Nocturnal Polyuria
Conditions
Keywords
Bladder diary
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.
Interventions
DIAGNOSTIC_TESTBaseline 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_TESTBladder 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).
DIAGNOSTIC_TESTTesting 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.
No other intervention
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of nocturia due to NP, NP with overactive bladder (OAB), NP with benign prostatic hyperplasia (BPH), and NP with BPH/OAB | 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. |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of nocturia due to NP across the subgroups of respondents | 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. |
| 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 | 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. |
Countries
United States
Outcome results
None listed