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

Nocturnal Polyuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125186
• Other study ID #: EVA-21176
• Status: Completed
• Start date: July 22, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10190
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nocturia
• Nocturnal Polyuria
• Polyuria

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).
• 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).
• 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

Locations

Country	Name	City	State
United States	Evidera Inc.	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 Polyuri — View Citation

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. Ne — View Citation

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 Jan 28. doi: 10.1007/s00192-022-05432-x. Online — View Citation

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 Fo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Prevalence of nocturia due to NP across the subgroups of respondents	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
Secondary	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
Secondary	To describe and compare burden of illness in participants with nocturia due to NP across the subgroups of respondents	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