JP. Differences in the Prevalence of Nocturnal Polyuria in the U.S. by Definition: Results from the Epidemiology of Nocturnal Polyuria Study. J Urol. 2022 Jul;208(1):144-154. doi: 10.1097/JU.0000000000002500. Epub 2022 Apr 21.

    PMID: 35446110RESULT

  • Chapple CR, Rosenberg MT, Mueller ER, Chughtai B, Weiss JP, Juul K, Brooks AB, Bacci ED, Andersson FL, Coyne KS, Bosch JR. The patient burden of nocturnal polyuria in the United States: Results from the epidemiology of nocturnal polyuria (EpiNP) study. Neurourol Urodyn. 2023 Mar;42(3):573-585. doi: 10.1002/nau.25126. Epub 2023 Jan 19.

    PMID: 36655731RESULT

  • Mueller ER, Weiss JP, Bosch JLHR, Chughtai B, Rosenberg MT, Bacci ED, Simeone JC, Andersson FL, Juul K, Coyne KS, Chapple CR. Nocturnal polyuria in women: results from the EpiNP study. Int Urogynecol J. 2023 Aug;34(8):1743-1751. doi: 10.1007/s00192-022-05432-x. Epub 2023 Jan 28.

    PMID: 36708403RESULT

Study Officials

  • Global Clinical Compliance

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

July 22, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

March 13, 2023

Record last verified: 2020-08

Locations

US(1)