Clinical trial 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
Official title: Epidemiology and Burden of Nocturia Due to Nocturnal Polyuria in the United States: The EpiNP Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturnal Polyuria
Keywords: Bladder diary
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-10-14
Enrollment: 10190
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of nocturia due to NP, NP with overactive bladder (OAB), NP with benign prostatic hyperplasia (BPH), and NP with BPH/OAB
timeFrame: Between July 2019 and June 2020
measure: 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
timeFrame: Between July 2019 and June 2020
measure: 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
timeFrame: Between July 2019 and June 2020
Secondary outcomes:
measure: Prevalence of nocturia due to NP across the subgroups of respondents
timeFrame: Between July 2019 and June 2020
measure: To describe and compare demographic and clinical characteristics in participants with nocturia due to NP across the subgroups of respondents
timeFrame: Between July 2019 and June 2020
measure: To describe and compare burden of illness in participants with nocturia due to NP across the subgroups of respondents
timeFrame: Between July 2019 and June 2020
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Evidera Inc.
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
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 Focus. 2022 Sep;8(5):1415-1423. doi: 10.1016/j.euf.2021.12.016. Epub 2022 Jan 14.
citation: 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.
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. Neurourol Urodyn. 2023 Mar;42(3):573-585. doi: 10.1002/nau.25126. Epub 2023 Jan 19.
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 Aug;34(8):1743-1751. doi: 10.1007/s00192-022-05432-x. Epub 2023 Jan 28.